ML20078Q080
| ML20078Q080 | |
| Person / Time | |
|---|---|
| Site: | 05200004 |
| Issue date: | 12/14/1994 |
| From: | Marriott P GENERAL ELECTRIC CO. |
| To: | Borchardt R NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), Office of Nuclear Reactor Regulation |
| References | |
| MFN-160-94, NUDOCS 9412210151 | |
| Download: ML20078Q080 (39) | |
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l GENuclear Energy P. W. Mamort. Mana9er GeneralEkx*ic Company AdwancedPlant Tocts1obges 175 Cumer Annue, MC 781 Sur Jose, CA 961251014 4M 9254940(phone) 406925-1993(facsunik)
December 14,1994 MFN No.160-94 Docket STN 52-004 Document Control Desk U. S. Nuclear Regulatory Commission Washington DC 20555 Attention:
Richard W. Borchardt, Director Standardization Project Directorate
Subject:
NRC Requests for Additional Information (RAls) on the Simplified Boiling Water Reactor (SBWR) Design
References:
1)
Transmittal of Requests for Additional Informaton (RAI)s Regarding the SilWR Design, Letter from M. Malloy to P. W. Marriott dated Nove:nber 25,1994.
The Reference letter requested additional information regarding the quality assurance program under which GIRAFFE helium tests are to be performed. In fulfillment of this request, GE is submitting Attachment I to this letter which transmits the response to RAI 900.95.
Sincerely, h). Advanced Plant Technologies P. W.
arriott, Manager, " Response to NRC RAl" cc:
P. A. llochnert (w/l copy of Attachment 1)
F. W. Ilasselberg (w/l copy of Attaclunent 1)
J. H. Wilson (w/2 copies of Attachment 1) 9412210151 941214 PDR ADOCK 0520 4
yo a
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i RAI Number: 900.95 Question:
The September 26,1994 response (MFN 113-94) to RAI 900.67 states that the new GIRAFFE helium tests will be performed by Toshiba in accordance with Japanese National Standard JEAG-4101-1990, " Guide for Quality Assurance of '
Nuclear Power Plants." The response also states that GE's review found that this standard meets the intent of Appendix 11 to 10 CFR Part 50 and the American i
National Standards Institute /American Society of Mechanical Engineers
[
(ANSI /ASME) NQA-1-1983.
Proside a copy of the analysis and/or evaluation that was performed to substantiate thatJEAG-4101-1990 is in compliance with the appropriate provisions of Appendix 11 to 10 CFR Part 50 and ANSI /ASME NQA 1-1983.
GE Resoonse:
GE compared the requirements of 10CFR50, Appendix 11 withJEAG-4101-1985 carly in the AllWR program and concluded at that time that theJapanese QA program met the intent of the US QA program (see attached "A Comparison lictweenJEAG-4101-1985 and 10CFR50 Appendix 11" by A.J. Levine dated 16 July 1987). In 1990, the Electrotechnical Standard Survey Committee of the Japan Electric Association revised the format ofjEAG-4101 into "llasic Matters",
" Supplementary and Recommended Matters", and " Reference Matters".
A comparison and evaluation of the "llasic Matters", " Supplementary and Recommended Matters" and " Reference Matters" ofjEAG-4101-1990 to NQA-1/la 1983 requirements and supplements are presented below. The comparison 3
is keyed to the Ilasic Requirements of NQA-1. Since the purpose of this evaluation is to compare theJapanese QA program requirements with those of the US programs, a detailed comparison of Appendix Il to 10 CFR Part 50 with NQA 1/la 1983 will not be addressed unless the differences help understand the requirements of theJapanese program, liased upon this comparison and evaluation, GE concludes thatJEAG-4101-1990 -
meets the intent of both Appendix 11 to 10 CFR Part 50 and the American i
National Standards Institute /American Society of Mechanical Engineers (ANSI /ASME) NQA-1-1983.
Comoarison and Evaluation The "llasic Matters" explained in Chapter 1, Section la ofjEAG-4101-1990 are requirements comparable to the liasic Requirements of NQA-1. The
" Supplementary and Recommended hiatters" are explained in Chapter 1, Section Ib as matters that "should be complied with as described or by substitutes". These are evaluated by GE to be comparable to the Supplements of NQA-1. The " Reference hiatters" are evaluated by GE to be comparable to the Appendices of NQA-1.
NOA-1/la-1983 Ilasic Renuirement 1. ORGANIZATION. and Sunnlement IS-1.
The corresponding sections inJEAG-4101-1990 are in Chapter 2,'S' ction 2, e
"llasic hiatters" and " Supplementary and Recommended hiatters". Although JEAG does not emphasize independence as forcefully as the US programs, "Ilasic hiatters", Section 2.2 requires the QA organization to have authority necessary to implement quality activities. TheseJapanese requirements meet the intent of flasic Requirement I and Supplement IS-1.
NOA-1/la-1983 Ilasic Reauirement 2. OUALITY ASSURANCE PROGRAM.
ancl Sunolements 2S-1 and'2S 2.
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The corresponding sections in JEAG-4101-1990 are in Chapter 2, Section 1, "llasic hiatters" and " Supplementary and Recommended hiatters".
In addition, the requirements for personnel qualification in the NQA-1/la-1983 Supplements are addressed in JEAG Chapter 2, "llasic hiatters" Section 8.2 and
" Supplementary and Recommended hiatters" Sections 8.2 and 13.2.1. These Japanese requirements, while located in different sections of theJapanese document, meet the intent ofIlasic Requirement 2 and Supplements 2S-1 and 2S-2.
NO_A-1/la-198311asic Renuirement 3. DESIGN CONTROL and Supolement SS-
.L The corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 4, "llasic hiatters" and " Supplementary i.,d Recommended hiatters". The independence of the verifier in theJapanese program is similar to 10CFR50, Appendix 11. The explicit preference in NQA-1 for non-participation of a supervisor is not found in either 10CFR50, Appendix Il orJFAG-4101-1990. The Japanese practice of conducting multiple team design reviews on each major product or system provides the diversity of review sought in Supplement SS-1.
GE evaluated theJapanese requirements as meeting the intent ofIlasic Requirement 3 and SS-1.
NQA-1/la-1983 Iktsic Requirement 4. PROCUREMENT DOCUMENT CONTROL ind Sunnlement 4S.
The corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 5, "llasic hiatters" and " Supplementary and Recommended hiatters". The Japanese section combines the requirements of procurement document control with the control of purchased items and senices. TheJapanese requirements meet the intent of Ilasic Requirement 4 and Supplement 4S-l.
NO_A-1/la-1983 Ilasic Reauirement 5. INSTRUCTION
S. PROCEDURE
S. ANL)
DRAWINGS.
The corresponding sections in JEAG-4101-1990 are in Chapter 2, Section 3, "llasic hiatters" and " Supplementary and Recommended Statters". The Japanese section combines the requirements for the control ofinstructions, procedures, and drawings with the requirements for document control. The Japanese requirements meet the intent of llasic Requirement 5.
NO_A-i/1a-1983 Ilasic Renuirement 6. DOCUNTENT CONTROL and Sunnlement f.6 L.
The corresponding sections inJEACM101-1990 are in Chapter 2, Section 3, "llasic hiatters" and " Supplementary and Recommended hiatters". As noted above, theJapanese section combines the requirements for the control of instructions, procedures, and drawings with the requirements for document control. An element of document control can also be found in " Supplementary and Recommended hiatters" Sections 4.2.4. TheJapanese requirements meet the intent ofIlasic Requirement 6 and Supplement 6S-1.
