ML20059D483

Summary of 931216 Meeting W/Numarc to Discuss Conceptual Issues Re Graded Implementation of 10CFR50 App B,To Evaluate Level of Progress Attained by NUMARC Working Groups on Assessment of Quality Assurance Practices

ML20059D483
Person / Time
Issue date:	12/23/1993
From:	Juan Peralta Office of Nuclear Reactor Regulation
To:	Office of Nuclear Reactor Regulation
References
NUDOCS 9401070321
Download: ML20059D483 (41)

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December 23, 1993 MEMORANDUM raR: Files FROM:

Juan D. Peralta Quality Assurance Section Performan'3 and Quality Evaluation Branch Divisior

/ Reactor Inspection and I r.ensee Performance Office r,f Nuclear Reactor Regulation

SUMMARY

OF MEETING WITH NUMARC ON DECEMBER 16, 1993 On December 16, 1993 a meeting was held with Nu:. lear Utilities Management and Resources Council (NUMARC) representatives to discuss conceptual issues related to the graded implementation of 10 CFR 50 Appendix B, to evaluate the level of progress attained by NUMARC Working Groups on their assessment of quality assurance practices at commercial nuclear power plants, and to provide a forum for public questions or comments on these issues.

The staff expressed'its support of the NUMARC initiatives on these issues and emphasized the importance of the graded QA initiative as it is based upon recommendations made by the NRC Regulatory Review Group. The staff stated.that the dialogue and close interaction with NUMARC, and the industry, will continue with a tentative goal of reaching a consensus by Fall of 1994.

The staff emphasized its view on the existence of flexibility in current regulations to accommodate a graded approach towards QA but acknowledged that due to the existence of inconsistencies in 10 CFR 50 Appendix B and 10 CFR 21, the possioility of rule changes.could not be entirely. dismissed.

' The staff envisions the implementation of a pilot program, or programs,-with interested utilities to develop workable approaches culminating in the issuance of'a Regulatory Guiae. Emulating the Maintenance Rule approach, the Regulatory Guide would endorse an acceptable methodology (including use of -

Probabilistic Risk Assessment (PRA) insights) on graded quality assurance implementation.. The staff, however, cautioned that PRA techniques-have limitations on design issues such as seismic and environmental qualification.

NUMARC inquired on the status of revisions to quality assurance related

. Regulatory Guides, The staff replied that revisions or changes to these Regulatory Guides have been placed on-hold pending the outcome of. the 1

development of graded.QA methodologies.

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4 Files' NUMARC representatives expressed agreement with all the staff concepts and reiterated their commitment to identifying and eliminating requirements marginal to safety. They added that the nuclear utility industry must strive to identify those specific attributes of an effective quality assurance program which would allow them to remain cost competitive while maintaining the required level of safety.

NUMARC presented an overview of the scope of work and goals of the Appendix B and Regulatory Threshold Working Groups, which have been tasked with the development of quality elements or attributes and assessment of their applicability to an established Q-List, and with the development of deterministic-based methodologies for prioritizing SSC's based on risk significance. NUMARC has proposed to apply these concepts to the Grand Gulf Nuclear Power Station on a trial basis as part of an EPRI/Entergy pilot program.

HUMARC expressed the need of new Regulatory Guides that would provide guidance to the industry in addressing quality assurance issues and stressed the paramount need of a cultural change in the way quality assurance programs are currently implemented and/or regulated. They added that they envision the globalization of suppliers under a common Qualified Suppliers List based on the criteria set forth in ISO 9000 Series or similar standards.

The staff challenged NUMARC to concentrate on the resolution of the issues that presently divert resources to marginal to safety aspects of ' quality assurance programs by identifying the significant Structures, Systems and Components (SSC's) based on their relative safety or risk significance in an approach not unlike that of the Maintenance Rule.

The meeting adjourned with both the staff and NUMARC expressing agreement to continue to meet periodically and to establish benchmarks to measure progress towards the mutually agreeable goal of Fall of 1994.

p-y Files Enclosed is a list of attendees and a copy of material provided by NUMARC and the.NRC staff.

