Effective Implementation of Quality Management Systems (Woodhead Publishing India) [1st ed.] 0857090011, 9780857090010, 9789380308036

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Effective implementation of quality management systems

Effective implementation of quality management systems

B. Purushothama

WOODHEAD PUBLISHING INDIA PVT LTD New Delhi

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Cambridge

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Oxford

Published by Woodhead Publishing India Pvt. Ltd. Woodhead Publishing India Pvt. Ltd., G-2, Vardaan House, 7/28, Ansari Road Daryaganj, New Delhi – 110002, India www.woodheadpublishingindia.com Woodhead Publishing Limited, Abington Hall, Granta Park, Great Abington Cambridge CB21 6AH, UK www.woodheadpublishing.com First published 2010, Woodhead Publishing India Pvt. Ltd. © Woodhead Publishing India Pvt. Ltd., 2010 This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission. Reasonable efforts have been made to publish reliable data and information, but the authors and the publishers cannot assume responsibility for the validity of all materials. Neither the authors nor the publishers, nor anyone else associated with this publication, shall be liable for any loss, damage or liability directly or indirectly caused or alleged to be caused by this book. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming and recording, or by any information storage or retrieval system, without permission in writing from Woodhead Publishing India Pvt. Ltd. The consent of Woodhead Publishing India Pvt. Ltd. does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from Woodhead Publishing India Pvt. Ltd. for such copying. Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. Woodhead Publishing India Pvt. Ltd. ISBN 13: 978-93-80308-03-6 Woodhead Publishing India Pvt. Ltd. EAN: 9789380308036 Woodhead Publishing Ltd. ISBN 10: 978-0-85709-001-0 Typeset by Sunshine Graphics, New Delhi Printed and bound by Sanat Printers, New Delhi

Contents

Preface

vii

1.

Sustaining business

1.1 1.2 1.3 1.4 1.5 1.6 1.7

Introduction Recession Business sustainability Evolution of QMS Definition of quality Imperatives of quality Quality from a larger perspective

2.

Understanding and implementation of ISO 9001:2008

14

2.1 2.2 2.3 2.4 2.5

Introduction Fifty Steps for implementation Undergo audits Post-certification audits Points to remember

14 17 46 47 48

3.

Roles and responsibilities of management representative

49

3.1 3.2 3.3

Who should be the management representative? Jobs expected from management representative Tips for management representative

49 51 55

4.

Internal quality audits: A strong tool for quality management

56

Need for audits Internal quality audits Quality control versus quality audits Product audit versus system audit Top management review versus quality audits

56 58 58 60 60

4.1 4.2 4.3 4.4 4.5

1 1 2 4 4 6 8 11

vi

Contents

4.6 4.7 4.8 4.9 4.10 4.11 4.12

Types of internal quality audits Pre-requirements of an auditor What is to be verified? Can we discontinue quality control investigation? Process audits Imperatives of effective audit Linking exercises – a strong tool for quality auditing

61 62 64 79 80 83 85

5.

Measuring maturity in QMS implementation

95

5.1 5.2 5.3 5.4

Need for measurement Measuring maturity by linking to the principles Measuring maturity by considering the clauses Guidelines for assessing maturity in QMS implementation

95 96 97 98

6.

Welcome the complaints

6.1 6.2 6.3 6.4

Who is interested in complaining? When customer complains? When customer does not complain? Customer – a free consultant

7.

Face the audits

7.1 7.2 7.3 7.4 7.5 7.6 7.7

Why to face audits? Basic human nature What shall be audited? Preparing for the audit Face the audits Role of a guide Understand the non-conformities and observations

133 133 134 135 136

138 138 140 140 141 142 143 143

Appendix – 1: Departmental objectives and expectations

146

References

157

Index

158

Preface

To survive on this earth, it is necessary to keep ourselves fit. It might be an individual or an organization. One need to follow certain disciplines to keep his body fit; similarly, an organization also has to follow certain basic disciplines. The concepts of ISO 9001 give guidelines for helping an organization to remain fit all the time. What is needed is to implement it whole heartedly. Remember, one has to do his exercises and follow the diet to remain fit. This cannot be delegated to others. It is unfortunate that the need for implementation of ISO 9001 was understood in a wrong way by majority of the people, and they consider it as a mere certification process to get entry to world markets. The concentration is on getting the certificate. The organizations somehow manage to convince the certifying body and get certificate with out even understanding the basic concepts. As the number of ISO 9001 certified organizations are increasing, the respect for the systems is coming down. When all are ISO 9001, there is no value for the same. There is a need to measure the level of implementation or the maturity of implementation. In my experience of implementing ISO 9001 for last 18 years, I have seen different types of managements and the people. There are very few, who have understood the real essence of the systems and implementing them by heart. They are building a good foundation for their organization to remain stable for long. However, majority of the companies I visited are concentrating mainly on getting the certificate, somehow manage the audits and keep auditors happy. The managements are not taking interest and getting themselves involved in the internal quality audits. They blame that ISO is increasing their work, adding the paper work and bureaucracy and not helping improvement. People quote different quality systems like 6 Sigma, Kaizen, Quality Circles etc., but do not understand that no system can remain or give results unless one has the basic discipline of planning and establishing the systems, implementing them through out the organization, monitoring and measuring the performance, correct the

viii

Preface

deviations and take preventive actions with the involvement of people and a committed management. The real implementation actually reduces the work, as you will be auditing, identifying the non-conformities and taking corrective and preventive actions, and go on improving your systems on a continual basis. As the activities are customer-focused, the sale is guaranteed. In this book, I have tried to explain the real need for implementing the systems, the steps in implanting, the roles and responsibilities of management representative, making effective internal quality audits by linking exercises, assessing the level of implementation of ISO 9001, inviting complaints and treating customer as a free consultant, and freely facing the audits. I hope this book will drive out some of the misconcepts and help the organizations to become strong and competitive. B. Purushothama

Sustaining business

1 Sustaining business

.

Introduction

In earlier days, normally, the trade was a family business. People used to stick to their family trade, irrespective of the profitability. They were respecting what their ancestors did. A carpenter’s son used to become a carpenter and a soldier’s son used to become a soldier. The community was recognised by the trade they did, and it was even used as surname. People were not entering in the trade of others, and an act of doing other’s trade was even punishable. There was no competition as the productions were less and the demand was certain. The increase in demands and the desire to earn more and more led to development of technology and ultimately to the industrial revolution. Gradually as the concepts of management was developed, the concepts of high speed production to reduce the cost of manufacturing pierced in the minds of the industrialists and technicians. Organized industries started replacing the earlier cottage industries or craftsmen business. The earlier craftsmen were compelled to join the organized industries as labourers as they were not able to compete with the industry by their craftsman skills. Rapid technological developments and system developments were seen in 20th century as a by-product of the world wars. There were social reforms also, and the barriers for others in the trade that was being managed by particular family or community no longer exist. Now a son of a farmer can become a doctor, and a teacher’s son can become an agriculturist. The education is open to all and anyone can enter the business. The labourer’s children no longer wish to work as a labourer as the earnings are much less compared to other trades. It is now very difficult to get servants to do petty jobs, where as earlier that was the main job of illiterate poor people. Now people are able to make their own assessment and try to enter into that trade where the earnings are more. A number of new industries are being started because of the financial supports given by governments and public. This very act led to the competition between units of the same industry and also between industries.

1

2

Effective implementation of quality management systems

The recent developments of free trade and globalization opened the markets that lead to the competition between countries. In earlier days, the trade was restricted within certain regions. The local manufacturers were protected by banning imports and the traders were able to sustain their business depending on the countries and their policies. To protect themselves, regional trade associations were started and certain trade barriers were put to prevent others entering in their segment. The 21st century started with fierce competition and a number of organizations boasting to be world leaders started collapsing, as they could not beat the competition. The world is changing very fast. The thinking, ideologies, and the expectations are all changing. We can see rising expectations worldwide and open-market economies are forcing people to compete with each other, more often on the basis of quality. It holds good for all, even to industry and business, and all have a number of players.

1.2

Recession

As the technology progressed, the speeds of production increased. The latest high speed machines can produce more than 3–4 times compared to the machines that were running two decades back. Further, the developments in engineering aspects assured good quality product even at the high speed. Therefore, the industries preferred replacing their old machines with latest state of the art machines to get higher production and better quality. Along with the growth of technology, the cost of living also started increasing. People demanded higher and higher remunerations as the speed of production increased. As people preferred to work where salaries are high, a scarcity was developed for skilled human workers, those could work at a lower wage. The latest technologies, therefore, concentrated on reducing the human dependency in the activities by automating wherever possible. The term ‘rationalization of employment’ came to restrict the component of employee cost in the total cost of manufacture. Voluntary retirement scheme (VRS) was introduced in the industries as well as service organizations including government establishments to reduce the number of employees. As the technology was developed, old machinery was removed and new high speed machines were put. The skilled people in a number of industries opted for VRS and started their own small units by purchasing the old machines on which they were working earlier as an employee. The governments supported small scale industries by giving them tax benefits and soft loans. These small industries became competitors for large industries because of the cheapness of their products. Also, the eruption

Sustaining business

3

of small industries added to total products available in the market, and the supply exceeded the demands. Adapting high speed machines and increasing productions were preached as an easy way of reducing the contribution of overheads per unit production and increasing profitability by the costing and management experts. The calculations were simple. The manufacturing industries started expanding and increasing their productions in volumes to reduce the cost of manufacture of unit piece. They were able to achieve this, but unfortunately were not able to sell their products, as the total demands remained same or started reducing because of the improved quality products that were durable. It is observed that the recession is a cyclic phenomenon. It is repeating every 10–12 years. As the technology developed, new machineries are installed and the production is increased. This led to competition and surplus material in the market leading to recession. The weak performers have to shut their operations, and even the good performers make loss during the recessions and reduce their productions. After some time, reduction in production leads to short of materials and the demand starts. This is called as a boom period. Recession is cyclic so also the boom period. When the boom period comes, everyone invests and expands, leading to recession again (Fig 1.1). Companies with good forward thinking does not simply expand, but also try to bring innovative products to the markets and will always be first to introduce new products and capture the market.

Performance

Boom period

Time years

Recession Recessi

1.1 Cycle of recession.

The recession affects the organizations and the economy as a whole. The planned projects cannot take off and people lose confidence among themselves. Numbers of hasty decisions are taken during recession leading to further worsening of the situation.

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Effective implementation of quality management systems

1.3

Business sustainability

One cannot keep quite just because recession is cyclic. The recession is cyclic only for those who survive in a recession. One should have strategies and action plans to face the recession and survive. Any organization should first sustain before thinking of anything. Sustained success is more important than making profit in some years and expanding, and making losses later and retrenching the people. A long-term approach is essential for sustaining the business. Dr. Ali AL-Zubaidi (1) explains sustained success as a result of the ability of an organization to achieve and maintain its objectives in the long term under dynamic organization’s environment. He explains organization’s environment as a combination of internal and external factors and conditions that can affect the achievement of an organization’s objectives, and its behaviour towards its interested parties. Everyone wants to be a winner as only a winner can survive (2). The technology and systems adopted have a wide variation from man to man, organization to organization and depends much on the culture developed over a period of time, the community and the economic systems. There is nothing like monopoly in any field and the competition is very high. Patenting, to some extent, protects the inventors of technology, but no one can prevent copying and adopting of good and effective systems developed elsewhere. Surviving has become difficult if one is not competitive. Everyone tries to adopt a system best suited for his environment, so as to achieve the best possible results, which is often called as Management System. The systems designed are trying to address the activities needed to achieve the required results right at the first time, with least expense. One who implements and succeeds in sustaining the benefits of the strategic decisions taken is called a good manager or a winner, and the organization becomes a winning organization.

1.4

Evolution of QMS

The Quality Management Systems (QMS) was developed in response to the challenges of increasing market globalization (3). The concepts of ISO 9000 series of standards are widely accepted world over as the basic guidelines for implementing a system that can help the organization to sustain in the changing environment. These standards are viewed as powerful tools for effective management not only for products and services, but also for business operations irrespective of their sector. The present concepts of documented quality management system was developed during the second world war and were maintained as military secret till 1976, when British Standard Institute came out with BS 5750. The same was adopted in total as ISO 9000 standards in 1987 by ISO, the

Sustaining business

5

International Organization for Standardization at Geneva. These standards went through amendments in 1994, 2000 and 2008. The guidelines given by ISO are the minimum requirements for implementation of a quality management system and it is expected for the organizations to move further by keeping this as a base. A number of quality management systems were developed by different trade groups, corporate offices, consultants, state award committees, etc., all with a view to help the industry sustain in the changing scenario. However, the base of ISO 9000 holds good for all the quality management systems. The International Organization for Standardization (ISO) defines quality management system as: The organisational structure, responsibilities, procedures, processes and resources for implementing quality management. – ISO 8042 (ISO, 1986) The QMS provides a structure to ensure that process is carried out in formal and systematic way (7). The ISO 9001:2000 guidelines insists that implementing a quality management system within an organization needs to be a decision by top management. (8) Pradeep Kumar Mathur (4) defines the term ‘quality management system’ as “The process of management of the systems of an organization, with regard to its quality related activities, for ‘meeting and enhancing customer satisfaction’ and also taking care of all other interested parties such as legislative and regulatory bodies, shareholders, suppliers, employees, etc”. Navin Shamji Dedhia (5) defines Quality Systems as a series of functions or activities (sub processes, stages, etc.) within an organization that work together for the aim of the organization. It comprises the processes in an organization intended to yield consistency or improvement to the enterprise of the corporation. The definition for quality systems by the author in his book Guidelines for Process Management in Textiles (6) was ‘An un-interrupted follow up of procedures for doing a work, which are written after judicious studies in order to achieve the best possible results’ and ‘A system designed to achieve reliability and performance is quality system’. The Engineers International (9) observes that the design and implementation of a quality management system vary depending on the type, size and products of the organization. Each company will have its own objective; however, most company’s objective is to increase profitability. A quality management system will assist by managing costs and risks, increasing effectiveness and productivity, identifying improvement opportunities and increasing customer satisfaction. A wellmanaged quality system will have an impact on customer loyalty and repeat business, market share, operational efficiencies, flexibility and ability to respond to market opportunities, effective and efficient use of resources,

6

Effective implementation of quality management systems

cost reductions, competitive advantages, participation and motivation of human resources, industry reputation and control on all processes. From all the above definitions we can understand that strategically planned and well-designed quality management systems enable us in achieving our company objectives, which is mainly to help sustenance by achieving customer and stakeholder satisfaction while maintaining the operations rationally and economically.

1.5

Definition of quality

Quality is defined by number of people in different ways (10). Joseph Juran and Frank Gryna define Quality as “Fitness for use”. The ISO 9000 defines it as ‘The totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs’. Armand Feigenbaum explains Quality as “A customer determination based upon a customer’s actual experience with a product or service, measured against his or her requirements – stated or unstated, conscious or merely sensed, technically operational or entirely subjective and always representing a moving target in a competitive market”. American Society for Quality (ASQ) opines that quality denotes an excellence in goods and services, especially to the degree they conform to requirements and satisfy customers. Peter Senge et al, in their book The Fifth Discipline Field Book, explains “Quality is a transformation in the way we think and work together, in what we value and reward, and in the way we measure success. All of us collaborate to design and operate a seamless value-adding system that incorporates quality control, customer service, process improvement, supplier relationships, and good relations with the communities we serve and in which we operate – all optimizing for a common purpose”. Dave’s definition is “Quality is a really, really boring definition that has no real meaning to most humans on this planet unless you are a millionaire consultant writing a new book or a quality coordinator applying for some ‘Quality’ award or certification so you can quit and become a millionaire consultant who writes books and produces infomercials from his private island in the Caribbean”. The definitions given by most are centred on meeting customer requirements effectively. It includes providing right quality goods and services at the affordable prices and at the committed time. Let us discuss on this in detail. Dreaded smuggler late Veerappan was cutting sandal wood trees and smuggling out of the forests in southern Karnataka and Tamil Nadu. He was also killing wild tuskers for the ivory. Why he was cutting sandal wood only and not other trees? His customers demanded sandal wood, so he was cutting sandal wood. Why he was killing elephants? He had to kill them because elephants were not giving ivory if he asked. The elephants

Sustaining business

7

were wild and they could have killed him if he tried to take ivory without killing them. He stayed in the forests where there were no houses, no luxury, no facilities and no protection. He had to spend day and night in forests along with wild animals. The police were after him, so he had to fight with them and kill the police. He had very good communication systems in those forest areas that never used mobile phones or satellite services. He was able to get the information about the movement of police precisely, where as police were finding very difficult to access he area in spite of having electronic gadgets, mobile phones, wireless, etc. From the point of definitions discussed above, i.e. fitness for purpose, working for customer satisfactions, totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs of a customer, etc., we must honour him as the ‘Best Quality Person’. We are not ready to sacrifice our life or family for the sake of customers, but Veerappan did it. Why are we not recognizing such quality persons and rewarding them? Take the examples of terrorists. They plan well and attack. They do their work right at first time for the sake of their customers, who are looking after their families and community. Can we call them as quality persons? Certainly we do not accept smugglers, poachers, thieves, robbers, terrorists as quality people. Then what is missing in the definition of ‘Quality’? Take some more examples. A garment company is producing good quality garments at a very low price and their customers are very happy. The deliveries are given in time as agreed in the contracts. They boast themselves as having the lowest lead time. To achieve this, the employees, who come from poor families, toil in a bad working condition. They are paid less and kept almost as ‘bonded labour’ much away from their families. The supervisors and workers work extra hours without getting the overtime wages as per the rules. The ladies are not looked after well. No facility of crèche is provided for the babies. The company makes profit, and world’s best brands get their garments stitched from them. The buyer’s agents who come for doing compliance audit give a clean chit to that factory, because, if they disqualify that factory, then they need to pay more and purchase from others. They shall become uncompetitive. The certifying bodies also give certificates of ISO 9001, SA 8000, etc, as their business depends on giving more certificates to the organizations. If they do not give certificate, they will loose the business and some one will give the certificate. Can you call that company as a good ‘Quality Company’? They are meeting the requirements of their customers. The actions taken by the management are fit for the purpose, i.e. providing the quality goods to the customers at lowest possible price and at lowest lead time. It meets the definition given by Armand

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Effective implementation of quality management systems

Feigenbaum that ‘Quality as a customer determination based upon a customer’s actual experience with a product or service, measured against his or her requirements – stated or unstated, conscious or merely sensed, technically operational or entirely subjective and always representing a moving target in a competitive market’. Another profit-making company was producing good quality and meeting the complete requirements of customers, but ● ● ● ●

● ●

●

The company is polluting the environment. Employees are harassed. Suppliers are not paid in time. Taxes are not paid to government as should have been paid by making some intelligent manipulations. Roads are frequently blocked because of the parking of heavy trucks. Roads are frequently getting spoiled because of the movement of heavy vehicles. Strikes and agitations disturbing the normal life of public.

Can we call this as a quality company? The definition of quality has gone much beyond the product requirements to the customer requirements and the International Quality Standards cover a bigger sphere. The quality does not restrict itself to fulfilling the customer requirements, but it should also consider the ethical and society needs and regulatory requirements. Understanding society needs and requirements and developing the systems and strategies to help community is essentially a part of quality. Any act that does not address human values is not a quality. The quality can thus be defined as “Achieving the customer and stakeholder satisfactions while adhering to business ethics, human values and the statutory, legal and regulatory requirements”.

1.6

Imperatives of quality

The quality should consider the following requirements: ●

●

Customer – Product features and tolerances, the delivery in time, reasonable price and quick and prompt service. The technology and systems adopted should be appropriate to the quality requirements. The training should be adequate for the people to produce the quality. The plant should have the capacity to produce the required quantity to deliver in time, and the management should have planned the resources and provided them in time to help delivering the goods in time. International standards – Measuring systems adapted should be inline with internationally recognized systems. Similarly, the labelling and

Sustaining business

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9

marking should meet the statutory and regulatory requirements. They should not mislead or confuse the customers and ultimate users. They should be user friendly. Regulatory requirements – Safety of product as well as users is the main concern of any regulation. The general interests of the community and environment are taken into consideration while developing the regulatory standards. It is essential for any organization to adhere to legal, statutory and regulatory requirements. Ethical requirements – The ethical requirements consider human values, business ethics and social obligations. One can make a shortterm profit by not adhering to ethics, but the affected people shall be waiting for an opportunity to over throw such establishments. Supplier – Timely payment for the materials supplied is the main expectation of suppliers. Suppliers cannot survive if their payments are not made in time, and hence the organization cannot expect the quality products and services from them. It affects the performance in terms of quality and productivity. Employees – Employees are the backbone of any organization. Unless the employees are involved in the activities by heart, it is not possible to get the required performance in terms of quality, productivity, cost, customer satisfaction, reputation, etc. Remunerations for the work and security of job and self are the main requirements of the employees, and it is the duty of the management to provide this. The scope to grow, the social security and the welfare activities are the secondary requirements. They are also very important. Community – The community supports an industry as it gives employment to the people either directly or indirectly. The community around us has to survive if our organization wants to survive. Providing a pollution free environment is one of the prime responsibilities of any organization. Legal and regulatory requirements should consider ■ No violation of the law of the land like minimum wages, working hours, overtime, minimum age for employment, providing crèche facilities where women employees are working, safety regulations, bonus, PF and other welfare measures. ■ When the activities are outsourced, it is the responsibility of the organization to ensure that the people are paid the minimum wages as per the Act, and the number of hours worked does no exceed the limits for both regular working and for overtime. ■ The employees need to be insured for their safety and health. ■ All safety aspects are to be maintained as per the law of the country

10

Effective implementation of quality management systems

The training of the employees is the responsibility of the organization, as they are committing the quality to the customers. ■ Regulatory requirements relating to product safety and the safety of the consumer include number of factors, for e.g., in a garment industry. ■ Use of metal free buttons and other accessories in garments. ■ Avoiding carcinogenic azonic dyes. ■ Preventing metal pieces like broken needle parts and staple pins in the garments. ■ The washing instructions are to be given with the internationally accepted symbols. The product safety requirements depend on the nature of the product, the culture and the conditions in which the users live and use the products. It depends upon the basic objective of the product. General regulatory requirements consider ■ The quantity despatched should match exactly the invoice and the delivery challan. ■ The product features mentioned should match the actual product features. ■ The packages should have the details of manufacturer, the period of manufacture and the country of manufacture. ■ Specifying expiry date is very essential for perishable products. ■ Specifying maximum retail price (MRP) is essential for commodity products. Business ethics include ■ The product shown in the catalogue to match with the final material delivered. ■ Performance according to the promises given to the buyer, either personally or as claimed in the advertisements. ■ The product quality to match the samples shown while taking orders. ■ Proper documentation as agreed during negotiations. ■ High quality label and instructions clearly describing the products and explaining their method of use and the precautions to be taken. ■ Timely delivery of material is as important as its quality and price. ■ Making in-time payment to suppliers, contractors, service provides and the government. Trade regulations’ requirements ■ Apart from the International Standards, it is necessary to refer ■

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Sustaining business

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1.7

11

to the trade practices and the regulations prevailing in the country to which the exports are made. ■ It might include the ban on certain chemicals, packing materials, packing systems, permissible limits for the traces of heavy metals, pesticides, etc., depending on the product and the end use. Societal safety factors emphasize that ■ Products do not create problem to the user because of its constituents and finishes. ■ No loss is made to society or environment because of the processes. ■ The industry should follow ethical standards and consider the community requirements. ■ There should not be any disturbance to the community, like the noise disturbing the sleep of people, frequent traffic jams because of the movement or parking of heavy and long trucks in narrow lanes adjacent to the factory, frequent strikes and lockouts because of unhealthy industrial relation approaches, etc.

Quality from a larger perspective

The discussions made above indicate that the quality is not a simple word, but has a large perspective. ■

■

■

■

■

The quality not only addresses the basic product requirements, but also other requirements of customers as well as of society. We need to work towards achieving both in order to survive in the competitive international market. We need to have appropriate procedures to address the requirements, implement the systems, verify the results and compare with the competitors and reengineer the systems to achieve improved results. Adherence to quality systems and ethics should be developed as a culture, and not for getting certified by third party. The certificates might give a confidence for new customers for entering into business with a supplier, but the actual quality and services, the ethics in dealing and the transparency are the real factors considered by the customers to stay in business.

The basic need is to adhere to ‘Agreed Quality Standards’. Quality standards must be recognized and agreed by all levels of management. In the absence of such agreement the operative does not know what is expected of him or her, becomes frustrated, and leaves, with the ensuing needlessly high labour-turnover and training costs of new labour. The next step is to identify the unspecified needs of the customers and address them. The unspecified needs are very important, as they are the deciding factors for continuation of a business.

12

Effective implementation of quality management systems Customer Requirements

Specified

Expectations are clear. Suppliers are clear. Customers are clear. Process is designed and monitored.

Unspecified

Customer has no time to sit and list out all requirements. Customer feels the requirement when a problem arises. Customer feels the requirement when some one else has got it. Customer knows the needs but does not effectively express. Customer expects the supplier to know.

1.2 Customer requirements.

Once the needs are clear, then we can design the processes to ensure that the quality is achieved. How quality is ensured? ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■

■

By devising correct work methods, Providing correct materials in time, Engaging competent personnel and training them adequately, Proactively inspecting the machines and maintaining them properly, Checking the material in process and the process itself, Reviewing the systems periodically for their continued suitability, By inspecting the material produced, Checking the documents produced, Getting the services of an external inspection agency, Rejecting the nonconforming materials, Visiting customer place to study the working of our materials and taking corrective actions and Getting customer feedback and taking measures to correct the situation.

All the points above can be implemented by taking guidance of International Standards of ISO 9000. One can take more benefits by adapting the guidelines given in these standards in the daily affairs rather than concentrating only on getting a certificate. Please remember that a certificate can impress a customer before starting the real business. Once the business is started, it is the consistency in the quality of products and services, the prompt and ethical dealings and your proactive efforts to address the concerns of the customers help in keeping the business continuous. Therefore, for surviving in the business, a whole-hearted implementation of quality management systems is very important rather than getting a certificate.

Sustaining business

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Getting certified for ISO 9001 is not the end, but it is the starting point. It gives confidence to the customers that you are on the right track. Unless you move, you cannot reach the destination. ISO 9001 explains the minimum requirements that are given as guidelines for us to design a quality management system and it is not the end. We need to improve our systems on a continuous basis taking the help of guidelines given in the standards. Goal Organization

ISO 9000

1.3 ISO 9000 does not allow the organization to slip.

The true implementation of ISO 9000 guidelines does not allow your company to slip down from what you have already achieved. It shall prevent you from making mistakes as you shall be following a procedure designed by you to achieve the results expected by you and you are continuously monitoring whether you are adhering to your systems and are taking suitable corrective and preventive actions in time or not. If you are not adhering to the requirements of the systems and just boast of having a certificate, you shall be hanged by your customers similar to as you are hanging your certificate.

IS O 900 1C ertifica te x xx

If you r ISO certifica te is m ea nt o nly for ha ng in g in yo ur o ffice, y ou r o rgan izatio n w ill be ha ng ed by y ou r cu sto m ers

14

Understanding and implementation ISO 9001:2008 Effective implementation of quality of management systems

2 Understanding and implementation of ISO 9001:2008

.1

Introduction

ISO 9000 series of standards, popularly known, as ‘Documented Quality Management Systems’ were amended and new guidelines for implementation of Quality Management Systems were released in November 2008, with slight changes from ISO 9001:2000. All the certified companies and the companies to be certified a fresh, need to adopt the amended guidelines. Let us discuss the steps involved in implementing the new system. The standards have 8 clauses as follows: 1. 2. 3. 4. 5. 6. 7. 8.

Scope Normative reference Terms and definitions Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement.

The scope of the standard specifies the requirements of quality management systems, where an organization needs to demonstrate its ability to consistently provide the product and services that meets the customers and applicable statutory, legal and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system. This includes processes for continual improvement and assurance of conformity to customer and applicable regulatory requirements. When we talk of the scope of the application for ISO 9000, we talk about the sections of the organization, which shall be offering them for third party audits to get themselves certified. When we write the Quality Manual, it is essential to specify the scope of the application, and also mention if any sub-clauses from Clause No. 7 are not applicable to us. This shall depend on the nature of activity. For e.g., Clause No. 7.5.4 viz. Customer Property might not be applicable to a factory or organization where they are not doing any job work, nor getting any materials from the

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Understanding and implementation of ISO 9001:2008

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customers to be incorporated in the final product. One needs to really see in detail to decide on the clause that could be excluded, as the exclusion of the clause should not come in the way of meeting customer requirements and also applicable statutory, legal and regulatory requirements. The clause on normative references specifies that the organization should refer the latest version of applicable procedures, standards and norms. There are standards developed by ISO for writing quality manual, vendor rating systems, preparing quality plans, project management, configuration management, auditing, quality assurance for measuring equipments, managing the economics of the quality, guidelines for performance improvements, training, application of statistical techniques, etc. We need to work out as to which standard is applicable to us, and adopt it so as to get the benefits of the systems. It is advisable to have continuous touch with the national body for standards, and get the information on the amendments in standards from time to time. In India, Bureau of Indian Standards provides the information on the changes in standards through their periodicals. Following are the standards referred in ISO 9001:2008: 1. ISO 9004 – Managing for the sustained success of an organization – A quality management approach. 2. ISO 10001 – Quality Management – Customer Satisfaction – Guidelines for codes of conduct for organizations. 3. ISO 10002 – Quality Management – Customer Satisfaction – Guidelines for complaint handling in organizations. 4. ISO 10003 – Quality Management – Customer Satisfaction – Guidelines for dispute resolution external to organizations. 5. ISO 10005 – Quality Management Systems – Guidelines for quality plans. 6. ISO 10006 – Quality Management Systems – Guidelines for quality management in projects. 7. ISO 10007 – Quality Management Systems – Guidelines for configuration management. 8. ISO 10012 – Measurement Management Systems – Requirements for measurement processes and measuring equipments. 9. ISO 10013 – Guidelines for quality management system documentation. 10. ISO 10014 – Quality Management – Guidelines for realizing financial and economic benefits. 11. ISO 10015 – Guidelines for training. 12. ISO 10017 – Guidelines for statistical techniques. 13. ISO 10019 – Guidelines for selection of quality management system consultants and use of their services.

