Automotive Quality Systems Handbook autottl.qxd 10/04/00 21:21 Page i autottl.qxd 10/04/00 21:21 Page ii Automotive Quality Systems Handbook David Hoyle autottl.qxd 10/04/00 21:21 Page iii Butterworth-Heinemann Ltd Linacre House, Jordan Hill, Oxford OX2 8DP 225 Wildwood Avenue, Woburn, MA 01801-2041 A division of Reed Educational and Professional Publishing Ltd A member of the Reed Elsevier plc group OXFORD BOSTON JOHANNESBURG MELBOURNE NEW DELHI SINGAPORE First published 2000 © David Hoyle 2000 All rights reserved. No part of this publication may be reproduced in any material form (including photocopying or storing in any 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 in accordance with the provisions of the Copyright, Designs and Patents Act 1988 or under the terms of a licence issued by the Copyright Licensing Agency Ltd, 90 Tottenham Court Road, London, England W1P 9HE. Applications for the copyright holders 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 is available from the British Library Library of Congress Cataloguing in Publication Data A catalogue record for this book is available from the Library of Congress ISBN 0 7506 7243 9 Typeset by Butford Technical Publishing, Great Milton, Oxford Printed and bound in Great Britain autottl.qxd 10/04/00 21:21 Page iv Preface xiii Acknowledgements xv Part 1 Understanding ISO/TS 16949 1 Chapter 1 The origins 3 Emergence of sector requirements 4 Emergence of a common certification scheme 13 Benefits 15 Chapter 2 Basic concepts 19 Quality 19 Classification of products and services 20 Quality and price 22 Quality and cost 22 High quality and low quality; poor quality and good quality 23 Quality characteristics 24 Quality, reliability, and safety 25 Quality parameters 25 Dimensions of quality 26 Achieving, sustaining, and improving quality 28 Quality control (QC) 31 Quality improvement (QI) 34 Quality assurance (QA) 37 Quality goals 40 Quality systems 41 Quality and ISO/TS 16949 43 A postscript on definitions 44 Chapter 3 The differences 45 Provisions of ISO/TS 16949 45 Scope of the standard 46 Differences with ISO 9001 46 Differences between existing automotive quality system requirements 48 Additional requirements 58 Removed requirements 60 Contents autotoc.qxd 10/04/00 21:22 Page v Chapter 4 Implementing ISO/TS 16949 61 Step 1 Coherence check 62 Step 2 Cultural analysis 62 Step 3 System analysis 63 Step 4 Process analysis 64 Step 5 System integration 64 Chapter 5 Third party assessment 65 The ISO/TS 16949 certification scheme 66 Effect of the rules 68 Summary 78 Chapter 6 Self assessment 79 Part 2 Satisfying ISO/TS 16949 requirements 85 Chapter 1 Management responsibility 87 Scope of requirements 87 Quality policy (4.1.1.1) 88 Defining quality objectives (4.1.1.1, 4.1.1.2, and 4.1.4) 102 Customer satisfaction (4.1.1.3) 105 Continuous improvement (4.1.1.4) 109 Responsibility and authority (4.1.2.1) 113 Resources (4.1.2.2) 127 Management representative (4.1.2.3) 130 Organizational interfaces (4.1.2.4) 133 Management review (4.1.3) 134 Business plans (4.1.4) 140 Analysis and use of company level data (4.1.5) 144 Employee motivation, empowerment, and satisfaction (4.1.6) 145 Impact on society (4.1.7) 149 Chapter 2 Quality system 157 Scope of requirements 157 Establishing a documented quality system (4.2.1) 159 Preparing the quality manual (4.2.1) 160 Maintaining a quality system (4.2.1) 170 Quality system procedures (4.2.2) 174 Ensuring effective implementation (4.2.2.1b) 183 Quality planning (4.2.3) 186 Product realization (4.2.4) 196 Plant facility and equipment planning (4.2.5) 212 Tooling management (4.2.6) 214 Process improvement (4.2.7) 215 Quality system performance (4.2.8) 215 Chapter 3 Contract review 221 Scope of requirements 221 Procedures for contract review (4.3.1) 223 Coordinating contract review activities (4.3.1) 224 Ensuring that the requirements are adequately defined and documented (4.3.2.1a) 225 Resolving differences (4.3.2.1b) 227 vi Contents autotoc.qxd 10/04/00 21:22 Page vi Ensuring that the supplier has the capability to meet contractual requirements (4.3.2.1c) 227 Identifying cost elements (4.3.2.2) 229 Meeting customer-specific requirements (4.3.2.2) 