Original sir H by:

Juan D. Peralt.

Quality Assurancs Section Performance and Quality Evaluation' Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation cc w/ enclosures:

Alex Marion Nuclear Management and Resources Council

Enclosures:

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Original signed by:

Juan D. Peralta Quality Assurance Section Performance and Quality Evaluation Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation cc w/ enclosures:

Alex Marion Nuclear Management and Resources Counc'l

Enclosures:

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Meeting Attendance List December 16,.1993 Meeting with NUMARC to discuss issues related to'the graded implementation.of 10 CFR 50 Appendix B NAME ORGANIZATION Bob Gramm NRC/DRIL Bill Bohlke FPL Bob Latta NRC/DRIL t

John _Craig NRC/RES V Lewis Killpack Weston Dick Vollmer NRC/0PP

. Gary Zech NRC/NRR J

Bruce L. Burgess NRC/RIII Uldis Potapovs NRC/VIB i

R. Correia NRC/RPEB C. Petrone NRC/RPEB Don Bouchey SAIC Bill Gleaves

.NRC/RES George Hubbard NRC/NRR/SPLB Roger Huston TVA Mark'W. Peranich NRC

'i Juan Peralta NRC/NRR

-Dale Bates CP&L Alex Marion NUMARC Jim Perry NUMARC Gil Millman NRC Darrel Nash NRC Tony Pietrangelo NUMARC Owen Gormley FRC Larry L. Campbell

.NRC Frank C. Cherry NRC/RES Bill Russell NRC/NRR Charles Rossi NRC/NRR 8

Bill Parkinson SAIC Les Constable NRC Mark Rubin NRC Leslie Hartz Virginia Power' Pete Hunter NACTEC A.lP. Heymer NUMARC Marc.Meyer CER Corp.

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' Frank _Rahn EPRI Robert Hartstern MACTEC-Ram Murthy-DOE Jack Spraul NRC Tom' Foley NRC Jacki Skolds SCE&G Fred Maura NRC Hector Barbeito Bechtel Roger F. Reedy Reedy Assoc.

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' Meeting Attendance List NAME' ORGANIZATION Mike Check NUS James J. Raleigh STS Roy Zimmerman NRC Moni Dey NRC L. S. Gifford GE Mike Meisner Entergy t

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NRC - NUMARC MEETING 10 CFR 50 APPENDIX B, GRADED IMPLEMENTATION Industry Participants _

William H. Bohlke......Vice President, Nuclear Engineering-&

Licensing, Florida Power & Light J. L. Skolds................Vice. President, Nuclear Operations, South Carolina Electric & Gas M. J. Meisner............. Director, Nuclear Safety & Regulatory Affairs Entergy Operations, Grand Gulf Station Alex Marion,............... Manager, NUMARC, Technical Division -

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CURRENT UTILITY APPENDIX B ACTIVITIES U

Improvement in Technical Specifications, Administrative Controls Implementation of performance-based programs Greater flexibility in audit frequencies Self Assessments

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DRAFT QUALITYLELEMENTS I

L ORGANIZATIONAL FUNCTIONS Accountability, Responsibility & Organization Performance Expectations -

Planning & Resource Management PROCESS CONTROL 1

- Procedures & Instructions

-. Identification of Required Processes

-- Identification of Measurement (Performance) Criteria ASSESSMENTS CORRECTIVE ACTION i

- Evaluation of the Cause-

- Resolution of Deviations NUMARC'

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REGULATORY THRESHOLD - APPENDIX B WORKING GROUP INTERFACE RTiNG

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Appendix B WG Develop PSA - Deterministic Develop Quality Elements-based methodologies for

& assess applicability-prioritizing/ categorizing i

to Q-List SSCs based on Risk Significance (Development

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EPRI/Entergy Appendix B Project i

i Graded Approach to Appendix B

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fi NRC/NUMARC Meeting on Appendix B lil December 16,1993 Mike Meisner Grand Gulf Nuclear Station i

