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UNITED STATES
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.g-NUCLEAR REGULATORY COMMISSION y
WASHINGTON, D. C. 20555 NOV a s an A. Patricli Leighton, III, Esquire ~
Shaw, Pittman, Potts & Trowbridge 1800 M Street, Pd IN P.ESPONSE REFER Washington, DC 20036 TO F0lA-84-793
Dear Mr. Leighton:
This is 'in further response to your letter dated April 17, 1984, in which you requested, pursuant to the Freedom of Information Act (FOIA), all records relating to the Ford Amendment Study.
The 17 records identified on the enclosed Appendix 0 are subject to your F0IA request and are already available for public inspection and copying at the NRC Public Document Room (PDR). The PDR file location is included with the description of each record.
The 103 records identified on the enclosed Appendix P are subject to your F0IA request and are now available for public inspection and copying at the PDR in folder F01A-84-293 under your name.
The one record identified on Appendix Q is being withheld from public disclosure pursuant to Exemption 5 of the F0IA (5 U.S.C. 552(b)(5)) an.d 10 CFR 9.5(a)(5) of the Commission's regulations. This record is withheld in its entirety because it is a predecisional, working draft of a letter to a member of Congress. This record contains the predecisional opinions of the Chairman's office and release of the infomation would tend to inhibit the open and frank exchange of ideas essential to the de'aiberative process. There are no reasonably segregable factual portions because release of the facts would permit an indirect inquiry into the predecisional process of the agency.
Pursuant to 10 CFR 9.15 of the Commission's regulations, it has been determined that the information withheld is exempt from production or disclosure, and that its production or disclosure is contrary to the public interest. -The person responsible for denial'of the record identified on Appendix Q is Mr. John C. Hoyle, Assistant Secretary of the Comission.
8601020424 851125 PDR FDIA LEIGHTOB4-293 PDR
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A. Patrick Leighton,.III, Esquire.
This denial may be appealed to the Secretary of the Comission within 30 days from the receipt of this letter. Any such appeal must be in writing, addressed to the Secretary of the Comission, U.S. Nuclear Regulatory Comission, Washington, DC 20555, and shou'Id clearly state on the envelope and in the letter that it-is an "Appdal from'an In.itial FOIA Decision." '
Ne wll comunicate with you further regarding additional records related to -
i the Ford Amendment Study.
Sincerely, rw Donnie H. Grimsley, Director-Division of Rules and Records Office of Administration
Enclosures:
As stated 5
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.m m.
1 a
4 Re: F01A-84-293 APPENDIX 0 RECORDS SUBJECT TO F01A-84-293 ALREADY IN THE PDR 1.
11/16/81 Memo to Commission from Eisenhut,.
Subject:
Trenching Conducted at Diablo Canyon (Board Notification No. 81-39)
Accession No. 8112030520, ADOCK/50-275P.
2.
11/19/81 Letter to Malcolm H. Furbush, PG & E, from Denton,
Subject:
Diablo Canyon IDVPs, Accession No. 8112230598, ADOCK/50-275P.
3.
12/04/8.1 Letter to Denton from Malcolm H. Furbush, PG & E,
Subject:
Design Verification Program, Accession No. 8112100352, ADOCK/50-275P.
- 4.
12/14/81 Memo to Commission from James J. Cummings, OIA,
Subject:
0IA Review-of NRC's QA/QC Activities for Nuclear Power Reactors Construction, Accession No. 8404030019, F0IA/ CHURCH 83-667.
5.
01/82 NUREG-0862, Issue 2, " Inspection Report of ' Preliminary Report, Seismic Reverification Program' at Diablo Canyon Nuclear Power-Plant, Un.its 1 and 2" by B.H. Fulkenberry, 0.C. Shackleton, Jr.,
Region V, Accession No. 8202160053, AD0CK/50-2750 6.
02/10/82 Statement of the Commission, Accession No. 8202120164 ADOCK/50-275G.
7.
09/24/82 Memo for Commission from Dircks,
Subject:
Diablo Canyon Design Verification Program, Accession No. 8210130056 ADOCK/50-275P.
8.
10/05/82 Letter.to R.H. Engelten, Region V, et al., from William E.
-Cooper, Teledyne Engineering Services, fubject: Program Plan for Construction Quality Assurance, Rev.1, Dated October 1, 1982 for Diablo Canyon, Unit 1, Accession No. 8210250167 l
AD0CK/50-2/5P.
t 9.
10/13/82 SECY-82-414, "Diablo Canyon Design Verification Program - Phase II Recommendations", Accession No. 8210290214 SECY/82-414,
- 10. 04/15/83-Memo to Commission from Eisenhut,
Subject:
QA/QC Allegations Regarding Diablo Canyon (Board Notification 83-51), Accession No.
j 8305030191 ADOCK/50-275P.
i i
- 11. 08/83 NUREG-0675, Supplement No. 18, " Safety Evaluation Report related to the operation of Diablo Canyon Nuclear Power Plant Units 1 and 2". Accession No. 8308230751 ADOCK/50-275E.
l i
Re: FOIA-84-293 APPENDIX 0 (Continued)
- 12. 08/05/83 SECY-83-328, " Third Quarterly Status Report on Implementation of the Quality Assurance ini.tiatives", Accession No. 8312270388
-F0IA/CALVERT 83-539.
- 13. 09/02/83. Memo for Comission from Eisenhut,
Subject:
Diablo Canyon QA Case Study - BN-83-135, Accession No. 8308300307 ADOCK/50-275P.
- 14. 10/14/83 Thomas S. Moore, ASLAB, et al, from Maurice Axelrad, Esq.,
Subject:
Prefiling of teiliii6ny of witnesses from the IDVP for Diablo Canyon, Accession No. 8310180354 ADOCK/50-275T.
15.
10/19/83 Note to NRC Staff Witnesses for Diablo Canyon from Philip M.
Harrison,
Subject:
Diablo Canyon Testimony, Accession No.
8310210228 AD0CK/50-275T.
- 16. 10/21/83 Memo for George W. Knighton from Hans Schierling,
Subject:
Meeting Notice - Diablo Canyon Unit 1 in Regard to Allegations Delineated in Board Notification 161 and 83-48, Accession No. 8311280010 AD0CK/50-275P.
- 17. 11/03/83 Hearing Transcript of ASLBP hearing on Diablo Canyon, Accession No. 8311090063 A00CK/50-275T.
Re: F01A-84-293 APPENDIX P RECORDS IN PDR FILE F0IA-84-293 1.
10/17/73 AEC, Directorate of Regulatory Operations, R0 Manual, R0 Predocketing Inspection of Utility / Applicant Quality Assurance Activities, signed by John G. Davis, AEC (34 pages).
2.
06/19/74 Memo to A. Giambusso~, AEC, from John G. Davis, transmitting Region IV sumary report of pre-docketing inspection of the South Texas Project conducted on June 5-7, 1974, with enclosed R0 repor.t Project 506 dated June 14, 1974 (3 pages).
3.
06/24/74 Letter to G. W. Oprea, Jr., Houston Lighting and Power Company, from E.. Morris Howard, AEC: Region IV, re inconsistencies of South Texas Project quality assurance program with AEC requirements with enclosed report of inspection conducted on June 5-7, 1974 (15 pages).
4.
09/81'
" Governance of Nuclear Power" by Graham Allison, Albert Carnesale, Paul Zigman, and Francis X. DeRosa, submitted to Nuclear Safety Oversight Comittee (53 pages).
5.
09/81
" Work Fo_rce Motivation and Productivity on targe Jobs" by John D. Borcherding and Douglas F. Garner in Journal of the Construction Division, Proceedings of Civil Engiiiiiers pp. 443-453 (6 pages).
6 09/10/81 "The Future of the ~ Nuclear Option," John F. Welch, Jr., General Electric Ccmpany (26 pages).
7.
09/30/81 Herno to E. L. Jordan, IE, from B. H. Faulkenberry, Region V, entitled "Results of Review of Seismic Related Inspection Activities at Diablo Canyon 1/2" (4 pages).
8.
10/21/81 Memo to D. A. Brand and R. V. Bettinger, PG&E, from J.V. Rocca, PG&E, requesting review and coment on attached report entitled " Report on the Design Interface Review of.the Seismic Reverification Program" by Robert L. Cloud Associates, Inc. (49 pages).
9.
10/24/81 Memo to J. L. Crews, IE, from T. W. Bishop, Region V, entitled
" Review of NRC: IE Programatic Inspections for Design During the Period of Diablo Canyon Unit 1 Construction" (4 pages).
