ML20151K802
| ML20151K802 | |
| Person / Time | |
|---|---|
| Issue date: | 05/03/1985 |
| From: | Grimes B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Martin R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| Shared Package | |
| ML20151K612 | List:
|
| References | |
| FOIA-87-866 NUDOCS 8505080027 | |
| Download: ML20151K802 (8) | |
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WAY 0 31985 MEMORANDUM FOR: Robert D. Martin, Regional Administrator Region IV THRU: James M. Taylor, Director Office of Inspection and E rcement FROM: Brian K. Grimes, Director Division of Quality Assurance, Vendor, and Technical Training Center Programs Office of Inspection and Enforcement
SUBJECT:
ASSESSMENT OF REGION IV REVIEWS OF QA PROGRAM DESCRIPTION (QAPD) CHANGE 5 I. Scope In accordance with the FY 1985 Regional Asse.ssment Plan and IE Office Procedure 0200, "Assessment of Regional. Implementation," this assessment provides an evaluation of the reviews performed by the Regional Offices of licensees' QAPD changes as required by 10 CFR 50.54 and 50.55. This assessment is to determine the timeliness and adequacy of program implementation; the consistenpy of program implementation relative to the. review of 0.APD 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. Draft Inspection Procedure 35001 transmitted to the Regional Offices in J. M. Taylor's memoranda of July 11, 1983 and February 29, 1984 is the baseline document which the reviews are evaluated against. This procedure instructs the reviewers to compare changes against the latest accepted QAPD to check for any reductions to the QAPD because of the changes, and to complete the reviews within sixty days from receipt of the change.
II. Assessment Activities An assessment of Region IV's review of licensees' QAPD changes took place on March 27,1985, at the Regional Office. This involved conducting an entrance meeting with the Region IV staff explaining the scope, objective and methodology of the assessment; evaluating review packages, including interviews with the principal reviewer; sumarizing the results of the assessment; and reporting the preliminary results of the assessment to the Region IV staff at an exit meeting. Enclosure 1 contains the plan used in the assetsment of the Regional Offices. Enclosure 2 identifies Region IV personnel contacted during the assessment and QAPD change packages evaluated. John Gilray of the IE QA Branch performed this assessment.
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Robert D. Martin '
III. Assessment Findings Region IV's present review process is as follows:
The QAPD change submitted enters the Region IV mailroom and is sent to the ,
Reactor Projects Branch within the Division of Reactor Safety and Projects.
The Reactor Projects Branch:
- 1) Evaluates those changes identified by the licensee against the previcusly accepted QAPD to determine if the QAPD has been reduced.
- 2) Resolves areas of concern either by telephone, meetings, or fonnal letters.
- 4) Issues an acceptance letter upon satisfactory resolutions of concerns and unresolved items. j
- 5) Notifies the licensee by letter if the review process is expected to I exceed 60 days. !
Adequacy of Region IV Review Process The overall Region IV review process of QAPD changes was found to be effective and carried out in a timely and acceptable manner. The revised pages were reviewed completely to assure that there was not a reduction to the previously accepted QAPD and that additional changes or deletions did not exist beyond those identified by the licensee. Major changes which were sensitive in nature were discussed with the IE QA Branch, through meetings or telephone conversations. The results of reviews were adequately documented and reflected effective and thorough reviews. The Region IV staff responsible for the review of the QAPD changes exhibited a sound knowledge in the review process and in the principles of QA/QC.
Timeliness of the Reviews All reviews by the Region IV office were perfonned in a reasonable and '
l acceptable timeframe. The time expended in reviewing each QAPD change was identified by Region IV. The License Fee Management Branch (LFMB) memorandum of February 7,1985, was discussed with Region IV relative to the reporting guidelines of QAPD change reviews. Region IV is considering an accounting method that would satisfy the LFMB memorandum concerning the review of QAPD changes.
Consistency and Need for Additional Guidance t
Region IV reviews appear to be consistent in regard to the depth of review and the degree and method of documenting the results. The Region IV staff realizes the usefulness of developing a procedure describing the review process to provide additional assurance that reviews are consistent.
i Such a procedure is expected to be in place in the near future. IE intends
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R'obert D. Martin l to evaluate this proceddre along with those being developed by other Regions to detemine the extent specific general guidance can be incorporated in ,
inspection procedure 3500. This would enable each Region to follow one standardized procedure in reviewing QAPD changes and therefore provide for a more consistent review process.
Concerns raised in other Regional assessments were also found in Region IV.
These concerns are as follows:
- 1) Changes to material referenced in the QAPD (i.e. , Q-lists, etc.) are not, in all cases, being reported to Region IV as part of the QAPD change. The intent of the QAPD change rule was to include this reference ma*.erial.
An IE Infonnation Notice may be necessary to correct this lack of 1 reporting. '
and not separately reporting such QAPD changes to the appropriate Regional Office. It appears appropriate for the Regional Office to update their QA 1 program review files by incorporating.these QAPD changes. This would provide a current reference of the QAPU against which future QAPD changes can be reviewed. This will be addressed further in the susmary report.
Conclusion Region IV is perfoming an effective and timely review of QAPD changes consistent l with the 10 CFR 50.54 and 50.55 change rule and draft IE Inspection Procedure 35001. Areas of generic concern will be further evaluated and reconynendations provided in the Sumary Report at the conclusion of the five Regional Office assessments.
/ s Brian K. Grimes, Director !
Division of Quality Assurance, Vendor, !
and Technical Training Center Programs 1 Office of Inspection and Enforcement
Enclosures:
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- 1. Assessment Plan
- 2. Attendance at Entrance / Exit Meetings and QAP Packages Evaluated O
memvu u i
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ASSESSMENT PLAN FOR REVIEW AND EVALUATION OF REGIONAL REVIEWS OF OAP CHANGE 5 .
