ML20149H117
| ML20149H117 | |
| Person / Time | |
|---|---|
| Site: | 05200004 |
| Issue date: | 05/31/1993 |
| From: | JAPAN |
| To: | |
| Shared Package | |
| ML20149H116 | List: |
| References | |
| JEAG-4101-1990, NUDOCS 9411170282 | |
| Download: ML20149H117 (95) | |
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1 l . 1 NOTICE OF REVISIONS I
Guide for Quality Assurance ofNuclear Power Plants (JEAG 4101)"was revised in May 1993 as follows:
Page 2 The following sentence has been added to (3) Quality Assurance Responsibility:
"In addition, the plant owner performs investigations, examinations, and evaluations by using personnel who operate independently from other organizations responsible for these tasks. (Explanation-4)"
Page 6 A new Explanation-4 has been added (with the previous Explanation-4 and Explanation-5 becoming -5 and -6, respectively). The new Explanation-4 reads:
"' .. investigations, examinations, and evaluations by using personnel who operate independently from other organizations responsible for these tasks' has the following meanings. ' Personnel' refers to those under the direct control of plant management and independent from individuals and organizations that are responsible for implementing quality assurance tasks. These personnel objectively investigate, examine, and evaluate the effectiveness and appropriateness of quality assurance activities at nuclear power plants, from the viewpoint of management.
After evaluating their results, these personnel propose suggestions and give opinions to management. They also make recommendations and give advice to the individuals and organizations mentioned above-endeavoring to follow up any corrective actions." l l Japan Electric Association 1 l 1 I I
+ .
[R E C OMME N D AT I ON] The technology of nuclear power generation progresses remarkably year after year. To further promote such technical and managerial advancement, the Ministry of International Trade and Industry (MITI), in quick response to technological progress and social change, has worked to improve the Technical Standards for Nuclear Power Generation Facilities and other relevant codes and guides. This serves to maintain the highest possible level of facility safety, and it implements private industrial advancements. Under these circumstances, the Electrotechnical Standard Survey Ccamittee of the Japan Electric Association (JEA) has systematically developed quality assurance guides. We would like to congratulate the JEA for revising and con-solidating the contents of all of these guides into a single quality assurance guide for nuclear power plants. This guide clarifies in detail the quality assurance requirements of nuclear power plants. I believe that it will be extremely helpful to those engaged in the practical application of these activities. 7 The Electrotechnical Standard Survey Committee consulted academics and de-liberated with experts in a wide variety of fields to compile this guide. I trust that it, together with the national Technical Standards and other relevant materi-al, will become essential reference material for maintaining excellence in nuclear power plant design, construction, maintenance, and operation. November 1990 Junichiro Mukai Deputy Director General Agency of Natural Resources and Energy Ministry of International Trade and Industry l i i 1
l
=. 4 l
[F O R EWO R D] In Japan, the history of quality assurance guides for nuclear power plants began in 1972. In that year, ' Guidelines for Quality Assurance in the Con-struction of Nuclear Power Plants,' cr JEAG4101-1972, was published in Japan and it referred to the 1970 U.S. law 10CFR50 Appendix B (Title 10, Code of Federal Regulation Part 50, App. B), or ' Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.' Later, the ' Guide for Quality Assurance of Nuclear Power Plants,' or JEAG 4101-1981, debuted and it referred to the 1978 IAEA Code of Practice 50-C-QA, or
' Quality Assurance for Safety in Nuclear Power Plants.' This work included a number of Japanese innovations, experiences, and examples.
To reflect ongoing circumstances and record actual application in Japan, the guide was revised and issued in 1985 as JEAGh101-1985. Seven complementary guides (JEAG4102, 4104-9) appeared in succession until 1988, when a system for quality assurance activity guides was completed. As I mentioned above, the Japan Electric Association (JEA) has made numer-ous efforts to develop and maintain guides. And our Subcommittee on Quality Assurance has been central to these activities. In 1989, the JEA received the twentieth Ishikawa Prize as an acknowledgement of its work toward management modernization. I believe that our efforts have made considerable contributions to the propagation of quality assurance activities. In the past, however, some users have observed that our guides have been inconvenient to use, as they appeared in separate volumes. They also noticed overlapping contents and other shortcomings. We considered these observations ' and because a sufficient length of time had elapsed since previous publications, we revised the entire guide. Specifically, we made revisions according to the following basic principles:
- 1. Current guides, consisting of separate volumes, should be consolidated into single bound volumes.
.When consolidating, we should avoid everlapping contents and composition.
. Quality assurance activity contents and procedures should be reviewed within the scope of current guides.
- 2. Any new guide should feature four classifications: Basic Matters, Supple-mertary and Recommended Matters, Reference Matters, and Explanations.
We should also clarify degrees of compliance with quality assurance activity requirements.
- 3. The new guide should refer to the latest standards and codes of the IAEA and other organizations.
I
1 l l We began revisions in January 1989, and in a little less than two years . l our work was complete and a number of experts in relevant fields confirmed our l changes. I sincerely hope that this new ' Guide for Quality Assurance for Nucle-ar Power Plants' (JEAG4101-1990) will serve a wide readership. I would like to express my deep gratitude to the government agencies, electric power utilities, plant manufacturers, subcommittee members, and others who extended their valuable support to these revisions. November, 1990 Kazuo Watanabe Chairman, Subcommittee on Quality Assurance Committee on Nuclear Power Electrotechnical Standard Survey Committee l l
s
. THE ELECTROTECHNICAL GUIDE Technical Standards based on the Electricity Utilities Industry Law legally prescribe the minimum regulations necessary to maintain electrical articles safety. j 1
The Electrotechnical Codes, prepared by the Electrotechnical Standard l l Survey Committee, are simple to understand. They concretely explain and pre-scribe Technical Standards, supplement and complete items which have not been explicitly defined, or in exceptional cases serve as reference material for tentative permits. They are private, independent codes for electric power utili-ties as well as for establishment and contractor applicants that are engaged in the design, construction, maintenance, and management of electrical articles. Depending upon their content, these fall under the categories of Mandatory, Advised, or Recommended Items. However there are many items for which it is difficult or inappropriate to prescribe regulations uniformly. Such items involve new technologies where future improvements are predicted or still face numerous research and development tasks - even though prescription is necessary from a safety standpoint. For example:
- 1. Items that concern new technologies with, as yet, too few actual example and experiences to prescribe regulations. These include cases overseas.
- 2. Items that are necessary to ensure safety, but lack the necessary academic research and methodology concerning their methods, countermeasures, and other aspects. In these cases, it would therefore still be difficult to prescribe broad, generally applicable regulations.
- 3. Items that include research and development that has not yet been clearly resolved or defined. It would thus be difficult to clearly classify their details into the Mandatory, Advised, and Recommended categories.
- 4. Cases where social conditions change rapidly and the prescription of regu-lations is thus not necessarily suitable.
The above examples represent items that should be regulated to guarantee safety. But the chances of immediately establishing precise regulations for these are limited. The Electrotechnical Guide assembles and addresses these areas. In principle, the Electrotechnical Guide should be complied in the same way as the Electrotechnical Codes, but when applying the guide we should pay attention to the following:
- 1. In their actual application, these guidelines should be interpreted in such a way to not interfere with technological pregress.
- 2. ~entents shall be understood completely, to discourage mistakes in design,
'l construction, and other areas.
- 3. Any items, methods, or other subjects not prescribed may be adopted if they are suitable in securing safety.
l The Electrotechnical Standard Survey Committee compiled the Electrotech-nical Guide after great deliberation, time, and effort. Numerous authorities in relevant fields and related government agencies participated in this effort. l We earnestly hope that a wide variety of people in relevant fields put this Guide to full use. As we will continue to improve upon this guide, we welcome any comments or requests. Please address these to the Japan Electric Association (JEA). I t i
LIST OF COMMITTEE MEMBERS WHO HAVE CONTRIBUTED TO THIS GUIDE (Honorifics omitted, and listed in fixed order) ELECTR0 TECHNICAL STANDARD SURVEY COMMITTEE (O INDICATES DIRECTOR COMMITTEE MEMBERS) Chairman O Yasuji Sekine Professor, University of Tokyo Director O Tadashi Takeda Federa*, ion of Electric Power Companies Director O Saburo Nakayama Japan Electric Association Member O Masao Sato Hokkaido Electric Power Co., Inc. Member Yoshinobu Katsumata Tohoku Electric I wer Co., Inc. Member O Shigeetsu Miyahara Tokyo Electric Power Co. Member O Kazuo Nagasawa Chubu Electric Power Co., Inc. Member Takakar fishimura Hokuriku Electric Power Co. Member O Yasuo Hashimoto Kansai Electric Power Co., Inc. Member Iwao Hasegawa Chugoku Electric Power Co., Inc. Member Hitoshi Minakuchi Shikoku Electric Power Co., Inc. Member O Susumu Tanaka Kyushu Electric Power Co., Inc. Member Kunikazu Aisaka Electric Power Development Co.,Ltd. Member Kazushige Hamazaki Japan Atomic Power Co. Member Bunzou Miyagi Okinawa Electric Power Co., Inc. Member O Tamao Hirose Japan Public Electric Utility Enterprisers Forum Gumma Prefecture Enterprise Manager Member Hiroshi Ohishi Power Reactor and Nuclear Fuel Development Ccrporation Member O Junichiro Daimon Japan Electrical Manufacturers' Association Member Hiroshi Igi Japanese Electric Wire & Cable Makers' Association Member O Ryuji Yukawa Japan Electrical Construction Association Inc.
]
Member Tsutomu Umehara Transmission Line Construction ) 1 Engineering Society (cf Japan) l Member O Nobuo Hattori Thermal and Nuclear Power Engineering Society of Japan Member Tsutemu Inoue Nuclear Power Engineering Test Center Member Sakae Yamamura Professor Emeritus, University of Tckyo
=
Member Yasuo Tamura Professor. Waseda University Member Mamoru Akiyama Professor, University of Tokyo Member Kazuya Ode Central Research Institute of Electric Power Industry Member Hiroshi Kashiwagi Electrotechnical Laboratory Sub-Director O Hidemi Ashizuka Federation of Electric Power Companies Sub-Director O Fujishige Yamauchi Japan Electric Association COMMITTEE ON NUCLEAR POWER (O INDICATES DIRECTOR) Chairman Mamoru Akiyama University of Tokyo Member O Yoshitsugu Mishima University of Tokyo - Member O Yoshio Ando University of Tokyo Member Kunihiro Iida University of Tokyo Member Heki Shibata University of Tokyo Member Teruyoshi Utoguchi University of Tokyo Member Susumu Suguri Nuclear Power Engineering Test Center Member Shunsuke Kondo University of Tokyo Member Tadao Takahashi Power Reactor and Nuclear Fuel Development Corporation Member Kouichi Hirata Hokkaido Electric Power Co., Inc. Member Toshiaki Yashima Tohoku Electric Power Co., Inc. Member O Katsuya Tomono Tokyo Electric Power Co. Member O Yoshikazu Ando Chubu Electric Power Co., Inc. Member Yasukichi Kyue Hokuriku Electric Power Co. Member O Masahide Mori Kansai Electric Power Co., Inc. Member Yaichi Fukuhara Chugoku Electric Power Co., Inc. Member Mamoru Sumida Shikoku Electric Power Co., Inc. Member Yasushi Kineshita Kyushu Electric Power Co., Inc. Member Shigeo Mita Electric Power Development Co., Ltd. Member O Kazuo Watanabe Japan Atemic Power Co. Member O Michio Suzuki Federation of Electric Power Companies Member O Jirou Kani Teshiba Corporation Member O Tadao Arakawa Hitachi. Ltd. Member O Ichircu Saruyama Mitsubishi Atomic Power Industries, Inc. Member Hideo Nakano Fuji Electric, Ltd. (Regular Yukou Kurashige Public Utilities Department Agency of participant) Natural Resources and Energy (Regular Hironcri Nakanishi Public Utilities Department Agency of
, participar.t) Natural Resources and Energy (Regular Masatomo Tanaka Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Hirobumi Kawai Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Kouichi Noda Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Kazuya Aoki Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Mikio Hattori Nuclear Safety Bureau, Science and participant) Technology Agency SUBCOMMITTEE ON QUALITY ASSURANCE (O INDICATES DIRECTOR) Chairman Kazuo Watanabe Japan Atomic Power Co. Member Toshiaki Kudou Hokkaido Electric Power Co., Inc. Member Katsuaki Inomata Tohoku Electric Power Co., Inc. Member Akinobu Nishiyama Tokyo Electric Power Co. Member Tadahiro Itou Chubu Electric Power Co., Inc. Member Yoshiyuki Matsubara Hokuriku Electric Power Co. Member Yasuo Kurozumi Kansai Electric Power Co., Inc. Member Tsaneo Onogi Chugoku Electric Power Co., Inc. Member Masamichi Watanabe Shikoku Electric Power Co., Inc. Member Mamoru Dangami Kyushu Electric Power Co., Inc. Member Nobuteru Masuda Electric Power Development Co., Ltd. Member O Masayuki Uchiyama Japan Atomic Power Co. Member Kiyoshi Futagawa Ishikawajima-Harima Heavy Industries Co. Member Yukio Yoneda Toshiba Corporation Member O Yoshinori Iijima Hitachi, Ltd. Member Nobuhiko Kobayashi Fuji Electric, Ltd. Member Shigeneri Suzuki Mitsui Engineering & Shipbuilding, Ltd. Member O Yoshiyuki Hayasaka Mitsubishi Heavy Industries, Ltd. Member Chikashi Saitou Power Reactor and Nuclear Fuel Development Corporation Member Shigeru Miyoshi Japan Power Engineering and Inspection Corporation Member Yoshinori Okaya Mitsubishi Electric Corporation Member Narumoto Shibaike Nippon Steel Corporation Member Hitchiko Nagoshi Obayashi Corpcration
l 1 (Regular Hironori Nakanishi Public Utilities Department, Agency of - j participant) Natural Resources and Energy (Regular Isao Asai Public Utilities Department, Agency of I participant) Natural Resources and Energy (Regular Toshichika Kuroki Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Masayuki Koyanagi Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Masatomo Tanaka Public Utilities Department, Agency of participant) Natural Resources and Energy (Regular Hirobumi Kawai Public Utilities Department, Agency of participant) Natural Resources and Energy NO.1 WORKING CROUP OF SUBCOMMITTEE ON QUALITY ASSURANCE Director Katsuhiko Suzuki Chubu Electric Power Co., Inc. Member Yukio Tsukada Tohoku Electric Power Co., Inc. Member Norio Koyanagi Hokuriku Electric Power Co. Member Haruo Kusunese Chugoku Electric Power Co., Inc. Member Kazuhiko Doi Shikoku Electric Power Co., Inc. Member Shizuo Tsuruta Japan Atomic Power Co. Member Ryuji Misumi Mitsubishi Heavy Industries, Ltd. Member Masaaki Watanabe Hitachi. Ltd. Member Yukio Yoneda Toshiba Corporation Member Kiyoshi Futagawa Ishikawajima-Harima Heavy Industries Co. Member Shigeneri Suzuki Mitsui Engineering & Shipbuilding, Ltd. Member Yorinao Shinohara Mitsubishi Electric Corporation NO.2 WORKING GROUP OF SUBCOMMITTEE ON QUALITY ASSURANCE Director Mitsuo Nishikawa Tckyo Electric Power Co. Member Shunsuke Shirai Hokkaido Electric Power Co., Inc. Member Yukio Tsukada Tohoku Electric Power Co., Inc. Member Tadahiro Itou Chubu Electric Power Co., Inc. Member Kiyoshi Miyata Hokuriku Electric Power Co. Member Toshio Kamiya Kansai Electric Power Co., Inc. Member Hirokuni Kadota Chugoku Electric Power Co., Inc. Member Kazuhiko Doi Shikoku Electric Power Co., Inc. Member Kaneki Narikuhi Kyushu Electric Power Co., Inc. Member Takahiro Yuhara Japan Atomic Power Co. l l l l I
. Member Masaaki Watanabe Hitachi, Ltd. Member Yukio Yoneda Toshiba Corporation Member Nebuhiko Kobayashi Fuji Electric, Ltd. Member Satoshi Morita Mitsubishi Heavy Industries, Ltd. Member Yorinao Shinohara Mitsubishi Electric Corporation Member Kiyoshi Futagawa Ishikawajima-Harima Heavy Industries Co. NO.3 WORKING GROUP OF SUBCOMMITTEE ON QUALITY ASSURANCE Director Yasuo Kurozumi Kansai Electric Power Co., Inc. Member Eiichi Oishi Kyushu Electric Power Co., Inc. Member Chikashi Saitou Power Reactor and Nuclear Fuel Development Corporation Member Jun Kaneko Electric Power Development Co., Ltd. Member Shigeru Miyoshi Japan Power Engineering and Inspection Corporation Member Masatoshi Satou Mitsubishi Heavy Industries, Ltd. Member Kiyoshi Futagawa Ishikawajima-Harima Heavy Industries Co. Member Tadahiro Itou Chubu Electric Power Co., Inc. Member Yukio Tada Hitachi, Ltd. Member Tatsumi Imaizumi Mitsubishi Electric Corporation NO.4 WORKING GROUP OF SUBCOMMITTEE ON QUALITY ASSURANCE Director Junichi Hashimoto Tokyo Electric Power Co. Member Shunsuke Shirai Hokkaido Electric Power Co., Inc. Member Yukio Tsukada Tohoku Electric Power Co., Inc. Member Tsutomu Masuda Chubu Electric Power Co., Inc. Member Eijirou Seki Kansai Electric Power Co., Inc. Member Kyugo Teguri Hokuriku Electric Power Co. Member Koremutsu Koshiba Chugoku Electric Power Co., Inc. Member Kazuhiko Doi Shikoku Electric Power Co., Inc. Member Seiji Kawamura Kyushu Electric Power Co., Inc. Member Masahiko Seki Japan Atomic Power Co. Member Mizuo Tateishi Toshiba Corporation Member Kazushi Shitomi Mitsubishi Heavy Industries, Ltd. Member Akinobu Tagishi Hitachi, Ltd.