Presentation Outline l \\ EPRI/Entergy Appendix B Project + Use of PSA in Prioritizing SSCs l + 1 1 ll&e Application to the Q-List + n ihk i $?b? [q'h a l =

EPRI/Entergy Project + Identify opportunities for cost reduction Process analysis to identify opportunities (plant design and modification process) y Evaluate safetyperformance

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• Evaluate cost savings potential y i,

+ Develop technical basis for changing QA requirements or ?ik processes 4 1 Graded QA approach Reduction of QA requirements orpractices + Perform case studies to demonstrate specific QA changes

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$d + Develop methodology for reduction of QA requirements or commitments and provide for technology transfer

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I Maintenance Rule - A Starting Point 's-' t '4 In anticipation of numerous future prioritization applications + it is important to maintain consistency amongst applications from the beginning i Maintenance Rule provides an approach for using PSA and + i ^* deterministic insights for evaluating risk significance i aw Scoping evaluation f PSA risk ranking 'f Expertpanel validation Performance monitoring The Maintenance Rule approach may need to be + supplemented for other applications f Applications beyond maintenance preventable failures i b Treatment of SSCs notin the PSA 1 m. m..

Q-List Versus PSA Risk-Significant SSCs + The large disparity between Q-Lists and PSA component lists can be overcome The disparity: l lO - Q-Lists containing safety-related and quality-augmented SSCs are roughly an order of magnitude larger than PSA componentlists llk%""h" - Whole systems on the Q-List are not addressed by f the PSA at all (e.g., security systems), or explicitly (e.g., the reactor coolant system) de

L l - t i l I Q-List Versus PSA Risk-Significant i SSCs (continued) r l = The means to overcome the disparity: l - PSA components (e.g., pumps) are often super-( components whose importance reflects more than lj L one component on the Q-List - System / train importance can be used to measure the importance of whole groups of components on the Q-9 g List

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I* - Certain instrumentation can be correlated with human performance events in the PSA (e.g., reactor waterlevel and depressurization) i$ - PSA initiating events often reflect whole systems flih (e.g., loss of sealinjection) whose importance can Q then be distributed to critical components i e e

Q-List Versus PSA Risk-Significant SSCs (continued) The means to overcome the disparity (continued): - Many safety-related system's only safety-related function is containment isolation which is at least e ik implicitly modeledin the Level 2 PSA xa - The risk significance of fire protection and seismic 11 over I components is being addressed in the IPEEE g k$ %gg* - The potential risk significance of a large number of components (e.g., tap lines and small valves) has been demonstrated to be insignificant by the PSA, even though they are not explicitly modeled pw ,A:, f.

Insights on Particular Modeling Issues + Risk significant initiating events in non-safety systems, e.g., loss of offsite power or instrument air, will require additional engineering analyses to identify risk significant components These systems may contain many components, but the 39^ few which are applicable to the risk-significant functions ~ must be identified PSA "models" are often single events reflecting generic industry data u, t; 44 - Causes of failure in the data can be related to components or groups of components in the system Recovery from the most likely failures may eliminate other components

• Ongoing analyses of " trip sensitive" systems may help provide supporting technical bases.

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Insights on Particular Modeling ISSUBS (continued) Instrumentation represents a large number of safety-related + components often not explicitly modeled in the PSA Risk-significant operator actions in the PSA can be l related to symptoms in procedures and symptoms mac related to instruments Significant redundancy and diversity has ensured ti Y individualinstruments or types ofinstruments are not risksignificant - Symptom based EOPs allow the operator to use diverse types ofinstruments - Individual types ofinstruments have multiple Nl channels - Localindications often provide backup to control V' room indication

insights on Particular Modeling ISSUBS (continuecy Instrumentation for automatic system actuation sometimes is modeled but is rarely significant due to manuaiactuation backup i %4 Systematic techniques for evaluating the risk significance ofinstrumentation have been appiled to .a a equipment qualification (NSAC-54) h A more straight-forward and cost-effective approach that better reflects diversity and redundancy is probably g%gNy attainable j 1 f E pt-p -.-i.- ~. e