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14. ISO 14001 – Environmental management Systems – Requirements with guidance for use. 15. ISO 19011 – Guidelines for quality and/or environmental management systems auditing. 16. IEC 60300-1, Dependability management – Part I, Dependability management systems. 17. IEC 61160 – Design review. 18. ISO/IEC 90003 – Software engineering – Guidelines for the application of ISO 9001 to computer software. The purpose of the Clause 3, i.e. the Terms and Definitions, is to give clarity about the terms used in the documents as well as in our daily communications. We can see that in normal life we use some abbreviations but with different meanings at different places leading to confusion. For e.g., TV is refereed as television, transfer voucher, tere-viscose, etc. The abbreviation MIS is used for management information systems, material issue slip, monthly income statement, materials in stock, etc. The term ‘AGM’ is referred for additional general manager, assistant general manager and also for annual general body meeting. Some times we see same activity or material is referred by different names or abbreviations. For example GRN (Goods Receipt Note) and GIN (Goods Inward Note) for the materials received at stores. CEO (Chief Executive Officer), COO (Chief of Operations), Executive Director, VP (Vice President) Operations, Sr. Vice President Operations, GM (General Manager) Operations, etc., are the different nomenclature for the simple term ‘Head of the Unit’. These different nomenclatures are developed for satisfying the ego of certain people, but can lead to confusion for the people in understanding their roles and responsibilities. One word should have only one meaning, so that there can be no confusion. To avoid confusions, ISO 9000:2005 was prepared as a guideline for vocabulary, by which every one in the organization, and also the auditors use the same terms and avoid confusion in understanding. It is suggested for the organizations to make a list of all abbreviations used in their organization and attach as an appendix to quality manual and the procedure documents. More than documenting, it is important to ensure that everyone uses the same nomenclatures and abbreviations all the time. As far as possible, avoid the abbreviations. The practical implementation in an organization starts from Clause 4, which says that the organization shall establish, document, implement and maintain a quality management system and continuously improve its effectiveness. This starts with the identification of various processes, determination of the sequence and interaction of the processes, determining the criteria and methods needed to ensure the operation and control of the processes, ensuring the availability of resources and necessary information,

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monitoring, measuring and analysis of the processes and implementing necessary actions to achieve the planned results and to improve. However to this activity, we need first to decide on the purpose for which we are running our organization, and align all our activities to achieve our company objectives. Again, each of the procedure developed should be clear about the purpose for which that procedure was developed. We need to have a mechanism to verify its effective implementation as without such verification implementation cannot be effective. The Clause No. 4 to 8 should be seen as one and not as separate, as these are interconnected. We need to interpret the guidelines given and decide the step-by-step implementation. The following 50 points are just an effort to explain the concepts in simple language so that people working in an industry or an organization can understand.

2.2

Fifty Steps for implementation

1. The first step in doing any activity is deciding on the purpose. We need to be clear on the purpose of the organization. This is called as Mission and need to be stated precisely as a Statement. This statement is supposed to be prepared by the top management; however, in a number of companies it is seen that these are left to some juniors or to some consultants. None other than the top management can be clear about the purpose for which the organization is being run. The consultants or the junior staff cannot really know the real purpose, which the top management wants to achieve. For e.g., a co-operative spinning mills might be having a mission of uplifting the cotton growers of their area and supply yarns at a reasonable price to the weavers in their area, where as some other mill might be having a purpose of exporting maximum so as to enhance the foreign exchange earnings of the nation. Some mills have only short-term goals of making quick profits, where as some are interested in the development of community around them. Some management are interested in diversification where as some others are interested in remaining in one field and emerging out as leaders. Unless the purpose is clear, planning the activities and identifying the processes shall not be proper. Therefore, defining the purpose shall be the first job of the top management. 2. Once the purpose is clear, the top management needs to spell out their Vision. It means what they would like to be over a period of time; this is worked out by understanding the trends and the possible developments in the future. Some companies are having a vision of expanding the activities and be the largest manufacturer in their field, where as some are interested in maintaining the same strength of

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Effective implementation of quality management systems

employees and achieve higher sales turnover and value additions. Some are interested in maintaining the same capacity of production, but change the product mix to get higher revenues. It is very essential to have a practical vision by considering the facts relating to strengths, weaknesses, opportunities and threat, or else, the vision shall remain only on paper. 3. The policy is the path in which we need to move to make the vision a reality while adhering to the purpose. In ISO 9000, it is termed as Quality Policy as here the concentration is on implementing the quality management system. The quality policy should be appropriate to the purpose of the organization, and should be committed to comply with the requirements of the quality management systems and to have continuous improvement in the systems. The quality policy should provide a framework to review the company objectives, and should be communicated down the line so that every one in the organization understands the policy and works in line with the policy. The top management should use the quality policy as a means for leading the organization towards improvement of its performance. It should be a consistent part of company’s overall policies and strategies. One should ensure that quality objectives are understood and pursued through out the organization. The quality policy should demonstrate the commitment and leadership of top management for achieving quality and for providing necessary resources for achieving the objectives. It should demonstrate the commitment for continuous improvement as related to satisfaction of customers and other interested parties like share holders, suppliers, employees, community, government, etc. Therefore, the quality policy is not a slogan for advertisement, but is a guide for implementing the systems. It should be written in as simple language as possible and ensure that every one understands it. 4. The quality objectives are derivatives of quality policy and the strategic planning of the organization. The top management should establish these objectives for leading the organization for improvement. These are to be capable of being measured in order to facilitate an effective and efficient review by management. These should consider the current and future needs of the organization and market served, relevant findings from the management review, current product and process performance, levels of satisfaction of interested parties, self-assessment results, benchmarking, competitor analysis, opportunities for improvement and the resources needed to meet the objectives. The communication of the objectives through out the organization shall be called as effective, when people in the organization can contribute effectively for the achievement. These

Understanding and implementation of ISO '00:2008

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objectives should be periodically reviewed and amended as per the change in the scenario. Therefore, we should not write vague phrases as quality objectives. The quality objectives of the organization should help in deriving quality objectives of each department and section of the organization. There should be a clear link between the company objectives and departmental objectives. It is suggested to prepare a matrix as shown in Fig. 2.1 and verify the linkages.

2.1 Linking company objectives to departmental objectives.

5. Once we are clear about our mission, vision, policy and objectives, we can work out the action plan. The plan should consider various aspects like the processes required, the present situation and the changes needed, the sequence and interaction of processes, the authorities and responsibilities, the control points and check points, the review frequency, skills and knowledge needed by the organization, resources needed, need for improvements at different levels, method of improving them, training needed to adopt the improved process or to experiment the proposed process to achieve the result, documentation and recording. Inputs for effective and efficient planning include the strategies of the organization, the

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Effective implementation of quality management systems

objectives, defined needs and expectation of customers and other interested parties, evaluation of the applicable statutory and regulatory requirements, performance data of the product and processes, the process capability and the maturity of systems, lessons learned from previous experiences, the strength, weakness, opportunity and threat analysis, etc. The plans should be written as precisely as possible, so that the implementers should not have any doubts or confusion. A chart may be prepared as shown in Table 2.1 to guide people as to which are the procedures that are to be referred for a particular action plan and the person responsible for that process. There should be periodical review to ensure that the persons shown as responsible have understood the action plan and are monitoring the activities. 6. Once the action plans are ready, we need to decide on the procedures for implementing the plans. They should clearly specify the objectives, the responsibility and the actions, how to do the work, when to do, where to do, what to control, what to check, when to check, how to check, what is to be recorded, where to record, in case of deviations what is to be done, etc., depending on the process. The procedures, therefore, should aim at the achievement of goals, which are to be revised from time to time depending on the situation. Therefore, procedures cannot remain same all the time, and the procedures written by some one cannot be copied and adopted at a different place, unless we have the same goals as the other person, and do not wish to improve. If it is the case, there is no meaning of implementing ISO 9001, as it aims at continuous improvement. It is, therefore, necessary to review all the procedures, instructions, job descriptions, process parameters, etc., periodically and amend them as per the changed situation. Some times, we may find some procedure / instruction / job description / process parameter as suitable in today’s context, it can be re-approved; but reviewing is a must. 7. The procedures depend on the processes involved, the type of equipments and infrastructures available, the competency of the men involved, the customer feed back relating to our quality and services, the resources available, and the goals to be achieved. When we talk of processes in a factory, normally people refer to manufacturing activities. But there are a number of other processes, which are as essential as manufacturing to make the company efficient and effective. Some of the examples are customer order fulfilment process, complaint management process, human resource management process, procurement process, supply chain management

Understanding and implementation of ISO 900: 008

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Table 2.1 Typical action plan chart Department / section objective

Action plan

1. Reduction 1.1 Reducing the travel expenses by planning in working expenses the vehicle movement, pooling the persons and materials and optimizing the truck capacities

Applicable procedure

Responsibility

Vehicle in1.1.1 Procedure for planning charge and monitorring vehicle movement 1.1.2 Procedure for sending people on out station activities

Factory manager

Logistic in1.1.3 Procedure for out sour- charge cing transport vehicles and taxis 1.1.4 Procedure for optimizing the truck loads 1.2.1 Procedure 1.2 Reducing the material for procuring cost by monitoring the materials wastes at all levels, accepting only good 1.2.2 Procedure quality materials to avoid for vendor in process wastes due to selection poor material and and vendor purchasing materials evaluation from reliable sources. 1.2.3 Procedure for determining maximum allowable process wastes and monitoring them

Purchase incharge

Purchase incharge Purchase incharge

Production incharge

1.2.4 Procedure for working out material realization percent and reporting

Quality incharge

1.2.5 Procedure for inspectting the incoming materials

Quality incharge

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Effective implementation of quality management systems

process, quality assurance process, company policy deployment process, product design process, investment process, information management process, strategic planning process, management review process, etc. When we talk of identifying the process and their sequence and interactions, we need to address all these. 8. Each process should have some objectives, those should be specified clearly. We need to identify the measurable parts of the objectives. These are called as key result areas (KRA). It is essential to develop methods and means to measure the same and periodically review the progress. The targets need to be fixed for each of the result area, and communicated down the line so that the men on spot are aware of the requirements and expectations. It is a good practice to display Table 2.2 KRA and unit of measurement Department / Action plan section objective

Key result area

1. Reduction 1.1 Reducing the 1.1.1 Reduction in travel expenses in working vehicle by planning the expenses movement vehicle move1.1.2 Reduction in ment, pooling people sent the persons and out on out materials and station actioptimizing the vities truck capacities 1.1.3 Reduction in out-sourcing expenses of transport vehicles and taxis

Measurement unit

Total KM of vehicle movement Number of men sent out and the distance travelled

Transport bills and taxi bills

1.1.4 Optimizing the Ratio of partial trucks truck loads to full trucks 1.2 Reducing the material cost by monitoring the wastes at all levels, accepting only good quality materials to avoid in process wastes due to poor material and purchasing materials from reliable sources

1.2.1 Reduction of incoming materials

Percent of materials rejected

1.2.2 Procuring materials at lowest possible price

Ratio of purchase price to the average market price for similar quality material on the day of procurement

1.2.3 Developing reliable vendors

Number of vendors developed and their rating

1.2.4 Increase in Material realization material reali- percent zation percent

Understanding and implementation of ISO 9001:2008

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the departmental KRAs so that every one in the department shall be clear about the same. The sectional KRA has to be displayed in the section and individuals need to be given their KRA in writing with a copy to the concerned HOD. 9. A documented quality manual has to be prepared to guide the people in implementing the systems. This manual should give an over view of the company, the mission statement, the product range, the target customers and market, the company policies and the steps taken to implement them, the authorities and responsibilities of key personnel implementing the systems, the process and procedures involved, the system of monitoring, measurement and taking suitable corrective and preventive actions, maintenance of records, reference to the procedures adopted against each clause of the standard, etc., so that any one can easily understand the systems. It is advisable to refer ISO 10013, that give guidelines for developing quality manuals and quality management system documentation, so that all necessary points are covered. 10. Effective internal communication is a very important means of implementing the systems to achieve the objectives, as there are a number of inter relations between the processes. A free, clear and interacting communication is very essential for the success of not only the systems but also for the organization. Therefore, the transparency of the system has to be maintained at all levels; however, it should be ensured that the information flow is restricted to the people involved in the operations, and should not go to unconnected persons, as it can create more problem than any help. 11. The customer focus is often talked, and one of the responsibilities of the top management is to communicate down the line the customer requirements. Here we need to understand a lot. It does not mean that all the terms and conditions of sales are to be told to each and every person in the organization. It also does not mean that the top management should conduct open programme and announce that meeting the customer requirements are important. The top management should demonstrate by their deeds that they are respecting the customer needs in all their activities, which shall automatically percolate down the line. There is a saying that “People follow the deeds of a leader and not the talks”. Same thing holds good here also. It is needed to explain to the concerned people regarding the specific requirements of the customers. For e.g., the delivery schedule should be known to the production in-charge, the production planning person and the despatch person, where as the product quality related requirement is to be known to even the

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Effective implementation of quality management systems

operators in production, but need not be to the despatch person. There are a number of commercial and trade regulatory requirements, which are to be known to the concerned persons, so that they monitor and fulfil the requirements. Primary requirements 1. 2. 3. 4.

Products of the specified quality Delivery in time Affordable price Prompt after sale service

1.

Quick response to the enquiries – The customer contact person should always be available to the customer. Quick and prompt resolution of complaints and other issues – The resolution should always be in favour of the customer. Packing should be attractive, but easily removable and disposable – It should help customer to build his reputation in case the products are directly going to showroom in the name of the customers. Supplier to communicate proactively regarding the despatch positions, changes if any in product configurations, the developments in the technology. Supplier to educate the people at customer’s end on the care to be taken while using the products and the correct methods of using them. Supplier should help in maintaining the equipments supplied by them – either freely or with concessional rates. Supplier should maintain the stock of finished materials in his account, preferably in a warehouse near to customer’s place, to help customer to get materials just in time. Supplier should take back the materials and replace with fresh materials whenever customer expresses dissatisfaction. Supplier should treat well whenever customer visits the supplier’s place and attend to all his needs – The senior members from the suppliers management should attend the customer. Supplier should give evidence of adhering to legal, regulatory and statutory requirements so that the customers should not be put in trouble for non-compliance. Supplier should bear with customer in case of any late payment due to any reason. Supplier should accept the change in product configuration suggested by customer at any time irrespective of whether production is started or not. Supplier should hold the deliveries if desired by the customer due to any reason. Supplier should give some discount either formally or informally – Informal discounts are preferred. The supplier should agree to change the product configurations or nomenclature in the delivery documents and packages to help customer getting some tax benefits. ……and so on.

Secondary requirements

2. 3.

4.

5.

6. 7.

8. 9.

10.

11. 12.

13. 14. 15.

16.

Understanding and implementation of ISO 9001:2008

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In some of the companies, there is a system of nominating one of their middle management personnel as a custodian of a particular customer, who in addition to his/her regular activities, verify the processes and quality of the materials that are being produced and shall have direct interaction with the buyer. In garment factories, it is a normal practice to have quality assurance persons and the merchandisers nominated for different customers. There are companies who boldly display the name of the customer for whom the materials are being manufactured and the previous complaints of that customer regarding the products and services. This system helps the operators and middle management to be alert in the specific areas where the customer has a concern. Some companies have a system of sending their senior workers and middle management staff to their customers on a periodic basis to understand the performance level of their products and to get their changed requirements if any, which are not normally identified and discussed while placing orders or taking orders by the commercial people. Some companies publish periodicals, either monthly or quarterly, exclusively for the use of their staff and workmen, in which they discuss about the market feed back and the changing requirements of the customers. The customer’s needs could be grouped as primary needs and secondary needs. It is essential to meet the primary needs, but in a number of cases, the business is lost not because of meeting the secondary needs effectively. 12. Another important responsibility of the top management is to communicate down the line the regulatory requirements. Here again, we need to understand what is to be communicated. The section heads should have a list of legal and regulatory requirements applicable for their section, and it is their responsibility to update themselves regarding the changes and implications. We cannot expect the top management to interpret all the changes and explain to the section chiefs. If it is the case, why it is put in the top management responsibility? It is because, the top management is responsible in case of any violation, they need to periodically review and ensure that the required statuary and legal requirements are being met. It is a normal practice in number of companies to have one senior HR manager exclusively for compliance. They boast of meeting all the regulatory requirements and they take various certificates of compliance. However, when we see in detail, that person shall be more interested in preparing the documents to convince the auditors, and also shall spend more time in entertaining the auditors and government officials. The standards want people to respect and follow

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Effective implementation of quality management systems

the legal and regulatory requirements all the times. Each one should be aware of the legal and regulatory requirements concerning to the activities being done and the product being produced. The standards insist more on implementation of the system rather than on convincing the auditor and getting certificate. There is a need to educate people concerned regularly on the legal requirements and the changes if any, and ensure that they work as per the requirements, rather than having a separate person to patch up the records to show to the auditors. 13. The standards requires certain documents to be maintained as mandatory, which include the quality policy, quality objectives, quality manual, documented procedures required by the standards, documents needed by the organisation to ensure effective planning, operation and control and records required by the standards. If one reads calmly, he can understand that the scope of documentation covers all the essential activities of the organization. There is a need to identify and define the documents and relevant records needed to establish, implement and maintain the quality management systems, and to support an effective and efficient operation of the organization’s processes. The nature and extent of the documentation should satisfy the contractual, statutory and regulatory requirements, and the needs and expectations of customers and other interested parties. This also should be appropriate to the organization. The documents can be in any form or medium suitable for the needs of the organization. For e.g., written procedures for implementing regulatory requirements, where as we can think of a video cassettes for showing the work practices like material handling systems, assembling and checking the parts, operating fire extinguishers, etc. We can have sign boards at appropriate places to give instructions to workmen relating to ‘Do’s and Don’ts’, or can have online work instructions on each machine for attending to routine problems. The option is left to the organization, but one should ensure that the documents are properly controlled. Figure 2.2 illustrates the documents needed for effective implementation of quality management systems in any organization. 14. What do we understand by the word document control? It means the documents are (a) approved by certain authorised and responsible persons after ensuring its adequacy and relevance to the operations, (b) are suitably identified to ensure that only the current version are in use, (c) given only to the concerned users and avoided from going to unauthorized persons, (d) the obsolete documents are promptly removed from the place of use, and (e) they are legible and easily identifiable.

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Quality policy Quality objectives – Company Quality objectives – Department Quality objectives – Products Quality manual Work procedures Work instruction Organization structure – with functional designations Job descriptions List of forms List of records List of external documents List of legal and regulatory requirements applicable List of equipments for inspection and testing and monitoring The specific terms used in documents – definitions to be given Specifications – need not be separate, as it is given with individual batches 2.2 List of documents needed for effective implementation of QMS.

It is normal practice to have a control copy seal and a control copy number on the documents to show it as a ‘Controlled Document’. The organizations also maintain number of ‘Uncontrolled documents and Records’, but are not clear as to why it should be uncontrolled. When asked, people normally reply that controlled documents were for ISO purpose and the uncontrolled were for their day-to-day activities. The controlled documents are kept in clean folders, where as there are number of over writings and some important tips about the activities. People should understand, if any document is required for the effective functioning of the organization, those documents need to be controlled. There is no need to have separate documents for ISO 9001 purpose. If anyone is maintaining certain documents that are not related to the organizations functioning, for e.g. technical

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articles collected from some magazines for reference, the activities of annual social gatherings, felicitations to some achievers etc., they can be kept as uncontrolled. However, if the employee development is one of the objectives, even these records need to be controlled. 15. In the documents relating to meeting the satisfaction of customer and other interested parties, the management should consider the contractual requirements from the customers as well as the requirements of the interested parties; acceptance of international, national, regional and industry sector standards, relevant statutory and regulatory requirements, decisions by the organization, source of external information relevant for the development of the organization’s competencies and information about the needs and expectations of the interested parties. Therefore, it is essential to identify and control the distribution of documents of external origin. Access to documentation needs to be ensured for people in the organization and to other interested parties depending on the organizations communication policy and requirements. The other interested parties include customers, suppliers, employees, share holders, government and the community around us. 16. The method of doing a work or performing a process is often called as procedure, where as what was done and its effects are recorded as a document is normally referred as record. The records are the data bank giving information about various aspects while implementing a procedure. They serve as an input for review and planning. Therefore, they should be preserved properly. However, the life of the records changes depending on the nature of data and its utility. Hence the management should decide on the life of each record. The records should be easily retrievable when needed and hence proper identification and storage is necessary. As the records are meant for using by others for review and decisionmaking, they need to be legible and protected from damages due to handling or any other reasons. People should develop the habit of keeping back the records in their original designated place immediately after the work. It is a good practice to specify the cupboard number and rack number also on the records along with the department and the sections. A full-proof method of putting a diagonal band as suggested by Shyam Talawadekar 11 is a very good system. Figure 2.3 gives an illustration of that simple, but very effective system. In order to have easy retrieval of information, it is essential to have standard formats for data gathering and presentation. This shall avoid

Understanding and implementation of ISO 9001:2008

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2

3

4

5

6

7

8

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9

2.3 Simple Poka-Yoke for storing files.

Name of the Company…………………………….. Department/Section………………………………… Subject………………………………………………. From………………. To…………………………….. Not to be discarded before (date)…………………. Location………………………………………………. Responsibility………………………………………

2.4 Legent of a record.

duplication of work and also help in computing the data for analysis. It is essential to list all the formats, index them and display so that people do not create a new format or use a wrong format. It is normal practice to allocate form numbers to all formats, and give reference of that format in the procedures, work instructions and job descriptions. 17. One of the prime functions of any management is to review the activities to ensure that they are effective and helping to meet the company objectives. This is called as management review. This

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includes the review of all activities relating to the implementation of quality management systems, product and process performance, feedback from customers and other interested parties, adhering to legal and regulatory requirements, actions proposed and taken to correct the deviations found in internal and external audits, and the changes in policies. The management review should be a planned activity and cover all the areas; however, the periodicity might depend on the criticality of the activity. Normally people refer management review to a meeting held after internal/external audits for ISO 9001 compliance, but it is not correct. It is only a management review for quality management system implementation; however, for the process conformance, product conformance, company performance, customer requirements analysis, financial commitments, supplier performance, human resource management, etc., the reviews need to be held at different levels, and the overall performance reviewed by the top management. Some people think that reviews should be done in a meeting only, where as, it is sufficient that the top management review the situation and take appropriate action in-time to correct the deviations and to improve the situation. A meeting shall help in solving the differences if any and brings people closer. The commitment of the top management to review the situation considering all the requirements of the system and the organization is very important. Following Table 2.3 gives an illustration as to how the reviews can be delegated and made effective Table 2.3 Delegation of reviews

Production Quality issues Suggestions received Complaints Corrective actions Preventive actions Profit and loss Actions on audit finding

Supervisor

HOD

Unit head

MD

Each shift Each shift NA NA NA NA NA NA

Daily Daily Weekly As and when received Weekly Monthly Monthly Monthly

Weekly Weekly Monthly Weekly Monthly Monthly Monthly Quarterly

Monthly Monthly Quarterly Monthly Quarterly Quarterly Quarterly Quarterly

18. The provision of resources is very important part from the top management commitment point of view. However, there should be a justification for the resources to be provided. It should help the management in enhancing customer satisfaction and satisfaction of other interested parties, i.e. stakeholders, to achieve the company objectives and fulfil the applicable statutory and regulatory requirements. Hence, the top management should identify the resources essential to the deployment of strategy and the achievement

Understanding and implementation of ISO 9001:2008

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of the organization’s goals. The resources may be people, infrastructure, work environment, knowledge, information, suppliers and partners, natural resources, financial resources and time. 19. The human resource is a very important resource. Even the best equipments and systems if handed over to non-competent people can result in a disaster. Therefore it is essential to identify the minimum competency level required for each job, and ensure that people with competence are engaged. The competency for doing a job depends on the job requirements and is expressed in terms of knowledge, skills, physical fitness and the maturity for taking decisions. One need to note down the work to be done and split the work into events, and then decide what competency is required. For e.g., a tester needs to collect material from each machine and check for the properties. For this work he should be able to identify the machine and material, the production element, time, etc. Hence an education to read and write the language in which the communications has to be made is required. Also he needs to test for the required property, and enter the figures in registers or in computer as per the system, and show to the concerned. This requires knowledge of basic mathematics, computer data entering, etc. Depending on the level of education in that area, one may prescribe it as 10th standard, metric, pre-university and degree, etc. He should be able to carry the material [samples] to the testing spot, and hence he should have a good physique to do that job. He should have good eyesight to identify the labels, signs written on machines, etc. He needs to communicate with the production people to find out the changes that have taken place and the changes required. Hence, he should be trained in basic communication skills, and should have the basic knowledge of the machineries and the technical words used in the production area. To that extent he should have been trained. Like this we have to analyse each and every activity with in a given job, and arrive with the minimum competency required (Table 2.4). 20. We need to verify the competency level of the people doing the job to ensure that they are qualified for doing the job allotted. This can be verified by the consistency in their performance rather than referring to their educational qualifications and the experience certificates. In case of low performance, it is needed to identify the cause, and if the competency is found as the reason, a suitable action like training, reallocation of job, simplifying the systems and providing an opportunity for the man to improve his skills and knowledge. What is more important is reviewing the actions taken and ensuring that they are giving the required results. Hence periodic evaluation is required.

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Effective implementation of quality management systems Table 2.4 Competency requirements of a tester

S. No.

Jobs done

Skills needed

Education needed

1.

Collect samples from each machine for testing

1. Identify the machines 2. Identify the materials 3. Understand the properties to be tested 4. Decide on the sample size 5. Identify and record the exact source of sample in multiple delivery machines

1. Able to read the numbers 2. Able to understand the codifications 3. General awareness of the properties to be tested 4. General awareness of deciding sample size 5. Able to identify the delivery positions

2.

Marking the samples, recording the sample details.

1. Identify the labels on samples and signs written on machines (Needs to have a good eye sight)

1. Able to read and write English

3.

Test for the required parameters

1. Operating the testing equipment 2. Checking the calibration before starting the test 3. Handling the samples with out disturbing or hurting self

1. Able to read the standard procedures and conduct the test 2. Able to check the calibration of materials 3. Understand the property of materials, study sample handling systems and safety precautions

4.

Entering the data in register or in computer systems

1. Data entering in registers or systems without mistake 2. Working out the mean, deviations and highlight the major deviations

1. Basics of data entry in computers and registers 2. Basic mathematics, fundamentals of statistics

5.

Carrying the samples from machine to testing lab and returning the samples back after testing

1. Material handling skills (Should be physically fit to carry the samples)

1. Education is not a must for this operation

6.

Submitting the results to concerned supervisor or fitter for taking action

1. Communication skills to explain the real deviation and the actions needed 2. Communicate the actions to be taken

1. Able to read, write and speak in the language of the people taking action

(Contd.)

Understanding and implementation of ISO 9001:2008 S. No.

Jobs done

Skills needed

33

Education needed 2. Basic knowledge of the working of the machine and effects of different operations

Summary – Minimum 12th standard passed with Science and Mathematics as optional, basic training of data entry, handling of samples, basic operations and functions of different parts, operating the testing equipment, data entry and presentations, communication skills for reporting the data.

21. People can work efficiently when they are empowered. This can be done by suitably defining the organization structure, with clearly defined authorities and responsibilities. Once a competent man/ woman is allotted the job, and is clear about his/her authorities and responsibilities, and is aware of the relevance of the work in achieving the objectives of the section and company, he/she shall be enthused to do the work and shall work with full potential. 22. The work environment needs to be maintained to get the required quality and productivity. There are two parts in this: one is physical environment like required lux level of light, maximum allowable dust level, maximum tolerable noise level, house keeping, level of pollution and controls, precautions for maintaining good hygiene, cleanliness, ergonomics, machinery layout, etc.; where as the second one is relating to human environment, which include the way in which the people are treated, the promotion policies, grievance handling systems, discipline at work, social justice, the welfare measures, etc., which all help in building a confidence among the employees that the top management is concerned about the well being of the employees and are taking care of them. 23. The other resource, viz, infrastructure includes various items like plant, working space, tools, equipments, support services, information and communication technology, transport facilities, etc., which are all essential for getting the product and service realization to achieve the company goals. Hence it is essential for the users of the above infrastructure to justify them as required for improving the systems and/or enhancing customer satisfaction and/or achieving the company objectives as per strategic plans. It is also essential to utilize the infrastructures optimally to keep the cost of operation as low as possible, while not compromising on the quality. 24. Now let us come to the core activity, i.e. product manufacturing, or as per ISO 9001:2008, product realization. The first activity in this area is the planning for product realization. We need to understand the product requirements before going for manufacturing. We need to know the customer’s stated needs, implied needs and expectations,

34

Effective implementation of quality management systems

and from that we need to work out the quality objectives of the product. This explains what is expected out of the product when it reaches the customer’s end. Let us take some examples: (a) Textile mill (i) Ne10s combed hosiery yarn – As the name indicates the yarn is going for knitting application, and hence the yarn should be soft twisted and waxed. The yarn is combed and expected to be free from kitties and neps and imperfections should be lower. The yarn should have sufficient strength and elongation to give a trouble free performance. However, we do not know as to what type of knitting machine the customer has. Now think of socks knitting, one for baby socks and the other for sports socks. For baby socks, the comfort of wear is more important, where as for sports socks, wear resistance is very important. Hence for baby socks we need to give a lower T.M. compared to sports socks. The short-term variations in yarn looks prominent in socks as the same yarn shall be coming again and again. (ii) Same Ne10s combed hosiery for doubling to use in sweaters – In this case, as the doubling operation is done at customers end, we have to give un-waxed yarn. The short-term variations might not be critical as in the case of socks. Uniformity in shade of yarn is very important, as the yarns are likely to be dyed and used as an outerwear. (iii) Ne10s combed soft twist going for candlewicks – In this case, uniformity in terms of thick and thin places are very important, and a kitty free yarn is required. The shade variation is not critical for this end use, and also the strength of yarn. (b) Engineering workshop Customer wants a shaft to be fitted to a drive. The basic question is: how much load it is supposed to carry. On that basis the diameter and the material is designed. The second question is about the speed on which it has to work, on which the bearing shall be decided. The third question shall be the atmosphere to which the shaft is exposed, on which the material to be used for the shaft shall be decided. The functional aspects are very important in deciding the product objectives. (c) Cafeteria Food is to be prepared for 10 people for lunch. We need to be clear as to whether they need light working lunch or heavy lunch. The purpose for which the lunch was ordered is very

Understanding and implementation of ISO 9001:2008

35

important, i.e. whether it was a happy occasion or just a simple gathering or lunch for people engaged in a specific official work. The age and sex of the people coming for lunch and their culture also have a say on the food to be served. The quality objectives of products depend on the purpose for which it is being used. We need to work out the objectives of the product against each product and for each customer or contract, so that all precautionary measures are taken while producing. 25. We need to work out the quality plan for each contract or purchase order, which should consider the starting date and time, the machines to work, the men to be engaged, the quality checks to be done, completing day of the production, despatching day, the procedures to be followed and the records to be maintained. It should be documented and circulated to all the concerned in the supply chain/activity. Follow up is required to ensure that the activities are carried out as per plan. A typical quality plan can be as below: Order no.

PR ######

Product

PQR$$##

Total quantity

25000 Pcs

Production to start on

20 Dec 2008

Production to end on

12 Jan 2009

Machine numbers allotted

Operation 1 à Machines 1, 2, 4, 6 Operation 2à Machines 2, 3, 4 Operation 3à Machines 1, 2, 5

Persons suggested

Operation 1 à Ticket No 20041, 20042, 20044, 20046 Operation 2à Ticket No 21042, 21043, 21044 Operation 3à Ticket No 23111, 23112, 23115

Testing to be done

As per IS ##, IS#%#, and IS###

Previous complaints on similar products

(1) Short working life although materials have required strength.

