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March 27, 1998
Mr. Samuel Rousso, Directorfor Program Management and Administration
Office of Civilian Radioactive Waste ManagementU. S. Department of Energy1000 Independence Avenue, S.W.Washington, DC 20585
SUBJECT: MINUTES OF THE JANUARY 21, 1998, QUALITY ASSURANCE MEETING
Dear Mr. Rousso:
Enclosed are the minutes of the January 21, 1998, Quality Assurance (QA) meeting betweenthe staff of the U.S. Nuclear Regulatory Commission and representatives of the U.S.Department of Energy (DOE).
The purpose of the January 21, 1998, meeting was to discuss items of mutual interestregarding QA and those areas contributing to resolution of Key Technical Issues of DOE's sitecharacterization program for Yucca Mountain. The meeting was a video conference betweenthe DOE office in Las Vegas, Nevada, NRC headquarters in Rockville, Maryland, and DOEheadquarters in Washington, D.C..
If you have any questions regarding this letter, please contact Ted Carter of my staff. Mr.Carter can be reached at (301) 415-6684.
Sincerely,
[Original signed by:]
Michael J. Bell, ChiefPerformance Assessment and HLW
Integration BranchDivision of Waste Management / 'IOffice of Nuclear Material Safety , J ,and Safeguards
Enclosure: As stated } ) 1
cc: See attached list
DISTRIBUTION:Central File PAHL r ACNW CGlenn WBelke EBrummett
DOCUMENT NAME: SDWM1PAHLTHC1QA-MTG2.MIN
OFC PAHL PAHkn e | | P f K-
NAME TCarter- SAY'er
DATE 3! /98 3//1/98 3 31 /98 ll
9504060369 980327NtMSS SUBJ d102.7 R uCMTCE
-
Letter to S. Rousso from M. Bell dated: March 2 1998
cc: R. Loux, State of NevadaB. Price, Nevada Legislative CommitteeJ. Meder, Nevada Legislative Counsel BureauW. Barnes, YMPOC. Einberg, DOE/Wash, DCN. Slater, DOE/Wash, DCA. Brownstein, DOE/Wash, DCM. Murphy, Nye County, NVM. Baughman, Lincoln County, NVD. Bechtel, Clark County, NVD. Weigel, GAOP. Niedzielski-Eichner, Nye County, NVB. Mettam, Inyo County, CAV. Poe, Mineral County, NVW. Cameron, White Pine County, NVT. Manzeni, Lander County, NVL. Fiorenzi, Eureka County, NVJ. Regan, Churchhill County, NVL. Bradshaw, Nye County, NVW. Barnard, NWTRBR. Holden, NCAIA. Collins, NIECS. Brocoum, YMPOR. Arnold, Pahrump County, NVN. Stellavato, Nye County, NVJ. Lyznicky, AMAR. Clark, EPAF. MarcinowskiA. Gil, YMPOR. Anderson, NEIC. Henkel, NEIS. Frishman, Agency for Nuclear Projects
___ _ _ __ _
. r, i
MINUTES OF THE JANUARY 21, 1998,U. S. NUCLEAR REGULATORY COMMISSION/U. S. DEPARTMENT OF ENERGY
QUALITY ASSURANCE MEETING
On January 21, 1998, staff of the U. S. Nuclear Regulatory Commission and U. S. Departmentof Energy (DOE) held a Quality Assurance (QA) video conference meeting in Washington D. C.and Las Vegas, Nevada. The purpose of the meeting was to discuss items of mutual interestregarding Quality Assurance and those areas leading toward or contributing to resolution ofNRC Key Technical Issues of DOE's site characterization program for Yucca Mountain. Themeeting was a video conference between the DOE office in Las Vegas, Nevada and NRCheadquarters in Rockville, Maryland. DOE headquarters in Washington, D.C. also attended themeeting.
Attendees
Attachment 1 provides the name, affiliation and telephone number of the attendees.
Agenda
Attachment 2 provides the agenda.
Opening Remarks
The meeting opened with the introduction of attendees. There was a short discussion todetermine the frequency of the QA meetings. Among the attendees, it was suggested thatscheduling a QA meeting annually or twice a year should to be adequate. DOE wanted inputfrom the State of Nevada before determining our next QA meeting, therefore the frequency ofthe QA meeting will be determined at a later date.
Status of Open Items
Attachment 3 provides the list and current status of open items. Since our last meeting, 11 of16 open items have been closed. Items 12, 14, 15 and 16 remain open. The actions taken toresolve the Open Items are described in the comments column of the NRC QA Open ItemsStatus Report.
Other A Topics
Attachment 4 provides the presentation handouts in accordance with the agenda.
