Nuclear Auditing Handbook

A Guide for Quality Systems Practitioners

EditorsCharles MoseleyKaren Douglas

Norman Moreau

ASQ Quality PressMilwaukee, Wisconsin

Nuclear Auditing Handbook: A Guide for Quality Systems Practitioners1986, 2009, 2021Copyright © by ASQ Energy and Environment DivisionAll rights reserved. Published 2021

Printed in the United States of America23 22 21 20 24 23 22 21 5 4 3 2 1

Publisher’s Cataloging-in-Publication Data

Names: Moseley, Charles H., 1943-, editor. | Douglas, Karen M., 1952-, editor. | Moreau, Norman P., 1952-, editor.

Title: Nuclear auditing handbook : a guide for quality systems professionals / Editors: Charles Moseley; Karen Douglas; Norman Moreau.

Description: Includes bibliography. | Milwaukee, WI: ASQ Quality Press, 2021Identifiers: LCCN: 2021942948 | ISBN: 978-1-63694-007-6 (paperback) |

978-1-63694-008-3 (ebook)Subjects: LCSH Nuclear power plants—Quality control. | Nuclear industry—

United States—Quality control. | Quality assurance. | Electric power-plants—Quality control | BISAC BUSINESS & ECONOMICS / Auditing | BUSINESS & ECONOMICS / Industries / Energy | TECHNOLOGY & ENGINEERING / Power Resources / Nuclear

Classification: LCC TK9023 .N78 2021 | DDC 621.48/35—dc23

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.

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iii

Table of Contents

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

SECTION 1—INTRODUCTION

HANDBOOK OBJECTIVE AND USE

1.1 Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

TYPES OF AUDITS

1.3 Quality System Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.4 Quality System Survey vs. Quality System Audit . . . . . . . . . . . . . . . . . 21.5 Other Types of Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

AUDITOR ETHICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SECTION 2—QUALITY ASSURANCE PROGRAM REQUIREMENTS

2.1 Commercial Nuclear Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . 52.2 Other Energy Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52.3 Reference Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

SECTION 3—AUDIT OBJECTIVES

QUALITY ASSURANCE SYSTEMS ASSESSMENT

3.1 Owner’s Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.2 Audit Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.3 Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

UTILITY/OWNER

3.4 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.5 Mandatory Audit Commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

iv Table of ConTenTs

OTHER PARTICIPATING ORGANIZATIONS

3.6 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163.7 Prime Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163.8 Sub-Tier Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

SECTION 4—DEVELOPMENT AND ADMINISTRATION OF AN AUDIT PROGRAM

DEVELOPMENT OF AUDIT ORGANIZATION

4.1 Company Management Policy and Authority . . . . . . . . . . . . . . . . . . . . 184.2 Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194.3 Auditor Independence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

PLANNING AND SCHEDULING AN AUDIT PROGRAM

4.4 Planning and Scheduling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224.5 Type of Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224.6 Development of an Audit Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234.7 Scheduling of Audit Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244.8 Personnel Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264.9 Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

AUDIT PERSONNEL ADMINISTRATION

4.10 Auditor Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274.11 Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314.12 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.13 Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

MAINTENANCE OF AUDIT RECORDS

4.14 Audit Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.15 Audit Personnel Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.16 Audit Follow-Up Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 374.17 Audit Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

SECTION 5—MECHANICS OF AN INDIVIDUAL AUDIT

AUDIT PREPARATION

5.1 Key Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385.2 Audit Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385.3 Defining Scope of Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.4 Audit Scheduling and Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405.5 Team Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415.6 Identification of Documents Required to Conduct the Audit . . . . . . . 415.7 Development of the Audit Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Table of ConTenTs v

AUDIT PERFORMANCE

5.8 Pre-Audit Conference Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425.9 Conduit of Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445.10 Adjustment of Audit Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445.11 Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455.12 Evaluation and Analysis of Audit Observations . . . . . . . . . . . . . . . . . . 455.13 Post-Audit Conference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