NOA-1/la-1983 liasic Renuirement 7. CONTROL OF PURCHASED ITENIS AN'D SERVICES and Sunnlement 7S-1 The corresponding sections in JEAG-1101-1990 are in Chapter 2, Section 5,
"!!asic hiatters" and " Supplementary and Recommended hiatters". As noted above, theJapanese section combines the requirements of procurement document control with the control of purchased items and services. The US emphasis for retaining procurement records at the nuclear power plant site is not required to the same degree inJapan because power plant owners require continued support, including document control and retrieval, over the entire plant life. The amount of retained and transmitted documentation is covered by contract. I.ikewise, commercial grade items are not a specified issue in Japan. The degree of detail inJEACM101-1990 Section 5 is similar to Appendix 11 of 10 CFR Part 50 rather than Supplement 7S-1. However, the issues of planning, supplier selection, bid evaluation, supplier performance, supplier documents, changes, acceptance, and nonconformities are addressed in the "llasic hiatters" or " Supplementary or Recommended Statters" sections 7.1, 5.3, 5.3, 5.4, 5.4, 4.5 & 5.2, 5.4, 5.4 & 10 & 11 of Chapter 2, respectively. As noted above, planning is considered more of a fabrication than a procurement activity and change control is impacted by design. Ilased upon the above, it is concluded that theJapanese requirements meet the intent of thtsic Requirement 7 and Supplement 7S-1.
I NOA-1/la-1983 liasic Requirement 8. IDENTIFICATION AND CONTROL OF ITENIS and Suoniement 8S-1 The correspon' ding sections inJEACM101-1990 are in Chapter 2, Section 6, "llasic hiatters" and " Supplementary and Recommended 5fatters". This Japanese section combines the requirements for identification and control of items and handling, storage, and shipping and its requirements meet the intent ofIlasic Requiremt nt 8 and Supplement 8S-1.
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'i NOA-1/la-1983 Basic Reauirement 9. CONTROL OF PROCESSES and Sunnlement 9S-1 Tlie' corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 7, l
" Basic Matters" and " Supplementary and' Recommended Matters". This J panese section extensively addresses fabrication and installation control and i
includes working process control and special process control during fabrication at the factory and during installation at the nuclear power plant. Its requirements meet the intent of Basic Requirement 9 and Supplement 9S-1.
NOA-1/la-1983 Basic Reauirement 10. INSPECTION and Sunnlement 10S 1 -
Th'c corresponding sections inJEAG-4101-1990 are in Chapter'2, Section 8, "llasic Matters" and " Supplementary and Recommended Matters". Inspection control is explicitly identdied in " Basic Matters" and " Supplementary and Recommended Matters" sections 8.2 and its requirements meet the intent of Basic Requirement 10 and Supplement 10S-1.
NOA-1/1a-1983 Basic Reauirement 11. TEST CONTROL and Sunnlement 1IS-1 The corresponding sections in JEAG4101-1990 are in Chapter 2,'Section 8,
" Basic Matters" and " Supplementary and Recommended Matters". This Japanese section combines the requirements for inspection and testing and its
. requirements meet the intent of Basic Requirement 11 and Supplement llS-1.,
l EOA-1/la-1983 Basic Reauirement 12. CONTROL OF MEASURING AND TEST EOUIPMENT and S'unolement 12S-1 The corresponding sections in,JEAG-4101-1990 are in Chapter 2, Section 8,
" Basic Matters" and " Supplementary and Recommended Matters". This Japanese section includes the requirements for the control of measuring and test equipment. " Basic Matter" 8.4 is dedicated to calibration and control of measunng instruments and test equipment and its requirements meet the intent of Basic Requirement 12 and Supplement 12S-1.
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. _ NOA-1/la-1983 Basic Reauirement 13. HANDLING. STORAGE. AND l
SIIIPPING and Sunnlement 13S-1 The corresponding sections in JEAG-4101-1990 are in Chapter 2, Section 6,
" Basic Matters" and " Supplementary and Recommended Matters". As stated I
above, thisJapanese section combines the requirements for identification and control of items and handling, storage, packaging, and shipping, and transportation and its requirements meet the intent ofliasic Requirement 13 and Supplement 13S-1.
NO_A-1/la-1983 liasic Reauirement 14. INSPECTION. TEST. AND OPERATING STATUS The corresponding sections inJEAG-4101-1990 are in Chapter 2 Section 8, l
" Basic Matters" and " Supplementary and Recommended Matters". These Japanese sections includes requirements for the indication ofinspection, test, and operation status in 8.5. Its requirements meet the intent of Basic Requirement 14 and Supplement 14S-1.
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' NOA-1/la-1983 Basic Reauirement 15. CONTROL OF NONCONFORMING ITNMS and Sunnlement l'5S-1 I
The corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 10 and l
- 11. "llasic Matters" and "Supplementag and Recommended Matters". The Japanese QA program puts major emphasis on both non-conformance control and actions to prevent recurrence and, in this case, is more descriptive than either NQA 1 or Appendix 13 of 10 CFR Part 50. This section meets the intent of Ilasic Requirement 15 and Supplement 15S-1.
NOA-1/12-1983 Basic Reauirement IG. CORRECTIVE ACTION i
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i The corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 10 and
- 11. "llasic Matters" and " Supplementary and Recommended Matters". As stated above, theJapanese QA program puts major emphasis on both non-conformance control and actions to prevent recurrence and, in this case, is more descriptive than either NQA-1 or Appendix 11 of 10 CFR Part 50.
Corrective action is also addressed in "Supplementag and Recommended Matters" section 13.4 under audits. TheJapanese sections meet the intent of liasic Requirement 16.
NO_A-1/la-1983 Basic Reauirement 17. O_UALI'IY ASSURANCE RECORDS and Sunolement 17S-1 t
Th'c corresponding sections inJEAG4101-1990 are in Chapter 2, Section 12, "llasic Matters" and " Supplementary and Recommended Matters" The issues i
of administration, receipt, storage, retrieval, and disposition are addressed in the "llasic Matters" or " Supplementary or Recommended Matters" sections 12.2, 12.3,12.4,12.3, and 12.4. TheJapanese sections meet the intent ofliasic Requirement 17 and Supplement 17S-1.
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. NOA-1/1a 1983 liasic Reauirement 18. AUDITS and Suoolement 18S-1 The corresponding sections inJEAG-4101-1990 are in Chapter 2, Section 13, "Ilasic Matters" and " Supplementary and Recommended Matters". The Japanese sections meet the intent ofIlasic Requirement 18 and Supplement 18S-1.
i NOTE-Chapter 2, Section 9 ofjEAG-4101-1990, " Operation and Maintenance Control" is not identified in the above evaluation because it addresses safe operation, maintenance, and modification work control at nuclear power plants. This topic is not directly addressed by NQA-1/la-1983.
PEN 12/12/94
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's 16 Jul'y 1987 j
AJL 8729-Frem: A.J.Levine -
k m/c 685, en 53217 Tc tribution
Subject:
A Comparison Between JEAG 4101-1985 and 10CFR50 Appendin B.
t A detailed comparison between the Japanese Que ity Assurance (OA) t requarements as described in JEAG 4101-1985
.ed the QA criteria in 10CFR 50 Appendix B has been completed and is forwarded,for your-review and comment.
Comments are requested-by _31_gyly_198Z.
C The translation of JEAG 4101 was providr a Sy AD-EX Translations t
' International as of Sept. 1986.
.r The comparison is in two major sections.