Where Can Graded Quality Assurance Take Us when Risk and Performance are Considered? Most risk-significant grade (i.e., high importance + components) l Full Appendix B requirements Least risk-significant grade (lowest importance components) 1 + l2 Procured to commercialstandards/ requirements = Risk-based methods / precedent exist for moving a ~ number of SSCs out of the top grade Q-lists numberin tens of thousands while risk-significant SSCs numberin the hundreds 71

i Where Can Graded Quality Assurance Take Us When Risk and Performance are Considered? (continued) 4 latermediate grade (s)

• Reduced QA requirements commensurate with importance j
• To achieve benefit from intermediate grade (s) QA requirements must be clear and simple to administer ffg
• Benefits must outweigh the burden to administer IL H

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t Proposed Graded QA Implementation Approach

1. Define risk-significant and risk-indeterminate SSCs - adjust.

Q-List appropriately l

2. (Optional) Perform engineering evaluation of risk-

. indeterminate SSCs to furtherrefine Q-List t } i

3. (Optional) Identify further opportunities for " grading" QA requirements and practices for the risk-significant items l

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4. Determine areas to which graded QA will be applied (e.g.

!s \\ procurement, design change process, etc.)

5. Adjustas necessary o

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Steps for Selecting QA Requirements + -i...,... n. ~ Step 1 Maintenance Rule IPE Results Detennine Risk Importance of SSCs

• NUMARC Guidance for Grading Risk Significant Non-Risk Significant

,v V Step t )k u ' ^$ Evaluate Risk-Indetenninate l i uwksi SSCs Risk Significant Non-Risk Significant Optional f Step 2 ljhlfI b q. Identify Critical Jy; FunctionalAttributes { h Step 4 Evaluate Nature and Complexityof the Work' 3 f 1I i. 1 f ' Step 5 _ c o m,,,gg,y Determine Appropriate Level considerations i DetermineAppropriate of QA Levelof QA h g y lits@%! APP y to Appendix B l ?A Step 6 Process (es) 's

How Is Quality Assurance Graded Now? f + Several grades currently exist, e.g., = Safety-related(SR) Quality-augmented group

• Non-safetyrelated

+ Other grading schemes exist relevant to QA (e.g., ASME l code) { $}$ 1 C + Now most SSCs are in the top grade whereas risk models suggest the opposite + - QA requirements applied to the augmented grade are not clearly defined (tendency is to treat these grades nearly the .1 same as the top grade) y

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Graded QA Approach Effect on Q-List Current Quality Grades "New" Risk Based Quality Grades l Risk Significant-Safety a h Safety Related y Related Risk Significant - ^ Q-Augmented Graded QA Q-List jgy; Q-List a Non-Q-List Non Risk Significant, includes: a -commercially important SSC = -non risk significant safety Non Safety Related barriers f} -SSC of minor importance E)jl) .? V s i m m. m i.- ....u~.. -

O r i ^ Selected Discussion Issues Risk-significant components from otherIPEs + \\ l Extent of regulatory review (i.e., interpretation of l + 10CFR50.54) prioritization methodology and criteria application of methodology to Q-List ranking

• use of re-ranked Q-Listin various Appendix B processes

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IYw How to overcome institutional resistance to change in + current QA practices both at utilities and within NRC staff fhi y, INl 4 --.~_*-n,. e--w ,. - ~, -- ---n-- .- e e m, - ~, -. w... w.,, e-

) Future Plans Complete opportunity screening and prioritization study + & Complete grading methodology development Define the risk-significant SSr3 (at the Q-List level of detail) + for Grand Gulf 1 + Evaluate acceptability of re-ranked Q-List under 10CFR50.54 - submit for NRC approval as necessary Pilot the utilization of the new risk-significant SSC list in one + or two example areas at Grand Gulf i; Candidate areas include: h. Procurement Design verification Records Graded corrective actions f = QCinspection m si

