ML20029E796
"Draft Meeting" is not in the list (Request, Draft Request, Supplement, Acceptance Review, Meeting, Withholding Request, Withholding Request Acceptance, RAI, Draft RAI, Draft Response to RAI, ...) of allowed values for the "Project stage" property.
| ML20029E796 | |
| Person / Time | |
|---|---|
| Issue date: | 05/10/1994 |
| From: | Zech G Office of Nuclear Reactor Regulation |
| To: | Rossi C Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9405200168 | |
| Download: ML20029E796 (15) | |
Text
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION s
WASHINGTON, D.C. 20556-0001
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May 10,1994 MEMORANDUM FOR: Charles E. Rossi, Director Division of Reactor Inspection and Licensee Performance, NRR i
FROM:
Gary G. Zech, Chief Performance and Quality Evaluation Branch Division of Reactor Inspection and Licensee Performance, NRR
SUBJECT:
SUMMARY
OF WORKING GROUP MEETING WITH NEI AND PIL0T PLANT i
PARTICIPANTS ON APRIL 26, 1994, ON GRADED QUALITY ASSURANCE j
On April 26, 1994, a Working Group meeting was held with representatives of the Nuclear Energy Institute (NEI) and the pilot plant participants to discuss details of the NEI draft guidance document concerning a graded application to quality assurance and to gain insights of potential pilot plant implementation approaches of a graded quality verification methodolog.
The NEI draft document " Guideline for Industry Pilot Project - Implementation of Graded Performance-Based Approach to Quality," dated April 1994, was previously provided to the NRC Working Group on April 11, 1994, for review and comment.
A description of the meeting agenda items is provided in Enclosure 1 and a listing of the proposed pilot plants is included as Enclosure 2.
The staff provided the opening comments which acknowledged aspects of the graded QA concept contained in the NEI draft guideline.
However, it was stated that a number of concerns were identified during the staff's initial review which would require resolution prior to the implementation of the pilot plant program.
These concerns were documented in an NRC letter from Mr. Gary G. Zech to Mr. Alex Marion, dated April 20,1994 (Enclosure 3), involving the ability of licensees to demonstrate that all safety-related structures, systems, and components (SSCs) will continue to meet the requirements of 10 CFR 50, Appendix B.
Specifically, as stated during the meeting, for those safety-related SSCs that are determined to be of low safety-significance using the agreed-upon methodologies of NUMARC 93-01, a licensee should determine which aspects of the Appendix B requirements will be applied in a graded manner. The staff also emphasized that the relative safety-significance of SSCs would not constitute a sufficient basis to make such a determination.
Other factors such as considering SSC safety-function and the appropriateness l
of applying quality provisions beyond a corrective action program are currently not included in the NEI guidelines.
Proposed pilot plant initiatives were discussed by each of the involved utilities including the scope of the graded QA application (e.g., systems and/or functional areas). The pilot plant representatives also identified, in general terms, the anticipated QA plan description, Technical Specifications, and FSAR revisions which would be necessary to support a graded QA concept. pbg '
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v Charles E. Rossi I consistent with the staff's concept, the staff noted that references to
" blanket relief" from the quality requirements of 10 CFR 50, Appendix B and the associated QA licensing commitments were not envisioned by the NRC for the pilot efforts.
i With respect to the staff's comments on the draft guidelines, NEI provided additional information regarding their proposed pilot project objectives, terminology, and principles.
The NEI handouts associated with these issues are included as Enclosures 4 and 5 of this summary. While the staff i
acknowledged the amplifying information, it was concluded that the NEI guideline provides insufficient specificity, particularly with respect to the expert panel activities, control over low-safety-significant SSCs, control of quality-related commitments, and operational experience feedback mechanisms.
Additionally, the staff disagreed with NEI's proposal to limit Appendix B applicability for low-safety-significant/ safety-related SSCs solely to performance monitoring and corrective action processes.
Relative to this issue, the staff's position is that the degree of application and j
documentation of Appendix B criteria should be determined based on an evaluation of the SSC safety-significance and safety function.
At the conclusion of the meeting, the quality verification treatment for low-safety-significant/ safety-related SSCs remained unresolved and was identified as an issue for resolution during the next scheduled meeting of the NRC and NEI Steering Groups on May 12, 1994. contains a listing of the meeting attendees.