230 Amendments to contract (4.3.3) 230 Maintaining records of contract reviews (4.3.4) 231 Application of requirements 231 Chapter 4 Design control 235 Scope of requirements 235 Design procedures (4.4.1) 237 Design and development planning (4.4.2) 238 Design interfaces (4.4.3) 242 Design input (4.4.4) 245 Design optimization (4.4.5.2) 250 Design output (4.4.5) 251 Design reviews (4.4.6) 255 Design verification (4.4.7) 259 Design validation (4.4.8) 264 Design changes and modifications (4.4.9) 269 Chapter 5 Document and data control 281 Scope of requirements 281 Document control procedures (4.5.1) 285 Control of external documents (4.5.1) 288 Document and data review and approval (4.5.2.1) 289 Identifying the current revision of documents (4.5.2.1) 292 Ensuring the availability of controlled documents (4.5.2.1a) 292 Obsolete and invalid documents (4.5.2.1b and 4.5.2.1c) 295 Control of customer engineering specifications (4.5.2.2) 297 Document and data changes (4.5.3) 298 Issuing changed documents (4.5.3) 301 Chapter 6 Purchasing 307 Scope of requirements 307 Ensuring purchased product conforms to specified requirements (4.6.1.1) 308 Customer-approved subcontractors (4.6.1.2) 311 Satisfying regulatory requirements (4.6.1.3) 311 Evaluation and selection of subcontractors (4.6.2.1a) 312 Control of subcontractors (4.6.2.1b) 320 Records of acceptable subcontractors (4.6.2.1c) 322 Developing subcontractors quality systems (4.6.2.2) 324 Subcontractor delivery performance (4.6.2.3) 324 Purchasing data (4.6.3) 326 Supplier verification at subcontractors premises (4.6.4.1) 328 Customer verification of subcontracted product (4.6.4.2) 329 Chapter 7 Customer supplied product 333 Scope of requirements 333 Verification of customer supplied product (4.7.1) 334 Storage of customer supplied product (4.7.1) 335 Maintenance of customer supplied product (4.7.1) 335 Reporting problems to the customer (4.7.1) 336 Marking customer-owned tooling (4.7.2) 337 Contents vii autotoc.qxd 10/04/00 21:22 Page vii Chapter 8 Product identification and traceability 339 Scope of requirements 339 Procedures for identifying product 340 Traceability 341 Chapter 9 Process control 345 Scope of requirements 345 Planning production, installation, and servicing processes (4.9.1.1) 347 Ensuring that work is carried out under controlled conditions (4.9.1.1) 348 Documented procedures and job instructions (4.9.1.1 and 4.9.2) 352 Suitable production, installation, and servicing equipment (4.9.1.1b) 355 Suitable working environments (4.9.1.1b) 355 Compliance with reference documents (4.9.1.1c) 356 Controlling process and product characteristics (4.9.1.1d) 357 Approval of processes and equipment (4.9.1.1e) 358 Workmanship criteria (4.9.1.1f) 358 Maintenance of equipment (4.9.1.1g and 4.9.1.5) 359 Special processes (4.9.1.1) 362 Maintaining cleanliness of premises (4.9.1.2) 364 Preparing contingency plans (4.9.1.3) 365 Designation of special characteristics (4.9.1.4) 366 Process capability and process control (4.9.1.1g and 4.9.3) 366 Verification of job set-ups (4.9.4) 369 Appearance items (4.9.5) 370 Chapter 10 Inspection and testing 375 Scope of requirements 375 Inspection and test planning (4.10.1) 377 Receiving inspection and testing (4.10.2) 379 In-process inspection and testing (4.10.3a) 384 Final inspection and testing (4.10.4.1) 386 Layout inspection and functional testing (4.10.4.2) 389 Inspection and test records (4.10.5) 390 Laboratory requirements (4.10.6) 392 Chapter 11 Inspection, measuring, and test equipment 397 Scope of requirements 397 Inspection, measuring, and test equipment procedures (4.11.1.1) 399 Control of inspection, measuring, and test equipment (4.11.1.1) 401 Calibration of inspection, measuring, and test equipment (4.11.1.1) 402 Maintenance of inspection, measuring, and test equipment (4.11.1.1) 404 Control, calibration, and maintenance of test software (4.11.1.1) 404 Ensuring measurement uncertainty is known (4.11.1.1) 405 Proving test hardware, comparative references, and test software (4.11.1.1) 406 Measurement systems analysis (4.11.1.2) 408 Identifying measurements to be made and accuracy required (4.11.2a) 409 Selecting appropriate inspection, measuring, and