'i Enclosura 3 NRC Regulatorv Framework For A Graded Aoplication Of Quality Assurance (12/16/93) o 10 CFR 50 Provisions for Graded QA Programs o Regulatory Guidance Provisions o Applicable Industry Codes and Standards o Graded QA for Procurement o Typical QA Program Descriptions o Conclusions

10 CFR 50 Provisions for Graded QA t P o 10 CFR 50 Anpendix A. Criterion 1 Structures, systems, and components (SSCs) important to safety are designed, fabricated, and tested to quality standards 1 commensurate with importance of safety _ functions performed. l 0_10 CFR 50 Accendix B. Introduction OA requirements shall be established for those SSCs that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety.of the public. Pertinent requirements of Appendix B apply to the i safety-related functions of those SSCs. o 10 CFR 50 Accendix B. Criterion ll The quality assurance program shall provide control over activities affecting the quality of identified structures, systems,_ and components, to an extent consistent with their importance to safety. z 1' t 2 b

Begulatorv Guidance Provisions Standard Review Plan o SRP 17.1 (Acceotance Criteria 283) The QA organization and the necessary. technical organizations participate early in the QA program definition stage to determine and identify the extent QA controls are to be applieri to specific SSCs. This effort involves applying a defined graded approach to certain SSCs in accordance with their importance to safety and affects such disciplines as design, procurement, document control, inspection, tests, special processes, records, and audits. o SRP 17 (Acceotance Criteria Ald) The QA Program Description (QAPD) is to provide measures to ensure the quality of items and activities to an extent consistent with their importance to safety. 3 i

? Regulatory Guidance Provisions Regulatory Guides o Regulatorv Guide 1.26 - Four quality groups o Regulatorv Guide 1.33 - Audits commensurate with safety significance o Regulatorv Guide 1.68- - Test Program based on importance-to safety - i o t P 4

APPLICABLE INDUSTRY CODES AND STANDARDS 0 ANSI N45.2 - Levels of control and verification are a function of item / service relative safety, reliability and performance importance O N45.2.11 - Applied based on importance of SSCs to safe operations o NO A-1 - Control consistent with importance o ASME Code - Graded fabrication controls and examination i o ANSI 18.7-1976 - Operational QA O ANSI N45.2.2-72 - Four protective measures levels o ANSI N45.2.3-73 - Five cleanliness levels L 5 i

y .i Graded QA for Procurement .j o ' ANSI N45.2.13 l.; 'l L: - QA based on safety significance or complexity L h 1 o Factors of Consideration - Importance of malfunction to plant safety - Need for special controls and surveillance over process- - Quality history - Suitability of end-product testing o Engineering judgement 6

TYPICAL' QA PROGRAM-DESCRIPTIONS 4 o SSCs generally sp'ecified for full Appendix B treatment or none- ? 0-Some non-safety systems on-O-lists for some'olants - SSC associated with liquid, gaseous and-solid radioactive waste. 1 ( - SSC associated with Fire Protection. 1 t - SSC not required to function following'a seismic event. a 1; a 1 - Radiation Protection (ALARA) .l s - Emergency Planning l - Security 3 - Fire Protection j i f -- Environmental Monitoring j t ~ 7 t 4 - +

-4 Conclusions o

Regulatory framework recognizes the safety benefit derived' from a graded application of the Quality Assurance program, o. Current QA programs do not explicitly define the means to achieve a graded application. i } + I

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m i L-.. Regulatory Review Grouc Quality Assurance Aspects o Graded Application of QA - Use of PRA insights o 10 CFR 50.54 (a) QA Program change control - Reduction in commitment - Meets Appendix B o QA Regulatory Guide Consolidation - Draft RG 1.28 (Rev 4) and NOA-2 endorsement on hold- - Awaiting further developments in graded QA interaction with NUMARC 9

p ' g '.- Technical Specifications Administrative Controls o NRC interactions with Owners Groups - Relocate majority of Administrative Controls for reviews and audits, records, and procedures to QA program - Assumption that suffic:ent regulatory controls exist for QA program licensee proposed changes o impact of Regulatory Review Group Recommendations - Re-evaluating what controls are necessary for items relocated to the QA program + 10 ,}}