GUIDE REVIEW WORKING GROUP OF SUBCOMMITTEE ON QUALITY ASSURANCE , Director Mitsuo Nishikawa Tokyo Electric Pcwer Co. Member Takahiro Yuhara Japan Atomic Power Co. Member Katsuhiko Suzuki Chubu Electric Power Co., Inc. Member Yasuo Kurozumi Kansai Electric Power Co., Inc. Member Junichi Hashimoto Tokyo Electric Power Co., Ltd. Member Masahiko Seki Japan Atomic Power Co. Member Masaaki Watanabe Hitachi, Ltd. Member Yukio Yoneda Toshiba Corporation Member Kiyoshi Futagawa Ishikawajima-Harima Heavy Industries Co. Member Yorinao Shinohara Mitsubishi Electric Corporation Member Takahiro Iizaka Mitsubishi Heavy Industries, Ltd. Member Nobuhiko Kobayashi Fuji Electric, Ltd. (Major Yasuhiro Yamanishi Tokyo Electric Power Co. participant) (Major Yuji Sekido Chubu Electric Power Co., Inc. participant) (Major Kiyosumi Koike Japan Atomic Power Co. participant) (Major Masahiro Katou Japan Atomic Power Co. participant) (Major Takeshi Yamanoi Hitachi Ltd. participant) (Major Shinichi Kumagai Ishikawajima-Harima Heavy Industries Co. participant) (Major Sadayuki Kubota Fuji Electric, Ltd. participant)
r- 1 l
. SECRETARY OFFICE General Manager of Technical Department (in general)
Fujishige Yamauchi Japan Electric Association i Person in charge of Electrotechnical Standard Survey Committee Kiyohiko Honda Japan Electric Association Person in charge of Committee on Thermal Power Kazuhiko Miura Tokyo Electric Power Co. Person in charge of Committee on Nuclear Power Hirotada Hata Chugoku Electric Power Co., Inc. Youichi Inaba Japan Atomic Power Co. Seiichi Koshii Electric Power Development Co., Ltd. Person in charge of Committee on Hydraulic Power Power Generation and Transformation Yoshikazu Kishi Kansai Electric Power Co., Inc. Person in charge of Committee on Power Transmission Kazuhiko Matsumura Kyushu Electric Power Co., Inc. Person in charge of Committee on Power Distribution Kazuo Hiraide Chubu Electric Power Co., Inc. Person in charge of Committee on Owner's Electric Facilities Yasunobu Watanabe Japan Electric Association Person in charge of Committee on Interior Wiring Code Kazuo Hiraide Chubu Electric Power Co., Inc. Yasunobu Watanabe Japan Electric Association i i i 1 1 l l
CONTENTS CHAPTER 1 CENERAL
- 1. GENERAL-~ ~ ~~~~ ~ ~ ~ ~ ~ ~ ~~--~~~~~~~~~1
- 2. SCOPE OF APPLICATION ~~ - ~~~ - ~ ~ ~ - ~ ~ ~ - -
~~~~-~-2 3 QUALITY ASSURANCE RESPONSIBILITY - ~ ~ ~ ~ - - -"~~~~~~~~"~~2
- 4. APPLICATION METHOD - ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ - - ~ ~ ~ ~ " ~ - -~ ~~- 2
- 5. DEFINITIONS- ~~~~ - --~~~ -
--"~~~~"~""~"""""-~~3 i
l iExplanations1- ~~ - ~ - ~~~~ - -- - ~~~~ ~~- ~~~ ~ 5 l i 1 a i CHAPTER 2 QUALITY ASSURANCE DETAILS l l 4 [ Basic Matters), [ Supplementary and Recommended Matters]~~~ - ~~~~ ~ ~~~ 7
- 1. QUALITY ASSURANCE PROGRAMMES ~ ~~ ~~~ ~ - - -""~~~~~~"-" - -7
- 2. ORGANIZATION ~ ~ - - - ~ ~ ~ ~ ~~~~~~~~--~~~~~~~~~~~8 3 DOCUMENT CONTROL ~~~ ~~ - ~~ -
~~~--~~~~~~~~~~~~~9
- 4. DESIGN CONTROL - ~~ ~~~ - ~ - - ~ - ~~~ ~~~~~~~~ ~~~ ~~ - 11 5- PROCUREMENT CONTROL- ~~~ ~~ ~ - ~~ ~ ~ ~~ ~ ~ ~~~ ~ ~ 15
- 6. MATERI AL AND COMPONENT CONTROL ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ - ~ ~ ~ ~ - 17 7- FABRICATION AND INSTALLATION CONTROL ~ ~~~~~~~~~~~~~~~-18
- 8. INSPECTION AND TEST CONTROL ~~ - ~ ~ - ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ - ~20 9- OPERATION AND MAINTENANCE CONTROL-~~~ ~~~~ - - ~~ - ~23
- 10. NON-CONFORMANCE CONTROL ~~~~ ~~~~~~~ ~~~~ - ~~ ~ ~~ ~ ~ ~ ~ ~ ~ 26
- 11. ACTIONS TO PREVENT RECURRENCE ~ ~~~~~ ~~~~~ ~~ ~ ~~ -- ~ ~28 12- CONTROL OF QUALITY RECORDS ~~~~ ~~~ ~ ~ ~~~~. - ~~~ ~~ - -"~29 13 AUDITS ~ ~~ - ~ ~ - - - - ~ ~ ~ ~ ~ ~ ~ ~ ~ - ~ ~ -
~ ~31 (Reference Matters]
- 1. QUALITY ASSURANCE PROGRAMMES ~~ -" ~~~ -~~-~~~- ~
~35
- 2. ORGANIZATION ~ ~~~~~~ - - ~~ ~~ ~ ~~ - ~~~~ ~~ - - -- -
~37 3 DOCUMENT CONTROL ~~~~ ~ ~~~ - . - ~ ~ ~ ~ ~ ~ ~ - -
~~~--38
- h. DESIGN CONTROL ~ - ~~~~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ -~
~38 5 PROCUREMENT CONTROL ~~~~~ - -- ~ ~ ~ ~ ~ - ~ ~ ~ ~ ~ - -
~43 6- MATERIAL AND COMPONENT CONTROL - ~~ - ~~~~~ - ~ ~ ~~~ - - ~45
- 7. FABRICATION AND INSTALLATION CONTROL ~ - - - ~~ ~ ~ ~ ~~~ ~46 8- INSPECTION AND TEST CONTROL ~~ - - - - - - ~ ~ ~ 47 9 CFERATION AND MAINTENANCE CONTROL- - - - + ~
- 49
- 10. NON-CONFORMANCE CONTROL" - - - - - -
~51
- 11. ACTIONS TO PREVENT RECURRENCE ~ - - -
~51
- 12. CONTROL OF QUALITY RECORDS .... -- ... - . . -
52
- 13. AUDITS .- . . . - .
54 lExplanations}. - - 59 Notice: The English version is translated from the first page to 83 of the Jap-anese version (Basic batters, Supplementary and Recommended Matters, Refer-ence Matters, and Explanations)- The latter half of the Japanese version is not translated because this part is contained in the first half-
CHAPTER 1. G E N E R A L 1
- 1. GENERAL This guide describes the quality assurance necessary to sseure the safety and reliability of nuclear power plants. (Explanation-1)
To promote the quality assurance of nuclear power plants. it is import;.;,t to programme activities affecting quality before commencement, ana implement them in accordance with the programme. In programming and implementing the activities affs uality, the following points are vital: (1) A quality assurance programme should be established and implemented at each stage from design to operation and maintenance of nuclear power plants; (2) The quality assurance programme should provide for control measures to r '- form systematic activities affecting quality; (3) Activities performed based on the quality assurance programme consist o1 ..~ implementation of quality-related tasks and the verification thereof. The basic responsibility for achieving the required quality, however, resides with the individuals or responsible organizations who implement these tasks. (Explanation-2) Since the degree of performing activities at each stage varies wi+' the quality of an item or service to be attained, the quality assurance acti. .es are classified into Basic Matters, Supplementary and Recommended Matters, Refer-ence Matters, and Explanations thereof. This guide describes Basic Matters, Reference Matters, and Explanations for these three matters. The differences in centents, degree of compliance, and sententious ex-pressions among these four matters are as follows:
- a. Basic Matters Basic Matters describe the basic quality assurance principles and indis-pensable matters based on past experiences or practices, and are mandatory requirements. Basic Matters are expressed by sentences like 8 -
shall.
- b. Supplemer++ry and Recom W ad Matters Supp) m tary and Recommended Matters describe supplementary matters that, in princip. hould be comed with in developing Basic Matters in detail, and recensended matters for which compliiance is desirable.
Supplementary Matters are those which, in principle, should be complied with as described or by substitutes, and are expressed by sentences like '. . . should. . - '. Recommended Matters are these which should be complied with from the view-
point of past experiences or practice, and are expressed by sentences like * .
.
- desired to . . . . ' or * . . - desirable .. .'.
- c. Reference Matters Reference Matters describe concrete examples and instances for methods, extent and ccntrol of Basic Matters, and Supplementary and Recommended Matters.
These are expressed by sentences like '. . . .is(are) . . . .' or * .
. .to be . .. .*.
- d. Explanations Explanations describe the meanings, interpretations, or the ways of think-ing of the words used in this guide, and relevant quotations.
- 2. SCOPE OF APPLICATION This guide applies to activities affecting quality such as design, pro-curement, fabrication, inspection, handling, storage, shipping, installation, testing, operation and maintenance of structures, systems, and components impor-tant to the safety of nuclear power plants, which are performed by plant owners (applicant for plant establishment), plant suppliers (plant manufacturers),
equipment suppliers (equipment manufacturers) and their subsuppliers. (Explanation-3)
- 3. QUALITY ASSURANCE RESPONSIBILITY (1) The plant owner is responsible for establishment and implementation of a quality assurance programme for nuclear power plants.
(2) The plant owner may delegate to other organizations such as plant suppliers or equipment suppliers, a part of its responsibility for establishment and implementation of the quality assurance programme, with the extent of re-sponsibility clearly defined. The organizations entrusted with the respon-sibility by the plant owner may also delegate successively to another organi-zation its responsibility in the same way. (3) The organizations that have been entrusted with a part of the responsibility for establishment and implementation of the quality assurance plan are res-ponsible for establishing and implementing the quality assurance programme within the entrusted extent. (Explanation-4)
- 4. APPLICATION METHODS In applying Basic Matters and Supplementary and Recommended Matters to actual projects, the organizations intending to apply this guide are to define the secpe of application to clarify the requirements of the quality control ac-tivities.
l
- 5. DEFINITIONS The terms used in this guide are defined as follows. (Explanation-5)
Service: An activity such as design, fabrication, inspection, testing, repair, installation, or operation. Audit: An activity performed to determine by investgation, examination, and evalu-ation of objective evidence the adequacy of and compliance with the application of codes and standards, established procedures, instructions, specifications, administrative plans and other applicable documents, and the effectiveness of I implementation. Inspection: An activity to verify by means of examination (including material. test-ing, non-destructive examination and mechanical testing), observation, or mea-surement, whether items and services conform to quality requirements. Verification: An action of determining and documenting, by means of reviewing, inspect-ing, testing, checking, and auditing to decide whether items, services, or docu-ments conform to specified requirements. Testing: An action of determining the conformance of an item to the specified requirements by subjecting the item to a set of physical or chemical environ-ments, or operating conditions. Finding (pointing out matters): The corrective actions requested for plans or activities which do not conferi t6 defined quality requirements. Item: A Eeneral term covering structures, systems, components including materials. and parts, and computer software that comprise a nuclear power plant. Design Analyses: All processes which use design requirements and generate the information necessary for preparatien of design output documents such as drawings, specifi-I J
1 I i cations, and procedures. Design analyses include calculations such as transient analyses, accident analyses, and stress analyses. Design Verification: An action of verifying that the design input requirements are incorporated correctly into the design documents and that the designs are adequate. The methods of design verification include design reviews, alternative calculations, i qualification testing, and other appropriate methods. l Design Interface: , The boundary between the design-related responsibilities and activities of one organization or a section therein, and another organization or a s.ection therein. This includes both the external design interface, which is the boundary , between different organizations, and the internal design interface, which is the l boundary between design sections of the same organization. Quality: ' Total features and characteristics of an item or service related to its ' ability to satisfy defined requirements. Quality Record: Documents which are objective evidence of the quality of items or services and of activities affecting quality. Quality Assurance: All planned and systematic actions necessary to provide adequate confidence that a nuclear power plant or items which comprise it will perform satisfactorily in its service. i Any activity based on the quality assurance programme is defined as a " quality assurance activity." i Non-Conformance: A condition that an item or service does not satisfy the defined require-ments and renders the quality of an item or service unacceptable or indetermi- , nate. ! Documentation: Delineated or pictorial information to define, specify, report, or certify activities, requirements, procedures, or results related to quality assurance. Recommended Matters: l Matters which conform to defined requirements, but are recommended by an audit team to be further improved. l
[EXP L AN AT I ONS] (Explanation-1): This guide has been compiled referring to the ' Nuclear Power Plants Safety Code -Quality Assurance ' (1988) (hereinafter called IAEA Code), which was compiled by the International Atomic Energy Agency with the participation of its member states, and has been designed to be applicable as much as possible to the national conditions in Japan. Essentially, quality assurance activities are not to be carried out in a cut-and-dry manner, and it would be difficult to expect them to be effective unless they are performed as an independent activity suitable to actual situ-ations. From this point of view, this guide does not attempt to set forth any fixed minimum requirements, but aims to set goals for performing independent quality assurance activities. (Explanation-2): This section has not been translated, because the original dealt with styles of Japanese writing. (Explanation-3): According to the ' Guide for Safety Draign of Light Water N:olear Power Reactor Facilities' (Resolved August 30, 1990), the terms ' structures, systems and components important to safety' are expressed by the terms ' structures, systems, and components with safety functions' , and these ' safety functions' are defined as:
' Safety functions' refers to the functions of the structures, systems, and components necessary to ensure the safety of nuclear reactor facilities. These are categorized as:
(1) Functions that, when lost, may cause abnormal conditions in nuclear reactor facilities, potentially leading to undue radiation exposure of public or site personnel. (2) Functions that prevent, in case abnormal conditions occur in nuclear reactor facilities, the escalation of such conditions or put such conditions under control immediately, thereby preventing or mitigating potential undue 1 radiation exposure of the public or site personnel. j According to the above, it is prescribed that the structures, systems, and components with ' safety functions' are to be defined separately by the 'Cuide fer Classification of Safety Function Impertance in Light Water Reacter Facilities' (Resolved August 30, 1990). It is also desirable fcr plant owners to apply this guide, within a speci- _5_
fled range, to not only those areas and conditions important to safety but also to those that secure the reliability of nuclear power plants. (Explanation-4): A plan which covers all quality assurance activities related to a nuclear power plant is referred to as the 'overall quality assurance programme' . The responsibility for establishing and implementating the overall quality assurance l plan rests with the plant owner, but the programme can only be implemented in cooperation with all participating organizations. On the other hand, a programme which covers a part of the activities performed by the organization (including the plant owner) participating partial-ly in the overall quality assurance programme is referred to as the ' constituent quality assurance programme.' (Explanation-5): The definitions given here are those used in reference to this guide. Some of them may differ from the definitions established in other Japanese standards, such as the JIS. I _e_
CHAPTER 2. QUALITY ASSURANCE DETAILS [B A S I C MATTERS] [S U P P L EMENT ARY AND RECOMMENDED MATTERS)
- 1. QUALITY ASSURANCE PROGRAMMES
[ Basic Matters) 1.1 General Quality assurance programmes shall be established to implement appropriate quality assurance activities. 1.2 Establishment of quality assurance programmes (Explanation 1-1) (1) Prior to quality assurance activities, quality assurance programmes shall be developed and documented. (2) Based on this guide, quality assurance programmes shall be such that methods for implementing quality assurance activities are clearly defined. (3) Quality assurance programmes shall be implemented in accordance with appro-priate documents. (Explanation 1-2) 1.3 Review of quality assurance prograsses ; (1) The adequacy of quality assurance programmes and the implementation of , quality assurance activities based on these programmes shall be reviewed by i the person who has been assigned the responsibility for their establishment l and implementation. (Explanation 1-3) ! (2) Corrective action shall be taken if deficiencies in quality assurance pro-grammes are discovered by review. l [ Supplementary and Recommended Matters) i 1.1 General (Not described) , l 1.2 Establishment of quality assurance progrannes-l 1.2.1 Development and documentation of quality assurance prograsses ; The developed and documented quality assurance programmes should be app-roved by the person who has been assigned responsibility for the establishment I and implementation of the programmes. (Explanation 1-4) ; i.e.2 Contents of nuality assurance programmes (1) The requirements for quality assurance prograiss5 5hould bc identified ac-l I i l 1
1
.l l
cording to the contents described in section 2 throu6h 13 in this guide. l (2) The degree cf quality assurance activity implementation should be clarified according to the characteristics of items or services. 1.2.3 Implementation of quality assurance programmes (Not described) 1.3 Review of quality assurance programmes 1.3.1 Review of implementation of quality assurance programmes (Not described) 1.3.2 Corrective action The implementation of corrective action should be confirmed, as appropriate.