test equipment (4.11.2a) 410 Calibration operations 413 Protection of measuring equipment 419 Chapter 12 Inspection and test status 427 Scope of requirements 427 Identifying inspection and test status 427 Maintaining inspection and test status 430 Inspection and test status procedures 430 viii Contents autotoc.qxd 10/04/00 21:22 Page viii Chapter 13 Control of nonconforming product 433 Scope of requirements 433 Classifying nonconformities 435 Ensuring that nonconforming product is not used (4.13.1.1) 436 Identifying nonconforming product (4.13.1.1 and 4.13.1.2) 436 Documenting nonconforming product (4.13.1.1) 437 Evaluation of nonconforming product (4.13.1.1) 438 Segregation of nonconforming product (4.13.1.1 and 4.13.1.2) 438 Disposition of nonconforming product (4.13.1.1) 438 Nonconformity reduction plan 439 Defining disposition responsibility (4.13.2) 439 Review of nonconforming product (4.13.2, 4.13.3, and 4.15.3.2) 440 Use of nonconforming product (4.13.2 and 4.13.1.3) 443 Deviating from approved processes (4.13.4) 444 Recording the actual condition of nonconforming product (4.13.2) 445 Re-inspection of repaired and reworked product (4.13.2) 445 Chapter 14 Corrective and preventive action 449 Scope of requirements 449 Corrective and preventive action procedures (4.14.1.1) 452 Assessing the degree of corrective and preventive action necessary (4.14.1.1) 453 Implementing and recording changes in procedures (4.14.1.1) 453 Corrective action (4.14.2) 454 Preventive action (4.14.3) 462 Chapter 15 Handling, storage, packaging, preservation, and delivery 473 Scope of requirements 473 Handling, storage, packaging, preservation, and delivery procedures (4.15.1) 475 Handling (4.15.2) 475 Storage (4.15.3) 476 Inventory (4.15.3.2) 479 Controlling packing, packaging, and marking processes (4.15.4.1) 480 Preserving and segregating product (4.15.5) 483 Delivery (4.15.6) 484 Monitoring performance to customer delivery requirements (4.15.6.2) 486 Chapter 16 Control of quality records 491 Scope of requirements 491 Types of quality records 491 Identification of quality records 495 Collection of quality records 496 Indexing of quality records 496 Access to quality records 496 Filing quality records 497 Storage of quality records 497 Maintenance of quality records 498 Disposition of quality records 499 Demonstrating conformance to specified requirements 499 Demonstrating the effective operation of the quality system 500 Pertinent subcontractor quality records 501 Retention of quality records 501 Availability of quality records 502 Quality records procedures 503 Authentication of records 503 Contents ix autotoc.qxd 10/04/00 21:22 Page ix Chapter 17 Internal quality audits 507 Scope of requirements 507 Audit procedures (4.17.1) 508 The audit program (4.17.1) 510 Planning quality audits 511 Verifying compliance with planned arrangements (4.17.1) 512 Determining the effectiveness of the system (4.17.1) 514 Scheduling quality audits (4.17.1) 515 The independence of auditors (4.17.1) 516 Reporting the results of audits (4.17.1) 517 Taking timely corrective action (4.17.1) 518 Follow-up audits (4.17.1) 519 Auditor qualification (4.17.3) 519 Chapter 18 Training 525 Scope of requirements 525 Identifying training needs (4.18.1) 527 Providing for training (4.18.1 and 4.18.3) 529 Qualification of personnel (4.18.1) 531 Evaluation of training effectiveness (4.18.2) 532 Maintaining training records (4.18.1) 533 Increasing sensitivity to customer requirements (4.18.3) 534 Chapter 19 Servicing 537 Scope of requirements 537 Performing servicing (4.19.1) 539 Reporting that services meet specified requirements (4.19.1) 541 Verifying that servicing meets specified requirements (4.19.1) 543 Communication of service concerns (4.19.2) 543 Servicing agreements with customer (4.19.3) 544 Chapter 20 Statistical techniques 547 Scope of requirements 547 Identifying the need for statistical techniques (4.20.1) 548 Implementing and controlling the application of statistical techniques (4.20.2) 550 Knowledge of basic statistical concepts (4.10.4) 550 Appendices A Glossary of terms 553 B Acronyms 567 C Bibliography 568 D Relationship of clauses 570 Index 571 x Contents autotoc.qxd 10/04/00 21:22 Page x [...]