The ASQ auditing handbook : principles, implementation, and use

399 Pages·2012·6.115 MB·English

by  J.P. Russell, editor

aSQ
The
aUdITInG
h a n d b o o k
Fourth Edition
J.P. Russell, editor
The ASQ Auditing
Handbook
H1435_Russell_pi-378.indd 1 11/2/12 10:19 AM
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H1435_Russell_pi-378.indd 2 11/2/12 10:19 AM
The ASQ Auditing
Handbook
P , i , U
rinciPles mPlementation and se
Fourth Edition
ASQ Audit Division
J. P. Russell, Editor
ASQ Quality Press
Milwaukee, Wisconsin
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American Society for Quality, Quality Press, Milwaukee 53203
© 2013 by ASQ
All rights reserved. Published 2012
Printed in the United States of America
18 17 16 15 14 13 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
The ASQ auditing handbook : principles, implementation, and use / ASQ
Quality Audit Division ; J.P. Russell, editor.—4th ed.
p. cm.
Rev. ed. of: The quality audit handbook. 3rd ed. c2005.
Includes bibliographical references and index.
ISBN 978-0-87389-847-8 (alk. paper)
1. Auditing—Handbooks, manuals, etc. I. Russell, J. P. (James P.),
1945– II. ASQ Quality Audit Division. III. Quality audit handbook.
HF5667.Q35 2013
657′.45—dc23
2012039493
No part of this book may be reproduced in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: William A. Tony
Acquisitions Editor: Matt Meinholz
Project Editor: Paul Daniel O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and
community excellence worldwide through learning, quality improvement, and knowledge
exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video,
audio, and software are available at quantity discounts with bulk purchases for business,
educational, or instructional use. For information, please contact ASQ Quality Press at
800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, visit our
website at http://www.asq.org/quality-press.
Printed on acid-free paper
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Contents
List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Notes to the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Part I Auditing Fundamentals ................................... 1
Chapter 1 Types of Quality Audits/Part IA .............................. 2
1. Method ......................................................... 2
2. Auditor- Auditee Relationship ...................................... 4
3. Purpose ......................................................... 6
4. Common Elements with Other Audits ............................... 8
Chapter 2 Purpose and Scope of Audits/Part IB ......................... 11
Audit Reason ...................................................... 11
1. Elements of Purpose and Scope ..................................... 13
2. Benefits of Audits ................................................. 16
Chapter 3 Criteria to Audit Against/Part IC ............................. 18
Discussion ......................................................... 18
Audit Requirements ................................................ 18
Chapter 4 Roles and Responsibilities of Audit Participants/Part ID ....... 21
Audit Participants .................................................. 21
Roles and Responsibilities ........................................... 22
Chapter 5 Professional Conduct and Consequences for Auditors/Part IE ... 26
1. Professional Conduct and Responsibilities ........................... 26
2. Legal Consequences .............................................. 38
3. Audit Credibility ................................................. 41
Part II Audit Process ............................................. 47
Chapter 6 Audit Preparation and Planning/Part IIA ...................... 49
1. Elements of the Audit Planning Process ............................. 51
2. Auditor Selection ................................................. 59
3. Audit- Related Documentation ...................................... 63
v
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vi Contents
4. Logistics ........................................................ 67
5. Auditing Tools and Working Papers ................................. 70
6. Auditing Strategies ............................................... 75
7. Communication and Distribution of the Audit Plan ................... 79
Chapter 7 Audit Performance/Part IIB .................................. 82
1. On- Site Audit Management ........................................ 82
2. Opening Meeting ................................................. 85
3. Audit Data Collection and Analysis ................................. 89
4. Establishment of Objective Evidence ................................ 97
5. Organization of Objective Evidence ................................. 98
6. Exit and Closing Meetings ......................................... 101
Chapter 8 Audit Reporting/Part IIC .................................... 107
1. Report Development and Content .................................. 107
2. Effective Reports ................................................. 116
3. Final Audit Report Steps .......................................... 118
Chapter 9 Audit Follow- up and Closure/Part IID ........................ 121
1. Elements of the Corrective Action Process ........................... 121
2. Review of Corrective Action Plan ................................... 123
3. Verification of Corrective Action .................................... 126
4. Follow- up on Ineffective Corrective Action ........................... 128
5. Audit Closure .................................................... 129
Part III Auditor Competencies ................................... 133
Chapter 10 Auditor Characteristics/Part IIIA ............................ 134
Education and Experience ........................................... 134
Interpersonal Skills ................................................. 136
Personal Traits ..................................................... 138
Chapter 11 On-Site Audit Resource Management/Part IIIB ............... 139
Time-Management Skills ............................................ 139
Chapter 12 Conflict Resolution/Part IIIC ............................... 141
Causes of Conflict .................................................. 141
Managing Difficult Situations ........................................ 142
Team Conflict ...................................................... 144
Chapter 13 Communication and Presentation Techniques/Part IIID ....... 145
Basic Rules for Effective Communication .............................. 145
Communication Technology ......................................... 146
Presentation Techniques ............................................. 150
Chapter 14 Interviewing Techniques/Part IIIE ........................... 151
Conversational Process .............................................. 151
Avoid Asking Leading Questions ..................................... 152
Interviewing a Group of People ...................................... 153
Using a Translator .................................................. 153
Corroborating Information ........................................... 153