~
Re: F0IA-84-293 APPENDIX P (Continued)
- 10. 11/19/81 NRC Order Suspending Licence 'for Diablo Canyon, Unit 1 (CLI-81-30) (4 pages) wich separate. dissenting opinion of Comiss'ioner Roberts. (3 pages) and attached request to PG&E to provide ~ additional information for NRC review (7 pages).
11.
12/03/81 Letter to George A. Maneatis, PG&E, from Robert -L. Cloud, enclosing report by Robert L. Cloud Associates, Inc.,
entitled " Design Verification Program Seismic Service Related Contracts Prior to Ju'ne 1978" (28 pages).
- 12. 12/10/81 Memo to Commission from William J. Dircks, EDO, entitled "Diablo Canyon Unit 1 Seismic Design Issues" (17 pages).
- 13. 03/01/82 Letter to Robert L. Cloud and Associates, Inc., from Roger F.
Reedy, P.E., attaching report entitled " Quality Assurance Review Report Phase I Seismic Safety-Related Design Services Perfomed for PG&E by ANCO Engineers (Formerly Applied Nucleonics, Inc.) Prior to June 1978" (7 pages) with attached handwritten note on Reedy report (1 page), and attached Appendix A, "ANC0 Tasks Related to contract 5-82-77" (80 pages estimate).
14.' 03/08/82 " Audit Checklist," R. F. Petrokas, Auditor, PG&E (2 pages).
- 15. 03/12/82 Letter to Harold R. Denton, NRR, from Robert L. Cloud, Robert L. Cloud Associates, Inc., informing Denton that R. L. Cloud Associates will issue nineth progress report on Seismic Yerification Program on 3/15/82 with' attached report entitled
" Quality Assurance Program Review Report Phase I Safety Related j
Activities Performed by Pacific Gas and Electric Prior to June 1, 1978 (50 pages estimate).
- 16. 03/12/82 Letter to R. H. Engelken, NRC: Region V, from Robert L. Cloud Associates transmitting report entitled " Quality Assurance Program Review Report Phase I Safety Related Activities Performed by Pacific Gas and Electric Prior to June 1, 1978" l
(50pages).
- 17. 03/19/82 Memo to J. L. Crews, IE, from T. W. Bishop, Region V, entitled,
" South Texas Project 'Quadrex Report' and its Relationship to Current Diablo Canyon Peverification" (4 pages).
l
- 18. 03/29/82 Memo to Harold R. Denton, NRR, from R. H. Engelken, Region V, entitled "Diablo Canyon Design Verification Program" (1 page).
l
1 Re: F01A-84-293 APPENDIX P (Continued)
- 19. 03/29/82 Memo to Harold R. Denton, NRR, from R. H. Engelken, Region V, entitled "Diablo Canyon Design Verification Program". (1 page).
Memo to Rich'rd H'. Vollmer, NPR, from Darrell'G. Eisenhut, flRR,
- 20. 04/12/82 a
entitled "Diablo Canyon Design. Verification Program" (2 pages)
- 21. 04/15/82 Comments by PG&E on R. F. Reedy, Inc., Quality Assurance Audit Report on Safety-Relat'ed Activities Performed by PG&E Prior to June 1978 (50 pages estimate).
- 22. 04/20/82 " Diab.lo Canyon Project _ Organization" (1 page)
- 23. 05/18/82 " Meeting Summary: April 30, 1982 Discussior, of Role of Bechtel Power Corporation in Completion of the Diablo Canyon Project, Units 1 & 2," by Hans Schierling, NRR (6 pages) with five enclosures (1) PG&E press release dated 03/22/82 (2 pages),
(2) Letter to Denton from Phillip Crane explaining integration of PG&E and Bechtel resources for Diablo Canyon (4 pages), (3) agenda of 04/30/82~ meeting (1'page), (4) Diablo Canyon Organization Chart (1 page), and (5) List of attendees at NRC-PG&E meeting on 04/30/82 (1 page).
- 24. 07/02/82 ASLAB, " Affidavit'of Warren A. Raymond, Charles W. Dick, 'and Michael J. Jacobson" regarding QA/QC deficiencies and construction work at Diablo Canyon (30 pages).
- 25. 07/02/82 ASLAB, "Pesponse of Pacific Gas and Electric Company to Joint
-Intervenors' Motion to Reopen the Record" (40 pages).
- 26. 07/25/83 Comission meeting transcript entitled " Briefing on President's Private Sector Survey on Cost Contiol" pp. 40-48.
- 27. 08/13/82 Letter to Frank J. Miraglia, NRR, from Phillip A. Crane, Jr.,
PG&E, providing additional information and clarification regarding the Diablo Canyon Project Quality Control Assurance Program in response to 08/02/82 letter to PG&E from Darrell G. Eisenhut (20 pages).
- 28. 08/31/82 Meno to J. L. Crews, IE, from T. W. Bishop, Region V, entitled
" Independent Verification of Diablo Canyon Construction Quality Assurance Programs (2 pages).
- 29. 09/09/82' Memo to J. L. Crews, IE, from P. J. Morrill, Region V, entitled
" Region V Inspection Activities Related to the Diablo Canyon Reverification Program" (2 pages).
Re: F0lA-84-293 APPENDIX P (Continued)
- 30. 09/13-17/82 "NRC's Quality Assurance Initiatives long Tern Study,"
briefing slides for presentations the week of September 13-17, 1982 at'Battelle, PNL; EG&G, INEL; and Sandia, Albuquerque (38'pages).
31.
10/01/82 Memo to D. G. Eisenhut, NRR, from R. H. Engelken, Region V, entitled " Adjunct Program for the Evaluation of Diablo Canyon Construction Quality Assurance" (3 pages).
- 32. 11/01/82 Pacific Gas and Electric. Company Organization Chart (1 page).
- 33. 1983
" Quality Assurance Case Study Working Paper The Diablo Canyon Nuclear Power Station of Pacific Gas and Electric Company" (12 pages).
- 34. 01/83 "More Construction for the Money - Sumary Report of the Construction Industry Cost Effectiveness Project" (97 pages).
- 35. 01/21/83 Meno to All Diablo Canyon Project Workers from R. D. Etzler, Project Superintendent, regarding preparation for fuel load (3 pages).
- 36. 01/24-27/83
" Agenda for PG&E Visit."
- 37. 01/24/83 "NRC's Quality Assurance Initiatives" - Briefing slides for Presentation.lanuary 24, 1983, at Pacific Gas and Electric Headquarters, San Francisco, CA (25 pages).
- 38. 02/16/83 "NRC's Quality Assurance Initiatives, Special Study of Nuclear Quality Assurance (Long-Term Review) Briefing Slides for Presentation February 16, 1983, at Battelle, Pacific Northwest Laboratories, Richland, WA, Dr. W. D. Altman, Project Manager (22 pages).
- 39. 02/28/83 Letter to Ken C. Caroll, EG5G, from Harold Harty, Battelle, PNL, with attacted evaluation of the generic key indicators for the Diablo Canyon nuclear plant (15 pages).
- 40. 03/01/82 Letter to Robert L. Cloud from Roger F. Reedy, with attached report by R. F. Reedy, Inc., entitled " Quality Assurance Program Review Report Phase I Seismic Safety-Related Design Services Performed for PG&E by Cygna Energy Services (EES)
Prior to June, 1978" (9 pages).
[..
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+
B Re: F01A-84-293 APPENDIX P (Continued)
- 41. 03/01/82 Letter to Robert L. Cloud from Roger F. Reedy, with-attached report by R. F. Reedy, Inc., entitled " Quality Assurance Program Review Report Phase'I Seismic Safety-Related Design Services Performed for PG&E by Wyle Laborator.ies Prior to June',-1978" (8 pages).
- 42. 03/02/83 Reportable Event' Report for 03/02/83 with event at Diablo Canyon on 03/01/83 when skip loader and five people were washed off south breakwater due to heavy wave action (1 page),
i
- 43. 03/05/82 Letter'to Robert L. Cloud from Roger F. Reedy, with attached report by R. F. Reedy, Inc., entitled " Quality Assurance Review and Audit Report Phase I Seismic Safety-Related Design Services Performed for PG&E by URS/J. A. Blume & Associates, Engineers Prior to June, 1978" (43 pages).
- 44. 03/11/83 Transcript of public meeting " Briefing on INP0 Construction Evaluation Program" (66 pages).
- 45. 04/05/83." Task Force Report on D0E, FERC, and NRC" Presidents Private Sector Survey on Cost Control (46 pages)
- 46. 05/16/83 "The Management Issue," by John-Heidenreich, N. C. Kist &
l Associates (5 pages).
"NRC S' ecial Study of Nuclear Quality Assurance Review Group"
- 47. 06/08/83 p
(4 pages).
I 48.
