Advanced Quality Auditing

Lance B. Coleman

Description

Auditors from any industry must "learn the language of upper management" if they truly want to effect positive change throughout their environments. If quality auditors want to remain relevant and keep from becoming marginalized, they need to add new skills and credentials, and even more importantly, move beyond conformance monitoring to determine how their work might impact the corporate bottom line.
The purpose of this book is to accept that challenge in presenting two ways that auditors can "learn [to speak] the language of upper management"-either by helping to drive continuous improvement or by helping to manage risk. This book has essential information that will help guide an organization's efforts to glean more value from their audit process. It helps grow the audit function beyond verification audits. It provides insight for using the audit function to improve organizations using lean principles. It also discusses how the audit function can contribute to and be formally integrated into the ongoing risk management program.
This book is about advancing the profession of auditing, as well as the skills of individual auditors.
"Buy. Read. Reread. It will kick start your risk-based thinking journey. Then, buy the book for each member of your auditing team."
center
Greg Hutchins, PE
Director, Certified Enterprise Risk Manager Academy "While there is a constant influx of books on auditing entering the market today, Advanced Quality Auditing: An Auditors Review of Risk Management, Lean Improvement and Data Analysis stands out among them as Lance excels at demonstrating to readers how they can embrace the methodologies for continual improvement as they apply to the audit program and audit professionals. By combining the use of the audit checklist development matrix tool (ACDM) and various lean tools that are traditionally applied to processes other than auditing, auditors can ensure they not only audit for compliance but also add value to the audits, demonstrating the value of audit program, and in turn, themselves.
The clarity of explanation and illustrative charts and diagrams of the Kano model makes it easy for the beginning auditor to understand and implement, while providing deeper insights to experienced auditors in how to leverage the model in the continual improvement of the audit program. Lance clearly makes the case that as audit professionals we should all embrace the use of the Kano model and apply it to our own audit programs to ensure we are always positioned to delight our customers."
Nancy Boudreau
ASQ Audit Division Chair (2014-2015)
Lance Coleman has taken a traditional topic on auditing and written a professional synopsis of key concepts in terms so clear as to make them understandable and useful to the reader. A great book to use and have as reference. Well done!
Dr. Erik Myhrberg
IRCA Certified QMS Lead Auditor
Co-author, A Practical Field Guide for ISO 13485:2003

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Auditing
• Economie gestion
• risk management
• Economics

Informations

• Publié par: ASQ Quality Press
• Date de parution: 25 mai 2015
• Nombre de lectures: 0
• EAN13: 9781953079718
• Langue: English
• Poids de l'ouvrage: 18 Mo

Extrait

Advanced Quality Auditing

Also available from ASQ Quality Press:

eAuditing Fundamentals: Virtual Communication and Remote Auditing J.P. Russell and Shauna Wilson

The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor

The Process Auditing and Techniques Guide, Second Edition J.P. Russell

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

AS9101D Auditing for Process Performance: Combining Conformance and EFectiveness to Meet Customer Satisfaction Chad Kymal

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: Simpliîed Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug

The Certiîed Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell T. Westcott, editor

To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http://www.asq.org/quality-press.

Advanced Quality Auditing

An Auditor’s Review of Risk Management, Lean Improvement, and Data Analysis

Lance B. Coleman, Sr.

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee, WI 53203 © 2015 by ASQ All rights reserved. Published 2015. Printed in the United States of America.

21 20 19 18 17 16 15 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Coleman, Lance B., 1962– Advanced quality auditing: an auditor’s review of risk management, lean improvement, and data analysis/Lance B. Coleman.  pages cm Includes bibliographical references. ISBN 978-0-87389-913-0 (hardcover: alk. paper) 1. Quality control—Auditing. 2. Risk management. 3. Auditing, Internal. 4. Industrial management. I. Title. TS156.C6155 2015 658.5’62—dc23  2015011925

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: Lynelle Korte Acquisitions Editor: Matt Meinholz Managing 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 ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.org/quality-press.

Printed on acid-free paper

Dedication

I dedicate this book to my wife and family. My wife of 29 years, Lorraine continues to be a source of love, support, and inspiration in all that I do. My four children Larissa, Lauren, Lance Jr., and Latrice were a joy and blessing to raise; now as adults I am proud to call them friends. Finally a shout out to my dogs Auggie, Leo, and Shii whose boundless exuberance and joy upon my simply entering the house bring a burst of joy into even the most dismal of days that we all sometimes face.