Original signed by:
Gary G. Zech, Chief Performance and Quality Evaluation Branch Division of Reactor Inspection and Licensee Performance, NRR cc: w/ enclosures Nuclear Energy Institute Attn: Alex Marion Suite 300 1776 Eye Street, NW Washington, D.C.
20006-3706
Enclosures:
As stated DISTRIBUTION:
See next page OFC SEND RPEB:DRIL SC:RPEB:DRIL BT[)RIL NAME TO RMlatta:Jp RAGram GG h DATE POR7 f / ([ /94
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/94 fY No Yes No Yes No COPY?
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' OfflCIAL RECORD COPY DOCUMENT NAME: " - ~ * *
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Charles E. Rossi '
l DISTRIBUTION:
Central Files'(PI-22)
LReyes, 12 D9 GHolahan, 9112 PDR (PI-22)
Eleeds, 12 G18 EJordan, 3701 RPEB R.F.
AThadani, 12 G18 JPage, NLS314 DRll R.F.
WTRussell,12 G18 MDey, NLS314 NRC Participants ARamey-Smith, 10 E4 0Gormley, NLS2178 l
JMilhoan, 17 G21 RZimmerman, 9 A2 WGleaves, NLS217B VMcCree, 17'G21 RWessman, 9 A2 JHeltemes, NLS007 EButcher, 16 GIS CMcCracken, 8 D1 MModes, RI GMizuno, 15 B18 MVirgilio, 8 E2 FJape, RII l
AGody, 13 E21 DFischer, 7 E23 BBurgess, RIII RVollmer,1 F22 Wang, RIV/ Walnut Creek i
O
l Charles E. Rossi DISTRIBUTION:
Central Files (PI-22)
LReyes, 12 D9 GHolahan, 9112 PDR (PI-22)
Eleeds, 12 G18 EJordan, 3701 RPEB R.F.
AThadani, 12 G18 JPage, NLS314 DRIL R.F.
WTRussell, 12 G18 MDey, NLS314 NRC Participants ARamey-Smith, 10 E4 0Gormley, NLS217B JMilhoan, 17 G21 RZimmerman, 9 A2 WGleaves, NLS217B VMcCree, 17 G21 RWessman, 9 A2 JHeltemes, NLS007 EButcher, 16 G15 CMcCracken, 8 D1 MModes, RI GMizuno, 15 B18 MVirgilio, 8 E2 FJape, RII AGody, 13 E21 DFischer, 7 E23 BBurgess, RIII RVollmer, 1 F22 Wang, RIV/ Walnut Creek l
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Meetina Acenda
Introductions
Overview of progress to date Discuss N,EI graded QA guidelines Discuss NRC draft regulatory guide elements Discuss proposed pilot plant initiatives a
Scope of graded QA application (system (s) and/or functional areas)
Projected milestones Anticipated QA plan / Technical Specifications /FSAR revisions to support graded QA NRC involvement and oversight of pilot programs Future activities to support pilot plant initiatives Closing comments l
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.4 LIST OF PROPOSED PILOT PLANTS FOR GRADED _QA METHODOLOGY DEVELOPMENT AS PROVIDED BY NEI (FORMERLY NUMARC)
DURING WORKING GROUP MEETING OF MARCH 2, 1994 Arkansas Nuclear One, Entergy Operations Byron, Conunonwealth Edison
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Crystal River, Florida Power Corporation Grand Gulf, Entergy Operations Monticello, Northern States Power Palo Verde, Arizona Public Service Surry, Virginia Power i
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April 20, 1994 j'
l Mr. Alex Harion i"
Nuclear Energy Institute 1776 I Street, N.W.
Suite 300 Washington, DC 20006 i
i
Dear Mr. Marion:
On April 11, 1994, the NRC staff met with you and other representatives from the Nuclear Energy Institute (NEI) to discuss the graded application of 10 CFR 50, Appendix B, quality assurance (QA).
At that meeting, you provided a draft copy of the proposed NEI methodology entitled " Guideline for Industry l
Pilot Project - Implementation of Graded, Performance-Based Approach to j
Quality," dated April 1994. The NRC's working group has completed its initial j
review of the draft guideline and has identified a number of concerns with NEI's proposed approach for implementing a graded QA program.
j The staff's primary concern is that, in our discussions to, develop guidance i
for the graded application of quality assurance, we have stressed the f
importance of licensees being able to demonstrate that all safety-related structures, systems, and components.(SSCs) will continue to meet the i
requirements of 10 CFR 50, Appendix B.