Furpose ,
This plan describes the IE methods to assess the Regional Office reviews of 0A program changes consistent with IE Office Procedure #0200 "Assessment of i
Regional Implementation." .
Objective The objective of this assessnent is to provide NRC management with information '
on (a) the acequacy of program implenentation, (b) on the consistency of program implementation relative to the review of QA program changes both within and among the five NRC Regional Offices and (c) the need for additional guidance or change to IE inspection procedures regarding review of QAP changes.
Procram The program being assessed includes those activities necessary for regional cf# ices to review and ottermine the acceptability of QA program changes l stomitted from nuclear power plant and fuel reprocessing plant construction permit holders or licensees as required by 10 CFR 50.54 and 50.55.
The draft Inspection Procedure f35001, "Changes to Quality Assurance Programs."
11, 1953 and J. N. Grace letter of February (Reference 29, 1964 J. Taylor letter of Julto the regional offices) yprovides interim gj implementation.
Generci Guidelines l
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- 1. Assessment trips will be scheduled and coordinated with IE Director's Office and the Regional Offices. Dates will be coordinated with ;the respective Regional Office two weeks in advance of planned travel.
Assessment trips will be scheduled so that:
- a. Norvally no more than one assessment trip will be conducted at the same time in one Regional Office,
- b. Norwally no more than one assessment trip to the Regional Office will occur per Region per program area during any 12 month assessment perioc.
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- c. A meeting between IE management and Regional Office management to ciscuss assessment findings will be held within 2-3 weeks after completion of the field activities in the Region if such a meeting ,
is necessary. j
- d. Regional RWports on IE assessment results for each program area assessed will be prepared during the year as the assessment activities for a '
given Region are completed. Nonnally these reports will be completed l within one month of completion of the field activities in a Region. ,
- e. Sunnary Reports for assessment of a selected program area will be prepared upon completion of all Regional Reports on assessment of th6t program area. Nonna11y a summary report will be completed within one month after comnietion of the last Region Report for that program area. However, all Sunnary Reports must be completed !
by no later than June 15.
- f. Copies of each Summary Report for essessment of a selected program ,
area will be provided to the ED0t The reports will be provided to the i EDO during the year as the assessment activities are completed, but I no later than June 15 of each assessment period. I
- 2. Assessment Report Format The assessment report will have the following general layout: l
- Scope: This section identifies the program or .]
program area selected for assessment. i Assessmertt Activities: This section identifies the in-office activities and the dates and location of travel to the Regional Office. ,
. , . Assessment Findings: This section addresses the results cbtained during the assessment regarding the Regional
- Office's implementation of the review of QA program changes. Tne assessment results will accress the completeness, adequacy and
, consistency of implerrentation. Results of
- IE and Regional management meetings will also be nodressed in this section. Copies of each Regional Report will be attached t'o the Summary Report to provide the necessary details and backup infonnation.
3 Assessment
Conclusions:
This section provides a brief summary statement of the IE assessment of the Regional Office's implementation of the IE program. The conclusions should be ,
clearly s'tated, f actual, and supported by l assessment findings, i l
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- 3. Assessment Factors: i 4
The following assessment factors will be used in reviewing and evaluating i regional reviews of QA program changes:
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- a. Program Implementation Factors a.1 Reviews are conducted within a reasonable time frame.
a.2 Reviews are complete with adequate close out of all outstanding concerns and request for additional information (RA1).
4.3 RAI and acceptance letters are complete and clear and are issued within a reasonable time f rame,
- b. Performance Acequacy Facters These factors should be considered in determining if program policies, !
procedures, and priorities are interpreteo as intended. l
. The scope of the review activity is consistent with 10 CFR and 50.55.
DeDth. The technical depth of the review is adequate to arrive at meaningful conclusions. l Focus on OA progran chances. Changet should not dilute nor cegrace previous accepted controis meeting SRP guidance.
Resource Utilization. Resources are efficiently amployed.
Inspection activities are conducted by indiviouais properly trained and qualified for the inspection activity conducted.
. Documentation and Correspondence. Documentation is consistent witn program requirements anc provides a clear record of accom-plishment of inspection procedures. Findings are clear and concise. Related correspondence is clear.
. Licensee Contacts. Meetings and contacts with the licensee are in iccorcance with established policies. This includes meetings, !
RAls, and oay-to-day contacts and telecons between the inspector and licensee personnel.
- c. Imolementation Consistency Factors. These factors will 'be considered i in cetermining if the IE program is implemented consistently among ;
the Regional Office or among similar licensees. j Prooram Imolementation. The degree of program implementation by the l regions shoulo be similar. j Scope. The scope of the review is similar among regicns and among TaRTities.
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Depth. The technical depth of the review activity is similcr amon.g
. regians and among f acilities. Consider the following:
Focus of OA program Changes. The regions provide similar ,
scope and cepth attention to QA program changes to assure previous controls have not been diluted nor degraded.
Resource Utilization. Resources are employed in a similar manner among regions and are consistent with requirements prescribed by the program. The manpower expenditure to complete a given portion of the program is consistent among regions (other parameters being equal).
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,. ENCLOSURE 2 ATTENDANCE AT ENTRANCE / EXIT MEETING E. H. Johnson Chief, Reactor Projects Branch 1, within the Division of Reactor Safety and Projects .
R. E. Ireland Chief, Special Projects and Engineering Section J. Boardman QA Reviewer QAP PACKAGES EVALUATED Arkansas Nuclear One i Cooper Fort Calhoun Fort St. Vrain l
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