06/08-09/83 "QA Review Group Meeting, June 8-9, 1983 Revised Agenda" l
(2 pages)
- 49. 06/08/83 " Quality Assurance in Contracts and Procurement" Briefing Slides for presentation by W. Altman, NRC, and M. Walsh, Battelle-HARC (14 pages).
- 50. 06/03-09/83 "More Prescriptive AIE Criteria" Briefing slides for presentation by B. Grimes, NRC (6 pages).
l 3
- 51. 06/08-09/83 "Public Coments on the Congressional Amendment" Briefing slides for presentation (8 pages).
I
- 52. 06/08/83 " Background and Overview of Project" Briefing slides for-presentation by J. Taylor, NRC (13 pages).
l
- 53. 06/08/83 " Role of Review Group" Briefing slides for' presentation by F.
Albaugh, Battelle, PNL, and B. Grimes, NRC (2 pages).
j i
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(
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Re: F0lA-84-293 i
APPENDIX P (Continued)
- 54. 06/08/83 "NPsC QA Review Activities" Briefing slides for presentation'by
~
W. Altman, NRC (9 pages).
t 55; 06/08/83 "QA Case Stu. dies and Preliminary Results" Briefing slides for presentation by W. Altman, NRC (11 pages).
r
- 56. 06/08/83 " Congressional Amendment Pilot Program" Briefing slides for prescntation by J. Taylor, NRC (11 pages).
- 57. 06/08/83 " Construction (CAT) and Design (IDI) Assessments" Briefing slides for presentation by J. Taylor, NRC (10 pages).
- 58. 06/09/83 " Reaffirmation Program" Briefing slides for presentation by E. W. Brach, NRC (5 pages).
- 59. 06/09/83 " Designated Representatives" Briefing slides for presentation by E. W. Brach, NRC (11 pages).
l
.i
- 60. 06/09/83 " Qualification and Certificates of OA/QC Personnel" Briefing slides for presentation by Melinda Malloy, NRC (5 pages).
l
- 61. 06/09/83 " Review of NRC, Industry and Government QA Programs" Briefing slides for presentation by E. W. Brach, NRC, and M. G. Patrick,
{l PNL (9 pages).
- 62. 06/20/83 Memo to Thomas E. Murley, Region T, et al., from James M.
l Taylor, IE, "Information Concerning STaTf Work in Quality
{
f Assurance" (164 pages).
t i
- 63. 06/21/83 Draft NRC report entitled " Review of Swedish Nuclear Power l
Program QA Activities" (19 pages).
i
- 64. 07/83 Article entitled " Study finds declining construction leadtimes for nukes being built," Electric Light and Power -(page 43-44).
1
- 65. 07/18/83 Letter to Leland S. Bohl, General Electric Company, from Fred
~
W. Albaugh, Battelle-PNL, regarding upcoming meeting on 09/07 and 09/08 of Review Group for the NRC Special Study of Nuclear Qvality Assurance (3 pages).
i j
- 66. 07/20/83 Draft Report entitled " Study of Quality Assurance in Contracts and Procurement - Trial Site Vis k Report" by M. E. Walsh, M. V. McGuire, and B. L. Hansen, Battelle PNL under NRC l
Contract No. FIN B2188 (49 pages).
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Re: F01A-84-293 APPENDIX P (Continued)-
i 4
- 67. 09/07/-09/83 Agenda for QA Review Group Meeting, Seattle, Washington (2 pages).
i
- 68. 09/07/83 "QA ' Case Studies". Briefing slides for presentation by W. Altman,.NRC (21 pages)
- 69. 09/07/83 " Review of NRC, Industry and Government QA Programs" Briefing l
slides for presentation by E. W. Brach, NRC, and M. G. Patrick, PNL (7 pages).
2
- 70. 09/07-08/83
" Quality Assurance in Contracts and Procurement" Briefing i
slides for presentation at Second Review Group Meeting, NRC Special Study of Nuclear Quality Assurance, Seattle, Washington (5 pages).
}
- 71. 09/07/83 "NRC Inspection Program" Briefing slides for presentation by James Taylor, NRC, and Ted Ankram, NRC (10 pages).
- 72. 09/19/83 Revised draft working paper entitled " Quality Assurance Case j
Study Working Paper - Case C" (42 pages).
l 73.
10/12/83 Memo to James P. Knight, NRR, from Walter P. Haass IE,
)
entitled " Revised Testimony for Design QA Hearing - Diablo i
Canyon" (6 pages) 74.
10/20/83 Memo to Q. A. Review Group Members fro;n J. A.
Christensen, Battelle, PNL, entitled "Second Review Group Meeting" (43 pages).
I 75.
10/21/83 Memo to NRC Ouality Initiatives Review Group from J. A.
Christensen, Battelle,'PNL, entitled " Third Meeting of QA Review Group" (1 page).
a 76.
10/24/83 Memo to P. T. Kuo, et al., from James P. Knight, NRR, entitled "Diablo Canyon Logistics" (2 pages) with attached ASLAB Order-dated 10/07/83 regarding reopened proceeding on issue of design quality assurance (8 pages) attachment Accession No. 8310120385 i
PDR/ADOCK/50-275G.
I
- 77. 10/28/83 Comission briefing outline for. D. Eisenhut, NRR, on Diablo j
' Canyon (7 pages).
4 78.
10/28/83 Memo to NRC QA Review Group Members from J. A. Christensen, Battelle PNL, entitled "Second Review Group Meeting Minutes 2
Report" (106 pages).
1 l
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Re: F0IA-84-293 APPENDIX P f
(Continued) l-79.
11/04/83 Note.to Walter P. Haass, ~IE, from Larry J. Chandler, OELD, regarding transcript for' Diablo Canyon case study (1 page).
80.
11/10/83 Note to NRC QA Review Group Members 'from J. A.- Christensen, Battelle, PNL, entitled "Second Review Group Meeting Minutes Report" (87 pages).
i
- 81. 11/18/83 ASLAB, Transcript of hearing on Diablo Canyon Nuclear Power Plant held at Avilia Beach, CA. (262 pages).
+
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- 82. 12/09/83 Letter to Edward Baker, IE, from James A. Christensen, Battelle PNL, entitled " Draft Summary Report of QA Review Group Comments" (16 pages).
- 83. 12/23/83 Memo to Commissioners from Victor Gilinsky entitled " Commercial i
Licensed Operating Experience of Diablo Canyon Licensed j
Operators" (1 page).
a
- 84. 03/30/84 Letter to Fred W.'Albaugh, Battelle PNL, from G. Ted Ankrum. IE, j
regardina completion of report to Congress on quality assurance (2pages).
I l
- 85. Undated
" Believers Versus Non-Bel.ievers and Programmatic Problems" (1 page).
i
- 86. Undated
" Recognition of Root Causes of QA Program Failures" by Larry Kubiecek, EG&G, INEL (5 pages).
]
- 87. Undated "NRC Review" by John L. Heidenreich, Richard M. Kleckner, and 2
N. C. Kist & Associates (7 pages).
- 88. Undated
" Labor, Contracts, and Craftsmanship" by Miles Patrick, Battelle PNL (14 pages).
- 89. Undated
" Impact of Long Construction Time" by Richard Kleckner, N. C.
}
Kist & Associates (8 pages).
i
- 90. Undated
" Organizational Senility" by Richard Kleckner, N. C. Kist &
Associates (4 pages).
- 91. Undated
" Historical Perspectives" by Harold Harty, Battelle PNL (9 pages).
l
- 92. Undated
" Nuclear Construction Project QA Case Study Methodology," EG&G, INEL (17 pages).
l
b Re: F01A-84-293 i
}
APPENDIX P i
(Continue'3) i j
- 93. Undated
" Background Information for'the First Review Group Meeting" l
(100 pages' estimate).
j
- 94. Undated "A Regulator's View of the Nee'd'for Better Management Controls" by James P. O'Reilly, Pegion V, at the ANS Executive Conference i
on Government and Self-Regulations of Nuclear Power Plants" j.
(13 pages).
- 95. Undateo "U. S. Reactor Orders Over the Years" (1 page).
}
i
-96. Undated -
" Nuclear Plants Receiving Construction Permits in 1968" (1 page).
I J
- 97. Undated
" Nuclear Plants Peceiving Construction Pennits in 1970" (1 page).
- 98. Undated
" Regulatory Criteria Changes" (1 page).
4
- 99. Undated
." Qualifications of Companies Proposed to Conduct Independent l
Reviews" (15 pages).
100. Undated "Public Comments - Summary by Subject" (28 pages).
i i
101. Undated
" Bibliography of Material Reviewed in Conjunction with Diablo Canyon Assessment" (5 pages).