Therefore, for those safety-related i
SSCs that are determined to be of low risk-significance, using the agreed-upon j
methodologies of NUMARC 93-01, a licensee should determine which aspects of the Appendix B requirements, as contained in its programs, will be applied in 4
a graded manner.
We've indicated that the relative risk-significance of SSCs j
would not in themselves be a sufficient basis to make such a determination, but that a process which describes how this determination would be made should i
be included. NEI's proposed guideline does not include such a process.
f The enclosure summarizes the staff's comments on the proposed NEI guideline.
Please be prepared to address these comments at our meeting scheduled for l
April 26, 1994.
Sincerely, Original signed by:
l 1
j Gary G. Zech, Chief i
Performance and Quality Evaluation Branch e
l' Division of Reactor Inspection and Licensee Performance j
Office of Nuclear Reactor Regulation
Enclosure:
i As stated i.
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Enclosure j
STAFF COMMENTS ON NEI GRADED QA DRAFT GUIDELINE The draft NEI " Guideline for Industry Pilot Project Implementation of Graded, Performance-Based Approach to Quality," dated April 8,1994, requires a number of changes to address comments provided to NEI during the working group and steering group. meetings.
Specific comments are as follows:
1.
The guideline does not provide a balanced perspective in that it focuses strictly on reducing QA measures and controls for low-risk, safety-related SSCs. A functional description of the philosophy behind the initiative is needed that includes, for example, a recognition of the safety benefits that will be gained by focusing a licensee's resources on the risk-significant SSCs.
2.
The guideline needs to acknowledge the existence of and applicability of licensees' commitments to regulatory guides and ANSI standards as well as technical specification requirements and separate regulations that would remain in effect or would need to be formally changed on the docket to implement a graded QA program.
3.
The guideline should propose how to address current requirements that l
would preclude an on-line implementation of the pilot program.
Based on that proposal, the NRC will determine if and how " relief" from the provisions of 10 CFR 50.54 (a) could be provided.
The staff has asked for specific examples of commitments for which prior NRC approval would be necessary.
NEI has stated that examples will be provided at the l
April 26th meeting.
Based on those examples, the NRC will determine whether this should be done on a plant-specific basis or that relief could be provided on a generic basis, provided there is a sufficient number of common commitments among licensees and a basis can be established to take such an action.
4.
In general, there is little detail provided in the guideline because NEI has proposed to use the pilot program to develop the details.
The NRC agrees that the pilot program should resu't in improvements to the
, document, but there needs to be sufficient substance to conduct the pilot program and upon which to base its success.
Additional detail is needed to be able to make an assessment on the acceptability of the proposed approach.
For example, the process that the panel would use to " determine the i
extent and depth of any amendments and adjustments of existing programs" l
(page 19 of the proposed guideline) needs to be more clearly described.
A description of the panel's role, constituency, and decision-making process needs to be provided.
An overall process flow diagram that includes the basic steps in the process and a separate description of those steps would be useful.
i
9 5.
The draft guideline would move those structures, systems, and components (SSCs) determined to be of " low safety-significance" (using NUMARC 93-01 methodologies) into a category in which existing regulatory commitments associated with quality assurance would be replaced by the guidance in the draft guideline.
That is, all quality practices and depth of implementation would be determined by facility management.
The effectiveness of the quality practices would be determined by meeting a predetermined set of performance criteria and the SSCs would be subject to a corrective action program (pages 4 and 5 of the proposed guideline).
Specific comments on this proposed approach follow.
l A process, similar to that discussed in 3., above, should be included i
that describes how a licensee will consider the application of other Appendix B criteria, either completely or in a graded manner, based on j
the safety function (s) and potential failure modes of the SSCs.
The potential impacts of excluding certain QA controls or applying them in a i
graded manner should be considered in areas such as procurei..ent, i
maintenance, inspections, audits, testing, and work control processes.
A j
simple checklist in a matrix format could be used to document this process.
The proposed corrective action program that would be used in conjunction with the performance-based aspects of the program is not described in any 4
detail, other than to say that " management would determine the extent and degree of implementing corrective action and base its action on the safety sigr.ificance of the SSC."
There is no reference to Arendix B, Criterion XVI.nor any indication as to how the appropriate corrective actions would be determined or how the significance of emergent problems would be considered. The staff believes that this' approach is insufficient to support a graded approach to quality because it is not clear that a licensee would be able to demonstrate that it is providing
" control over activities affecting the quality of SSCs to an extent consistent with their importance to safety" (Criterion II of Appendix B).