The first, (pgs.2-26),
t identifies all those sections in both documents which were. determined to be very similar in content and/or intent.
The second, (pgs. 27-32), identifies those portions of both documents where either
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the language was different enough that similarity was not clear, or, the topic or intent was not addressed in the other document.
All the words of both documents are included cn referenced in the I
compertson.
i Distribution:
J.L.Embley m/c 682 J.F. Quirk m/c 782 P.E. Smith mc/ 780 J.S.Spirakfs m/c 517 f
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J.S. Gay m/c 685 J.N. Fox m/c 782 i
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4 COMPARISON BETWEEN JAPANESE ELECTRIC ASSOCIATION JEAG 4101-1985 091DE_E96_999611Y_BS59BBUGE_E98_U9GLE68_EDWEB_EL6 BIS AND U.S. CODE OF FEDERAL REGULATIONS 10CFRSO APPENDIX B 99861IY_9ESYB6Ngg_ gBJ Jg BJ S_ EgB_ yggg g68_ BQygB_ g(69Jg_6hp_ Egg 6 BEEB99EEW199_EL6 BIS 18159D.9GI19U The f ollowing compari son is intended to show the significant similari ty between the U.S.and Japanese Quality Assurance (OA) j requirements.
In the columns which follow, those portions of the 18 criteria f rom 10CFR50 App.B and the comparable sections ~of' JEAG 4101-1985 are shown.
Included in the compari son are the
" Explanations" referenced in the body of the text in JAEG 4101-1985 and contained in the Explanations appendix to JAEG 4101-1985.
t Those portions of both documents which are not the same or where the requirements were not addressed in a similar manner, or, a requirement addressed in one document was not in the other document are shown in the Differences section of this document.
Some of the differences are attributable to the f act that the Japanese licensing process' is different than that in the U.S.,
e.g. there are no safety analysis.
reports, separate construction permits or operating licenses.
G9BCL93193 r
It was determined that the goals of both documents are identical.
Because the requirements in both documents are so similar., it can be concluded that there are no fundamental differences between the documents and adherence to the requirements of either document will resul t in a quality product.
LEEGL_GEELIGGIl99 1
The introductory description to JEAG 4101-1985 states:
" Technical standards based on the Electrical Utility Industry Law I
prescribe in a legally obligatory manner the minimum items nccessary for maintaining the safety of electrical structures."
where it is desirable to prescribe regulations in broad general terms for the sake of guaranteeing safety but where precise regulations are difficult to prescribe immediately, the practice is to organize the regulations in terms of "Electrotechnical Guides."
" Consequently, as a general rule it is desirable for the the Electretechnical Guides to be obeyed in the same way as the Electrotechnical Regulations -~~~--------- "
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i In this way the "Electrotechnical Guides" have the same force of law as the US Code of Federal Regulations and associated Regulatory Guides.
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Prepared by A. J. Levi ne 15 July 1987 1
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e 10GEBQQ_GEEze 2E9E_4191:1255 t
10tteduttt9a E9shz l21 111 Every applicant is required to A quality assurance plan must be include a description of the established at each. stage from quality assurance program to be designing to operation of applied to the desi gn, nuclear power plants.
l fabrication, conntruction and testing of the structures, systems, and components of the faci 1ity.
Englgogtigg_ _3 Nuclear power plants and fuel The " Guide for Evaluation of reprocessing plants include Safety Designs Concerning-structures,, systems, and Light-Water Reactor Facilities components that prevent or for Fower Plants" (June 14,1977, mitigate the consequences of Atomic Energy Commission) gives postulated accidents that could the following definition for cause undue risk to the health
" structures, systems and and safety of the public.
equipment important in safety":
Structures, systems and equipment which, should they cease to function, would be 3
feared to expose the general i
public and employees to excessive radiation in the event
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of an accident."
E '12 1 This appendin establishes quality This Guide establishes the basic assurance requirements for the items concerning quality design, construction, and assurance needed for securing operation of those structures, the safety of nuclear power t
systems, and components.
plants and maintaining the health of the general public and employees.
EDEtz1z2 The pertinent requirements of This Guide applies to activities this appendix apply to all influencing the quality buch as activities affecting the safety-designing, procurement, r el at ed functions of those manufacturing, inspection, structures, systems, and handling, storage, shipment, components; these activities on-site assembly, installing, include designing, purchasing, testing, operation and fabricating, handling, shipping, maintenance of the structures, installing, inspecting, testing, systems and equipment important operating, repairing, refueling, in the safety of a nuclear power and modifying.
plant.
2
19GESLQ_etEue 4E60_d191:1200 Enttt_1t1_121 As used in this appendin, The quality assurance plan must
" quality assurance" comprises all establish methods for executing those planned and systematic systematically activities which actions necessary to provide will have an influence on adequate confidence that a quality.
This plan must also structure, system, or component include the creating of records will perform satisfactorily in indicating that the necessary service.
Quality assurance quality has been achieved.
includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, Engl30ptige_ _2
. structure, component, or system The " person" executing tasks to predetermined requirements.
refers to the "I ndi vi dual " or
" organization" executing them here and in the following chapters.
It9CGEGLEttign Ses%2_123_lil The applicant shall be The installer has the responsible f or the establishment responsibility for establishing and execution of the quality amd implementing the assurance program.
quality-assurance plan of a
nuclear power plant.
Sestz_1t?_121 The applicent may delegate to The installer can delegate to others, such as contractors, another organization such as the agents, or consultants, the werk plant manufacturer or equipment establi shing and executing the manufacturer some of the actions ot quality assurance program, or any of establishing and implementing part thereof, but shall retain the quality-assurance plan, the responsibility thereof.
provided that the range of responsibility is clearly defined.
An organization which has been delegated such actions also in turn delegate them can to another organization in the same way, i
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10GEBEQ_GEEtB dE6@_4101: lies Eustt_1tI_131 The authority and duties of An organization which has been persons. and organi z ati ons delegated some of.the actions of performing activities affecting establishing and implementing a the safety-related functions of quality-assurance plan has the 3
structures,. systems, and.
responsibility for the actions components shall be clearly of establishing and implementing' established and delineated in the quality-assurance plan writing.
t within that range.
Hecht_st1_111 An organi ation must be established in which the range of responsibility and authority for implementing the quality-assurance plan or the distribution of the tasks is clearly defined.
- Moreover, systems of communications inside and outside th9 organi:ation must be clearly established.
EEEtt_1ti ill These activities include both the Quality-assurance activities performing functions of attaining consist of the execution and quality objectives and the verification of quality-related quali ty assurance f unctions.
The tasks at each stage from quality assurance functions are designing to operation.
The
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those of (a) assuring that ab person executing the tasks is appropri ate quali ty assurance the one that bears the program is established and responsibility for achieving the effectively executed, and (b) necessary quality.
veri f yi ng, such as checking, auditing, and inspection, that the Activities af f ecting the safety-related functions have been correctly performed.
Bestt_st1_121_s The persons and organizations Those verifying the quality and performing quality assurance those giving guidance and advice functions shall have sufficient to ensure that a suitable authority and organi:ational quality-assurance plan is freedom to identify quality established and executed problemst to in2tiate, recommend, effectively must have the or provide solutions; and to necessary authority to perform veri f y i mpl ementati on of those tasks.
solutions.
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19GEB00_8EEtB JE80.6191:1E05 11c_QueLLtr_6anutente_Etentem Sestz_211_l11 The applicant snail establish at The quality-assurance plan must the earliest practicable time, be established and formulated in consistent with the schedule for writing before the beginning of accompli shing the acti vi ties, the quali ty-assurance acti vi ties a
quality assurance program which concerning the nuclear power complies with the requirements of p l ar. t.
this appendix.
