ASME STP-NU-062-1-2015 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS.pdf

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1、Comprehensive Comparison of InternationalQualityStandardsSTP-NU-062-1STP-NU-062-1 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS Prepared by: William K. Sowder, PH.D. Quality Management Services Co., LLC Date of Issuance: June 30, 2015 This report was prepared as an account of work spon

2、sored by ASME Nuclear Codes and Standards and the ASME Standards Technology, LLC (ASME ST-LLC). Neither ASME, ASME ST-LLC, the author, nor others involved in the preparation or review of this report, nor any of their respective employees, members or persons acting on their behalf, makes any warranty

3、, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness or usefulness of any information, apparatus, product or process disclosed, or represents that its use would not infringe upon privately owned rights. Reference herein to any specific commercial prod

4、uct, process or service by trade name, trademark, manufacturer or otherwise does not necessarily constitute or imply its endorsement, recommendation or favoring by ASME ST-LLC or others involved in the preparation or review of this report, or any agency thereof. The views and opinions of the authors

5、, contributors and reviewers of the report expressed herein do not necessarily reflect those of ASME ST-LLC or others involved in the preparation or review of this report, or any agency thereof. ASME ST-LLC does not take any position with respect to the validity of any patent rights asserted in conn

6、ection with any items mentioned in this document, and does not undertake to insure anyone utilizing a publication against liability for infringement of any applicable Letters Patent, nor assumes any such liability. Users of a publication are expressly advised that determination of the validity of an

7、y such patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted as government or industry endorsement of this publication. ASME is the registered

8、trademark of the American Society of Mechanical Engineers. No part of this document may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. ASME Standards Technology, LLC Two Park Avenue, New York, NY 10016-5990 ISBN No. 9

9、78-0-7918-6914-7 Copyright 2015 by ASME Standards Technology, LLC All Rights Reserved Summary of Changes June 2015 STP-NU-062-1 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS The following changes have been made to the first revision of STP-NU-062. Page Location Change All - Document nu

10、mber on all pages changed from “STP-NU-062” to STP-NU-062-1 All - General change to all pages, NQA-1 title from NQA-2008 to NQA-2012 All - General change to all 18 NQA sections lead pages, from “100 Basic “ to “100 General” ii 2nd Page Date changed to June 2015 vi Foreword ASME NQA-1 “Quality Assura

11、nce Requirements for Nuclear Facility Application-Edition 2008”, changed to ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2012”, 2 Section 2 ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2008” changed to ASME NQA-1 “Quality

12、Assurance Requirements for Nuclear Facility Application-Edition 2012” 17 Appendix A, Requirement 1 Requirement 1, 201 General, add (c) quality achievement is verified by those not directly responsible for performing the work 19-35 Appendix A, Requirement 2 Requirement 2, 100 General, deletion of “Th

13、e program shall identify the activities and items to which it applies.” 45 Appendix A, Requirement 3 Requirement 3, revise first paragraph “The design shall be defined, controlled, and verified.” 52-53 Appendix A, Requirement 3 Requirement 3, 500 Design Verification, revise and add to (a) paragraph

14、“This verification may be performed by the originators supervisor, provided (1) the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design; or (2) the supervisor is the only individual in the organiza

15、tion competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of this Standard.” 109 Appendix A, Requirement 12 Requirement 12, 303 Control, delete paragraph “Methods and frequency of checking accuracy shall be defined in procedures.” 123 Appendix A, Requirement 1

16、7 Requirement 17, Sub-Section 100 General delete 4th paragraph “The term records, used throughout this section, is to be interpreted as quality assurance records.” 6 References Updated NQA titles as shown here: ASME NQA-1 Part IV, SUBPART 4.1.1 Guidance to Modification of an ISO 9001:2008, Quality M

17、anagement Systems Standard for Compliance With NQA-12008, Part I With the NQA-1a2009 Addenda ASME NQA-1 Part IV, SUBPART 4.1.4 Guidance to Modification of an IAEA GS-R-3 Quality Program to Meet NQA-1a2009 Requirements and Modification of an NQA-1a2009 Quality Program to Meet IAEA GS-R-3 Requirements