REPORTING AUDIT RESULTS

5.14 Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465.15 Objective/Subjective Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475.16 Reporting Format and Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

CORRECTIVE ACTION AND FOLLOW-UP

5.17 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485.18 Follow-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

SECTION 6—AUDIT TECHNIQUES

ASSEMBLING AND REVIEW OF AUDIT MATERIALS

6.1 Program Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 516.2 Ancillary Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 516.3 Trace Back of Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526.4 Review of Quality Assurance Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

AUDIT CHECKLISTS

6.5 Requirement Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556.6 Auditor’s Option Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 606.7 One-Item Trace Back vs. List of Questions Checklist . . . . . . . . . . . . . . 616.8 Procedures as Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 626.9 Standard Audit Checklist and Procedures . . . . . . . . . . . . . . . . . . . . . . . 64

PRE-AUDIT CONFERENCE

6.10 Rapport Establishment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

AUDIT CONDUCT

6.11 Fact Finding and Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 686.12 Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 716.13 Environment for Interview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 746.14 Auditor’s Obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 756.15 Tactics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

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FINDINGS

6.16 Objectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 776.17 Keeping Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 776.18 Backup Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 776.19 Reproduction of Copies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 786.20 Discussions of Findings During Audit . . . . . . . . . . . . . . . . . . . . . . . . . . 79

POST-AUDIT CONFERENCE

6.21 Overall Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 806.22 Presentation of Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 806.23 Presentation of Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 816.24 Presentation of Observations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

HUMAN FACTORS

6.25 Facts vs. Opinion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 826.26 Reporting Writing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 846.27 Understanding People . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 846.28 Analytical Ability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 866.29 Audit Team Motivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 876.30 Audit Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 886.31 Psychology of Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

SECTION 7—Industry Initiatives and Developments (Updated 2021)

Section 7.1 Commercial Grade Dedication . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Section 7.2 Software Used in Design Analyses. . . . . . . . . . . . . . . . . . . . . . . . 102Section 7.3 CGD of Software Used in Design and Analysis . . . . . . . . . . . . . 106Section 7.4 Control of Electronic Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110Section 7.5 Counterfeit, Fraudulent, and Suspect Items . . . . . . . . . . . . . . . . 119Section 7.6 Control of Electronic Records Code of Federal Regulations . . 132Section 7.7 Suspect/Counterfeit Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

FIGURES2.1 Document Relationships Construction . . . . . . . . . . . . . . . . . . . . . . . . . . 72.2 Document Relationships Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82.3 Document Relationships Construction/Maintenance . . . . . . . . . . . . . 93.1 Commitments Applicable to Various Organizations . . . . . . . . . . . . . . . 123.2 Mandatory Audit Commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134.1 Example of Format of Lead Auditor Qualification Record . . . . . . . . . 254.2 Example of Audit Report Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284.3 Example of Audit Finding Report Form . . . . . . . . . . . . . . . . . . . . . . . . . 304.4 Example of Format of Lead Auditor Qualification Record . . . . . . . . . 35

Table of ConTenTs vii

5.1 Example of Audit Work Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 496.1 Example of Audit Plan/Checklist Form . . . . . . . . . . . . . . . . . . . . . . . . . 536.2 Example of Document Distribution Checklist Form . . . . . . . . . . . . . . . 556.3 Example of Requirements Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . 576.4 Example of Requirements Audit Checklist with Special Questions . . 586.5 Example of Requirements Audit Checklist with Special

Questions and Remarks Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 596.6 Example of Blank Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 606.7 Example of Completed Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . 616.8 Example of Panel Assembly and Test Checklist . . . . . . . . . . . . . . . . . . . 626.9 Example of Audit Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 646.10 Example of Blank Audit Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 656.11 Example of Completed Audit Procedure . . . . . . . . . . . . . . . . . . . . . . . . 666.12 Example of Audit Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 676.13 Example of Prescriptive and Descriptive Type of Documents . . . . . . . 726.14 Guidelines for Effective Communications During an Audit . . . . . . . . 836.15 ASQ Code of Ethics (February 2019) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 897.1 Overview of Commercial Grade Dedication . . . . . . . . . . . . . . . . . . . . . 967.2 Source Verification of Supplier for Dedication of