This program shall be documented by written EnglaOct190-4 pol i c i us, procedures, or There are both comprehensive and instructions and shall be carried separate quality-assurance out throughout plant life in plans.
A comprehensive
,accordance with those policies, quality-assurance plan is one procedures, or instructions.
which establishes the comprehensive quali ty assurance plan concerning the designing, fabrication, construction, operation, etc. of a nuclear power plant.
A separate quality-assurance plan is one which establishes the quality-assurance plan of products or services.
Bestz_221_l31 The quality-assurance plan must be executed in accordance with specifications, written procedures, written instructions, drawings, etc.
suited to the achievement of these activities.
l
19GEBEQ_6EEcE 4E60_d191:1205 Eteleuetten_2 The applicant shall identify the The " Guide for Evaluation of structures, systems, and Safety Designs Concerning compcnents to be covered by the Light-Water Reactor Facilities quality assurance program and the for Fower Flants" (June 14, majer organizations participating 1977, Atomic Energy Commission) in the program, together with the give the following as definitive designated functions of these examplea of " structures, organizations.
The quality systems, and equipment important assurance program shall provide to safety":
control over activities af f ecting the the quality of the identified
" Structures, systems and structures, systems, and equipment important to safety" components, to an extent include reactor coolant pressure consistent with their importance boundaries, emergency core to safety, cooling system, containment facilities (containment boundaries, the reactor building in SWRs and the annulus part in FWRs), containment heat removal system, atmospheric cleaning system of containment facilities, flammability control system, safety protection systems, reactor shutdown system, reactivity control system, control-room and
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control-room ventilation and air-conditioning facilities, auxiliary feedwater facilities (FWRs only), residual-heat removal system, off-site auxiliary power system, emergency on-site power system, spent fuel storage facilities, stacks, core-support structures, fuel assemblies, equipment containing highly radioactive gases, and other instrumentation and control systems and c ool i n g-wa t er systems necessary in the operation of the aforsaid facilities.
1 6
J 10GEB50_8EEtB 2E6@_d191:120s Eest_Its The program shall provide for the Those carrying out activities indoctrination and training of personnel performing activities influencing the quality must be af f ecting quality as necessary to given the necessary education assure that suitable proficiency and training in accordance with' their knowledge, experience, and is achieved and maintained, skills.
i Activities affecting quality Entit_2t1_121 The quality-assurance plan must shall be accomplished under in a suitable manner specify suitably controlled conditions, clearly the methods for executing the quality-assurance activities in line with the requirements of each chapter of this guide.
t Escit_911_1114121 The program'shall take into (1) In order to assure the account the need for special quality of products conforming controls, processes, test with the requirements of the equipment, tools and skills to laws, standards, codes, design attain the required quality as documents, etc., items such as necessary to assure that a the work, equipment and skills suitable proficiency is achieved and maintained.
of werkers relating to f abrication and installation must be managed.
(2) The following items must be taken into consideration if appropriate when establishing i
methods for managing these items:
- a. Construction methods and working sequences,
- b. Equipment andd' devices.
- c. Working environment.
- d. Skills of ~ the workers.
Sastt_2t2_111 The applicant shall regularly The person who has revi ew the status and the responsibility for the adequacy of the quality assurance establishment and implementation
- program, of the quality-assurance plan must, whenever necessary, examine the validity of such plan and its state of implementation.
i Entit_2t2_121 Should inadequacies be discovered in the quality-assurance plan as a
result of examinations, measures I
must be taken to correct them.
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19GEB59_GEEtB JE6@_4191:1200 Eettt_1ts_121 Management of other organications An organization which has been participating-in the quality del egated some of the actions of assurance program shall regularly establishing and' implementing a review the status and adequacy of quality-assurance plan has the that part.cf the. quality responsibility for the actions assurance program which they are of executing.
establishing and implementing the quality-assurance plan within that range.
111tDestun_Genttet Ss5tz_D.1_111 Measures shall be established to Managen.snt methods must'be assure that applicable regulatory established in order.to reflect
' requirements and the design correctly the design basis, as defined in 50.2 and as requirements such as laws, specified in the license standards, codes and basic application, for those design conditions in the' design structures, systems, and documents (specifications, components to which this appendix written procedures, written applies are correctly translated instructions, drawings, etc.).
into specifications, drawings, These management methods.must procedures and instructions.
include management of changes These measures shall include and departures from design provisions to assure that requirements.
appropriate quality standards are specified and included in design documents and that deviations from such standards are control l ed.
595ts_Erl_111eab Measures shall also be Concerning structures, systems established for the selectior, and or equipment, the methods must review for suitability of establish the selection of the application of materials, parts, following, as well as studies of' equipment, and processes that are the validity of their essential to the safety-related applications functions of the structures,
- a. Materials and parts which are systems, and components.
important in their functioning.
- b. Construction methods applied to them.
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19CEEEQ 6EELE dE6@_4191 19@5 Eectz Et2 LLLtL2L Measures shall be established for (1) Design tie-ins between the identification and centrol of organizations carrying out the design interfaces and for designing and between coordination among participating departments within an-design organizations.
These measures shall include the organi:ation must be clearly established in writing.
establishment of procedures among participating design.
organizations for the revi ew, Concerning the creation, approval, release, distribution, and revi si on of documents examination, approval, publication, distribution, and involving design interfaces.
revision of design documents 7
concerning design tie-ins, the responsibility of the relevant organization or department within the organi:ation must be clearly established.
(2) Design information concerning design tie-ins must 9
be managed, ar.d methods for transmitting it must be established.
As a general rule, this design information must be transmitted in writing to organizations and departments in an organization which will be influenced by it.
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EeEtt Et2.111 The design control measures shall Suitable management methods must provide f or verifying or checking be established for verifying the the adequacy of the design, such validity of the design of as by the performance of design structures, systems, or reviews, by the use of alternate equipment.
Depending on their or simpli fied calculational degree of importance, such measures, or by the use of a methods may be design suitable testing program.
examination, alternate calculations, proving tests or other methods.
EeEt&_Iti 121b The verifying or checking process When quality is verified, it shall be perf ormed by individuals shall be carried out by someone or groups other than those who other than the person executing performed the original design, the tasks subject to but who may be from the same verification, organs:ation.
9
S P '
19GEBQ0_GEEtE 4E89_d191:12es EEEtt_EtE 121A121 (2) Verification of. designs must be made by persons other than i
the original. design 9r.
(3) The results et verification muut be formulated in writing.
Euelanat190_:_U.
Design control measures shall be appl i ed to items such as the Design management methods are applied, for example, to items following: reactor physics, such as the following:
t stress, thermal, hydraulic, and
- a. Transi ent anal ysi s accident analysis; compatability b.
Radiation protection and of materials; accessibility f or exposure evaluation
. inservice inspection,
- c. Reactor physical analysis maintenance, and repair; and
- d. Thermal flow analysis delineation of acceptance
- e. Stress analysis (including criteria for inspections and tests.
seismic analysis) f.
Accident analysis
- g. Evaluation of suitability _of materials l
l SSEtz_9zd_l1141214121 Design changes, including field (1) Procedures to be used during changes, shall be subject to design revisions (including design control. measures on-si te revi sions) must be commensurate with those applied established.
to the original design and be (2) approved by the organization that Design revisions must be carried out by the same design performed the original design management methods as those I
unless the applicant designates applied to the original des 2gns, another responsible crganization.