Actions taken

(a) Testing of water for *%*%*%*% properties (b) Conducting ageing test of the product (c) Monitoring the temperature and curing time

36

26.

27.

28.

29.

Effective implementation of quality management systems

Some companies give date wise break up of machineries to be allotted, and maintain the records of production in a minusing register that will be giving the numbers out standing as on date or shift. In order to understand the real requirements relating to the product, it is needed to have a close contact with the customers and day-today interactions relating to changing requirements. We need to understand the critical requirements those affect the performance and quality at customer’s end and the regulatory requirements if any. The critical requirements depend on the type of machines the customer is having, the working atmosphere, the work culture, the expectation of their customers, the end use of the materials and the changes in regulatory requirements. Once we understand the requirements, we need to verify whether we can supply the same in terms of required quality, price, delivery schedule, after sales service requirements if any, and the regulatory requirements specified. It is common practice to have periodic studies of process capability and product capability so that one can then enter into a contract with confidence of fulfilling it. This is called as contract review. In case we are not in a position to fulfil any of the requirements, it needs to be suitably conveyed to the customer and get the contract amended. Similarly, if the customer needs any change, he needs to inform the supplier and get the contract amended. The attitude of giving false assurances to get the orders can lead to dissatisfaction of customers and finally they shall go away from us. Customers believe in what they got and not on what you assured. We need to have facilities and systems for an effective communication with customers relating to the product information, changes in market positions, performance of our materials at customer’s end, actions taken on complaints and feedbacks, the information required by customers relating to product features offered by us, the contracts and the production schedules, likely delivery positions, payments, etc. This shall reduce confusions and complaints, and help in building a good relationship so that we can have long-term association. The present day trend is to give free access to the customer to the ERP systems implemented so that they can see the position of their orders on line. Some companies have even given the test results online to the customers. Once the product requirements are clear, we need to design and develop the product so that it suits the exact requirements of the customers. Some manufacturers say that they do not design the products, as they are making only standard items as per customer’s designs. But if we see in detail, we need to do some changes depending on the raw material properties, seasonal changes, changes

Understanding and implementation of ISO 9001:2008

37

in the machinery configuration, etc., even though the basic specifications remain unchanged. Further, depending on the production requirement, we need to select the raw materials, change the speeds, settings, timings and temperatures etc., which are all a part of product design. For designing we need to consider the inputs like the customer requirements, the availability of raw materials, the type and condition of the machinery we have, the regulatory requirements, the competency of people working, etc. The designer should have the complete knowledge of the risks involved and the way in which the material is likely to be handled at the customer’s end. He should also have the knowledge of the process capability of his factory and a sound knowledge of statistical quality control to draw inferences from the data obtained while conducting trials. The design should give information relating to the requirement of raw materials and spares, the process parameters to be adopted, the modifications in the machines required, the quality levels achievable, the controls required, safety precautions required, the cost of manufacture, the risks involved and the training required to be given to the employees. 30. The designs need to be verified to ensure that the assumptions and calculations are correct, reviewed to predict the problems the product can pose to the organization as well as to customers if manufactured in bulk, validated by making prototype samples to ensure that the product meets the customer requirements, documented so that there are no lapses while implementing in a large scale, and controlled from being leaked till the process of design is complete and given for regular manufacturing while ensuring that the design does not reach the wrong hands which can harm the company’s interests. It is a normal practice in number of companies, especially where large brand owners are purchasing the materials, the samples from the development stage as well from the materials being manufactured are validated by the customer. 31. Once the design is clear, the materials could be procured to start the production. We need various types of materials, like raw materials, spares, packing materials, lubricants, capital equipments, etc. If we need the quality as per our expectations, and the costs as calculated, we should purchase materials from such suppliers whom we feel as capable and reliable for supplying materials as per our requirement. Hence we need to select vendors and periodically review their performance and ensure that they are suitable to meet our requirements. For vendor rating, we can make use of IS 12040:2001 by giving suitable weightage for critical factors like quality, price,

38

Effective implementation of quality management systems

delivery, service, approachability, etc. The weightage given are to be decided item wise considering its importance in manufacturing and in achieving the quality level. The cost factor and the space for storage is also a point of consideration. For example, for precision spare parts, the weightage for quality shall be very high compared to price and delivery, whereas for packing materials, the delivery schedule becomes more important. Following Table 2.5 gives an idea of giving weightage to each item being procured in a cotton spinning mill. Table  Weightage to be given to items procured in spinning mill

Product Quality Delivery Price Service Total

Spindle Top arm 85 80 3 3 2 2 10 15 100 100

Rubber cot 60 20 15 5 100

Bearing Packing material 60 30 10 40 20 20 10 10 100 100

Brooms 30 30 35 5 100

The weightage given can be used for evaluating the vendors as per the formulae given below. Quality rating =

Number of items approved Number of items received

´ weightage for quality

Number of consignments received in time Delivery rating =

Number of consignments received

´

weightage for delivery

Ranking in price among the quotations received Price rating =

Number of quotations received

´

weightage for price

Number of satisfactory services Service rating =

Number of service requests made

× weightage for service

32. The information to be given to suppliers in purchase orders should have the complete description of the product including the catalogue numbers, (machine serial number for which the spare is being ordered) reference to standards, drawing or sample depending on the material being ordered and its criticality in product realization. This also should include our method of approving the products, the quantity ordered, delivery requirements, transportation and insurance related data, applicable taxes, payment terms and any other specific requirements.

Understanding and implementation of ISO 9001:2008

39

33. ISO 9004:2000 (18), the guidelines for performance improvements addresses effective purchasing process as follows: ● Timely, effective and accurate identification of needs and purchase product specifications. ● Evaluation of the cost of purchased product, taking account of product performance, price and delivery. ● The organization’s need and criteria for verifying purchased products. ● Unique supplier processes. ● Consideration of contract administration, for both supplier and partner arrangements. ● Warranty replacement for nonconforming purchased products. ● Logistic requirements. ● Product identification and traceability. ● Preservation of product. ● Documentation, including records. ● Control of purchased product, which deviates from requirements. ● Access to supplier’s premises. ● Product delivery, installation or application history. ● Supplier development. ● Identification and mitigation of risks associated with the purchased product. ● Involvement of suppliers in purchasing process in order to ensure timely supply and reduction of inventory. It is suggested to read and understand the guidelines given in ISO 9004, and design your systems to align with the guidelines given. 34. It is essential to have a system of verifying the purchased product to ensure that the products meet the purchase requirements. However, we need to prioritize the activities considering the criticality of the products purchased as verifying all the materials procured might not be feasible. 35. Control of production activities in order to get the required quality products at the planned productivity rates is the important process in a manufacturing activity. This involves the availability of information describing the characteristics of the product to the men on shop floor engaged in the production activity, availability of procedures and work instructions, process parameters as necessary, use of suitable machinery and equipment depending on the product requirement, availability and use of monitoring and measuring devices, implementation of release, delivery and post delivery activities.

40

Effective implementation of quality management systems

Here it is essential to ensure that the decisions taken in designing, quality planning, and the environment identified in resource management are strictly adhered to. The machines needs to be maintained in such a way that they give the required performance. It is also essential to ensure safety of men, materials and the machineries as a part of controlling of production activities. 36. There are processes like turning, drilling, milling, etc., where we can check the quality of the material while the process is on. We can check the dimensions and take corrective actions. There are some processes like painting, welding, polymerization, dyeing and finishing of textiles, moulding, fusing, operations involving chemical reactions etc., where the in-between tests are not possible and we need to wait till the process is completed. This type of process requires a thorough study and fixing the process parameters, and employing people who are well trained to get the right quality right at first time. This type of process is called a special process. Taking a small sample and processing them to establish the parameters is a normal system adopted to validate the special processes. It is normal practice to get the materials validated by the customers or a custodian of customer for such products produced out of special processes. 37. Whatever may be the process adapted, proper identification of the materials and processes at all stages are essential to ensure the quality and accounting. Similarly we should be able to trace the material backward to the machines and time on which they were processed, so as to analyse the effects of various actions taken or to identify the source of a problem when nonconforming products are noticed in further processes. The system of identification and traceability should be clearly communicated down the line, as workmen handle the materials, and the work goes on round the clock. Display of the coding system is a normal practice in good companies to educate the people on the materials being worked. The coding may be by colours, labels, markings, use of specialized containers, barcodes, etc., depending on the materials and the culture. The allocation of lot numbers, batch numbers and mentioning of date and time of packing is essential and the production people should have the history of the complete processes adopted for that product. 38. In case a factory is processing the materials belonging to customers on a job work basis, it is essential to ensure proper accounting of the materials received and inform the customers in case of any shortcomings. Similarly, the quality of materials received should be checked and advised to the customer if they are not suitable to produce the quality as committed. It is always better to nominate a person to deal with such products by maintaining proper accounts and record

Understanding and implementation of ISO 9001:2008

41

the transactions. It is our responsibility to safeguard the customer property. Normal examples are raw materials received for manufacturing, semi-finished materials received for finishing, yarns received for twisting or weaving or dyeing, fabrics received for dyeing or printing, finished fabrics received for garment stitching, etc. There are some other products, which are not raw materials but some add on items, like labels for putting on the final products going for retail market, hangers for garments, packing materials with neutral labels, etc. One more very important customer property identified recently is the technical know-how given by a customer for developing a product and to exclusively supply the products to them, which are mainly in the form of a recipe, or software programme. 39. Preservation of products by proper packing and by handling them properly to avoid damages in storage and transit are also very important. The first impression the customer gets about our quality is in the presentation of packages. We need to identify the type and size of packing depending on the materials being packed, the type of transportation adopted, the condition of roads and the distance to be travelled, likely atmosphere conditions at the place of destination and also on the way, the type of handling systems the customers are having, etc. For example, if the cartons are loaded in waterproof containers at the factory, the transit damages shall be less compared to loading material in a truck, and transporting it on road for a long distance with two or three transshipments in between. At some places, the customers have only lady workers, and do not have material handling equipments, and hence they prefer small packages. The customers, who have very high wage rates, prefer to go for mechanized material handling systems like fork lifts, and would prefer the material supply on pallets. In some cases, the customers prefer staple-less cartons, where as some prefer only recyclable materials depending on the regulatory and ecological requirements. Hence, it is needed to understand the packing requirements from the customers rather than offering our standard packing to all. The packing quality is very important as it gives the first impression about the product and the company to a customer. Therefore, utmost care is to be taken in packing area, and only dedicated people are employed. Any mistake done in packing can spoil all the efforts done during the manufacturing activities. It is essential to have proper records of the people engaged in packing and the packages they packed. The packers are supposed to check the quality of the materials by visual means before packing, and hence are accountable in case of poor quality materials reaching the customer. In order to avoid smuggling and trafficking of banned items, some companies have made the packing area as restricted and unauthorized persons are not allowed. The names,

42

Effective implementation of quality management systems

photos and addresses of the employees permitted to enter packing area are displayed and a security person monitors. 40. The controlling of measuring and monitoring devices is a very important aspect of production and quality monitoring. Now we have a number of online monitoring devices for both quality and productions, and most of them are electronic based. We need to ensure that the readings given by these devices are reliable, as the decisions taken depend on the data provided by them. Similarly, we have pressure gauges, temperature gauges, length measuring units, etc., on various machines. In a number of cases, it is seen that the pressure gauges become weak after usage for some years, and show higher pressure even though the actual pressure is low. Similarly, the lengths measured by length measuring units on machines are normally found erratic and do not match with that displayed. It is essential to develop systems to monitor the gadgets, on which we take decisions. We can take the help of recognized laboratories or can develop our own system to verify the accuracy and reliability of data, and to apply corrections depending on the extent of uncertainty noticed. It is always better to develop full-proof systems to avoid deviations, rather than depending on the verification of process outputs and taking corrective actions. Periodic assessment of test results by participating in round tests help in getting a confidence in testing equipments. Very important aspect is to ensure that the measuring and monitoring devises are maintained well and protected from getting tampered. In case any deviation is noticed, it is essential to trace back the materials processed, and recheck them and ensure that the quality as okay. 41. The decisions taken should have a base and supported by facts and figures. Decisions without backing of facts can lead to failures or in high costs. Measurement data are important for making fact-based decisions. The measurement is needed for evaluation of quality, productivity, costs, wastes, product realization, customer satisfaction, supplier capability, performance of various sections and processes, effectivity of systems, etc. The measurement data should be converted into information and the knowledge should benefit the organization. With the modern machines having online data systems, we get number of information on the performance, which are either displayed or stored in memory. In a number of organizations, it is seen that although lots of measurements are made, people are not using them for taking decisions. This information should be used to establish appropriate priorities for the organization. Communication of this information to the concerned persons in time, and involving the users in decisionmaking is very essential to get the real fruits of the measurement systems.

Understanding and implementation of ISO 9001:2008

43

42. The system compliance is verified by internal quality audits. Periodic internal audits help the organization to identify the system deviations and help in correcting the situation, and also for improving the systems on a continuous basis. The auditors should be suitably trained to see the systems with an unbiased view, and to project the deviations to the management without hurting the feelings of the people working. It is important that managements ensure the improvement actions in response to internal audit findings. Internal audit is a very good tool for team building and self-development, as the auditors discuss the issues with auditee, and indicate the deviations while convincing the auditee of the deviations and its importance in meeting the objectives. In the mean time, the auditors also learn the systems adopted at various sections of the same organization. Over a period of time, they shall have fairly good knowledge of the overall systems of the organization. The Chapter 4 deals with various aspects of internal quality auditing. 43. It is very essential that the auditee takes the audit output seriously, and attends to the non-conformity in time. Getting the audits done and taking corrective actions in time is the responsibility of the auditee and not of an auditor or the management representative. The management representative plans the audits and allots the auditors. The auditee should follow and get his/her section audited so that the deviations if any are corrected and system is made effective. Any delay in attending the non-conformities indicates the lack of commitment of the top management in communicating the importance of implementing a quality management system and implementing them. 44. The process measuring and monitoring aims at achieving the targeted process performance, which involves getting required productivity and production, reduction of wastes (product/process/system/documents/ cycle time, etc.), reduction of costs, getting best out of people by suitable training as and when required, getting information, communicating and recording the information, getting required material in time by developing supplier’s (internal as well as external) capability, improving infrastructure, preventing problems, developing methods for processing, monitoring process yield, etc. For each process, there shall be inputs, and we need to identify the methods for making best use of the inputs. The process monitoring should result in optimum utilization of all these. The company should develop checklists and formats for monitoring the process and decide on the frequency of monitoring depending on the type of process and the variables involved. 45. Measurement of customer satisfaction has been given importance in the ISO 9001 since its amendment in 2000. Unless we are in a position to understand the level of satisfaction of our customers towards our product and services, we cannot take the required steps. We might

44

Effective implementation of quality management systems

be doing a number of unwanted things with out getting fruitful results. We need to assess the customer satisfaction from the customer perception. It is always better to discuss frankly with customer and get his views. There are a number of methods for understanding the customer satisfaction levels, which include periodic surveys, visiting the customer place and collecting information, customer conferences, analysing data on supplies and feedbacks, interaction with competitor’s customers, market share analysis, trends in forward booking, share of our products in the total purchases of a customer, payment received in time, repeat orders, reference given by our customers to other customers, etc. Some people try to develop an index and compare it to understand the trends in customer satisfaction, where as some other monitor data customer wise, as there is no meaning in going by average when a particular customer is dissatisfied. It is needed for the top management to decide on the method they would like to adopt for monitoring customer satisfaction so that they can take suitable steps to enhance. The real indication of a good satisfaction level of customers is the increase in sales and consistency in demands. A matrix as shown in Fig. 2.4 helps in understanding the customers well. In the example given, a supplier is supplying 3 products, viz., P1, P2 and P3 and supplied to 3 customers, viz., C1, C2 and C3. There were 23 complaints assigned to 5 reasons. By this type of matrix, we can understand clearly the preferences and concerns of individual customers, and address them accordingly. 46. Product conformity to the customer requirements is to be ensured by online and offline monitoring of product and process quality. The product parameters need to be verified with agreed parameters with customers. Normally, some parameters are regularly checked for which specifications are available, where as there are a number of unspecified needs, which we need to meet depending on the quality objectives of the product. Hence, it is necessary to develop measurement systems for those parameters and monitor the same. 47. Continual improvement is needed for any business for its survival, as the competitors are continuously improving. Hence, getting bench marking information, identifying potential areas for improvements, plugging the loss making areas, taking timely corrective and preventive actions and continuous upgradation of knowledge are essential steps. Prompt and periodic review of targets, objectives, procedures and policies are indicative of the top management’s commitment for continual improvement. Without modifying the systems from time to time, continuous improvement cannot be achieved.

45

Understanding and implementation of ISO 9001:2008

R5

R4

R3

R2

R1

Reasons

Period : From__(date)__ to __(date)_

Product

Customer

P1

5

P2

2

C1

P3 P1

1 1

P2 P3

1

P1 P2 P3

1

4

C2 1

1

4

1

C3 1

 Product-wise/reason-wise/customer-wise complaint matrix.

48. The corrective action taken promptly and communicated through out the organization to prevent it from recurring is a very important step in achieving improvement. We normally see that the same types of problems and complaints are repeating, and people happily change the nomenclature as routine problems. There are a number of books available on the causes and remedies for routine problems found in an industry. What is required is to develop Poka-yoke or full proofing the systems and eliminate those problems once for all. A detailed root cause analysis for all the deviations and problems is essential and the root of the problem needs to be attacked to prevent it from surfacing again. 49. We should have a system of identifying the potential problems before a problem can occur. For example, when a new technology is implemented, the people on the spot shall not be aware of the problems they are likely to get. In such cases, a brain-storming session can help in identifying the potential problems. Similarly changes in social scenario, political changes, economic changes, competition, environmental issues, etc., are to be analysed and discussed to identify the potential problems. It is needed to analyse the problems in detail to find the root cause, take action, verify the action and if found suitable standardize. 50. Once we are clear and confident that we are following the system, we can go for certification. We should understand clearly that a

46

Effective implementation of quality management systems

certificate is only a ‘Moral Booster’ and not guarantee that we are doing everything right. We have to do the work and get the results. A certificate shall influence the customer to have some confidence in us, that we are following some good systems, and we can understand his needs and work to his expectations. The customer, during the process of using the materials supplied by us, shall be observing the performance for the life time. Hence the certificates cannot influence a customer to come back, but the performance of our products and services. We need to make our systems strong to remain strong. Getting ISO 9000 is not the ultimate goal. It is only a starting point. We need to go on improving the systems, and win the confidence of customers, so that they remain loyal to us, and our business can run. It is just like our baby getting entry to KG 1, and now we can be confident that she shall get guidance from good teacher. We need to guide her regularly to see that she comes up. Similarly, we need to ensure that the systems are reviewed periodically and aligned with the changing scenario and implemented whole-heartedly to get continuous improvement.

2.3

Undergo audits

It is seen that normally people hesitate to face audits. They are afraid of the remarks that are likely to be made by an auditor. The main reason is the lack of confidence. One needs to understand that audit is a process to ensure conformity to the systems. It is conducted by trained experts. Auditor is not interested in finding a mistake, but any deviation found from actual to practice shall be highlighted as a deviation; might be a non-conformity or an observation. It does not mean that non-conformity is bad. You might have done some improvement, but not documented it. The auditor helps you to document it by raising non-conformity. We go to doctor periodically to get ourselves checked. If any disease is found building up, we take preventive medicines, and some times even undergo surgery to prevent the problem. Here auditor is a doctor, and hence we should cooperate with him and show frankly whatever is asked. Care should be taken not to show anything which is not asked, as auditor is not a perfect doctor to suggest you remedies for everything. The certifying body conducts and adequacy audit before auditing the processes. This is done for ensuring that the quality manual documented addresses all the applicable clauses of ISO 9001 adequately, and there are procedures are documented appropriately. The auditor shall identify any lapses and suggests correcting them. Adequacy audit is not meant for verifying the compliance to the standards, and non-conformities are not

Understanding and implementation of ISO 9001:2008

47

raised. The auditor shall discuss with management representative and asks him to amend the manual wherever it is needed. Once the corrections are made and the quality manual is found okay, the dates for the audits shall be fixed. Wherever an organization is not confident, they can request for a trail audit from the certifying body. The auditors shall go deep in each process area and try to identify maximum number of deviations and advise the organization to correct them. Once all the non conformities are attended, the organization can offer them for final audit. In case the organization is confident they can directly opt for final audit without going for a trial audit. The auditors verify whether the organization is complying with the minimum requirements of the quality management system or not, and raise non-conformities whenever deviations are seen. It is the duty of the auditee to correct them without delay. Certificate cannot be granted if there are any pending non-conformities. However, by seeing the nature of the nonconformity, the auditor can recommend for the grant of certificate, while giving a deadline for correcting the deviations and getting verified by the auditor. Even though implementation of QMS is not a one time job and implemented and monitored on a continuous basis, still we need to prepare our selves for facing audits. The Chapter 7 explains various fine aspects of getting ourselves prepared for an audit. Once the audit is started, face with confidence. Your confidence helps you to win over the auditor.

2.4

Post-certification audits

ISO 9001certification is not a one-time certificate like university degrees. In case of academic degrees, people study a lot and take the degree, but forget what they learnt after some time. However, to get continuous good results, we should continuously work as per system, and cannot afford to forget. Therefore, we need to get ourselves assessed periodically from a third party. This type of audit is called surveillance audit. There shall be minimum four surveillance audits before renewing the certificates. Some of the auditors and auditees opt for half yearly surveillance audits. During each surveillance audit, only selected processes shall be audited, so as to cover all the processes at least twice before going for renewal of certificate. After a period of 3 years, the complete organization shall be thoroughly audited, and if found okay, the certificate shall be renewed. This audit is called as renewal audit. During the post-certification audits, the auditors are supposed to verify the improvements compared to previous audits, and ensure that continuous improvement is visible in the systems and the performance. Therefore, it

48

Effective implementation of quality management systems

is suggested to keep records of all amendments and the reasons for amendments, the corrective and preventive actions taken and the results after each action, the trends in performance for all the key result areas and the records of review of documents and policies.

2.5

Points to remember

1. We need to implement ISO 9001 for improving our performance and to have continuous improvements, and not for the sake of having a certificate as a mark of superiority. 2. Design system to meet the organization’s goal and verify its suitability from time to time. 3. Systematic and uninterrupted following of systems only can give results and not ad-hoc implementation. 4. Procedures are to be developed to suit our requirements to meet our organization goals, and not to be borrowed from others. 5. The process owners should write the procedures and not expect the management representative to write them. 6. We need to satisfy ourselves that we are on the right path in planning, implementing, reviewing and controlling. 7. Document what is needed to ensure smooth working and not what is documented by some one somewhere. 8. Systems designed should empower people to take decisions and move forward to achieve company goals, and not to wait for instructions all the time. 9. The ISO 9001 systems are based on eight management principles, and we need to adhere to them. They are ● Customer focus ● Leadership ● Involvement of people ● Process approach ● System approach to management ● Continual improvement ● Factual approach to decision-making ● Mutually beneficial supplier relationships. 10. Use of five golden questions12 for self-evaluation helps in making the systems effective. Ask yourselves the following five questions every time you are doing an activity and get yourself satisfied. ● Are we having a procedure? ● How do we ensure it as the best to achieve the goals? ● How did we implement? ● Did we get the result as anticipated? ● How do we compare with our competitors?

3 Roles and responsibilities of management representative

!.1

Who should be the management representative?

Management representative is a key person in the implementation of ISO 9000 systems in any company. As per ISO 9001:2008 (14), Clause 5.5.2, top management shall appoint a member of organization’s management who, irrespective of other responsibilities, shall have responsibilities and authority that includes (a) Ensuring that processes needed for the quality management system are established, implemented and maintained, (b) Reporting to top management on the performance of the quality management system and any need for improvement, and (c) Ensuring the promotion of awareness of customer requirements throughout the organization. Note – The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. From the above statements it is clear, that the management representative represents the top management in implementing the quality management systems, which are aimed to achieve the company objectives, while ensuring enhanced customer and other stakeholder satisfaction. He is therefore authorised by the top management to act on their behalf in implementing the systems. To make him successful, the management representative should be a senior person, who commands respect from other members of management and staff. Appointing a junior person as a management representative shall be a hindrance for effective implementation of system organization wide. The management representative must be a person from the organizations’ management, and cannot be an out sourced person. In some of the companies, it is seen that a fresh candidate from college is appointed as a junior executive, who does the work of management



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Effective implementation of quality management systems

representative. His work is to maintain the records and keeping the manuals and procedure documents in a safe place. In one such case it was found that the management representative had not undergone the basic awareness programme on ISO 9001, but the company was an ISO 9001:2000 certified. Some consultants were managing to get the certificate. By taking certificate in this manner, the company cannot get any benefit as the systems are not improved. They will have a certificate hanging, without realizing that the company’s future itself is hanging. In some of the companies, it is seen that management representative is a separate man from the regular activities of the organization and is not assigned any regular responsibilities. This man will concentrate only of documentation, conducting audits and liaising for management reviews and audits. The reason given is “The activities are too many and the documentation is difficult. A separate man as MR can concentrate on documentation, and shall be able to explain to auditors so that the certificate is got”. Here the basic purpose of implementing ISO 9000 is lost. The organizations should realize that ISO is not a separate activity, but a part of the activities that are being carried out in order to meet the objectives of the company. There is no need for doing an activity that is not contributing for meeting the objectives of the company. By keeping MR as a separate entity, without any regular assignments, the management gives a message to all that ISO 9000 activities are additional activities, and is not a part of regular activities. By this the MR shall have resistance from the co-employees, who get a feeling the ISO 9000 activities are a burden. A management representative should be a role model, who can demonstrate to the people by implementing the concepts of quality management system in his routine works. The management representative should be a senior manager with regular responsibilities, and should be able to implement the systems while doing his regular activities. Then only he can command others to implement the systems as a part of their regular activities. If he is a separate man, he shall never get recognition. It is a normal practice in majority of the companies that the chief of quality control becomes the management representative, because they are implementing quality management systems. It is a wrong understanding. The quality control activities are normally concentrated on product quality, and it is a technical job. The ISO 9001 is concentrating on the quality of the management system and not only on the quality of the products. If the management system is good, the quality shall be good at all places. Therefore, a senior manager having command on all the sections and departments is the best person to become a management representative and he should be dedicated.

Roles and responsibilities of management representative

3.2

51

Jobs expected from management representative

The following are the jobs normally expected from the management representative. 1. Understanding the company mission, vision, policies and objectives carefully, and communicating the same in simple language down the line. He should ensure that people have understood the same and will be able to demonstrate it in their routine activities. 2. Helping HODs in deriving the departmental objectives, policy and goals considering the company objectives and policies. The concerned HOD is responsible for writing the policy and goals for his department and sections. The management representative helps in writing them precisely by linking them with the company objectives and goals. 3. Liaising with standard bodies and getting the latest applicable national and international standards required for implementing and maintaining ISO 9000 series of standards. It is expected that the management representative is always thorough with the changes in the standards. It is suggested that he become a member of professional bodies, create alerts in internets, browse the internet on regular basis and get updated with the changes. He should be a leader in understanding the concepts. 4. Explaining the concepts of ISO 9000 throughout the organization. Help of expert professionals can be obtained in giving training. It is always better that the management representative trains people within the organization for explaining the concepts down the line rather than hiring experts from outside. The help of outside experts are to be taken only to educate the top management and senior managers. 5. Communicating the importance of meeting customer as well as regulatory requirements during the training programme or in any other occasion found suitable for this purpose. The management representative needs to liaise with marketing, quality and production people in understanding the real concerns and requirements of customers and ensure that they are communicated down. It does not mean that the management representative should personally communicate these things down the line. He needs to verify and ensure that the systems are working to communicate the customers concerns and needs down the line. 6. Proactively discussing with the people and ensuring that all have understood the real essence of the quality policy, quality objectives and goals, their role in achieving the goals and in complying with the statutory, legal and regulatory requirements. He should educate

52

7.

8.

9.

10.

11.

12.

Effective implementation of quality management systems

the internal quality auditors to verify the compliance for statutory, legal and regulatory requirements during the audits. However, it is found that importance is not given to this point during internal quality audits in majority of companies. Preparing quality manual is one of the main responsibilities of the management representative. This should be done in line with the guidance given in ISO 10013 and in consultation with the top management. The manual should be written in simple words so that all can understand with out any confusion. Getting the manual approved and releasing them in time is also the responsibility of management representative. Identifying the processes required for implementing quality management systems that can help achieving company goals is a very important step in the implementation of quality management system. The management representative should conduct interactive sessions among departments and map the activities in a flow chart, and identify the control points. The management representative should take active part in helping the HODs in identifying the controls in processes identified and documented. This should be done by considering the company objectives, goals, requirements of quality management systems and legal and regulatory requirements. Developing procedures for document identification, document control and amendment of documents, withdrawal of documents, document distribution and for maintaining documents for reference are the prime responsibility of the management representative. In some companies it is seen that the controlling documents relating to one’s specific section is made the responsible of the concerned HOD, and the management representative does not interfere in it. Getting the documents viz. work procedures, work instructions, job descriptions, process parameters and specifications, etc., prepared by the concerned personnel and bringing them under control is one of the important jobs of a management representative. In some companies they expect the MR to prepare those documents, which is a wrong practice. The concerned HOD, who is doing the work, should prepare the procedures, instructions, etc. The MR should only control them from getting duplicated, or going to unauthorized persons. Over a period of time, we see number of formats is developed in an organization, and some of them may be a duplication of work. Scrutinizing all the formats used in the organization and standardizing them is a very important activity, for which the management representative is responsible. He need to collect all the forms, list them and index them, and discus with the concerned people and

Roles and responsibilities of management representative

13.

14.

15.

16.

17.

18.

19.

20.

21.

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modify them to reduce the number of forms and make them more effective and user friendly. Maintaining the master list of all documents, records and forms, and the distribution charts is one of the prime responsibilities of the management representative. It is normally seen that numbers of records are maintained in any organization. There might be duplication of records, and some vital information might not have documented at any place. It is the responsibility of management representative to help the HODs in identifying the records to be maintained considering the company/ department/section and individual activities, goals and targets. Interpreting the customer requirements and communicating down the line is an important activity in any organization. The management representative is expected to help the concerned HODs in preparing the specifications and guidelines for meeting the requirements. As the technology advances and the company adopts new technology and systems, there is a need to amend the procedures and the documents. Arranging for adequacy audits in case of any changes in system, process or the people is one of the main tasks of a management representative. Preparing the procedures, instructions, manuals and documenting them is not the end of implementation. Everyone needs to read them, understand and implement in their routine works. Training the people to adapt to the systems is very important. The management representative is expected to arrange for training of users for the use of documents and records. We need a team of internal quality auditors to periodically audit the systems through out the organization. Identifying the potential internal quality auditors and arranging for their training is one of the responsibilities of the management representative. Internal quality audits should be effective and all auditors and auditee should follow the requirements meticulously. Developing procedures for internal quality audits and training the users for the implementation is the responsibility of management representative. Internal audits needs to be planned in advance and communicated to the users for the effective implementation of the systems. It cannot be a surprise audit as a quality control man does. Planning internal quality audits and arranging for the audits is one of the prime responsibilities of the management representative. Closing the non-conformities without undue delay is the responsibility of the auditee. However, it is seen in a number of cases that unless the management representative is after the auditee and auditor, the non-conformities are not attended and closed. Hence, following up

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22.

