1、Comprehensive Evaluation of the NSQ-100 Nuclear Safety and Quality Management System RequirementsSTP-NU-061-1STP-NU-061-1 COMPREHENSIVE EVALUATION OF THE NSQ-100 NUCLEAR SAFETY AND QUALITY MANAGEMENT SYSTEM REQUIREMENTS Prepared by: William K. Sowder, PH.D. Quality Management Services Co., LLC Date
2、of Issuance: June 30, 2015 This report was prepared as an account of work sponsored by ASME Nuclear Codes and Standards and 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 respectiv
3、e employees, members or persons acting on their behalf, makes any warranty, 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 upo
4、n privately owned rights. Reference herein to any specific commercial product, 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
5、 this report, or any agency thereof. The views and opinions of the authors, 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 p
6、osition with respect to the validity of any patent rights asserted in connection 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
7、publication are expressly advised that determination of the validity of any 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 gover
8、nment or industry endorsement of this publication. ASME is the registered 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 Sta
9、ndards Technology, LLC Two Park Avenue, New York, NY 10016-5990 ISBN No. 978-0-7918-6907-9 Copyright 2015 by ASME Standards Technology, LLC All Rights Reserved Summary of Changes June 2015 STP-NU-061-1 COMPREHENSIVE EVALUATION OF THE NSQ-100 NUCLEAR SAFETY AND QUALITY MANAGEMENT SYSTEM REQUIREMENTS
10、OF ASME NQA-1 The following changes have been made to the first revision of STP-NU-061. Annex A ASME NQA-12012 General change to all 18 NQA sections lead pages, from “100 Basic” to “100 General” Page 13 Requirement 1, 201 General (c) quality achievement is verified by those not directly responsible
11、for performing the work Page 15-20 Requirement 2, 100 General deletion of “The program shall identify the activities and items to which it applies.” Page 24 Requirement 3 revise first paragraph “The design shall be defined, controlled, and verified.” Page 30 Requirement 3 500 Design Verification, re
12、vise and add to (a) paragraph “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 o
13、nly individual in the organization competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of this Standard.” Page 62 Requirement 12 303 Control delete paragraph “Methods and frequency of checking accuracy shall be defined in procedures.” Annex B ASME NQA-1 2012
14、General change to all 18 NQA sections lead pages, from “100 Basic” to “100 General” Page 82 Requirement 1, 201 General (c) quality achievement is verified by those not directly responsible for performing the work Page 84 Requirement 2, 100 General deletion of “The program shall identify the activiti
15、es and items to which it applies.” Page 92 Requirement 3 100 General revise first paragraph “The design shall be defined, controlled, and verified.” Page 98 Requirement 3 500 Design Verification, revise and add to (a) paragraph “This verification may be performed by the originators supervisor, provi
16、ded (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 organization competent to perform the verification. Cursory supervisory reviews
17、do not satisfy the intent of this Standard.” Annex C ASME Section III Page 149-150 NCA-4134.2 Subparagraph (c) revised Page 189-190 NCA-4134.6 revised Page 232 NCA-4134.17 New subpara. (e) added; former subpara. (e) redesignated as (f) ASME NQA-1 2012 General change to all 18 NQA sections lead pages
18、, from “100 Basic” to “100 General” Page 147 Requirement 1, 201 General (c) quality achievement is verified by those not directly responsible for performing the work Page 149-152 Requirement 2, 100 General deletion of “The program shall identify the activities and items to which it applies.” Page 16
19、2 Requirement 3 100 General revise first paragraph “The design shall be defined, controlled, and verified.” Page 169 Requirement 3 500 Design Verification, revise and add to (a) paragraph “This verification may be performed by the originators supervisor, provided (1) the supervisor did not specify a
20、 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 organization competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of this Standa
21、rd.” Page 219 Requirement 12 303 Control delete paragraph “Methods and frequency of checking accuracy shall be defined in procedures.” Page 229 Requirement 17, SubSection 100 General delete 4th paragraph “The term records, used throughout this section, is to be interpreted as quality assurance recor
22、ds” Annex D ASME Section III NCA 2013, Subsections 3850 Page 245 NCA-3853.1 Subparagraph (d) Page 250 NCA-3853.3 First sentence revised Page 251-252 NCA-3855.5 (1) Subparagraphs (a), (a)(1), and (a)(3) revised; New subpara. (a)(4) added and subsequent subparagraph redesignated Page 256-257 NCA-3856.
