Quality Assurance Management

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1 Quality Assurance Management Michael J. Fox Associate Consultant University of Paisley Quality Centre Associate Tutor Durham University Business School SPRINGER-SCIENCE+BUSINESS MEDIA, B.V.

2 First edition Michael J. Fox Originally published by Chapman & Hall in 1993 Softcover reprint of the hardcover 1st edition 1993 Typeset in 10Y 2/12pt Sabon by Graphicraft Typesetters Company, Hong Kong ISBN DOI / ISBN (ebook) Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the UK Copyright Designs and Patents Act, 1988, this publication may not be reproduced, stored, or transmitted, in any form or by any means, without the prior permission in writing of the publishers, or in the case of reprographic reproduction only in accordance with the terms of the licences issued by the Copyright Licensing Agency in the UK, or.ip: accordance with the terms of licences issued by the approprjate Reproduction Rights Organization outside the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publishers at the London address printed on this page. The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made. A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication data Fox, Michael J. Quality assurance management I Michael J. Fox. p. em. Includes bibliographical references and index. 1. Quality assurance-management. I. Title. TS156.. F '62-dc on permanent acid-free text paper, manufactured in accordance with the proposed ANSUNISO Z X and ANSI Z

3 Quality Assurance Management

4 Contents Preface Xl Part One What Managing Quality Means 1 1 What is quality, and how can it be managed? 3 Introduction 3 Where quality is today 3 The meaning of quality 4 Quality 'grade' and quality 'level' 6 Industrial quality: specification and contract 7 Measuring quality 8 Quality in service industries 9 The management of quality 11 The quality management system 15 2 Quality in marketing 18 Defining quality 18 Planning is essential 21 Good communications are important Market readiness Conclusion 26 3 Quality in specification and design 27 Introduction 27 Design 27 Some important aspects of design 39 Products of the design process 43 Management of change 43 Value engineering 43 Conclusions 44 4 Quality in purchasing 45 Introduction 45 Evaluating suppliers 45 Procuring supplies 49 Good purchasing data- now what? 51

5 vi Contents Supplier evaluation 56 Conclusions 60 5 Quality in production 61 Introduction 61 Planning - the key to quality 61 Documentation 64 Control of manufactured items and of manufacturing 65 processes Adjustment of corrective action 69 Manufacturing control 70 Records 71 Role of quality assurance in manufacturing 71 Quality manager's department 72 Conclusion 74 6 After-sales quality 75 Introduction 75 Storage, packing and delivery 75 Marketing and servicing 78 Maintenance 83 Resolving customer queries and complaints 85 Summary 88 Part Two Quality Assurance Techniques 91 Introduction 91 7 Creating the quality system 93 Introduction 93 Planning for quality 93 The quality system 97 Corrective actions to improve quality 101 The importance of a quality system standard ISO the international quality standard 107 Introduction 107 The international standard for quality systems 107 Elements of a quality system: ISO Guidance for the use of ISO 9000 series documents Quality auditing techniques 121 Introduction 121 Quality auditing 121 Product, process and service quality audits 123 Auditing the quality system 125 Conducting a formal quality system audit 127 The auditor 129

6 Contents vii 10 Inspection techniques 132 Introduction 132 Inspection 132 Frequency of inspection 136 Who carries out the inspection? 139 Measurement and calibration 140 Calibration systems Statistical sampling inspection 145 Introduction 145 Statistical frequency distributions 145 Statistical acceptance sampling 148 T abies for sample inspection by variables and by attributes Statistical process control 155 Introduction 155 Statistical quality control 155 Control charting technique 161 Statistical design of experiments 164 Designing for yield and process control The place of the computer 168 Introduction Electronic computer system equipment The design and control of computer software 169 Computer applications within the business 173 Applications of computers within the QA department 175 Summary Reliability assurance 180 Introduction 180 What is reliability? 180 Reliability and the market-place 182 Organizing to achieve reliability 185 Reliability of a system 188 A reliability and maintainability programme 190 Failure mode, effects and criticality analysis 192 Summary 194 Part Three Using People More Effectively 195 Introduction The sociology of people at work 197 Introduction 197 The team 197

7 viii Contents Scientific management 197 Examples of Taylor's experiments 198 The Hawthorne experiments 200 Theories of human motivation 202 A people-based philosophy 205 Summary Motivate or involve? 210 Introduction 210 Motivation or participation? 210 Zero defects 214 Quality circles 217 Similarities and distinctions between quality circles and zero defects American quality 'gurus' 222 Introduction 222 Introducing the 'gurus' 222 Crosby 223 Deming 226 Juran 229 Shainin Japanese quality management style 233 Introduction 233 The Japanese business 233 How are the Japanese companies managed? 235 Japanese quality authorities 239 Summary Quality in the United Kingdom 245 Introduction 245 Quality in the United Kingdom 245 Leadership and quality management in industry in the United Kingdom 245 Working for Japanese companies 248 United Kingdom 'gurus' 252 BS 5750: a standard for quality management systems Total quality management 260 Introduction 260 Total quality management 260 The quality chains 262 Quality in all functional departments 265 Three major components of TQM 267 Planning the implementation of TQM 268 A model for TQM 270