- 2. ORGANIZATION
[ Basic Matters] 2.1 General An organizational structure shall be established to ensure the implement-ation of quality assurance programmes. 2.2 Responsibility and authority An organizational structure with clearly defined functional responsibili-l 1 ties and levels of authority, or assignment of scope of work shall be estab-l 11shed to implement quality assurance pregrammes. l The following shall be taken into consideration at the establishment of the organization:
- a. The fundamental responsibility to attain the required quality resides with the individual or responsible organization who implements the works. I
- b. When verification of conformance to established requirements is necessary, it is implemented by those who do not have direct responsibility for imple-menting the work.
- c. The individuals and organizations who verify conformance to the quality ,
of work, and who guide and advise the establishment of adequate quality ! ' assurance programmes for efficient implementation of activities, have the j ; i authority necessary to implement these steps. l !
; 2.3 Communication and cocrdination among organizations When quality assurance programmes are implemented by plural organizations, internal and external communication systems among organizations shall be clearly l
defined. The methods of communication and adjustment among organizations shall i
)
I
-also be provided.
l
, 2.4 Indoctrination and training All personnel responsible for implementing activities affecting quality shall be indoctrinated and trained as necessary according to their educational background, experience, and proficiency. (Explanation 2-1)
[ Supplementary and Recommended Matters) 2.1 General (Not described) 2.2 Responsibility and authority (Not described) 2.3 Communication and coordination among organizations (1) The function of each organization and the relations among the organizations should be defined clearly when methods for communication and adjustment among the organizations are established. (2) At the procurement stage, communication and adjustment should be implemented among not only purchaser organizations but also organization groups between the purchaser and the supplier. 2.4 Indoctrination and training Indoctrination and training programmes, in such areas as engineering and skills, should be established and implemented for all personnel responsible for implementing quality assurance activities affecting quality at each stage such as design, procurement, fabrication, installation, and operation and maintenance. 3 DOCUMENT CONTROL [ Basic Matters] 3.1 General ' i Control measures for preparation, review and approval, issuance and dis-l
'tribution, and change of documents essential to quality assurance activities shall be established to ensure that the appropriate and correct documents are femployedforqualityassuranceactivities.
I
- 3. 2 Document preparation, review, and approval Cont.rol measures fer preparation, review, and approval of documents shall
_ 9 __
e l be established. . In determining the control measures, the individuals or organizations responsible for preparation, review, and approval of each document concerned shall be identified. 3.3 Document issuance and distribution Control measures for the issuance and distribution of documents shall be established. (Explanation 3-1) 3.4 Document change control r Document change control measures shall be established. In determining these measures, the following shall be considered:
- a. In principle, changed documents are to be reviewed and approved by the same individuals or organizations who performed the original review and approval.
- b. The review and approval of changed documents are to be implemented by the use of necessary information and an understanding of original requirements and their background.
- c. Changed or revised documents are to be identified.
- d. Enough attention is to be paid to prevent the use of obsolete documents, and information concerning the changed document is to be promptly relayed to affected individuals and organizations.
[ Supplementary and Recommended Matters) 3.1 General The organizations related to each stage of desi6n, procurement, fabrica-tion, natallat' ion, and operation and maintenance should establish their own document control measures. 3.2 Document preparation, review, and approval (Not described) l 3.3 Document issuance and distribution j The distribution and receipt of documents should be controlled by pre-paring and maintaining document lists or other means. (Explanation 3-1) 3.4 Document change control (Not described) i
- 4. DESIGN CONTROL (Explanation t-1, 4-2)
(Basic Matters] 4.1 General (1) Control measures shall be established for activities at the design stage to ensure that the design requirements such as regulations, codes, standards, and basic design conditions are satisfied. (Explanation 4-3) (2) The control measures shall include the following:
- a. Design process (Explanation 4-4)
- b. Design interface
- c. Design verification
- d. Design changes 4.2 Design process (Explanation 4-5)
(1) Control measures shall be established to ensure that design requirements are correctly incorporated in the design documents. They shall include provisions for controling the changes and deviations from the design requirements. (Explanation 4-6, 4-7) (2) The design documents shall be prepared to permit evaluation by personnel other than those who performed the original design. 4.3 Design interface (1) Design interfaces between organizations performing the designs shall be ; indentified in the document. (Explanation 4-8) (2) The information related to the design interfaces shall be controlled by establishing methods for communicating them, 4.4 Design verification (1) Control measures shall be established to verify the adequacy of design, as appropriate, through design reviews, alternative calculations, verifica-tion tests (such as prototype or qualification test, engineering, proof or acceptance test, or other applicable test) or other suitable methods accord-ing to the degree of importance of the structure, system, or component con- ; cerned. (Explanation 4-9, 4-10, 4-11, 4-12) (2) Design verification shall be implemented by individuals or groups other than those who performed the original design. l (3) Design verification results shall be documented. 4.5 Design changes (Explanation 4-13) l (i) Control measures shall be provided for effecting design changes (including
! en-site changes).
(2) Design changes shall be subject to the same design control measures as these applied to the original design. Review and approval of design change documents, in principle, shall be implemented by the same individuals or organizations who reviewed and ap-proved the original design documents, i (3) Methods shall be established for transmitting information concerning the design changes. i The information, in principle, shall be transmitted by document to affected f crganizations. l [ Supplementary and Recommended Matters] 4.1 General (Not described) 4.2 Design process 4.2.1 Design process planning and design implementing Taking the following into consideration, a design process should be plan-ned and a design activity should be implemented.
- a. Establishment of design process as follows:
(a) Design requirements (b) Design analyses (c) Design verification (d) Design documentation
- b. On structure, system, or component, selection, and reviewing the adequacy of the applications:
(a) of materials and parts which are essential to functioning thereof (b) of fabrication / installation methods applied thereon 4.2.2 Design requirements In determining the control measures for design requirements, the following should be included:
- a. Specify the design requirements
- b. Designate the division or department responsible for the design requirements and changes thereto
- c. Review and approve the design requirements in accordance with established l procedures to preclude the use of incorrect data l 4.2.3 Design analyses i Design analyses should be implemented according to the design process plan, and design analysis reports should be documented. (Explanation 4-14) i 1
i
4.2.4 Design documents Procedures for preparing design documents should be established as neces-sary. 4.3 Design interface 4.3.1 Interface between organizations (1) Prior to implementing design activities, measures should be established to control external design interfaces (those between organizations) and in-ternal design interfaces (those between the departments inside the organi-zation). (2) Responsibilities concerning design interfaces between design organizations should be clearly defined. (3) The organization responsible for preparation, review, approval, issuance, distribution, and revision of design documents related to design interfaces should be identified. 4.3.2 Communication between organizations (1) Control measures should be established for transmitting information neces-sary to design (including changes as work progresses) to organizations concerned. (2) When design information is transmitted from one design organization to another, it should be transmitted by means of specifications, drawings, or other documents equivalent to them. When design information is initially transmitted orally or by other informal means in an urgent case or others, the transmittal should later be confirmed by controlled documents. 4.4 Design verification 4.4.1 Method of design verification (1) Of design reviews, alternative calculations, verification testing, and other suitable methods, one or more should be implemented as appropriate ac-cording to the degree of importance of the structure, system, or component concerned, to verify the adequacy of design. (2) It is not necessary to implement design verification repeatedly for iden-tical structures, systems, or components, but even in such cases, a verifi-cation should be made that desi6n requirements applying to the design are the same for each application. (3) Where changes (including new design) to previously verified designs have been made, design verification should be implemented for those changes, including evaluation of their effects en the overall design. I i
4.4.2 Design review (Explanation 4-9) The type and method of design review should be specified in design control procedures, etc. 4.4.3 Alternative calculations (Explanation 4-10) (1) Alternative calculation methods should be those that are capable of ccn-firming the adequacy of the original design. (2) Where alternative calculations are implemented, the adequacy of calculation assumptions, design requirements, and computer codes should also be con-firmed as in the case of the original design calculation. 4.4.4 Verification testing (Explanation 4-11) (1) Verificatien tests should be implemented in accordance with test procedures. (2) When tests are being implemented on scale models, scaling laws should be verified. (3) In principle, qualification tests should be performed, if possible, under the most adverse conditions for the specific design requirements. Where this is not possible, these may be per &med under other conditions provided that the test results can be extrapolated to the most adverse design conditions and the adequacy of the design can be verified for spe-cific requirements. (4) When qualification testing is intended to confirm the adequacy of the design for all design requirements, tests should be carried out under conditions which satisfy all these requirements. Where the testing is intended only to verify specific items, the adequacy of the design for other design require-ments should be verified by other means. (5) Verification test results should be evaluated to assure that design require-ments have been satisfied. 4.4.5 Performing of verification (Not described) 4.4.6 Documentation of verification results To permit confirmation that the design verification has been properly implemented, design verification results should be documented with the identifi-cation of the individuals who have verified and approved, and the date of veri-fication. 4.5 Design changes 4.5.1 Control measures for design changes When design changes are effected, the reasons. changed portions, circum-stances of the changes, and cthers should, in principle, be documented. 4.5.2 Implementation of design changes (Not described) 4.5.3 Transmission of changes (Not described)
- 5. PROCUREMENT CONTROL (Explanation 5-1, 5-2)
[ Basic Matters] 5.1 General To procure items and services of adequate quality, methods for specifying quality requirements, evaluation of bidders, and control measures of procured items and services shall be established. 5.2 Clarifying quality requirements (1) Quality requirements shall be specified in the procurement documents. (Expla,ation 5-3) (2) The following shall be included in the quality requirements to ensure ade-quate quality: (Explanation 5-u)
- a. Scope of work implemented by bidders
- b. Technical requirements such as design, fabrication, installation, inspec-tion, testing, applicable regulations, etc.
- c. Provision for the submission of quality assurance programmes
- d. Provision for access to the supplier's place of business fer the purpose of inspection, testing, audit, etc.
- e. Provision for the submission of documents and submission and storage of re-cords
- f. Provision for the treatment of non-conforming items
- g. Provision for extending the application of requirements in the procurement documents to the contractor's suppliers 5.3 Evaluation of bidders In selecting suppliers, the purchaser shall evaluate whether or not the bidders are able to supply items or services conforming to the requirements of the procurement documents.
The following shall be included as appropriate in bidder evaluations:
- a. Technical ability and quality assurance system
- b. Past supply records of items or services ,
- c. Past use records of items or services
- d. Samples of items 5.4 Control of procured items and services (1) Control measures which confirm that purchased items and services conform to I
J
the requirements of the precurement documents shall be established. (2) Quality records which certify that the purchased items conform to the re-quirements of the procurement documents shall be made available at factory or at site prior to their use. (Explanation 5-5) [ Supplementary and Recommended matters] 5.1 General (Not described) 5.2 Clarifying quality requirements 5.2.1 Specifying in procurement documents (1) It is desirable to specify the quality requirements of items and services in the procurement documents, and the purchaser and supplier should agree on them beforehand. (2) As for changes in quality requirements, it is desirable to evaluate and examine the adequacy of the supplementary or corrective requirements prior to contract changes and incorporate the results discussed between purchaser and supplier in the procurement documents. 5.2.2 Quality requirements (Not described) 5.3 Evaluation of bidders (1) The purchaser should identify the responsible individuals or organizations for the evaluation of bidders, and should document the results. (2) During the evaluation of the quality assurance system it is desirable to refer to section 13 ' AUDIT' in this guide. 5.4 Control of procured items and services 5.4.1 Control measures for procured items and services The following should be included in control measures as appropriate: (1) Inspection and testing;
- a. To confirm that procured items and services conform to the requirements of the procurement documents, the purchaser should plan and perform inspection and testing.
- b. Inspection and testing should be performed by using the procedures, instruc-tions, check sheets, etc., in which requirements and acceptance criteria are provided.
(2) Treatment af ter reception; (Explanation 5-6) When precured items and services could not be confirmed to have satisfied 16 - I 1
procurement requirements at the time of reception, the control measures there-after should be established and implemented. (3) Control of documents submitted by supplier; Purchaser should provide control measures for submission and return of doc-uments submitted by supplier. (h) Guide and advice to supplier; It is desirable for the purchaser to instruct and advise the supplier to smoothly execute design, fabrication, installation, inspection, testing, etc. according to the purchaser's requirements. 5.4.2 Quality records of procured items (Not described)
- 6. MATERIAL AND COMPONENT CONTROL
{ Basic Matters] 6.1 General Control measures of identification and handling etc. shall be established to use materials, parts, and components adequately at all stages, from fabri-cation to operation and maintenance. 6.2 Identification Identification control seasures shall be established to use adequate ma-terials, parts, and components and to assure the traceability as necessary of non-conforming items. 6.3 Handling, storage, shipping, etc. Control measures for handling, storage, packaging, shipping, and trans-portation shall be established to prevent materials, parts, and components from damage, deterioration, or loss. [ Supplementary and Recommended Matters] 6.1 General (Not described) 6.2 Identification (1) Identification should be indicated on the items as far as possible by using ! appropriate numerical numbers or signs. These indications should satisfy the following provisions:
- a. Clear and easy to distinguish
-n-1 l
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- b. Not prone to fading
- e. Have no harmful effects on quality When storing parts for fabrication, installation, or maintenance, at-tention should be paid toward maintaining identification.