As a general rule, the revised design documents must be examined and approved.by the same person who examined and approved the original design documents.
(3) Methods for transmitting information concerning design revisions must be established.
4 As a general rule, this information must be transmitted in writing to the organizations 4
and to the departments within the organizations which will be influenced.
10
19CEE59 6EEtE 4E6@_d191:1205 12t_EcoEutement_Detweent_Genttel i
Sests_s11_l114121 Measures shall.be established to (1) In order to procure products assure that applicable regulatory and services of a suitable requirements, design bases, and quality, a method must be other requirements which are necesary to assure adequate established for specifying
{
quality are suitably included clearly the requirements or referenced in the documents for concerning quality in the procurement documents.
procurement of material, (2) Items such'as the following equipment, and services, whether are included if appropriate in purchased by the applicant or by its contractors or the requirements concerning quality, but they are not l
r subcontractors.
' limited to these alone.
a.
Work items ~to be performed by the supplier.
- b. Technical requirements such as designing, fabrication, testing, inspections, and applicable laws.
Items concerning the c.
submission of quality-assurance plans.
- d. Items concerning witnessing of tests, inspections, auditing, etc. at the suppliers place of business.
Items concerning the e.
submission of documents and submission and preservation of records.
- f. Items concerning inadmissable processing.
g.
Items ex tendi ng requirements-
.in the the procuremont documents as far as the contractor's suppliers.
Bests _622 To the extent necessary, In selecting suppliers,'an procurement documents shall require contractors'or evaluation must be made about whether or not the supplier is subcontractors to provide a able quality assurance program to supply products or services matching the consistent with the pertinent requirements of the procurement 4
provisions of this appendix.
documents.
The evaluation includes the f ollowing i tems if appropriate:
- a. Technical ability and quality assurance system.
- b. Past record in suppl ying products or services.
c.
Froduct samples.
11
10GEEEG_GEEtB 4E60_d191:1202 Eup.Lenetten_:_6
" Procurement documents" mean documents such as the purchase specifications, estimate specifications, contract specifications, and purchase orders.
Entlenetton_:_B The quality-assurance plan compiled by the supplier should include items corresponding to the requirements of the person who placed the order.
Mit_Uggumget_Ggottgl Eustt_ Sci Measures shall be established to Management methods must be control the issuance of established concerning the documents, such as instructions, creation, examination and procedures, and drawings, approval of the necessary including changen thereto, which documents concerning quality prescribe all activities assurance activities affecting quality.
(quality-assurance plan documents, specifications, written procedures, written instructions, drawings, etc.).
E2Ett_dt2 Management methods must be established concerning revision of documents.
Enttt_St1 These measures shall assure that When management methocs are documentn, including changes, are established, the persons who reviwed for adequacy and approved have responsibility for for release by authorized creating, examining and personnel and are distributed to approving the documents must be and used at the location wnere clearly defined.
the prescribed activity is performed.
Segt _422 3
Concerning the publication and distribution of documents, management methods must be established ensuring that the appropriate and correct documents will be used, such as the method of using document distribution lists.
12
19GEBL9_9EEtB JE65_d191-1295 heb L_
Changes to documents shall be L
reviewed and approved by the same Enamination and approval.of document revisions must, organications that performed the general rule,.be performed by as a i
original review and approval the person who first carried out unless the applicant designates their examination and approval.
I another responsible organization.
Care must be taken in handling old documents in order to i
prevent misuse of the old documents, and information
'3 concerning their revisions must be transmitted promptly to the concerned persons.
211t_Couttel_ei_Eutsbesed
_detettett_EGuineentx_ cod
_EetxLEet t
F SeGiz_hz2_Ill Measures shall be established to In order to confirm'that the assure-that purchased material, purchased products and services equipment, and services, whether purchased through contractorn or conform with the requirements of subcontractors conform to the the procurement documents, they must.be managed by checking the procurement documents.
quality records, etc. provided by the supplier, by inspection i
and audits at the suppliers place of business, by tests at the time of delivery etc.
GeEtt_ktL_L2L_etGt4tetLLGs These measures shall include Items such as the following are prov2sionn, as appropriate, for included if appropriate in the source evaluation and selection, requirements concerning quality, objective evidence of quality' but they are not limited to furnished by the contractor or theses alone, subcontractor source, and
- a. Work items performed by the examination of products upon supplier.
delivery.
Items concerning the submission c.
of quality-assurance. plans.
d.
Items concerning the witnessing of tests, inspections, aud i t i,on, etc. at the supplier's place of business.
e.
Items concerning submission of documents and submission and preservation of recoros.
f.
Itemn concerning inadmissable I
processing.
- g. Items for extending the contractor's requirements in the procurement documents asa far as the contractor's suppliers.
i I
i igcEBgg_eEEsg 4E60_e191:1E9E Etatenetten_ _Z The requirements must' include the requirement that, when a contractor in his turn places.an order f or' an i mportant product,
{
he must obtain the approval of the subcontractor by the person who placed the order.
1 Essiz_bza_l21 Documentary evidence that-.
It must be possible for material and equipment conform to-i
,the procurement. requirements quality records proving that the purchased products conform with shall be available at the nuclear the requirements of the power plant or fue1' reprocessing procurement documents to be used plant site prior to installation at the factory or"at-the site or use of such material or prior to their fabrication, equipment.
assembly, installation or use.
This documentary evidence shall
@HEts_6x1_1gl_b t Items such as the followine are be retained at the nuclear included if appropriate in the powerplant or fuel reprocessing requirements'concerning quality, plant site and shall be but they are not limited to sufficient to identify the these alone, specific requirements, such as (b) Technical requirements such codes, standards, or as designing, fabrication,-
)
speci f i ca ti ons, mot by the testing, inspections, and purchased material and equipment.
applicable laws.
Essiz_lazi It must also be possible to collate these records with the products in question.
P P
14
19GEBE9_GEEtt JEeG_d191:12e=
Enctt_st2 The effectiveness of the control of quality by contractors and In selecting suppliers, an evaluation must be made about subcontractorn shall be assessed whether or not the supplier is by the applicant or designee at able to supply products or intervals consistent with the services matching the importance, complenity, and requirements of the procurement quantity of the product or documents.
The evaluation ser vi ces.
includes the f ollowing items if appropriates a.
Technical ability and quality-assurance system.
- b. Past record in supplying products or services.
- c. Past record of use of products or services.
- d. Product samples.
EBRleQetieO_2 It is desireable that the person evaluating the technical ability and quality-assurance system should, as far as possible, go to the supplier's place of business to make the evaluation.
Y111t_IdenttiLEstL90_end_Ge01tel
______ei_detecielni_Eettat_end
______Gemneuents Sestt_211_lil Measures shall be established for A suitable method for the identification and control of identifying the materials and materials, parts, and components, equipment through the stages including partially fabricated assemblies, from fabrication to operation must be established in order to ensure that appropriate materials and equipment (including parts) will be used, or in order to trace their history as needed if there are unsuitable products.
15
v t
4 19GE559_6EEtB dEBE_d191:12eh Eestc_Zti_121 Theue measures shall assure that Engravings, tags, nameplates, or identification of.the item is the like 5 earing the heat maintained by heat number, part numbers, lot numbers, part number, serial number, or other numbers, machine numbers or appropriate means,.either on the other suitable symbols must be item or on records traceable to used as the identification y
the item, as required throughout markings, and they must be fabrication, erection, marked as.far as possible on the installation, and use of the materials or the equipment.
i item.