Commercial Grade Item . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 987.3 Commercial Grade Item Dedication—Technical Evaluation . . . . . . . . 997.4 Commercial Grade Item Acceptance Record . . . . . . . . . . . . . . . . . . . . . 1017.5 Commercial Grade Dedication of Software . . . . . . . . . . . . . . . . . . . . . . 107

APPENDICES

APPENDIX A—REFERENCE DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . 153

APPENDIX B—CASE STUDIES

Case Study 1—Internal Audit of Nuclear Utility . . . . . . . . . . . . . . . . . . . . . . . 156Case Study 2—Utility Audit of Manufacturing Supplier . . . . . . . . . . . . . . . . 161Case Study 3—Internal Audit of Nuclear Utility (Construction/Civil) . . . . 165Case Study 4—Internal Audit of Nuclear Utility

(Construction/Mechanical) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168Case Study 5—External Subcontractor Readiness Audit

(Technical/Laboratory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173Case Study 6—Commercial Grade Dedication of Item . . . . . . . . . . . . . . . . . 179Case Study 7—Suspect/Counterfeit Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Case Study 8—Software Use in Nuclear Applications . . . . . . . . . . . . . . . . . . 186Case Study 9—Software Verification and Validation . . . . . . . . . . . . . . . . . . . 189Case Study 10—Control of Electronic Records . . . . . . . . . . . . . . . . . . . . . . . . 195Case Study Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

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APPENDIX C—EXAMINATION QUESTIONS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216Additional Lead Auditor Exam Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . 230Additional Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236

APPENDIX D—AUDITING IN A NUCLEAR POWER PLANT

Introduction to Auditing at a Nuclear Generating Site . . . . . . . . . . . . . . . . . 237Nuclear Oversight Qualifications and Training Table of Contents . . . . . . . . 240Nuclear Oversight Audit Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276Nuclear Oversight Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2782016 Nuclear Oversight Fleet Design Control (A-Des-[Plant X])

Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310Nuclear Oversight Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 328

APPENDIX E—AUDITING OF NUCLEAR INDUSTRY SUPPLIERS

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349Summary Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351

APPENDIX F—BLANK FORMS

Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423Audit Finding Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425Attendance Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 426Audit Observation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 427Audit Notification and Audit Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 428Audit Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429Auditor - Annual Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 430Auditor Participation Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 431Introduction of Audit Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432Nuclear Oversight Audit Exit Meeting Outline . . . . . . . . . . . . . . . . . . . . . . . . 433Standard Audit Plan: Applies to This Audit . . . . . . . . . . . . . . . . . . . . . . . . . . 434Nuclear Oversight Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435Audit Feedback Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 438Nuclear Oversight Auditor Certification of Qualification . . . . . . . . . . . . . . . 439

SOLUTIONS TO APPENDIX C EXAMINATION QUESTIONS . . . . . . . . . 442

ABOUT THE AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445

ix

This Handbook is published by the American Society for Quality (ASQ) as an audit-ing guide primarily for nuclear-related industries. It was developed as a tool for train-ing, indoctrination, and qualification of personnel conducting audits on nuclear quality systems. It is directed primarily at the development of the lead auditor or audit team leader. This Handbook may also be used as a reference by quality managers who plan or are subject to quality system audits. It provides detailed material in such aspects as the development, administration, planning, preparation, performance, and reporting of quality system audits in nuclear-related fields.

The third edition of the Handbook has undergone changes to make it timelier and more useful to individuals actively involved in quality system auditing. Requirements and standards, including those in the 2019 editions III of ASME NQA-1 “Quality Assur-ance Program Requirements for Nuclear Facility Applications” and ASME BPVC Sec-tions I; IV; and VIII, Divisions 1 and 2, have been added.