... E-mail: hoyle@transition-support.com January 2000 Other books by the same author: ISO 9000 Quality Systems Handbook 3rd Edition 1998 (ISBN 0-7506-4024-3) QS-9000 Quality Systems Handbook 1996 (ISBN 0-7506-9861-6) ISO 9000 Quality System Assessment Handbook 1996 (ISBN 0-7506-2563-5) ISO 9000 Quality System Development Handbook 1998 (ISBN 0-7506-2562-7) ISO 9000 Pocket Guide 1998 (ISBN 0-7506-4025-1) autoack.qxd... acted more promptly Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012 One of these schemes was addressed by my QS-9000 Quality Systems Handbook, published in 1996 In the same year the automakers of the USA and Europe formed the International Automotive Task Force (IATF) which,... in two parts, with the first part devoted to the origins of the standard and the differences between ISO/TS 16949 and other automotive quality system requirements, with some guidance on implementation I have included a chapter on basic concepts from my ISO 9000 Quality Systems Handbook, with some slight modification The second part is divided into chapters that reflect the order of subsections in section... certification/registration bodies ISO Guide 62:1996 General requirements for bodies operating assessment and certification/registration of quality systems ISO 10011 Guidelines for auditing quality systems EN 45012 General criteria for certification bodies operating quality system certification EN 45013 General criteria for certification bodies operating certification of personnel ISO 9000 is not a statutory... invoking their own quality system requirements within contracts, perpetuating fragmentation and duplication, and driving up costs Until ISO 9000 emerged in 1987, the automotive industry used a variety of customerspecific standards to govern a suppliers quality management practices The British contribution Prior to the publication of ISO 9000, several nations had developed national quality system standards,... equipment With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-military applications The result was BS 4891, which was published in 1972 In 1974 this was followed by BS 5179 with the title Operation and Evaluation of Quality Assurance Systems However, BS 5179 was intended only... Geneva with a view to developing an international quality system standard and eventually a committee was formed Using BS 5750 as its basis, the ISO 9000 series of standards was born Although the UK, and in particular the UK automotive industry, had been at the forefront of the development of non-military quality system standards, harmonization within the automotive sector beyond BS 5750 was believed too... competency will be autopref.qxd 10/04/00 21:23 Page xii NEE 2HAB=?A enhanced, a higher level of confidence should begin to develop within the global automotive industry, and product quality will improve not that quality has been a significant problem in the automotive industry in the last 10 years! I bought my first car in the mid 1960s, at a time when rust started to appear before cars were three years... is not a quality product So the final arbiter on quality is the customer The customer is the only one who can decide whether the quality of the products and services you supply is satisfactory and you will be conscious of this either by direct feedback or by loss of sales, reduction in market share, and, ultimately, loss of business There are other considerations in understanding the word quality, ... differences are not differences in quality would be misleading, since the products were all designed to fulfill the higher specification As there is a market for such products it is expedient to exploit it There is a range over which product quality can vary and still create satisfied customers Outside the lower end of this range the product is considered to be of poor quality Quality and price Most of us . Automotive Quality Systems Handbook autottl.qxd 10/04/00 21:21 Page i autottl.qxd 10/04/00 21:21 Page ii Automotive Quality Systems Handbook David. 19 Quality 19 Classification of products and services 20 Quality and price 22 Quality and cost 22 High quality and low quality; poor quality and good quality