Enclosure
Closing Remarks
There were no additional issues noted by the representatives in attendance. The meeting wasadjourned at 1:45 p.m. EST.
ea eH. derTheadr dDivision of Waste Management Office of Nuclear MaterialSafety and Safeguards
U.S. Nuclear Regulatory Commission
redek C. RodgersRegulatory Integration DivisionOffice of Civilian RadioactiveWaste Management
U.S. Department of Energy
ATTACHMENT I
NRC-DOE QUALITY ASSURANCE MEETINGNRC-DOE QUALITY ASSURANCE MEETING ATTENDANCE LIST
January 21, 1998Videoconference betweenDOE Las Vegas/YMSCO
NRC/Rockville
Bob Clark DOE/OQA 702-794-5583
Bill Belke NRC 702-794-5047
Catherine Hampton DOE/OQA 702-794-1387
Woody Hudson QATSS 702-794-1490
Richard Peck QATSS 702-794-245_
Hank Greene QATSS 702-794-1498
Robert Habbe QATSS 702-295-2675
John Therien QATSS 702-794-5408
Richard Kettche QATSS 702-794-1412
Ali Haghi M&O/DUKE 702-295-487_
Mary McDaniels QATSS 702-794-1468
Charlie Warren QATSS 702-794-1487
Dan Tunney QATSS 702-794-1489
Albert C. Williams DOE/OQA 702-794-5580
Donald G. Horton DOE/OQA 702-794-5568
Emily Reiter QATSS 702-794-5013
Ted Carter NRC 301-415-6684
Sandra Wastler NRC 301-415-6724
Sidney Crawford Self 301-515-6398
John L. Russell CNWRA 301-881-0289
Bakr Ibrahim NRC. 301-415-6651
Anne Ramirez NRC 301-415-6631
ATTACHMENT 2
AGENDANRCI)OE QUALITY ASSURANCE MEETING
January Z1, 1998Video conference: DOEILV. Atrium Room; NRC( Headqtarters
10:00 AM PST (1:00 EST)
* OPENING REMARKS
* QA TOPICS
Status of Open Items
.10 CF&, Part 21 (DOE Response)
- QARD, Revision 8 Overview
- DOE Audit Schedule (Potential Audits Observed by NRC-)
. ResultsReport of 1997 Independent QA Management Asmelt
* Brief Overview by DOE of the M&O Engineering AssuranceOrgnzatlon Responsibilities and Activities performed
- Discusion of Combining or Absorbing Compliance Audits WithPerfomance bfased Audits
* Supplier Baselining Effort
. Transition of TSPA from Non-Q to Q
- QA InvoIvement In Application to Viability Assessment
* CLOSING REMARKS
* ADJOURN
12:00 FM PST (3:00 PM EST)
NRC/DOE
DOE
DOE
DOE
DOE
DOE
DOE
DOF.
DOE
DOF
K%- A
ATTACHMENT 3
MRC QA OPEN rrEMS SrATUS REPORT
JANUARY 20,1992
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ATTACHMENT 4
QARD, REV. 8EFFECTVE DATE 6/5/98
m * HIGHLIGHTS OF REVISION
* Section 2.0, Quality Assurance Program - Revised Subsection 2.2.12, (Personnel Qualification to incorporate a graded approach to trainingand qualification.
* Supplement I, Software - Modified, Subsection 1.1 to clarifyapplicability of Supplements I and V.
* Supplement III, Scientific Investigation - Subsection H1.2.4, Data,Review, Adequacy, and Usage and Subsection I1.2.5, Technical (Report Review were rewritten. This establishes new categories(qualified, accepted, and existing) for data and adds technical _assessment as an alternative method for qualification of data. m
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J I QARD, REV. 8EFFECTIVE DATE 6/5/98
HIGHLIGHTS OF REVISION (Continued)
* Appendix C, Mined Geologic Disposal System - Added newSubsection C.2. 1, to define requirements for conducting expertelicitation.
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* Glossary - Added definitions of special terms used in AppendixC, Expert Elicitation (i.e., expert elicitation, generalist, normativeexpert, and subject-matter expert). Added definitions of specialterms used in Supplement III (i.e., accepted data, acquired data,developed data, existing data and technical report). Modifieddefinition of "qualified data."
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C) REVISION I CURRENTLY APPROVEDBY DIRECTOR, OQA
REVISION 2 TO BE APPROVED
FEBRUARY 1998
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FY 1998INTERNAL AUDIT SCHEDULE
(Continued)
J ELEVEN COMPLIANCE AUDITS OFAFFECTED ORGANIZATIONS
J THIRTEEN PERFORMANCE-BASED
AUDITS OF PRODUCTS/ACTIVITIES(I
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FY97 QAMA RECOMMNDATIONS
%ml 0 he responsible OCRWM and M&O line manager should closely monitor the EA orgaizatiOnto ensure that the EA role is clearly defined and implemented.