23.

24.

25.

26.

27.

28.

29.

Effective implementation of quality management systems

with the auditors and auditee for the timely closing of non-conformity has become the responsibility of the management representative. Due to various reasons, the auditee might not accept the nonconformity raised by an auditor (especially in the internal quality audits). Sorting out the difference of opinions between auditors and auditee relating to the non-conformities and the observations during audits by referring to the standards is one of the responsibilities of the management representative. It is seen in a number of cases that the auditors fail to write the nonconformity notes precisely explaining the nature of the nonconformity and its potential effects and linking the observed nonconformity to the clauses of ISO 9001. Guiding the auditors in writing the non-conformity notes and linking them to the guidelines given in the standards has become one of the responsibilities of the management representative. Conducting periodic review of the activities is the responsibility of the top management. However, due to their varied nature of activities and the changing priorities, they do not proactively conduct the reviews. They expect that discussing with the top management and arranging for periodic review as the responsibility of management representative. Therefore, this activity becomes one of his regular tasks. Similar to internal quality audits, the external audits also are to be done periodically. Liaising with the certifying body and top management and getting audits done is the responsibility of management representative. Normally the auditee, although capable, expects the management representative to guide him in closing the non-conformity raised during external audits. Following up for closing of non-conformities in time becomes the responsibility of the management representative. After the audits, getting the certificate and audit reports is very essential. Following up with the certifying body in getting certificate is one of the responsibilities of the management representative. Educating all concerned in the organization regarding the certificate and ensuring proper display of the same at prominent points also is the responsibility of the management representative. The responsibilities of the management representative include maintaining the records of internal quality audits, management review, external audits, auditor’s attendance and performance, auditor’s training, trends in performance, follow up for the actions decided in the management review and the correspondences relating to the implementation of quality management systems.

Roles and responsibilities of management representative

55

30. Reporting the progress in the implementation in the quality management systems to the top management from time to time is one of the prime responsibilities of the management representative. 31. The management representative is expected to get information proactively on the changes coming in the quality management systems and alarming the people in the organization in time.

3.3

Tips for management representative

1. Help the people in preparing and documenting the procedures, but do not prepare yourself. 2. Help the auditee to close the non-conformities by showing the path, but do not prepare the documents yourself for closing the nonconformities. 3. The auditee is responsible for attending and getting the nonconformity closed in time and not you. You can only insist them to attend. 4. Let the concerned HOD have the responsibility of reviewing and approving the procedures. Do not take that on your shoulder. 5. You are representing the management, and hence, all your words shall have a weight, for which top management is accountable. Hence be careful while talking. 6. You are considered as a ‘Guru’ for implementing the systems. Involve yourself and understand the systems fully. 7. Management representative often referred as ‘MR’, ‘mentally retarded’ as he tries to improve the culture among the people and the organization that have not felt its need. They feel that they are the best and there are no ways to improve further, but this ‘mad management representative’ goes on insisting them to implement systems and improve. He is mad, and he should be mad after implementing the systems. 8. As a management representative, you are a key person for implementing the quality management systems. You should command the same respect as the top management. 9. The management representative cannot be an isolated person in the organization, but a part of daily activities. Therefore, proactively involve yourself in various activities of the company. 10. Understand your role and responsibilities, and be a role model in implementing QMS in your routine activities.

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Internal quality audits Effective implementation of quality management systems

4 Internal quality audits: A strong tool for quality management

4.1

Need for audits

We might claim to have developed good procedures and systems and might be following them religiously; however, we cannot forget that we are human beings, have a tendency to relax and forget vital things unconsciously. We, unlike machines, get tired and use our own logics while following instructions or procedures and tend to bypass parts of system feeling it as not essential. It also might be a fact, that a particular activity was really not essential to get our results and meeting objectives without problems. In a number of cases, we are unable to identify the inadvertent mistakes or deviations while we are on the job, but can realize when others point it out. It is essential that there is a system of monitoring. A process can be monitored by various means, which include supervision by the concerned supervisors, checking by quality control investigators, review by heads of the department, online process monitoring by using electronic devices, internal quality audits and audits by external agencies, etc. The quality audit (15) is defined as timely process or system inspection to ensure that specifications conform to documented quality standards. An audit also brings out discrepancies between the documented standards and the standards followed and also might show how well or how badly the documented standards support the processes currently followed [Ref: Six Sigma Quality Dictionary]. As per ISO 9000 (16), the audit is a systematic, independent and documented process for obtaining audit evidence (records, statements of facts or other information which are relevant to audit criteria), and evaluating it objectively to determine the extent to which audit criteria (set of policies, procedures or requirements used as a reference) are fulfilled. The book by Pradeep Kumar Mathur (4) on implementing ISO 9001:2000 defines quality audit as a systematic, independent and documented process of examining any activity of an organization based

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on objective evidence, to determine the extent to which quality activities and related results comply with the planned arrangements, the extent to which these arrangements have been implemented effectively, and whether these arrangements are suitable to achieve the quality objectives. Periodic audits help us in identifying the deviations in systems, procedures or quality, so that timely actions can be taken to rectify them. It helps us in bringing back the systems to track and ensure quality and in taking corrective actions to prevent recurrence of the problems or deviations. Audits give a confidence to the management that the systems and quality produced are as per the requirements. In a production department the concerned supervisors and the heads of the departments are responsible for both quality and productivity, where as the quality control investigators are responsible only for quality. The auditors of both internal and external shall only identify the deviations and report, but are not responsible for getting corrective actions. The auditors are responsible for verifying the corrective actions. The online monitors are programmed electronic equipments, which monitor certain parameters and cannot have their own thinking. The production supervisors and the concerned departmental heads are normally production oriented as their performance is measured by the productions they achieve. Therefore, their priority becomes getting production and pushing them further. They cannot spend time for going in detail to the adherence to the systems and process parameters, unless otherwise there is a problem in working. They feel that if the production is coming as per expectations, the quality and process must be correct. The quality control investigator otherwise goes in a different direction. He checks some machine or process and notes down all the deviations. He informs to the top boss highlighting the deviations. The grievance of the production people is that the top boss normally fires the production people for the deviations reported, but never sees how much good work is done by them; on the contrary, the quality control man does not do any work other than finding mistakes of production people who are already loaded with different problems like production, labour handling, maintenance, balancing of back process, maintaining house keeping, and so on. Therefore, the quality control people are normally treated as enemies of production people. In a number of companies, it is not tolerated if quality control man is friendly with production people. The latest concepts of quality management always insist on internal quality audit rather than checking by fixed quality control auditors. Let us discuss in detail regarding the concepts of internal quality audits.

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4.2

Internal quality audits

Internal quality audits are done by the people inside the organization, who are normally engaged in different tasks like production, quality control, maintenance, accounts, stores, human resource management, information management, etc. They audit the process of different sections, other than their own, as per the planned programme. The auditors are specially trained with a skill of identifying the deviations. They are also trained for highlighting the non-conformances without targeting the person working, but as a deviation in the process or system being followed. They explain the deviations and verify the corrective actions taken and report to the top management. Internal quality audits are not surprise checks as done by quality control investigators, but are planned. They are planned well in advance and informed to the auditee. In case of surprise checks, only a small area can be checked, and in that some deviation if found may be highlighted. The concerned persons correct the deviations highlighted. In this case we do not know about the deviations in the areas not checked, which shall continue to produce poor results. In case of internal quality audit, as the information is given well in advance, the process is checked by the people on spot thoroughly, and they themselves take corrective actions. What the company needs is corrective actions in time and produce good results, and not finding fault and taking action on some one. The auditors are in-house people, and they know the company systems. Hence while auditing they shall be keeping that point in view. As the internal auditors conduct audits of different sections of an organization in rotation, they get an idea of the complete systems in the organization. Therefore, it helps the development of staff conducting audits in understanding the complete systems and problems of the company. It helps them when they are promoted to higher posts and they shall be able to tackle the problems effectively. This system also wakens up the inner morale of the auditors. When I see a deviation in some other department, my mind works to find out whether I have a similar deviation in my section. I shall try to attend it immediately, as I do not want someone raising nonconformity in my operations. So in one stroke we are correcting at two places, with out making a hue and cry.

4.3

Quality control versus quality audits

The quality control and quality audit, although look similar, have number of differences. A process can be monitored by various means, which include supervision by the concerned supervisors, check by quality control investigators, review by heads of the department, online process monitor

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by using electronic devices, internal quality audits, and audits by external agencies, etc. The concerned supervisors and the heads of the departments are responsible for both quality and productivity, where as the quality control investigators are responsible for checking the quality and reporting suitably in time. The auditors of both internal and external shall identify the deviations and report, but are not responsible for getting corrective actions; however, they are responsible for verifying them. The online monitors are programmed electronic equipments, which shall monitor certain parameters only and cannot have their own thinking. Let us study the definitions. Control [As explained by Six Sigma Quality Dictionary] (15) – Statistical control process is one that is free of assignable/special causes of variation. Such a condition is most often evidence on a control chart which displays an absence of non-random variation. It is a technical function in nature and a continuous process by which the expected results are measured against predetermined criteria or standards. In case of variances, a disciplinary action will be undertaken or improvement actions will be pursued. Quality control [As explained by Six Sigma Quality Dictionary] (15) – Quality control is the managerial process during which actual process performance is evaluated and actions are taken on unusual performance. It is a process to ensure whether a product meets predefined standards and requisite action taken if the standards are not met. Quality control measures both products and processes for conformance to quality requirements (including both the specific requirements prescribed by the product specification, and the more general requirements prescribed by quality assurance). It identifies acceptable limits for significant quality attributes and identifies whether products and processes fall within those limits or falls outside them and reports accordingly. Correction of product failures generally lies outside the ambit of quality control. Correction of process failures may or may not be included. Audit [As explained by Six Sigma Quality Dictionary] (15) – A timely process or system, inspection to ensure that specifications conform to documented quality standards. An audit also brings out discrepancies between the documented standards and the standards followed and also might show how well or badly the documented standards support the processes followed. Corrective, preventive and improvement actions should be undertaken to mitigate the gap(s) between what is said (documented), what is done and what is required to comply with the appropriate quality standard. Audit is not only be used in accounting or something that relates to mathematics but also used in information technology.

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Effective implementation of quality management systems

4.4

Product audit versus system audit

The product audit consists of verifying the parameters of the product against customer requirements; for e.g., in garments the fabrics feel, garment dimensions, fittings, the trims used, the labels, etc. In case of deviations found the materials are returned for rework. If rework is not possible or not feasible, they shall be down graded. Depending on the lot size offered for inspection, sample size is decided. The acceptance or rejection is decided referring to AQL tables or as agreed between customer and the supplier. The product audits do not verify whether the people are following the systems as required to get the required quality. The system audits emphasize on following of the systems in line with standards or documented procedures. If system is followed religiously, the result is bound to come and assure quality. In labour-oriented consumer product industry, both product audit and system audits are followed regularly. The system audit is more important, when it is a labour intensive industry, and the employee turnover is very high. Recruitment, training and system audits are continuous processes. The system audits verify not only the manufacturing activities but also the management systems, adhering to legal and regulatory requirements, social accountability, and welfare activities.

4.5

Top management review versus quality audits

The top management reviews the performance on a regular basis to understand whether the activities are carried out as per the plan. They base their reviews on certain control points and check points, which they feel important. This is also called management by exception. The effectivity depends on the capability of the top man. As the same person reviews the activities, there are chances of bias getting developed, and might not be able to see the deviations. In case of internal quality audits, different auditors from different sections conduct audits, and hence their views are different. They can identify certain vital deviations, which top man cannot identify. The people working observe the top man on a regular basis and identify his likings, disliking and expectations. Moreover, the review frequency and the timings are almost fixed and people try to project only those points which are liked by the top man. By this, some vital deviations or drawbacks get camouflaged and go unnoticed. As auditors are unbiased and outsiders, one cannot selectively hide the facts and hence the real deviations are exposed. Actions can be initiated to correct the deviations. The top man, by his involvement and experience, shall be clear about the process and able to identify vital deviations faster. Auditor shall not be able to identify inefficient procedures that are followed, where as an experienced top man with deep knowledge of the process requirements

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questions the basis of the procedure adopted, and modifies them. An auditor being an outsider cannot suggest any improvement, but can only say that a deviation is found. He doesn’t know whether the deviation found was advantageous or disadvantageous. Table 4.1 gives few differences among quality control, review by top man and internal quality auditing. Table  Few differences among quality control, review by top man and internal quality auditing. Type of monitoring

Quality control checks

Review by top man

Internal quality audits

Planned/Surprise

Surprise checks

Planned review

Planned audit

Action taken on

Deviations found

Deviations found

On all aspects in advance, and especially on deviations found.

Relations

The production person always sees QC man as a faultfinder, and hence no team work.

Top man is the boss, and hence people down the line hesitate to highlight the mistakes in instructions.

Free atmosphere as auditor is a third person, and does not find only faults, but shows the area for improvement. Hence it is teamwork.

Action starts

Action starts after the deviation is noticed.

Action starts after the deviation is noticed.

Actions start before deviation is noticed.

What is reported

Mainly deviations

Both compliance and deviations

Both compliance and deviations

Career development

No chances

Slight to the extent the boss educates.

Self-learning while auditing the systems of other sections.

Improvement chances at the other end

Nil

Nil

Auditee improves his own systems after seeing good systems at auditee place.

Anxiety

Anxiety prevails as we do not know what shall be reported by QC man to top person.

No anxiety as the boss tells clearly his findings.

No anxiety as the auditor discusses with auditee while drafting his report, and while rising nonconformities.

Participation

Only by the incharges and the QC investigator.

Only by boss and the in-charges

By all working in the section along with the auditors and the boss.

4.6

Types of internal quality audits

The internal audits are of two types: adequacy audit and compliance audit. The adequacy audit is to ensure that the procedures laid out cover all the

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aspects of the quality management, where as the compliance audit ensures that the procedures laid out are followed religiously. The adequacy audits for process and systems shall be done by the senior officers of the concerned section, where as they can take the help of the management representative of ISO 9000 to ensure proper linking to the requirements of ISO 9000. In some industry, teams are made to audit the system for adequacy, which can see the systems from different angles because of their varied experiences. The teams such formed might include senior officers, junior officers, officers from quality control as well as production, senior workmen, etc. The compliance audits are normally done by a third person from another section or department. He shall first go through the procedures laid out and verify the compliance to the laid out procedure. He shall have no authority to judge and report a deviation as a better system, although it gives better results. He shall only say that the system followed is different from the system laid out. It is up to the auditee to change either the documented procedures or to adhere to the documented procedures. One can take the help of outsiders to do compliance audits if needed. The internal audits for process may be decided for a particular part of process and need not be for complete operations of a section, like checking the systems of channelisation and colour codification, the system of new product introduction, the system of changes to be made during product changes, the system of training the workmen, the system of material handling, the system of safety operations, maintenance systems, record keeping and their utility, actions on complaints and feed back, etc. The machine audit, the tools audit, the safety gadgets audit, the power distribution system audit, the material handling equipments audits etc., are specialized audits done only by qualified and experienced technical personnel, and not by others.

4.7

Pre-requirements of an auditor

Internal auditors are people from within the organization those have been trained to conduct audits. The training can be done by the organization itself if the expertise exists or by an expert body hired for the purpose. There may be any number of internal auditors in a section. More the auditors, it is always better. The auditors shall not audit their own section except for internal adequacy audits. The auditing is not a fault-finding process but a fact-finding process. It is not a crime if deviations are found. If we are not getting the results as required, then we need to re-discuss as to whether follow the process as documented or not. When we get the results, it is suggested to document

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the process as being followed. Our final aim is to achieve the results as a result of following a judicious system and not getting a result by chance, or in other words, by grace of someone like God. So the auditor shall instigate the auditee to think and take the real corrective action for the deviation found, and not just changing the documents to close the nonconformity rose. The auditor is a friend and not an enemy. He comes to show the deviations made by us so that we correct ourselves. Auditor is not supposed to suggest corrective actions. However, in case of process management relating to production operations done by a senior technical person of the same organization, the advantage can be taken to improve the system. The auditor finds the deviation as a deviation from the system and not as a mistake done. A deviation in system can be due to improper communication, improper understanding of the process or by some new developments done recently for improvement that was not documented. The auditor shall not target any person for highlighting the deviations. He shall highlight the events where deviations were found, and can give the name of the person as an example. The auditor should verify the compliance by asking for evidences, like production records, test results, demonstration of calibration, demonstration of an activity, personally checking the speeds, setting, etc., visiting the spot of actions being taken and the process going on, questioning the people on the spot to understand the extent of understanding of the objectives, targets, procedures and systems by the people working on the spot, the display boards put in the department for giving various instructions, etc. The auditor is not supposed to assume any thing, and he should record only what he has verified. The auditor should go with a proper checklist prepared after carefully going through the procedures, work instructions, job descriptions, process parameters, etc. He should identify the links between the processes and procedures and verify the effects of non-compliance. This is called a linking exercise. A change done at one place might affect the performance of other section, and auditor is the person who can highlight that. The auditor should be friendly with people and has no authority to fire any of the auditee members, even though he is a junior person. His job is to convince the other man regarding the deviation observed comparing to what was planned. The auditor is not a trouble shooting man, going with a mission of identifying a root cause for a problem and implementing corrective actions. His job ends only in identifying the deviations. If required, the company can ask the auditor, after the audits are over, to become a member of trouble shooting team to solve the problems found during audit, as a normal process

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of forming a cross-functional team for problem solving. This activity should not be linked to auditing activity. The auditor is supposed to give a written report of the findings, with clarity on what was actually found and what was in the documents, how it affects the systems and objectives. Therefore, the auditor should have good knowledge of writing the reports in the language that can be understand by the auditor. The auditee should write the cause for that deviation and proposes corrective actions. Once the corrective actions are taken, the non-conformity shall be closed. The wordings used in the report given by an auditor should be simple, easy to understand and give clear meaning of what the auditor found as a deviation. Hence, writing the report is a highly skilled job, and the auditors are to be suitably trained. The auditor should hence be a good communicator.

4.8

What is to be verified?

The auditors need to plan and carry out internal audits based on the status and importance of the area to be audited as well as the results of the previous audit. The most important is ensuring objectivity and impartiality in the audits carried out. The auditor should ensure that the actions taken after audit are verified again. In order to make the job easy, the auditor should prepare a questionnaire before starting an audit and prioritize the questions in order to save his as well as the auditee’s time. This depends on the purpose of audit. In case of adequacy audits, the questions are prepared to verify whether a particular aspect is addressed effectively or not. These are done mainly for the formats designed for various purposes in process monitoring, the flow chart and the procedures, the work instructions and process parameters. For example, a questionnaire designed to verify a form for sort change on loom in a textile mill could be as follows. Table  Questionnaire for sort change Question

Status

Whether the sort number is allotted? Whether the material and count details are covered? Whether the construction details are given? Whether the loom speed is specified? Whether the set lengths are specified? Whether the reed type is defined? Whether the fabric specifications are defined? Whether the selvedge construction specified? Whether starting and end time of loom gaiting mentioned? Whether customer feed back indicated?

Yes Yes Yes No. left to the weaver Yes No. Left to the weaver Only construction. No. Left to the weaver Yes Yes

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The technicians can prepare their own questionnaire or a checklist depending on the importance of the activity. Following are some of the guidelines.

4.8.1

General

1. Understand the activities carried out in the auditee section, and link it to the main process of the company. 2. Find out the importance of the activity in achieving the company goals. 3. Verify whether any targets are set for the goals. 4. Find out how the auditee is monitoring the activity. 5. Check for the evidence for monitoring. 6. Find out whether the procedure for doing and monitoring the activities are documented. 7. Verify how the objectives stated in the procedures have been linked to the targets set. 8. Verify whether the objectives specified for each procedure are measurable or not. 9. Enquire how the procedure written is helping in achieving the targets set. 10. Verify whether the people performing the job have understood the procedures documented. 11. Check whether the resources required are adequately documented. 12. Verify the process of getting the resources for performing the job. 13. Verify whether the applicable legal, regulatory and statutory requirements are identified and documented. 14. Verify the legal and regulatory requirements section wise that are to be fulfilled. 15. Check whether the people performing are clear about the legal and regulatory aspects that they need to fulfil. 16. Verify the records identified by the section. 17. Verify whether the records cover all the activities of the section or not. 18. Verify how the records are used in taking decisions. 19. Whether the records identified cover all the objectives spelled out? 20. Whether the records are maintained properly to have easy retrieval? 21. Verify whether the records are controlled and protected from getting damaged. 22. Verify whether the life and disposal of records are determined and followed. 23. Verify whether the people are aware of their authorities and responsibilities.

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24. Verify how the authorities and responsibilities determined help in achieving company goals? 25. Whether the people are aware of the complaints and feed backs from internal and external customers? 26. Verify the actions initiated considering the feedback and complaints. 27. Find out whether the actions taken are documented and relevant procedures amended to prevent the problem from recurring. 28. Verify how the customer (internal/external) gets reaction for the feedback/complaint. 29. Verify the activities reviewed periodically and their frequency. 30. Verify the actions taken on the review out puts. 31. Verify whether the actions taken gave the required results. 32. Where the required results are not achieved, verify the process adopted to rectify the same.

4.8.2

Top management

1. Verify whether the purpose (mission), vision, quality policy and quality objectives are defined. 2. Verify the linkages between the various statements made by top management, viz, mission, vision, quality policy, quality objectives, departmental objectives, company concerns and the policy decisions taken from time to time. 3. Verify the organization structure defined and compare with the actual. 4. Verify the involvement of top management in communicating down the line the importance of meeting legal and regulatory requirements. 5. Verify the involvement of top management in monitoring the compliance to legal and regulatory requirements. 6. Verify the regularity of conducting reviews and follow up actions on the review out puts. 7. Verify whether the inputs for management review meet the minimum requirements for quality management systems. 8. Verify whether the reviews are effective and helping in achieving continuous improvement in process, system, product and customer related results. 9. Verify the process of deploying the policies down the line by the top management. 10. Verify whether the people down the line have understood the policies. 11. Verify the system of reviewing for adherence to legal and regulatory requirements. 12. Verify whether the potential problems in meeting the regulatory requirements are identified and suitable remedial actions taken.

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13. Verify the system of communications for conveying the importance of meeting customer and regulatory requirements down the line. 14. Verify the involvement of top management in planning the quality management systems. 15. Verify the resources identified as required for enhancing quality systems. 16. Verify the system of reviewing the resource requirements in order to enhance customer satisfaction, achieving company objectives and for improving quality management systems. 17. Verify the involvement of top management in providing/maintaining human related work environment. 18. Verify whether the management representative is adequately trained to implement the systems. 19. Verify whether the management representative is updating self regarding the changes in the quality management systems and applicable standards 20. Verify whether the internal quality auditors are adequately trained. 21. Verify whether the trainers were competent. 22. Verify whether the internal quality audits were done as scheduled. 23. Verify the actions taken on the findings of internal quality audits and their effectivity. 24. Verify whether the actions are taken without undue delay for closing the nonconformities raised during audits or quality control checking. 25. Whether the results of internal quality audits show a trend of continuous improvement? 26. Verify the system of identifying potential problems and taking remedial actions. 27. Verify the system of getting involvement of people in improvement activities.

4.8.3

Production

1. Verify the system of planning the processes needed for product realization. 2. Verify the linkage of the system of planning for product realization to the adopted quality management system. 3. Verify whether quality plans are available for all the products being manufactured. 4. Verify whether quality objectives are defined for each product being worked. 5. Verify whether the customer requirements are clear to the people in production line.

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6. Verify whether any minimum information requirements are worked out to assess the customer needs and to help translating them to production parameters. 7. Whether the process capability is worked out for the production process to ensure meeting the customer requirements? 8. Verify the production activities as on date and their relevance to the quality plan. 9. Whether the products to be manufactured are adequately designed to meet the customer requirements? 10. Whether the product quality objectives are translated into product specifications? 11. Whether the resources specific to the product are prepared? 12. Whether the required verification, validation, monitoring, inspection and test activities specific to the product are worked out and documented? 13. Verify whether the required verification, validation, monitoring, inspection and test activities for each product are conveyed to the people on the spot responsible for production. 14. Whether the authorities and responsibilities are determined for the design and development activities during planning for the product realization? 15. Whether a system exists for interface between the different groups involved in design and development of the product? 16. How the planning of designs ensure effective communication during design and development of the product? 17. Verify the system in force for ensuring the inputs for design are adequately defined and documented. 18. Verify whether the functional and performance requirements of the product are considered as a part of the input requirement or not. 19. Verify whether the applicable statutory and regulatory requirements are considered as a part of the design input requirements or not. 20. Whether all the determined design inputs are reviewed for its adequacy? 21. Is it ensured that the design requirements are complete, unambiguous and not in conflict with each other? 22. Are the outputs of design and development provided in a form enabling verification against the design and development inputs? 23. Whether the designs are reviewed to ensure trouble free working? 24. Whether the designs are verified by competent authorities to ensure that the product meets the required quality objectives? 25. Whether the designs are validated to ensure that the product meets the requirements?

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26. Verify whether the design out put meet the design input requirements or not. 27. Whether the design changes are properly recorded? 28. Verify whether the designs of the products are controlled effectively or not. 29. Verify the process parameters adopted and compare with those derived by the design process. 30. Whether any special processes exist in the production line, where the results can be known only after the work is complete? 31. Whether the special processes are identified or not? 32. In case of special processes, whether the process is validated to ensure the requirements are met? 33. Does the validation demonstrate the ability of these processes to achieve planned results? 34. Whether any control points and check points are prepared for the process being followed? 35. Verify whether the working conditions like temperature, humidity, noise level, light, dust level, etc., are maintained as appropriate to the process. 36. Verify whether the men employed are having adequate knowledge and skills required for the job. 37. Verify the safety precautions that are followed in relation to the safety requirements. 38. Verify the system adopted for identification and traceability of materials in relation to the systems documented. 39. Verify whether the status of the product is displayed based on monitoring and measurement requirements. 40. Look for the monitoring systems available on the production equipments, and their utilization in process monitoring. 41. Is the monitoring and measuring device that has been devised and implemented are capable of providing evidence of conformity of product to determined requirements? 42. Does the monitoring and measuring are in a manner that is consistent with the monitoring and measuring equipment? 43. Check whether the validity of results measured previously are revalidated when equipment is found non-conforming to the requirements. 44. Check the material handling systems adopted and their suitability for the materials being handled. 45. Inspect the material storage place and verify in relation to norms considering the safety and quality. 46. Verify the maintenance systems adopted and compare with documented system.

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47. Verify whether the maintenance activities gave the results as anticipated or not. 48. Whether any auditing is done for maintenance system to ensure its effectiveness? 49. Whether any records are available to study the trend of continuous improvement in maintenance activities and results as a result of good maintenance in quality, production etc.? 50. Whether the materials being produced are checked at different levels as decided in quality planning? 51. Whether the equipments used for testing and monitoring are calibrated and ensured for reliability and accuracy, and are traceable to national or international standards? 52. Whether the maintenance of testing instruments done to ensure the accuracy of the readings? 53. Whether there are any material supplied by customers to be incorporated in the product being produced? 54. Whether proper accounts are maintained to monitor the customer supplied products? 55. Whether any person is designated to monitor and communicate relating to customer supplied products? 56. Whether adequate care is taken to prevent materials from damages during handling, storage and transporting? 57. Whether material handling equipments are maintained periodically to ensure their quality? 58. Whether places are demarked for keeping non-conforming products? 59. What measures are taken to monitor the process? 60. Whether process monitoring is done as per the planned programme? 61. Whether any norms are given to the process monitoring personnel for monitoring? 62. Whether the persons monitoring the processes have the knowledge as to why they are maintaining those process-monitoring norms? 63. How the non-conforming materials are being dispatched? 64. Whether any structured system is available to take corrective actions for non-conforming process and products? 65. What data are collected for daily monitoring of the process? 66. How the data collected are utilized? 67. Whether the auditee can demonstrate continuous improvement in the process and product quality? 68. Whether any systems exist to proactively look into the problems and take preventive actions?

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4.8.4

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Human resource management

1. Verify whether the human resource requirements are planned. 2. Verify the method adopted for planning the human resources. 3. Verify how the human resource planned is linked to company objectives and goals. 4. Whether the objectives of HRD for the process being audited are specified? 5. Whether the HRD objectives are achieved as committed? 6. Verify the actions initiated where the objectives are not fulfilled. 7. Whether the actions taken are evaluated to ensure that they gave the results? 8. Whether minimum competency requirements are spelled out for the jobs being handled? 9. Whether the competency levels of the person engaged meet the minimum requirements specified? 10. Whether records are available for monitoring the competency levels of persons and the job requirements with the concerned process owner? 11. In case the competency levels are not up to the requirements, what actions are taken to correct it? 12. How the actions taken are evaluated? 13. Verify whether the people working are aware of the relevance and importance of their work in achieving the quality objectives of the product and also the company objectives. 14. Whether the work environment required for the process are defined and documented? 15. What processes are adopted to maintain the work environment to uplift the morale of the employees? 16. Whether the critical processes like taking disciplinary action, recruitment and promotion etc., have defined procedures? 17. Whether the training needs are identified for critical persons? 18. Verify the method of imparting the training and evaluation of its effectivity. 19. Whether the persons giving training are adequately qualified to give training? 20. Verify whether the training needs identified is logical to bridge the gap in the competency level. 21. Whether the persons working are clear about the legal and regulatory requirements? 22. How the auditee section of the process ensures that the legal and regulatory requirements are met? 23. Verify the evidence of meeting regulatory requirements.

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24. Verify the system of analysing data related to accidents, fires, absenteeism, indiscipline reported, grievances, unrest, strike etc., and the results of actions taken. 25. Verify the system of planning welfare activities, and prioritizing the activities. 26. Verify the system of evaluating the effects of welfare activities undertaken.