8 Contents ix The 'mind-set' 272 Conclusion Quality managers and their departments 274 Introduction 274 The management representative for quality 274 The quality assurance function 278 QA department personnel Quality in service industries 290 Introduction 290 Material and personal services 291 ISO 9000 Guidelines for Services 292 Quality in marketing a service 294 Analysis and improvement of service performance 297 Part Four Quality - the Key to Prosperity 299 Introduction Ways of looking at quality-related costs 301 Introduction 301 The importance of measuring quality 301 Different ways of looking at quality-related costs 303 Total loss to society 304 The process cost model 305 The concept of economic quality 307 Summary The prevention-appraisal-failure model 312 Introduction 312 The cost of quality 312 Prevention costs 314 Appraisal costs 316 Failure costs 317 Collecting quality cost information 319 Monitoring quality costs 323 Presenting and using quality cost information 325 Summary Just-in-time and variability reduction 328 Introduction 328 Cost savings of prevention 328 Just-in-time 331 Compatability of design with manufacturing capability Quality, safety and product liability 343 Introduction 343 Quality, safety and consumerism 343

9 X Contents The European Community Directive on Product Liability 344 Risk minimization 346 Product safety and liability in ISO The international market-place 354 Introduction 354 Winner takes all! 354 The single European market 356 Best practice benchmarking 362 Learning through other companies' experiences 363 Benefits of BPB Quality trends, challenges and opportunities 365 Introduction 365 Quality trends, challenges and opportunities 365 Appendix: British Standards mentioned in the text 368 References 371 Index 373

10 Preface The book is aimed towards students of quality assurance as well as active practitioners. Moreover, since the advantages of formal quality assurance, and the benefits of practising it are becoming more widely appreciated in service companies, it should be of value to non-specialist executives in smaller companies. It will help you manage your business responsibilities to ensure that you satisfy the expectations of your customers as economically as possible, and in a way which gives you visibility of the status and progress of your 'quality'. It will direct your attention to the writings of the most influential interpreters of quality concepts, especially in the USA and Japan, and how their lessons have been adopted and adapted by successful businesses throughout the world. In order to maximize the usefulness of the book to students studying for professional qualifications in Quality Assurance, the requirements of the following examinations were taken into account when planning the scope of the book: The Institute of Quality Assurance's Associate Membership examination syllabus (as revised April 1990) for papers: A 1 Introduction to Quality Assurance A2 Specifications, Standards and Quality Audit A3 Quality Assurance Management The City and Guilds of London Institute's syllabus for course: 743 Quality Assurance Aims of the book This book is adapted and expanded from the course material which I created for the Quality Management module of the Durham University Business School's open distance learning MBA degree. This in turn evolved from a distance learning course prepared earlier for use by the Rapid Results College. As well as the cited authorities, the book draws on my interpretation of my own experience in quality assurance management within the microelectronics industry, and latterly as a consultant, a trainer and an assessor of quality systems. Origins of the book

11 xii Preface Structure of the book Acknowledgements The book is intended as an introduction and convenient reference to its subject, and will cite other works which explain certain topics in more detail. Books on Quality Management tend to fall into one of two groups: 1. There are a limited number of reference books which aim to be comprehensive. These assume no initial knowledge, and yet try to cover each topic in depth. The two best-known of these are Juran's Quality Control Handbook, and Feigenbaum's Total Quality Control. Both these books originated from material written in the early 1950s, but because of their popularity, they have been regularly updated and reissued. Of the two Feigenbaum is the shorter, available as a paperback of 851 pages, still less than half the length of Juran's tome. 2. Other books either concentrate on a particular element of Quality Management (e.g. Quality Circles or Quality System Audit) or else they focus on a particular way of looking at Quality Management, addressing their comments to people whom they see as already practising quality management. The present book aims to be more concise than Feigenbaum or Juran, yet broader in the topics covered than most other works, so as to be of value to beginners as well as practitioners with Quality Assurance experience. It is divided into four sections as follows: Part One: Part Two: Part Three: Part Four: The meaning of quality, and how it must be managed if it is to be achieved. Specialist 'Quality Control' and 'Quality Assurance' techniques. Getting a whole workforce to contribute to the maintenance and improvement of quality. The monetary dimension of quality; quality and competitiveness in world markets. My thanks go first to Durham University for their permission and encouragement to develop course material, of which they hold the copyright, into this book. Secondly to Mr Barry Reavill, FlEE FIProdE FIQA MBIM of Portsmouth Management Centre, who provided the material for the DUBS course which forms the basis of Chapters 2 to 6 of this book. Thirdly to the British Standards Institution and to the Department of Trade and Industry for permission to quote extensively from standards and booklets which are BSI or Crown copyright. Fourthly but not least to my DUBS students in Europe and the Far East, through whose tutor-assessed assignments I have learned more about quality, as well as about the topics where students can find difficulties.