J 102. 01/28/83 " Notes from Diablo Canyon Case Study," by Bill Altman, IE j
(8 pages).
i l
103. 01/28/83 " Notes from Diablo Canyon Case Study" by Bill Altman, IE i
(8pages).
4 i
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i
Re: FOIA-84-293 APPENDIX Q Rett..] SUBJECT TO F01A-84-293 WITHHELD IN ITS ENTIRETY 1.
01/25/83 Draft letter to Hon. Morris K. Udall, Chairman, Connittee on Interior and. Insular Affairs, U.$. House of Representatives, from Nunzio J. Pa'!adino, Chaiman, NRC, in response to Udall letter of 01/11/83 regarding five specific concerns dealing with the rec,;irements which must be satisfied prior to authorization to load fuel at the Diablo Canyon Nuclear Power Station (10 pages).
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U. S. ATOMIC ENERGY C0!'/4ISSI0t!
M DIRECTORATE OF REGULATORY OPERATIONS RO KdlUAL
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TEMPORARY INSTRUCTI0tl COVER SHEET pNO.
4000/1 Date:
10/1s/73 I
Subject:
P0 Predocketino Insoection of Utilit'//Aonlicant Quality
' Assurance Activities J-i Applicability:
All utilities who apply af ter September 1,1973, 5
for a construction permit to build a power reactor.
I
j 1.
c-4 lc Expiration: - Uoen incorporation into Chanter 4000.
2 Other Cornnentsi The attached instruction containing inspection require-b-
ments and guidance was prep'ared by the Construction Branch, R0, and is issued for'i:m:ediate implementation.
This instruction supersedes
..s,;
y memoran' dun dated July 6,1973, with encle'sures.
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J n G. Davis Deputy Director
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Directorate of Regulatory Operations
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REGULATOR'T OPERATIONS PRE-DOCKETING QA INSPECTION
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0F UTILITY / APPLICANT QUALITY ASSURANCE ACTIVITIES I.
INTRODUCTION
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The Directorate of Regulatory Operations has the responsibility to
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enmine an applicant's QA program prior to docketing of his applica-I' i
j tion to determine whether,the applicant has e,stablished and imple-3-p i 2 -
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_mented a QA. program which meets. thec. requirements of. Appendix.B 'to
[-i 3; 9-l 10 CFR 50.
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i To carry out this responsibility the cognizant Regional Office
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l (t) a subseantive review of the applicant's QA manuat.
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to verify Quplementatio,n of "AEC. Guidance on Quality Assurance Require-4 A.'-
a ments During Design and Procurement Phase of Nuclear Power Plants",
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dated June 7,1973 '(AEC Guidance or " gray book"m); (2)(concurrent with 2
7 p [. X L-QA substantive pre-docketing review, the Region will review for 4
o consistency with the QA manual and implementat' on of application com-l q
mitments and (3) the Region will conduct a substantive pre-docketing
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inspection at the applicant's corporate offices, to verify ' mplementa-I.' ;
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tion of the appl _.icant's QA manua.l and its supporting procedures,
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instructions and forms, commensurate with the activities in progress.
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II. DEFINITIONS'
>1 For definitions pertaining to:
(1) Quality Assurance; (2) Quality Control; and (3) Objective. Evidence, refer to ANSI document N45. 2.d.j,-
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'Cualits Assurance Program k s d.9.l.G Ulk*i\\
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Quality Assurance Prograni is the program established by the applicant A
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and the requirements of 10 CFR 50, Appendix B, " Quality Assurance p
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Criteria for Nuclear Power Plants". The QA program, includes all s.
implementing activities delegated to contractors, c.onsultants and
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vendors.
kII. ' INSPECTION OBJECTIVES
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The RO inspection objectives are to determine whether the applicant - ~ ~ - - D i'
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has:
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Performed the necessary planning and scheduling to assure the timely develcpmene and implementation of the QA program for work in process.
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B.
Established and implemented those aspects of the QA programfcon-cerning the PSAR developmen and design and procurement activities, which are consistent with AEC Guidance and the status of the project,(and which do not include substantive deficiencies [ f These objectives are to be accorp11shed through the eramination of the ikgf
.when requested by the Depuf:y Director's Office for Field Operations, 7
applicant'sjicplemented_QA progrna manuals pt the Regional Office, and
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,r through the examination of program implementation at the offices of the applicant.
IV.
PRE-INSPECTION REQUIREMENTS The Licensing Project Manager (LPM) shall be responsible for schedul-ing an "early" meeting with the liceasee, and vill notify RO:HQ, and the cognizant Region, 30 days prior to the date of the meeting. The e
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meetings will usually be held in the corporate offices of the applicant with the appropriate corporate management, and their engineering and QA staff in attendance. The AEC attendees will include the LPM, the cognizant representative fro:s the Licensing QA Branch (L-QA) and ey cognizant RO personnel.
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The Region, in conjunction with L-QA, will develop the agenda for the Q']. '
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meeting and furnish copies to the LPM for information and transmittal
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to the applicant. The development of the agenda will: require close
-M comemmications between the Region and the cognizant L-QA personnel, to establish the presentation method and sequence to ensure complete
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coverage cf the pre-docketing procedures, and to ensure the applicant's
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complete understanding of the program. The agenda should include, But not necessarily be limited to, the material outlined in Section II,
" Guidance - Early Meeting".
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These instructions supersede CM-3900, dated December 14, 1970, require-i monts of subsection 3910.03 but de not aff4ct other requirements of
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CH-3900 pertaining to subsection 3910.02. The Regional Office shall 2b u,
schedule a meeting with the utility to implement the remaining require-mants of CM-3900. This meeting, if practible to do s'o, should occur
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just prior to the pre-docketing meeting.
V.
' SCOPE OF THE QA ~ PROGRAM ' AND ~ ACTIVITIES StTBJf.CT TO INSPECTION
' The inspection will be performed in two parts:
(1) examination of the QA manual prior to going to,the utility's offices; and (2) camination
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of program implementation at the utility's offices.
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Our inspection at a utility's office will cover the examination of the impicmentation of the QA program as required by the provisions of the guidance previously mentioned. Particular attention should be given to determining how the applicant has assumed and retains f.g,
2 the responsibility for the establishment and execution of the QA
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program, including those aspects of the program delegated to~ con-
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!/ ' 3 tractors and consultants, and whether the activities of his organi-l'* ; ;
2 sations in these matters are consistent with the work in progress.
g h determination to be made is not whether the program and imple-mentation is acceptable in every detail, but whether substantive.
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' deficiencies exist which could result in a recommendation against Q,,
docketing of the tendered application.
h pre-docketing inspection shall be limited to the examination of
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the program and implementation for p'roject activities in progress-or completed as noted below.
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- t..d 1.:'PSAR' Development eI Activities performed in the preparation of the Prelimina 7, /. l U
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Safety Analysis Report (PSAR) which establishes the basis to hg
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determine the acceptability of the data and commitments placed in the PSAR.
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2 Engineering-Design fi a
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/.sf 'q s Preparation and reviews of analysis add /or calculations, design e
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(f drawings, content of specifications and procurement documents, 1
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and control of engineering documents and changes thereto.
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Procurement i
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Controls exercised prior to and during the " Award of Contract (s)"
1 (or " Letter of Intent" or " Work Orders", etc.), including pre-3
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award evaluations of. contractors (A-E, N,SSS, Pressure Vessel,,
A a. ~.:V Consultants) QA programs, and audits of procured ' activities,
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1.he above activities f PSAR development engineering-design and pro-7 a.
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i curement, may in part be performed by the applicant and in part dele-t.
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gated by the applicant to other organizations. However, in either case, j
owners must have program measures in effect requiring the participation
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of individuals from his own organization to the extent necessary for him to 1
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make a determination during each phase of 'the project that an accept-1 v.
N.b able program has been eatablished' and is being executed in accordance
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.L witit the requirements of the program.
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VI. MEASUREMENT'0F IMPLEMENTATION OF QA PROGRAM
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RO will be performing reviews of a utility's. QA manuals prior to the
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Licensing Safety Review of the Qk commitments of the tendered appli '
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cation and under these circumstances the inspector hhall measure the
.[ l acceptabil' ty of the design and procurement provisions of the QA i
- g manuals against the AEC Guidance provided to the utilities on this,
1 matter. Upon receipt of one copy of the tendered. application.and even though application commitments will not be utilized by R0 as
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i the primary basis from which to measure the acceptability of the i
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utility's QA program, the inspector should check the consistency of pro-5 gram' implementation with the QA concitments of the application. Subse-quent to completion of Licensing's substantive QA reviews, the Region
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j will receive one copy of L QA Branch substantive comments from the
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, Office of the Deputy Director for Field Operations. The Region is
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expected to consider these comments when preparing for the. inspection.