This page intentionally left blank.

Table of Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 1: Traditional Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  What Makes a Good Audit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  QMS Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Process Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Conducting the Audit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Audit Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 2: Lean Auditing for Business Improvement . . . . . . . . . . .  Introduction to Lean Principles . . . . . . . . . . . . . . . . . . . . . . . . . . .  Plan-Do-Check-Act (PDCA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Integrating Lean Tools into the Audit Program . . . . . . . . . . . . . .  Constructing a Lean Audit Checklist using the  Audit Checklist Development Matrix . . . . . . . . . . . . . . . . . .  Case in Point 2.1: Lean Receiving Audit . . . . . . . . . . . . . . . . . . . .  Case in Point 2.2: Lean Logistics . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 3: Risk-Based Quality Auditing (RBQA) . . . . . . . . . . . . . .  What is Risk Management? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Risk Management Integration. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Risk-Based Quality Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Case in Point 3.1: Auditing for Risk . . . . . . . . . . . . . . . . . . . . . . . .

vii

i

x

x

i

xiii

1 2 3 4 7 9

13 13 17 18

19 21 24

25 25 28 33 35 40

viiiContents

Chapter 4: Data and Trend Analysis . . . . . . . . . . . . . . . . . . . . . . . . . .  Statistical and Data Analysis Tools. . . . . . . . . . . . . . . . . . . . . . . . .  How to Analyze Data Eectively. . . . . . . . . . . . . . . . . . . . . . . . . .  Auditors and Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Case in Point 4.1: Measurable Goals and Objectives . . . . . . . . . .

Chapter 5: Root Cause Analysis and Corrective Action . . . . . . . . .  How to Accomplish Successful Root Cause Analysis (RCA) . . .  The Dierence Between Corrective and Preventive Action. . . .  RCA Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  What are the Steps of the Corrective Action Process . . . . . . . . . .  How and When to Close a Corrective Action. . . . . . . . . . . . . . . .  Case in Point 5.1: Is/Is Not . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Case in Point 5.2: Traïc Accidents. . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 6: How Delightful is Your Audit Program? . . . . . . . . . . . .  The Audit Function as a Service . . . . . . . . . . . . . . . . . . . . . . . . . . .  What Makes a Good Audit Program . . . . . . . . . . . . . . . . . . . . . . .  How to Objectively and Consistently Evaluate  Your Audit Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Case in Point 6.1: Audit Program Based on Existing Records . .

Chapter 7: Audit Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 8: Charting a Path Forward . . . . . . . . . . . . . . . . . . . . . . . . . .  Needed Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Steps Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Basic Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Control Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43 43 45 46 47

49 49 50 50 52 53 54 56

61 61 61

65 70

7

7

79 79 81

83 83 84

8

9

9

1

List of Figures and Tables

Figure 1.1 Figure 1.2 Figure 1.3 Figure 1.4 Table 1.1

Figure 2.1 Figure 2.2 Case in Point 2.1 Figure 2.3 Figure 2.4 Case in Point 2.2

Table 3.1 Table 3.2 Table 3.3 Table 3.4 Table 3.5 Table 3.6 Table 3.7 Figure 3.1 Table 3.8 Figure 3.2 Case in Point 3.1

Figure 4.1 Case in Point 4.1

L. O. C. k S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TheWFactor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Process map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. O. o R. S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Audit checklist template. . . . . . . . . . . . . . . . . . . . . . . . . .

PDCA cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Audit checklist development matrix (ACDM) . . . . . . . Lean receiving audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Receiving process owchart. . . . . . . . . . . . . . . . . . . . . . . Receiving value stream map . . . . . . . . . . . . . . . . . . . . . . Lean logistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Risk matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Risk assessment form risk matrix . . . . . . . . . . . . . . . . . . Likelihood of detection . . . . . . . . . . . . . . . . . . . . . . . . . . . Deîning likelihood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deîning impact. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FMEA table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sample auditor risk management training matrix . . . . Risk identiîcation and response process ow. . . . . . . Finding classiîcation by risk. . . . . . . . . . . . . . . . . . . . . . Hiring process map showing enablers and risks . . . . . Auditing for risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Measurable goals and objectives . . . . . . . . . . . . . . . . . . .

ix

2 3 4 7 9

18 20 21 21 23 24

29 30 30 31 31 32 34 35 38 39 40

43 47