These identification and Identification markings on the control measures shall be materials and equipment must designed to prevent the use of satisfy the following 1
,the incorrect or defective conditions.
material, parts, and components.
They must be obvious and a.
distinguishable from others.
t
- b. They must not disappear easily.
They must not exert an c.
7 adverse effect on quality.
Euelecat190_:_19 If materials bearing.
identification markings"are divided into segment the identification mark:
must be moved to each. segment oefore they are divided.
The identification markings'on materials and equipment must be such that they are not erased by surface treatment, coating, etc., unless they are replaced by some substitute. method.
IEt_Gechtel_ef_Seestel_Etetesses i
Esstz_8 2_1112321 Measures shall be established to (1) The work must be managed in 2
assure that special processes, accordance with requirements including welding, heat treating, established in suitable t
and nondestructive testing, are documents such as written controlled and accomplished by procedures, written quali fied personnel using instructions, drawings, etc.
qualified procedures in (2) In cases where work in accordance with applicable special processes is requ2 red by standards, specifications, the laws, standards, codes, or criteria, and other special requirements.
design documents, etc., methods must be established for carrying it out by means of the approved workers, working methods or equipment.
16
I.w ll w
12GEB52_GEEtB 4E60_d121:lleQ Eunlecetten_:_11 Special processes means work processes in which the results of the work depend to a high'
+
degree on the management of the-process of execution,'the skill I
of the workers, or both, and the required quality cannot be judged easily by inspections. or testing.
Examples include welding. heat treatment, washing, surface treatment etc.
$x_105aestten Sestz_22 1 (1)2351 A program for inspection of (1) A Plan for inspections must activi ties af f ecting quality be established'and inspections shall be established and executed must be carried out in order to by or for the organization.
performing the activity to verify verify that the procedures and services match the conformance with the documented specifications, written instructions, procedures, and procedures, written drawings for accomplinning the instructions, and drawings.
ac t i vi ty.
(5) The way to judge the results of the inspections and whether t
the inspection is passed or not must be formulated.in a t'
document.
E8n12021190_:_16 Written inspection procedures or testing procedures must. include i
the following' items if appropriate:
(1) Parts subject to inspection or testing, items inspected.or tested.
(2) Applicable laws, standards, Codes.
(3). Methods of inspection or testing, procedures, items.to be recorded.
(4) Criteria for judgement..
(5) Format of document listing l
results of inspection or testing.
(6) Other necessary items.
17
i 1QGEB52_6EEta 4E80_d191:12em Eastz_Sti_121 Such inspections shall be Inspections must be carried out j
performed by individuals other according to the written than those who perf ormed the inspection procedures, etc.-by activity being inspected, someone'other than the person who carried out the work subject
/
to inspection. The 3
qualifications of the inspectors must also be established when necessary.
Sggtz_2z1_Jyl If inucection of processed In cases where inspection.is material or products is impossible after working or impossible or disadvantageous, assembly,-or when it is indirect control by monitoring necessary to monitor something.
processing methods, equipment, else during a process, indirect-and personnel shall be provided.
management such as monitoring of the working methods or devices or the skills of the workers must be estetlished.
Best_221_Idl If mandatory inspect.cn hold In cases where an inspection 11s points, which require witnessing required at a hold point, beyond or inspecting by the applicant's which the work must not proceed designated representati ve and without the' approval of a beyond which work shall'not specified organi:ation, the hold proceed without the consent of point must be indicated in its designated representative are advance in'a suitable document.
reouired, the specific hold points shall be indicated in Segtz_2x2_Jsl.
appropriate documents.
In cases where tests are required.at a hold point, the hold point must be indicated in advance in a suitable document.
t
's t
18 m.
4 19GEBL9_6EEtB 4E6e_d191:1269 Eup_Leneti eG_:_16 A hold noint means a point j
beyond which the work must not proceed without the approval of a specified organication.
The I
specified organization mny be various organizations depencing on the circumstances, but examples might include the I
installer, the supplier's quality-assurance depertment or the inspection agency.
The suitable document incicating the hold point may take various forms depending on the circumstances, such as specifications, written procedures, or documents related to work management.
X1t_ Inst _G90tt9L 59s12_2t2_l11 _161 A test program shall be (1) A plan fo testing must be established to assure that all established, and tests must be testing required to demonstrate carried out, in order to prove that structures, systems, and that a product matches the compontqts will perform established requirements and sat z st actoril y i n servi ce is f ulfills its f unctions toentified and performed in satisfactorily during operation.
accordance with written test L4) The way to judge the test procedures which incorporate the results and whether the tests requirements and acceptable are passed or not must be limits containec in applicable formulated in a document.
decign documents.
EE21f0fli90_:::_12 The test program shall include, Testing includes as appropriate, proof tests pri or pressure-resistant and leakage to installation, preoperational testing, functional testing and tests, and operational tests perfortnnte testing of units and during nuclear power plant or systema, plent trial operations, fuel reprocessing plant certification testing of operation, of structures, execution muthods and devices, systems, and components.
and certification and durability testing of prototypes.
19
10CEbE9_SEELE E.E60 6191:118E
%ectt_?t;_L;L Test procedures shall includo The tests must also be carried proviwlons for ausuring that all out by suitable persons under prerequi sites f or the gi ven test suitable environmental have been met, that adequate test c or.d i t i on s.
Jnstrumentation is available and used, and that the test is performed under suitable environmental conditions.
SeEtz_2 2_l31 Test results shall be documentoo The way to judge test results and evaluated to assure that test and whether the tests are passed requirements have been met.
or not must be formulated in a document.
Es9120st190_ _1d_l314_ld14_lD1 Wtitten inspection proceduras or testing procedures must include the following items if appropriates (3) Methods of inspection or testing, procedures, items to be recorded.
(4) Criteria for Judgement (5) Format of document listing results of inspection or testing.
Elit_Genttei_ei_Meenutite_ cod
_____lett_Eauinment sestt_e ;
Measures shall be established to The equipment, devicesand tools z
assure that the tools, gages, used in the work must have the instruments,and other measuring required functions and and testing devices used in precision.
activities affecting quality are Suitable inspection, maintenance properl y controlled, calibrated, and handling methods must be and adjusted at specified established in order to maintain periods to maintain accuracy their f unctions and preci sion, within necessary limits.
20
t
[
10GEbE2_BEEtB 4E60_d191-1200 Enntz_2t2 (1) Methods must be established-for assuring that the measur ing instruments and testing devices, etc.'used for judging the inspections and tests.are ofcthe
~
suitable measuring ranges, types, accuracy and preci sion.
(2) The measuring instruments and testing devices must be calibrated and adjusted at j
established intervals or oefore in order to maintain their use necessary accuracy.
(3) When it has been found that the accuracy of the measuring instruments and testing devices is outside the permissable j
range, the validity of the i
measurements, inspections or testa carried out after the last l
calibration must be evaluated, and the products inspected or tested must be evaluated again as to whether or not they have passed.
(4) Management metnods must be
~
established concerning suitable
~.
handling, storage, and use of the' measuring instruments and testing devices.
X111t_dendlinex_Et90enet_and
_Ebientna Sestz_Zz2 Measures shall be established to Methods for handling, storing, control the handling, storage, washing, packaging, shipping and shipping, cleaning and transporting the materials and preservation of material and equipment in accordance with work equipment must be established in order to prevent their damaging, and inspection instructions to deterioration or loss..Other prevent damage or deterioration.
matters such When necessary for particular as covers, handling devices and envieonmental products, special protective conditions must also be environments, such as inert gas established.
atmosphere, specific moisture leveld, and temperature l evel s,
shall be specified and provided.