(2) If it is difficult to indicate identification on the materials and compo-nents, or if there are any mere indications of risks of misuse, measures for identification should be made by separating them by reception, delivery, storage, etc. locations. 6.3 Handling, storage, shipping, etc. 6.3.1 Handling (1) Handling equipment which is used to remove or transport materials, parts, and components should be examined periodicaly. (2) Protection measures should be considered to prevent materials, parts, and components from damage. 6.3.2 Storage Special attention should be paid to the storage measures of materials, parts, and components which are liatle to deteriorate through environmental conditions. Confirmation of the storage conditions by checking etc. should be includ-ed in the storage measures, as appopriate. 6.3.3 Packaging, shipping, and transportation The following should be confirmed at the time of shipping:
- a. Items conform to the specified quality requirements
- b. Items are packed according to specified methods and identification of con-tents is indicated
- c. Requirements of handling, storage, etc. during transportation and af ter arrival are clarified as necessary
- 7. FABRICATION AND INSTALLATION CONTROL (Explanation 7-1)
{ Basic Matters] 7.1 General i (1) To assure the quality of items conforming to the requirements of regu-i lations. codes, standards, design documents, etc., control measures shall be established concerning fabrication and installation. (2) The following shall be included as appropriate when establishing control j measures: I
- a. Fab'leation/ installation methods and sequences !
)
i b Working area environment l
- c. Equipment and devices i l I' i l
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- d. Skill of workers 7.2 Working process control 1 (1) The work shall be performed in accordance with requirements provided in suitable documents such as procedures, instructions, drawings, etc.
(2) In cases where qualification for work in special processes is required by regulations, codes, standards, etc., measures shall be established for carrying the work out by means of qualified workers, working methods, or equipment.(Explanation 7-2) (3) The environment in the working area shall be maintained so that the work can be carried out suitably. 7.3 Control of equipment, devices, and tools (1) The equipment, devit.es, ari tools used in the work shall have the required functions and precision. (2) Suitable methods for inspection, maintenance, and handling shall be estab-lished to maintain their functions and precision. 7.h Control of new fabrication / installation methods (1) When new fabrication / installation methods are to be applied, the adequacy methods shall be conf 1rmed by a suitable ructhod. (2) When new fabrication / installation methods are to be applied to actual work, necessary control measures shall be established. (Supplementary and Recommended Matters] 7.1 General To assure the quality of items conforming to the specified requirements, the following should be planned before performing fabrication or installation:
- a. Process for reception of materials, parts, and items etc. , fabrication, assembly, installation, erection, tests and commissioning tests etc.
- b. Documents to be applied
- c. Hold point specified by regulations and contract
- d. Other provisions to be especially considered (special processes, new fabri-cation / installation methods, etc.)
7.2 Working process control 7.2.1 Instruction and performance of work (Not described) 1
8 7.2.2 Control for special processes It is desirable to include the following provisions as appropriate when establishing control measures:
- a. Scope of qualification
- b. Valid term for qualification
- c. Issuance of qualification certificate
- d. Requalification method
- e. Record of process name
- f. Confirmation or checking during valid term 7.2.3 Working area environment l
l The environment in the working area should be maintained by proper control l methods, such as the setting of the working area, temperature / humidity control, prevention of dust / foreign material, control of cleanliness, as necessary, so that work can be carried out suitably. j l l 7.3 Control of equipment, devices, and tools (Not described) 1 1 7.4 Control of new fabrication / installation methods (Not described)
- 8. INSPECTION AND TEST CONTROL
[ Basic Matters] 8.1 General Control measures concerning inspection and testing shall be established to verify the conformity to established requirements for items and services. B.2 Inspection control (1) A programme for inspections shall be established and implemented to verify that the items and services conform to the specifications, procedures, instructions, and drawings. (2) Inspections shall be performed in accordance with inspection procedures, etc. (3) Inspections shall be carried out by people other than those who carried out I the work subject to inspection. The qualification of the inspectors shall also be established when necessary. (4) In cases where inspection is impossible after working, assembly, or instal-lation, or when a separate control is required during a process, indirect !
; control such as control of working methods, devices, or worker skills shall
4-l be established. i
- (5) In cases where inspections are required at a hold point, beyond which the work shall not proceed without the approval of a designated organization, the hold point shall be indicated in advance by a proper document.
(Explanation 8-1) , (6) The results of the inspections and the judgement of acceptance or rejection shall be formulated in a document. 8.3 Test control (1) A programme for testing shall be established and executed to verify that the ,
~
items conform to established requirements. (2) The tests shall be performed in accordance with procedures etc. by suitable i persons under suitable environmental conditions. 1 (3) In cases where tests are required at a hold point, the hold point shall be indicated in advance in a suitable document. (4) The test rsults and the judgement of acceptance or rejection shall be formulated in a document. , 8.4 Calibration and control of seasuring instruments and test equipment (1) Methods shall be established for assuring that the seasuring instruments and ; test equipment, etc. used for judging the result of inspections and tests l are of the proper ranges. type, accuracy, and precision. (2) The measuring instruments and test equipment shall be calibrated and adjust- 1 ed at specified intervals or before use to maintain necessary accuracy. { (3) When the accuracy of the measuring instruments and test equipment is found to be beyond permissible limits, an evaluation shall be made of the validity . I of inspections or tests after the last calibration, and the acceptance of inspected or tested items shall be reassessed. (4) Control seasures shall be established for proper handling, storage, and use i of the measuring and test equipment. i 8.5 Indication of inspection, test, and operating status (1) Status concerning inspection or test of items (including acceptance or re-jection) shall be indicated by proper mea.is. Identification control of items shall be performed as necessary to ensure that only the accepted items for fabrication, installation, or operation are used. l(2)Measuresshallbeestablishedtoindicatetheoperatingstatusofsystems
! and components and thus prevent inadvertent operation.
[ Supplementary and Recommended Matters] 8.1 General (Not described) 8.2 Inspection control 8.2.1 Inspection programme When establishing a programme for inspections, the items to be inspected, types of inspections, method and schedule thereof, etc. should be included as appropriate. 8.2.2 Inspection procedure, etc. Inspections should be performed in accordance with procedures, etc. (in-cluding instructions and check sheets), which clarify the requirements and acceptance criteria. 8.2.3 Inspector (Not described) 8.2.4 Indirect control . (Not described) 8.2.5 Hold point - The hold point should be indicated in proper documents such as procedures, instruction:, etc. 8.2.6 Inspection results It is desirable to prepare formats of records. 8.3 Test control 8.3.1 Test programme When establishing test programm, the items to be tested, types of tests, method and schedule thereof, etc. should be included as appropriate. 8.3.2 Test procedures, etc. Tests should be performed in accordance with procedures, etc. (including instructions and check sheets) which clarify the requirements and acceptance criteria. 8.3.3 Hold point The hold point should be indicated in proper documents such as procedures, instructions, etc. 8.3.4 Test results It is desirable to prepare formats of records. 8.4 Calibration and control of measuring instruments and test equipment 8.4.1 Application method for inspection / test , (Not described)
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8.4.2 Performance of calibration / adjustment It is desirable to record the results of calibration and adjustment as necessary and indicate the identification of the instruments, and test equipment. 8.4.3 Confirmation of validity (Not described) 8.4.4 Control of handling, storage, and use (Not described)
- 8.5 Indication of inspection, test, and operating status 8.5.1 Indication of inspection and test status (Not described) 8.5.2 Indication of operating status (Not described)
- 9. OPERATION AND MAINTENANCE CONTROL
[ Basic matters)
\
9.1 General To maintain the safe operation of nuclear power plants, operation and maintenance and modification work control measures shall be established. (Explanation 9-1) 9.2 Operation control Operating manuals, etc. for operation under normal, accidental and mal-functioning plant conditions, for routine patrol / check, and for surveillance test during operation, etc. shall be established. Operation shall also be carried out by those operators who have received suitable indoctrination and training in accordance with established operating manuals, etc. (Explanation 9-2) 9.3 Fuel control Fuel control measures shall be established. j 9.4 Radioactive waste control Radioactive waste control measures shall be established. 9.5 Radiation control 1 Control measures shall be established to minimize the dose equivalent of ' personnel engaged in radiation work.
9.6 Maintenance control i i j Maintenance activities such as patrols and checks, periodic inspections, j l repairs,etc.shallbecarriedcutinaccordancewithestablishedprocedures, j letc.(Explanation 9-3)
! Also, when modification work is to be carried out, it shall be controlled I
in accordance with the applicable provisions of this guide. ! l ! l 9.7 Emergency measures ! i Centrol measures for actions to be taken in case of emergency shall be i
! established.
[ Supplementary and Recommended Matters] 9.1 General l In establishing operation and maintenance control measures, the operation and maintenance requirements defined in all relevant regulations, codes and standards, etc. should be reflected in the operation and maintenance documents. (Explanation 9-4) 9.2 Operation control (1) The following should be specified in operation control:
- a. Understanding of plant operational characteristics and the specific perform-ance of each component
- b. Preparation ol' operating manuals, etc. for normal, accidental and malfune-tiening plant ccnditions, routine patrol checks, surveillance tests during operation, etc. and special tests l
- c. Ensuring that the necessary number of operators have received indoctrination and training for plant operation
- d. Implementation of smooth and proper transition procedures from work shift to wcrk shift l
l (2) Operational limits should be specified to maintain safe operation of nuclear power plants. (3) Provisiens to be confirmed prior to the start of operation and to be follow-ed during normal operation should be established as prerequisites for safe reactor operation. (4) Action to be taken against abnormal occurrences at nuclear power plants I shoulo be established. 9.3 Fuel control The following should be specified as fuel ecntrol measures: l l l i
- a. New fuel carrying, inspection, storage, and leading
- b. Irradiated fuel inspection, unloading, storage, and reloading 1
- c. Carrying and storage of spent fuel l l
1 i 9.4 Radioactive waste control The following should be specified as radioactive vaste control measures:
- a. Storage
- b. Handling
- c. Carrying
- d. Treatment 9.5 Radiation control (Not described) 9.6 Maintenance control -
9.6.1 Patrols and checks Patrol and check measures should be defined to confirm that the quality of structures, systems, and components is maintained. 9.6.2 Periodic inspection (1) Periodic inspection programmes should be established to verify that the quality of structures, systems, and ccaponents is maintained, and control measures should be defined. (2) Af ter completing inspection, the results should be reported to relevant organizations, as necessary. 9.6.3 Repair work control (1) When repair work is to be done to maintain the quality of structures, systems, and components, repair programmes should be established and control measures should be specified taking the following into consideration:
- a. Review and approval of work which is determined important for safety by relevant organizations (Explanation 9-5)
- b. Procurement control of items and services
- c. Identification, handling, and storage to use proper materials and components (including parts)
(2) In defining procedures, etc. the following should be considered: The repair work steps (including clarification of hold points required beforehand in the proper documents) meet the requirements specified in appropriate documents such as procedures, instructions, and drawings. (3) After completing repair work, the structures, systems, and components should be restored to their normal states. These results should be reported to relevant crganizations, as necessary. l l l 9.6.4 Modification work control (1) To appropriately carry c+ut modification work, work programmes should be established and control measures for design, procurement, fabrication and installation, inspection a.nd test, etc. should be defined, as apprcpriate. (2) After completing modification work, the structures, systems, and components should be modified as pla.nned by check or inspection and test, etc. The results should be reported to relevant organizations, as necessary. 9.7 Emergency measures (Explanation 9-6) The following should be specified in the control measures:
- a. Preparatory countermeasures
- b. Initial stage activities
- c. Emergency prevention activicies
- 10. NON-CONFORMANCE CONTROL
[ Basic Matters) 10.1 General Control measures concerning review and disposition for the identification and disposition thereafter of the non-conforming items or services shall be established to prevent their inadvertent use or receipt in cases where non-conforming items or services such as through the design to operation and maint-enance stages. (Explanation 10-1) 10.2 Identification of non-conformances Non-conforming items and services shall be identified by appropriate methods to prevent their inadvertent use or receipt. 10.3 Review and disposition for non-conforming items and services (1) The disposition for non-conforming items and services shall be decided ac-cording to established procedures after evaluating their contents and influ-ence on others. (2) The responsibility for review of non-conformances and the authority to dis-pose of them shall be defined. (3) In cases where non-conforming items and services which do not satisfy re-quirements for procurement are used or received as is or after significant repair work, their technical adequacy shall be documented and approved by I the purchaser. i i
, l
[ Supplementary and Recommended Matters] i 10.1 General I (Not described) i 10.2 Identification of non-conformances The following should be taken into consideration to establish control methods for identification of non-conformances:
- a. Identification methods (a) Marking (b) TaEging (c) Physical separation (d) Recording on document sheet (e) Other appropriate methods
- b. Organization to implement identification markings (including releasing from the non-conforming status after disposition).
10.3 Review and disposition for non-conforming items and services 10.3.1 control method for review and disposition The following should be taken into consideration to establish control methods for review and disposition of non-conforming items and services:
- a. Assignment of review responsibility and the authority to make disposition decisions
- b. Disposition procedures (a) Preparation of report (b) Reporting format decisions (c) Reporting route and others
- c. Disposition of items (a) Do not use or receive (b) Use or receive after repair (c) Use er receive as is :
- d. Evaluation of item or service influence on other areas
- e. Verification after completion of disposition (a) Reinspection or retesting (b) Review of revised documents, etc.
10.3.2 Responsibility and authority for reviewing and disposition decisions (Not described) 10.3.3 Approval scope by purchaser The secpe for significant repair and reworkings subject to the approval of the purchaser should be decided by a contract between the purchaser and supplier.
- 11. ACTIONS TO PREVENT RECURRENCE
[ Basic Matters) i l11.1 Ceneral Control measures shall be established to clarify the causes of non-l conforming items, and corrective action shall be taken to prevent recurrence. and executed. I 11.2 Clarification of causes l
! Causes of non-conformances shall be clarified prior to establishing corrective action to prevent recurrence.
11.3 Planning, decision, and execution of corrective action The necessary corrective action to be taken to prevent recurrence shall be planned, decided, and executed based on the clarified causes. 11.4 Cause and corrective action information Causes of non-conformances and corrective action to prevent recurrence shall be reported to concerned organizations. [ Supplementary and Recommended Matters] 11.1 General (Not described) 11.2 Clarification of causes (Not described) 11.3 Planning, decision, and execution of corrective action (1) For the planning, decision, and implementation of corrective action, at least the following should be considered:
- a. Reflection corrective action on the same type of products (including future and cperating plants)
- b. Reflection on the same type of services (2) The following should also be considered, as necessary:
- a. Reflection on quality assurance programmes
- b. Reflection on design, procurement, fabrication / installation, inspection /
test, and operation / maintenance procedures, etc.
- c. Reflection on facilities and equipment
- d. Reflection on indoctrination and training
I 4 i (3) Follow-up activities should be performed to ensure that the corrective actions have been implemented. 11.4 Cause and corrective action information The organization that receives ir. formation regarding causes and corrective action should take appropriate action to prevent non-conformance recurrence due - to the sdme or related causes.
- 12. CONTROL OF QUALITY RECORDS
[Brsic Matters] 12.1 General Control measures for generation, handling, and retention of quality rec-crds shall be established to ensure the control of quality records. 12.2 Generation of quality records (1) When carrying out the quality assurance programmes, adequate quality records shall be generated. (2) Each quality record shall be such that it can be correlated according to the , corresponding item or service. 12.3 Handling of quality records Control measures for the handling of quality records, such as submittal / receipt, correction / addition, and retrieval / access shall be defined. 12.4 Retention of quality records The types of quality records and retention periods shall be clarified, and control methods for retention shall be defined. (Explanation 12-1) [ Supplementary and Recommended Matters] 12.1 General (Not described) 12.2 Generation of quality records 12.2.1 Generation of records (1) Quality records should be generated accurately and legibly. (2) It is desirable to predetermine the scope of required contents for quality records. Wnen establishing the scope of required contents for quality records, it is _ 39 _ l
l desirable to avoid over-documentation. 12.2.2 Collation of quality records (Not described) 12.3 Handling of quality records 12.3.1 Submittal and receipt It is desirable to clarify the types of subject records when submitting or receiving quality records. 12.3.2 Correction and addition of quality records When records are to be corrected or added, this should be done in accordance with appropriate procedures by the organization which originated the records. 12.3.3 Retrieval and access (1) Quality records should be made readily retrievable at storage areas by suit-able methods such as indexing, as necessary. (2) It is desirable to ease access to necessary records under access control at the storage area for quality records. 12.4 Retention of quality records 12.4.1 Retention period and categories of quality records (1) Quality records should be categorized as ' permanent records' and 'non-permanent records' with their retention periods specified. (2) In defining retention periods, the following should be taken into account: (Explanation 12-2)
- a. Retention purpose
- b. Importance classification for facility / component
- c. Category of necessity
- d. Verification timing l
- e. Category of retention period
- f. Regulation requirements regarding records retention (3) Among records with the following retention purposes, those technical records directly necessary in terms of activity or work at stages of operation /
maintenance should be retained as permanent records: I
- a. To demonstrate the capability for safe operation of a nuclear power plant
- b. To enable routine patrol / checks, periodic inspections or repair of the item
- c. To enable modification of the item
- d. To determine the cause of an item's malfunction
- e. To provide required baseline data for in-service inspection of the item (4) Quality records other than these in (3) above should be retained for speci-fied periods as non per'nanent records to demonstrate the accottplishment cf quality assurance requirements.