23、3 Subparagraphs (c) and (e) revised STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document vi TABLE OF CONTENTS Foreword vii Abstract . viii Abbreviations and Acronyms ix 1 PURPOSE AND SCOPE . 1 2 NQSA ORGANIZATIONAL SUPPORT STRUCTURE 2 3 DIFFERENCES OF STANDARD DEVELOPMENT ORGANIZATIONS . 3 4
24、 IMPORTANT DIFFERENCE IN FOCUS OF REVIEWED DOCUMENTS . 4 5 EVALUATION RESULTS 5 6 SUMMARY OF EVALUATION AND ASSESSMENT RESULTS 7 References . 8 Annex ANQA-1-2012 and NSQ-100 Comparison . 9 Annex BNQA-1-2012 and NSQ-100 Certification Comparison 75 Annex CCertification Requirements Between Section III
25、 NCA 4100 and NSQ-100 . 143 Annex DCert ification Comparison Section III NCA 3850 and NSQ 100 242 STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document vii FOREWORD This technical report was developed to comprehensively evaluate the NSQ-100 document and its related guidance documents against
26、the corresponding ASME products. Comparisons were made of the various corresponding documents of ASME and the Nuclear Quality Standard Association (NQSA). The report discusses the competitive strengths and weaknesses of the NSQ-100 products compared to the corresponding ASME products. Established in
27、 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 e
28、nhance 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 sol
29、e 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 an
30、d 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. STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document viii ABSTRACT This technical report revision
31、 summarizes the assessment that was performed addressing the competitive strengths and weaknesses of NQSA products compared to the corresponding ASME products. The products compared during this assessment were the NSQ-100 document “Nuclear Safety and Quality Management System Requirements”, Revision
32、 0 with an issue date of December 2011 1 and the corresponding ASME Standards; NQA-1 “Quality Assurance Requirements for Nuclear Facility Application Edition 2012” 2 and “ASME Section III Rules for Construction of Nuclear Facility Components-Subsection NCA General Requirements for Division 1 and Div
33、ision 2 Edition 2013” 3. STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document ix ABBREVIATIONS AND ACRONYMS AREVA French public multinational industrial conglomerate ASME American Society of Mechanical Engineers ASME ST-LLC ASME Standards Technology, LLC AFCEN French Association for the rule
34、s governing the Design, Construction and Operating Supervision of the Equipment Items for Electro Nuclear Boilers Bureau Veritas Multinational Company providing conformity assessment, certification and consulting services to industry, government and individuals DOE US Department of Energy IAEA Inter
35、national Atomic Energy Agency ISO International Organization for Standardization NQSA Nuclear Quality Standard Association NRC US Nuclear Regulatory Commission QSC Quality Systems Certificate SGS Socit Gnrale de Surveillance, a multinational Company headquartered in Geneva, Switzerland which provide
36、s inspection, verification, testing and certification services STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document 1 1 PURPOSE AND SCOPE A number of concerns were voiced in the USA, Europe and Asia concerning how the NSQ-100 document was to be used by construction and engineering companies,
37、 regulators, standard developing organizations, vendors and suppliers. These concerns ranged from the validity of the document as a standard, how this new standard was to be used, its certification and accreditation activity, and the replacement of existing standards that have formed the basis of a
38、large majority of new nuclear construction and existing nuclear plant replacements globally. This technical report provides the reader with results of an evaluation and assessment of the NSQ-100 “Nuclear Safety and Quality Management System Requirements”. STP-NU-061-1: Evaluation of NSQ-100 Nuclear
39、Quality Document 2 2 NQSA ORGANIZATIONAL SUPPORT STRUCTURE The NSQ-100 document was developed and issued by NQSA, a nonprofit organization jointly launched by AREVA Corporation and Bureau Veritas SA in January 2011 with the stated goal of promoting the application of the NSQ-100 standard and setting
40、 a nuclear oriented supplier evaluation process. The NSQ-100 document was issued as a draft document in June 2011 and a Revision 0 was released in December 2011. AREVA Corporation is a stockholder company, funded in large part by the Commissariat lnergie Nuclaire (CEA) and the French government budg
41、et process, and has global subsidiaries with major centers in France, Germany and North America. Bureau Veritas is an international testing, inspection and certification organization based in Paris, France. The newest member of the NQSA organization is Socit Gnrale de Surveillance (SGS), which is a
42、leading inspection, verification, testing, and certification company based in Geneva, Switzerland with global offices as well. The NQSA organizations website, http:/www.nqsa.org/nsq100-standard/nsq100.html explains its purpose in developing the NSQ-100 document as such: “A new environment generates
43、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 terms of quality and safety by creating and promoting a new standard: NSQ-10
44、0”. It goes on to say that the “NSQ-100 is a new standard based upon ISO 9001:2008 and two other major nuclear quality standards IAEA GS-R-3:2006 and ASME NQA-1-2008 (and addenda 2009). NSQ-100 standard is also complemented with a correspondence matrix to GS-R-3 standard called NSQ-110 and eight (8)
45、 application guides. NSQ-100 aims to provide high quality and reduce costs and supply chain delivery time”. STP-NU-061-1: Evaluation of NSQ-100 Nuclear Quality Document 3 3 DIFFERENCES OF STANDARD DEVELOPMENT ORGANIZATIONS The primary difference between the development of the NSQ-100 document from N
46、QSA and its corresponding ASME document NQA-1 is that the two organizations developed their documents from two different viewpoints. The ASME is not funded by, reporting to or a part of any U.S. Governmental Agency. The ASME organization standards development function is a total volunteer-based effo
47、rt. It is a global organization with functional chapters, student associations and industrial partners from over 100 nations, providing the expert knowledge and experience necessary to develop the ASME Codes and Standards over the past 125 years. The NSQ-100 document was developed within the members
48、hip of the NQSA organization. This document was not developed using a broad base of global expert knowledge and experience such as the consensus process used historically in ASMEs document development. The ASME Codes and Standards are developed using a broad base of industrial companies, manufacturi
49、ng and construction companies, regulators, engineering and inspection organizations and private consultants from the global user base. The ASME meetings are open to public involvement and active participation. There are over 500 standards developed by ASME that are being used in over 100 countries and ASME also administers over 40 US Technical Advisory Groups (TAGs) for the ISO development process. In addition to the developing groups, the ASME standards were initially intended to be used by private organizations, including manufacturers
