ASQ AS9101D AUDT PROC PERF-2011 AS9101D Auditing for Process Performance.pdf

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1、AS9101D Auditing for Process Performance(This page intentionally left blank)Also available from ASQ Quality Press:A Practical Field Guide for AS9100CErik Valdemar Myhrberg, Dawn Holly Crabtree, and Rudy “RE” HackerThe ASQ Auditing Handbook, Third EditionJ.P. Russell, editing directorQuality Audits f

2、or Improved Performance, Third EditionDennis R. ArterThe Making of a World-Class OrganizationE. David Spong and Debbie J. CollardISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, John E. “Jack” West, and Joseph J. TsiakalsISO Lesson Guide 2008: Pocket Guide to ISO 9001:2008, Third Edition

3、J.P. Russell and Dennis R. ArterISO 9001:2008 Internal Audits Made Easy: Tools, Techniques, and Step-by-Step Guidelines for Successful Internal Audits, Second EditionAnn W. PhillipsProcess Driven Comprehensive Auditing: A New Way to Conduct ISO 9001:2008 Internal Audits, Second EditionPaul C. Palmes

4、ISO 9001:2008 Interpretive Guide for the Design and Construction Project Team (e-Book)Prepared by members of the ASQ Design and Construction Division and edited by John R. BroomfieldThe Quality Toolbox, Second EditionNancy R. TagueMapping Work Processes, Second EditionBjrn Andersen, Tom Fagerhaug, B

5、jrnar Henriksen, and Lars E. OnsyenRoot Cause Analysis: Simplified Tools and Techniques, Second EditionBjrn Andersen and Tom FagerhaugThe Certified Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorTo request a complimentary catalog of ASQ Quality Press p

6、ublications, call 800-248-1946, or visit our website at http:/www.asq.org/quality-press.(This page intentionally left blank)ASQ Quality PressMilwaukee, WisconsinAS9101D Auditing for Process PerformanceCombining Conformance and Effectiveness to Achieve Customer SatisfactionChad KymalAmerican Society

7、for Quality, Quality Press, Milwaukee 53203 2011 by ASQAll rights reserved. Published 2011Printed in the United States of America17 16 15 14 13 12 11 5 4 3 2 1Library of Congress Cataloging-in-Publication DataKymal, Chad.AS9101D auditing for process performance : combining conformance and effectiven

8、ess to achieve customer satisfaction / Chad Kymal.p. cm.Includes bibliographical references and index.ISBN 978-0-87389-807-2 (hardcover : alk. paper)1. Aerospace industriesStandards. 2. AeronauticsSpecifications. I. Title.TL671.1.K96 2011657.867dc22 2011013141ISBN: 978-0-87389-807-2No part of this b

9、ook 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. TonyAcquisitions Editor: Matt T. MeinholzProject Editor: Paul OMaraProduction Administrator: Randall BensonASQ

10、 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 avail

11、able 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

12、-248-1946. Visit our website at http:/www.asq.org/quality-press.Printed on acid-free paperviiTable of ContentsList of Figures and Tables . xiiiPreface xviiChapter 1 History of Aerospace Industry Standards 1AS9000:1997 . 1AS9100:1999 (Revision A) . 2AS9100 Revision B. 3AS9101Audit Checklist 3AS9104 3

13、Foundation Years 2000 and 2001 4AS9100 Revision C. 5AS9100, AS9110, and AS9120 Standards 6Aerospace, Defense, and Space Industries . 6Maintenance Organizations. 6Distributors to Aviation, Space, and Defense . 7Common Aerospace Auditing Standard . 7Summary 15Chapter 2 AS9100C Key Changes and the Impa

14、ct to the Quality Management Systems 17AS9100 Changes. 17Impact of Key Characteristics and Risk Management Process on the QMS 18Customer Focus and Customer Satisfaction 23AS9101 Changes . 24Customer Core Principle 1 (CP1)Customer Driven 25Customer Core Principle 2 (CP2)Process-Based Approach. 27Cust