30 - 4 J l
.-. _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ - . - . - _ _ _ _ _ _ _ __..______.___._---_______-___-J
I 12.4.2 Storage I (1) Quality records should be stored in such a manner as to prevent deteriora-tion or loss. ) (2) It is desirable to difine procedures including the following, prior to storing I records in a stcrage area:
- a. Records configuration for storage and their retention periods (Explanation 12-3)
- b. Collating of records and list of retained records
- c. Personnel access control to storage area
- d. Filing of corrected or added records and disposition methods for obsolete records
- e. Control of removed records from storage area 12.4.3 Transfer of quality records When transferring records, transfer methods should be clarified.
12.4.4 Disposition of quality records The organization responsible for records retention should define the procedures for disposition. To encourage smooth operation, it is desirable to dispose of non-permanent records after specified retention periods. 12.4.5 Checking stored records It is desirable to check the condition of stored records, as appropriate.
- 13. AUDITS
[ Basic Matters) 13.1 General , Measures for audits shall be established to verify, as necessary, the imple- , rsentation and effectiveness of the quality assurance programme. 13.2 Management of audit An audit organization shall establish the methods for managing audits. 13 3 Execution of audit Audit organizations shall carry out audits according to the established methods. 1~: .4 Corrective action If findings necessitate corrective action. implementation of the cor-lrectiveactionshallbeverified. i L_
{ Supplementary and Reccamended Matters) 13.1 General (Not described) 13.2 Management of audit The audit organization should establish the methods for audit management, takirg the following into consideration. 13.2.1 Auditor qualification or registration It is desirable that auditors be qualified or registered according to , internalcempany p.ocedures. (Explanation 13-1) 13.2.2 Timing of audit execution It is desirable to perfors an audit for the following cases according to l the status and degree of importance of objective activities to be audited:
- a. When it is necessary to evaluate the quality assurance programme of the supplier and its capability of executirr, the programme prior to orders
- b. When it is necessary to verify the supplier's compliance with the quality assurance pregramme after orders
- c. When significant chrges in a quality assurance programme, such as significant changes in organization or procedures have taken place
- d. When a significant non-conformance has occurred or might occur due to de-ficiency of the quality assurance programme or deficiency in implementing the quality assurance activity
- e. When it is necessary to verify implementation of the corrective action
- f. When it is necessary to verify periodically the state of implementation and the effectiveness of the quality assurance programme 13.2.3 Audit objectives Audit objectives for internal and external audits should be distinctly clarified. (Explanation 13-2) 13.2.4 Audit procedures The audit organization should establish audit procedures prior to their execution.
13.3 Execution of audit 13.3.1 Audit team organizations Audit organizations should perform the following when organizing the audit team:
- a. Selecting auditors from organizations other than that which is audited
- b. Deciding lead auditor and auditors 13.3.2 Pre-audit activities ,
Audit organizations should establish appropriate audit execution plans prior to the audit, and perform the audit according to these plans. 13.3.3 Pre-audit conference A conference involving the addit team and the organization to be audited should be conducted at an appropriate time, or the audit execution plan should be sent beforehand to the organization to be audited. 13.3.4 Execution of audit Audits should be executed according to checklists or procedures to verify that the quality assurance requirements are satisfied. 13 3.5 Explanation and confirmation of audit results To conclude the audit, a post audit meeting should be organized between the audit team and the audited organization so the audit team can explain the audit results and present its findings, if any, and thus ensure that the audit findings are reasonable and agreeable. 13.3.6 Audit reports The audit team should prepare audit reports without delay. 13.3.7 Confirmation of audit reports The audited organization should receive an audit report and confirm its contents. If in doing so the audited organization finds any points on which it cannot agree, it should give its response to the audit team in a timely manner. 13.4 Corrective action 13.4.1 Preparation of corrective action report After the audited organization examines the findings to which it agreed, it should prepare and submit a report of its corrective actions to the audit team within a specified period. 13.4.2 Evaluation of the corrective action report The audit team should evaluate the report received from the audited organization. If there are points which cannot be agreed upon, the audit team shotild inform the audited organization of those points. 13.4.3 Follow-up for corrective action The audit team and the audited organization should follow-up corrective action. l l, [ REFERENCE MATTERS) 1 1
- 1. QUALITY ASSURANCE PROGRAMMES 1.1 General (Not described) 1.2 Establishment of quality assurance programmes 1.2.1 Development and documentation (1) The understanding of the concepts ' quality' and ' quality assurance' is important.
(2) Quality assurance programmes consist of an adequate combination of two fundamental activities, namely control-oriented and work-oriented activities. (Explanation 1-5) (3) These are two kinds of documents for control-oriented activities (adminis-tration documents). These are quality assurance programme documents, and control procedures for quality assurance. When preparing these documents. . I the matters to be considered are as follows: (Explanation 1-6, 1-7) 1 a All requirements in this guide necessary for the items or services concern-ed are described in the quality assurance programme documents. And descrip-tion of these documents is detailed enough to convince the management respon-sible for the establishment and implementation of the plan of the adequency at the time of review. Furthermore, the matters to be included in the quality assurance programme documents are below, but the documentation is not necessary for non-applicable items and services. (a) Purpose of the quality assurance programme (b) Scope of the items and services covered by the quality assurance programme { t (c) Review of the quality assurance programme ' (d) Organizations for the quality assurance programme (e) Document control (f) Design control (g) Procurement control (h) Material and component control (1) Fabrication and installation control j (j) Inspection and test control (k) Operation and maintenance control (1) Non-conformance control (m) Actions for prevent, ion of recurrence (n) Control cf quality records (o) Audits l 4
1 l 1 l l
- b. Control procedures for quality assurance indicate the detailed processes and methods for all activities to accomplish the quality assurance require-ments. These procedures are to be described to simplify understanding and encourage appropriate executicn of control processes and methods. The following are also to be included as appropriate in the procedures:
(a) Purpose of the procedures (b) Scope of the procedures (c) Definition of specific terms used in the procedures (d) A series of processes to be executed to accomplish the purpose of the pro-cedure, method, and assignment, of each process (e) Document format for communication and instruction (f) Type of quality record to be described and format of the record (4) The documents for work-oriented activities (documents for works) include the work plan documents, work procedures, work instructions, and drawinp . When preparing these documents, the matters to be considered are as follows: (Explanation 1-8,1-9)
- a. The work plan documents are to be described in such a way to plan the work carried out by each organization beforehand and execute it systematically and orderly. And if necessary, the working matters, working processes, working standards to be applied, and working schedule, etc. are to be includ-ed in the work plan documents;
- b. The documents, such as work procedures, work instructions, and drawings are to be described to provide concrete information. This will make appropriate executions of activities possible according to the control procedures for quality assurance and the work plan document. The documents are to be concise and clear.
(5) The existing quality assurance programmes are applicable if the necessary requirements in this guide are reflected in these programmes as a result of their review. 1.2.2 Contents of quality assurance programmes The most important way to clarify the degree that quality assurance activi-ties are performed is to consider the influence that the functional non-con-formity of items and service errors have on the safety of nuclear power plants. Additional matters to be considered are as follows:
- a. The complexity, uniqueness, or novelty of the item or service l
i
- b. The need for special controls and inspection for processes, methods, and equipment
- c. The degree to which compliance for functional requirements can be demon-strated by inspection or testing
- d. The quality history and degree of standardization of the item or service 9
- e. The accessibility to the item installed for maintenance, in-service inspec-tion, and replacement 1.2.3 Implementation of quality assurance programmes (Not described) 1.3 Review of quality assurance programmes 1.3.1 Review of quality assurance programmes implementation (1) The review may be carried out based on the reports of the individual or organization authorized by the management to implement the quality assurance programme.
(2) At the review, the matters to be attended to are as follows:
- a. Implementation status of important quality assurance ::tivities
- b. Quality trenda and :t:tua of non-confermance occurrence
- c. Degree worker skills
- d. Deficiencies in quality assurance programme
- e. Need for quality assurance programme revision 1.3.2 Corrective Action (Not described)
- 2. ORGANIZATION
- 2. General (Not described) 2.2 Responsibility and authority At fabrication and installation stages, there are two kinds of organizations, namely, those which directly produce the target quality into the items and services in the process and those which verify the quality.
2.3 Communication and coordination among organizations Many organizations participate in nuclear quality assurance activities. The responsibility, authority, and assignment scope of work at each organization are to be identified. The communication routes, methods of communication, adjust-ment meetings, and solution methods for quality problems, etc. are to be includ-ed in the communication and adjustment method among these organizations. 2.4 Indoctrination and training (1) Upon the establishment of indoctrination and training programmes for fabri-cation. installation, and operation and maintenance stages, a consideration regarding those who require qualifications according to laws and regulation is to be taken account of. (Explanation 2-2) (2) In regard to indoctrination and training for the acquisition of personnel qualfications, it is important to establish programmes and implement them from a long-term point of view.
- 3. DOCUMENT CONTROL 3.1 General (Not described) 3.2 Document preparation, review, and approval (Not de:critsd) 3.3 Document issuance and distribution (Not described) 3.4 Document change control (1) Methods to identify changes or revisions include indicating revised portions and assigning revision numbers.
(2) Methods to prevent the use of obsolete documents include identification, abandonment, and withdrawal. (3) Reasons for changes and their background are to be included in the informa-tion relayed to affected individuals and organizations as necessary. And these reasons, revised portions, and processes for changing documents, etc. are to be indicated on the changed document.
- 4. DESIGN CONTROL 4.1 General In establishing design control measures, the following are to be considered:
- a. Identifying the starting point for design-related quality assurance activities and the application scope of design activities.
In this case, different degrees of controls may be assigned taking, as ap-propriate, the degree of importance to safety, nature of the design activities, advancement of various components, systems and structures, and nature of the design phase, etc. into consideration. (Explanation 4-15)
- b. Preparation of design control procedure document to implement oesign activities Typical items to be covered by design control procedure document are as follows: )
[ Typical items to be covered by procedures for design control) l
- 1. Organization and its scope of work and responsibilities
- 2. Indoctrination and training
- 3. Design document control (preparation, review, approval, issuance, revi-sion storage) l l
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- 4. Design process (1) Identification of appropriate design criteria and other design requirements (2) Designation of quality standards, acceptance crite- ,
ria, and requirements for recording (3) Use of historical reports in practice
- 5. Design interfaces
- 6. Design verification
- 7. Design changes
- 8. Execution of activities to prevent recurrence
- 9. Audit of design activities 4.2 Design process 4.2.1 Design process planning and design implementation for design process planning and design implementation, the following are to be taken into account, as additional matters:
- a. Suitable selection of parts and their assemblies which are essential to the function of structures, systems, and components, and the review and approval for their adequate application
- b. Specifying suitable quality standards as necessary for structures, systems, components, and their parts, and the review and approval for their adequate selection (Explanation 4-16, 4-17)
- c. Similar control measures to those mentioned in b. when changing specified quality standards or deciding of items and services deviate from the standards
- d. Arrangement of design information, accumulated from research and development and experience, taking their implementation for design work and verification into consideration.
4.2.2 Design requirements (1) Design requirements include such items as the following:
- a. Regulatory requirements (including the regulations, codes, guides, and standards that they refer to)
- b. Design conditions (performance and function requirements, technical condi-tions, design interfaces, etc.)
Typical design requirements are as follows: (Typical design requirements)
- 1. Basic functions of each structure, system, and component
- 2. Performance requirements (such as capacity, rating, system output)
- 3. Applicable regulations, codes, and standards
- 4. Conditions of fluid used (such as pressure, temperature, chemical properties)
- 5. Load cenditions (such as seismic, wind, thermal)
- 6. Environmental conditions anticipated during construction, operation and mainte-l nance (such as temperature, humidity, site elevation, wind direction, dose e-quivalent)
- 7. Interface requirements (identifying the functional and physical interfaces in-1 volving structures, systems, and components)
- 8. Material requirements (such as compatibility, insulatien properties, corro-sion resistance) ;
- 9. Mechanical requirements (such as ability to withstand stress, vibration, and shock)
- 10. Structual requirements (covering such items as equipment foundations r.ad pipe supports)
- 11. Hydraulic requirements (such as pump net positive suction heads, allowable pressure drops, and allowable fluid velocities)
- 12. Chemistry requirements (such as limitations on coolants and provisions for sampling)
- 13. Electrical requirements (such as source voltage, cabling, insulation, and motor requirements) 1h. Layout and arrangement requirements
- 15. Operational requirements under various conditions
- 16. Instrumentation and control requirements (such as instrument and control systems, types of alarms and instruments, installed spares, range of mea-surement, and location of indicators required for operation, testing, and l
maintenance)
- 17. Access and administrative control requirements for plant security
- 18. Redundancy, diversity, and separation of structures, systems, and components to meet safety and reliability requirements (such as fail-safe)
- 19. Requirements to ensure that structures, systems, and components can with-stand the events and accidents defined by design
- 20. Test and inspection and pre-operational test requirements
- 21. Accessibility, maintenance, repair, and in-service inspection requirements
- 22. Transportability requirements (such as limitations on size and weight)
- 23. Handling, storage, cleaning, and shipping requirements
- 24. Fire prevention, protection, and firefighting requirements
- 25. Safety requirements for preventing injury to personnel (such as radiation control, restricting the use of dangerous materials, escape provisions l from premises, and grounding of electric systems)
- 26. Ergonomic (human factor) considerations (such as man-machine interface)
- 27. Dese equivalent restriction for plant personnel and the public
- 28. Cther requirements to prevent undue risk to the health and safety of the pulic
- 29. Requirements divised in respense to past non-conformances
(2) Design requirements are to confirm that the activity concerned has been carried out correctly, and that it provides a consistent basis for evaluating each design analysis, verification, and change. 4.2.3 Design analyses In design analysis documents the following are to be included, as appropriate:
- a. Purpose of analysis
- b. Analysis methed
- c. Assumption and conditions set for the analysis
- d. Design requirements
- e. Referenced data books and documents
- f. Computer programmes, input data, and output data
- g. Unit system 4.2.4 Design documents The design documents are to include the following, as approprate:
- a. Use of format, drafting method, symbols, abbreviations, etc.
- b. Identification method for design documents by plant name, document number, revision number, applying objects, etc.
- c. Indication method fer design document status, such as review, approval, and revision
- d. Proceeding of processes for review, approval, etc.
- e. Method of storage for originals and distribution of copies
- f. Method of revision, partial changes, and control of obsolete design documents
- g. Method of issuance for completed documents r
- h. Control measures for non-conformance in regard to design documents 4.3 Design interface ;
Interface between organizations l 4.3.1 Many organizations are often responsible for design interface documents. When there are two or more organizations responsible for a document, one re-sponsible organization is to be identified for each item. 4.3.2 Communication between organizations (1) Of the information transmitted concerning design interfaces, the status of the information provided and required items such as coordination, evalua-tion, review, or approval are to be identified, as necessary. l, I (2) Control measures are to be established according to this guide, as necessary, for interfaces between the design organization and organizations involved in other stages such as procurement, fabrication, installation, cperation, and maintenance. I ( l l l
4.4 Design verification 4.4.1 Method cf design verification (1) Design verification is implemented to review, confirm, or substantiate that all design requirements are correctly incorporated in the design documents and that the design is adequate. (2) The scope of design verification ranges from review of design documents par-tially within the design division in which the design was originated, to extensive review and evaluation by a third party. 4.4.2 Design review The following are to be confirmed, as necessary, in the design review:
- a. Adequacy of selection of design requirements
- b. Prepriety and reasonability of assumptions adopted in the design
- c. Propriety cf design method and compliance with specified quality standards
- d. Correct incorporation of design requirements into the design documents and propriety of the contents
- e. Compliance with design process
- f. Designation of nccessary design and verification requirements for related organizations with design interface 4.4.3 Alternative calculations (Not described) 4.4.4 Verification testing In test procedures for verification testing the following are to be de-scribed:
Design conditions, test conditions, acceptance limits and other conditions such as environmental conditions, test devices, and requirements for data ac-quisition, etc. 4.4.5 Performing verification Design verification may be performed by individuals who belong to the same division to which the original designer belongs, including the origina-tor's supervisor. 4.4.6 Documentation of verification results (Not described) f 4.5 Design changes 4.5.1 Control measures for design changes For design changes the following are to be considered:
- a. Evaluation of the influences brought about by the design changes and their adequacy
- b. Documentation of the required disposition
- c. Transmission of information concerning design changes to the affected
-n-
organizations and divisions. 4.5.2 Implementation of design changes If the review and approval of design change documents cannot be implement-ed by individuals or organizations which reviewed and approved the originals, others may be designated. This designation assumes that they have access as necessary to concerned background information, they have demonstrated competence in their specific design area, and they have an adequate understanding of the requirements and intent concerning the original design. 4.5.3 Transmission of changes (Not described)
- 5. PROCUREMENT CONTROL 5.1 General (Not described) 5.2 Clarifying quality requirements 5.2.1 Specifying in procurement documents (Not described) 5.2.2 Quality requirements (1) Concrete contents of quality requirements include the following:
- a. Scope of work implemented by bidder the scope of work implemented by the bidder (in case of plural bidders, mutual 4 interfacing), etc. is included.
