The Process Approach Audit Checklist for Manufacturing

Karen Welch

Description

Finally, a comprehensive process audit checklist has been developed to be used with ISO 9001:2000! This manual was developed to assist anyone involved with conducting or planning quality system audits including quality auditors, quality managers, quality system coordinators, management representatives, and quality engineers. In addition, potential auditees in any function or position should find the questions useful in preparing for an audit. Although the checklist could be amended to work for a service company, the manual was created with a focus on the manufacturing sector to cover common processes such as production, management, customer-related, design and development, training, purchasing, etc. The manual includes: a brief overview of the process approach, discussion of problem areas often found by third party auditors, the process audit checklist, and forms to be used in conjunction with the process audit checklist to increase audit effectiveness.

Sujets

• Techniques
• Technologies de Fabrication
• Auditing
• Economie gestion
• Economics
• Business

Informations

• Publié par: ASQ Quality Press
• Date de parution: 31 décembre 2004
• Nombre de lectures: 1
• EAN13: 9780873890557
• Langue: English
• Poids de l'ouvrage: 21 Mo

Extrait

H1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page i
The Process
Approach Audit
Checklist for
ManufacturingH1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page ii
Also available from ASQ Quality Press:
Process Driven Comprehensive Auditing: A New Way to Conduct
ISO 9001:2000 Internal Audits
Paul C. Palmes
The Process-Focused Organization: A Transition Strategy for Success
Robert A. Gardner
The Process Auditing Techniques Guide
J. P. Russell
The Internal Auditing Pocket Guide
J. P. Russell
How to Audit the Process-Based QMS
Dennis R. Arter, Charles A. Cianfrani, and John E. (Jack) West
ISO Lesson Guide 2000: Pocket Guide to Q9001:2000, 2nd Edition
Dennis R. Arter and J. P. Russell.
Quality Audit Handbook, 2nd Edition
ASQ Quality Audit Division
Quality Audits for Improved Performance, 3rd Edition
Dennis R. Arter
The ISO 9001:2000 Auditor’s Companion
Kent A. Keeney
To request a complimentary catalog of ASQ Quality Press publications,
call 800-248-1946, or visit our Web site at http://qualitypress.asq.org.H1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page iii
The Process
Approach Audit
Checklist for
Manufacturing
Karen Welch
ASQ Quality Press
Milwaukee, WisconsinH1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page iv
American Society for Quality, Quality Press, Milwaukee 53203
© 2005 by
All rights reserved. Published 2004
Printed in the United States of America
12 11 10 09 08 07 06 05 04 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Welch, Karen, 1961–
The process approach audit checklist for manufacturing / Karen Welch.
p. cm.
Includes bibliographical references and index.
ISBN 0-87389-644-0 (alk. paper)
1. Quality control—Auditing. 2. ISO 9000 Series Standards. 3. Process
control. I. Title.
TS156.W45 2004
658.5'62—dc22 2004022390
ISBN 0-87389-644-0
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: Annemieke Hytinen
Project Editor: Paul 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.
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Printed on acid-free paperH1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page v
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Chapter 1 The Process Approach: An Overview . . . . . . . . . . 1
Section 1.1 Audit by Process . . . . . . . . . . . . . . . . . . . . . . . . . 3
Section 1.2 Interview All Functions and Levels . . . . . . . . . . . 8
Section 1.3 Encourage Top Management Involvement . . . . . . 8
Section 1.4 Welcome Nonconformities as Opportunities . . . . 8
Section 1.5 Focus on Known Weaknesses . . . . . . . . . . . . . . . 9
Section 1.6 Thoroughly Train Your Auditors . . . . . . . . . . . . . 9
Section 1.7 Allow Time for Auditors to Adequately
Prepare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Section 1.8 Encourage Auditors to Put Auditees at Ease . . . . 10
Section 1.9 Use a Process-Based Audit Checklist . . . . . . . . . 10
Chapter 2 Common ISO 9001:2000 Mistakes to Avoid . . . . . 11
Section 2.1 Improper Exclusions Identified . . . . . . . . . . . . . . 12
Section 2.2 Failure to Adequately Define Each Process . . . . . 13
Section 2.3 FAdequately Determine Sequence
and Interaction . . . . . . . . . . . . . . . . . . . . . . . . . 13
Section 2.4 Failure to Identify Measures for Each
Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Section 2.5 Failure to Identify Control of Outsourced
Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Section 2.6 Failure to Include “Legible” in Procedure
for Documents . . . . . . . . . . . . . . . . . . . . . . . . . 15