The corrective action program description needs to be comprehensive j
enough to ensure that licensees will consider the appropriate elements of Criterion XVI, commensurate with the safety significance of SSCs, when 3
performance criteria are not met. A determination that an SSC is of low
' risk-significance is not by itself a sufficient basis.
J 4
6.
The terminology used in the guideline needs to be consistent both within the document and with other uses.
For example, NEI uses the terms safety-significant and non-safety-significant to describe the SSCs after applying the NUMARC 93-01 methodologies. The terms preferred by the staff are high-risk-significant and low-risk-significant since we're dealing with safety-related SSCs and, unless reclassified, they have some safety significance, but may be of low risk-significance.
The concern is that the use of NEI's terms raises the potential for a de-facto-downgrading of safety-related components.
2
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j GRADED, PERFORMANCE-BASED QUALITY PILOT PROJECT OBJECTIVES Implement and assess the feasibility, improvements and benefits of changing current quality implementation practices from a prescriptive, paper-dominated system to a performance-based quality regime that focuses on results and performance (plantwide and l
system level criteria) for non-safety significant structures, systems and components.
Provide input into potential changes to policy and regulatory requirements.
NUMARC 1
9 d
NRC -INDUSTRY MEETING ON
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GRADED, PERFORMANCE-BASED QUALITY
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April 26,1994 9
__n TERMINOLOGY l
Safety significant = risk significant Non-safety significant = non-risk significant = low risk significance = low safety significance Draft guideline uses safety terminology i
- blend of PSA and deterministic insights
- consistent with Appendix B terminology
- better to communicate about safety than risk
- consensus of both RTWG and ABWG l
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i PRINCIPLES t
Draft guideline adopts the two main concepts embodied in maintenance rule implementation:
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Use of PSA and deterministic insights to a
i establish the safety significance of SSCs Use of a performance-based approach to provide reasonable assurance that non-safety significant SSCs are capable of performing their intended i
functions i
3 NEl
DRAFT GUIDELINE DOCUMENT PROCESS SCOPE OF SSCs e
4 1
I 1r APPLY PSA &
4 ERT DETERMINISTIC 4
ANEL INSIGHTS 4
4 4
1r i
YES CURREW SAFETY
^LI SIGNIFICANCE P CT C S 4
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EXPERT w
PANEL f
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QUALITY PRACTICES 1
1 PERFORMANCE CRITERIA e
CORRECTIVE ACTION D
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USNRC l
MEETING ATTENDANCE LIST j
April 26, 1994 l
Name Organization NRC/NRR/DRP III,IV Brian Holian Adel El Bassioni NRC/NRR/DSSA/SPSB Millard Wohl NRC/NRR/DSSA/SPSB Tom Alexion NRC/NRR/DRPW/PD IV-1 George Kalmhn NRC/NRR/PD IV Mark Reinhart NRC/NRR/ DORS /0TSB l
Harvey Spiro NRC/0PP Michael E. Modes NRC/RI Juan D. Peralta NRC/NRR/DRIL/RPEB Richard Norovan New York Power Auth.
Douglas A. Brown Commonwealth Edison Co.
Daryl Prisby Commonwealth Edison Doug Swartz Commonwealth Edison Theresa Sutter Bechtel Mike Fecht TVA Edwin Froats Florida Power Corp.
Kenneth B. Baker Florida Power Corp.
l Ted Amundson Northern States Power l
Steve Hammer Northern States Power Mark Lombard MDM Bob Gramm NRR/DRIL l
Gary Zech NRR/DRIL Bob Latta NRR/DRIL Chuck Casto RII/DRS/EB Gil Millman RES/DE Bruce Burgess RIII Richard Correia NRR/DRIL/RPEB Ernie Rossi NRR/DRIL Alex Marion NEI Tony Pietrangelo NEI Adrian Heymer NEI Danny Bost Entergy Operations Carter Rogers Arizona Public Service M. L. Bowling Virginia Power Ed Rogers Entergy Operations Tim Taylor-Brown Entergy Operations l
Michael Knapah McGraw-Hill Frank Rahn EPRI l
Leslie Hartz Virginia Power Hans Renner NUS Susan Fonner NRC James J. Raleigh STS I
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