15、omer Core Principle 3 (CP3)Organizational Performance Focus . 28viii Table of ContentsCustomer Core Principle 4 (CP4)Audit Methodology 30Customer Core Principles CP5 and CP6. 30ISO 9001:2008 Changes. 30Summary 32Chapter 3 AS9110 and AS9120 Key Changes 33AS9110 Revision ARequirements for Aviation Mai

16、ntenance Organizations 34Human Factors and Safety . 35Resource Management 35Counterfeit Part and Suspect Unapproved Part 36Quality Manual and Procedures . 36Management Review 37Control of Production and Service Provision . 38AS9120ARequirements for Aviation, Space, and Defense Distributors . 38Claus

17、es 3.3 and 3.7Counterfeit Part/Suspected Unapproved Part (SUP) . 397.1Planning of Product Realization . 397.1.1/7.5.3Configuration Management. 397.1.2Work Transfer 40SummaryAS9110 and AS9120 Changes. 40Chapter 4 Understanding AS9101D Auditing RequirementsWhat Has Changed. 41Process Approach 43Audit

18、Methodology. 45Clauses 4.1.2.1, Customer Focus, and 4.1.2.2, Organizational Focus . 45Clause 4.1.2.3, Quality Management System Performance and Effectiveness . 46Clauses 4.1.2.4, Process Management, and 4.1.2.5, Process Performance and Effectiveness . 47Clause 4.1.2.6, Continual Improvement . 47Comm

19、on Audit Activities 49Clause 4.2.1, Audit Planning 50Clause 4.2.2, On-Site Auditing 50Clause 4.2.3, Audit Reporting . 53Clause 4.2.4, Nonconformity Management. 55Clause 4.2.5, Audit Records 55Audit Phases 55Clause 4.3.1, Pre-Audit Activities 55Clause 4.3.2, Stage 1 AuditConclusions/Outputs 56Table o

20、f Contents ixClauses 4.3.3, Stage 2 Audit, and 4.3.4, Surveillance 56Clauses 4.3.5, Recertification, and 4.3.6, Special Audits . 57Summary of AS9101D 57Chapter 5 The Aerospace Auditing ApproachProcess Approach, Customer Focus, and Leadership 59Process Approach 59Understanding the Process Approach an

21、d the Organizations Processes 59Understanding a Process Map 60Process Hierarchy 60Examples of Customer Oriented Processes. 62Process Interfaces between Sites in an Organization . 64Process Map and Process Interfaces 65Measuring and Monitoring Processes. 66Relationship between Process Performance and

22、 Overall Performance . 66Auditing Each Process. 66Customer Focus . 70Auditing Customer Focus 71Summary 81Chapter 6 Understanding Audit Trails 83Audit Trails and Customer Oriented Processes . 83How to Use Audit Trails When Auditing Processes 84Business Planning and Management (BPM) Review Audit Trail

23、 . 86Links and Samples . 87New Product Development (NPD) Audit Trail 89Links and Samples . 91Provision Audit Trail . 92Links and Samples . 94Production and Service Provision Audit Trails . 95Audit Trails and Audit Planning. 96Process Monitoring and Improvement 97Conducting a Process Approach Audit 9

24、7Links and Samples . 98Completing the Process Audit Worksheet/PEAR . 100Chapter 7 Stage 1 Audit 105Step 1: Obtain Materials for Stage 1 Audit 107Step 2: Evaluate the Process Focus 108x Table of ContentsStep 2a: Confirm Supporting Functions and Determine Process ResponsibilitiesStudy the Scope 109Ste

25、p 2b: Processes Showing Sequence and Interaction, Including Key Indicators and Performance Trends, for 12 Months . 110Step 2c: Conduct Document Review and Confirm That the Processes Address All Requirements of AS9100/AS9110/AS9120 113Step 2d: Confirm That a Quality Manual Is Available for Each Site

26、to Be Audited 115Step 3: Conduct Customer Focus and Performance Analysis . 115Step 3a: Study Customer Performance: Scorecard Results, Policy, Performance Objectives and Targets, and Past Customer Failures 115Step 3b: Evaluate Internal Audit and Management Review Results from the Previous 12 Months 1

