ML20059G969
| ML20059G969 | |
| Person / Time | |
|---|---|
| Issue date: | 12/23/1993 |
| From: | Juan Peralta Office of Nuclear Reactor Regulation |
| To: | Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9401260112 | |
| Download: ML20059G969 (40) | |
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NUCLEAR REGULATORY COMMISSION E-If WASHINGTON, D.C. 20555-0D01 December 23, 1993 MEMORANDUM FOR: Files FROM:
Juan D. Peralta Quality Assurance Section Performance and Quality Evaluation Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
SUBJECT:
SUMMARY
OF MEETING WITH NUMARC ON DECEMBER 16, 1993 On December 16, 1993 a meeting was held with Nuclear 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_ possibility of rule changes could not be entirely dismissed.
The staff envisions the implementation of a pilot program, or prcgrams, with -
interested utilities to develop workable approaches culminating in the-issuance of a Regulatory Guide. 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 'ive been placed on-hold pending the outcome of the development of graded QA methodologies.
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- 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 i
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.
l f-NUMARC 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 globalizatioi. 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 i
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.
y i
Files.
Enclosed is a list of attendees and a copy of material provided by NUMARC and the NRC staff.
i 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 Council i
Enclosures:
As stated DISTRIBUTION:
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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 l
Bob Latta NRC/DRIL John Craig NRC/RES V. Lewis Killpack Weston Dick Vollmer NRC/0PP l
Gary Zech NRC/NRR Bruce L. Burgess NRC/RIII U1 dis Potapovs NRC/VIB R. Correia NRC/RPEB j
3 C. Petrone NRC/RPEB Don Bouchey SAIC Bill Gleaves NRC/RES George Hubbard NRC/NRR/SPLB Roger Huston TVA Mark W. Peranich NRC Juan Peralta NRC/NRR Dale Bates CP&L Alex Marion NUMARC Jim Perry NUMARC Gil Hillman NRC Darrel Nash NRC Tony Pietrangelo NUMARC Owen Gormley NRC Larry L. Campbell NRC Frank C. Cherry NRC/RES Bill Russell NRC/NRR Charles Rossi NRC/NRR Bill Parkinson SAIC Les Constable NRC Mark Rubin NRC Leslie Hartz Virginia Power Pete Hunter MACTEC A.
P.. Heymer NUMARC Marc Meyer CER Corp.
Frank Rahn EPRI Robert Hartstern MACTEC Ram Murthy DOE Jack Spraul NRC Tom Foley NRC Jack Skolds SCE&G Fred Maura NRC Hector Barbeito Bechtel Roger F. Reedy Reedy Assoc.
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i Page 2 of 2 Meeting Attendance List
.I NAME ORGANIZATION i
Mike Cheok NUS James J. Raleigh STS Roy Zimmerman-NRC l
Moni Dey-NRC L. S. Gifford GE Mike Meisner Entergy 1
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NRC - NUMARC MEETING 10 CFR.50, APPENDIX B, GRADED IMPLEMENTATION THURSDAY, DECEMBER 16,1993 n
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e 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 2
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CURRENT UTILITY APPENDIX B ACTIVITIES 1
m improvement in Technical Specifications, Administrative Controls i
implementation of performance-based 1
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Self Assessments NUMARC 3
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i DRAFT QUALITY ELEMENTS ORGANIZATIONAL FUNCTIONS
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- Accountability, Responsibility & Organization
- Performance Expectations
- Planning & Resource Management PROCESS CONTROL
- Procedures & Instructions
- Identification of Required Processes
- Identification of Measurement (Performance) Criteria i
ASSESSMENTS CORRECTIVE ACTION
- Evaluation of the Cause
- Resolution of Deviations NUMARC
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REGULATORY THRESHOLD - APPENDIX B WORKING GROUP INTERFACE RTWG
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A_ppendix B WG Develop PSA - Deterministic Develop Quality Elements based methodologies for
& assess applicability prioritizing/ categorizing to Q-List SSCs based on Risk Significance (Development Other Applications EQ of Risk-Based Q-List)
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EPRI/Entergy Project Identify opportunities for cost reduction
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= Process analysis to identify opportunities (plant design I
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Develop technical basis for changing QA requirements or lQ
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1 ii$b processes Graded QA approach i
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= Reduction of QA requirements orpractices Perform case studies to demonstrate specific QA changes 1
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l Develop methodology for reduction of QA requirements or G
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Maintenance Rule - A Starting Point In anticipation of numerous future prioritization applications
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it is important to maintain consistency amongst applications from the beginning Maintenance Rule provides an approach for using PSA and
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.ja deterministic insights for evaluating risk significance
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Expertpanel validation Performance monitoring The Maintenance Rule approach may need to be l
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1:!qin Applications beyond maintenance preventable failures O
