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Quality and Standards in Electronics PDF

244 Pages·1997·26.505 MB·English
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To my daughter Samantha Quality and Standards in Electronics Raymond L. Tricker Newnes An imprint of Butterworth-Heinemann Linacre House, Jordan Hill, Oxford OX28DP A division of Reed Educational and Professional Publishing Ltd -& A memberof the ReedElsevier pic group OXFORD BOSTON JOHANNESBURG MELBOURNE NEW DELHI SINGAPORE First published 1997 Transferredtodigitalprinting 2004 © Raymond L.Tricker 1997 All rights reserved. No part of this publication may be reproduced inany material form (including photocopying or storing inany medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright holder except inaccordance with the provisions of the Copyright, Designs and Patents Act 1988 or under the terms of alicence issued by the Copyright Licensing Agency Ltd, 90 Tottenham Court Rd,London, EnglandW1P9HE. Applications for the copyright holder's written permission to reproduce any part of this publication should be addressed to the publishers. British Library Cataloguing in Publication Data A Catalogue record for this book isavailablefrom the British Library. ISBN0 7506 2531 7 Library ofCongress Cataloguing in Publication Data A catalogue record for this book isavailablefrom the Library of Congress. Typeset by LaserWords, India Foreword Wherever you go nowadays, it seems that you are always hearing the word 'quality', especially in relation tothe requirements of 'ISO 9000', but even though these have become everyday words, they are often misused, misquoted and misunderstood. Why is this? Well,normally youwillfindthatwhenmostpeopletalk aboutthequality of an object, they are talking about.its excellence, perfection and/or value. In reality, of course, they should be talking about how much it meets its designed purpose and comes up to the manufacturer's or supplier's orig inal specifications. Referring to the quality of a single article is, of course, fairly simple;problems occur,however, whenonehastotalkaboutcomplex systems.Thenitcanbecomeverydifficultindeedtoassessalevelofquality. Consumers (i.e. purchasers) have always had difficulty in choosing between products of the same type and, in this age of technological complexity, it has become almost impossible to do so without some form of professional assistance. For this reason purchasers have tended to form organizations (suchasconsumers associations),tocritically examine similar objects and to grade them according to the level of quality that a particular manufacturer or supplier has achieved. Butconsumers arenotjust interested inthelevelofquality 'intended' by themanufacturerorsupplier.Theyarefarmoreinterestedinthemaintenance of the manufacturer's or supplier's quality level and want an assurance that the article they arebuying truly meets the quality standardthat wasinitially offered or recommended. This consumer requirement has, quite naturally, had a sort of knock-on effect which has meant that manufacturers and suppliers (especially in the larger companies) have now had to pay far more attention to the quality of their product than was previously necessary. Manufacturers and suppliers have had to set up proper quality-management systems in order to control and monitor all stages of the production process and they have had to xvi Foreword provide proof to the potential customer that the article they are selling is a guaranteed, and in some cases certifiable, assurance that they have achieved the level of quality required by the customer. In other words, the manufac turer or supplier has had to work within aquality system in order to provide some degree of quality assurance for their product. Unfortunately, with the current trend towards microminiaturization, most modem-dayproducts havebecomeextremely complex assemblies ofcompo nents compared with those which were available a few years ago. This has meant that many more people are now involved in the manufacture or supply of a relatively simple object, and this has increased the likelihood of a production fault occurring. Similarly, the responsibility for the quality of a product has been spread over an increasing amount of people which has meant that the manufacturer's (or supplier's) guarantee of quality has, unfortunately, become less precise. Theseproblems arenotjustrelated tothelargermanufacturing companies and suppliers, they also affect the smaller companies, even those employing onlytwo orthree people. Infact, nomatter how large orsmall thecompany, there has to be an increasing reliance on quality and the recommendations of ISO 9000 in order to meet customers' requirements. So where do these companies obtain details of these quality require ments? Almost every country within Europe has its own National Standards Organization (NSO) which can provide this information. The UK is no exception, for the British Standards Institution (BSI) has been in existence since 1901. It has produced numerous regulations and standards covering almost all manufacturing and supply functions and has been at the forefront in the production of ISO 9000 series of Standards for Quality Assurance. Within the European Union (EU), there is a potential marketplace of some 350-400 million people and selling to these people is an extremely competitive business. With the amalgamation of these nations into a single market there has been anincreasing reliance on aninternationally agreed set ofquality procedures, andBritish manufacturers andsuppliers willhave had to conform to the ISO 9000 recommendations in order to gain a foothold in the European market. In fact, for anyone wanting to sell their product in the multinational European Single Market, the ISO 9000 publications are essential reading. Together they provide a comprehensive set of rules and regulations, specifications and recommendations that enable amanufacturer (orsupplier), largeorsmall,tosetup workable quality-assuranceprocedures and operate within their constraints. As time goes on, more and more organizations are obviously becoming aware of these conditions but, although the ISO 9000 publications are very comprehensive, there is still a need for the person who is trying to