18、 STP-NU-062-1: Comprehensive Comparison of International Quality Standards v TABLE OF CONTENTS Foreword vi Abbreviations and Acronyms vii 1 PURPOSE AND SCOPE . 1 2 SELECTION OF STANDARDS . 2 3 DIFFERENCES BETWEEN STANDARDS DEVELOPMENT 3 4 IMPORTANT DIFFERENCE IN FOCUS OF REVIEWED DOCUMENTS . 4 5 SUM

19、MARY OF EVALUATION RESULTS 5 References . 6 Appendix AInternational Quality Standards Comparison 7 REQUIREMENT 1 Organization . 8 REQUIREMENT 2 Quality Assurance Program . 20 REQUIREMENT 3 Design Control . 46 REQUIREMENT 4 Procurement Document Control 69 REQUIREMENT 5 Instructions, Procedures, and D

20、rawings . 74 REQUIREMENT 6 Document Control 75 REQUIREMENT 7 Control of Purchased Items and Services 78 REQUIREMENT 8 Identification and Control of Items 89 REQUIREMENT 9 Control of Special Processes 91 REQUIREMENT 10 Inspection . 99 REQUIREMENT 11 Test Control . 102 REQUIREMENT 12 Control of Measur

21、ing and Test Equipment 109 REQUIREMENT 13 Handling, Storage, and Shipping . 115 REQUIREMENT 14 Inspection, Test, and Operating Status 118 REQUIREMENT 15 Control of Nonconforming Items . 119 REQUIREMENT 16 Corrective Action . 123 REQUIREMENT 17 Quality Assurance Records 125 REQUIREMENT 18 Audits . 13

22、4 STP-NU-062-1: Comprehensive Comparison of International Quality Standards vi FOREWORD This technical report was developed to comprehensively evaluate the following international quality standards: ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2012” 1, NQSA NSQ

23、-100 “Nuclear Safety and Quality Management System Requirements” 2, IAEA GS-R-3: 2006 “The Management System for Facilities and Activities” 3, and ISO 9001:2008 “Quality Management Systems Requirements” 4. The report discusses the competitive strengths and weaknesses of these documents. Established

24、in 1880, the American Society of Mechanical Engineers (ASME) is a professional not-for-profit organization with more than 135,000 members and volunteers promoting the art, science and practice of mechanical and multidisciplinary engineering and allied sciences. ASME develops codes and standards that

25、 enhance public safety, and provides lifelong learning and technical exchange opportunities benefiting the engineering and technology community. Visit www.asme.org for more information. The ASME Standards Technology, LLC (ASME ST-LLC) is a not-for-profit Limited Liability Company, with ASME as the s

26、ole member, formed in 2004 to carry out work related to newly commercialized technology. The ASME ST-LLC mission includes meeting the needs of industry and government by providing new standards-related products and services, which advance the application of emerging and newly commercialized science

27、and technology and providing the research and technology development needed to establish and maintain the technical relevance of codes and standards. Visit www.stllc.asme.org for more information. The author wishes to acknowledge, with deep appreciation, the activities of ASME staff and volunteers w

28、ho have provided valuable technical input, advice and assistance with review of, commenting on, and editing of, this document. STP-NU-062-1: Comprehensive Comparison of International Quality Standards vii ABBREVIATIONS AND ACRONYMS ASME American Society of Mechanical Engineers ASME ST-LLC ASME Stand

29、ards Technology, LLC Bureau Veritas Multinational Company providing conformity assessment, certification and services to industry, government and individuals DOE US Department of Energy IAEA International Atomic Energy Agency ISO International Organization for Standardization NQSA Nuclear Quality St

30、andard Association NRC US Nuclear Regulatory Commission QA Quality Assurance QSC Quality Systems Certificate TAG Technical Advisory Group TC Technical Committee STP-NU-062-1: Comprehensive Comparison of International Quality Standards 1 1 PURPOSE AND SCOPE This report was developed to evaluate and a

31、ssess the various international quality and management documents that are in use today for new nuclear construction. A number of concerns were voiced in the USA, Europe and Asia, about how these documents are being used by construction and engineering companies, regulators, standard developing organ