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However, since L findings of acceptability. reflect only absence of sub-
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... l stantive negative findings, the primary basis for measuring the accept-M>c :
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j ability of the QA programimplementation shall be in the provisions of '
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the previously referenced AEC Guidance.
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i The inspector aust become thoroughly familiar with the AEC Guidance
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prior to performance of the' inspection. The inspection shall give par-
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ticular emphasis to the examination of objective evidence that would i
indicate that the applicant has satisfactorily responded to Part D.1.,
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Subsections a., b., c., and d., of the " guidance". The titles of these 1
subsections are:
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i Establishment of the Quality Assurance Program.
a.
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Training of Personnel.
c.-
Review of Program by Management.
d.
Organization.
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c.
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Tine and comprehensive response by utility t'op management for activities
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i in progress is essential.
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'(5 Ihe AEC Guidance is currently the sole standard of reference for s
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acceptability of the utility's progrdm. Should the AEC Cuidance in ~
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k the inspector's opinion be insufficient or inappropriate in certain
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h areas to determine seceptability of implementation of the QA program (t
for design and precurement, this deficiency in the guidance provided
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M utility's QA program, but should be brought to the attention of RO:HQ by separate memo.
u A.7 Measurement ~of Functional Organizations The fonowing AEC Guidance shall be utilized to measure the
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acceptability of:
(1) QA program procedures and instructions;
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and. (2) the implementation of the provisions of the QA program for and by the following functiot.a1 organizations.
- 1.'~QA Organization 3
ANSI-N45.2., Sections 2(II), 3(I), 6(V), 7(VI),17(XVI),
19 (XVIII); Draf t N45.2.9TXVII); and Part D.1.aib~.c. (II),
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and d.(I).
1 For utilities who delegate the responsibility for design to others (A-E and NSSS),it is expected' that the examination of the QA program through the QA organizations will also cover the program instructions required to meet these criteria for the orgnizations of engineering g
and procurerent. Howeve, for utilities who act as the A-E and per-form the vendor surveillance, or as otherwise required, the inspector should examine the detailed instructions developed by the engineering and procurement organizations to satisfy the general provisions of the QA progran and these criteria. Where the utility has delegated I
the desi'gn activity to others the inspection shall examine the mea-sures utilized by the' applicant's organization to assure that the design provisions of the AEC Cuidance are being adhered to.
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2.
Engireering Organizations I
ANSI-N45.2, Sections 4(III), 5 (IV), and 8(VII); Draft
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N45.2.11(III and IV); (also refer to footnote (*)); and "1. ~
Part D.2.a. (VII).
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- 3. ' Procurement ' Organizations (Includes, As Appropriate,
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Vendor Evaluation)
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ANSI-N45.2, Sections 8(VII) and 19(XVIII); and Part C.3.
I.G i (AEC Extracts from N45.2.13); and.D'raf t N45.2.12(XVIII).
VII. INSPECTION REQUIRDEhTS The instructions set forth below will be followed by the RO inspection
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staff in the conduct of inspections of the utility's QA program per-
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taining to pre-docketing activities.
A. ' Performed'at'the' Regional Office Prior to Visiti'ng the Utility's I
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,$f Id hafne the QA manualfand determine acceptability of the o[ t
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c program for activities in process in the areas ofkAR i
de slopment] design and procurement. Determine if program e,[ '
l instructions and the organizations described in the QA man-uals meet the requirements cf the AEC Guidance provided for these determinations and is generally consistent with the -QA program description of the application. Also, entain a thorough understanding of,the responsibilities.
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authorities, interfaces with other organizations, and of 4
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the functioning structure of. the, organization.
See previous page.
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B.
Performed at the Utility's Office 1.
Determine if the planning and scheduling for the implemen-tation of the QA programs for the organization (s) examined
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is consistent with work in progress.'
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2.
Determine if the required QA program' procedures and instruc-T_r.
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tions are available for use by each of the organizations "i,'
e (QA, Engineering, Procurement).'
3.
Determine the acceptability of implementation of tha' QA' program by selectively examining the act'ivities and documents of f r --
participating organizations in the areas of: PSAR develop-
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6' ment, design, procurement, vendor evalua~ tion, and management reviews.
4.
ring the performance of the inspection ' continue to examine
., f, any areas of apparent QA program implementation deficiencias
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determined during the Regional Office r' view of tha qA manual
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or as selected for e===in4 tion from the list of L substantive 7 '.i fiadings.
5.
At the conclusion of the inspection and to minimize all possible.
misunderstandingst I
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a.
Inspectors will provide to appropriate members of the l
utility staff a verbal summary of inspection findings.
d b.
Inspectors will inquire whether there exists other F
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objective evidence not examined by the inspectors, which would resolve or further clarify identified
. areas of concern.
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c.
Inspectors will not volunteer comments regarding the significance of their findings as they will apply to
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the staff recommendation to docket or reject the_ _ _ _ _.
application.
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C.
Subsequent to the Insbection at the Utility's Offices l,'
- Based on a study of the summary of objective evidence for activities in process, make a determination regarding the
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presence or absence of substantive deficiencies in QA l
I program implementation regarding i
- 1.. Organization.and staffing..
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- 2..Independency and authority established.and being exercised,
. as appropriate..for ther- (1) reviewer; (2) auditor; and
- Uj (3)' those who measure the effectiveness of the QA program.
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3.
Management Raview and implementation of management assigned
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QA responsibilities.
4.
Provisions of the program, and implementation, which provide tha utility a means to be clearly ", responsible" for the
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astablishment and execution of the QA program, including
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those program elements delegated to other contractors. (This o
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1-should inluede the examination of objective evidence regarding the participation.of the appropriate organi-
'3 zations (or individuals) of the utility, for those activ-ities in process.).
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5.
General consistency of the QA manual instructions examined t
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with the QA commitments of the tendered application.
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Preparation of summary findings and submittal of a pre-
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14mhary RO pre-docket inspection report to RO:HQ 21 days after submittal of the tendered application to Regulatory with the Region's recommendation for or against docketing of*the tendered application.
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- 7. ~The effice of the Deputy Director for Fie,1d Operations
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. will prepare and transmic to L, by the 25th dity af ter receipt of the application this Directorate's conclusion
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regarding the docketing or rejectica of the application.
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D. ' Inspection Report N'3,%,
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The' Regional Office shall provide for the normal distribution
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-1 of the pre-do.cketing inspection report subsequent to the t'ime
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vhen L informs the applicsnt regarding the L coinclusion to docket or reject the application.
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VIII. CUIDANCE FOR PERFORMANCE OF INSPECTION REQUIREMENTS AND SELECTIVE EXAMINATION OF PSAR DEVELOPMENT, DESIGN AND PROCGEMENT ACTIVITIES A.
Performance of Inspection Recuirements The text of the attached training document entitled " Pre-Docketing
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QA Inspection Program", Rev. 1, dated 9/21/73, and Video Training 3
ye Tape No. 003 provides the inspector with guidance regarding:
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- y..'; L (1) Program Requirements; (2) Evaluation of Inspectica Findings;
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(3) Inspection Techniques; and (4) the added list of questions i.'
T,'"l and answers obtdined during Regional Training Sessions on Pre-
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.c Docketing QA Inspection Program Requirements (8/20-24/73).
B.
Selective Examination
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The guidance provided below is consistent with the information
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-J provided to the industry during the Conference on Quality Assurance for Design and Procurement for Industry Representatives.1/
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Typical examples of examinations for mini-rsvieG inspections of quality assuring activities are provided under the inspection
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c%g-subject headings of: Organization;,QA Program: Design Phase QA; v
9 Procurement Phase QA; and Audits, Based on information obtained regarding the status of project design and procurement activities',
inspectors shall select applicable examples of examinations pro-vided below for the inspectios of quality affecting activities in process for the organizations of: QA; Engineering; and Procurement.
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Appendix to Remarks by D. F. Knuth entitled " Regulatory Operations Panel Discussion at Regional Conferences on Quality Assurance" (Conferences
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held 7/16-20/73).
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_ Organization
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a-In regard to the organization requirements, inspectors will
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seek objective evidence which establishes that the applicant has exercised his responsibility to establish a Quality Assur-g j.,,
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ance Program and Organization that is in compliance with M. '
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ANSI-N45.2, Sections 2 and 3, and is ' consistent with Part D.l.(a),
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" Establishment of the Quality Assurance Program" and (c), " Organ-6f'.g.
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ization", and appropriate guidancc. of oth@ N45.2 Standards of l
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the "AEC Guidance".
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In the following text,. typical examples of applicable Y '.-
guldance are provided by paren'thetic references to sectionc of m.
the " Guidance" as indexed on
- p. age 25 of this document.
