ML20151K931
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@ fJM 24 N U N 3EGION W,F MEMORANDUM FOR:
Thomas E. Murley, Regional Administrator, RI J. Nelson Grace, Regional Administrator, RII James G. Keppler, Regional Administrator, RIII Robert D. Partin, Regional Adninistrator, RIV
-* John B. Martin, Regional Administrator, RV FROM James M. Taylor, Director Office of Inspection and Enforcement
SUBJECT:
SUMMARY
REPORT ON THE ASSESSMENT OF REGIONAL REVIEWS OF QA PROGRAM DESCRIPTION (QAPD) CHANGES This Summary Report provides an overview of the national implementation of regior.31 reviews of QAPD changes and is prepared in accordance with IE Office Procedure 0200 "Assessment of Regional Implementation."
1.
Scope The implementation of the FY 1985 Regional Assessment Plan included an assess-ment of the reviews perfonned by the regional offices of licensees' QAPD changes as required by 10 CFR 50.54 and 50.55.
This assessment addressed the timeliness and adequacy of program implementation; the consistency of program implementation relative to the review of QAPD changes both within and among the five NRC regional offices; and the need for additional guidance or change to IE inspection procedures regarding review of QAPD changes. Oraft Inspection Procedure 35001 transmitted to the regional offices in my memoranda of July 11, 1983, and February 29, 1984, which the regional reviews were evaluated.was the baseline document against II. Assessment Activities Specific notification to the regional offices of these assessments were announced in my memorandum of February 5,1985.
The assessments of all five regional offices were completed by March 29, 1985, and individual reports describing the results of the assessment were issued to the appropriate regions.
Copies of these reports including memoranda from Regions I, II, and III responding to these reports are attached as Enclosure 1.
Each assessment involved an entrance meeting with the regional staff explaining the scope, objective, and methodology of the assessment; evaluating review packages; conducting interviews with the principal reviewers; sumarizing the results of the assessment; and reporting the preliminary results of the assessment to the regional staff at an exit meeting.
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III. Overall Assessment Findings Adequacy of the Review Process Controlled methods have been established by the five regional offices for promptly identifying incoming QAPD change submittals and for initiating the reviews in a timely manner.
The results of the regional reviews were ade-quately documented which included correspondence to and from the licensees regarding requests for additional information, responses, and the acceptance of the changes.
In general, the overall regional reviews of the QAPD changes were performed in a complete and effective manner consistent with the 10 CFR 50.54 and 50.55 change rule and draft Inspection Procedure 35001.
Questions were, however, raised in the assessment where development of addi-tional guidance is warranted to gain further assurance in the consistent and proper implementation of the rule.
Refer to the latter section of this report titled "Need for Additional Guidance" for more infortnation on this subject.
Most reviews were completed within the required 60 day timeframe.
In those instances where the review time was expected to extend beyond 60 days the licensee was notified in advance of this extension in writing.
The regions appeared to be expending the necessary resources to perform effective reviews of QAPD changes in a timely manner.
Need For Additional Guidance While several regions have developed temporary instructions describing their review process, others were in the process of procedurally documenting their review process.
In this regard, we believe it may be more appropriate to incorporate the necessary specifics of the review process in the final version of IE Inspection Procedure 35001, which would then serve as a standardized instruction for the regional offices to follow. This would provide additional assurance that there is consistency between regions.
In each of the assessments of the five regional offices, specific issues were raised by the regiort and/or the IE staff which warrant additional guidance from the IE staff and which will be incorporated either in Inspection Procedure 35001 or in an Infonnation Notice.
The issues and the proposed actions to resolve them are as follows:
1.
The need to clarify the method of accounting for the time expended in the review process to enable proper fee charging for the review of changes that are reductions from previously accepted commitments.
This clarification will be addressed in Inspection Procedure 35001.
The 1.icense Fee Management Branch will be involved in developing this clarification.
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The need to ensure that changes to those QA commitments that are reflected in the QAPD as references (e.g., comitments to the Q-list and Regulatory Guides) are reported to the appropriate region as QAPD changes.
An IE Infonnation' Notice in under consid'eration to notify licensees of the need to, provide the regions with these type of changes.
3.
Whether there is a need for the regional offices to update their QAPD files by incorporating those QAPD changes that are submitted in the annual SAR updates but not separately reported to the appropriate regional office.
This effort would ensure that the regional offices have a complete and current QAPD against which future QAPD changes may be reviewed to determine if QA program reductions exist.
This activity, and your views on staff workload impact, will be addressed in Inspection Procedure 35001, 4
The need to provide clearer guidance describing what constitutes a reduction to a previously accepted QA comitment and the criteria to be used in detennining the acceptability of QA reductions.
This clarification will be addressed in Inspection Procedure 35001.
The IE staff will consult ELD in preparing this clarification.
5.
The need to revise and fonnally release Inspection Procedure 35001.
This procedure will be revised and should be ready for release by fall 1985. We expect the regional offices will play an active role in com-menting on this updated procedure prior to release.
I am encouraged by the careful treatment by the regions of the regionalized Quality Assurance licensing function for operating plants.
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Jame lor 1 rector Off ce of Insp ction and Enforcement
Enclosures:
Assessment Reports and Regions I, II and III responses
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