Section 2.7 Quality Objectives Not Established at Relevant
Functions and Levels . . . . . . . . . . . . . . . . . . . . 16
vH1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page vi
vi Contents
Section 2.8 Failure to Communicate the Effectiveness of the
Quality Management System . . . . . . . . . . . . . . 16
Section 2.9 Incomplete Management Review Records . . . . . . 17
Section 2.10 Competency Not Defined . . . . . . . . . . . . . . . . . . . 18
Section 2.11 Failure to Evaluate Effectiveness of Training . . . 18
Section 2.12 Personnel Not Aware of How They Contribute
to the Achievement of the Quality
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Section 2.13 Method of Customer Communication Not
Established . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Section 2.14 “Reevaluation” of Suppliers Not Performed . . . . 20
Section 2.15 “Revalidation” of Processes Not Performed . . . . 21
Section 2.16 No Record for Customer Property . . . . . . . . . . . . 21
Section 2.17 Raw Material Shelf Life Unknown . . . . . . . . . . . 22
Section 2.18 When Calibrated Equipment Found Out
of Tolerance, No Record of Assessment . . . . . 22
Section 2.19 No Proactive Method to Determine
Customer Satisfaction. . . . . . . . . . . . . . . . . . . . 23
Section 2.20 No Evidence of Continual Improvement . . . . . . . 23
Section 2.21 Lack of Definition for Audit Criteria, Scope,
and Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Section 2.22 Disregarding a Requirement . . . . . . . . . . . . . . . . 24
Chapter 3 The Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Guidelines for Use . . . . . . . . . . . . . . . . . . . . . . . 25
Section 3.1 Management Process . . . . . . . . . . . . . . . . . . . . . . 26
Section 3.2 Customer-Related Process . . . . . . . . . . . . . . . . . . 31
Section 3.3 Design Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Section 3.4 Purchasing Process . . . . . . . . . . . . . . . . . . . . . . . . 49
Section 3.5 Production Process 60
Section 3.6 Corrective/Preventive Action Process. . . . . . . . . . 88
Section 3.7 Internal Audit Process . . . . . . . . . . . . . . . . . . . . . 91
Section 3.8 Resource Management/Training Process . . . . . . . 93
Section 3.9 Product Realization Process . . . . . . . . . . . . . . . . . 97H1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page vii
Contents vii
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Appendix A: Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Appendix B: Documents 102
Appendix C: Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Appendix D: Calibration 104
Appendix E: Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Appendix F: Interview Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Appendix G: Management Review Meeting Checklist . . . . . . . . . . . 107
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
TABLES OF TYPICAL AUDIT REQUIREMENTS
Table 1 Customer-Related Process . . . . . . . . . . . . . . . . . . . . . . . 5
Table 2 Design Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 3 Purchasing Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Table 4 Production Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 5 Management Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 7H1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page viiiH1244 Welch 00 FM.qxd 11/9/04 5:16 PM Page ix
Preface
inally, a comprehensive process audit checklist has been developed to
be used with ISO 9001:2000! This manual was designed to assist any-Fone involved with conducting or planning quality system audits—
including quality auditors, quality managers, quality system coordinators,
management representatives, and quality engineers. In addition, potential
auditees in any function or position should find the questions useful in
preparing for an audit. Although the checklist could be amended to work for
a service company, the manual was created with a focus on the
manufacturing sector to cover common processes such as production, management,
customer-related, design and development, training, purchasing, and so
forth. The manual includes:
• A brief overview of the process approach
• A discussion of problem areas often found by third-party
auditors
• The process audit checklist, shown in scaled-down size in the
book’s pages and included in full-page size on the accompanying
CD-ROM as Microsoft Word files
• Forms to be used in conjunction with the process audit
checklist to increase audit effectiveness, which are also
included on the accompanying CD-ROM
As a third-party auditor, I have seen genuine limitations in internal
quality audit processes due to inexperienced internal auditors. Many of
them tell me they just aren’t sure what questions to ask. After all, most of
them only audit once or twice a year. How could they be as effective as
someone who audits professionally? Utilizi