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Examples for inspector examinations in de'termining the accept-v n...
bility of the quality affecting activities of the utility's organizations of Quality Assurance; Engineering; and Procure-ment, are:
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, Execution of program instructions for PSAR, design, and - _.
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procurement activities initiated.
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- b., Timely staffing of positions responsible' for quality affecting a-tivities (A.l.a.).
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Management and staff understanding of QA program assf.gnments.
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. working of the overal2 program, and the performance of their
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.y assigned responsibilities (A.1.a. and c.; D.2.).
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d.
Establish that individuals who are assigned key QA' responsibilities are not also assigned in-line production
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responsibilities (A.l.d. ; B.3. ; D.6.1.,11.1; E.2.1.).
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2.
Quality Assurance Program In regard to the QA program requirenents inspectors will seek if
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objective evidence which establishes that the applicant has:
6 cm (1) a QA program implemented which addresses all activities of design and procurement initiated; (2) implemented the pro-visions of the QA program for activities underway in design
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and procurement areas.
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Examinations of the QA program will seek objective evidence that the quality assurance program for design and procurement activities underway is implemented in compliance with ANSI-
- K45.2, Sections 1-8 and 17-19, and is consistent with Part
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. -.. D.1. (a), Establishment of the Quality Assurance Program; (b),
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Training.of Personnel; (c), Review of Program by Mariagement; -
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and (d), Organization, and other "AEC Guidance".
Examples cf the inspector's examin'ations in determining the,
. acceptability of the QA program and program implementation are:
a.
Examination of the QA Program (at Regional Offices)
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A general review of QA program procedures, and program r[
- referenced instructions, which respond to the requirements
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of ANSI-N45.2, Sections 1-8 and 17-19, and other guidance
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provided for the design and procurement phase. Examinations should determine if the application of these requirements and supporting guidance include required procedures and l*,
instructions for activities delegated to each of the utility's
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functional organizations.
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Particular attention should be given to examination of pro-
-visions regarding:
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(1) QA policies of top management.
(2) Responsibilitie's assigned to management j
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(3)
Illustration and~ description of the QA,' engineering, i#U and procurement organizations and responsibilities,
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including the identification of independency require-i*
ments.
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(4)' Responsibilities assigned to the staff of the utility's l.
organization, other organizations, and identification of
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1,a interface requirements for each activity performed.
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- (5) Identification of. delegated activities, structures,
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systems, and components to be covered by the quality l.
assurance program..
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(6) Program provisions which will assure that all prerequisites
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n for a given activity are identified and will be' satisfied.
(7) Program provisions regarding indoctrination and training l
i of personnel performing activities affecting quality.
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(8)
Program provisions regarding applicants' or other organizations' regular review of the status and adequacy of the QA program.
(9)
Consistency of the QA program with the description of the QA program provided in Section 17 of the application.
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t (10) Program provisions regarding: Design Control; Procure-
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- ment Document Control; Docunent Control; Vendor Evalua-
~ 5 tion and Surveillance; Oorrective Action; QA Records:
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and Audits.
.b.* Examination of Program Implementation *(at Utility's Offices)
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Examination of program implementation (at. utility's offices) g :,
should include records and activities pertaining to the organizations of QA; Engineering; and Procurenent, such as:
(1) Planning and scheduling of audits providing for the timely. examination of internal and external activities in process (E.3.-S. and 3.4.).
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(2) Training accomplished (A.1.b.; D.2.2.(7); E.2.3.).
e (3)
Control of documentation, including identification of document flow path and individual positions responsible for: Preparation; review; approval and change control;.
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in-process' and permanent file index systems for QA records; and compatibility thereof; and reviews of typical documentation. Examples of documents seleccad c'
are:
(B.7; D.5. and.7.).
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(a) QA program procedures and detailed instructions.
(b) Procurement do'cuments.
(c)
Design specificati*ons.
(4) Position -description, qualification requirements and
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the qualification of individuals. assigned to various
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positions.
(B.3.; Note: Generic qualification require-47, '
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j ments are not established. We look to see wh'at require-ments have been escablished by the utility.)
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.v (5) Corrective actions initiated independent of the sudit s
process (resulting from reviews, recommendntions of
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management, etc.).
(B.17.; D.9; F.3.e.)
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Reports to management, including such items as: Status w-of the program related to project activities; and Essessment of those implemented elements of the QA program (A.l.c.; B.19.; E.4.4.).
(7) Records regarding the performance of " Management Reviews".
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cised, as appropriate, for the:
(1) reviewer; (2) auditor; f.ef and (3) those who measure the effectiveness of the. QA prog <ua (D.6.1.; E.3.2.6.).
(9) Deterhinn if the required QA program procedures and instr {ctions are available for use by each of the. organ-(
izatiqns.(QA; Engineering; Procurement, including Manage-
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r-ment thereof, who are,' or who should be, participating in L
'activities in process).
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_ Design Phase QA In regard to design phase activities, RO inspectors should examine the implementation of the QA program for activities delegated.to the organizations of the applicant, including applicant-performed " management reviews" of the development
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T9'.3 and execution of design QA activities delegated to other if ;
organizations.
The activities performed are expected to be i
's consistent with the provisions of ANSI-N45.2.11 and N.45.2.9,
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and Part D.l.(c) of the "AEC Guidance".
'?
Exgmples of records and a'ctivi, ties pertaining to design phase (Q-j8
_ ' activities, and utility / management reviews of these activities,
? ;,
subject to selective examinations are:
Identification of sequential review requirements and assign-a.
ments for each function throughout the engineering process.
S. ' '
such as PSAR-Development, Conceptual and PreHmfnary Design,
~'
and Development of Drawings, Specifications, and supporting. 7. a.:._
,c;::'.
~ calculations.
(D.3.1. and 6.3.1.)
~
~
b.
Iden'tification of those p'ositions responsible for document
~
preparation and input; and like identification of "inde-pendent" reviewers throughout the development of these docu-ments, and their capability to review the technical and e.
quality input requirements initiated by the originator.
(D.6.3.1.,7.'Oand8.d) c.
a e
10/4/73
.._..._.....__.-,-._...a..._..
s w.
Records of reviews performed for items such.as:
(1) c.
technical and quality commitments of the application; (2) analysis; (3) conceptual aad preliminary designs
't (used as basis for further design); and (4) drawings,
[, -
specifications, and supporting calculations (D.10.).
.]
d.
Verify with the assigned reviewer the incorporatica of
,..D...
M...
b regulatory requirements, design bases and quality standards
[Gi
-: v~j within engineering output documents. Also, discuss with
.~
the reviewer the means he uses to determine the suitability 1.'.
of application of materials, parts, equipment, and pro-cesses (B.4. and 5.; D.6.3.1.).
a
(-:]:
For example; a typical examination of an engineering specification prepared to obtaiti materials, equipment and services may pursue the following:
(1) Requirement to' develop and implement and provide for
(',7.
examination (prior to award) a QA program that 's i
- 9... '
- : \\
- p 'v consistent with ~the requirements of ANSI-N45.2, :as. - : f r :-~
-l y.~.\\
appropriate, for the items to be suppued. Particular
[ '. I j
attention will be given to the imposition of design and procurement document control requirements, if appropriate to do so (B.5.).
(2) Specific requirements for the material, component or structure, such as:
(D. 6.3.1.)
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.. 1.*.
10/4/73
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v:r (a) Test and calibration requirements and associated
_ limits or tolerances.
(b) Inspections and acceptance requirements.
.. ~.
(c)
Identification of materials'or items.
';;9-(d) Identificatio'n,of special processes and. cont oiling
[c."
. s:;;. -
- criteria, j:e 4.
f (e) Handling, storage, shipping, and environmental
}.'cf*.,
1.:
protection for the item.
. +..
(f) Incorporation of designated technical, code.and'
'/
s standards' requirements.
.p...
(g) Designation, as appropriate, of design requirements
.j7 p-,-
[...'W,
and operation limits; such as stresses that are i
y;,.; :
N=g y imposed on valve body, or system requirements of O
' Q..-
a pump or motor-generator.
(3) Other examinations may include:
,9::r.
(a) Identification' of originator (s), review (s),
~~
required approvals,.and adequacy of review and
.- ~ $ ~
approval documentation (D.4. and 7.0.(1)). ~
R d.
j'gg ';
(b) Review commants,. pre' pared by appropriate disciplines,
,1 their resolution, and control documentation (D.5.1.4.).
(c) Calculations; associated review documentation; identi-fication of the calculatica to structure, system or component; the system initiated for filing and A
~
~
10/4/73 r-
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.- 1.
N.
retrieving project calculations and examination of calculation files and records (D.4.2., 10.0).