In Section 2, “Quality Assurance System Requirements,” Figure 2.1 previously depicted document relationships and imposing authorities of various regulations and standards that govern only the design and construction of nuclear facilities. Addi-tional figures now consider the operation of a nuclear facility, including procurement of replacement items and services and the complete nuclear life cycle through plant decontamination and decommissioning.

The numerous figures involving forms presented throughout the text have been expanded, improved, and clarified. Each form is now shown as a blank (not completed) form for convenient use by the auditor and also as a completed form for reference in training auditors. The completed forms are placed within the text while the blank forms are located in the Appendices.

Appendix A, “Reference Documents,” has been expanded to include ASME NQA-1, NUREG, technical specifications (Appendix to Operating License), and additional ASME sections. Table A.1 includes standards used in international nuclear industry applications.

The Appendices have also been expanded to include new glossary sections of major terms, which are presented for easy reference by the auditor as well as those involved in training auditors.

Six case studies have been added to Appendix B, and the solutions for all 10 case studies now include a relevant nuclear standard section to improve their overall useful-ness for and suitability to the training of auditors.

This document has been developed by ASQ’s Nuclear Committee of the Energy and Environment Division. The committee members recognize that the preparation of this Handbook was accomplished as a group effort and many people have been involved in

Preface

x PrefaCe

the writing, reviewing, and editing processes. Special appreciation must be given to the organizations that supported the participation of the committee personnel and provided the secretarial and other types of assistance needed to assemble such a publication.

Credit is given to the American National Standards Institute, Nuclear Regulatory Commission, American Society of Mechanical Engineers, ASQ, and other organizations and individuals from whose publications information was extracted and modified for the development of the text material shown in this Handbook. Selected passages and figures are quoted from James H. Rusk’s “Quality Assurance System Audit,” with the permission of General Atomic Company, San Diego, California. References included in this edition direct the reader to further research topics of interest. Selected passages and figures are also quoted from the course material for the ASQ short course “Quality Audit—Development and Administration” with permission.

Special credit is given to those individuals and their organizations who contributed significant effort in the tedious review of the entire text and the subsequent valuable comment of a positive and useful nature. Mr. J. Norris and Mr. J. H. Rusk of Manage-ment Analysis Company, in particular, voluntarily gave of their expertise, which was extremely helpful and greatly appreciated by each of the committee members.

The members of the committee who were instrumental in developing the contents of the 2021 Handbook are as follows:

Authors

Charles MoseleyNorman MoreauThomas EhrhornStephen PrevetteJames HillAbhijit SenguptaKaren Douglas

Reviewers

Mitch IveyThomas EhrhornMichael GilmanBenjamin TrujilloRonald PostStephen PrevetteKaren DouglasJeffrey WorthingtonAbhijit Sengupta

James HillCharles MoseleyNorman Moreau

Editors

Carol SmithKaren DouglasCharles MoseleyNorman Moreau

1

Section 1Introduction

HANDBOOK OBJECTIVE AND USE

1.1 ObjectiveThis Handbook provides prospective lead auditors and auditors with sufficient formal training to assist in meeting the training and maintenance of proficiency requirements for quality system auditors in nuclear-related industries. Courses utilizing this Hand-book should leave students with a knowledge and understanding of auditing methods and techniques. The material includes the development, organization, and administra-tion of an audit program; the mechanics of an individual audit; audit objectives; and auditing techniques, as well as case studies on particular aspects of auditing. Upon completion of such a course, auditors should be examined to measure their comprehen-sion of the material presented.

1.2 UseThis Handbook can be used outside of the classroom situation. It is essentially a refer-ence text that includes auditing techniques and information from many sources. As a textbook, the Handbook can be used by teachers, learners, and practitioners alike either for classroom training, on-the-job training, a self-help training aid or refresher for prac-ticing auditors. The Handbook is comprised of the following:

a. Quality assurance (QA) systems and reference informationb. Basic auditing theory and techniquesc. Case studies to provide practical examples of auditing situations and methodsd. Examination base

As indicated above, this Handbook is comprehensive, and except for actual auditing experience, provides the QA auditor with the written information required to become a qualified lead auditor. With proper guidance and satisfactory experience, persons aspir-ing to be fully qualified lead auditors will find in the Handbook answers to their ques-tions on ethics, auditing methods, quality organization, reporting of results, and many other useful items needed for successful auditing.