32、izations, vendors and suppliers. There is also a question of the compatibility with existing standards that were the basis of a large majority of new nuclear construction and existing nuclear plant replacements, globally. The comparison provided herein, offers a comprehensive look at these issues. S

33、TP-NU-062-1: Comprehensive Comparison of International Quality Standards 2 2 SELECTION OF STANDARDS This technical report compares the requirements contained in ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application Edition 2012” Part 1, NSQ-100 “Nuclear Safety and Quality Manag

34、ement System Requirements”, IAEA GS-R-3: 2006 “The Management System for Facilities and Activities”, and ISO 9001:2008 “Quality Management Systems-Requirements”. These standards were selected on the basis of their relevance to the nuclear industry. The ASME NQA-1 document reflects industry experienc

35、e and current understanding of the quality assurance requirements necessary to achieve safe, reliable, and efficient utilization of nuclear energy, and management and processing of radioactive materials. The Standard focuses on the achievement of results, emphasizes the role of the individual and li

36、ne management in the achievement of quality, and fosters the application of these requirements in a manner consistent with the relative importance of the item or activity. The International Atomic Energy Agency (IAEA)-IAEA Safety Standards Series No. GS-R-3, “The Management System for Facilities and

37、 Activities (IAEA GS-R-3)”, defines the requirements for establishing, implementing, assessing and continually improving a management system. A management system designed to fulfill these requirements integrates safety, health, environmental, security, quality and economic elements. IAEA GS-R-3, tog

38、ether with its supporting Safety Guides, supersedes Safety Series No. 50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations. This document was issued in 2006 by the IAEA in their IAEA Safety Standards Series. This series covers nuclear safety, radiation safe

39、ty, transport safety and waste safety. The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The ISO 9001:2008 was prepared by Technical Committee ISO/TC 176 of this organization. The ISO is designed to promote the adoption of a process appr

40、oach when developing, implementing and improving the effectiveness of a quality management system, and to enhance customer satisfaction by meeting customer requirements. This Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to

41、consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicabl

42、e regulatory requirements. The NSQ 100 document was issued as a draft document in June 2011 and a Revision 0 in December 2011 by the Nuclear Quality Standard Association (NQSA) organization. The NQSA organization is a joint venture of AREVA, SAS and Bureau Veritas and the purpose of its development

43、is as stated on the NQSA organizations web site, “A new environment generates new needs and calls for a new standard. In 2011, the NQSA (Nuclear Quality Standard Association) open to all major nuclear utilities, nuclear engineers and manufacturers responded to the nuclear supply chain challenges in

44、terms of quality and safety by creating and promoting a new standard: NSQ-100”. The newest member of the NQSA organization is Socit Gnrale de Surveillance (SGS), which is a leading inspection, verification, testing, and certification company based in Geneva, Switzerland with global offices as well.

45、STP-NU-062-1: Comprehensive Comparison of International Quality Standards 3 3 DIFFERENCES BETWEEN STANDARDS DEVELOPMENT The primary difference between the development of the NSQ 100, IAEA GS-R-3 and ISO 9001 Standards and Documents and the corresponding ASME NQA-1 Standard is that they are developed

46、 from different viewpoints. The ASME is not subsidized by, reporting to or a part of any U.S. Government Agency. The ASME organization standards development function is a total volunteer-based effort. ASME NQA-1 is primarily focused on assuring quality of the design, construction and operation of a

47、facility in a regulated environment to assure nuclear safety. While it includes requirements for assuring quality of the items and services provided to support the overall objective, it is not primarily directed at management and continuous improvement processes needed to achieve customer satisfacti

48、on. The NSQ 100 document was developed within the membership of the NQSA organization and is comprised of three companies previously mentioned. This document was issued in December 2011 with very little history of use. The IAEA Standard represents a consensus view of the IAEAs Member States. The IAE

49、A GS-R-3 Management System Standard uses an integrated management system approach and the integration of safety, health, environmental, security, quality and economic elements of the management system to ensure that safety is properly taken into account in all activities. The ISO 9001 was prepared by Technical Committee ISO/TC 176 of ISO and voted on for approval by the members of the TC176 Technical Committee with each member country allowed one vote. The ISO 9001:2008 Standard is a Quality Management System Standard, and used by companies to manage the