(d) System for controlling distribution of, documents and a check of this control for the document.
4 selected for examination (D.5.1.4.).
.y ; ;
- tuQ (e) System to identify, dis. tribute and control changes C,c --
g.
to the PSAR, in particular PSAR changes which are f'J ' '
. ~,..
unique to the document selected for examination
'Y'.
(D.7.).
(f) " Standard" designs or specifications prepared to procure nuclear power plant materials, systems 'or
.I Q
I..
C'i structures:
M-
.P
- i. Organization responsible for preparation, review and approvals (B.3. and D.5.1.4.).
11.
Records of review and approvals (D.10.)
j ' 3.,
F.'
iii. Authorization and controls regarding use of m.n,
standard design and specifications (D.7.).
gE,
- :. c,..
.y::n-iv.
System to update the developed standard design 8.h documents, to include: Code and regulatory
~
~ changes responding to known industry problems with certain materials,' components and auxiliary
~
devices (D.6.2. and 7.(4)).
.n
- v., System for review of standard documents 'against r,
spacific PSAR requirements.
(D.6.3.1.)
Q:
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10/4/73
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s 4.
Procure =ent Phase QA in regard to. require =ents applicable to procurement phase activities, inspectors should examine the implementation of the QA program ~ for activities delegated to the organizaticas of the applicant, including applic' ant-performed " management raviews" regarding the development and execution of pcocurement QA hS activities delegated to other organizations. The activities C
performed are expected to be consistent with the provisions of Sections 7 and 8 of ANSI-N45.2; and ANST-N43.2.9; F.45.2.11; N.45.2.12; N.'45.2.13, and related parts from Part D.2.
of the "AEC Guidance".
~.
(. :.. ~.
Q: -
Examples of records and/or activities, or utility management reviews of these activities, subject to selective examination l
are:
a.
Activities of the P*oturement Agent (Buyer)
^
(1) Management' directives regarding use and application
., y, of the requirements of the QA program for and by the buyers of: Materials; Construction; and Vendor Pro-curement. Also, availability of assigned QA program t
Procedures and ins tructions (B.2., 3. and 8. ; A.l.,
j Part D.2.).
(2)
Controls (reviews, approvars, and updating) regarding j
t
" standard buyer list items" for materials and com-
~ '.
(
ponents (B.4. and 5.; b.6.3.1.).
L l
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10/4/73 1
)
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\\[.
(3) Procurement Docu: cent Record File:
(a) Authorization to seek bids (B.7.).
(b)
Identification of
- changes (proposed or approved) 1 to the document submitted for procurement or the
. s?,t contracted procurement document - (A.l., Part D.2.).
. b '
9.
(c) Authorizations to accept contractor proposed
.. C. "
..~*
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z.:::
alternates to the initini document, received during the pre-award bid process, or changes
- j..
y.
initiated subsequent to the award of the contract (B. 7.).
'h*
(d) Records regarding buyer distribution of changes
/ :.
, g to be reviewed by appropriate organizations.
,*7.'.
1 (B.7.; D.7.)
g-(4), Review of provisions of " Letter of Intent", " Work Orders" or other interim documents (A.l.; Part D.2.).
.; ;, l b.
Activities of Vendor Evaluation (B.8.; F.2. and 3.)
.. (, '*,:7 (1) _ Instructions, staff an'd. general system to perform eval-
.A6.- :
N;$'
S,:
untion of consultants, suppliers, constructors, and N
1 manufacture'rs and/or fabricators.
i
_1 (2) Records reviews _ performed of vendors and bidders' QA l '. I programs.
nF
'J (3) A review of previous contractor " history" documentation j'
regarding date of last evaluation, applicability, and
["
data ?.eading to acceptability on this basis.
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10/4/73
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i. e.
(4)
Records of inspections performed and findings.
-;~
i (5) Records of audits performed, findings and conclusions.
5.-
Audits In regard to requirements fpr audit of activities in process.
g P
4 or for evaluation purposes, inspectors should exanine the.
MC
, - ep.
31.. -
implementation of the QA program for activities of the applicant's
?,,;f.
.c.:,
.q....
d auditing function, including applicant-performed." management reviews" regarding the development and execution of' auditing n;
9 activities delegated to other organizations. The activities j
performed are expected to be consistent with the auditing " ro-p visions, Section 19 of ANSI-N45.2; ANSI-N45.2.11 and N.45.2.12;
~
,-R, w.
SS and Part D.l. nnd 2.,
of the "AEC Guidance".
i
' f,_
Examples of records of activities, or utility management reviews of the auditing activities subject to selective examination f~
I's,
.?
I,f[y-.
. Records of Personnel. Qualification and Training.
s.
i b.
Records ' f Audit Planning and Scheduling of Audits.
o Presence of detailed instructions or check lists regarding p',
c.
i the performance of audits.
d.
Records of audits performed, including our reviews of:
Scope; independency and authority of audit team members;
~
actions initiated or recorded which act to resolve and pre-
- I j
(.,-
clude repetition of identified deficiencies; and reviews of
,.3 9
~
10/4/73
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1
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.-. ~.
- r.. -.
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1.
A audit reports by management of the audited activity.
l~
(E.1.4.,3.0,4.0and5.b).
l
- e.. Summary of audit records which provide objective evidence
/
- 3. y+
that audits ar's planned and are b'eing performed which will:
".,'s'.T i.-.
.(1) Verify compliance with all aspects of the quality.
^$~%
' f '-
- .:.c assurance program; and t.,
- y..
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(2) Determine the effectiveness of the program..
I g'
- g.v..
x.v.
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~
~
GUIDANCE REFERENCE TO SECTION VIII, PART B.1 THROU2 B.5 h;..,
.. n., :s A.
"AEC Guidance".
'/.:, '. c 1 g..i y.,a
~ -
j q';
A.l.
"AEC Guidance", Part D.l., Subsection a., b.,. c. or d., as in -j
. denoted by sub-let.ter to A.l."
l B.,
~ N45.2, subsections 1-19, as denoted by sub-number to "B."
~
C.
N45.2.9, Subsection number is denoted by sub-number to "C."
Y '-C
'G':-
- D.
N45.2.11, Subsection number is denoted by sub-number to "D."
-1 a
' D. ~
a.
E.
N45.2.12, Subsection number 13 denoted'by sub-number to "E."
- DI'
..~.
.tu fr - -
F.
Supplementary Quality Assurance Requirements for Control of
-;~ 1i r i
Procurement of Equipment, Materials and Services for Nuclear Y *,
- Power Plants,' Subsection number is denoted by sub-number to c
ny,n 4
1:. s,
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- e os g o g.e es _
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7, II.
GUIDANCE - EARLY MEETING
?-
Recommended outline of discussion material and presentation assignments
[ 1., I for the early meeting with the utility is provided as follows. Final
. v.
O.J ;,,, :
arrangements to assure the e'ffective, coordination of the material to,
./gi t!,
i
- ,q..
be discussed shall be accomplished by Licensing Project Manager and QA MS :
%fg'.:*:.
=
Branch personnel, and RO, Regional personnel assigned to carry out this
.- @ ~.,
activity. Time alocations are suggestions only and should be adjusted,
}$7[
~
as appropriate; for each, meeting.
4 15,
- n. :...
A.
Introduction -' Review AEC Press Release No. R-244 [ LPM 5-10 min.] -
.'s.
1 When a Project Manager has been assigned, he will discuss the
.. r 4.
content cf IEC Press Release No. R-244, AEC Announces New
- 4. u t c'.:
l h.5 Quality Assurance Procedures for Nuclear Power Plants.
If the
.?
~
y%:.....
e 1
1 Project Manager is not assigned and the Regional Director l "--
is in attendance (due to CH-3900 requirements),
the
- t l
Regiunal Director should perform the introduction. If neither
- Li
.+
~
the Project Manager nor Regional Director is in attendance, the
[$., "
.y;;..
L QA Branch will perform the,_ introduction,
- iri, t
- c :.
.c p -
$g5.,
B.
QA and t.he First Licensing Decision (Review Remarks by LMM) [L-QA.15 min.]
Mr' g[;Q The L QA Brsach will itarate or highlight the q
s I
l
" Remarks by L. M. Muntzing", made to the industry during the
.veek of July 16-20, 1973.
.r.
1 t'g
-C.
- R0 Standards for Design and Procurement (Review Remarks by WMM)[RO 15 min.' Y g 20 will sumasrize pages 1-3 of the " Remarks by W. M. Morrison",
^
j j
July 16-20, 1973, with special emphasis on applic.able criteria
- /~.