4.8.5

Maintenance activities

1. Verify the system of planning the maintenance activities. 2. Verify how the maintenance activities planned help fulfilling the company objectives. 3. Verify whether the tools being used for various activities are suitable for the purpose. 4. Whether the workmen are clear about the tools to be used for various works? 5. Whether the maintenance gadgets are adequately calibrated to ensure accuracy and reliability? 6. Whether the workmen are adequately trained to handle the equipments? 7. Whether safety precautions to be taken are known to workmen? 8. Verify the safety precautions taken while working. 9. Verify the objectives of the maintenance section and their relevance to company objectives. 10. Verify the action plans developed for meeting the maintenance objectives and targets. 11. Verify the method of monitoring the maintenance activities. 12. Verify the results of maintenance activities in terms of reduced breakdowns, reduced machine downtime due to breakdown, improved quality of the products, reduced power consumption and costs. 13. Verify the system of maintaining safety equipments including fire fighting, ambulance and safety gadgets provided on machines, safety alleys, etc. 14. Verify the systems for maintenance of civil works, water supply, power supply, water purification, boiler, effluent treatment and sanitation systems. 15. Verify the methods followed for waste disposals.

4.8.6

Marketing

1. Verify the process of getting the customer requirements and communicating to production and service operations.

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2. Verify the system of segmenting the markets and products, and for targeting the customers before approaching them for offering the products. 3. Verify whether any requirement is given by the production/service department as minimum information to be collected from customer while deciding on the customer requirements. 4. What is the system adopted to determine the customer requirements when the customer has not given documented requirements? 5. Whether the product requirements worked out by the mills are communicated to customers and their approval taken prior to acceptance of order? 6. Verify the communication systems for dealing with customer. 7. Verify whether the communication systems followed with customers cover the product information, enquires, contracts or order handling, amendments to contracts, customer feed backs and customer complaints. 8. Verify the training needs identified for the customer contact personnel. 9. Verify whether the training is imparted effectively. 10. Verify whether the contracts or orders differing from those previously expressed and accepted are resolved. 11. Whether records are maintained for the reviews done for each contract and their results? 12. Verify whether the contracts entered have been reviewed to ensure taking care of company capability for supplying the product. 13. Verify how the customer perception as to whether the product and services met their requirements is gathered. 14. How the customer’s perception data and feedback are analysed to take suitable action to enhance customer satisfaction? 15. Verify whether all the requirements of customers are documented in the contracts or not. 16. Verify the method of ensuring that all the requirements of the customers are covered in the contract. 17. Verify whether the legal requirements relating to products and trade applicable are identified and communicated to the personnel responsible to fulfill. 18. Verify the system of communicating the customer requirements, including the amendments in time to concerned personnel at production area, viz, production planning, manufacturing and quality assurance, packing of final products, despatch, costing and training sections. 19. Verify the system of following up to ensure that the customers get the materials and services as specified by them.

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20. Whether any defined procedure is there to collect the dues from customer in time for the materials supplied to them? 21. Verify the system of getting customer feedback/complaints, and communicating the information to concerned production personnel and back to customers. 22. Verify the system of deciding on the prices and other terms and conditions of marketing while entering a contract. 23. Verify the system of reviewing marketing performance. 24. Verify whether the system adopted to review marketing performance has helped in achieving continuous improvements.

4.8.7

Purchases and stores including outsourcing

1. Verify the system of getting requirement from the users for various materials to be procured. 2. Verify the system of ensuring that the users have given the complete description of the materials required to ensure procurement of correct material. 3. Verify the system of identifying the appropriate supplier for various materials being procured. 4. Verify the system of grouping the materials and suppliers in order to have effective purchase management. 5. Verify the system of evaluating the suppliers to ensure their suitability for supply. 6. Verify whether there exists a formal periodic vendor rating system. 7. Verify the factors and weightage for various materials considered for supplier evaluation and the logic behind it. 8. Verify whether the description given by users is promptly forwarded to suppliers. 9. Verify the system of informing suppliers on their supply performance to enhance supply services. 10. Verify the system of ensuring the statutory requirements are met in purchase activities. 11. Verify the system of following up with suppliers for timely supplies. 12. Verify whether the acceptance criteria and the method of inspection are made clear to the supplier. 13. Verify the system adopted for identifying the received items and their inspection and storing. 14. Verify whether the persons involved in inspection of received materials are adequately trained and equipped. 15. Verify whether the system of storing is suitable for the type of material being stored to prevent any damage or deterioration during storage.

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16. Verify the system of issuing materials to users while ensuring only approved materials are issued. 17. Verify the methods adopted for effective traceability of supplies and suppliers. 18. Verify whether any system exists for visiting suppliers for inspection evaluation. In such cases whether the suppliers are informed suitably the purpose of visit. 19. Whether any material is given to suppliers for conversion or incorporation in the product being procured. In such cases, what system is followed to ensure that the same materials are being used and accounted properly? 20. Verify the system of covering the risk while materials are in transit or in stores. 21. Verify the system of ensuring that the materials in stock maintain the properties similar to that of while receiving. 22. In case of materials likely to lose their salient features over a period of time, verify how the shelf-life is determined and the deliveries monitored. 23. Verify the system of informing accounts section relating to the materials received and approved. 24. Verify the system of informing the users relating to the delivery positions of the materials ordered. 25. Verify the system of monitoring the stock levels of regular moving items in order to have smooth working. 26. Verify the system of actions taken for non-moving items and rejected items. 27. Verify the system of stocktaking and their valuation.

4.8.8

Despatches

1. Verify the system of receiving and storing the materials at warehouse ready for despatch. 2. Verify whether applicable regulatory requirements are identified and listed and system exists for proactive monitoring. 3. Verify the system of identifying the materials in warehouse. 4. Verify the storage system adopted to ensure that the materials are prevented from damages. 5. Verify the system of storage of flammable and/or hazardous items like chemicals, petrol, diesel, etc., before despatch. 6. Whether any system exists to ensure that the material in stock has not deteriorated during storing for a long time?

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7. Verify the system of handling the materials while loading and unloading to ensure that the materials are not damaged. 8. Verify the system of identifying the rejected materials in warehouse. 9. Verify the procedure for engaging the transporters for shipment of materials to customers. 10. Verify the system of preparing the dispatch documents and compare with the legal and contractual requirements. 11. Verify the system of preparation of invoice and compare with the contractual requirements. 12. Verify the system of stock updating and valuation. 13. Verify the actions taken on the deviations found during stock verification. 14. Verify the safety measures taken in warehouse and during transit.

4.8.9

Information management

1. Verify the system of identifying the information required for decisionmaking in the process adopted. 2. Verify how the data source is identified to get the required information. 3. Verify the system of data integration and information generation. 4. Verify how the reliability of data is ensured. 5. Verify the system of data control to ensure that data are made available to concerned only. 6. Verify the system of data accessibility for the users. 7. Verify the system of reviewing the information generation and utility. 8. Verify the systems of maintenance of IT equipments and software. 9. Verify the system of validation of software for reliability. 10. Verify the system of educating users for use of data integration and information generation activities.

4.8.10 Quality assurance 1. Whether the criteria for acceptance for the products under manufacture are determined and conveyed to all concerned in production, quality assurance and marketing? 2. Verify the system of identifying the parameters to assess the product and process conformity. 3. Verify the linkage of parameters identified for assessing product and process conformity to the product quality objectives. 4. Whether records needed to provide evidence that the product realization process meet requirements are available?

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5. Whether records are available to provide evidence that the resulting products from the process adopted for product realization meet the product requirements? 6. Whether the customer requirements are reviewed prior to committing to customers? 7. Verify the system of determination of sample size for ensuring reliability of the test results. 8. Verify the system of ensuring reliability of test data. 9. Verify the quickness in getting and conveying test results and other data to the users for taking suitable action. 10. Verify the system of maintenance and calibration of measuring and monitoring equipments. 11. Verify the system of compiling test data and informing the concerned to take timely action. 12. Verify the system of arriving at acceptance criteria for various product and process quality. 13. Verify the system of approving materials for despatch to further process. 14. Verify the system of follow up for disposal/correction of nonconforming products. 15. Verify the system of analysis of process deviations. 16. Verify the system of analysing customer complaints and feedback. 17. Verify the actions taken basing on customer feedback to prevent market complaints. 18. Verify whether the complaint and feedback redressing are documented suitably in procedures, instructions, and records are maintained appropriately. 19. Verify the actions taken on market complaints and feed backs and the changes in procedures, instructions, product specifications or process parameter as required. 20. Verify the system of educating the concerned for on-line quality monitoring and assurance.

4.8.11 Capital investments (Projects) 1. Verify the system of identifying and justifying the capital investments required for improving the process efficiency and to enhance customer satisfaction. 2. Verify the system of identifying the infrastructure requirement to achieve the product conformity to requirements. 3. Verify the system of prioritising and allotting funds for capital expenses.

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4. Verify the system of identifying and grouping the investments as short term, medium term and long term. 5. Verify the system of deciding on the technology, equipments and the manufacturers. 6. Verify whether the equipment manufacturers are evaluated for their performance in providing equipments and services. 7. Verify the system of educating and training the users for using the new technology and equipments. 8. Verify the system of planning the installation of equipments. 9. Verify whether the applicable legal and regulatory requirements are identified and provisions made to fulfil them. 10. Verify the system of addressing safety and pollution control aspects in the projects. 11. Verify whether the system for evaluation and selection of contractors for implementation of project works. 12. Verify the system of implementation of projects, viz. Installation and commissioning of projects. 13. Verify the system of evaluation of project for its effectiveness. 14. Verify the system of presenting the project reports for top management for review.

4.8.12 Finance and accounts 1. Verify the system of planning finance requirements for the processes identified. 2. Verify the system of prioritizing the finance allocations. 3. Verify the system of users giving their requirements of resources for allotting finance. 4. Verify the system on deciding the source of finance. 5. Verify the system of evaluation of finance providers so as to select the one suitable for the circumstance. 6. Verify the system of following and collecting the dues so as to provide finance for the required expenses. 7. Verify the system of following up for the payments made and to be made. 8. Verify the system of accounting incomes and expenditures. 9. Verify the system of getting data from various functions for working out the costs and budgets. 10. Verify the system of verifying the data obtained from various sources for costing and accounting for their accuracy and reliability. 11. Verify the system of presenting data for top management for review. 12. Verify the system of identifying the applicable legal and regulatory requirements and proactively acting to fulfill them.

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13. Verify the system of handling cash and assuring security for the persons handling cash.

4.8.13 Security 1. Verify the system of checking the incoming vehicles and the materials. 2. Verify the method of checking the incoming men and their belongings. 3. Verify the system of checking the out going vehicles, men and materials. 4. Verify the system of checking the documents and signatures on documents and gate passes. 5. Verify the system followed for security in final packing area. 6. Verify the system of security patrols. 7. Verify the training provided for the security personnel. 8. Verify the method of selecting security service providers and the security personnel. 9. Verify the system of monitoring the fire extinguishers, fire hoses and the condition of fire fighting equipments. 10. Verify the system of maintenance of weapons and security tools.

4.9

Can we discontinue quality control investigation?

From the discussions we had till date, we can conclude that the internal quality audit is a strong tool for monitoring the process. It does not mean that we should discontinue with routine quality control checks or reviews. Internal quality auditing should be an additional activity, as it shall bring involvement of people for taking proactive corrective and preventive actions. Also the expertise of internal auditors is different compared to the expertise of quality control investigators. Where analysis of a specific technical problem and trouble shooting is to be done, the quality control investigators shall be more helpful. They shall concentrate on one area and spend more time, and view the problem with different angles. They shall be able to do root cause analysis, where as an internal quality auditor can only identify that there is a deviation, but cannot identify the root cause. The quality control investigator is a specialist trained in a particular area, and has always has the market complaints and feed back in the back of his/her mind, and hence shall concentrate from the point of view of customer. The internal quality auditor concentrates only on adhering to systems as documented, and cannot visualize the necessity for change in a system from his angle. The quality control investigator goes beyond the set procedures, and insists a change in system to avoid market complaints

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by looking into to potential problems. However, by systematically following the internal quality audit systems, some of the checks done by quality control investigators might be dispensed, which depends on the technology adopted, the product features, the market for which the products are supplied and the customer’s critical requirements. A proper balancing of the activities of quality investigators, internal auditors and the reviews by concerned senior officers together gives the results as expected.

4.10

Process audits

Normally, internal quality audits are done department wise, as an auditor cannot audit his own section. By this it is difficult to understand whether the interaction between sections is congenial for the success of a process. Process audit is a strong tool for understanding the process flow, whether all the activities are done as per requirement, and more over, whether the inter departmental communications, interactions are going with the process requirement. Let us see how a process audit can be done. Steps to do the process audit of a particular purchase order: 1. Go to marketing department and select a consignment which was dispatched recently. 2. Note down the following details: (a) Purchase order received from customer and date (b) Customer (c) The product description (d) The committed date of despatch as per contract (e) Actual date of despatch (f) Quantity expected to be dispatched (g) Actual quantity dispatched (h) Whether customer’s consent is taken for variation in quantity and the difference in despatch date? (i) Whether any analysis is done for this discrepancy? (j) What was the finding and whether any action is initiated? 3. Verify the method of informing the concerned in the purchase, production and PPC (Production Planning and Control) sections regarding the order requirement. (a) Whether all the requirements are communicated? (b) Whether the requirements communicated is documented by the actual implementer or service provider? 4. Verify the minutes of order clarity meeting (Meeting before execution of an order to understand the requirements of the order) for this consignment.

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5.

6.

7.

8.

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(a) Decision on the quality and quantity of raw material. (b) Decision on the accessories to be procured. (c) Decision on the quality checking issues. (d) Decision on the production lines to be utilized. (e) Decision on the date of starting of first operation. (f) Decision on outhouse activities and their control. Note down the responsibility and commitment of different sections for this consignment. (a) For deciding and placing orders for raw material. (b) For deciding the accessories and giving indent for purchases. (c) For preparing the samples and submitting for approval – stages, numbers and dates. (d) For preparing pattern/dies and markers. (e) For sending the materials for value adding processes and their receipt after the work is done. Check for the working out of requirements for raw materials and other accessory required for this consignment: (a) The raw material specifications (b) The product realization (Percent of raw material getting turned out as the final product) assumed and the basis for assumption (c) Specific accessories required for this consignment – quantity, quality specifications. (d) The outhouse activities, the selection of vendors and getting the work done. Verify whether costing is approved from costing section for the activities. (a) Costing for raw material procurement (b) Costing for accessories procurement. (c) Costing for out house activities. (d) Costing for production activities. Verify the following in the purchase order for raw material: (a) The purchase order and date. (b) The supplier; verify whether the supplier is in approved list. (c) Quantity ordered. (d) Delivery schedule demanded. (e) Actual date of receipt of materials. (f) Inspection report of incoming fabric quality. (g) Remarks written by the incoming material inspector. (h) Verify the action taken on the inspection report. (i) Verify the quantity ordered and quantity received. (j) Verify the records of materials sent to warehouse for issue to production. (k) Verify the requisitions from production for this consignment.

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9. Verify the following in the purchase orders for accessories: (a) The specification of accessories. (b) The quantity ordered for each of the accessory. (c) Date of ordering – accessory wise. (d) The specified delivery date – accessory wise. (e) Actual date of receipt – accessory wise. (f) Follow up action for late receipts. (g) The normal lead time, minimum and maximum for each of the accessory for last one year. (h) The lead time assumed/negotiated while placing order. (i) Quality inspections specified. (j) Quality inspections done and their remarks. (k) Actions taken on the remarks of quality checking. 10. Verify the production planning activities as follows: (a) Data of production rate for the type of product in the order. (b) The efficiency assumed and the logics for efficiency assumption. (c) The basis for deciding the number of lines and dates allocated for this consignment. (d) Manufacturing charges and its relation to tech pack (Specifications given by the customer) for this consignment. (e) Number of lines loaded, and the plant utilization considered for the period. (f) Actual efficiency achieved against the planned in this consignment. (g) Logics for assuming efficiency and utilization. (h) Analysis made for deviation in efficiency. (i) Action taken for the deviation in efficiency. 11. Verify the following in the production process: (a) Date on which the production plan was given for production for this order. (b) The tables/machines/lines allotted for this order. (c) Production records. (d) Efficiency achieved against planned. (e) Wastes generated vs. the projected wastes. (f) Quality reports of the activities. (g) Actions taken on deviations in production and utilization losses. (h) The quantity produced against the quantity to be produced as per purchase order. (i) Verify the identifications put to identify the process. 12. Verify the following in finishing process (a) Packing planned and actually packed. (b) Quality check reports of finishing.

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(c)

13.

14.

15.

16.

Verify the identification made for tracing the production process. Quality assurance and audits (a) Check the inspections made in line for this consignment and compare with the purchase order requirements. (b) Verify the final product inspection (Final Statistical Audit) report, and the remarks. (c) Verify when the final audit was done and when the material was dispatched. (d) Check the analysis made for defects and the actions. (e) Check the details of laboratory tests if any relating to this consignment. (f) Verify the status of calibration of equipments used during the manufacture of this consignment. (g) Verifications done for the outhouse activities. (h) Actions taken for the deviation found in out house activities. Check the following in maintenance: (a) The machines which failed during the manufacturing of this consignment. (b) The reasons for machine failures. Has it any link with the products? (c) What actions are taken to prevent failures? (d) Verify the online performance reports for this consignment. Verify the following at costing: (a) Whether the deviation in production efficiency is considered in costing, and actions taken? (b) Whether the variance in packing cost and cost of accessories are updated for this consignment. (c) Whether any alarm was given to top management for the deviation in costs? Verify the following from HRD: (a) Who were the people working on different lines/machines/ tables for this consignment? (b) Whether all the operators were trained as per the need of the material? (c) Whether the critical requirements of this consignment were explained to the operators before starting productions?

4.11

Imperatives of effective audit

To have an effective audit, the involvement of auditee is very important. The head of the department of auditee section should take lead and invite the auditor to conduct the audits and ensure that all his subordinates participate

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actively in the audits. He should encourage people to give prompt answers and show the records and documents as required. One should always remember that the audits are for the benefit the auditee, and the auditee is responsible for getting the audits conducted at his place and taking timely actions. Audits should be planned in advance, and the dates and times are to be mutually agreed between auditor and auditee. However, the audits are not supposed to go on getting postponed with the excuse of either ‘Auditee is busy’ or ‘Auditor is busy’. Audit should be conducted with in the time frame allotted. The auditing has a number of stages as information gathering, preparation including adequacy auditing, opening meeting, auditing and report preparation, closing meeting, attending the non-conformities and closing of the non-conformities. The information gathering includes understanding of size, complexity and scope of the area being audited, the standards against which the audits are conducted, and the activities. The auditor should carefully read the manuals and procedures, and understand the system being followed. A checklist needs to be prepared so that all relevant points are verified, and in the process, time is not wasted. Audit should start with a formal meeting with the head of the department in his office, where the members of the auditors are introduced to auditee, and the scope of auditing is explained. The leader of the auditee team should provide necessary support to the auditors for conducting audits, like providing disturbance-free place to sit and verify the documents, conducting audits, writing reports, etc. During the audits, the auditee should ensure that disturbances are not there because of phone calls, subordinates coming and asking for clarifications, the bosses calling and asking some reports or information, etc. The role of top management is very important, and they should have the basic discipline of not disturbing the people who are doing audits or getting audited. The top management must insist that the audits are conducted as per the agreed plan, and ask for explanations for not conducting audits in time. During audits, the auditor should ensure that entire scope of audit is covered, clear and precise discrepancy reports are raised based on sound objective evidence, and the auditee is explained of the deviations. The auditee should understand the root cause of the deviation and make sincere attempt to eliminate the cause and avoid recurrence of the deviation. Just doing something and getting the non-conformity closed will not help the organization in improving the quality, but deteriorates the systems and controls. Top management must insist on root cause analysis and taking effective corrective actions, and not just be happy for closing the non-conformities. Rather than closing the nonconformities, the process adopted in identifying the root cause, explaining all concerned about the cause of the deviation, taking corrective actions and educating the concerned to work with improved system to avoid the recurrence of the non-conformity is more important.

Internal quality audits

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Auditing is a very useful tool for continual improvement provided we take it seriously, document them properly and refer again and again. Records are not just meant for showing to auditors but for us to refer and improve. Auditor is a catalyst for improvement provided we are sincere in our efforts and value the auditing system.

4.12

Linking exercises – a strong tool for quality auditing

Audit programme are planned considering the status and importance of the process and areas to be audited. The management responsible for the area being audited ensures that actions are taken without delay to eliminate detected non-conformities and their causes, which leads the company for continual improvement. The role of an auditor is very important in this process. The auditor is required to identify the non-conformities that are hindrance to the performance of the organization, communicate it in a convincing way to the auditee in order to help taking corrective actions. The auditor needs to understand the systems by referring various manuals and documents, and confirm the conformance. Only by referring what is documented and verifying for its conformity might not identify the pits and potential problems. Linking exercises explained here can help the auditor to effectively identify the loopholes in the systems. Organizations have a number of activities. The activities are normally interlinked. The decisions taken or the modifications done at one place, will affect at some other place. Normally, when systems are started afresh, considerable care would have been taken to integrate the systems. Because of changes in the situations and developments taking place at different spheres, amendments are made in the procedures. The amendments normally are done to overcome some problems or shortcomings at some place; where as, its after effects or the effects at other places are not worked out in detail. Also in a number of cases, the activities and developments are not considered at other places. We base our decisions and actions on our own experience. We will not know where we are and get lost. We need to understand the relations and links to ensure that systems do not affect elsewhere and are implemented fully. The activities to understand the links are termed as linking exercises.

4.12.1 Use management tools Seven management tools were identified by Shigeru Mizuno in 1989 to help taking decisions. A careful understanding of these tools can help us identify the links between systems and processes. The seven tools are as follows. ●

Affinity diagram

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Relation diagram Tree diagram Matrix data analysis Matrix diagram Process decision programme chart (PDPC) Arrow diagram

Affinity diagram – This collects large amount of disorganized and confused verbal data and groups based on natural relationship. It is a creative process and not a logical process. Affinity diagram is used where participants have no past experience, situation is complex, need to find a pattern among thoughts and when there is a need to arrive at a consensus and no unity exists. We can use affinity diagram to link working by identifying the group to which the activity belongs. Next we need to identify similar activities supporting this and then verify the linkage between activities. The differences in the style of performing the activity are then verified and also the reasons for having different styles. By this we can verify the likely effect of the action taken at one place. Relations diagram – This is a tool for finding solution to problems that have complex casual relationships. It helps to untangle and find the logical relations among the intertwined causes and effects and allows for multidirectional thinking rather than linear thinking. This can be used to identify the relation between documents and systems (Fig. 4.1).

4.12.2 Relation among QMS elements It can be used for verifying whether the relations identified are addressed in procedures, instructions, job descriptions and flow charts, and how strong the relation is. Then the system of communication and co-ordination and the decision making authorities inline are verified with Relationship diagram. Tree diagram – It is a technique for mapping out full range of paths and tasks for identifying the primary goals and related sub-goals. It is similar to an organization chart and helps to understand the sequence of tasks that need to be completed. The links between primary goals and secondary goals are represented as a tree. We can make use of this tool to link the effect of various activities. In the illustration in Fig. 4.2, the root cause for work not being done is the lack of clarity with the top management as to who should be given responsibility for doing a certain job. During auditing, the auditor needs to map the process and find out the links between process steps. This helps in auditing the links. Figure 4.3 shows a typical process mapping.

Internal quality audits

Customer Expectations

Company Policies and Objectives

87

Departmental Policies and Objectives

Departmental Procedures

Statutory, Legal and regulatory Requirements Company Manual and General Procedures Organization Structure

Training

Work Instructions

Job Descriptions Records

4.1 Indicates relations between different documents used in implementation of ISO 9000.

Arrow diagram or PERT chart (Fig. 4.4), which helps in project planning, scheduling and monitoring is a network technique using nodes for events and arrows for activities. It is a very useful tool when we want to plan the activities of a known but complex task. Process mapping can be in the form of an arrow diagram also. After mapping the process, it becomes easy to find the links. ●

●

●

●

●

●

Documents may have reference of other documents. This can be verified by writing down a matrix. Organization can follow a system which has a link to another system or document. Different documents may use different words or terms may be used for the same activity or material. Some records are identified and referred in the procedures, but some other are in practice. Certain objectives are defined by the company and something else is defined for the departments. Organization has developed data collection check sheets.

A matrix can be used to analyse the links between processes, procedures, standards, instructions and other documents (Fig. 4.5).

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Result

work is not done

HOD is leaving the responsibility to senior executive

Job description of senior executive mentions this

Senior executive is waiting for the instructions from HOD

Job description of HOD does not mention Work procedure says HOD is responsible Quality manual says HOD is responsible for the activity

No clarity with the top management as to who should do the work

4.2 Tree diagram for not doing work.

The matrix can also be used to identify the links between the company objectives, the departmental objectives, the targets and action plans. Table 4.3 is an illustration for the same. Process design programme chart – This is a useful and powerful method to overcome problems when a goal is to be achieved by mapping out all the conceivable events or contingencies that can occur in the implementation stage. A PDPC chart is constructed by the following steps. ● ●

● ● ● ● ● ● ●

Identify existing situation. Draw a normal flow chart assuming that no problem will be encountered. Discuss the constraints. Write the activities that are to be done in case of constraints. Prepare a list showing the possible problems and the contingency plan. Review for any missing information. Prepare final drawing and implement. Watch the progress and darken the line where activities are completed. Study deviations and re-plan.

Internal quality audits

89

Map the Process Start Support 1

Activity 1 Check 1

Activity 2

Support 2

Support 1 Activity 3

Check 2

Support 3

Support 5

Check 3

Activity 4

Activity 7

Check 4 Activity 7

Activity 2

Activity 8

4.3 Mapping the process.

The auditor need to verify whether the procedures address alternative actions in case of any deviation is expected.

4.12.3 Tips for auditors The following tips are useful to auditors to do an effective auditing considering the links between processes and documents. ●

● ● ● ●

●

● ● ●

● ●

Read carefully each line in the documents like procedure, instructions, job description and quality manual, etc. Ask for evidence for each statement/instruction in the document. Ask for linked instructions, job descriptions, forms etc., for each step. Verify the linking document, and identify further links. Verify the checklists. Verify whether there is any instruction to gather those data and information Verify the link between the objectives written in the top of the procedure to the steps written. Ask for the data for the objectives written in the procedure. Ask for the system of monitoring the implementation of a procedure. Verify the responsibility written in the procedure and compare with the responsibility written in the job description and in the quality manual. Verify the hierarchy as per organization structure. Verify whether job descriptions are written for all the jobs in the organization.

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Arrow Diagram 6

5

2

3

5 days

1 Start

1

3

4 days

2

6

3

5

7

3 4

4.4 PERT chart.

4.5 Matrix showing linking between different clauses of ISO 9001:2008.

End

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Internal quality audits Table 4.3 Linking of policy to objectives and action plans

Objective 5

=

=

Objective 4

=

=

Objective 3

=

=

Objective 2

=

=

Objective 1

=

=

=

Objective 4

Objective 3

Objective 2

Objective 1

Action plans

Plan 1

Plan 2

Plan 3

Plan 4

Quality Policy

Departmental objectives

Sectional objectives

Company objectives Objective - 1

=

Objective - 2

=

= =

●

● ●

● ●

= =

Objective - 3

=

●

=

= =

Objective - 4 Objective - 5

= =

Verify the responsibilities documented and compare with hierarchy. Verify the specified minimum competency requirement and compare with the hierarchy. Verify the actions recommended in case of failures or emergency. Verify the link between alternate actions recommended to the instructions or procedures. Verify the link between parallel activities. Verify the process of monitoring parallel activities.

Let us discuss some examples of how an auditor can expand the meaning of a small statement made in a document and search for the links. Example 1 Procedure says “Supervisor shall give an indent for…..” ●

Verify the job description and find out whether supervisor is authorized to give that indent.

92 ●

● ● ●

● ● ●

Effective implementation of quality management systems

Verify the list of format, and see whether that indent format is controlled. Ask for the record where the copies of indent are filed. Check the list of records, whether that record is controlled. Check to whom this indent is given. Verify the procedure at the receiving end, whether the acceptance of this indent is documented. Verify whether any work instruction is written for writing this indent. Verify the procedure for deciding on writing the indent. Verify whether all the criteria were fulfilled for a completed indent.

Example 2 Verification of the linkage between procedure and departmental objectives. Note down the points in the procedure that has a link with the objectives. Department – ABC Linking procedure to departmental objectives Department objectives WP No

OBJ- 1

OBJ- 2

XXX-WP-01

Point 1 Point 5

XXX-WP-02

OBJ- 3

Point 2

OBJ- 4

OBJ- 5

OBJ- 6

OBJ- 7

Point 5

XXX-WP-03

Point 2

XXX-WP-04 XXX-WP-05

OBJ- 8

Point 3 Point 5

Point 7 Point 8

Point 2

Point 3

Point 8

XXX-WP-06 XXX-WP-07 XXX-WP-08

Point 5

Point 3

In the example above, no procedure is found addressing the objective no. 4 of the department. It normally happens as the objectives are specified by the top management, and the procedures are not verified. Example 3 Verification of links between job description and the departmental objectives. Following is an example of linking job descriptions to objectives.

93

Internal q    Linking job description to departmental objectives Department objectives JD No

OBJ- 1

OBJ- 2

XXX-JD-01

Point 1 Point 5

XXX-JD-02

OBJ- 3

OBJ- 4

Point 2

OBJ- 5

OBJ- 6

OBJ- 7

Point 5

XXX-JD-03

Point 2

XXX-JD-04 XXX-JD-05

Point 7 Point 3

XXX-JD-06

Point 6

XXX-JD-07 XXX-JD-08

OBJ- 8

Point 3 Point 5

Point 8 Point 3

Example 4 Verification of the minimum competency levels specified and comparing with the hierarchy for the mismatches. The competency expectations must be of higher level for seniors in the hierarchy compared to those at junior level. Following is an example of mismatch. Minimum competency – Training staff in a garment factory Education

Experience

Training

Skills

Training manager

Any degree with Knowledge of local language and English

10 years experience in shop floor

G.S.D

Good communicator

Training in-charge

Degree or Diploma in garment manufacturing

8 years of experience as a training in-charge in a garment factory

G.S.D and train the trainer course

Good communicator, keen observer, good counsellor

Training executive

PG degree or diploma in garment manufacturing

5 years as a trainer

G.S.D

Good communicator, keen observer, good counsellor

Trainer

Diploma in tailoring

Not specified

Not specified

Training skills

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Example 5 Verify the records of stoppages and the reasons documented. Link it to the efficiency or productivity achieved. Say, the production department has recorded 4 hours stoppage of a machine for breakdown, where as the maintenance department has recorded 3 hours stoppage. When the production is verified, they have achieved 60% of their normal production in that shift indicating a loss of 3 hours and 12 minutes. It means the machine was started 12 minutes late after it was handed over by the maintenance, but additional stoppage was shown to project a better efficiency. Example 6 Verify the objectives and targets specified for a section and between sections of an organization. See whether they are complementary or contradictory. Example 7 For each target check the proposed action plan. Each target should be supported by an action plan in order to achieve it. The method of implementation of the action plans must be specified in the work procedures, or else it is not possible to implement. There should be the responsibilities defined and the records identified. Auditor needs to check whether the documents explain the method of taking action, where the records are kept and who is responsible. Linking exercises can be a very powerful tool for an auditor. It helps in identifying the real pits and helps the management to take necessary corrective actions. The seven management tools can be suitably made use for linking exercises. Linking exercise helps to integrate different activities of an organization. It helps effective implementation of systems organization wide.