- b. Technical requirements such as design, fabrication and installation, inspec-tion and testing, etc.
Performance and function requirements, criteria for the design interface, requirements for the materials and parts, and requirements for the fabrica-tion, inspection and testing, cleaning, packing, and installation, etc. are included.
- c. Provisions for submitting quality assurance programmes Quality assurance programmes issued by bidders are deemed satisfactory if they include the purchaser's requirements.
- d. Provision for access to the bidder's place of business to inspect and test, and audit, etc.
The necessity for access to the supplier's place of business is to be clarified according to the scope of products or services to which inspection and testing, and audit, etc. are applied and the importance and content complexity, e'.c. of the items or services
- e. Prevision for the submission of documents and storage of records, such as spec-ifications, procedures, drawings, and quality records I
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l These are submitted for study or purchaser approval, and they detail submission steps, schedule of documents, and the way that storage and disposal cf quality records, etc. is done. l T. Provision for the treatment of non-conforming items This establishes the bounds of reports to purchaser and the way that non-conforming items er services are treated.
- g. Provision for extending the application of procurement documents requirements to the contre.ctor's suppliers.
This clarifies extending the application of purchaser quality requirements to the subcontractors and the bounds of purchaser approval for subcontractors. (2) As an exception to (1), when the supplier orders important items or services, there may in turn be items that reauira purchaser cpproval. 5.3 Evaluation of bidders (1) Concrete items for evaluation are as follows:
- a. Technical ability and quality assurance system a) Technical ability or capacity of the bidders manufacturing equipment concern-ing the items or services to be purchased b) Policy of bidders regarding quality, quality assurance programme, and their implementation
- b. Supply records regarding the use of items or services These are bidder supply records of the items or services that are the same or similar to those to be purchased.
- c. Records of item or service use Records of use and the quality level of the items or services to be purchased that are the same as or similar to the one possessed by the purchaser,
- d. Samples of items Conformity to quality requirements for the samples of the items to be procured.
(2) There are various restrictions on the evaluation of bidders of imported items. Countermeasures are as follows:
- a. Selection of suppliers qualified by an official organization such as the ASME, etc.
- b. Selection of suppliers with good results These results refer to impcrtant matters other than purchase specifications.
5.4 Control of procured items and services 5.4.1 Control measures for procured items and services (1) Inspection and testing planning are as follows:
- a. Implemented items dimension inspection, appearance inspection, pressure testing, etc.
- b. Implementation method : all items, sampling, witness, records, and confirmation, etc.
- c. Implementation time : halfway, upon completion, after installation, etc.
- d. Implementation place supplier, purchaser, etc.
(2) Control items for treatment after reception are as follows:
- a. Preparation of receiving conditions etc.
- b. Decision of confirmation method, time, and person for unconfirmed procurement requirements
- c. Treatment of items when non-conformance occurs (3) Control measures for documents submitted by supplier are as follows:
- a. Route of document submission and return
- b. Term of document submission and return (4) Indoctrination, advice to supplier are as follows:
- a. Provisions for quality assurance organizations, quality consciousness, etc.
- b. Matters taken into consideration during designing (Function, use conditions, interface, etc. including their backgrounds as necessary)
- c. Provisions for fabrication and installation techniques, equipment, etc.
- d. Provisions for the inspection and testing methods, records, etc. .
5.4.2 Quality records of procured items (Not described)
- 6. MATERIAL AND COMPONENT CONTROL 6.1 General (Net described) 6.2 Identification (1) Charge, lot, part, and component numbers, etc. are adopted for proper numbering, and stamping, tags, and nameplates, etc. are used for identi-fication.
(2) When identified materials are divided, identification is to be attached as necessary prior to division. , Identifying indications on the surface of materials and components are also ! to be made permanent by surface treatment, painting, etc. unless substituted by alternative means. (3) While items are being fabricated, installed or maintenaned, identification is to be made as necessary by marking items or by using records etc. that assure traceability up to completion. l 6.3 Handling, storage, shipping, etc. 6.3.1 Handling Handling devices are to be operated by people with the necessary profi-ciency and skill for their use. 6.3.2 Storage (Nei described) 6.3.3 Packing, shipping, and transportation (Not described)
- 7. FABRICATION AND INSTALLATION CONTROL 7.1 General (Not described) 7.2 Working process control 7.2.1 Instruction and performance of work (1) The format and description of procedures or instructions vary in accordance with the purpose and organizations involved. These descriptions include the following:
- a. Title : Name of items or services to which the procedures or in-structions are to be applied. (Including identification no., revision no. or revised date and status of approval)
- b. Purpose, : Contents and applicable scope, etc. intended in the proce-scope dures or instructions.
- c. Relative : Standards, specifications, procedures, etc.
documents
- d. Preliminary : Individual activities and term to be completed, conditions term to be secured, etc. before starting work.
- e. Notifications : Special requirements and safety and bygsnic notification for devices or personnel.
- f. Implementation : Procedure of work, existence of hold point, etc.
process
- g. Acceptance : Quantitative or qualitative acceptance criteria to evaluate criteria or judge that the activities are performed successfully.
- h. Format of : Format of record to be kept as a result of work, inspec-record tion and testing.
(2) It is important to confirm before beginning of fabrication or installation that the design documents such as drawings or specifications are applicable to the work at hand. . (3) Control measures are to be established to ensure that only qualified workers perform certain work, as specified by regulations, codes. etc. l 1 i For special processes, refer to 7.2.2. (4) Documents, such as procedures or instructions, which are prepared by fabri-cating and installing organization, transmit detailed information concern-ing the application of the quality assurance programme, working plan, and schedule. 7.2.2 Control for special processes Special processes are to be defined in advance by design documents, etc. 1 7.2.3 Working area environment (Not described) 7.3 Control of equipment, devices, and tools (Not described) 7.4 Control of new fabrication / installation methods (Not described)
- 8. INSPECTION AND TEST CONTROL 8.1 General (Not described) 8.2 Inspection control 8.2.1 Inspection programme The inspection programme is as follows:
- a. Items to be . Vessels, piping, pumps and valves, etc.
inspected
- b. Inspection item . Dimensional / visual inspection, pressure test, etc.
- c. Inspection method 100% or sampling inspection, witnessed or recorded inspection, etc.
- d. Timing of inspection : In process, after fabrication or after installation, etc.
- e. Organization : Pre-use inspection, etc.
- f. Place of inspection Supplier, purchaser, etc.
- g. Kind of inspection Commercial, model, and annual inspection, etc.
8.2.2 Inspection procedures, etc. l Items included in the inspection procedures are as follows:
- a. Items to be inspected, purpose of inspection, and inspection item
- b. Applicable regulations, codes, and standards
- c. Inspection method / procedures and recorded items )
1
- d. Acceptance criteria j
- e. Fermat of inspection record I l
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- f. Other necessary provisions 8.2.3 Inspector (1) Because inspection testing (such as non destructive testing) requires inspector-level skills, inspector qualification is necessary.
(2) Work control cheeks e.g. intermediate checking of the process, can be performed by the worker. 8.2.4 Indirect Control (Not described) 8.2.5 Hold point (Not described) 8.2.6 Inspection results (Not described) 8.3 Test control 8.3.1 Test programme The test programme is as follows:
- a. Items to be tested . Motors, pumps, valves, etc.
- b. Test item Electric characteristics, performance, character-istic test, etc.
- c. Test method : 100% or sampling test, witnessed or recorded confirmation, etc.
- d. Timing of test : Component test pre-operational testing, start-up testing, etc.
- e. Organization : Pre-operational testing and start-up testing, etc.
- f. Place of testing : Factory or site, etc.
- g. Kind of testing . Pre-operational, start-up, and periodic testing, etc.
8.3.2 Test procedures, etc. Items to be included in test procedures are as follows:
- a. Items to be tested, test item
- b. Applicable regulations, codes, and standards
- c. Test methods / procedures and recorded items
- d. Acceptance criteria
- e. Format of test record
- f. Other necessary provisions 8.3.3 Hold point (Not described) 8.3.4 Test results (Not described)
B.4 Calibration and control of measuring instruments and test equipment 8.4.1 Application method for inspection / test (Not described) 8.4.2 Performance of calibration / adjustment (Not described) 8.4.3 Confirmation of validity In cases where reinvestigation of acceptance or rejection of items etc. by I evaluation of inspection / test validity is required, it is necessary to identify the inspection / test in which the measuring instruments, etc. were used. Methods to centrol the above include recording the application history of measureing I l instruments and test equipment, or describing the name and number of measureing l measuring instruments, etc. on the inspectionitest record. 8.4.4 Control of handling, storage, and use (Not described) 8.5 Indication of inspection, test, and operating status 8.5.1 Indication of inspection and test status Methods to indicate inspection / test status include marking, tagging, and labeling. 8.5.2 Indication of operating status Methods to indicate operating status include tagging valves and switches. I
- 9. OPERATION AND MAINTENANCE CONTROL I 9.1 General (Not described) i
{ 9.2 Operation control . I l j (1) To keep the operator informed regarding changes in operational performance ' and conditions, the reactor facility conditions, instruments, and display equipment, etc. are to be monitored as appropriate. (2) In defining operational limits, the following are to be taken into consid-eration:
- a. Limits on the thermal power of reactors
- b. Thermal limiting values of reactors
- c. Limits on concentration of iodine-131 in primary coolant (Explanation 9-7)
- d. Limits on increased concentration of iodine-131 in primary coolant l
- e. Limits on rate of change in primary coolant temperature
- f. Limits on temperature and pressure of primary coolant to prevent non-duc-tiledestruction of reactor vessels
- g. Limits on rate of leakage of primary coolant
- 4 9 __
i 1 l (3) In defining operational conditions, the following are to be taken into con- ' l 1 sideration: l
- a. Assurance of reactor coolant (Explanation 9-7) !
- b. Operation of control roda
- c. Shutdown margin of reactors
- d. Automatic shutdown function of reactors
- e. Preset values for safety protection circuits, etc.
- f. Functions of engineered safety facilities (4) In defining measures against abnormal occurrences, the following are to be taken into consideration (Explanation 9-8):
- a. Grasp of circumstances and emergency measures
- b. Measures to prevent worsening of abncrmal conditions
- c. Investigation of causes and measures required for security 9.3 Fuel control In defining for fuel control measures, the following are to be taken into consideration:
- a. Measures to not reach criticality
- b. Whether or not to allow continuous use of irradiated fuel
- c. Method for handling fuel 9.4 Radioactive vaste control In defining for radioactive waste control measures, the following are to be taken into consideration:
- a. Solid waste (a) Place for storage (b) Measures to prevent contamination (c) Confirmation of storage conditions
- b. Liquid and gaseous waste (a) Target values of discharge control (b) Measures in case discharge occurs in excess of target values 9.5 Radiation control In defining for radiation control measures, the following are to be taken into consideration:
- a. Zone control
- b. Control of dose equivalent
- c. Measurement of dose equivalent rate, etc.
- d. Contrcl of transportation of articles
- e. Control cf radiation measuring instruments, etc.
9.6 Maintenance control 9.6.1 Patrols and checks (Not described) 9.6.2 Periodic inspection (Not described) 9.6.3 Repair work control If identical items to the original cannot be procured, other products may be used after confirming that they satisfy the equivalent quality requirements. 9.6.4 Modification work control (Not described) 9.7 Emergency measures In defining for emergency measure control methods, the following are to be taken into consideration:
- a. Organizations to cope with emergencies
- b. Provision of equipments to cope with emergencies
- c. Communications with internal and external organizations concerned
- d. Emergency and relief measures
- e. Announcement and clearance of emergency systems
- 10. NON-CONFORMANCE CONTROL 10.1 General (Not described) 10.2 Identification of non-conformance The non-conformance of services that are difficult to correlate with products shall be identified by recording into reference documents (procedures, etc.) or other documents (reports, etc).
10.3 Review and disposition for non-conforming items 10.3.1 Control method for review and disposition (Not described) 10.3.2 Reaponsibility and authority for reviewing and disposition decisions (Not described) 10.3.3 Approval scope by purchaser (Nct described)
- 11. ACTIONS TO PREVENT RECURRENCE 11.1 General It is important to establish and perform corrective action by identifing
_. g _
the causes through examining changes in actual quality results or trends in past non-conformances. 1 11.2 Clarification of causes (Not described) i 11.3 Planning, decision, and execution of corrective action (1) Corrective action is to be planned, decided, and executed if considered to be necessary after evaluation based on the cause of non-conformance. (2) The decision to implement corrective action is generally made by the same organization that makes decision to take measures for non-conforming items er services. 11.4 Information of cause and corrective action (Not described)
- 12. CONTROL OF QUALITY RECORDS 12.1 General ,
(Not described) 12.2 Generation of quality records 12.2.1 Generation of records (1) Information to be described in the records includes the following:
- a. Necessary information
- b. All information described in the records is legible l
- c. All information described in the records is factual (2) In addition to the above, the following information is to be described in records:
- a. Identification number of records
- b. Names of plants and units, and names of items or services
- c. Names of organizations that generated the record
- d. Date, sign, or seal for generation, review, and approval of the record
- e. Applied codes, standards, or procedures 12.2.2 Collation of quality records (Not described) l l
t 12.3 Handling of quality records l 12.3.1 Submittal and receipt Upon defining the procedure for submitting or receiving records, the following i are to be taken into consideration:
- a. List of records designated to be submitted c,3 -
- b. List of reccrds for submittal or receipt
- c. Confirmation cf submitted or received records f 12.3.2 Correction and addition of quality records (1) Upon defining the procedure for correcting or adding records, the following are to be taken into consideration:
- a. Retaining the original information which caused the corrections or additions
- b. :iandling of the original records which have been subjected to correction er addition
- c. Indication of the date and name of organization that performed the correction er addition (2) When the correction or addition by the organization which organinated them is impossible, another appropriate organization may correct er add the records.
12.3.3 Retrieval and access Some indexing contents are as follows:
- a. Name of plant and unit
- b. Name of item or service l
- c. Name of organization which originated the record
- d. Retention period of the records 12.4 Retention of quality records 12.4.1 Retention period and categories of quality records (1) For records that have retention periods specified by regulations, the re-tention periods of the records are to follow them.
(2) When determining the specific retention periods for records classified as non permanent, the final verification timing for demonstrating the accomplish-ment of quality assurance activities is to be clarified, and the appropriate retention period is to be determined accordingly. (3) Records of particular items among the permanent records are to be retained and maintained by or for the plant owner at least up to the time when the item is removed. (Explanation 12-4) 12.4.2 Storage The following are to be taken into account fer storage facility features:
- a. Location of facilities, type, structure, etc.
- b. Prevention of flooding
- c. Ventilation and temperature / humidity
- d. Fire protection 12.4.3 Transfer of quality records Upen transferring records, the following are to be taken into account:
- a. Name of organization or place to receive transferred records
- b. List of records to be transferred i
I _ _ _ --- - -- _ -- _ ------- -- _ -_- _ ___ _ -- - - - _ _ _ _ _ _ _ _ 1
- c. Identifying the configuration of the records to be transferred (original, reproduced copy, microfilms, etc.)
- d. Collating transferred records with the list of records 12.4.4 Disposition of quality records Even if the records are categorized as permanent, those for particular items may be disposed once they are removed.