Potential Problems .................................................. 154
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Contents vii
Chapter 15 Team Dynamics/Part IIIF ................................... 157
1. Team Building ................................................... 157
2. Team Facilitation ................................................. 159
3. Stages of Team Development ....................................... 160
Part IV A udit Program Management and
Business Applications .................................... 163
Chapter 16 Audit Program Management/Part IVA ....................... 164
1. Senior Management Support ....................................... 164
2. Staffing and Resource Management ................................. 165
3. Auditor Training and Development ................................. 166
4. Audit Program Evaluation ......................................... 170
5. Internal Audit Program Management ............................... 174
6. External Audit Program Management (Supplier Audits) ............... 181
7. Best Practices .................................................... 186
8. Organizational Risk Management ................................... 188
9. Management Review Input ........................................ 194
Management Review ................................................ 195
Chapter 17 Business and Financial Impact/Part IVB ..................... 196
1. Auditing as a Management Tool .................................... 196
2. Interrelationships of Business Processes ............................. 199
3. Cost of Quality (COQ) Principles ................................... 200
4. Emerging Roles of the Auditor ..................................... 205
Part V Quality Tools and Techniques ............................ 207
Chapter 18 Basic Quality and Problem- Solving Tools/Part VA ............ 208
Pareto Charts ...................................................... 208
Cause-and-Effect Diagrams .......................................... 209
Flowcharts and Process Mapping ..................................... 210
Statistical Process Control (SPC) Charts ................................ 215
Checklists, Check Sheets, Guidelines, and Log Sheets .................... 220
Scatter Diagrams ................................................... 224
Histograms ........................................................ 225
Root Cause Analysis ................................................ 227
Plan-Do-Check-Act (PDCA/PDSA) Cycle ............................. 230
Chapter 19 Process Improvement Techniques/Part VB ................... 232
1. Six Sigma and the DMAIC Model ................................... 232
2. Lean ............................................................ 234
Chapter 20 Basic Statistics/Part VC .................................... 250
1. Measures of Central Tendency ...................................... 250
2. Measures of Dispersion ........................................... 251
3. Qualitative and Quantitative Analysis ............................... 253
Patterns and Trends ................................................. 255
Chapter 21 Process Variation/Part VD .................................. 260
1. Common and Special Causes (Theory of Variation) .................... 260
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viii Contents
2. Process Performance Metrics ....................................... 264
3. Outliers ......................................................... 265
Chapter 22 Sampling Methods/Part VE ................................. 266
Types of Sampling .................................................. 266
Statistical Sampling (Random and Systematic) .......................... 268
Sampling Standards (Acceptance Sampling). . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
Proportional Stratified Sampling ..................................... 272
Risks in Sampling .................................................. 273
Sampling Summary ................................................. 275
Chapter 23 Change Control and Configuration Management/Part VF ...... 278
Document Control .................................................. 278
Configuration Management Control .................................. 279
Conclusion ........................................................ 280
Chapter 24 Verification and Validation/Part VG ......................... 281
Techniques ........................................................ 281
Process Auditing and Techniques ..................................... 282
Chapter 25 Risk Management Tools/Part VH ............................ 283
Quantification of Risk ............................................... 283
Failure Mode and Effects Analysis .................................... 284
Critical to Quality .................................................. 285
HACCP ........................................................... 287
HHA .............................................................. 288
Appendix A ASQ Code of Ethics ...................................... 291
Appendix B Notes on Compliance, Conformance, and Conformity ........ 292
Compliance ........................................................ 292
Conformance ...................................................... 292
Conformity ........................................................ 292
Appendix C Example Guide for Technical Specialists
(or Subject Matter Experts) ........................................... 294
Introduction ....................................................... 294
Contact ........................................................... 294
Job Description ..................................................... 294
The Report ........................................................ 295
Appendix D The Institute of Internal Auditors Code of Ethics ............ 296
Introduction ....................................................... 296
Applicability and Enforcement ....................................... 296
Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
Rules of Conduct ................................................... 297
Appendix E History of Quality Assurance and Auditing ................. 299
Quality Assurance and Audit Functions ............................... 299
Theories and Practices in Auditing .................................... 301
Environmental, Safety, and Health Programs and Audit Functions ........ 304
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Contents ix
Appendix F Certified Quality Auditor Body of Knowledge ............... 306
Six Levels of Cognition based on Bloom’s Taxonomy (Revised) ........... 315
Appendix G Example Audit Program Schedule ......................... 317
Appendix H Example Third- Party Audit Organization Forms ............. 323
Appendix I Example Audit Reports .................................... 333
Appendix J Product Line Audit Flowchart .............................. 343
Appendix K First, Second, and Third Edition Contributors and
Reviewers .......................................................... 345
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 358
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
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