Measuring maturity in QMS implementation

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5 Measuring maturity in QMS implementation

5.1

Need for measurement

It is a known fact that unless we measure, we cannot improve. It is suggested to convert all subjective statements to objective statements by developing some means for measurement. In the quality management systems, measuring the results is given maximum importance. All objectives must be measurable. The standards also insist on continuous improvement at all places. Continuous improvement can be demonstrated only when we have objective evidences, and the means for measuring. The QMS implementation is not an exemption for this. We need to improve the effectivity of implementation of quality management systems on a continuous basis. Therefore, we need to learn the method of measuring the maturity of QMS implementation. ISO 9000 quality management systems have emerged out as one of the most popular quality management systems. The standards which were adopted from BS 5750 in 1987 underwent amendments in 1994 and 2000, and now again in 2008. Why these amendments? There is a mechanism for reviewing the suitability of the systems to the changing business environment. Similarly, it is essential to see the suitability of the systems adopted in a company to the changing requirements. Only adhering to basic requirements to get a certificate is not sufficient. By considering the advantages of getting consistency in the supplies and smooth working, the organizations who were familiar with BS 5750 / ISO 9000 started insisting their suppliers for getting accredited to ISO 9000. The government agencies also started insisting on ISO 9000 certificate from their suppliers before submitting tenders for various supplies of products and services. This insistence compelled number of organizations to align their activities inline with the requirements of QMS, and the number of companies with ISO 9001 certification is increasing alarmingly. People started using different means to (some how) get the certificate. As the numbers of certifying bodies are increased there is a competition between them. Their survival depends on the number of clients they have. Therefore, they are forced to grant more and more certificates. The certifying agencies started becoming lenient in giving certificates. In

95

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a number of cases, it is found that auditors are closing their eyes even when a major non-conformance is noticed. ISO 9001 guidelines give basic requirements for a good quality management system, which are practical and simple. In the initial stages, people were considering the certification of ISO 9000 as a great achievement, but now due to innumerable number of certificate holders, it is no more considered as an achievement. It has become the basic or fundamental requirement for any organization to survive. If one is not following a QMS, he is likely to collapse shortly. With over one million ISO 9000 certified companies world over, the significance of the certificate is getting lost. Almost everyone is ISO certified. The customers, who were recognising their suppliers because of their accreditation to QMS, are now in confusion. They are finding difficulty in identifying good suppliers those are matured in understanding the requirements, could proactively respond and have quality management systems implemented effectively company wide and following religiously. There is no method of assessing the effectiveness of implementation, although some companies have developed their own systems to measure their performance. There is a need for scientific/logical measurement of the maturity of implementation of quality management in an organization.

5.2

Measuring maturity by linking to the principles

The British Standard Institute (BSI) (17) has recently started benchmarking system in QMS. The companies are assessed considering the eight quality management principles adopted in ISO 9001:2000. For each principle five criteria are verified, and the companies are fitted in one of the five levels, viz No level, Bronze, Silver, Gold and Platinum. In BSI method, there are 5 × 8 = 40 questions, and each question has maximum of 50 marks. Total marks are 2000. The companies scoring 20% and below shall not get any rank. The Bronze status is given for companies getting 21–40% marks, Silver for 41–60% marks, Gold for 61–80% marks and Platinum for 81–100%. The members can have an access to find out the highest ranking in each category. BSI gives reports for each principle separately and also indicates threat, risk, business impact and area for improvement. Any company, whether ISO 9000 certified or not, can participate in this benchmarking assessment. Once a company is assessed and graded, a certificate is issued, which is valid for 2 years. There shall be one assessment every year. This certificate helps the companies in impressing their customers. The customers are likely to prefer the companies with platinum ranking compared to bronze or silver ranking, although they are ISO 9001 certified.

Measuring maturity in QMS implementation

5.3

97

Measuring maturity by considering the clauses

Any one if wants to improve, should first know the level in which he is. It is true for the companies also. It might not be feasible for all to go for a benchmarking survey, as one need to wait for one year after getting assessment to understand the changes in status if any. Also the external auditors might not get complete exposure to the depth the systems have gone. As the purpose is to assess self and plan for improvement, we need to device a method, which is simple and can be handled by internal quality auditors. The assessment should be done after each internal quality audit so that the effects of efforts made can be understood. One needs to carefully understand the requirements of the quality management system and the extent to which it can be implemented. The various levels between a starting level company and the best company may be identified and marks may be allotted. By this it shall be possible to understand the level at which we are working and the area needed to be improved and track the performance of quality management systems in numerical terms. The internal auditors, who are matured enough and trained in assessment for maturity, can allot the marks independently followed by a consensus method. By this the company can assess the level of implementation of QMS and work out the plans to make it more effective. The guidelines are explained in section 5.4. The companies, who are still not matured enough to have self-assessment, can understand the expectations of a good QMS system by reading the guidelines for assessment. The concepts which have been given higher marks are the ones to be benchmarked. In the guidelines prepared, the maturity is assessed by 100 different angles, referred as elements of implementation of QMS. In each element, 5 possible levels are identified and marks are allotted for them. One need to verify in which level the company is there against each element of QMS. The maximum marks are 5 for each element and minimum is 1. Zero mark is not considered as we have taken a company for assessment which already has implemented QMS and is certified. A company can therefore have maximum of 500 marks and minimum of 100. If the company scores 100 marks, it is considered as base level or Level 1. Company scoring between 101 and 200 is Level 2, 201 and 300 is Level 3, 301 and 400 is Level 4 and 401 and 500 shall be Level 5. The chances of a company falling in Level 1 is very remote, as they cannot score just 1 in all the 100 elements, but could score more than 1 in number of elements. As the concepts in QMS change depending on the developments of new concepts, the guidelines prepared also will change. However, by the

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logics adopted here, we can measure the effectiveness of implementation of any quality management system.

5.4

Guidelines for assessing maturity in QMS implementation

The following are the general guidelines. They are developed considering the clauses of ISO 9001:2008. The auditee should give frank answers. There is nothing called as wrong. Frankness helps in understanding the level, and suitable action plan might be prepared to move further. As systems undergo changes, we can rework the guidance. Level and marks 1 2

3

4

5

Description

1. Scope of application Covers production, maintenance and quality control sections. Covers production, purchases, production planning, quality control, research and development, maintenance and delivery operations. Covers production, purchases, production planning, quality control, research and development, marketing, maintenance and delivery operations. Covers production, purchases, production planning, quality control, research and development, designing, marketing, outhouse trading, maintenance and delivery operations. Covers all sections of the organization including accounts, finance and corporate functions. 2. Purpose of implementing QMS

1 2 3 4

5

The customers are demanding. To get entry in export market, and also in some public bidding with out ISO certificate. Implementation of QMS improves the image of company and helps entering into new markets with ease. Implementing QMS gives confidence to customers that product and services shall meet their requirement. We can analyse self, identify the loop holes and work towards continual improvement. This can build confidence in our customers and we can have long-lasting relations. Apart from self-analysis and correcting the loops, we can identify potential problems and take suitable strategic decisions to prevent the problems.

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99

3. Awareness and use of quality policy 1

2

3

4 5

Quality policy is released and displayed at prominent places. However, people working are not in a position to explain what it is. Quality policy is explained to all employees by conducting programme apart from display at prominent places. However, no evaluation is done to understand whether the people have understood it. Understanding of quality policy is verified during internal quality audits, and the people are able to recite the quality policy any time. However, they are unable to explain how it is connected to the day-to-day activities. People are clear about the linking of their activities to the quality policy and are able device procedures accordingly. All procedures are reviewed periodically and verified for its suitability to meet the changed quality policy considering the changing situation. The procedures are modified to work inline with the changed policy. 4. Deriving of quality policy

1 2 3 4

5

Quality policy is decided by referring to a number of good companies, and the combination is made to get the best Policy. Quality policy was decided by the chairman after discussing with eminent consultants in QMS. Quality policy was decided based on the purpose of the company by the chairman. Quality Policy was decided basing on the purpose of the company by the chairman after a number of rounds with chief executive and the functional heads. Quality policy is reviewed periodically by the team consisting of chairman, chief executive and the functional heads considering the changing economic and social scenario. 5. Deployment of quality objectives

1

2

Quality objective is defined for the company and displayed at prominent places. However, there is no clarity as to how the objectives were arrived. Departmental objectives and goals are prepared and displayed at prominent places in the work spot. However, there is no clarity as to how the departmental objectives are arrived.

100 3

4

5

Effective implementation of quality management systems

Integration of quality policy, company quality objectives and department objectives are made by involvement of top management and the functional heads. The procedures and action plans are prepared to achieve them and concerned officers are educated. The employees on work spot are clear about the departmental objectives and company objectives, but are not in a position to link their day-to-day works for achieving the objectives. Individuals are clear about their roles, responsibilities and goals, which are aligned with department objectives and goals, and in turn are aligned with company objectives and goals. People review the achievements periodically and modify the action plans wherever required. 6. Determination of quality objectives

1 2 3 4 5

Quality objectives are specified considering the benchmark companies. The objectives are defined for the area where the company has strength, so that the auditors could be impressed. Objectives are determined by considering the quality policy requirements. Objectives are decided considering the requirements of the customers and the effectiveness of processes. Objectives are reviewed periodically to suit the changing requirements of the customers, the company and the society. 7. Preparation of quality manual

1 2

3 4

5

Quality manual is prepared by referring the manual of a benchmarking company that has been certified long back. Quality manual is prepared referring to the clauses of quality management system, and care is taken to ensure that all clauses are addressed. Quality manual is prepared to guide the people to work as per the requirement of quality management system. Quality manual is prepared to explain how we are implementing the QMS at our company by taking the guidance of international standards. Special training classes are conducted for the staff to read and understand quality manual, and to link their procedures and other documents to the quality manual.

Measuring maturity in QMS implementation

101

8. Distribution of quality manual 1 2 3 4

5

The quality manual is kept with management representative. It is issued to senior managers and a copy is kept in the library. The copies are given to each departmental head and the section head for reference. All employees are made aware of the quality manual and its use, and interested employees were given permission to read the manual and return to the head of the department. The HOD ensures that every one has read the manual and understood the contents and refers them regularly as a routine work. They either correct or advise the management if any deviations are observed in the system. 9. Process evolution

1 2 3 4 5

Processes being followed in the company are listed down. Processes mandatory for the implementation of QMS are identified and listed. Processes required for achieving the company objectives while moving in the path defined by quality policy are identified. Processes required to enhance QMS to achieve continual improvements are identified. Processes required to achieve the results at par with benchmarks are identified and implemented. 10. Process implementation

1 2 3 4 5

Processes required for the implementation of QMS are identified and listed. The sequence and interaction of the processes are identified and charts prepared. Control points and check points for each process are determined, and the users are educated to use them on regular basis. The processes are evaluated periodically to ensure their effectiveness, and modifications made to make it more effective. The users do the analysis of process performance and compare with the best achieved results. Root cause analysis is made for the deviations and actions taken to correct them. 11. Terms and definitions

1

People are supposed to understand the terms used as they are working here from a long time.

102 2 3 4

5

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List of abbreviations used are given in the end of each document and the meaning is defined. The abbreviations used in different documents are listed and a chart is made giving the meaning. A separate document is prepared indicating all the technical terms and abbreviations used company wide and in the industry, and are defined. Periodic audits are done to ensure that the terms used give the same meaning as defined, and the users are repeatedly trained to use the words with same meaning all the time. 12. Work procedures documentation and control

1 2

3

4

5

Mandatory procedures as per the guidelines for the implementation of QMS are documented and controlled. All the processes required for fulfilling the company objectives are identified and procedures documented. The procedures are controlled and referred in the quality manual. All the managers and staff are trained for using the documented procedures and its usage is ascertained by periodic audits. A separate committee of experts reviews the procedures for their suitability. The procedures are reviewed at a periodic interval by the concerned heads of the department and the senior staff to ensure their suitability considering the changing need. The trials are conducted with changed systems before deciding on the amendments. Employees are encouraged to read the procedures and give their feedback from time to time for the suitability and effective implementation. The procedures are amended as and when required. All employees refer the procedures on regular basis even for the routine works. 13. Procedure deployment

1 2 3 4

The copies of the procedures are given to concerned heads of the department. The copies of the procedures are made available to all users by displaying them prominently at strategic points. The HOD conduct monthly meeting for the staff and ensure that everyone has read the procedure and understood. The internal quality auditors verify the understanding level of procedures by asking number of questions during audits.

Measuring maturity in QMS implementation

5

103

The head of the department conducts monthly review of the performance, and verifies the achievement of objectives against specified in the procedure. Corrective actions are taken for the deviation. 14. Review of procedures

1 2 3 4 5

While writing a new procedure, or while amending a procedure, review is done by the management representative. While writing a new procedure, or while amending a procedure, review is done by the person preparing the procedure. Procedures are reviewed for suitability by the concerned HOD before approving. Procedures are reviewed at least once in 2 years by the HOD to ensure that they are suitable for working condition. Procedures are reviewed periodically to ensure them as the best possible for the activity in question. Amendments are made as and when better method is established or defined. 15. Work instructions

1 2 3 4 5

The work instructions are written for important activities in production area. Work instructions are documented for all the activities done by workers, and displayed at prominent places. The work instructions are written in local language and the workers are encouraged to read them while working. Senior workers are involved in writing work instructions so as to ensure that all practical aspects are covered. Senior workers train the junior workers on a regular basis for the use of work instructions in their routine works and they contribute for amending the instructions when needed. 16. Organization structure

1 2 3

4

The company has a documented organization structure giving broad outline of the authorities and responsibilities. The organization structure is defined up to shop floor supervisor level. Their authorities and responsibilities are documented. The staff is involved in preparing the organization structure as and when a change is made. The HOD specifies the authorities and responsibilities of each designation. The top management reviews periodically the changes taking

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place, and changes needed in the organization structure. They define the authorities and responsibilities of all key positions, and empower them to perform. The top management ensures that the organization structure defined is effective in achieving the company objectives, the communications are smooth and there is no confusion or friction at any place. People are suitably empowered so that there is no need for them to wait for instructions in routine matters. 17. Roles and responsibilities

1 2 3 4

5

Roles and responsibilities of heads of the departments are documented in quality manual. Roles and responsibilities of all the staff are documented as separate job descriptions and controlled. Roles and responsibilities of all the designations in the company are established and documented and made known to all concerned. Roles and responsibilities are reviewed as and when there is a change in organization structure, and documented. All concerned are educated on the changes. Roles and responsibilities of all employees are reviewed periodically and aligned with the company and departmental objectives. People are completely aware of their roles and responsibilities in achieving the goals. 18. Document control

1 2 3 4

5

The documents required as per the QMS requirements are identified, listed and controlled. All documents generated are identified with specific codes, listed in the master list and their distribution controlled. Document distribution is reviewed periodically by an expert committee and their distribution controlled. In addition to the in-house documents, the external documents are also listed and maintained at a centralized library for the benefit of users. All documents including those of external origin are reviewed periodically by users for their continued suitability, and revised suitably. 19. Document changes

1

Documents prepared for the implementation of QMS are not

Measuring maturity in QMS implementation

2 3

4 5

105

changed unless there is a non-conformity identified by an auditor. Documents are verified before each audit and amendments are made as needed to avoid non-conformities during audit. Documents are reviewed periodically by an expert committee along with management representative and changes are made as required. Documents are reviewed periodically by internal auditors with in the sections and amendments are made as per the suitability. The management representative reviews the changes suggested by users in the documents, verify the alignment with the QMS requirements and releases the changed document. 20. Control of obsolete documents

1

2

3

4

5

The management representative sends note to all users to return the old documents while issuing new documents. He keeps one set for his reference, and destroys others. The internal auditors verify the documents during the audits and raise nonconformity if obsolete documents are found. Such documents are removed and NC is closed. The team representatives periodically verify the documents they have and compare with the master list of documents with the management representative. All users have an access to the master list of documents with the amendment status, and are empowered to do self-auditing to identify redundant documents. The HOD verifies periodically the master list of documents and the documents he has. He ensures the return of old documents to management representative. 21. Record control

1 2 3 4 5

Records as specified in QMS are identified, maintained in files or registers. All the files and registers maintained in the company are listed, coded and brought under control. All the records including those maintained in soft copies are listed and controlled. Records are scrutinized by the concerned HOD on periodic basis for its effective maintenance. All records are reviewed periodically and aligned with the changing needs and controlled.

106

Effective implementation of quality management systems

22. Maintenance of records 1

2

3

4 5

All records are having title, starting date, responsibility, life and storage place mentioned on it as per the list of files and records. The records are kept in their identified places, and office boys are trained to maintain the records in their places. The record keeping place is clean and tidy. Periodically, the record maintenance is audited by internal quality auditors, and corrective actions are taken as per their findings. Each user ensures that the records used by him/her are kept back in the specified place after the work is completed. The HOD personally conducts a file recall exercise and ensures that all records are available as required. 23. Information availability

1 2

3

4

5

The users are responsible for ensuring that they get the required information from the right source. The concerned HOD by his experience and knowledge identifies the key information requirement, and arranges for data collection and information generation on a regular basis. The information required for the effective implementation of QMS is identified by an expert committee, and programme is developed to collect those data and information on a regular basis. The users review periodically the effectiveness of the information available for the implementation and control of the required activities, and design means to acquire the data from the reliable sources. The HODs review the information availability for taking decisions and for carrying out the activities, and discuss with the concerned persons and make arrangements for their procurement. 24. Understanding customer requirements

1 2 3 4

Whatever customer sends in writing is regarded as requirements. Customer is asked to send a sample and complete specifications to avoid confusions. Agent visits the customer and collects all information. Senior marketing personnel visit the customer and understand the requirements.

Measuring maturity in QMS implementation

5

107

Senior production personnel visit the customer along with marketing personnel and understand the customer needs by discussing with the actual users. 25. Communicating the customer requirements

1 2 3

4

5

Marketing sends the customer needs to PPC and production managers. Marketing persons discuss with production, PPC and quality heads regarding the orders booked and enquiries received. Marketing persons discuss with all HODs regarding the market trends, feedbacks, requirements and specific customer requirements in a meeting. Customers are invited to the company to discuss with the concerned production, quality, PPC, maintenance and sourcing personnel regarding the specific requirements of customers. Production, quality and maintenance personnel are sent to customer’s place to discuss with the actual users to understand their specific requirements. 26. Communicating customer concerns

1 2

3

4 5

All market complaints are recorded and discussed in the management review meeting. All market complaints received are displayed prominently in the work area so that concerned persons can take suitable remedial actions. Marketing person visits the customer and brings the feedback and complaint samples and discusses with concerned production and quality personnel. Senior managers visit the customer’s place to understand the concerns, and explain the same in an open house to all the staff. Production and quality executives visit the customer place, study the working, discuss the concerns with the actual users, and explain the same to the people involved in manufacturing and quality control. 27. Communicating legal and regulatory requirements

1 2

The circulars relating to legal and regulatory requirements are kept in a file at the library, and HODs has an access to them. The CEO conducts a meeting of all HODs and explains the legal and regulatory requirements. HRD collects the latest

108

3

4

5

Effective implementation of quality management systems

gazette notices and sends circular to concerned officers as and when required. The persons responsible for monitoring the compliance to legal and regulatory requirements are given periodic refresher training, and sent to seminars and conferences as needed. Periodical audits are conducted by internal auditors for compliance to legal and regulatory requirements, and corrective actions are taken. The procedures, work instructions, job descriptions etc., are reviewed periodically to ensure their alignment with legal and regulatory requirements. The quality auditors verify the compliance, and the HODs take action. 28. Verification of compliance to legal and regulatory requirement

1 2 3 4 5

The government authorities verify the compliance by their surprise rounds. If any deviation is found, suitable action is taken. The buyer nominated auditors verifies the compliance during audits. The HRD officers are responsible for adhering to compliance, and hence they verify adherence on a regular basis. A special committee headed by HRD verifies the adherence to legal and regulatory requirements. The CEO takes personal interest in ensuring that the legal and regulatory requirements are met, and nominates internal auditors to audit the systems on a regular basis. 29. Compliance to safety requirements

1 2 3 4 5

A separate safety officer is appointed to take care of all safety requirements. Safety audit is conducted once in every 3 months and deviations found are reported to management. A safety committee is formulated, which meet every month and discuss on the requirements, and give report to management. The safety officer along with the maintenance in charge takes rounds especially for safety and ensures the compliance. The users are educated on safety requirements, and they check the safety gadgets before starting the work, and the shop floor supervisor monitors the activities.

Measuring maturity in QMS implementation

109

30. Management representative 1 2

3 4

5

A fresh, highly qualified person is recruited specially for implementing QMS as a management representative. A young officer from quality control section is freed from all responsibilities and made independent to work as management representative. The head of the quality control section is given the responsibility of management representative. A senior manager is relieved from his regular responsibilities and made management representative, and is assisted by a trained internal auditor in documentation works. A senior manager has taken the additional responsibility of becoming management representative, who is a certified lead auditor and has undergone training in management representative skills. 31. Management representative reports to

1 2 3 4 5

Quality control in-charge Head of production operations Factory manager / Head of HRD General manager / Unit head CEO / MD of the company 32. Management review is conducted by

1 2 3 4 5

Quality control in-charge Head of production operations Management representative General manager / Unit head CEO / MD of the company 33. Consistency of management review

1 2 3 4 5

Conducted Conducted Conducted Conducted Conducted

when the CEO and HODs are free. before external audits. before the next internal audit. with in one month from the scheduled date. periodically on the specified date and time.

34. Records of management review 1

The management representative maintains the record.

110 2 3 4 5

Effective implementation of quality management systems

Management representative prepares the minutes and sends hard copies to the members who attended the meeting. Minutes are sent to all the HODs irrespective of their attending the meeting. The minutes of meeting are sent by e-mail to all, and the users keep the record at their place for reference and taking actions. The internal quality auditors verify the records for the actions taken on the decisions made at management review. 35. Points discussed in management review

1 2 3 4 5

The non-conformities rose in the audits and whether they are closed. The performance against the targets fixed for production, quality, cost and the non-conformities. The corrective actions taken for the non-conformities and market complaints, along with the performance review. The performance, resource utilization, the cost cutting, future plans, non-conformities and market feedback. The performance, proactive preventive actions, customer feedback, future plans, resource utilization, recommendations for improvements and changes that could affect QMS implementation. 36. Members attending management review

1 2 3 4 5

The internal auditors and the auditee who faced the audits All staff members One representative from each department The heads of the departments or their next person in hierarchy All HODs and senior executives 37. Minimum competency fixed

1 2 3 4

People best suitable for the job are selected from the available candidates. No minimum criteria are fixed. Minimum competency is documented for all posts by actually referring to the competency the people have. The minimum competency is fixed in consultation with a qualified HR consultant. Jobs of similar nature are identified and grouped. The company requirement is judged by a team of experts along with an expert in HRD.

Measuring maturity in QMS implementation

5

111

Each element of the job needed to be performed is analysed and the competency required is identified. The highest level got is decided as minimum requirement. 38. Competency evaluation

1 2 3

4

5

Competency is checked while recruiting, and promotions are given as per seniority. Efficiency and performance levels are judged by the concerned heads of the department. Records are maintained of individuals for their efficiency and quality and the one with higher productivity and quality is considered as competent. Periodic assessments are made for performance, behaviour, attendance and records are maintained, which is used for evaluating the competency. Periodically, the employees are interviewed and enquired about the additional skill or competency acquired by them. They are encouraged to participate in trial order production or take extra assignments. Performance is measured by experts. 39. Training need identification

1 2 3

4 5

Good performers are encouraged to attend trainings conducted by eminents. About 4 to 6 people are sent for training in a year. We ensure that everyone undergoes training. Hence, people are sent on rotation to seminars and conferences. The HOD identifies the training needs at the time of annual appraisal. He recommends the trainings from the selected subjects given by the HRD. The performance of individuals is tracked, and the low performers are sent for training to training department. The competency requirements for the jobs to be done and the changes likely to take place are considered, and the competency of the persons likely to do those are analysed. The training is provided in case a gap is found. 40. Maintaining the record of competency

1

2

The HRD maintains personal files of all employees with details of their qualification and experience which was collected during recruitment. Training manager maintains the records of persons attending

112

3

4

5

Effective implementation of quality management systems

different training programme. HOD can get the data as to who all have completed the training. Training manager maintains the person wise record of trainings attended in our company. The industrial engineer maintains the records of skill and speed. The industrial engineering department maintains the records of skill and speed of each operator. The training department maintains the person wise records of training attended. The medical officer maintains the record of physical fitness. The HOD maintains the records of people working under him with the details of trainings undergone, not only in this company but also prior to joining this company, the types of works done, the responsibilities shouldered along with the present physical condition. 41. Training evaluation

1 2 3 4

5

Immediately after a training programme, a feedback form is given to all participants and their opinions taken. Members participating in training are encouraged to make a presentation to colleagues and explain what they learnt. Feedback is taken from the HOD regarding the performance of the candidate after 3 months of the training. The performance of individuals are tracked for quality, productivity, discipline, safety precautions etc., depending on the programme undergone and analysed for trends. The extent to which the departmental objectives were met as a result of trainings given are analysed, which not only evaluates the participants for their learning, but also the competency of the HOD in identifying the training needs and utilising the trained persons effectively. 42. Infrastructure decided by

1 2 3 4 5

Project engineer or an expert consultant Heads of the department General manager discusses with CEO Board of Directors and MD Users discuss their requirements with CEO and give justification that the infrastructure is for improving customer satisfaction, achieving the company goals and for meeting legal and regulatory requirements.

Measuring maturity in QMS implementation

113

43. Physical work environment 1 2 3 4 5

Minimum requirements given as per Act. We are better than the neighbouring company. We have provided better than the best benchmark. Work environment provided considering the suggestions given by employees. Studies are conducted as to which level of light, noise, dust level, passage etc., give the best results considering the quality and productivity. 44. Human related work environment

1 2 3 4 5

We honour the agreements made. We give incentives to the best performers. We sit and negotiate before taking any decision. We take suggestions from employees and act in time to solve their grievance. Transparency is there in all the activities and decisions relating to Human relations. 45. Quality objectives of the product

1 2 3 4 5

We go by our standard specifications. We honour the specifications agreed with in the limits of legal requirements. We study our competitor’s quality and try to give slightly better than that, but with in the legal limits. We analyse the market feedback and complaints and arrive at unspecified needs of the customer. We understand the real requirements and concerns by personally discussing with the customers. 46. Quality planning

1 2 3

4

The shift supervisors plan the activity for their shift considering the production completed and to be completed. Production plans for next day is written on a white board, so that the activities can be done smoothly. Weekly planner board with the details of machines to be used, the critical points to be observed is displayed prominently. Monthly operation plans are maintained with the HOD. Order-wise plans are made and the shop-floor operators are made clear about the production plan by their superiors so that

114

5

Effective implementation of quality management systems

they can keep all the required materials ready to achieve maximum production. Market complaints and feedback received for a similar product and from the same customer are displayed on the machines to facilitate inspection and testing by quality control personnel and the machine operators. 47. Contract review

1 2 3 4 5

The orders booked and are served on first-come first-served basis. Marketing personal refers the monthly plan and target proposed by PPC, and books order accordingly. PPC indicates the orders blocked and capacity available on daily basis to the marketing personnel, who in turn books the order. Detailed review is done by production, quality, maintenance and planning personnel of the proposal given by marketing. The limitations if any in providing quality of products and services are discussed with customer representative, and consensus is made if they can have an in-between solution when we do not have confidence. 48. Complaint handling

1 2

3

4

5

Customer contact person is responsible for convincing the customer. The complaints are received at marketing. The marketing chief and the manufacturing chief shall study together and make a reply to customer. Customer complaint is recorded, and sent for analysis to laboratory. After getting the reply, the customer is suitably informed by marketing. Customer’s complaint is acknowledged and a senior person from marketing visits the customer to assess the losses. If needed, a technical person from factory shall visit to suggest the actions to be taken at customer’s end to overcome the problem. Customer is provided with an alternate supply to prevent production loss while the complaint is being analysed. The customer is apprised of the situation, and the help offered to consume the materials in stock made for them. 49. Design inputs considered

1

Customer specification or the sample dimensions.

Measuring maturity in QMS implementation

2 3 4 5

115

Functional and performance requirements of the products and applicable statutory and regulatory requirements. Details of previous similar product development and the problems faced during the development of previous sample. Apart from the product requirements, the present process capability, human capability, availability of raw materials, etc. Apart from the product requirement and company capabilities, the critical concerns of the customer, the seasonal effects on quantity and quality. 50. Design output

1 2 3 4 5

Blue print and standard operating procedures developed. Apart from blue print and SOP the raw material requirement, availability, cost etc., are worked out. Product characters are described for its safe use in the blue print and SOP. Estimation of wastes, seconds and reworks are made along with the blue print, SOP, production parameters and specification. Problems likely to be faced while manufacturing, the skill level of workmen required, the modifications to be done on the machines, etc., are provided along with SOP, blue print and other details. 51. Design review

1 2 3 4 5

The design head knows the problems and shall specify if there is any thing likely to affect. The design head discusses with the design team members and quality control team. The design team discuss with production team for the likely problems. A team consisting of members from design, quality and production work together to identify the likely problems. A team consisting of members from design, manufacturing, quality, maintenance, purchase study the design in detail and identify the likely problems. 52. Design verification

1 2 3

Verification is done by the designer himself. The design head verifies the designs made by all subordinates. The design is verified by quality control personnel.