12.4.5 Checking stored records Upon checking records, the following are to be taken into account:
- a. Storage condition of the records is appropriate
- b. Stored records are accessible
- c. Records are stored in appropriate area
- d. Storage area for records is kept in a suitable condition
- e. Stored records are not deteriorated nor damaged
- 13. AUDITS 13.1 General (Not described) 13.2 Audit managenest 13.2.1 Auditor qualification or registration (1) The following knowledge, experience, and capability shall be considered when an auditor is qualified or registered:
- a. Special knowledge and experience of the area to be audited
- b. Knowledge and experience of audit methodology and techniques
- c. Knowledge of standards, procedures, and production processes
- d. Skill in communication, suitability, faithfulness, etc.
(2) The following knowledge, experience, and capability shall be considered when a lead auditor of the audit team is qualified or registered:
- a. Epucation, experience, professional ability, etc.
- b. Experience with audits
- c. Experience in document reviewing concerning quality assurance
- d. Experience in participating in general education, seminars, etc. on quality assurance 13.2.2 Timing of audit execution (Not described) 13.2.3 Audit objectives (Not described) 13.2.4 Audit procedures The following are to be included in audit procedures:
- a. Audit team
- b. Execution sequence, frequency, timing, etc.
- c. Objective scope of audit
- d. Audit plan documentation
- e. Notification to the auditee
- f. Audit report
- g. Findings, recommended matters, and their corrective actions
- h. Confirmation of corrective actions 13.3 Execution of audit 13.3.1 Audit team organization (1) The roles of the lead auditor are as follows:
- a. Preparation of audit, investigation, and pre-audit conference
- b. Command of the audit team
- c. Reporting of the audit, etc. by putting together findings and corrective actions (2) Members of the team might be selected from among experienced technical spe-cialists in addition to the qualified or registered auditors.
(3) Audit teams are not to force auditees to show information which the auditee judges to be confidential business or technology. 13.3.2 Pre-audit activities Audit execution plan is to include the following:
- a. Audit objective organ' ation
- b. Audit objective scope and business contents
- c. Audit team members
- d. Audit scheduling table
- e. Audit check list and procedures
- f. Audit notification 13.3.3 Pre-audit conference The following are to be confirmed at the pre-audit conference:
- a. Audit scope and scheduled date and time
- b. Audit direction method
- c. Conference date after audit
- d. Communication route 13.3.4 Execution of audit (1) Auditee is to make preparations for investigation facilities, documents, anc records.
(2) The following are to be confirmed and evaluated:
- a. Review cr quality assurance programme b, Review of specifications, procedures, and instructions
- c. Confirmation of the execution status of the quality assurance activities
- d. Investigation of personnel training and qualification statuses
- e. Investigation cf approved er accepted products, design calculations, drawing, etc.
- f. Investigation of process control and its records
- g. Follow-up for the findings and corrective actions of the previo>2s audit 13.3.5 Explanation and confirmation of audit results (Not described) 13.3.6 Audit Reports (1) The following are to be included in the audit report. In case there are findings, their basis for inclusion is to be clearly stated:
- a. Brief discription for the objectives and scope of the audit
- b. Main documents list used for evaluation
- c. Names of the audit team members
- d. Auditee's main representatives
- e. Brief discription of the pre-audit conference
- f. Brief discription of the findings and evaluation of quality assurance activ-ities
- g. Recommendations for improving quality assurance programmes (2) The audit report is to be distributed to the audited organization af ter receiving the approval of the responsible person at the audit organization.
13.3.7 Confirmation of audit reports (Not described) 13.4 Corrective action 13.4.1 Preparation of the corrective action report The follow. 3 are to be included in the audit report on corrective action:
- a. Contents of the findings
- b. Contents of the corrective actions
- c. Name of the responsible person for corrective actions
- d. Completed date or planned date for the corrective actions
- e. Name of the person who confirms the completion of corrective actions 13.4.2 Evaluation of the ccrrective action report (Not described) 13.4.3 Follow-up for corrective action Follow-up for corrective actions is to be performed according to the follcwing procedures, as necessary:
- a. The audited organization is to report the results of evaluations it has done on its corrective actions to the auditing organization
- b. Follow-up activities may include re-audits by the auditing organization or confirmation by documents i
[ EXPLANATIONS]
- 1. QUALITY ASSURANCE PROGRAMMES (Explanation 1-1):
" Establishment of quality assurance programmes" means the development and j documentation of those programmes.
(Explanation 1-2):
" Appropriate documents" means documents such as the quality assurance programme documents, control procedure documents for quality assurance, work plan documents, work procedures, work instructions, and Crawings.
(Explanation 1-3): l l I
" Reviews" include revices for quality information based on the verifi-cation results of the items or services and for audit reports in regard to the implementation status of quality assurance programmes.
(Explanation 1-4): In general, "the person who has been assigned responsibility for the es-tablishment and implementation of the quality assurance programmes" means the manager of the responsible section or department in the company. (Explanation 1-5): Control-oriented activities include the activities that establish quality assurance programmes and the activities related to the management of quality assurance programmes during all stages, from design to the operation and mainte- l 1 nance of nuclear power stations. ' Work-oriented activities are those activities that satisfy the technical requirements for design, procurement, installation, inspection, testing, oper-ation and maintenan.:e, etc. Work execution and its verification are included in these activities. (Explanation 1-6): The quality assurance programme documents describes control matters in- l cluded in the quality assurance programmes and the functions of these control matters. In some cases these documents are called quality assurance manuals er quality assurance procedures, etc., and their composition and methods of de-scription are not under special restrictions. If necessary, it is permissible to quote their detailed control procedures, work plan documents, werk instruct-icns, procedures, drawings, and standard sheets for quality assurance. It is common practice to prepare a quality assurance programme document at each stage of construction and operation and maintenance. (Explanation 1-7):
"The detailed control procedures for quality assurance" means procedures which prescribe detailed methods of control based on quality assurance programms. The
procedure for document control, for example, is included in the control procedures. - (Explanation 1-8): Examples of " documents for work plans" includes engineering schedules, fabrication process sheets, fabrication flow charts, inspection and test process sheets, QC check sheets, etc. (Explanation 1-9):
"The procedure for work" instructs work methods or inspection and test methods. The instruction sheet concretely instructs individual work in con-formity to drawings and procedures.
- 2. ORGANIZATION (Explanation 2-1):
" Activities affecting quality" in this sentence includes not only work-oriented activities but also specific control-oriented activities (audits, etc.).
(Explanation 2-2): The expression " regulations, codes, etc. " is used in this sentence, because there are some cases where the qualifications authorized by formal stan-dards are required by a contract, and others where those authorized by an enter-prise standards are applied.
- 3. DOCUMENT CONTROL (Explanation 3-1):
Documents related to each stage, from design to operation and maintenance, are divided into those issued by the organization that performs activities at each stage (e.g. procedures and instructions for fabrication / installation), and those issued by others which do not perform the activities directly (e.g. design documents and procurement documents for fabrication / installation). Basic Matters 3.3 describes those documents issued and distributed the by the organiza1on which performs activities, and Supplementary and Recommended Matters 3.3 describes both those documents issued and distributed by the organization which performs ac-tivities and those issued by other organizations and received by the former.
- 4. DESIGN CONTROL (Explanation 4-1):
The term " design" in this guide means the technical and managemental ac-tivities that range from identification of design requirements to issuance of design documents. (Explanation 4-2): Each section of this paragraph also applies to the design activities imple-mented, relating to items and services procured under this guide. ~ (Explanation 4-3): Design control measures also apply to the following:
- a. Evaluation of compatibility of materials
- b. Evaluation of in-service inspection, cperation and maintenance, and repair and repair ease
- c. Establishment of acceptance criteria for inspection and tests (Explanation 4-4):
In general, " design process" covers serial activities that begin with iden-tification of design requirements, followed by work based on those requirements, and verification of design adequacy. This leads to and includes issuance of design cocuments. Design verification is so important it is referred to as the con-clusive activity that assures design quality. It furthermore includes methods such as verification testing performed separately from the series of processes. It is therefore treated here inde-pendently as "c. Design verification." (Explanation 4-5): . The control of design requirements are, generally, executed by design divisions and this division is thus responsible. We have thesefore decided to handle this in
- des 16n process", regarding it as a part of the serial design activities. These activities include preparation of design documents which is done subsequent to design work.
(Explanation 4-6): ! Design requirement control measures are established to ensure that design requirements and their changes are correctly identified, documented, and approved. (Explanation 4-7): I
" Design documents" include specifications, procedures, instruction manuals, drawings, etc. l (Explanation 4-8): l
*0rganizations performing the design" means the organizations and the di- l visions involved in the organizations which perform activities that affect design ;
quality, such as specifying codes and standards, preparation of design documents and specifications, and instructing of technical matters. They are also called
" design organizations" in short. l (Explanation 4-9):
" Design reviews" are activities that confirm that the design documents are correct and satisfactory through a versatile review of such documents. These range from review by a single person to review by the group or crganization charged with the design work.
I The depth of design reviews ranges frcm a limited check of specific de-sign documents and of the design approach and its results to a detailed check er I I
review perferred systematically. (Explanation 4-10):
" Alternative calculations" are methods to verify calculations er analyses i by comparing the results with those obtained by other calculations or analyses. l (Explanation 4-11):
" Verification testing" is a method to verify some designs or specific de-sign requirements using a prototype unit, etc. under adequate conditions.
I (Explanation 4-12): Other design verification methods include the following: These methods are to be centrolled and performed, in principle, in the same way as verification testing described in this guide:
- a. Verification in ecmmissioning, etc. of the plant
- b. Verification by model engineering, etc.
- c. Verification using earlier fabricated items
- d. Verification by actual results obtained from earlier constructed plants (Explanation 4-13):
" Design changes" results from the following:
- a. Design review, alternative calculation, er qualification testing results
- b. Experience obtained during fabrication / installation;
- c. Structures, systems, er components which do not meet functional requirements
- d. Dispcsition cf non-conformance ,
- e. Changes du regulatory or other requirements
- f. Operation and vitenance experience
- g. .esign improvements (Explanation 4-14):
" Design analyses" include the following:
- a. Transient analyses
- b. Radiation protection and dose equivalent evaluation
- c. Reactor physics analyses
- d. Thermal and hydraulic analyses
- e. Stress analyses (including seismic analyses)
- f. Accident analyses (Explanation 4-15):
" Nature of the design activities" means the differences in design activity characteristics within and among the various orgenizations (plant owner and each contractor) concerning the preparation and review of design documents, design interface control, verification testing, and so on. " State of the art" means the difference in technical expertise such as in experiment:,1, develcpmental, or standard design. " Nature of design phase" mear.s the difference in character-1stics of each design phase such as basic design and detailed design.
e T l (Explanation 4-16):
" Quality standt:,-d" refers collectively to "The technical standards for construction of nuclear power plant components," "The standard for construction of boilers and pressure vessels," " Japanese Industrial Standards (JIS) " " Japan Electric Association Code (JEAC)," " Jai,an Electric Association Guide (JEAG)"
and standards and norms issued by other societies or associations. Designers and design organizations are responsible for confirming that appropriate quality standards are specified in the design requirements, designating the appropriate standards, the scope to apply them, and the grade in the documents which they issue. Especially, when designs are performed to standards or norms with partial modifications made to the generally used commercial ones, or when items complying with the designated specifications are selected from the products manufactured to commercial grade standards or norms by inspection / testing, it is necessary to make sure that the products are represented in the design document as different from commercial grade items. (Explanation 4-17): The selection of quality standards includes, mainly, the following design activitiea:
- a. Classification according to regulations
- b. Designation of grade or rating according to standards
- c. Selection or designation of specifications corresponding to type er model
- d. Selection or designation of standardized items or specifications, and selection of items which comply with designated specifications, or disposal requirements when adding partial processes
- 5. PROCUREMENT CONTROL (Explanation 5-1):
Various organizations such as plant owners, plant suppliers, equipment suppliers, etc. take part in activities which affect the quality of the nuclear power stations. The relationship among these organizations as seen from procurement control is as follows: 1 i 1 i l l Placement of order Bidder (before contract) Purchaser er Supplier (after contract) Placement of order Bidder (before contract) Purchaser or Supplier (after contract) Placement of order Purchaser (Ex. Plant owner - Plant supplier- -Equipment supplier--) (Explanation 5-2): Section 5 (PROCUREMENT CONTROL) defines the ;ctivities performed by the purchaser itself and the control performed by tk.e purchaser to suppliet; . Attached Fig. 1 shows an example of precurement control. (Explanation 5-3):
" Procurement document" means purchase specifications, estimation specific-ations, contract specifications, order sheets, etc.
(Explanation 5-4): It is not necessary to include all quality requirements from a to g in the following cases: ;
- a. Purchase of services (machining, heat treatment, or cleaning, etc.)
(In this case, it is not necessary to include such items as a, b, c, d, and g)
- b. Purchase by means of catalogues of parts, materials, components, etc. which are not cf high importance (In this case, it is not necessary to include such items as a, b, c, d, and g)
- c. Cases which are considered similar to a and b above (Explanation 5-5):
"Use" here means not only use during operation and maintenance but also use under fabrication, assembly, and installation of the procured items.
(Explanation 5-6):
" Reception" here means basically agreement of receiving process.
Figure 1 EXAMPLE OF PROCUREMENT CONTROL CONTROL PROCEDURE PURCHASER SUPPLIER
- 1. Clarifying quality Clarifyir.g the procurement requirements requirements j 4 l
- 2. Evaluation cf bidders l Evaluation of bidders l l 4
Selection of supplier
, a
- 3. Control of procured Procurement
- Placement of Receiving items and services specifications order order i
4 3.1 Control of documents Coordination, review, . Pre l Design l submitted by supplier approval -+ ratNn- , of sub-mitted Fabri-3.2 Indoctrination and advice to supplier l Indoctrination, advice [+. docu-ments cation 1 Inspection 3 3 Inspection and testing Witness, records and testing confirmation i Acceptance criteria Accepted lNotaccepted 4 3.4 Treatment after Receiving : l Shipping l receiving inspection 4 Control of quality records l Use l Non-conformance control i l
- 6. MATERIAL AND COMPONENT CONTROL
- i (Not described)
- 7. FABRICATION AND INSTALLATION CONTROL (Explanation 7-1):
The boundary between " fabrication" and " installation" is the point in time when the items are transferred from fabricating organization to the installing organization at site. Installation includes pre-operational testing performed before fuel loading. (Explanation 7-2):
"Special processes" are the processes whose results strongly depend on control of the working process, skill of the worker, or both. In these processes it is hardly possible to judge whether or not the required quality is satisfied by inspection or testing, that include welding, heat treatment, cleaning, and surface treatment, etc.
- 8. INSPECTION AND TEST CONTROL (Explanation 8-1): ,
" Hold point" is the point beyond which work may not proceed without the approval of specified organizations.
"Specified organizations" according to circumstances refers to various organizations, which include the quality assurance division of the plant owner and supplier and official inspection organizations.
"The proper document indicating the hold point" means various forms of documents such as specifications, procedures and working control documents.
- 9. OPERATION AND MAINTENANCE CONTROL (Explanation 9-1):
Operation and maintenance stages are the stages after initial fuel loading. Therefore, commissioning tests subsequent to initial fuel loading is also included in this section. (Explanation 9-2): These are determined for light water reactors. Other types of reactors are also to be managed respectively acceding to type. (Explanation 9-3): Periodic inspection plans, inspection procedures, inspection systems, and control cf measuring and testing eqapment are to be based on section 8 (INSPECTION AND TEST CONTROL). (Explanation 9-4): The relevant laws to be observed in operation and maintenance activity
stages are as follows: Electricity Utilities Industry Law Nuclear Regulation Law (The Law for the Regulation of Nuclear Source Mate-rial, Nuclear Fuel Material, and Reactors)
- Radiation Hazards Prevention Law (The Law Concerning Prevention of Radiation Hazards due to Radio-isotopes, etc.) and other such laws Relevant regulations and codes include:
Regulations Governing the Installation and Operation of Generating Nuclear Reactors in Practical Use
- Technical Standards for Nuclear Power Generating Facilities Technical Standards for Construction of Nuclear Power Generating Facilities Technical Standards for Welding of Electrical Article Works, etc.