27、18Step 3c: Identify Suspect Processes (That Is, Those Suspected of Poor Performance Based on Customer and Performance Data Analysis) 120Step 3d: Confirm the Customer-Specific Quality Management System Requirements to Be Included in the Audit . 121Step 4: Determine the Appropriate Scope . 123AS9100/A

28、S9110/AS9120, Clause 1.2 . 123Step 5: Determine the Organizations Readiness 124Step 6: Prepare and Deliver the Stage 1 Report . 125Step 7: Create an Audit Plan 125Clause-Driven Audit Plan versus Process-Driven Audit Plan 126Auditor Requirements . 127Step 8: Conduct Process Analysis and Prepare a Cus

29、tomized Process Worksheet. 129Preparing the Process Audit Worksheet/PEAR . 129Preparing Audit Checklists . 129Auditor Requirements . 130Chapter 8 Stage 2: On-Site Audit 135Conducting the Audit . 135Step 9: Conduct Audit of Remote Supporting Functions 137Auditor Requirements . 137Table of Contents xi

30、Step 10: Opening Meeting . 138Auditor Requirements . 138Step 11: Conducting the Audit 140Audit Trails and Audit Planning . 140Following the Prioritized Audit Plan 142Conducting an Aerospace Process Approach to Audits . 142Links and Samples . 142Completing the Process Audit Worksheet/PEAR 144Performa

31、nce Analysis . 149Step 11a: Conduct Facility Tour, If Needed 150Step 11b: Study Customer and Organizational Performance 151Step 11c: Meeting with Top Management 151Step 11d: Audit Organizational Processes 153Step 11e: Verify That All Processes and Clauses Are Audited 154Step 12: Writing Nonconformit

32、ies . 154Major Nonconformity (Clause 3.2) . 155Minor Nonconformity (Clause 3.3). 155Auditor Requirements . 156Step 13: Closing Meeting 158Closeout Meetings 158Step 13a: Determine Audit Team Next Steps . 158Step 13b: Prepare the Draft Report. 158Step 13c: Conduct Closing Meeting 159Step 14: Audit Rep

33、ort . 160Formality of the Audit Report. 161Clause-to-Process Matrix 161Management Representative Acceptance of Audit Report 161Auditor Requirements . 161Step 15: Corrective Action and Closeouts . 161Auditees Responsibility . 162Auditors Responsibility . 162Step 15a: Evaluate Root Cause Analysis and

34、Systemic Corrective Action 163Step 15b: Complete a Follow-up Audit as Needed . 166Conclusion . 167Appendix A Confidential Assessment Report for Stage 1 169xii Table of ContentsAppendix B Confidential Assessment Report for Stage 2. 209Appendix C AS9100C Checklist by Clause and Objective Evidence Reco

35、rd (OER) CD-ROMAbout the Author 231Index 233xiiiList of Figures and TablesFigure 1.1 International Aerospace Quality Group (IAQG) global organization. 2Figure 1.2 Foundation of the AS9100:1999 (revised) standard. . 5Table 1.1 Comparison of ISO 9001:2008 to AS9100, AS9110, and AS9120. 8Figure 1.3 Mod

36、el for process-based auditing. . 15Figure 2.1 Interrelationship between special requirements, critical items, key characteristics, and risk management process. . 19Figure 2.2 Embedding risk within the product realization process. 20Figure 2.3 Customer focus and customer satisfaction. 23Figure 2.4 QO

37、S/BOS model. 24Figure 2.5 Customer oriented process example. . 26Figure 2.6 Multiple COPs in an organization, termed an octopus diagram by the automotive industry standards. . 26Figure 2.7 Turtle diagram example. . 27Figure 2.8 Organization process approach. . 28Figure 2.9 BMS control plan example.

