ML20153H390
| ML20153H390 | |
| Person / Time | |
|---|---|
| Issue date: | 09/08/1998 |
| From: | Ted Carter, Wastler S NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20153H380 | List: |
| References | |
| REF-WM-11 HLWR, OAR-98-03, OAR-98-3, NUDOCS 9810020031 | |
| Download: ML20153H390 (6) | |
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U.S. NUCLEAR REGULATORY COMMISSION OBSERVATION AUDIT REPORT OAR-98-03 OF THE YUCCA MOUNTAIN QUALITY ASSURANCE DIVISION
- AUDIT OCRWM-ARC-9818 r
OF THE OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT L
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09/8fh98 t/[4/L -
M/A09/ h/98 Ted Carter Nf Sandra Wastle@(#Btfon Chief Quallity Assurance Specialist Performance Assessment & HLW ,
Performance Assessment & HLW Integration Branch Integration Branch Division of Waste Management Division of Waste Management Enclosure 9810020031 PDR WASTE 9so91b WPf-11 PDR
)
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1.0 INTRODUCTION
A member of the U.S. Nuclear Regulatory Commission (NRC) Division of Waste Management !
Quality Assurance (QA) staff observed the U.S. Department of Energy (DOE), Office of Civilian l Radioactive Waste Management (OCRWM), Office of Quality Assurance, Yucca Mountain )
Quality Assurance Division (YMQAD) compliance audit of the Office of Civilian Radioactive Waste Management (OCRWM) Quality Assurance Program in Washington, DC. The audit, OCRWM-ARC-98-18, was conducted on August 10-13,1998.
2.0 MANAGEMENT
SUMMARY
The NRC staff has determined that the YMQAD Audit OCRWM-ARC-98-18 was useful and effective. The audit was organized and conducted in a professional manner. Audit team members were independent of the activities they audited. The audit team was well qualified in the QA and technical disciplines, and its assignments and checklist items were adequately described in the audit plan.
The audit team concluded that the OCRWM QA program had been satisfactorily implemented.
One deficiency (see Attachment 1) was reported at the exit meeting. The NRC staff agrees with the audit team finding and recommended action. The NRC staff determined that this audit was effective and that the OCRWM QA program implementation was adequate.
3.0 AUDIT PARTICIPANTS ,
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3.1 NRC Ted Carter Observer (QA Specialist) 3.2 YMQAD/ Quality Assurance Technical and Support Services (QATSS)-MACTEC Charles Warren Audit Team Leader (ATL)
Emily Reiter Auditor Gary Wood Auditor 4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION This YMQAD audit of OCRWM was conducted in accordance with OCRWM Quality Assurance Procedure (QAP) 18.2, "Intemal Audit Program," QAP 16.1Q, " Performance / Deficiency Reporting" and AP 16.2Q, " Corrective Action and Stop Work." The NRC staff's observation of this audit was based on the NRC procedure, " Conduct of Observation Audits," issued October 6, 1989.
4.1 Scope of the Audit The following QA program elements were audited:
1.0 Organization 2.0 Quality Assurance Program 3.0 Design Control 4.0 Procurement Document Control
e 5.0 _ Implementing Documents 6.0 Document Control 7.0 Control of Purchased items and Services <
17.0 Quality Assurance Records Supplement V Control of the Electronic Management of Data The following QA program elements were also considered, however, OCRWM currently has no activities to which these elements apply:
8.0 identification and Control of items 9.0 Control of Special Process 10.0 Inspection 11.0 Test Control 12.0 Control of Measuring and Test Equipment 13.0 Handling, Storage, and Shipping 14.0 Inspection, Test, and Operating Status 15.0 Nonconformances 16.0 Corrective Action 18.0 ' Audits Supplement i Software Supplement il Sample Control l Supplement lll Scientific Investigation 4.2 Conduct of the Audit i
The audit was performed in a professional manner and the audit team was well prepared and <
demonstrated a sound knowledge of the OCRWM and DOE QA programs. Audit team personnel l were persistent in their intentiews, challenged responses when appropriate, and performed an acceptable audit. l 1
The DOE audit team and NRC observer caucused at the end of each day. Also, meetings of the audit team and OCWRM management (with the NRC observer present) were held each morning to discuss the current audit status and preliminary findings.
4.3 Examination of QA Programmatic Elements l The NRC staff observed that each of the auditors reviewed related documentahon and !
interviewed a representative sample of OCRWM personnel to determine their understanding of ,
implementing procedures and processes. Checklists were used effectively and the NRC observer was provided ample opportunities to provide comments and ask questions.-
Training, education, and experience records were reviewed to assure OCRWM personnel were in compliance with their individual position descriptions. Objective evidence was provided and reviewed by the auditor and it was determined that all personnel were in compliance.