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(page 3, Criteria I - VII, XVI,' XVII, and VIIII). Also relate
.j I
10/4/73
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i
(, -
(.,
i these criteria to the primary instructions (for that criterion) of the "AEC Guidance" which will satisfy criterion requirements (NOTE: This could be prest.nted by vievgraph as follows.)
'^'
CRITERION
, PRIMARY GUIDANCE
, ' ~
I N45.~, Section 3; N45.2.n, Section 5; N45.2.12, H '.
G.
Section 1.4; Part D.1 3.b.,
and Figure 1, page
[.. '.'~
- r,.,.
D.9
~,_
N45.2, Section 2; N45.2.n, Sections'2 and 4; a?
Il
~
Port D.1.a.b.c.
N45.2.. Section 4; N45.2.11, Sections 3, 6 and 8..
T III N45.2, Section 5; N45.2.11, Sections 3, 6 and 8.
gf IV
\\ldt~
V An parts of "AEC Guidance" provided.
sr N45.2, Section 7; N45.2.n, Sections 7 and 8.
VI N45.2, Section 8; N45.2.13; Part D.2.a.
VII 3
~
N45.2,Section 17; N45.2.11, Section 9; N45.2.12, VII
_ w Section 4.5.
- p., _
_ -. a. i 25j'? '
N45.2,'Section 18; N45.2.9..
,y IVII
.m IVIII N45.2., Section 19; N45.2.12; and N45.2.11 Section 11.
/,
j As a conclusion to this part, emphasize that "AEC Guidance" also establishes i
the acceptance criteria by which RO inspectors will continue to measure the
.,.. l
' F, development of the applicant's overall QA program subsequent to docketing 1
of the application.
l
{;..
~
l
. ~......
10/4/73
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[
. h D.
QA Review by Licensing (Review Remarks by RHV) [15 min.]
~
We L QA Branch will summarize the remarks of R. Vollmer, made at
.[ $
the July M-20,1973 industry conference, entitled " Quality.Assur-ance Review by Licensing at Prelimi ary Review Stage".
5 E. ' 'Early QA Inspection by-RO (Review Kemarks by DFK) [RO 15 min.]
'i'
~ -4I.' : '
~ R0 will summarize
- the " Regulatory Operations' Panel' Discussion ~ at
~~'
"3 },
x 4 :.
R:!gional Conferences on Quality Assurance", by D. F. Knuth. The M' D following viewgraphs are recommended during this presentation:
s
.'y
- .~
1.
Display the 5 areas of.the QA program for design and procure-*
M?li
- z..
a'T_'
ment subject to inspection.
1 2.
Display examples of selective examiitations of:
I[.
~
U!
Utility's organization (refer to page 2 of Appendix to a.
'~
~
vg' Remarks by D. F. Knuth).
b.
(
QA Program (refer to page 8 of Remarks by D. F. Knuth).
QA in the Des.ign Phase (refer to page 10 of Remarks by (i
c.
D. F. Knuth).
- !.,ll?,
d.
QA for Procurement (refer to pages 'll and 12 of Appen_ dix
.. ((,, ;
~
to Remarks by D. F. Knuth).
D7b '
c
. e.' Audits (refer to pages 14 and 15 of Remarks by D. F. Knuth).
A-On page 2 of. " Remarks by D. F.. Knuth", a request is made for the QA
~
manuals to be submitted 30 days prior to the filing of the applica-tion. Emphasize this request, and include a request for a status of
~ ','i those project activiites that are in progress to be submitted with
.c o i the QA inanuals. Also emphasize that if the QA manual is unavcilable or incomplete or contains significant deficiencies that these condi-tions will probably result i:2 the rejection of the application for docketing. Also, that late submittals of the QA manual will most likely~ delay the schedule for completing pre-docketing 30-day reviews.
9 6
10/4/73 2
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...._'n
.... _.. c.
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- ['
-,L F.
Licensing Review - Details and Sequence [L 1 hr.]
L may wish to discuss further details of and sequence of events j
regarding the preliminary L QA Branch 7-day substantive review and L 30-day coupleteness reviews, and L QA Branch /RO/ Project
.ff T. '
Manager interface during this period.
(Questions...)
~
~
x --~ ; q..
G.
'RO Inspection Activities - Details and Sequence [RO 1 hr.]
f.'d'[
- 40y r
RO should provide a general description of the sequence of RO
".[.h
?.
l pre-docketing inspection. activities and RO/L'QA Branch interface.
.j. g.
..u during this period. Items that should be highlighted at this
~
time are:
(Questions...)'
s;..,
l
..e e
gg 1.
Tight schedules mandate timely receipt of QA manuals and the i F b;,-
iE PSAR.
. p i
2.
Clarify that RO examinations of QA manuals.
r at this time, are accomplished to determine
- w..
~' ~
I.
the absence of substantive findings and should not be con-l sidered to be a detailed examination of the instructions of
.r..,
the QA asnuals. More detail owninations will take place 14.=
u -- M,#,:
r '.
,.e i
subsequent to docketing of the application.
- 'E[
\\
3.
Tentative scheduling of the inspection.
i 4.
Tha QA commitments of the PSAR are reviewed to determine the 4
3 consistency of the implemented instructions of the QA manual-4 l
with the PSAR. Major inconsistencies would be considered to be significanc'in thct they, would represent lack of control
~
- of the project by,the applicant.
i i
i 4
l.
I 10/4/73 f~
5.
Performance of the inspection.
General Scop'e, refer to Remarks by, D. F. Knuth.
a.
l' Note that areas selected for examination would include areas of the QA program identified by the
- r.
L QA Branch 7-day reviews to be of concern. Also,
- } : ;
stress that RO examinations would evaluate the imple-
. !;c mentation of an acceptable QA program for activities
,T.
important to assuring quality and safety that should
- ~.,.,. >
be in effect today.'Ihis will be done by the examina-
" ' ~
tion of past records that should be in existence.
~
6.' Exit Meeting. Highlight that generally RO will not be T
- b.,
'yj, soliciting corrective action commitments from the utility
.p,
regarding identified areas of concern and that the recom-i 1
mandation nada by the Regional Office regarding docketing of the application will almost exclusively be based on
,1 ',..
- ' the significance of the findings at the time of the 4;
'N inspections.
~
@_g 7.
Note that detail discussions regarding the significance
,f, of RO inspection findings will be oiscussed subsequent to q
.the completion of the L 30-day reviews at a meeting at Bethesda or by correspondence initiated by the Project Manager. Also, all findings prior to the issuance of the final conclusion by the Region are considered to be
(
, g Preliminary.
\\
4 10/4/73
. ~.
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i s.
8.
Note that the RO inspection report will be prepared I
sfter the inspection is performed and it will be transmitted to the utility subsequent to L's formal
[
notification to the applicant regarding the conclusions y
o'f Mthe L 30-ilay review.
i 'i
- J'+
9.
In addition, if not covered previously, RO should stress. -. - -.
e5 -
the importance of thei QA program to provide comprehensive 7 f J
and explicit requirements in areas wh'ere ve historically, _.
- ,V r
i have found program instructions to be ineffective.
j Examples of these are:
a.
Maintaining the independence of the organization f':$;
E-or personnel who verify that an activity is performed j
correctly.
[-
~
b.
Development of a documented and comprehensive QA
]
program and of detailed QC procedures.
s 4
c.
Audits to measure the effectiveness of the QA program..
,)/
d.
An effective corrective action system.
-- e :- r - u _. s r.n i? l-e.
Documentation of deviations or nonconformances,
..i including retclution or disposition, especially for I
those technical records required to provide the bases
{
for in-service inspection.
1 f.
Design control for all phases, of engineering;' i.e.,
conceptual engineering, engineering design, draf ting j
J and layout, design changes, and asrbuilt of drawings and specifications.
j
_ _._ 10/4/73
.+
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- 8. -
1 g.
Verification that procurement documents contain i
appropriate requirements relating to all of the 18 AEC QA Criteria and that proposals and bid
^
4 packages received by the owner and his contractors
?
.e,
address and are adequately responsive to these T
.~=i 18 criterino acf
- a., <.
The determination, prior to issuance of contracts,
['.' ' ).~
h.
1
.u-of which records the applicant will require to f,
a accompany the delivery of the item to the site and
'1c" ~
1 which records will be permanently retained.
~
H.
Conclusion [ LPM S-min.]
Subsequent-to completion of the discussion.provided by the L QA Branch and RO personnel.the Project Manager should conclude t
l the meeting, adding of course any further clarification of
{
his own activities subsequent to receipt of'the L QA Branch
~~
and RO recommendations regarding docketing of the application.
j.i.
)....
(Note-if a Project Manager is not assigned, follow the_guid ;a.,
p :,. -
.t f
ance provided by "A." above to effect the end of the meeting.)
A i
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10/4/73
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