38、29Figure 4.1 Summary diagram of AS9101 auditing process. 42Figure 4.2 Process Effectiveness Assessment Report (PEAR) example. . 44Figure 4.3 Turtle diagram example. . 45Figure 4.4 Process map example. 48Figure 4.5 Relationships between audit phases and common audit activities. 50Figure 4.6 Objective

39、 Evidence Record excerpt. . 51Figure 4.7 Standard Nonconformity Report example. 52Figure 4.8 Process Matrix Report example. 54Figure 5.1 Process map example. 61Figure 5.2 Multiple COPs in an organization, termed an octopus diagram by the automotive industry standards. . 62Figure 5.3 Process map bloc

40、ks and expectations of an auditor. . 63Figure 5.4 Process map showing information/action flows between sites. . 65Figure 5.5 BMS control plan example. 68Figure 5.6 Turtle diagram example. . 69Figure 5.7 Customer focus and customer satisfaction. 70Figure 5.8 Customer results. 76Figure 5.9 Recommended

41、 charts for key indicators and performance trends. 77Figure 5.10 Functions versus processes versus results. . 78Figure 5.11 Grouping risks into common categoriesexample. . 79Figure 6.1 Business management processes. 85Figure 6.2 Business planning and management review audit trail. . 86Figure 6.3 Cus

42、tomer Expectation Sampling Sheet example. . 88Figure 6.4 New product realization audit trail. 90Figure 6.5 Provision audit trail. 93Figure 6.6 Process map example. 99Figure 6.7 Turtle diagram example. . 100Figure 6.8 Process Audit Worksheet/PEAR example. 101Figure 7.1 Stage 1 audit process flowchart

43、. 106Figure 7.2 Organization of processes by location. . 110Figure 7.3 Elemental process development approach. 112Figure 7.4 Functional process development approach. 113Figure 7.5 Customer Expectation Sampling Sheet example. . 117Figure 7.6 Grouping suspect processes. . 121Figure 7.7 Grouping proces

44、ses by common risk categories. 122Figure 7.8 Clause-driven and process-driven audit plans. . 127Figure 7.9 Turtle diagram example. . 130Figure 7.10 Process Audit Worksheet/PEAR example. 131Figure 8.1 Stage 2 audit process flowchart. 136Figure 8.2 Opening meeting checklist. 139xiv List of Figures and

45、 TablesList of Figures and Tables xvFigure 8.3 Quality management system process map. 143Figure 8.4 Turtle diagram example. . 144Figure 8.5 Process Audit Worksheet/PEAR example. 145Figure 8.6 Process characteristics. . 146Figure 8.7 Process map example. 147Figure 8.8 Sample evidence of corrective ac

46、tion closeout. . 157Figure 8.9 Root causes of a problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163Figure 8.10 What makes a great internal auditor? 168Figure A.1 Assessment plan for stage 1 audit. . 171Figure A.2 Opening and closing meetings checklist. 172Figure A.3 Customer oriente

47、d processes. . 177Figure A.4 Customer Expectation Sampling Sheet. . 184Figure A.5 Information from Customer Scorecard. . 184Figure A.6 Assessment Planning Table. 186Figure A.7 Stage 2 Assessment Plan. 191Figure A.8 Detailed Findings Table. 194Figure A.9 Documentation and Process Cross-Reference for

48、AS9100C. 197Figure A.10 Process Audit Worksheet/PEAR example. 203Figure A.11 Process matrix. 204Figure A.12 Stage 1 completion checklist. . 208Figure B.1 Stage 2 audit report. 210Figure B.2 Audit Conclusions. . 212Figure B.3 Opportunities for improvement/observations. 213Figure B.4 Employee Shift De

49、tailsSite/Remote/Support Location. . 215Figure B.5 Process Audit Worksheet/PEAR example. 219Figure B.6 Assessment PlanStage 2. 220Figure B.7 Stage 2 Process/Clause Matrix. . 221Figure B.8 Nonconformity chart. . 225Figure B.9 Nonconformity Report (NCR). . 227(This page intentionally left blank)xviiThe aerospace industryunlike some other industries who have been badly hurt in the economic downturnhas not only survived, but all indications point toward a period of strong growth. Most organi-zations in the aeros