ML20151K846
| ML20151K846 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1985 |
| From: | Grimes B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Martin J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| Shared Package | |
| ML20151K612 | List:
|
| References | |
| FOIA-87-866 NUDOCS 8505240195 | |
| Download: ML20151K846 (8) | |
Text
"I h#,,' e.,to g Cf .8W(r-UNITED STATES
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[ g NUCLEAR REGULATORY COMMISSION L j WASHINGTON, D, C. 20555
- \*****/ MAY 151965 f
MEMORANDUM FOR: John 8. Martin, Regional Administrator Region V THRU: James M. Taylor Director Office of Inspection and forcement FROM: Brian K. Grimes, Director Division of Quality Assurance, Vendor, and Technical Training Center Programs Office of Inspection and Enforcement
SUBJECT:
ASSESSMENT OF REGION V REVIEWS OF QA PROGRAM DESCRIPTION '
(QAPD) CHANGES I. Scope In accordance with the FY 1985 Regional Assessment 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 detennine 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. 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 QAFD, to check for any reduction
- to the QAPD because of the changes, and to complete the reviews within sixty ;
days from receipt of the change. :
II. Assessment Activities ,
I An assessment of Region V's review of licensees' QAPD changes took place on ,
March 28, 1985, at the Regional Office. This involved conducting an entrance meeting with the Region V staff explaining the scope, objective, and methodology ,
of the assessment; evaluating review packages, including interviews with the '
principal reviewer; summarizing the results of the assessment; and reporting
. the preliminary results of the assessment to the Region V staff at an exit
- meeting. Enclosure I contains the plan used in the assessment of the Regional Offices. Enclosure 2 identifies Region V personnel contacted during the i
assessment and QAPD change packages evaluated. John Gilray of the IE QA Branch performed this assessment. ,,
Fern 57- M 1 P4f d %$ 6/y
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John B. Martin 1 III. Assessment Findings i
Region V's present review process is as follows:
Each QAPD change submitted enters the Region V mail room and is sent to the Engineering Section of the Reactor Safety Branch. The Engineering Section:
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Evaluates those changes identified by the licensee against the previously accepted QAPD to determine if any QAPD controls have been reduced.
- 2. Resolves areas of concern either by telephone, meetings, or formal letters.
, 3. Interfaces with the IE QA Branch as necessary.
- 4. Issues an acceptance letter upon satisfactory resolution of concerns and unresolved items.
- 5. Notifies the licensee by letter if the review process is expected to exceed 60 days.
Adequacy of Region V Review Process The overall Region V review process of QAPD changes was found to be effective and carried out in a timely and acceptable manner. The revised pages where the changes were incorporated were reviewed completely to assure that there was no 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 V staff responsible for the review of QAPD changes exhibited a sound knowledge in the review process and in the principles of QA/QC.
i Timeliness of the Reviews All reviews by the Region V office were performed in a reasonable and acceptable timeframe. The time expended in reviewing each QAPD change was identified by Region V.
The Licensee Fee Management Branch (LFMB) memorandum of February 7, 1985, was change discussed with Region V relative to the reporting guidelines of QAPD reviews.
4 Region V is considering an accounting method that would y satisfy the LFMB memorandum concerning the review of QAPD changes. {
Consistency and Need for Additional Guidance Region V reviews appear to be consistent in regard to the depth of review and the degree and method of documenting the results. Region V is in the process y
of developing a procedure describing the review process to provide additional assurance that reviews are consistent. IE intends to evaluate this procedure along with those being developed by other Regions to determine the extent to 4
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John B. Martin .
g I which specific generic guidance can be incorporated in the final version of ,
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 V. #
These concerns are as follows:
- 1) Changes to material referenced in the QAPD (i.e. , Q-lists, etc.) are not, ;
1 in all cases, being reported to Region V as part of the QAPD change. The i intent of the QAPD change rule was to include this reference material, An IE Information Notice may be necessary to correct this lack of l
reporting. '
- 2) Certain licensees are submitting QAPD changes in the annual FSAR updates and not separately reporting such QAPD changes to the appropriate Regional Office. It appears appropriate for the Regional Of fice to update their QA /
program review files by incorporating these QAPD changes. This would provide a current reference of the QAPD against which future QAPD changes I can be reviewed. This will be addressed further in the summary report. !
Conclusion Region V is performing an effective and timely review of QAPD changes consistent 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 recommendations provided in the Summary Report at the conclusion of the five Regional Office ,
assessments. ; '
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w Brian K. Grimes, Director l Division of Quality Assurance, Vendor, and Technical Training Center Programs Office of Inspection and Enforcement
Enclosures:
- 1. Assessment Plan
- 2. Attendance at Entrance / Exit Meetings and QAP Packages Evaluated j
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l ASSESSMENT PLAN FOR REVIEW At1D EVALUAT10t OF (
i REGIONAL REVIEW 5 OF OAP CHAtiGE5 i
I Purpose , j j This plan descrities the IE methods to assess the Regional Office reviews of ;
' OA program changes consistent with IE Office Procedure !0200
- Assessment of !
2 Regional Implementation." !
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Oojective l
ine objective cf this assessnient is to provide tiRC management with infoma ion on (a) the acequa:y of program implementation, (b) on :ne consisten:y of program ,
implementation relative to the review of QA program changes both wi:ntn and !
i am'ong the five t;R: Regional Offices and (c) the need for aeditional guidan:e i cr change to IE inspection procedures regarding review of DAD changes, i
l Procram I l ine pre; ram bein; assessee incluces those activities ne:essary for regionai
! cffices to revie, anc cetemine the a:ceptability of QA pro; rat changes !
l submi;;ed from nu: lear power plant and fuel reprocessine plant constru:: ion j , ,
,pemit holders or licensees as required by 10 CFR 50.54 and 50.55, i ine craf t inspe:: ion Procedure f35001 "Changes to Quality Assuran:e Programs." !