achieve these quality standards to have a broad background knowledge of the subject, its terms, conditions, justifications and requirements. This book seeks to provide the reader (especially those from smaller companies) with this background knowledge. Foreword xvii Althoughthisbookismoreintheformofareferencemanual,itisnotjust meanttoserveasaguidetothevariousstandardsandorganizationsinvolved in quality assurance. It is also meant to assist the small company in under standingthe implications andrequirements ofaquality system and,through examples,casestudiesandrecommended auditprocedures,toenablesmaller companies to set up their own quality management system (QMS). A quick note with regard to the various acronyms that are used in this book. Despite having spent most of my working life in the Army, I still haven't got used to the proliferation of acronyms that the Government, and especially the Military, insist on using. It is not so much just the fault of these bodies, it is more the fault of trying to please everyone by simpli fying someofthe more lengthy titles into something moremanageable (e.g. The North Atlantic Treaty Organization Communications and Information Systems Agency, NACISA). Personally, I have always hated this as I could never remember what all thosewretched acronymsreally meant,andIconstantlyhadtorefertoacrib sheet. Withthis in mind, and in order that these various Parts, Annexes and Attachments can be read separately (ifrequired), as soon as anew acronym appears in a chapter it is also given in its full expanded form. To assist readers a Dictionary of Abbreviations has been included at the end of the book. One finalnote: certain technical terms and usages in this book, although reflectingonlythemasculine genderare,infact,theparlanceofthefieldand should be interpreted to apply to both sexes. In a similar manner the use of theword 'manufacturer' canbe assumedtoapplyequallytoamanufacturer, supplierand/orserviceindustry,unless otherwise stated.Theuseoftheterm 'ISO 9000' instead of its full title 'BS EN ISO 9000' has been used in this book owing to the international recognition of this standard. Preface A recent study into the electronic industry post-20l0, anticipates that many companies will do away with their own in-house manufacturing facilities and rely on third-party contract manufacturers to meet their requirements. The report anticipates that in 15years time there will possibly be as few as fivemajor companies in the world completing electronic product assembly. The study considers it highly unlikely that any of these five companies willactuallyproduceallthecomponents,subassembliesandindividualitems required for these electronic product assemblies; instead subcontractors will manufacture and supply these items to them. This almost total reliance on others, however, requires a high degree of confidence in the subcon tractors producing the right item, on time, to the correct design and within budget.This confidenceisavailablethrough theimplementation ofaquality management system, as described in the ISO 9000 series of standards. Acknowledgements Writingareference bookcannot beachieved without the assistance ofmany people. Toname all of them would be an impossible task., but I would like to take this opportunity of particularly mentioning Julian Rowse and the ILl team, Sebastian St John-Clarke and all atTechnical Indexes Ltd and, of course, Pamela Danvers and all the library staff at BSI Chiswick. Without their help I could not have managed to write this book. Part 1 The Importance of Quality Control and Quality Assurance In Part 1 the reader is introduced to the requirements of quality control and quality assurance. The significance and the types of specifications are explained; manufacturer's and purchaser's responsibilities are defined; and a thorough review of quality during a product's lifecycle enables the reader to appreciate the costs and benefits of quality. 2 Quality and Standards in Electronics The international definition of 'Quality' as defined in ISO 8402 is 'the totality of features and characteristics of a product or service that bear on its ability to satisfy a given need' or, more simply, 'fitness for intended use'. Althoughtheterms 'quality assurance' and 'quality control' are both aimed at ensuring the quality of the end product, they are in fact two completely separate procedures. 1.1 Quality control Quality control (QC) is the 'operational techniques and activities that are used to fulfil requirements for quality' (Ref. 24 - ISO 8402). It is the amount of supervision that a product is subjected to in order to ensure that the workmanship associated with that product meets the quality level required by the design. In other words, it is the control exercised by the manufacturer to certify that all aspects of their activities during the design, production, installation and in-service stages meet the desired standards. Qualitycontrol isexercised at alllevels and, as allpersonnel arerespon sible for the particular task they are doing, they are all quality controllers to some degree or other. Departmental heads and section chiefs, because of their positions and responsibilities, have more control over their own particular process and therefore have more control over the finalquality. It is true, therefore, to say that all personnel are quality controllers and that departmental heads are the principal quality controllers, within their own particular section. 1.2 Quality assurance Quality Assurance (QA) is 'all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality' (Ref. 24 - ISO 8402). Quality is fitnessfor intended use. Assurance is a declaration given to inspire confidencein an organization's capability. Quality assurance in a product (or service), by consistently achieving stated objectives is, therefore, a declaration given to inspire confidence that a particular organization is capable of consistently satisfying need, as well as being a managerial process designed to increase confidence Quality assurance is therefore a declaration given to inspire confidencethat aproducthas achievedthehigheststandardsandthatitsmanufacture,modi ficationor repair has been completed in an efficientand timely manner.

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