The instructor should present the information at an undergraduate college level since the student background should be about two or more years of college or equiva-lent. The Table of Contents provides a course outline and is structured in a topical sub-ject matter to facilitate classroom presentation.

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The case studies can be used as work assignments for after-class study or workshop-type sessions during class time. Classroom discussions should be utilized to evaluate student comments and reactions to the case study situations and to practice the tech-niques presented.

Referenced standards should be made available to explain requirements and to expand upon technical points noted in the Handbook. Students utilizing the Handbook for self-help should do likewise.

This third edition of the Handbook uses the contemporary titles and names of stan-dards, references, and organizations. Care should be taken by the student to ensure that current reference information is utilized. Although these requirements may change because of revision and reorganization of agencies and companies, the philosophy of quality system auditing is basic and generally unchanging.

TYPES OF AUDITS

This section first defines a quality system audit and then differentiates it from a quality system survey. Other types of audits are also discussed, but the emphasis is on quality system audits.

1.3 Quality System AuditA quality system audit is a documented activity performed in accordance with written procedures or checklists to verify by examination and evaluation of objective evidence that applicable elements of the QA program have been developed, documented, and effectively implemented in accordance with specified requirements. The results of qual-ity system audits are intended to be used by management to determine the degree to which company organizations meet commitments established by management and how effective the program is in assuring quality.

Generally, nuclear quality system audits are based upon criteria established in either Title 10 of the Code of Federal Regulations, Part 50 (10 CFR 50), Appendix B, with further details specified in American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance-1 (NQA-1); ASME Boiler and Pressure Vessel Code (BPVC) Section III; or ASME BPVC Sections I, IV, and VIII require QA programs that may be the subject of quality system audits. Code revisions applicable will be those specified in the contract.

Utilities with nuclear facilities often combine the quality system audit program with the technical specification audit program. The approach and objectives of the technical specification audit program are basically the same as those for quality system audits.

1.4 Quality System Survey vs. Quality System AuditFor the purposes of this Handbook, a quality system survey is defined as an activity similar to a quality system audit but one with a different purpose. A quality system survey takes place with relation to a prospective procurement of a service or an item. Generally, they are conducted prior to contract award and are used to evaluate the overall capabil-ity of a prospective supplier/contractor, including the adequacy and implementation of their QA program. Those performing such a survey will point out deficiencies found in the QA program or its implementation. They should also discuss their company’s poli-cies relative to requiring correction of deficiencies prior to placing a purchase order or contract.

inTroduCTion 3

A quality system audit is a detailed evaluation of an existing QA program for its conformance to company policies, contract commitments, regulatory requirements, and performance to additional requirements specified. It includes the preparation of formal plans and checklists based on established requirements, evaluation of the implementa-tion of detailed activities within the QA program, and formal request(s) for corrective action where necessary. The quality system audit may be performed either externally or internally. External audits are conducted by an organization on a QA program not retained under its direct control and not within its organizational structure. Such audits are used to determine whether the audited organization is meeting its obligations for QA, and whether the management controls on the product(s) or service(s) provided meet the requirements of the contract. Internal audits are audits of portions of an orga-nization’s QA program retained under its direct control and within its organizational structure. The following summarizes quality system survey vs. quality system audit considerations.

Quality System Audit vs. Quality System Survey

Considerations Survey Audit

When does it occur? Prior to contract award. During a contract or after a commitment.

Is it planned? Yes. Yes.

Is it scheduled? Yes, up to several months in advance.

Yes, up to one year in advance.

Are checklists used? Yes. Yes.

Are qualified people required to perform it?

Yes. Yes.

What requirements are used?

Regulatory or auditor’s standard.