! (Reference J. Teylor le::er cf Jul 11, 1953 and J. !< Grace 1e::er of February .
j 25, 1954 to :ne regional offices) yprovices interim guicelines for program imolementation.
Generai Guicelices
! 1. Assessmen trips will be scheouled an: coordinated with IE Dire::or's Offi:e l
and :ne Re;ional Offices. Dates will be coordina:ec with the respe::ive ;
l Ryionai Office two weeks in acvance of planned travel.
Assessment trips will be scneouled so that:
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- a. koma'.ly no more inan one assessment trip will os conducted a
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! - same :1ne in one Regional Office. <
4 homa*.iy no more : nan one assessment trip to :he Regional Offi:e wili lj l b.
o::ur per Region per program area curing any 12 m:n:h assessment
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l c. A meeting between IE management and Regional Office management to i 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. -
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- d. Regional R6 ports on IE assessment results for each program area assessed ,
will be prepared during the year as the assessment activities for a i given Region are completed. Nonnally these reports will be completed within one month of completion of the field activities in a Region. ,
- e. Sumary Reports for assessment of a selected program area will be prepared upon completion of all Regional Reports on assessment of thht program area. Normally a sumary report will be completed within one month af ter completion of the last Region Report for that program area. However, all Sumary Reports must be completed by no later than June 15.
- f. Copies of each Summary Report for assessment of a selected program i area will be provided to the EDO. The reports will be provided te the ;
EDO during the year as the assessment activities are completed, but ,
no later than June 15 of eacn assessment period. ,
- 2. Assessment Repert Format :
Tne assessment report will ha*.e the following general layout: l Scope: This section identifies the program or program area selected for assessment, ,
Assessmen: Activities: This section ioentifies the in-office i i activities and the dates and location of l 4
travel ;o tne Regional Office. !
. , . Assessment Findings: This section addresses the results cbtained
- during
- ne assessment regarding the Regional
! Office's imolementation cf the review of QA
. program changes. Tne assessment results
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wili ace'ress the comcieteness, adecuacy and ,
i consistency of impierentation. Results of -
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IE anc Regional managemen meetings will i also oe accressed in this section. Ccoies !
of eacn Regional Report will be attachec to
- the Summary Repor: to provide the necessary l 2 details and backup infomation. ;
Assessment
Conclusions:
This section provioes a brief sumary statement of the IE assessment of the Regionai Office's implementation of the i IE program. The conclusions should be !
. clearly stated, f actual, and suppor:ec by I i assessment findings. ]
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- 3. Assessment Factors:
The following assessment factors will be used in reviewing and evaluating !
regional reviews of QA program changes:
- a. Procram Imolementation Factors I
a.1 Reviews are conducted within a reasonable time frame.
i a.2 Reviews are complete with adequate close out of all outstanding concerns and request for aeditional information (RAI).
a.3 RAI and acceptance letters are ecmplete and clear and are issued i within a reasonable time frame.
I b. Perfoman:e Aceouacy Factors These factors should be consicered in cetemining if program policies, ,
procedures, and priorities are interpreteo as intended.
5:oce. Tne s: ope of the review activity is consistent with 10 CFR 50.54 anc 50.55.
! De:tn. Tne tecnnical depth of the review is adequate to arrive at i meaningful conclusions.
Focus on OA orocram chances. Changes should not dilute nor i cegrace previcas accepteo controls meeting SRP guidan:e.
F.esour:e Utili:ation. Resources are efficiently employed, inspe:tien ac 1vities are conducted oy incivicutis preoerly ;
trainee and qualified for the inspe: tion activity concutted. ;
Do:umentation and Correserncence. Documentation is consisten-w1 n program rec;1rements an: provices a clear recore cf accom- D piisnment of inspection pro:ecures. Findings are clear anc
- n:ise. Reitte: corresponden:e is clear, i i
Li:ensee Conta:ts. Meetings anc contac s witn the licensee are in a::orcan:e witn establisne: poli:ies. Inis in:1uces meetings, RA:s, an: cay-to-day conta:ts an: telecons between the inspector and licensee personnel.
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- c. Imolementation Censistency Factors. These ft:ters will be consi:ered 4
in cetermining if tne IE program 1s implementec consistently among i the Regional Office or among similar licensees. l l
Drocram imelemantation. The degree of program implementatien by the l regions snovic ce similar. !
! 5:oce. The scope of the review is similar among regions and among it:liities.
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(r (r Deoth. The technical depth of the review activity is similar among '
regions anc among f acilities. Consider the following:
Focus of OA program Changes. The regions provide similar scope anc ceptn attention to QA program changes to assure !
previous controls have not been diluted nor degraded. ,
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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 AND QAP PACKAGES EVALUATED B. H. Faulkenberry Deputy Regional Administrator (2)
D. F. Kirsch Acting Director, Division of Reactor Safety and Projects (2)
R. J. Pate Actfag Chief, Reactor Safety Branch (1)(2)
T. Young, Jr. Chief. Engineering Section (1)(2)
W. Wagner Reactor Inspector, Engineering Section (1)(2)
(1) Present at entrance meeting (2) Present at exit meeting QAPD Packages Evaluated -
San Onofre Trojan Palo Verde l
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