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The J.P. Russell, editor h a n d b o o k Fourth Edition aUdITInG aSQ The ASQ Auditing Handbook H1435_Russell_pi-378.indd 1 11/2/12 10:19 AM Also available from ASQ Quality Press: Quality Audits for Improved Performance, Third Edition Dennis R. Arter The Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second Edition J. P. Russell Auditing Beyond Compliance: Using the Portable Universal Quality Lean Audit Model Janet Bautista Smith Process Driven Comprehensive Auditing: A New Way to Conduct ISO 9001:2008 Internal Audits, Second Edition Paul C. Palmes AS9101D Auditing for Process Performance: Combining Conformance and Effectiveness to Meet Customer Satisfaction Chad Kymal Lean Acres: A Tale of Strategic Innovation and Improvement in a Farm-iliar Setting Jim Bowie Lean ISO 9001: Adding Spark to your ISO 9001 QMS and Sustainability to your Lean Efforts Mike Micklewright The Quality Toolbox, Second Edition Nancy R. Tague Mapping Work Processes, Second Edition Bjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E. Onsøyen Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T. Westcott, editor To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at http://www.asq.org/quality-press. H1435_Russell_pi-378.indd 2 11/2/12 10:19 AM The ASQ Auditing Handbook PrinciPles, imPlementation, and Use Fourth Edition ASQ Audit Division J. P. Russell, Editor ASQ Quality Press Milwaukee, Wisconsin H1435_Russell_pi-378.indd 3 11/2/12 10:19 AM 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 H1435_Russell_pi-378.indd 4 11/2/12 10:19 AM v 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 H1435_Russell_pi-378.indd 5 11/2/12 10:19 AM 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 H1435_Russell_pi-378.indd 6 11/2/12 10:19 AM 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 Audit 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 H1435_Russell_pi-378.indd 7 11/2/12 10:19 AM 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 H1435_Russell_pi-378.indd 8 11/2/12 10:19 AM 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 H1435_Russell_pi-378.indd 9 11/2/12 10:19 AM x List of Figures and Tables Figure I.1 Types of audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix Part I Figure 1.1 Classifications of audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Figure 5.1 ASQ code of ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Figure 5.2 The Institute of Internal Auditors code of ethics (selected sections) . . . . . . . 28 Figure 5.3 Whistle-blower statutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Figure 5.4 Example of other whistle-blower laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Figure 5.5 Illegal auditor activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Part II Figure 6.1 Audit plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Figure 6.2 Process audit scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Figure 6.3 Assignment considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Figure 6.4 Evaluation considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Table 6.1 Summary of auditing strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Figure 6.5 Notification letter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Figure 7.1 Detailed audit schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Figure 8.1 Typical audit report format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Table 8.1 Report issues and concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Table 8.2 Report attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Table 8.3 Suggestions for improving reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Figure 9.1 Sample request for corrective action form for first-party audits . . . . . . . . . . 124 Part III Table 10.1 Auditor certification requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Table 10.2 Tools and programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Table 10.3 Communication skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Table 10.4 Auditing skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Table 10.5 Auditor personal traits and attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Figure 12.1 Common time-wasting ploys and possible solutions . . . . . . . . . . . . . . . . . . . 143 H1435_Russell_pi-378.indd 10 11/2/12 10:19 AM List of Figures and Tables xi Figure 14.1 Open-ended questions contrasted with closed-ended questions . . . . . . . . . 152 Figure 15.1 Team developmental stage progression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Part IV Figure 16.1 Audit program measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Figure 16.2 Audit result linkages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Figure 16.3 Charting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Figure 16.4 Sample audit program contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Figure 16.5 Open-ended questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 Figure 16.6 Areas requiring procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179 Figure 16.7 Best Practices Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 Figure 16.8 Auditor or lead auditor risk management duties . . . . . . . . . . . . . . . . . . . . . . 192 Figure 16.9 Audit manager risk management duties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192 Figure 17.1 Production viewed as a system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 Part V Figure 18.1 SQM software example of a frequency Pareto analysis . . . . . . . . . . . . . . . . . 208 Figure 18.2 Cause-and-effect diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210 Figure 18.3 Common flowchart symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 Figure 18.4 Activity sequence flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212 Figure 18.5 Top-down flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 Figure 18.6 Matrix flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 Figure 18.7 Flow process worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214 Figure 18.8 A process map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214 Figure 18.9 Control chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 Figure 18.10 X _ and R chart example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 Figure 18.11 u chart for the average errors per truck for 20 days of production . . . . . . . . 218 Figure 18.12 WECO rules for signaling “out of control.” . . . . . . . . . . . . . . . . . . . . . . . . . . . 219 Figure 18.13 Any point above +3 sigma control limit (a point above 3 sigma, C line) . . . 219 Figure 18.14 Consecutive points above the average (trend: 8 points in a row but within 3 sigma, C line) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 Figure 18.15 Four out of the last five points above +1 sigma . . . . . . . . . . . . . . . . . . . . . . . . 220 Figure 18.16 Sample checklist, ISO 9001, clause 8.2.2, Internal auditing . . . . . . . . . . . . . . 221 Figure 18.17 Sample quality system checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222 Figure 18.18 Calibration area checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222 Figure 18.19 Check sheet for documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223 Figure 18.20 Data correlation patterns for scatter analysis . . . . . . . . . . . . . . . . . . . . . . . . . . 