116 4 5

Effective implementation of quality management systems

Design is verified by senior production personnel. Design is verified in a team meeting, consisting members from production, design, quality, maintenance and purchase. 53. Design validation

1 2 3 4 5

Design validation is done by the design team. Validation is done by quality control team. Validation is done jointly by quality and production team. Validation is done by market team. Validation is done by the customer. 54. Control of design and development changes

1 2

3

4

5

Final parameters of the approved samples are entered in a register, and the samples are kept in cup board. Records with the parameters of the product, process and raw materials are maintained along with a sample for all the successful designs, after getting approval from marketing/ quality head. Records with all the parameters of the product, process, raw materials etc., are maintained along with a sample for all the successful designs, after getting approval from customer. While records are maintained for all the trails conducted along with the samples, the approved samples and their records are maintained in a separate file. All trials are coded, and the parameters used are documented. The reason for not approving the sample is discussed and documented. A cause and effect analysis is made for the approved samples and the rejected samples. 55. Vendor selection

1 2 3 4 5

Vendors are selected by closed tender system, and lowest price bidder gets the order. Vendors are selected after verifying the samples, and negotiating the price. Vendors are selected by referring to other companies who are buying materials from them. Vendors are selected after getting their profile and getting approval from the CEO. Vendors are selected after visiting the actual manufacturing area and assessing their quality and performance level, capacity,

Measuring maturity in QMS implementation

117

logistic problems, technical capability for giving after sales service. 56. Vendor evaluation 1 2 3

4

5

We purchase from the lowest bidder. Vendors are evaluated for quality along with price on yearly basis. Vendor evaluation is done for major suppliers on the basis of quality and price on yearly basis. Vendors are updated by a separate letter. Vendors are evaluated on the basis of quality, price, delivery and service on yearly basis. Vendors are updated by a separate letter. Vendors are evaluated on the basis of quality, price, deliver, after sales service, with different weightage depending on the product on a quarterly basis. Vendors are updated on-line and invited to discuss their problems and plans. 57. Vendor development

1 2 3

4

5

Purchasing shall be done from standard vendors and original manufacturers. Chance shall be given to new vendors to develop by giving free trial orders. Our technical team shall explain the critical requirements, and the suppliers are encouraged to see our machines and type of working so that they can decide on developing. Our technical team shall be involved in the designing, developing and validation of products at suppliers end before bulk supply. Our technical and commercial teams keep regular vigil on the happenings and provide necessary assistance where the supplier finds it difficult to manage. 58. Purchasing information

1 2

3

Purchase order consists of product name, purchase conditions, transport requirements, quantity and value. Apart from the product name, the catalogue number, the standard reference (for e.g., ISI Number) is given in purchase order. Apart from the normal purchase order details, the criteria for

118

4

5

Effective implementation of quality management systems

approval of the product and the procedure reference of testing are incorporated. Purchase orders are verified for adequacy by an expert team before the orders are sent to suppliers. Samples are provided where ever it is required. Supplier is invited for discussions to understand the critical requirements of the product and also to collect dimensions and other details in case required to avoid duplication or rejection. 59. Verification of purchased product

1 2 3 4

5

Stores verify the quantity and issue the materials to users. Users verify the quality and approve the products received. Only approved product shall be issued. The representative of supplier is invited while inspecting critical materials. The quality checkers visit the supplier place and check the materials ready for despatch to ensure that they meet our requirement. The quality checkers visit the supplier place and check the critical components being used for the product being manufactured for us. 60. Validation of processes

1 2 3 4 5

Special processes are not identified. Special processes are identified and the work procedures are documented. Procedure for establishing process parameters is established. Periodic validation is done for the process parameter fixed to ensure its continued suitability. The workers are retrained whenever there is a change in process parameter and audited periodically to ensure adherence to the systems. 61. Identification and traceability

1 2 3

All materials in process are identified by their physical appearance. Materials in process and material in stock are identified by suitable colour coding / bar-coding systems. The codes used for identification and traceability are displayed prominently in the production area.

Measuring maturity in QMS implementation

4 5

119

A record is maintained of the identifications used on different days for the products being manufactured. Employees are repeatedly educated on the colour codes being used, and periodically audited to ensure that every one is following the same coding system. 62. Customer property

1

2

3

4

5

Customer supplied materials are used along with other materials. At the end of the production, account is given considering the materials supplied back to customer. Account is maintained at stores for the customer supplied products, entries are made while issuing it to production and information is sent to customer regarding rejections. Senior managers are nominated for different customers to follow up with the materials being supplied by customer for incorporation in the product. Quality issues or any discrepancy in quantity are handled by that nominated manager. Periodic audits are done by the nominated manager for the materials in stock, the wastes generated and materials consumed. Periodic reconciliation is made and submitted to customer. Nominated managers keep in touch with customer on day to day basis and update them on quality and productivity aspects, and take instructions for correcting the situation in case of problem. 63. Preservation of product

1 2 3 4 5

Final product is packed as required by customer by taking all care, and are preserved in a dry and clean area. Apart from the final product, the raw materials are ensured of proper packing and kept in clean warehouses to avoid losses. The in-process materials are kept in suitable containers to prevent them from getting damaged due to handling. Suitable material handling equipments are used to ensure no damage due to handling. Materials in stock are periodically checked for their continued acceptability. 64. Control of monitoring and measuring devices

1 2

A list of all monitoring and measuring equipments is made. Master samples of each equipment or device is identified and got calibrated by an authorised laboratory.

120 3

4

5

Effective implementation of quality management systems

Calibration is done for all monitoring and measuring devices. Operators are trained for handling the monitoring and measuring devices. Periodically, the equipments are validated by conducting round tests apart from the calibration. The deviations if found are analysed statistically. Periodic checks are done for the validity of calibration and the accuracy of results. 65. Decision of out sourcing

1 2 3 4 5

Out sourcing is done to reduce the cost of manufacturing. Out sourcing is done not only to reduce costs but also to avoid labour problems. Out sourcing is done as we are not capable of meeting the despatch schedules. Out sourcing is done from a good party when we are not getting quality. Out sourcing is done for the process which we do not have. 66. Control of out-sourced goods

1 2 3 4

5

Payment shall be made only for good quality materials supplied in time. Out sourcing contractor is educated on our requirements by the sourcing manager. Our quality control person visits the out sourcing unit regularly and inspects the materials before packing. The staff and other employees of the out sourcing unit are educated on the quality requirements, and trained on job by experts at our cost to produce required quality. The internal quality auditors audit the out sourcing units also on a regular basis to ensure compliance to the system requirements. 67. Measurement of customer satisfaction

1 2 3

Reputed consultants are appointed for conducting customer satisfaction survey. The customer satisfaction is measured by the number of complaints received and the orders booked. Customer satisfaction is measured by continuity of a customer for a long time with repeated orders.

Measuring maturity in QMS implementation

4

5

121

Customer satisfaction is measured by discussing with the customer regarding the critical concerns and our ability to meet his requirement in a scale of 1 to 5. The customer’s customers are contacted with the knowledge of our customers to find out the performance of our products at the customer’s end. 68. Customer satisfaction assessment

1 2 3 4 5

The customer is assumed as satisfied when we do not get any complaint. Customer is assumed as satisfied when he is coming back with repeated orders. Customer is assumed as satisfied when he comes and discusses the performance and gives suggestions for improvement. Customer is assumed to be satisfied when he increases our share in his purchases. Periodic reviews are made to validate the customer satisfaction data by linking it to company performance. New devices are developed to get fairly reliable information for taking action in time. 69. Internal quality audits – schedule

1 2 3 4 5

Audits are not done as per plan and in some cases audits are not done. Audits are not done as per plan in 50% of the cases and are replanned where it is not done. Audits are not done as per plan in some area, where as 75% area, it is as per plan. Audits are not done as per plan on the same day but at different timing. All audits are done as per plan. 70. IQA – Quality of audit

1

2

The audit reports are written but auditors have not written date, time, etc. at number of places. The auditee has signed and accepted the non-conformity, but has not written the root cause, the proposed date of taking action. The clause numbers are not correct. The clause numbers written by auditor are not correct and no one has taken objection for that. The auditee has written the

122

3

4 5

Effective implementation of quality management systems

proposed date of action, but has not identified the root cause. The clause number is correct, but the non-conformity is in a suggestion mode or dictation mode. The root cause analysis is not made by the auditee. The MR has written the root cause. The root cause analysis is made by the auditee for all the nonconformities and actions taken. Trend analysis is made for identifying the repeated type of nonconformities and taking preventive actions. The MR is tracking the progress. 71. IQA – Closing of the NC

1

2 3

4 5

Number of NC is not closed and kept pending for months. They are closed after the follow up of MR just before the external audits. Non-conformities are closed but later than the committed date. The MR follows up on weekly basis for closing the NCs. Non-conformities are closed on the committed day in majority of the cases, where as in few cases it was late. The auditee takes initiative. Majority non-conformities are closed before the committed date. Average days for closing NC is monitored and trends are drawn which show a continuous improvement. 72. IQA – Auditor competency

1 2 3

4

5

Quality control checkers are taken as quality auditors as they have experience of auditing on a regular basis. Smart intelligent officers from different sections are taken and given the responsibility of auditing. Auditors are selected from all sections, with an aptitude for learning and are smart in identifying the deviations. They were trained internally by a consultant as auditor. Auditors are sent for training by a competent authority, which train and conduct a test and give certificate to those who have completed successfully. Auditors are trained under eminent lead auditors, and refresher trainings are given to improve their auditing skills. 73. IQA – Auditor punctuality

1

A number of auditors have not reported for the audit and MR could not make any alternative arrangement.

Measuring maturity in QMS implementation

2 3

4 5

123

Some of the auditors could not attend in time, but have informed the MR in advance. No alternative arrangement is made. Auditors are conducting the audits on specified date or on mutually agreed date in consultation with the management representative. Some reports are delayed. Analysis of auditor’s punctuality shows a positive trend and continuous improvement. Some audit reports are submitted late. All auditors are attending the audit as per schedule, and submitting the report in time. 74. IQA – Auditee response

1 2

3 4 5

Auditee is afraid of the audits and wishes to avoid. Some of the HODs have not faced the internal audits. Some of the auditee team members are confident of facing an audit, and are covering other colleagues. The HOD always presents such persons to face the audit. All members are ready to face an audit, but prefer not to get audited. All members are willing to get audited and invite the auditor to conduct audit in his/her area. Members are disappointed if the auditor does not visit their area. 75. IQA – Auditor–Auditee interaction

1 2 3 4 5

Auditee simply accepts the report given by the auditor. Auditee seeks the help of management representative for understanding the comments made by auditor. Auditee demands clarification where the wordings are not clear. Refuses to accept a non-conformity if clarity is not there. Auditee accepts the non conformities willingly and works to close at the earliest. Auditee closes the NC at the earliest and goes to auditor to close the NC. 76. Top management commitment in audits

1 2 3

Heads of the department are not following for getting their area audited. Heads of the department are not getting their area audited, but are directing the auditors towards subordinates. Head of the department sits for audit for some time, and then

124

4 5

Effective implementation of quality management systems

goes out because of emergency works/meeting/follow up for production. Head of the department attends the audit fully, but leaves the responsibility of closing the NC on the subordinates. Head of the department takes active part in audits and follows up with his subordinates and gets the non-conformities attended at the earliest. 77. Measurement of processes

1 2 3 4

5

Processes are assessed on a subjective basis, as no measurables are identified. Majority of the processes have measurable parameters. All processes have measurable parameters that can be controlled and used as a tool to measure. Critical processes are periodically reviewed by top management for performance, where as others are left to supervisors and shop floor workers. Critical processes are reviewed by top management on a regular basis, and the HODs review all the processes in their work area on a periodic basis. 78. Monitoring of process

1 2 3 4

5

Processes are set as per the suggested parameters before the start of the works. Quality control investigators study the process efficiency and give their report to the management. Control points identified for the process are monitored by shop floor supervisors and reported to HOD on daily basis. The HOD is reviewing the monitoring activities at random along with the supervisors and ensures the compliance and performance. The system of process monitoring is reviewed periodically by the top management for its effectiveness. 79. In-process product inspection

1 2 3

Concerned departmental head sends samples to laboratory and get the quality tested before starting any new lot. Laboratory assistant collects samples as per the sampling plan given to him, and get the materials tested in lab. The shift supervisors test themselves some of the lots in addition

Measuring maturity in QMS implementation

4

5

125

to laboratory testing in case of critical quality requirements. The operators ensure the quality by checking the materials produced with reference to a standard material at the start of each day/shift. The operators ensure the quality by checking the materials produced with reference to a standard material at regular intervals. 80. Final product inspection

1 2 3 4

5

SQC inspectors draw the samples from packed materials at random and check for the conformance. SQC inspectors draw samples ready for packing and check for the parameters and then allow the packing to be done. SQC inspectors draw samples from ready stock as well as from warehouses and check for their conformance. SQC draws sample on daily basis before packing and test them. The results are compiled for the lot, and the variations with in lot are studied before despatching. Apart for checking the materials before packing, after packing before despatch, SQC draws samples from the passed lots and preserve at the laboratory, and check them for change in properties after lapse of certain months and season. 81. Acceptance criteria

1

2

3

4

5

The specifications and tolerance developed by statistical approach by our R&D shall be the base. Any material out of tolerance shall be rejected. The specifications and tolerance given by the customer shall be the base. If any material is found out of tolerance shall be rejected. Basing on the customer specifications control charts are developed and run theory is applied for accepting and correcting the product. A process capability index of 1.33 is targeted (3ó level). Control limits are made stringent to accept only if the process capability is 1.7 and above with the specifications and tolerance given by the customer as the base. Control limits are set to accept materials if the process capability index is around 2 with the specifications and tolerance given by the customer as the base (6ó level).

126

Effective implementation of quality management systems

82. Identification of non-conforming product 1 2 3

4

5

The packers identify the non-conforming products and remove them before packing. Non-conforming products are identified by specially trained QC checkers on line apart from the final inspection by packers. Apart from the QC checker, whenever the HOD and general manager come on round, they identify some non-conforming products and remove them. Supervisor checks the quality of material in process and in stock and removes the non-conforming material. This is in addition to checking by QC and the final packers. The operators ensure the quality by carefully observing the materials produced and identifying the non-conforming products on-line, in addition to inspection by QC, supervisors and the packers. 83. Segregation of non-conforming products

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4

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Rejected materials are kept at a specified place as decided by the supervisor and the details are written in log book. Rejected materials are tagged with Red tag and kept at the place decided by the supervisor, and the details are written in log book. Specific bins are identified and earmarked for keeping the rejected material. The supervisor enters the details in the log book. Specific bins are identified and earmarked for keeping the rejected material. The supervisor ensures that all rejected materials are kept in that bin, and entered in the log book. Non-conforming materials are put a tag or given a different colour code and kept at the bin reserved for rejected materials. A separate register is maintained for tracking the generation and use of rejected material. 84. Authority to dispose non-conforming products

1 2 3

Worker on the spot is empowered to take a decision for scrapping or using the nonconforming materials. The supervisor on floor is authorised to decide on spot the disposing of the nonconforming material. The chief of production operation is authorised to decide on the mode of disposal of rejected goods including its reuse as per the situation.

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The chief of quality shall discuss with the chief of production, and jointly decide the disposal action. The chief of marketing, chief of production and chief of quality jointly take a decision for the disposal of non-conforming materials. 85. Recording of non-conformities and actions

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5

The supervisor daily enters the quantity of wastes produced in the log book. The supervisor daily enters the quantity of wastes produced and the wastes reused, the rejections made and sent as saleable wastes in the log book. The supervisor records the reason-wise non-conformities found and the quantity rejected and reused/altered in log book, which is reviewed by the HOD on daily basis. A separate register is maintained for tracking the generation and use of rejected material. The supervisor ensures the entry of required information reason-wise. The physical verification of non-conforming materials in stock is made once in month to reconcile the data entered in the register. 86. Verification after correction

1 2 3 4 5

The one who is correcting is responsible for ensuring the quality, and delivers to packing. The packing in-charge gets the verification done of the repaired/ corrected items. A separate quality control team verifies the corrections made and approves the corrected material. Verification after correction is done by the same person who had rejected it. Verification after correction is done by a team consisting of quality control and marketing personal along with the person who had rejected it earlier. 87. Analysis of data

1 2

The concerned supervisor or in-charge analyses the data on dayto-day basis to ensure it as correct, and takes decision accordingly. The HOD analyses the data submitted to him for its correctness and takes actions for the deviations.

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The HOD gets the trend charts prepared of the data and analyses on a monthly basis. The cause-wise trends are prepared and analysis is made on monthly basis, season wise, product wise and submitted to top management. The trends of improvement or deterioration are compared with similar industry, and also with the best in the class. The reasons for deviations are identified. 88. Measuring the objectives

1 2 3 4

5

The company objectives are the targets to be achieved on a long-term ideal situation and cannot be measured. Measurable for each objective is identified, and the unit of measure is defined. The extent to which the objectives are achieved are verified on an annual basis while preparing for surveillance audits. The measurable are identified for each of the key result area identified for the objectives, and performance is measured and reviewed on a monthly basis. The measurable identified are reviewed on a yearly basis to find their suitability to represent the achievement of the objective in a true sense. 89. Continual improvement

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5

Areas where improvements are seen are highlighted on monthly basis to encourage others to improve. Targets are revised considering the performance of previous month on a practical approach. Targets are given in selected area, and teams are formed to achieve it. The results are monitored and presented in management review. Key result areas are identified for meeting the company objectives and targets are fixed for them. Action plans are made to achieve them. Targets are stretched where the results are achieved to move towards the benchmarks or to remain as benchmarks. 90. QMS effectiveness

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The quality policy and objectives are known to senior officials. The procedures are written as per mandatory requirements. Quality manual is written.

Measuring maturity in QMS implementation

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Procedures and instructions are written for all activities. Processes are audited as per schedule. Records are maintained as per the requirement The policy, objectives, procedures, organization structure are reviewed periodically and communicated to all. The people are adequately trained to perform their jobs. All the processes are realigned considering the market needs, the resources are provided to achieve the results, and process is corrected when deviations are found. Proactive actions are taken to prevent deviations in the process performance and in delivering the goods and services. Continual improvement is achieved in customer satisfaction, company performance, and in the employee morale. 91. Corrective action

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Reply made in time for the complaint and non-conformities received. Complaints and non-conformities are discussed with senior members and suitable reply is drafted in a convincing way. The persons responsible for the non-conformity are apprised of the situation and the corrective actions to be taken are decided depending on the situation. Analysis of the complaint and non-conformity are done by a team of experts and the root cause is found. Actions are taken to correct the root cause. People working are involved in analyzing the problem, and identifying the root cause. The corrective actions are jointly arrived at by considering the pros and cons. Actions are taken and the procedures are modified to ensure that the problem does not repeat. 92. Preventive action

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3

The Board of Directors by taking views of eminent consultants works out the strategy to face the potential problems. The CEO discusses the potential problems with the HODs in a meeting during his visit to the company. Serious issues are discussed by taking the union into confidence. The HR, purchase and marketing personnel, who have daily contacts with outside world, collect information through various sources regarding the changes that are taking place and advise the management regarding the potential problem.

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All employees are encouraged to identify potential problems according to their level of thinking and submit to the HRD. These are reviewed by a committee where preventive actions are proposed for the potential problem. The person identifying a potential problem is encouraged by making him a committee member for identifying a suitable preventive action and for training the fellow employees in preventing the problem. The top management gives full support to prevent that problem. 93. Involvement of top management

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5

Preparation of quality policy and objectives. Involved in defining of organization structure, authorities and responsibilities, and preparing the quality manual. Involved in the regular internal audits, reviews of all activities and training programme. Actively involved in getting the nonconformities closed in time of all sections, physically verifying the resource utilization and company wide implementation of QMS. Reviewing periodically the effectiveness of implementation of QMS and providing necessary guidance and resources for making it effective company wide. 94. Employee well-being

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Minimum wages are assured for employees as per the statutory requirements. Workers are paid bonus, gratuity, provident fund, ESI facilities etc., as per the regulations. Workers are encouraged to do overtime so that they can earn something extra. Salary advances are given for festivals. Employees are allowed to accumulate their leaves and encash when needed. Incentives are given based on regularity in attendance and achievement of production. Workers intending to study are encouraged by adjusting their shifts and providing leaves for examinations. Scholarships are paid to meritorious children of employees in tenth standard. Soft loans are given to needy employees considering their performance. Employee’s children are given preference for jobs. Interactions are made with families of employees to understand their needs, and help rendered where ever practical.

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95. Employee satisfaction measurement 1 2 3 4

5

Employee satisfaction is measured by conducting survey from external agencies. Employee satisfaction is measured by the absence of strikes Employee satisfaction is measured by the reduction in absenteeism, employee turn over. Employee satisfaction is measured by improved performance per employee, i.e. production along with quality at lower expenses. Employee satisfaction is assessed by close interaction with employees and understanding their views and problems. 96. Strategy for continual improvement

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Latest technology shall be adopted by keeping continuous vigil on the technological developments. Training and retraining the employees shall be given preference to improve productivity and reduce wastes. Benchmarking the best in category shall be adopted to improve the systems continually and reduce costs. Unexplored area by our competitors shall be explored to develop niche products and markets. Market surveys are done along with customers for their market to understand the change in requirements and processes are aligned as per the future needs. 97. Involvement of people

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People never refuse instructions. People willingly come forward and take instructions. People discuss the points before accepting. People do the work as required and there is no need for follow up. People report the activities from time to time and get ensured that they are as per target. 98. Supplier relationship

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Suppliers have to agree to our terms as we are giving them business. We ensure proper payment in time as agreed provided the quality of materials are good and supplied in time.

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Supplier takes back the materials and settles claims whenever we complain. Supplier discusses his problems and costs and the same are studied carefully to enhance price if needed. Supplier is involved in product development and the costs are worked out jointly and processes are adjusted to suit the required. 99. Leadership

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People respect the CEO. Whenever he visits, complete premises shall be kept clean and senior officers shall be present during his rounds. Whatever the CEO says is the ultimate and everyone follows it with out any grumbling. CEO discusses the plans and problems with senior managers, and reviews during his next visit. CEO demonstrates his commitment to the system by personally following it all the time. CEO discusses his plans even with senior workmen and union leaders while planning for future, and implements the plan as discussed. 100. Fact-based decision

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Records are maintained at all important places, and decisions are based on the data available. The decisions are taken basing on the facts provided by the concerned heads of the department who scrutinize the data before submitting further. ERP system is implemented and hence all data are captured by the system and decisions taken accordingly. Computer software is periodically calibrated to ensure its suitability and reliability for the purpose. Linking exercises are done to cross check the validity of data before taking any decision.

By assessing our present level of maturity, targets can be given to achieve the next level in certain time frame. Once the targets are given, it is not only the employees, but also the top management must work to achieve the target. Once we achieve the score at highest level, the questions may be changed considering the latest developments in the concepts and the systems.

Welcome Welcome the complaints

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6 Welcome the complaints

“Sulabha purusha loke satatam priyavaadina Apriyasya cha pathyascha vakta shrota cha durlabha” – Vasista

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Who is interested in complaining?

The shloka (stanza) quoted above is from Ramayana, the first known written epic on this earth; that was written about 51 centuries back by saint Valmeeki. He quotes the advices of Guru Vasista explaining to Lord Rama when he was crowned as an emperor. He says that it is very easy to get people always uttering sweet words and praising, but it is very difficult to get people who can tell the truth (comments and facts) that is not liked or tolerated by others and also the people who can listen to those comments and facts. This does not apply only to an emperor like Lord Rama, but also for all and at all the time. It is true with our customers also. The customers are interested in doing their business and are not really interested in wasting their time and efforts in making comments, either good or bad, about the products and services they received. If the quality is good, they shall be happy to come back to us. If the quality is not satisfactory, the customer might grumble. Customer makes a complaint when he/she feels that the complaint is likely to help his/her business/ activities. It is observed that a customer will not complain every time even though the quality of products and services are very poor. Out of 100 customers, only 10–15 customers make complaints or comments. Even if we send the questionnaire, or personally request the customers also, we never get 100% response. A response of 25–30% is found normal in the customer satisfaction surveys. Let us have some examples. ●

While you are driving in an unfamiliar road, you go to a road side café and take a cup of coffee or tea. The quality is not good. Are you going to complain? The answer is “No”. But if the quality of tea is bad in your favourite hotel, where you go regularly, you will complain. If you happen to go in the same road again, you might prefer to try

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at some other café, and not go to same place where your experience was not good. You feel something as unethical and you are not doing it. Some one, whom you do not know is doing that unethical work, are you going to advise him? The answer is “No. It is not my business”. If the same is done by your brother or a close friend, you are advising. In your office, your boss is not good in language. He makes mistakes in using appropriate words, and hence it might mean different. Are you going to tell your boss to correct his language? The answer is “No”. If the same mistake is done by your younger brother or sister, you would like to correct them and explain as to why that was wrong. Some times you might make a skit by imitating the language and style of your boss on a happy occasion with your friends.

When customer complains?

A customer makes a complaint when he/she has a feeling that the company listen him/her and is likely to improve. When customer is interested in your products and services, and feels to continue business, he shall explain the lapses and request you to improve in those areas. The customer is interested in getting good products and services in time so that his business is not affected. Normally, customers are not interested in changing their suppliers. You can take your own example. Even though there are hundreds of grocery shops dealing with the same commodities in a market, you normally go to a specific shop. The products are same, the quality is same, the price is same and even then you do not go to another shop. Somehow you are comfortable with that shop. If some one asks you, you cannot justify with proper reasons as to why you like that shop. Similar is the case with our customers also. For any business identifying new customers and convincing them to buy their products and services is not an easy task. It requires lot of efforts and there will be expenses. Similar is the case with developing a supplier. Developing a supplier to meet our exact requirements may be sometimes costlier and also risky. This is truer when we are making specialty products with our own innovations. The customers do not like to change their suppliers if they have a confidence that the supplier shall improve and provide quality and services as needed. The customers give their feed back to their suppliers when they are satisfied with the performance. If the supplier is not improving, the customers have no other alternative than to search for a new one. Another interesting phenomenon observed is that as the quality improves, the complaints also increase. People might laugh at this statement, but it is true. Take some examples.

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People travel daily in crowded city busses or local train. The buses or trains might come late or the commuters might not get a seat to sit comfortably. But they never complain either for the train or bus coming late or for not getting a seat for sitting comfortably, although they have paid money for ticket. They can sue the railways or bus service for not providing a seat and making them standing or virtually hanging in a bus or train, or not for maintaining the time as per the published time table. It is the duty of railways or road transport corporations to provide seat to all their passengers, or charge less for the passengers standing. The bus or train services should compensate for loses incurred by the commuters for delays. But it never happens. By seeing the plight of their employees, if a company introduces free bus service, then people complain of not coming in time. Normally, seat is provided for all on all the days; however, on a particular day, due to some emergency, if one or two passengers are taken extra, the people make complaint. The customers want consistency in quality and supplies and not very good quality at some times. If you are consistently providing a poor quality and service, your customers get adjusted to it. They will be coming to you till they find another alternative that is better than you. They will not make any complaint. However, if you start improving your quality of products and services, the customers shall be happy and they will stick to you. The expectations of customer will increase as your quality of product and services improve. They will now have a different tolerance for the same products and services, based on the best services you provided. They will show their displeasure if you slip down from your achieved levels. Therefore, you should always have a system of reinforcing the systems and sustaining the performance at improved levels.

6.3

When customer does not complain?

Normally, people will be happy when they do not receive any complaint. They assume that their products and services are good. They feel bad when they receive a complaint. However, we need to go deep and analyse. A customer, who was earlier making complaints, has stopped making complaints. Is it a good sign or a bad sign? Please make analysis. Have you really improved the products and services to his satisfaction? Have you responded to customer all the time positively? Whether customer had agreed with your views and changes made? Are you having a mechanism to verify from whom that customer is procuring similar products? What is your share in the products and services to that customer? Whether that share is increasing or decreasing? Whether the customer is having the same confident as he was having earlier? A customer who was regularly complaining cannot stop complaining unless he has decided to move out

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from you. People in business do not want to complain while departing as they want to maintain relationship. They may come back to you after some time. If the customer loses confidence in you, he will not complain. The customer might be continuing with you because he has no alternate source. The moment he identifies another source, he shall stop buying from you. Till that time, he shall be somehow managing with you. It does not mean that he is very happy. The customers come to you by seeing your advertisements, outward look of you factory, the certificates you have, the machineries and the infrastructure. However, he gets the real feel of your company after getting your products and services. He makes an analysis and finds the gap between his expectations about your company and the extent to which they are accomplished. If the gap is more, the customer makes an opinion that you are not suitable for his business. He does not want to waste his time and money in complaining, sending the complaint samples, making correspondence, etc. He rather utilizes that time and money to find an alternative source. It is observed that the customers those are complaining are the ones taking more materials from us. It is observed that only 10–15% of the customers make complaints but they normally lift 65–75% of the materials produced. Non-complaining customers are normally one time visitors, or using us as a standby supplier. The one-time customers are very dangerous. A dissatisfied customer, who is moving out, is found to advocate at least 20 other potential customers not to try with that supplier. These 20 potential people quote this customer to their friends for not choosing a particular supplier. It is very difficult to build an image, but is very easy to destroy.

6.4

Customer – a free consultant

If we are responding to customer needs, the customers shall proactively give us feedback on the changes in market requirements, the changes we need to incorporate in our products and services, the likely changes in the legal and regulatory requirements, etc. Good companies make use of this and improve. If we do not listen to the customers, and feel that he is making complaint only to squeeze us, then he will not make any complaint or give any feedback. Customer is a free consultant. He shall not charge for the suggestions given by him, but would like us to incorporate those suggestions in regular working. If we improve, he will get good quality products and services. Therefore, he can improve. If he improves because of us honouring his suggestions, he will stay with us. It is therefore essential for us to respond

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to the customer and take advantage of his knowledge and experience in making our products and services competent, so that we can survive in the market. If we want the suggestions from a consultant, he shall charge for it. The consultant can give a suggestion, but not the business. But a customer gives business when his suggestions are honoured. Customer shall be happy and give business even if his idea or suggestion could not give an anticipated result. He shall be happy that we have honoured him and are with him.

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Face the audits Effective implementation of quality management systems

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7.1

Why to face audits?

The audits are conducted to ensure that the company is adhering to the requirements of the standards, and are following their procedures that are written in order to achieve their organization goals. A periodic audit helps the auditee to take corrective actions on the deviations and align the processes inline with the requirements. This helps in reducing the mistakes. Audits may be internal or external, but have the same objective of ensuring compliance to the systems and to highlight the deviations for taking actions. Audits are the eye openers and help in detecting the deviations in the beginning itself, before it grows as a major problem or become fatal. The studies and experiences have shown that eliminating a problem at seed stage is easier than removing a grown tree. The analysis made by American Association for Safety and Health revealed that behind every fatal accident there were 30 near misses and 300 unsafe conditions. To prevent fatal accidents one has to concentrate for proactively eliminating unsafe conditions. The unsafe condition is easy to attend like a problem in the seed stage; but people ignore the signal given by the spread of unwanted seeds. The near misses are like a problem in the seedling stage. It is possible to remove the seedling with slight effort, but people do not spare their time to do that. Finally, when it becomes a tree, it is not possible to remove or not viable to remove. People learn living with the problem or become a victim of it. The same is true in case of the non-conformities raised by the internal and external auditors. It is easy to stabilize the systems by making root cause analysis for all the non-conformities observed and taking prompt corrective and preventive actions. However, it is seen in a number of cases that the people try to avoid facing audits because of the fear of a non-conformity being identified in their section. They feel bad when non-conformity is written. By feeling bad or avoiding the auditor, we will be allowing the unwanted seeds of problem to grow ultimately resulting in major problems. One might have devised a very good system, but whether the same is implemented as per expectations is always a question, as the one who designed is normally different from the one implementing. There might be number of unintentional deviations because of communication lapses, understanding with a different perspective and the circumstances.