21 I
.__..,_,.-_.m___,
r 19 GEE 59_8EEth dE0e_d191:12@U 11Yt_10Enettlect_Ishtz_end Reeta1LO9_Etatus 5 c%z_219 11L 9
'Measuren shall be established to l
' States concerning inspection or indicate by the use of markings testing of the products such as stamps, tags, labels, (including passing or routing cards, or other suitable non passing) must be indicated means, the status of inspections by marks, tags, labels, and tests performed upon the other suitable. method.
or some i ndi vi dual items of'the nuclear Identification management of the power plant or fuel reprocessing products must be performed as plant.
These measures shall necessary'in order to see that provide for the identification of only products which have passed
' items which.have satisfactorily will be used, installed or passed required inspections and operated.
tests, where necessary to preclude inadvertent bypassing of such inspections and tests.
.[
l 5ect. 9.4 (2)
Measures shall also be 1
In order to prevent accidental established for indicating the operations, methods for operating status of structures, indicating the operating states systems, and components of the of the systems or equipment by nuclear power plant or fuel attaching tags to the valves or reprocessing pl ant, such as by switches must be established as tagging valves and switches, to necessary.
prevent inadvertent operation.
i
/
t t
KYt_N90EEnietmLQ9_dSLEticlEz Partsz_gt_Ggmagngets
{
b
~
Sect. 11.1 Measures shall be established to i
Should disqualified products or control materi al s, parts, or components which do not conform services occur, methods for identifying them in order to i
to requirements in order to prevent their inadvertent use or prevent them from being used or installation.
accepted accidentally, as well l
as methods concerning examination and processing concerning their subsequent handling, must be established, i
i
'22
.~.
.-- ~
.i 5
+
I 10CFR50 i
- - - - - - - _ _ A_ F F_. B-gggg_gygg_ggg EEEtt_1152_111 These measures shall include, as Disqualified products or appropriate, procedures f or identification, documentation, services must be identified by suitable methods such as by segregation, disposition, and marking them, by attaching' tags notifscation to the affected org an i z at i ons.
to them, by putting them aside, by documents, so that.they or will not be'used or accepted accidentall y as they are.
Bestt_1152_III The responsibility for i
examination of disqualified products or services and the r
authority for, deciding about their disposal shall be established.
{
Eests_1152_121t_lel Non-conforming items shall be (2) Disqualified products must'be i
reviewed and accepted, rejected, examined according to an.
repaired or reworked in accordance with documented established procedure, and i
procedures.
decisions must be reached about.
i whether they are.notLto;be accepted, whether they are to be s i repaired and accepted, or whether they are to be accepted j
as they are.
(4) In cases where disqualified t
products or services which do t
not satisfy the procurement requiremennts are to be accepted as they are, or where disqualified products are to be i
eccepted with serious repairs, the technical validity of this must be formulated in documents and the approval of the person who placed the order must be obtained.
Euclecet190 r_19 The range of serious repairs requiring the approval of the person who placed the order must be established in advancu between the person who placed the order and the supplier.
23
10 GEE 50_BEEzB 4E80 d101:1209 I?lz GaccecLLye eCLLea 59512 1211 1111 121 Measures shall be established to (1) Should cisqualifications assure that conditions adverse to occur, their causes must be quality, such as f ailures, elucidated, measures to prevent malfunctions, deficiencies, devi ati ons, defective material their recurrence must be formulated and decided upon, and equipment, and and nonconformances are promptly management methoca for implementing them must be identified and corrected.
In the established.
case of significant conditions (2) Those concerned must be adverse to quality, the measures informed of the causes of the shall assure that the cause of occurrence of the
.the condition is determined and disqualifications and the corrective action taken to measures preclude repeti ti on.
The to prevent recurrence.
identification of the significant condition adverse to quality, the cause of the condition, and the correcti ve acti on taken shall be documented anc reported to appropriate l evel s of management.
XY11s_Quelity_GasutsnEe_5esetdn sestz 12z1 Sufficient records shall be When maintained to furnish evidence of carrying out activi ties af f ecting quality.
quality-assurance plans, The records shall include at suitable quality records must be created.
least the following: Operating The quality records must be records serving logs and the results of reviews, objective evidence of the as inspections, tests, audits, product quality and as objective monitoring of work performance, evidence of the and materials analysis.
quality-assurance activities at each stage from designing to operation.
It must also be possible to collate these records with the products in question.
24
.4 i
I i s i
)
i 19CEE59_6EEtB 4E60_d191:12B5 i
EEEtt_12t2 Records shall be identifiable and retrievable. Consi stent wi th The quality records must be spplicable regulatory managed in accordance with established methods'of handling, requirements, the applicant shall j
storage, etc.
When establishing establish requirements concerning the management methods, the record retention, such as types of quality records and duration, location, and assigned responsibility, their storage periods must be-12111t_6tdLis clearly specified.
r Erst _1921_ (1)
A comprehensive system of planned In order t
to verify the state of and periodic audits shall be carried out to verify compliance implementation of the quality-assurance plan and its with all aspects of the quality efficacy, audits must be carried surance program to determine out as necessary.
ie effectiveness of the program.
A method including the following' The audits shall be performed in accordance wi th the written items must be established for carrying out audits:
procedures or check lists by appropriately trained personnel Organization for carrying cut a.
not having direct audits and auditors..
b.
responsibilities in the areas Items subject to auditing.
being audited.
Procedures for carrying out c.
- audits, d.
Auditing schedule Cross-checking of specified e.
items.
i' EEEtt_1St2 Audits must be carried out in
'j any of the following cases in accordance with the circumstances and the importance j
of the activities subject to auditing (1) When, before placing an f
order it is necessary to judge j
whether or not the supplier has i
a quality-assurance plan and the ability to carry it out.
(2) When, after' placing an 1
order, it i s necesary to confirm that the supplier is carryi ng out his f unctions exactly au set
(
forth in the quality-assurance plan.
(3) When serious changes have been made in the functional aspects of the quality-assurance plan, such as serious organizational changes or changes in the management procedures.
25
~.
~_
...... ~.. -. -
E
?
l l
1QEES59_GEEtB JE60_d191:12a5
~(4) When there is a. concern about-the quality of products or services on account of inadequacies in the quality-assurance plan.
(5) When there were specified items'for which corrections were required and it is necessary'to' j
verify that the items have been
'l corrected (6) When it is necessary to,
confirm other items concerning the circumstances of implementation of the quality-assurance plan and its efficacy.
EEG18021190_2_12' Auditors as a general rule to be persons belonging to an organization'other than the organization being audited.
It is desireable 'for auditors to be selected according to prescribed
{
standards.
'l gestt_1st1_121 Followup action, including reaudit If there are any specified items of deficient areas, shall be taken where indicated.
for which corrections are required, it must~be verified that they have been corrected.
.t i
t 4
l l
t
\\
26
. ~...,, _ _.. _ _ _.
ElEEEEENGE@
JAPANESE ELECTRIC ASSOCIATION JEAG 4101-1985 GY1DE_E98_996LIIY_655986NgE_E98_Nyg6g68_EgyEB_EL6UIS AND U.S. CODE OF FEDERAL REGULATIONS 10CFR50 APPENDIX B 996 LIIX_6E SYB6dg E_ gBJ 1gBJ 6_ EgB_ NyGL E66_ EgygB_EL6NIg_6ND_
^
BEEB99ESSIUD_ELBUIS 199EB52_6EEzB i
JE69_4191:1205 101C9d951190 Reference is made to submittal of Because the licensing process in safety analysis report for a a
Japan is different, no reference construction permi t and operating is made to construction permits 1.canse.
or operating 1Acenses.