224 Figure 18.21 Histogram with normal distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225 Figure 18.22 Common histogram patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226 Figure 18.23 Five whys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229 Figure 18.24 PDCA/PDSA cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 H1435_Russell_pi-378.indd 11 11/2/12 10:19 AM xii List of Figures and Tables Figure 18.25 SIPOC diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 Figure 19.1 Value stream map—macro level (partial) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 Figure 19.2 Value stream map—plant level (partial) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 Figure 19.3 Takt time analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247 Figure 19.4 Typical U-shape cell layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249 Table 20.1 Frequency distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252 Figure 20.1 Histogram data dispersion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253 Figure 20.2 Line graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255 Figure 20.3 Bar graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256 Figure 20.4 Pie chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257 Table 20.2 Area of responsibilities matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257 Table 20.3 Audit planning matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258 Table 20.4 Lost-time accident monthly summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258 Figure 20.5 Lost work this month . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259 Figure 22.1 Producer risk or Type I error (note: sample taken from shaded area) . . . . . 274 Figure 22.2 Consumer risk or Type II error (note: sample taken from shaded area). . . . 274 Table 22.1 Sampling methods summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276 Figure 25.1 Consumer risk or Type II error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286 Figure 25.2 Causal relationship in developing key process measurements . . . . . . . . . . . 287 H1435_Russell_pi-378.indd 12 11/2/12 10:19 AM xiii Foreword C hange is the only constant, and changes to the audit profession continue in order to improve effectiveness and efficiency and to adjust to changes in technology. We are no longer just process and system auditors—rather, members of our profession are valued teammates, adding fresh eyes and organi- zational expertise to the wealth of tools available to management. Management system standards such as ISO 9000–based management systems are now viewed as starting points for organizational excellence. ASQ Audit Division members are no longer considered compliance police. Rather, our membership has evolved to meet the challenges of the new millennium, just as Norm Frank predicted in his foreword to the second edition of this handbook. We are no longer just auditors—we are assessors, and our chosen discipline has grown to include advis- ing management on best practices. We are teachers in the true sense of the word. This edition of The ASQ Auditing Handbook reflects those changes. Subject- matter experts skilled in the audit profession have grown the Body of Knowledge (BoK), working in tandem with the ASQ Certification Department, and this book reflects the latest revision. Teams of ASQ Certified Quality Auditors (CQAs), working on your behalf, met at ASQ headquarters and volunteered long hours to ensure that the BoK, reflected herein, represents generally accepted, world- class audit prac- tices. Contributors to this book, also subject- matter experts, volunteered their time to ensure that the excellence of the new BoK is scholastically available to audit professionals the world over. The words thank you don’t begin to express my appreciation to the ASQ Certifi- cation staff, the CQAs involved in updating the BoK, the Audit Division members who volunteer to manage the certification program, the CQAs who meet every year to write test questions, and the fine authors who contributed to the latest edition of this book. This book has become the text of choice for candidates sitting for the CQA examination. The exam is written such that the handbook is a major source of information needed to attain the CQA credential. Enjoy our latest edition, and use the information to grow your expertise. The path leading from compliance auditing to system assessing is great, but the rewards are worth the effort. I think you’ll find this book to be an invaluable resource to help you along that path. George Callender Chair, ASQ Audit Division H1435_Russell_pi-378.indd 13 11/2/12 10:19 AM xiv T his handbook supports the quality auditor BoK, developed for the ASQ CQA program. The quality audit BoK was revised in 2012. The fourth edi- tion addresses new and expanded BoK topics, common auditing (quality, environmental, safety, and so on) methods, and process auditing. The handbook is designed to provide practical guidance for system and process auditors. Practi- tioners in the field provided content, example audit situations, stories, and review comments as the handbook evolved. New to the fourth edition are the topics of common and special causes, outli- ers, and risk management tools. Besides the new topics, many current topics have been expanded to reflect changes in auditing practices since 2004 and ISO 19011 guidance, and they have been rewritten to promote the common elements of all types of system and process audits (quality, environmental, safety, and health). The text is aligned with the BoK for easy cross- referencing. We hope that use of this handbook will increase your understanding of the auditing BoK. The Use The handbook can be used by new auditors to gain an understanding of audit- ing. Experienced auditors will find it to be a useful reference. Audit managers and quality managers will use the handbook as a guide for leading their auditing programs. The handbook will also be used by trainers and educators as source material for teaching the fundamentals of auditing. It is not designed as a stand- alone text to prepare for the ASQ CQA exam. As with all ASQ certification activities, you are encouraged to work with your local section or the Quality Audit Division for preparation. The ASQ Auditing Handbook, when used in conjunction with other published materials, is appropriate for refresher courses, and we hope that train- ers will use it in that manner. The handbook contains information to support all aspects of the CQA BoK and is not limited to what new auditors need to know. Hence, the amount of mate- rial in each part of the handbook is not directly proportional to exam emphasis. The CQA exam is designed to test a candidate’s basic knowledge of quality audit- ing. All the information in the handbook is important, but those preparing for the CQA exam should spend more time on their weakest areas and on those parts of the BoK receiving more emphasis on the exam. The number of questions and the Notes to the Reader H1435_Russell_pi-378.indd 14 11/2/12 10:19 AM

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