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Some times it is seen that the system documented is outdated and the people have adopted an improved method for their works. In such cases, the audits indicate that the procedures need to be documented properly as per the changed working systems. If the documentation is not changed, there are chances of some people following the old system and some with new, finally resulting in the variations and poor quality. It is a known fact that one cannot identify some of his/her mistakes or deviations, where as an outsider with an open mind can identify them. Therefore, getting the self-audited by an outsider at periodic intervals is suggested. ● Audit is a process to ensure conformity to the systems. ● Audit is conducted by trained experts. ● Auditor is not interested in finding a mistake, but any deviation found from actual to practice shall be highlighted as a deviation; might be a non-conformity or an observation. ● We go to doctor periodically to get ourselves checked. If any disease is found building up, we take preventive medicines, and some times even undergo surgery (for e.g. by pass surgery) to prevent the problem. Here auditor is a doctor, and hence we should cooperate with him and show frankly whatever is asked. ● Do not show anything which is not asked, as auditor is not a perfect doctor to suggest you remedies for everything. Behind every fatal accidents there are 30 near misses and 300 unsafe conditions.

Problem in tree stage [Disasters at work place/ Company is in trouble] Problem in seedling stage [Prompt actions not taken on market complaints

Problem in seed stage [Signal ignored/ Actions not taken on the NC found in Audits]

1 Fatal Accident

30 Near Misses

300 Unsafe Conditions

Problems at work place //Deviations in systems

7.1 Theory of –!0–!00.

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7.2

Basic human nature

It is normal that human beings want to rest and enjoy their life. They try to avoid the works whenever an opportunity is there. This basic nature led to the development of science and technology. Lots of automations are done and the machines are doing the works that were earlier done by humans. The basic aim is to reduce the works as much as possible and still get the result. Another nature of a human being is to forget. It is a gift given by got, although we find in a number of cases the ill effects of forgetting. We cannot remember everything. But we cannot always remember what we are supposed to remember. The reason for forgetting is mainly due to diversions in our attention because of changed requirements. We normally do not forget the steps in an activity that is done on a regular basis. As the time passes, we forget those events. It is therefore suggested to refer the documented manual and procedures periodically and ensure that we are following all the steps as documented, and modify the documents in the event of any improvement done.

7.3

What shall be audited?

The auditing is done mainly to verify the conformity to systems and not to pinpoint that a person has done a mistake. It should identify the deviations in systems and not one person’s failure in performing an act. The audit should concentrate on; ● ● ● ● ● ● ●

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Whether we are clear on our roles and responsibilities. Whether we have established systems to carry out the activities. Whether all are working as per the established systems that are documented. Whether we can provide evidence of adhering to documented systems all the time. Whether we are clear with the job description for each job with clear authorities and responsibilities. Whether we have defined clearly the minimum competency levels for each job. Whether we are clear about the competency levels of the people doing the jobs and whether the records are maintained with the concerned HOD or section head to facilitate them allotting job to people. Whether we are analysing the deviations for the root cause and taking appropriate corrective and preventive actions.

The questions detailed in Chapter 4 under the heading of internal quality audits holds good for external audits also.

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Preparing for the audit

Although we say that we work always as per the systems, the mind needs certain preparation before facing an audit. We need to keep some time reserved for interacting with an auditor. Therefore it is common that the audit date and time are fixed with the consent of the auditor and the auditee. The dates are announced in advance so that both auditor and auditee can prepare themselves. The auditor prepares himself by reading the manuals, procedures and the previous audit reports before coming for an audit. The auditee needs to ensure that all are working as per the systems, people are confident and can explain their activities to the auditor and clarify the doubts or questions asked. The following are some of the tips to prepare for facing an audit. ●

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Ensure that all the staff members have read quality manual and understood. Ensure that all are well versed with the procedures and instructions. Ensure that all are clear about quality policy and can explain their role in implementing it. Prepare trend chart for the objectives achieved in your section for at least one year. Ensure that all records are up to date. See that records are kept in their respective places all the time. Check for the label, title etc., for the records as per procedure. Ensure that for all non-conformities, complaints etc., actions are taken and are recorded. [Note: There should not be any pending nonconformity] Check the calibration status for all the equipments. Ensure calibration stickers on instruments. Demark place for keeping non-conforming products at appropriate places in production, stores and ware houses. Do not keep any unwanted material, machine, men etc., in work place. If any idle machine is there, put a board stating it as idle, and not to start. Remove the fuse for safety. Ensure that all associates are clear about work instructions. They should read and explain. Ensure that all forms used are numbered, and referred in work procedures and work instructions. Ensure that all non-conformities raised in previous audits are closed in time. There should be a root cause analysis for each of the market complaints, non-conformities raised not only in ISO 9000 audits, but also for the points given in quality control audits, buyer audits, safety audits, tool audits etc. Keep evidences for the actions taken.

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Effective implementation of quality management systems

Ensure that actions are taken in time for the points raised in Management Review Meeting. [Note: Any delay or non-taking action shall be taken seriously by external auditors as they reflect badly on top management commitment]. Make market complaint analysis party wise, reason wise, and product wise and show the trends for at least one year. Keep the records of vendor analysis ready. Keep the proof of letter written to suppliers for rejections, and low rating in vendor evaluation. Keep the records of training need identified and training given as per the training need identified.

Face the audits

Face the audits with confidence. There is no need for panicking. An auditor is a friend who has come to show us the possible areas for improvement. Following are some tips for facing an audit. ●

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The Audit shall start with an Opening Meeting. All H.O.D and the guides must be present in time. No one should come late. Introduce yourself briefly to the auditor during opening meeting and express your willingness to improve self by the audits. Ensure that meeting is concluded as per the time table given. Do not waste the time by talking unrelated matters. Keep good house keeping as it shall give the first impression of your systems. Head of the Department must be present in the audit. Introduce yourself and your assistants to the auditor before the audit starts. Offer Tea, Coffee or soft drinks while the audit is going on, but after asking the auditor about his/her choice. Do not attend to any phone calls during audits. Tell very clearly that you are in audit, and no one should disturb you. The top management must ensure that they do not disturb any one when an audit is in progress. Do not allow any one to enter the auditing area, unless the auditor/ auditee wanted him/her for audit purpose. Listen to the question carefully before answering. Answer only to the point, and do not show or tell any thing which is not asked. Do not argue with auditor while auditing is going on. Just note down his remarks and discuss with MR and unit head before closing meeting. Do not bluff. Remember that auditor is a well matured person who

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7.6

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can make out what is real. He shall be linking your statement to some other area for verification. Do not become nervous. Remember that auditor is our friend who shall show the area where we need improvement. Auditor has seen different industries and has a fair idea of what is practicable and what is not. Although auditor is not supposed to suggest, shall give a hint while asking questions. Observe him carefully and note down his reactions or observations. Show the actions taken on the observations and nonconformities to the auditor before the closing meeting. It shall impress the auditor and shall demonstrate our enthusiasm for improvement. Everyone who attended the opening meeting must be present in the closing meeting, along with representatives of the area audited. Maintain timings of the audit and the meetings.

Role of a guide

As auditors are out siders and do not have the clarity of different departments and sections you have, please provide some one as guide. The guide should be a neutral person for the section being audited. He shall just introduce the auditor to auditee and make arrangements for getting the required people. The guide will not answer any question on behalf of the auditee. He shall just note down the questions and the reactions, and inform the management representative in brief. Following are some tips for the guides. ●

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7.7

A guide is a person who shall take the auditor round the sections as required and introduce him to auditee. Guide shall not answer to any question asked during audit, unless the auditor asks the guide to give clarification. Guide shall note down all the points like the questions asked, answers given, points highlighted and remarks of auditor etc. Normally a guide shall be a trained auditor from other section. We need to announce the guides in the opening meeting itself and introduce them to auditors. Guide shall be interacting with management representative regarding the progress of the audits, deviations found etc., so that MR shall initiate corrective actions to close the NC before the closing meeting.

Understand the non-conformities and observations

During the audits, the auditors observe some deviations. They either put it as nonconformity or as an observation. The non-conformities are

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supposed to be closed without undue delay by the auditee. It is found that some of the leading certifying bodies have a practice of giving 90 days time to close the non-conformity irrespective of the nature of the non-conformity. The auditee feels it as not urgent. One should understand that the non-conformity is a deviation and needs to be corrected without wasting time. If a non-conformity can wait for 90 days to correct, there is no harm if it is not corrected at all. The auditee is found normally happy when non-conformity is converted as an observation, as there is no need for closing it. However, these observations, if not attended can lead to serious problems. The external auditors are normally not interested in writing non-conformities for a certified company, as they are afraid of their accreditation bodies who question them as to how the certificate was granted. They are writing the serious problems, where top management involvement is needed and time taken to close it shall be more as ‘Observations’ instead of ‘Non-conformity’. If any deviation is simple and the auditee can take immediate action, it is written as non-conformity. It is actually a bad practice of the certifying bodies. If a company wants to improve, give equal weightage for observations also and see that they are attended without undue delay. It is normally seen that the people regard the auditors as experts and go by the wordings. It should be noted that an auditor is an out sider, and in a number of cases, a man from different discipline. You are the one working all the time and you know your business. Therefore try to understand the essence and device the systems suitable to you. If you are not convinced with a non-conformity or observation, you can discuss with the auditor and ask him to clarify your doubts. On should remember that auditors also are human being like us, and in number of cases, they do not have the practical experience. Therefore, there are instances that they are over emphasizing and making the life of auditee miserable. Numbers of unwanted documents are prepared just to satisfy the auditors, and hence in a number of companies, people hate the audits and the auditors. The auditor should be able to explain the ill effects of a non conformity and its severity in making a company ineffective. The concept of “So What?” is to be applied. The auditor should ask himself as to what will happen as a result of the deviation found. There are cases where the auditee has maintained his records and documents in soft copy, and are maintaining hard copies because the auditor insisted. In one of the textile mill, the auditor had raised a non-conformity on quality control department for not maintaining the action taken record for the environmental impacts because of shrinkage testing. In shrinkage testing, a 50 × 50 cm grey fabric is soaked in water and dried. What environmental impact can be made by this test? In another instant, the auditor had raised

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non-conformity for computer services department of a large textile mill, that the power consumption was not monitored, where as that room had one server, 4 personal computers and 8 tube lights. What is the impact of power of this section compared to the machineries run in the textile mill? The same auditor writes it as an observation if the testing laboratory has no adequate control on the humidity being maintained, as it needs an investment and the auditee cannot close the nonconformity immediately. The testing results are affected by the temperature and humidity, and the international norms insist that 65±2% RH at 20ºC are maintained and materials are conditioned in that atmosphere for 24 hours before testing. As the mills cannot wait for 24 hours for taking a decision, the same is not maintained. A number of equipments have come out to give rapid conditioning for textile materials and all leading laboratories are following it. But still the international standards organizations are not geared up to understand the user requirements and are still insisting the 24 conditioning. Whatever may be the case, for an external auditor as the auditee refers that testing procedures as written by the internal standard organizations like ASTM, BSI, BIS, etc., it should be viewed as non-conformity, but they are just writing it as an observation. The auditee should challenge if the auditor is insisting on something that is not practicable or not helping the industry to improve. The impact of that deviation on the quality and environment are to be seen. If it is a legal requirement, then also a careful analysis is to be made of the situation. If the deviation is affecting the safety then it should be regarded as non-conformity, and not just an observation. In a number of companies, it is seen that the safety precautions are not adequate, and the auditors just write it as an observation. It is seen that numbers of companies do not follow the rules relating to overtime payment, hours of working, payment of wages, etc., but none of them are reflected as nonconformity during the audits by external auditors. They argue that as out side the purview of their audits, but forget that ISO 9001 insists following all the legal and regulatory requirements, and clause 6.4 talks on work environment, not only the physical environment but also the social environment that can motivate the people to concentrate and work towards achieving quality and productivity. Therefore the people are not recognizing an ISO 9001 certified company as an ethical company. Even the companies having ISO 14001 are not respected by public. Whatever may be the stand an auditor takes, the auditee should be sincere in addressing all the issues and take corrective actions as the ultimate judge is the customer, who shall be inspecting each and every product through out its life, and can make an opinion of the company depending on the products and services given on a consistent basis. Getting certificate is to boost the morale of the people, and cannot be to satisfy the customer or community around.

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Appendix Effective implementation of quality management systems

Appendix – 1 Departmental objectives and expectations

In this appendix, some examples are given for different sections of an organization about their objectives, methods of measuring performance, the results that can be shown, the procedures required and the records that are to be maintained. Each organization should work out for themselves depending on their activities and the objectives and develop systems.

1. Training Objectives 1. To provide required training to the employees to meet the product requirements and to achieve company objectives while adhering to legal and regulatory requirements. 2. To enhance the skill of employees to help them improve productivity and quality while reducing the wastes. 3. To build confidence in the employees regarding their ability to perform and to achieve. 4. To build the feeling of oneness among the employees. Performance indicators 1. 2. 3. 4.

Reduction in market complaints relating to worker controllable errors. Improvement in worker efficiency. Reduction in wastes relating to worker errors. Clarity about the job content, the responsibility and authorities among the employees. 5. Clarity about the product requirement among the employees. 6. No loss of production due to shortage of required skills. Key result areas 1. Number of people trained; department wise, subject wise, skill wise, in-house and out-house, on-the-job and in class room. 2. Number of training classes conducted; department wise, subject wise, skill wise, in-house and out-house, on-the-job and in class room.

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3. Improvement in average skill level among employees. 4. The changes in syllabus/curriculum made to enhance the level of learning and knowledge . 5. Number of group discussions, experience exchange programme, brainstorming, seminars and conferences conducted and the participants attended. 6. The results of training evaluation for all the trainings conducted: inhouse as well as out-house. 7. No repetition for the training need identified for the same person. Procedures 1. 2. 3. 4. 5. 6.

Planning the training activities and training resources. Preparing training calendar. Evaluation of trainers; both in-house and external faculty. Evaluation of trainees. Evaluation of training activities. Preparation and evaluation of training syllabus.

Records 1. 2. 3. 4. 5.

The persons trained subject wise, section wise. The training hours per employee. Training evaluation report. Evaluation report of training faculty. Evaluation report of the training aids; machines, equipments, slides and other presentation materials, books and manuals, slogans and displays etc.

Reference documents 1. 2. 3. 4. 5. 6.

Operating instructions Standard work practices Work norms Product safety requirements Company standing orders Job descriptions

2. Human resource development departments Objectives 1. To provide required human resources to the organization to meet the requirements.

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2. To enhance the cohesion among employees and management to help them improve productivity and quality. 3. To build confidence in the employees and the community regarding company’s activities as ethical and legal. 4. To monitor all the activities of recruitments, promotion, termination, disciplinary actions, welfare, industrial relations etc., while ensuring them in line with the legal and regulatory norms, the business ethics and human values. 5. To build the feeling of oneness among the employees. Performance indicators 1. No loss of production or delay in activities due to short of human resource. 2. Reduction or no complaints relating to non-compliance of regulatory norms. 3. Reduction in legal expenses. 4. Reduction in absenteeism. 5. Reduction in strikes and disputes. 6. Reduction in employee turnover. 7. Reduction in employee expenses as a percent of sales turnover. 8. Availability of complete information in the personal records regarding the employees. Key result areas 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Number of people indented and recruited department wise. The time taken for recruitment. Expenses for recruitment as percent of sales turnover. Employee turnover. Absenteeism. Number of grievances reported and settled. Number of strikes and loss due to strikes. Number of legal cases in court. Legal expenses as percent on sales turnover. Welfare activities and amount spent (Budgeted and actual). Welfare expenses as percent of sales turnover. Number of activities conducted for uplifting the morale of employees and management. 13. The results of exit interviews. 14. The results of employee satisfaction surveys. 15. Employee expenses as percent of turnover.

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Procedures 1. Planning the human resource requirement. 2. Calling the applications, conducting interviews, selecting the candidates by referring to minimum competency requirements. 3. Providing induction to new recruits and explaining Standing orders of the company and the legal requirements. 4. Maintaining attendance and providing data to accounts section for salary and bonus payments. 5. Preparation and maintenance of personal records. 6. Preparation of statutory returns and submitting. 7. Monitoring the compliance to statutory, legal and regulatory requirements. 8. Taking disciplinary actions for wilful violations of laid out laws and systems. 9. Taking actions on absenteeism. 10. Taking action on negligence. 11. Monitoring overtime. 12. Counselling and handling grievances. 13. Encouraging employee involvement in activities of the company. 14. Receiving suggestions, processing them and taking necessary actions. 15. Transferring of employees. 16. Promoting employees. 17. Fixing salary for each job category. 18. Evaluating the job contents and fixing work loads. 19. Negotiating with trade unions and community leaders. 20. Planning welfare activities and implementing them. Records 1. Personal files of each employee including those of retired, left and dead. 2. Applications received for jobs. 3. Selection formalities like written tests, interviews and offers. 4. Attendance records. 5. Leave records. 6. Provident fund records. 7. ESI records. 8. Records of welfare activities. 9. Suggestions received and actions taken. 10. Records of grievances received and handled. 11. Minutes of meetings and negotiations. 12. Correspondence with factory inspector and other government offices. 13. Records of legal proceedings.

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Reference documents 1. Applicable Factory Acts (a) Minimum wages (b) ESI (c) PF (d) Safety (e) Working hours (f) Settlement of disputes etc. 2. Applicable legislations – Copy of gazettes 3. Reference of dispute settlements (Court judgments) 4. Standing orders

3. Stores Objectives 1. To receive the materials and store them in identified location. 2. To get the approval of materials received by the concerned user department. 3. To issue the approved materials to the users as per requirements. 4. To send the bills of approved materials for passing to accounts section. 5. To ensure safe storage of material . 6. To educate management regarding non-moving items from time-totime . 7. To maintain accounts of materials received, issued and materials in stock and provide information for taking decisions on purchases. 8. To dispose rejected, damaged and non-moving items. 9. To send materials out on returnable or non-returnable basis depending on the situation. Performance indicators 1. Reduction in complaints relating to non-traceability of materials intime. 2. Time taken for preparing the goods receipt notes (GRN) and getting the materials approved. 3. Zero difference in stock shown and the actual stocks in stores. 4. Reduction in wastes and damages due to handling/storing at stores. 5. Clarity about the shelf-life of materials, storing them accordingly and issuing by referring to expiry date. 6. Clarity about the materials requirement for different sections of the organization. 7. No loss of production due to shortage of required materials in stores.

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8. Following up activities relating to materials sent out on returnable basis. Key result areas 1. The complaints and feedbacks received from other departments. 2. Number of days for preparing goods received notes and sending for approval. 3. Number of days taken for sending the bills for passing to accounts. 4. Difference in actual stock and book figures. 5. Stock of non-moving materials in stores. 6. The damages during storage. 7. Inventory in stores as a percent of annual sales turnover. 8. Following up and receiving the materials sent out on returnable basis. Procedures 1. 2. 3. 4. 5. 6. 7. 8.

Receiving, storing and issuing of materials. Preparation of goods receipt notes and sending to user department. Sending the bills of approved materials for passing. Perpetual and periodic stock taking. Identification and traceability of materials in stores. Storing of hazardous materials. Disposal of rejected, damaged and non-moving items. Sending materials out on returnable and non-returnable basis.

Records 1. 2. 3. 4. 5. 6. 7.

The materials received The materials issued The materials waiting for inspection Materials rejected Rejected materials in stock Evaluation report of stocks Material sent out on returnable basis

Reference documents 1. 2. 3. 4.

Material safety data of the materials received Shelf-life information of the materials in stores Insurance guidelines for materials stored Directory of transporters and material handling crew

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4. Accounts department Objectives 1. 2. 3. 4.

To maintain accounts of all monetary transactions. To verify and approve the spending with respect to budget. To pass the bill of approved materials and making payments. Verifying the legal aspects and ensuring adherence to legal requirements in money transactions. 5. To prepare the returns of monetary transactions as per statutory requirements and filing them in time. 6. To prepare the statement of accounts like income and expenditure, profit and loss, current assets and liabilities, balance sheets, etc., as needed by the top management and submitting in time. 7. Advise the management in case of unwanted or excess expenses, transactions violating the statutory and legal norms.

Performance indicators 1. Speed of giving the accurate information relating to monetary position. 2. Time taken for preparing the accounts statements like Income and Expenditure statements, Profit and Loss accounts, Balance sheet, etc. 3. Zero difference in accounts shown and the actual money in hand. 4. Reduction in wastes and losses due to improper accounting and nonfulfilment of statutory and legal requirements. 5. Clarity about the accounts, and appropriate allocations. 6. Clarity about the money requirement for different activities of the organization. 7. No loss to the company due to mistakes or delays in accounts sections. 8. Following up activities relating to money to be recovered. Key result areas 1. The complaints and feedbacks received from other departments, suppliers and customers relating to accounts. 2. Number of days for preparing accounts statements and balance sheet. 3. Number of days taken for passing the bills and making payment. 4. Difference in actual money in hand and book figures. Procedures 1. Classification of income and expenditure and entering in records. 2. Preparation of accounts statements and submitting to management.

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3. Preparing returns as per statutory requirements. 4. Monthly stock taking and preparing the statements of inventory and realization. 5. Identification and traceability of records. 6. Maintaining the records securely. 7. Disposal of obsolete records. 8. Following for payments for materials send out, money given on loan, payments to be received as per regulations, etc. Records 1. 2. 3. 4. 5.

The money received and spent party wise, section wise, reason wise. The statutory returns filed. The tax deducted and paid to government and taxes to be deducted. Cash flow analysis and cash in-hand. Audited statement of accounts and balance sheet.

Reference documents 1. Tax regulations – latest. 2. Bank and other financial institution regulations. 3. Statutory regulations.

5. Production department Objectives 1. To produce the required quality materials in time of the required quantity. 2. To maintain the efficiency and utilization at optimum level to have the lowest cost and get the required quality. 3. To maintain health and safety conditions for the employees as well as for the products and equipments. Performance indicators 1. 2. 3. 4. 5. 6.

Production achieved product wise Quality levels of the products Reduction in rejections Utilization of men and machinery Production efficiency Reduction in wastes

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Increase in product realization Cost of manufacturing per unit production Accident free performance Provision of required work environment

Key result areas 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

The production achieved against targeted. Machinery utilization percent. Reason-wise loss of production. Production per operator. Rejection percent. Delivery committed and the actual delivery of final product to ware house. Cost of manufacturing per unit production – product wise. Number of accidents. Product realization as a percent of material consumed. Power consumption per unit production. Water consumption per unit production. Dust level in production area. Noise level in production area. Level of light (Lux) in working area.

Procedures 1. 2. 3. 4. 5. 6. 7. 8. 9.

Production procedures for different products. Production planning. Work instructions for each activity of workmen. Allocation of men as per product requirement. Arriving at process parameters for each product. Identification and traceability of materials. Maintaining the production records. Disposal of obsolete records. Following for maintenance and attending of breakdowns.

Records 1. 2. 3. 4. 5. 6.

Production records Rejection records Analysis of rejections and action taken Analysis of breakdowns and actions taken Analysis of accidents and actions taken Action taken records for other non-conformities

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7. Maintenance and machine history 8. Materials received and consumed, wastes generated and product realization Reference documents 1. Customer requirements (specifications and purchase order details) 2. Industry norms of production, quality and work allocations

6. Maintenance department Objectives 1. To maintain the machines to produce the required quality materials in time of the required quantity. 2. To maintain breakdown free performance of the machines. 3. To maintain health and safety conditions of the machines and equipments. 4. To maintain machines at lowest possible cost. Performance indicators 1. 2. 3. 4. 5. 6.

Breakdown free performance Quality levels of the products and rejections Utilization of machinery Production efficiency Cost of maintenance per unit Accident free performance

Key result areas 1. 2. 3. 4. 5. 6. 7. 8. 9.

The availability of machines for production as percent of available time. Machinery utilization percent. Reason-wise breakdown. Production loss due to breakdowns. Rejection percent due to improper maintenance. Cost of maintenance per equipment/machine. Power consumption per unit production or per machine shift. Noise level in production area. Consumption of critical parts.

Procedures 1. Procedures for periodic preventive maintenance.

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Planning maintenance activities. Planning for spares and indenting for procurement. Procedure for attending breakdowns. Work instructions for each activity of workmen. Allocation of men as per skill requirement. Setting the machines as per required process parameters. Identification and traceability of materials. Maintaining the maintenance records. Conducting tool audits. Verification of calibration of equipments and setting them. Disposal of obsolete records.

Records 1. 2. 3. 4. 5. 6.

Machine-wise maintenance records Machine history Analysis of breakdowns and actions Action taken records for rejections and other non-conformities Spares and other materials received and consumed Calibration records

Reference documents 1. Machinery catalogues and manuals. 2. Catalogues and manuals of lubricants, bearings, belts, etc., required in the company.

References

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References

References

1.

2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

DR . ALI AL -ZUBAIDI

– “Business Sustainability: Key to Long-term Success” – training organized by HKQAA on 27 March 2009. http:// qualityalchemist.blogspot.com. B . PURUSHOTHAMA – “Winning Strategies” – Pubadchi Publications – 2009. D . L . SHAH TRUST – ISO 9000 Quality Management Systems – Guidelines for enterprises in developing countries – 1996. PRADEEP KUMAR MATHUR – Implementing ISO 9001:2000 – Vikas Publishing House Pvt Ltd – 2003. NAVIN SHAMJI DEDHIA – Quality from Many perspectives – D . L . SHAH TRUST . B. PURUSHOTHAMA – Guidelines for Process Management in Textiles – CVG Books 2007. Wikipedia – The Free Encyclopedia – http://en.wikipedia.org/wiki/Quality_ management_system. ISO 9001:2000 guidelines. Quality Standards ISO 9001:2000, Quality Management System http:// www.engineers-international.com/qualitysystem.html. Definitions of Quality – http://web2.concordia.ca/Quality/definitions.html. SHYAM TALAWADEKAR – Visual Management through Five-S: A Japanese Tool of Kaizen – Publisher “Quality Management Systems” Thane. B . PURUSHOTHAMA – Five Golden Questions – A self assessment tool – Quality Update Nov 2007 – Indian Society for Quality. B . PURUSHOTHAMA – Role and Responsibilities of Management Representative – Quality Update April 2007 – Indian Society for Quality. ISO 9001:2008 Guidelines – Quality Management System Requirements. Six Sigma Quality Dictionary. ISO 9000:2005 Quality Management Systems – Fundamentals and Vocabulary. British Standard Institute – Bench marking QMS implementation. ISO 9004:2000 – QMS Guidelines for Performance Improvements.

Index

Accounts department, 152 Action plan, 19 Adequacy audit, 46, 62 Affinity diagram, 86 American Society for Quality, 6 Arrow diagram, 87 Audit evidence, 56 Auditee interaction, 123 Auditee response, 123 Auditee, 83, 84 Auditor competency, 122 Auditor punctuality, 122 Auditor, 43, 63, 84 Audits, 46, 59, 138 Benchmarking assessment, 97 Boom period, 3 British Standard Institute, 4, 96 Bureau of Indian Standards, 15 Business ethics, 10 Capital investments, 77 Certificate, 47 Certification, 47 Coding system, 40 Communication systems, 73 Community, 9 Company objectives, 19, 51, 128, 146 Competency evaluation, 111 Complaint handling, 114 Compliance audit, 62 Continual improvement, 44 Contract review, 36, 114 Controlled document, 27 Corrective action, 45, 58 Cost factor, 38 Customer complaints, 133 Customer feedback, 74 Customer focus, 23

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Customer perception, 73 Customer property, 41, 119 Customer requirements, 12, 72, 73, 77, 106 Customer satisfaction, 43, 120 Data analysis, 127 Departmental objectives, 19 Design control, 37 Design documentation, 37 Design review, 37, 115 Design validation, 116 Design verification, 37, 115 Despatch, 75 Document changes, 105 Document control, 26, 104 Documentation, 26 Documented quality standards, 56 Documents, 26 list of, 27 Effective audit, 83 Effective communication, 36 Employees, 9 Engineers International, 5 Ethical requirements, 9 Final audit, 47 Finance requirements, 78 Free consultant, 136 Full-proof systems, 42 General regulatory requirements, 10 Human resource, 31, 147 Information availability, 106 Information management, 76 Information, 42 Infrastructure, 33

Index Internal auditors, 62 Internal communication, 23 Internal quality audits, 43, 56, 58 International Organization for Standardization, 5 International Quality Standards, 8 ISO 9000 activities, 50 ISO 9000 quality management systems, 95 ISO 9000 series, 4, 14 ISO 9000, 12, 46 ISO 9000:2005, 16 ISO 9001 guidelines, 96 ISO 9001, 13 Key result areas, 22, 146, 148 Legal and regulatory requirements, 9, 26, 107, 108 Linking exercises, 85, 94 Maintenance activities, 72 Maintenance department, 155 Management representative, 49, 50, 109 Management review, 29, 30, 109 Management system, 4 Management tools, 94 Market complaints, 107 Marketing performance, 74 Material handling, 41 Maximum retail price, 10 Measurement data, 42 Measuring devices, 42 Minimum competency, 31 Mission, 17 Monitoring devices, 42 Non-conformities, 122, 138 Normative references, 15 Obsolete documents, 105 Organization structure, 33, 103 Out sourcing contractor, 120 Out sourcing, 120 Packing quality, 41 Packing, 41 Performance indicators, 146 Periodic audits, 57, 119 Periodic evaluation, 31 Periodic reviews, 121

159

Planned arrangements, 57 Poka-Yoke, 29 Potential problems, 45 Procedure, 20, 28 Process audit, 80 Process design programme chart, 88 Process evolution, 101 Process implementation, 101 Process mapping, 87 Processes, 21 Product audit, 60 Product conformity, 44 Product design, 37 Product preservation, 41 Product realization, 33, 38 Product safety requirements, 10 Production control, 39 Production department, 153 Provision of resources, 30 Purchase order, 117 Purchased product verification, 39 QMS effectiveness, 128 QMS elements, 86 QMS implementation, 95, 98 Quality assurance, 76 Quality audit, 56, 79 Quality control investigator, 79 Quality control, 58, 59 Quality management system, 4, 5, 13, 14, 49, 52 Quality manual, 15, 23, 52, 100 Quality objective, 18, 19, 34, 35, 99 Quality plan, 35 Quality policy, 18, 99 Quality standards, 11 Quality systems, 11 Quality, 6, 7, 11 Questionnaire, 64, 65 Rationalization of employment, 2 Recession, 2, 3, 4 Record control, 105 Record maintenance, 106 Record, 28 Regulatory requirements, 9, 10, 25 Rejected materials, 126 Relations diagram, 86 Renewal audit, 47 Reviews, delegation of, 30

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Routine problems, 45 Safety requirements, 108 Security, 79 Societal safety factors, 11 Special process, 40 Specific bins, 126 Standard formats, 28 Statement, 17 Statistical control process, 59 Stoppages, 94 Storage space, 38 Store, 150 Surveillance audit, 47 Sustained success, 4 System audit, 60 Technical know-how, 41

Top management review, 60 Top management, 25, 130 Trade regulations, 10 Trail audit, 47 Training evaluation, 112 Training need, 111 Tree diagram, 86 Uncontrolled documents, 27 Vendor development, 117 Vendor evaluation, 117 Vendor selection, 116 Vision, 17 Voluntary retirement scheme, 2 Work environment, 33 Work instructions, 103