1_9cae01:stieo i
Such persons and organizations Eualana1190_:_1 I
performing quality assurance This Guide was compiled with reference to the " Standards for functions shall report to a Implementation.of Quality management level such that this required authority and Assurance for Safety in Nuclear Power Plants" (1978) organizational freedom, including (hereinafter called the sufficient independence from cost and schedule when opposed to
" Implementation Standards"),
safety considerations, which were compiled by the are International Atomic Energy provi ded.
Decause of the many Agency with the participation of
?
variables involved, such as the the member countries.
It was number of personnel, the type of designed to be as applicable as activi ty being perf ormed, and the location or locations where possible to the national conditions in Japan so that it acti vities are perf ormed, the could be a guide in'their organi:ation1 structure for application.
Essentially, executing the quality assurance program may take various forms quality-assurance activities are provided that the persons and to be carried out in a not organi:ations assigned the cut-and-dried' manner, and it I
quality assurance function have would be difficult to expect thi s required authori ty and them to be effective unless 1
they are carried out organizational freedom, as an l
independent activity suiting Irrespective of the the actual situation.
From organizational structure, the this viewpoint,this guide does i ndi vi dual (s) assigned the not attempt to set forth any responsibility for assuring effective execution of fixed minimum requirements, but any portion of the quality assurance aims at giving goals _for carrying out independent program at any location where quality-assurance activities.
acti vi ti es subject to this 4
appendin are being performed shall have direct access to such levels of management as may be necessary to perf orm this function.
27
19GEBQ9_6EEtB 4E6@_d191:12@D The intent for quality assurance to be an independent activity is recognized but the organi=ational freedom requirement is not addressed as in 10CFR50 Appendix B.
- Further, App. B specifically addresses the freedom from cost and schedule considerations for the quality assurance organization.
Il_90elltE_9EEMC60EE_EC99Cem Ersiz_2212121_st This section states the applicant The basic responsibility for
'may del egate to others the work of executing the quality achieving the required quality belongs to the one executing the assurance program but the tasks.
applicant "---shall retain the responsibility therefor."
c Although the responsibility designation is different, in both documents the responsibility for achieving the required quality assurance is specifically designated.
E"E18081190_ _2 Not specifically addressed.
Incidentally, it is desirable for the installer to apply this p
Guide, witnin a specified range, I
also to those which are not important to safety but which are important in assuring the reliability of the power plant.
69Etz_@z2_121 Controlled conditions incluu. the The environment in the workplace use of appropriate equipment; must be maintained so that the suitable environmental conditions work can be carried out for accomplish 2ng the activity, suitably.
such as adequate cleanliness; amd assurance that all prerequisites for the given activity have been satisfied.
The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.
Although the specifics of the definition of controlled conditions are not addressed, i
the intent of this portion is
{
the same as that in App.
B.
2@
i 19CE6E9_6EEtB EE6@_619121E@E Gestt_;t?
Not speci fi call y addressed.
When the quality-assurance plan is executed by more than one organization, a method must be 1
established for coordination and communication between the organizations.
Not speci f i call y addressed.
Sectt_9c6 (1) When new construction methods are to be applied in fabrication anc installation, the validity of these construction methods must be confirmed by a sui table metnod.
(2) When a new construction method is to be applied to an actual work, the necessary management methods must be established.
Not speci fi call y adderessed.
Best _19t1 In order to maintain safe operation of a nuclear power plant, management mathods concerning operation.
maintenence and reconstruction must be established.
Not speci fically addressed.
Eest_19t2 (1) Operation must be carried out by operators who have received suitable' education end training in accordance with the prescribed written procedures and routines etc.
(2) The written procedures and routines, etc. must set forth matters such as the normal operating procedures, the operating procedures during accidents and failures, the ordinary rounds of inspection, and the tests during operation.
29
1 i
1 19 GEE 09_6EEtE dE60 9191:1Ee5 Not speci fi call y addressed.
Essic_19t?
The maintenance work such as ordinary inspections, regular inspections, repairs, etc. must be carri ed out in accordance with the prescribed written procedures, routines, etc.
EREtt_19tS Not specifically addressed.
When reconstruction work is to be carried out, it must be managed in accordance with the r el evant articles and sections of this guide.
111_Denien_Centtet i
Not speci fi call y addressed.
Ennlanatie0_:_5_lb1
- h. Evaluation of ease of in-service inspection, operation, maintenence and repairs Enetenetteo_:_1; Where a test program is used to The " inspection" and " testing" verify the adequacy of a specific mentioned in thin Guide design feature in lieu of other correspond to " inspection" and verifying or checking processes,
" testing" as defined in the it shall include sui t abl e
" Standards for Implementation of qual i f i cat i ons testing of the Quality Assurance" of the IAEA.
prototype unit under the most adverse design conditions.
Inspection includes materi als testing, nondestructive testing, mechanical testing and incpection of the external appearance and dimensi ons.
Testing includes pressure-resistance and leakage testing, functional testing and performance testing of units and systems, plant trial operations, certification testing of execution methods and devices, and certification and duracility testing of prototypes.
30
I 19 GEER 9_GEEtB JE60_4191:1geg Yt_letttunttcast_Ecoteducent_ cod Etew1.enn Acti vi ties af f ecting quali ty Although not speci fi cal l y shall be prescribed by documented identified, the intent to have instructions, procedures, or drawings, of a type appropriate comparable requirements can be found in Sect. 6.2 and 6.3 for to the circumstances and shall be procurement documents; in accomplished in accordance with Explanation 14 for acceptance those instructions, procedures, criteria er drawings.
Instructions, in written inspection testing procedures and, in or procedures, or drawings chall Sect. 9.2 (4) for documentation in:lude appropriate quantitive or of criteria for judging test quali tati ve acceptance criteri a results.
.f or determining that important acti vi ti es nave been satisfactorily accomplished.
Y1z_Desueent_ggeltg1 IJot speci ficall y addressed Sestz_Sts When document revisions are to be examined and approved, the information necessary for that must be used, and the initial requirements and their gists must be understood.
Y111t_ideettiLEett90_eed_Genttel
_ei_detettelat_Eettna_and
_Geenenteint Not specifically addressed.
59st _221_121 When it is difficult to make identification markings on materials and equipment, e~ when there is fear of mi suce i t onl y they are used, other methods must be used to ensure accurate identification, such as by storing in classified r,torage places or establishing instructi ons f or managing the procedures for payment upca del i very.
31
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10GEEeQ 6EEth
.dE@@_d1Q1:12@g At_Innnectice Enelanatien_r_12 Examinations, measurements, or Plans for inspections or plans tests of material or products for tests are plans setting
{
processed shall be performed for forth such matters such as the each work operation where parts which are subject to
{
necessary to assure quality.
inspections or tests, the items inspected or tested, and the schedules for carrying them out.
Both inspection and process Not specifically addressed.
monitoring shall be provided when control is inadequate without both.
i XVII. Quality _633ucaggg_Bgggcd3 The records shall also include closely-related data such as Not specifically addressed.-
qualifications of personnel, j
procedures, and equipment.
Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted.
XY111t_8udita Audi t resul ts shall be documented Not specifically addressed.
and reviewed by management having responsibility in the area audited.
r 1
6 ll D
a 1
32
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