Contract/commitments.

On what organizations is it performed?

External. External/internal.

Are formal reports required?

Yes. Yes.

Are follow-up actions required?

Yes, when contract is awarded.

Yes.

1.5 Other Types of AuditsIn addition to quality system audits described in this Handbook, the other types of qual-ity audits most frequently referred to are product audits and process audits.

A product audit is the examination, inspection, or test of a product that has been previously accepted for the characteristics being audited. Such an audit is a reinspec-tion and retest of the product that has already been accepted or a review of documented evidence of acceptance. It includes performing operational tests to the same require-ments used by manufacturing, using the same production test procedure, methods, and equipment. The audit will measure the level of product conformance to specified stan-dards of workmanship, performance, and quality. It is an indicator of quality going to the customer. The audit frequently includes an evaluation of packaging; examination

4 nuClear audiTing Handbook

for cosmetics; and checking for proper documentation and accessories such as proper tags, stamps, shipment preparation, and protection. The audit may involve a check of accuracy of the tests, test equipment, and test procedure.

A process audit is a verification by evaluation of a manufacturing or test operation against documented instructions and standards to measure conformance to these stan-dards and the effectiveness of the instructions. Such an audit is a check of conformance of process, personnel, and equipment to defined requirements such as time, tempera-ture, pressure, composition, amperage, component mixture, etc. It may involve special processes such as heat treating, soldering, plating, encapsulation, welding, and nonde-structive examination. The audit is a check for adequacy and effectiveness of the process controls over the equipment and operators as established by procedures, work instruc-tions, and process specifications.

AUDITOR ETHICS

To ensure that the audit is conducted in a professional manner, the lead auditor should be guided by the American Society for Quality (ASQ) Code of Ethics (see Figure 6.15) and the ethical conduct described in this Handbook when interfacing with the auditee and audit team.

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About the Authors

Nuclear Quality Assurance Auditor Training Handbook Third Edition 2021

Karen M. DouglasKaren M. Douglas is a Longenecker & Associates nuclear engineer with more than 25 years of experience contributing to Department of Energy (DOE) and National Nuclear Secu-rity Administration (NNSA) programs, including the NNSA Office of Secure Transportation, where she served as a nuclear quality assurance (QA) specialist and nuclear safety specialist. Karen managed strategic partnerships programs for more than five years, serving interagency and corporate sponsors including the Nuclear Navy, Air Force, Nuclear Regulatory Commission (NRC), and Kodak. For several years Karen offered Los Alamos National Laboratory

(LANL) QA and materials engineering support to the NNSA Pit Project Office. She chaired the DOE/EM Site Technology Group for four years, matching environmental cleanup projects with technologies from DOE and NNSA national laboratories. Karen first contributed to DOE programs by serving as an NQA-1 lead nuclear QA auditor for the WIPP and UMTRA sites and authored the initial DOE nonweapons QA program approved in 1993. She initiated her professional career as a metallurgist and materials program manager for the General Electric Nuclear Energy Division and subsequently served as a QA manager for Raychem Corporation, attaining the ASME NQA-1 Lead Nuclear Quality Assurance Auditor qualification and ASQ Certified Quality Auditor and Certified Quality Engineer credentials. She is a senior member of ASQ and cur-rently serves as chair of both the ASQ Energy & Environmental Division, and the ASQ Nuclear Committee. Karen earned a Bachelor of Science in Biomedical and Nuclear Engineering from the University of New Mexico and a Master of Science in Materials Science and Engineering from Stanford University.