Other relevant standards include: Japanese Industrial Standards (JIS) Japanese Electrotechnical Committee (JEC) Standards Japan Electro-Machine Industry Association (JEMA) Standards, etc. In operation and maintenance stages, there are articles (for example, Safety Provisions for Nuclear Reactor Facility) prescribed by the plant owner based on the Nuclear Regulation Law. (Explanation 9-5):
"The work judged to be important to security" means the work affecting the functions and performance of structures, systems, and components important to safety.
(Explanation 9-6):
" Emergency" means the cases in which a release of a large amount of radio-active material is likely to cause or actually has caused hazard, and situations in which it is difficult for normal power plant organizations to perform activi-ties in a swift and appropriate manner to remove the cause of the accident and prevent its spread.
(Explanation 9-7):
" Nuclear reactor coolant" is used in the case of BWR only, and " primary coolant" in the case of PWR only (or both BWR and PWR).
(Explanation 9-8):
" Abnormal occurences" here means the cases among the following in which the security of nuclear reactor facilities may be seriously affected:
(1) When an abnormality is found during routine monitoring and patrol checking. (2) When an abnormality is found before start-up and after shutdown. (3) Who alarms designated in advance among other alarms related to nuclear reactor facilities are actuated. (4) W. hen an abnormality such as an automatic nuclear reactor shutdown, occurs in ' the nuclear reactor facilities.
- 10. NON-CONFORMANCE CONTROL (Explanation 10-1):
"Non-conforming services" is the state where the performed service does not meet the specified requirements (for example, specifications, procedures, etc.).
- 11. ACTIONS TO PREVENT RECUFRENCE (Not described)
- 12. CONTROL OF QUALITY RECORDS (Explanation 12-1):
Guidelines for retaining the organization of quality records is shown below taking into consideration regulatory requirements, maintenance of records to be retained, and necessity of use: (1) The records relating to licenses, permits, and security are to be retained by the plant owner. However the records concerning licenses and permits for which applications have been submitted by the supplier, such as welding in-spection of an electric article, are to be retained by the supplier. (2) The retention responsibility for records which have been submitted from the supplier to the purchaser (such as those from plant manufacturers to plant owners, and from component manufacturers to plant manufacturers) is to be determined by agreement between the purchaser and the supplier. (3) Records other than those in (1) and (2) above, are basically to be retained by the organization which originated them. (Explanation 12-2): (1) The attached Table 1 shows the retention purposes of records. (2) The attached Table 2 shows sample classifications that take the safety / stable supplying capabilities of electric power into consideration. However specific classifications will be determined by the plant owner and the sup-plier. (3) The Attached Table 3 shows classifications that evaluate the degree of ne-cessity of records and when they will be used. (h) The attached Table 4 shows the classification for their verification timing. (5) The attached Table 5 shows the classification for their retention periods. (6) Basic guidelines for determining retention periods are shown in the attached Figure 1 with the attached Table 1 through 5 as supplementary information. In addition to the above, practical procedures are shown in the attached Figure 2. (7) Sample classifications for typical quality records are shown in the attached Table 6, and sample evaluation results of retention periods for the above records in accordance with the procedures shown in the ati. ached F16ure 2 are shown in the attachment Table 8. (Explanation 12-3): (1) When selecting a configulation to retain quality records, the following are to be taken into consideration: a) Retained of originals
- a. Recording methods are to be ler;;1c, not deteriorated, nor discolored
- b. Each record is to have identification such as record number and page number
- c. Records are to carry the name of the issuing organization, personal seal, or signature of the generator, reviewer, and approver
- d. Control to prevent inadvertent correction b) Retained as reproduceable copies (copy, microfilm, electronic / optical media)
- a. Duplicating no more or no less information than that included in the orig-inal, and reproducing similar information
- b. Control to prevent inadvertent correction or deletion
- c. Periodic renewal taking the media's validity period into consideration (2) The attached Table 7 shows considerations for use of duplicates.
(Explanation 12-4):
"Particular item describe" in this sentence means any item which is impor-tant to safety and that which has been pre-determined between the plant owner and the supplier. This item also includes their spare parts.
- 13. AUDITS (Explanation 13-1):
Instead of qualifying or registering auditors in advance, there is another inside procedure method. Select or designate auditors when organizing the audit team, taking their knowledge, experience, and proficiency into conside-ation. (Explanation 13-2): There are two types of audits, one being an external audit where the purchas-er audits the supplier, and the other being an internal audit where the purchas-er or the supplier audits his own organization. Table 1 RETENTION PURPOSES OF QUALITY RECORDS PURPOSE OF STORAGE SUBJECTED RECORDS l@ To demonstrate
- capability' for Necessary quality records at each stage safe operation at nuclear power of construction, and operation /mainte-
, plant nance of nuclear power plant. For en-i dersing licenses, permits, and operation l / maintenance. when required to report, j certify, explain, and audit / review safe safe operation by requirement of law, regulation, and others.
I f,; To enable routine patrols / checks, Necessary quality records during periodic inspection, and repair of operation / maintenance stages of nuclear an item power plant, for routine patrols / checks, periodic inspection, and repair (includ-ing replacement) that maintain safety, i stable supplies of electric power, and l prevent malfanction. I@ To enable modification of an item Necessary quality records during operation / maintenance stages of nuclear l
, power plant, for modifications which l achieve functional improvement of power pla-t, reflect past experience, and preclude recurrence of malfunction. @ To determine the cause of an Necessary quality records during item's malfunction operation / maintenance stages of nuclear power plant, to resolve the cause of a malfunction and dispose of it. @ To provide required baseline data Necessary quality records during the for in-service inspections (ISI) maintenance stage of nuclear power plant to evaluate degeneratien of components e @ To demonstrate2 the accomplishment Necessary quality records at each stage of quality assurance requirements cf construction er operation / maintenance cf nuclear power plant, to prove that the quality assurance activities have been performed as planned and the requirements have been accomplished.
Those are to be retained during specified periods to save as quality records for endorsing or evidencing information for required reports, to certify or to explain by requirement other than @ through @ above. l i
l'otes 1 The ability of a structure, system, or component important to safety of in a nuclear power plant to continue operation without caustrg excessive irradi-ation to the general public or plant personnel through maifunction. Solidly stated, " capability for safe operation" means to demonstrate that all permit and licensing items necessary for structures, systems, and component important to safety have been applied and approved. This also means that those components, etc. that satisfy the license and perrit items through fabrication, installation and pre-operation, and operation / maintenance activi-ty stages necessary to operate in accordance with laws and regulations, are carried out at the operational stage. 2 To explain something and its basis to related persons and get under-standing and approval by means of license and permit documents, contract-re-lated documents reports, achievements, records, etc. i I l I
)
9 Table 2 IM?ORTANCE CLASSIFICATION OF FACILITIES / COMPONENTS CLASSIFICATION DEFINITION i Level I Indispensable facilities / components that maintain the safe functioning cf nuclear power plants. I Level H Important facilities / components that maintain the safe function-ing of nuclear power plants, and indispensable facilities / components to maintain the stable supply of electric power. Level B All other Facilities / components. Table 3 NECESSITY CLASSIFICATION OF RECORDS AND RETENTION PERIODS CLASSIFICATION NECESSITY RETENTION PERIOD Technical records which are directly Fermanent a necessary for works (records to be used directly in works) Technical records which are necessary for Non-permanent b comfirmation of works (records to supplement
- a " above, although basic records exist)
Technical records which are desirable for Non-permanent c confirmation as reference (records to be used indirectly or for supporting purposes) Administrative records which are desirable Non-permanent d for conf;rmation as reference (records to be used indir ectly or for supporting purposes) Not app'.1 cable - l l l l
n Table 4 VERIFICATION TIMING CLASSIFICATION OF QUALITY RECORDS CLASSIFICATION VERIFICATION TIMING REMARKS a Completion of item or service b Pre-use inspection e Pre-operational test l d Start of commercial operation Completion of the first periodic inspection of each component for the records originated in operation / maintenance sta6e e Completion of the first Completion of the second period-periodic inspection ic inspection of each component for the records originated in operation / maintenance stage (move up the order thereafter) f Time of next calibration / check / revision, renewal, invalidation, and work g Time of audit Not applicable When applicable record does not exist, or is evaluated as permanent 4 _ 7j _.
Tablt 5 RETENTION PERIOD CLASSIFICATION OF NON-PEPRANENT RECOROS CLASSIFICAT40N RETENTION PERIOD REMARKS A Up to start of operation Up to start of commercial operation (if in operational stage, up to start of operation after completing
; periodic inspection)
B lUptocompletionoffirst 1. Completion of the first periodic periodic inspection inspection of component. In cases such as turbines for which partial periodic inspection is applied, or those tith long intervals for inspection, up to start of operation after complet-ing first major periodic inspection
- 2. In operational stages 1 above is applied at the start of operation af ter the completion of periodic inspection as a stating point.
C Up to completion of Guaranteed period by contract guarantee D Up to completion of ISI Inspection period specified by I cycle JEAC4205, titled "In-service Inspec-tion of Light Water Cooled Nuclear Power Plant Components", Inspection Program I (10 years /1005, 20 years / 100% 30 years /1005, 40 years /100%) er Inspection Program H (3 years / 100%. 10 years /100%, 23 years /100%, 40 years /100%) E Up to period specified of law / regulation F Others (specific periods) 1. Revision: up to next revision
- 2. Renewal : up to next renewal
- 3. Calibration / check: up to com-pletion of next calibration / check
- 4. Audit : up to next audit
- 5. Work up to completion of next work
- 6. Others periods specified by each organization 1
Table 6 TYPES OF QUALITY RECORDS STAGE TYPES Construction Records of licenses, permit, and security b Records of control-oriented activities l Records of work-oriented activities l (1) Design . (2) Procurement' . (3) Fabrication, installation,-inspection, examination, ; and pre-operation l 1 Operation Records of operation and maintenance 4 (Those of modificaten are to follow those of the i construction stage) 'I
?
1 Table 7 CONSIDERATION FOR USE OF DUPLICATES ! 4 SUPPLEMENTS
- 1. Duplicate a. Selection of duplicate type taking its accuracy and stability during retention into consideration
- b. Reduction rate or method for dividing duplicates
- 2. Microfilm a. Selection of film type, reduction rate, and developing; {
~
nethod taking its resolution and stability during retention period into consideration
- b. Method for divided exposure
- c. Index for retrievir4'
- d. Selection of storage method and place to minimize the '
degradation of resolution
- e. Renewal interval of film l t
- 3. Electronic or a. Selection of media type, reduction rate, and data storing ;
optical media method taking its resolution and stability during retention period into consideration
- b. Method of shearing data input for storing i
- c. Indexing systes for data retrieval (software) l
- d. Selection of storage method and place to minimize the r degradation of resolution
- e. Control measures for revision or correction of stored information i
l
- , _ . . . . . - .- a
Table 8 EVALUATION SAMPLE OF RETENT!DN PERIODS FOR QUAL.lTY RECORDS x Retention purpose N a aHon ucusW b lpging
\ _ leportance classification of facilities / components N @ @ @ @ @ @
na ad a Remarks
. _ Name of quality records N IIHlE IlHlE IIHIE IIHIE IIHIE I I H l lil IlDlE 1,. Records cf licenses t permits, tnd security. , , , , , , , . . .,,,,
I'kIIiEM'atlIchdNubtg Hg wa er nuclu r p r reactor a).. - - - - - ..P., bl e , , ,,
"II ). es , .,
..!.nspeqtion certificate., ., .)
,n .
- - - - - P,
. ,, ...,e . .e ...s.
...w ..e.. a e
.v
.kO911.t.r.assuranet progree..pacuents.,.aab v v ,.
**6 e*6 e .n.+.-. *
- d) .91. .d >+-d).e-ea4)..,e ..--
.. -.eq. d)oa.e..-,uwe.a.
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Note: I to V show sample of quality records la construction stage.
- Records concerning welding / pre-sse inspection are included in @ To demonstrate capability for safe operation @ To determine a cause of a malfunction records of licenses, permits, and security. and their retention Q Enable rentine patrols / checks. periodle @ To provide for 151 pertods are permanent, inspection, and repair @ To demonstrate the accomplishment of
_ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ m __ __ _ _ . _ _ _ - .__
e v 4 LEGEND. (laportance classification of facilities / components) Level I - Indispensable facilities / components for maintaining the safe function of nuclear power plants levet 11 Important facilities / components for salatsining the safe function of nuclear power plants, and indlapensable facilities / components for salataining the stable supply of electric power Letel E - All other factiltles/ components (Necessity classification of records and retention periods) a) : Technical records which are directly necessary for works. (Records to be used directly la works) b) : Technical records which are necessary for confirmation of works. (Records to supplement
- a
- above. although baale records exist) i c) : Technical records which are desirable for confirmation as reference.
(Records to be used Indirectly or for supporting purposes) i d) : Adelaistrative records which are desirable for confirmation as reference. (Records to be used Indirectly or for supporting purposes)
- Not applicable j (Verification timing classification of quality records) y a completion of ites or service
{ b c
- pre-use inspection pre-operational test i
d : start of commercial operation e . completion of the first perledic inspection f : time of next calibrallen/ check / revision, renewal. Invalidation, and work
- time of audit not applicable -
(Retention periods classification of records) 4 P . Permanent. l A Up to start of commercial operation 8 : Up to completion of first periodic inspection , C Up to completion of avarantee * ! D - Up to completion of ISI I cycle i E - Up to specified period of law / regulation F : Others(Specific periods: revision to next revision, renewal to next renewal, calibration / check-sp to completion of next calibration / check. audit to next audit. work to completion of next work.' other periods specified by each organtration) l l l l _ __ __ ___---_ _ - . _ _ _ . . . . . - - _ _ . _ _ _ - _ _ . - ~ __ _. _ . - .._ __ , ._. ._. .
f Figure 1 BASIC SYSTEW FOR ,L.ERMINING RETENTION PERIODS OF QUALITY RECORDS Types of records Table 6 Y Retention purpose Determining Regulatory requirements procedure for records retention Table 1 for retention periods Necessity classification Table 3 Importance Verification timing classification p of facilities / Table 4 components -~ Retention periods Table 2 classification Table 5 Figure 2 V Retention period Table 8 l l l 4 Figure 2 DETERWINING PROCEDURES FOR RETENTION PERIODS OF QUALITY RECORDS l Types of records l g s! !!!!!*"' 1 ff!!!!!f!!!!ifi.*!"l'!"!!Fitr 1 - 1 1 UA!'!:l regu
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Evaluate necessity of records 3 3 categorized under these Permanent Non* retention purposes for
# *" e!!Sf!!$$1{l!!febap!ne!$s 1 (Table 2. 3)
!!c!!ba!!e**!IEne!!!s!!y" I
(Table 3) , l Permanent l Retention purpose T
@ Enable restine patrols / checks. a and repair b @ Enable modification - -* I @ To determine a cause of e malfunction 8 @ To provide for ISI s
Evalsate necessity of records of each retention purpose @ throsch
@ f or laportance classification of each facilities / components (Table 2. 3) fle'b!gE!!I!!!ess$I$ ""
(Table 3) l Permanent l l Retention purpose j
@ To demonstrate the ,
accomplishment of quality assurance reanfrements [ (Non-permanent records only) - Specify final verification tialog of records for saporsance classificat.cn of each facilities / components 1 (Table 2. 4) l
!ch'h" son verift!akorfe!!a!hh!!s'{oihei!
ing (Table 5) 1
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- Overseas orders should be sent to : .'
6' i i, ? g i Japan Publications Trading Co., Ltd. j j i Book Export 11 Department i, 0 j P. O. Box 5030 Tokyo International l ' g;
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j Tokyo 100-31 Japan i j Te 1 : +81 ( 0) 3 -3292 -3753 l Fax +8 1 ( 0 ) 3 -3292-J764 : ELECTR0 TECHNICAL GUIDE NUCLEAR POWER EDITION JEAG 4101-1990
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, ,,, _ .. i.a Guide for Q6alithAs[sN6e!6fhNiiclear e n. . m ;2=' . .. ..
- ~ Power Plants.
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5 Published March 31, 1993 e' , Price Y4,300 y
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Y i Compiled by ELEC TR0 TECHNICAL STANDARD SURVEY COMMITTEE 1, Published by JAPAN ELECTRIC ASSOCIATION - Yurakucho 1 1, Chiyoda-ku, Tokyo, JAPAN 1 4 C JAPAN ELECTRIC ASSOCIATION 1993 Printed by Otowa Printing Co.. Ltd. ; l
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