C* Management leadership, vision and authority are needed within the OCRWM and the M&Oin order to address ffie design interface control and inegration issue on a progam-wide basis.
The M&O should use, to the extent possible, the information developed as a result of earierrequirement research efforts.
* OCRWM and M&O management need to identify what is needed to control baseline changes,articulate the policy, streamline the process and define a single system for the entire OCRWMProgram..
* Ensure that policy and uppcr-tier procdure for documenting key decisions is reviewed bypeople with NRC licensing expeenceso that the process will effectively identify meaningfulthresholds and avoid over-commitnents.
(La* OCRWM should he an integrated Cmmitnent Mamagement Program in place to
effectively manage all regulatory commitments from inception to closure. L.Vaa
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em 44k FY97 QAMA RECOMMENDATIONS (Continued)
mini Adequate resources and authority need to be given to the TSPA task force, along withcontinued M&O senior management s t to complete the cultural change that isneeded in the zation's performing PA activities. C
* The "record submittal" control feature of the Records Management Program shouldbe evaluated to determine if it will adequately spport OCRWM's need during thelicensing process.
* OCRWM managemnt should evaluate the organtional structure and correspondingresponsibilities to ensure that ownership of fimions and processes are clearly definedand communicaled and responsibilities do not overlap.
* M&O management should evaluate the current organizational structure and removeany barriers to horizontal communication.
(- M&O management in consultation with OCRWM management should evaluate the
need for a Chief Engineer, tking into account the need for the licensee t establishdesign authority and consistency within each project.
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FY97 QAMA RECOMMENDATIONS (Co2tinued)
For the procurment of commercially available items and services, OCRWM andthe M&O should identify and endorse those nationally recognized QA standardsthat have a proven track record for adequate controls. (
* The constcton specifications fbr comnon building materials should be revisedto remove the excessive QA requirements in favor of commercial requirements.
- M&O management should provide Ihe Director, OCRWM, With a response to therecommendations identified in the FY 996 QA Management Assessment of the M&O.
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M&O ENGINEERING ASSURANCE ORGANIZATION
* ESTABLISHED AS A RESULT OF TRANSITION OF QAFUNCTION TO THE OQA
* M&O LINE ORGANIZATION RESPONSIBLE FOR:
- IN-LINE REVIEW OF M&O DOCUMENTS- VERTICAL SLICE REVIEW OF M&O DOCUMENTS- METRICS AND EVALUATION OF M&O
ACHIEVEMENT OF QUALITY
* STAFFED WITH PERSONNEL WHO HAVE EXPERIENCE INQUALITY ASSURANCE AND WHO ARE FAMILIAR WITHM&O TECHNICAL WORK PRODUCTS
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BASELINE REVIEW OFSUPPLIERS QA PROGRAM
J REVIEW SUPPLIERS QA PROGRAMTO DETERMINE EXTENT OF QARDAPPLICATION
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J A TOTAL OF 47 SUPPLIERS ON QSLAS OF SEPTEMBER 9, 1997
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REVIEWS
PERFORM REVIEW OF FY97 PURCHASEORDERS ISSUED BY AOS
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PERFORM REVIEW OF SUPPLIER QAPROGRAM AGAINST GRADED QARDCRITERIA AS LISTED ON PURCHASEORDERS OR GUIDELINES DOCUMENTFOR CALIBRATION AND ANALYTICALSERVICES
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RESULTS
PROCUREMENT DEFICIENCIES HAVE BEENIDENTIFIED AT EACH AO PROCURINGORGANIZATION
0 SUPPLIER QA PROGRAM REVIEWS IDENTIFIED:
- 27 SUPPLIERS WERE FOUND TO HAVEPROGRAMS THAT MEET APPLICABLECRITERIA
- 20 SUPPLIERS WERE FOUND TO HAVE CPROGRAMS THAT DO NOT MEETAPPLICABLE CRITERIA
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CORRECTIVE MEASURES
O ISSUE CAR TO DOCUMENT PROCUREMENTPROBLEMS
O ADJUST STATUS OF SUPPLIERS ON QSL
O3 AS OF JUNE, 1997, OQA REVIEWS ALL QPROCUREMENT DOCUMENTS TO ENSUREGRADED QARD CRITERIA ARE INCLUDEDIN PRs and POs
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PROGRAM DOCUMENTATION
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