Thomas (Tom) F. EhrhornTom Ehrhorn began his quality career by designing and implementing a software QA program for US Air Force B-52 and KC-135 simulators. After retiring from the Air Force and a short stint as a contractor, Tom returned to the quality profession as an on-site engineer for various simulators, where his responsibilities included overseeing the simulator contractors’ quality programs. Tom then became a QA specialist providing

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quality services to one of the national labs. He did various software development and software quality jobs until he transitioned to a corporate QA department as a quality engineer. In this role, Tom was responsible for establishing an NQA-1 compliant soft-ware quality program and developing numerous procedures for that program. He also developed a software configuration management database, allowing the various divi-sions of the company to track their software and associated configuration items. As part of the QA department, Tom was also responsible for both internal and supplier audits. He has presented software QA papers at various conferences, beginning with a paper titled “Software Quality Assurance for Aircrew Training Devices,” which he presented at the 1984 Interservice/Industry Training Equipment Conference in Washington, DC. Tom has since presented at various other industry conferences and at ASQ’s World Conference on Quality and Improvement (WCQI). He holds ASQ Certified Quality Auditor and Certified Software Quality Engineer credentials. At the time of his retire-ment from AREVA, he was also a certified NQA-1 lead auditor. He has participated in ASQE’s body of knowledge and test development workshops for both the software quality engineer and quality auditor certifications. Tom is a member of the Energy and Environment, Audit, and Software Divisions of ASQ. He served as a member of the Software Division leadership team as well as that of his section. He is a senior member of ASQ and has been a member for 25 years. He is currently treasurer of the Albuquer-que section.

James HillJames Hill is an information technology program manager with Xcel Energy. His nuclear career started as a hands-on machinist mate and radiation-chemistry specialist in the US Nuclear Navy Submarine Service. After his military service he worked in various individual and management func-tions in the commercial nuclear industry, including plant and corporate management roles in engineering, quality, performance improvement, and project management. His current focus is to support Xcel’s nuclear fleet operation improvement through the use of innovative IT applications and infrastructure. He has an electrical engineering degree from the University of Illinois, an MBA from Cardinal

Stritch University, is a licensed professional engineer in Minnesota and Wisconsin, and has held a senior reactor operator license, issued by the NRC. He is a senior member of the ASQ. James’s ASQ certifications include Manager of Quality/Organizational Excel-lence and Quality Auditor. He is a certified project management professional, and is ITIL Foundation certified. He has served with the Midwest-based Performance Excel-lence Network as an evaluation team leader, judge, and chief judge in assessing applica-tions from organizations that apply the Baldrige Performance Excellence program to improve their performance. He is also a certified master evaluator with the American Health Care Association National Quality Award Program, which uses the same Bald-rige performance criteria. He has consulted and contracted with International Atomic Energy Association working groups for nuclear knowledge management guides and is currently participating in the Electric Power Research Institute’s Plant Modernization effort, focused on identifying and using technology to lower operating costs for com-mercial nuclear plant operation.

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Norman (Norm) P. MoreauNorm Moreau is the CEO and chief instructor of Theseus Profes-sional Services, where he has provided consulting services and implementation support, performed assessments, and trained on all nuclear QA-related subjects. He has worked directly for NRC and international licensees, DOE facilities and laboratories; and at all level within the nuclear industry supply chain. He began his QA journey in 1986 working as a quality engineer at the Fort St. Vrain Nuclear Generating Station in Colorado. He became an NQA-1 lead auditor in 1989. He expanded his audit-ing experience by becoming a lead auditor for a registrar for ISO

9001 ISO 14001, ISO 13485, and OHSAS 18001. In addition to being a practicing lead auditor, Norm has been training lead auditors since the mid-1990s. His NQA-1 Lead Auditor course has made it possible for many students to become successful lead audi-tors. He has taught students at all levels of the nuclear supply chain in the United States and abroad. Learners include regulators and utilities as well. In 2008 he started sharing his knowledge and experience with candidate lead auditors directly for the ASME Learning and Development organization. Norm has been an active participant of the ASME NQA-1 Standards Committee since 1992 to remain current with nuclear industry practices and to influence the content of this standard. He is also a member of the NQA Main Committee and a former co-vice chair and chair of the Executive Committee. In 2008 he was elected to lead the newly formed Subcommittee on Software Quality Assur-ance (SQA). He also has served as a vice-chair of engineering and procurement practices and as a member of the subcommittees on SQA, international activities, engineering and procurement process, and work practices. In 2021 he was awarded the NQA Out-standing Service Award. Norm holds a Bachelor of Science in Mechanical Engineering and a Master of Science Administration in Software Engineering Administration. He is a licensed professional engineer, ASME fellow and life member, ASQ senior member, and holds ASQ Certified Quality Auditor and Certified Software Quality Engineer credentials.