4.4 Examination of Technical Activities None.
l 4.5 Audit Team Qualification and Independence The qualifications of the ATL and audit team members were found to be acceptable in that they each met the requirements of QAP 18.1, " Auditor Qualification." The audit team members did not have prior responsibility for performing the activities they audited. Tne audit team members were '
prepared in the areas they were assigned to audit and were knowledgeable of applicable procedures. The checklist was adequately formulated and covered the subject matter well.
4.6 Summary of YMQAD Findings The audit team identified one deficiency in the OCRWM program which is documented on the draft " Performance / Deficiency Report"(see Attachment 1). A summary table of audit results is provided as Attachment 2.
OCRWM-98-D-128 !
HLP-3.10, Revision 0/0, Section 5.2e, states, in part, that the preparer of changes to the CRD documents the following on Requirements Analysis Sheets for each requirement: " Statement on whether the requirement applies to a function or activity that is subject to the quality Assurance Requirements and Description (QARD) document". The preparer omitted the required QARD applicability statements from the Requirements Analysis Sheets prepared for Revision 4 of the CRD.
4.7 NRC Staff Findings The NRC staff determined that the audit was effective in determining OCRWM compliance with requirements in the areas examined. The audit was conducted in a professional manner and the audit team adequately evaluated activities and objective evidence. The ATL was extremely effective in his daily presentation to the OCRWM management and staff in providing guidance to the audit team. The checklist questions provided a sound basis to conduct the audit. Both the auditors and OCRWM staff were knowledgeable in their respective disciplines.
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' O Performance Repos omos OF CIVit.lAN E tWwency Repon RADICACTWE WAtTE MANAGEMENT U.o. DEPARTMENT OF ENEROY No stmim &12q j ,D.C.
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Mt.P 3.1Q, Revision 04, Preparation of CRWMS Requirement Document (CRO) t .._
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. i MLP 3.10, Rev6ainn 0m, Section 6.2e, states, in part, e-t the Pieperor of Changes to tne CRD on Requeements Analysis Sheets for each requirement t 8tatement en whether the requirement applice to e function or activity that is subject to the Quality As Regulrumente and Descripten (QARD) document.
sseeenesenercaneten The Properor omitted the requitec QARD epplicability statements from the Requirements Analysis Sheets p Revision 4 of the CRD.
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- 1. Determine impact of nonenmpilence wilh MLP-3.1Q.
- 2. Take appropriate remedesi schone based on the impact determinsten.
- 3. IrWiiste actlDn to preclude recurrence on this tendnion tttR1g;;;;r--
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_.____m, emes emme Robert W. Clerk egneswe Opte a senaen assusvesen n c o weves or can nr m QAR Dm AD004 Data GE$siv.te.to.1 Rev.084347 Attachment 1
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Audit Report OCRWM-ARC.98-18 Page 8 of 8 ATTACHMENT 2
SUMMARY
TABLE OF AUDIT RESULTS ELEMENT IMPLEMENTING DETAILS RECOMMEND- PROGRAM ggg DEFICIENCIES PROCEDURE g ATIONS ADEQUACY COMPLIANCE
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1.0 QAP 1.1, R1 Pga.1-5 CDA #1 N l SAT SAT SAT HLP 2.lQ, R1 Pas.15-24 N N SAT HLP-2.3Q, R0 Pgs.Il-12 N N SAT
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HLP-2.10Q. R0 Page 13 N N 2.0 N/I QAP 2.3, R0, R1 SAT ---
SAT Page 6 N N N1 QAP 2 6. R1 Page 7 N N N'I QAP 2.7, R4 Page 810 N N SAT 3.0 Hl.P-3.lQ,R0 Pgs.25 32 N N SAT SAT SAT 4.0 & 7.0 Hl.P-7.!Q, R1 Pgs.5259 N N SAT SAT SAT 5.0 QAP 3.1, RR Pgs. 33-39 N g gg, SA'l SAT SAT IILP-6.10. R0 Pga. 40-44 CDA*2 N 6.0 QAP 6.2, R2 SAT SAT SAT Pgs. 45-51 N N 17.0 AP 17.lQ, RO Pgs. 60 66 CDA #3,#4 N SAT SAT SAT Supp.V QARD, R2 Page 14 N N SAT N/I SAT CDA .. ........ Corrested During the Audit ADi'QUACY ...... . Requirernents in Procedure Meet QARD N . . . . . . . . .. . . . None COMPLIANCE .. . Procedures Impicmented N/I ........... . No implementation OVERALL. . . . . Suuunary of Element SAT. . ......... . Satisfactory Attachment 2
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