Charles (Chuck) H. Moseley Jr.Chuck H. Moseley Jr. has over 45 years of progressively respon-sible technical and management experience in the nuclear indus-try and has worked extensively with DOE and in the commercial nuclear power sector. He is highly skilled in the development and review of safety programs, most notably in the areas of pro-grammatic QA and operational QA and quality control. He has provided DOE headquarters assistance in developing QA orders and guidance documents, as well as NNSA programmatic initia-tives for implementation across the complex. He is a nationally recognized expert in nuclear standards and has received the

ANS Standards Award for lifetime achievement. He retired from Oak Ridge (Y12) as the quality programs manager and has provided assessments, surveys, training, and con-sulting services to DOE and the commercial industry. He assists utilities and suppliers evaluate and develop ASME NQA-1-compliant programs and performs due diligence of companies for DOE. He has a BS in Engineering from the United States Military Academy, an MS in Nuclear/Civil Engineering from Princeton University, an Executive

MBA from the University of North Carolina, Chapel Hill, and a Master’s Certificate from the Southeastern Baptist Theological Seminary.

Stephen (Steve) PrevetteSteve Prevette is an advocate of Dr. Deming’s management methods and applies statistical process control to performance metrics. He is an ASQ fellow and an ASQ certified quality engi-neer. Steve is an employee of Fluor Corporation’s “Government Group” and supports nuclear sites in Ontario, Ohio, South Caro-lina, and Idaho with statistical performance analyses. This includes development and oversight of statistical process con-trol-based contractor assurance and other performance metrics at Canadian Nuclear Laboratories and Savannah River National Laboratory. He has been active with ASQ since 1996. Steve is a

past chair of Section 614 (Richland, WA) and has maintained ties with the section since moving to South Carolina in 2009, acting as its current webmaster. Steve started his career as a US Navy Nuclear Submarine Service officer. At the end of the Cold War, he left the Navy and was hired by Westinghouse Hanford as a tank farms maintenance supervisor. Steve was transferred to the desk job of running performance indicators in June 1993 and has fulfilled that function for various DOE contractors ever since. He taught evening courses at the former City University campus in Richland and devel-oped courses as an adjunct instructor for Aiken Technical College’s Nuclear Quality Assurance program. He currently teaches data analysis and software project courses for the Information Technology Department at Southern Illinois University at Carbondale.

Dr. Abhijit SenguptaDr. Abhijit Sengupta’s areas of specialization include light water-pressurized and boil-ing-water reactors engineering inspections following both ASME Sections II (Materials), III (Construction), V (NDE), IX (Welding), and XI (In-Service Inspection), and 10 CFR 50, 52, and 50.55a. He has extensively used 10 CFR 50 Appendices A and B. Abhijit’s expe-rience extends across primary water stress corrosion cracking mitigation, flaw crack growth analysis in dissimilar metal welds in reactor pressure vessels, license renewals, heat exchangers, steam generators, and emergency nuclear plant response, among other areas. He has authored several engineering publications and was awarded ASQ’s high-est honor with two others in 2018, becoming an ASQ fellow. He is a certified Six Sigma Black Belt and holds ASQ Certified Quality Auditor, Reliability Engineer, and Quality Engineer credentials. Abhijit is also associated with ASME quality standard NQA-1, ASM, and ASQ committees. He currently serves as newsletter editor for ASQ’s Energy & Environmental Division.

Disclaimer: This write-up is provided for information and educational purposes only, and the views expressed are those of Dr. Abhijit Sengupta and not necessarily those of the US Government.

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