Treatment of SSCs not in the PSA c
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Q-List Versus PSA Risk-Significant SSCs The large disparity between Q-Lists and PSA component lists
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can be overcome The disparity:
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- Q-Lists containing safety-related and quality-augmented SSCs are roughly an order of magnitude larger than PSA componentlists 3ej ih"*
- Whole systems on the Q-List are not addressed by the PSA at all (e.g., security systems), or explicitly (e.g., the reactor coolant system) i $:
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Q-List Versus PSA Risk-Significant SSCs (continued)
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- The means to overcome the disparity:
- PSA components (e.g., pumps) are often super-I components whose importance reflects more than
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- System / train importance can be used to measure the importance of whole groups of components on the Q-i List fll I
- Certain instrumentation can be correlated with human performance events in the PSA (e.g., reactor waterlevel and depressurization) l$
- PSA initiating events often reflect whole systems
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(e.g., loss of sealinjection) whose importance can lj then be distributed to critical components f
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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
, c ' dii implicitly modeledin the Level 2 PSA
- The risk significance of fire protection and seismic II overI components is being addressed in the IPEEE
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- The potential risk significance of a large number of i
components (e.g., tap lines and small valves) has been demonstrated to be insignificant by the PSA, even though they are not explicitly modeled 1
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Insights on Particular Modeling ISSUBS Risk significant initiating events in non-safety systems, e.g.,
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loss of offsite power or instrument air, will require additional l
engineering analyses to identify risk significant components p"'
= These systems may contain many components, but the j
few which are applicable to the risk-significant functions
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must be identified
- PSA "models" are often single events reflecting generic i
industry data N
- Causes of failure in the data can be related to u{
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 p
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Insights on Particular Modeling ISSUES (continued)
Instrumentation represents a large number of safety-related
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components often not explicitly modeled in the PSA
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related to symptoms in procedures and symptoms
- a related to instruments Significant redundancy and diversity has ensured
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risk significant iy%
- Syn otom based EOPs allow the operator to use o,; erse types ofinstruments
- Individual types ofinstruments have multiple
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- Localindications often provide backup to control
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Insights on Particular Modeling ISSUES (continued) i instrumentation for automatic system actuation sometimes is modeled but is rarely significant due to manualactuation backup fly l $
Systematic techniques for evaluating the risk significance ofinstrumentation have been applied to i
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equipment qualification (NSAC-54)
A more straight-forward and cost-effective approach that better reflects diversity and redundancy is probably attainable 3
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Where Can Graded Quality Assurance Take Us when Risk and Performance are Considered?
i Most risk-significant grade (i.e., high importance
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components) m Full Appendix B requirements Least risk-significant grade (lowest importance components)
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Risk-based methods / precedent exist for moving a number of SSCs out of the top grade y
= Q-lists numberin tens of thousands while risk-significant SSCs numberin the hundreds ye i !)
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Where Can Graded Quality Assurance.
Take Us When Risk and Performance are Considered? [ continued)
Intermediate grade (s)
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Reduced QA requirements commensurate with importance l
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To achieve benefit from intermediate grade (s) QA requirements must be clear and simple to administer y$Q; Benefits must outweigh the burden to administer g
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Proposed Graded QA Implementation Approach
- 1. Define risk-significant and risk-indeterminate SSCs - adjust Q-List appropriately
- 2. (Optional) Perform engineering evaluation of risk-indeterminate SSCs to further refine Q-List g
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- 3. (Optional) Identify further opportunities for " grading" QA requirements and practices for the risk-significant items (e.g., using functional considerations) 4 i,
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- 4. Determine areas to which graded QA will be applied (e.g.
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procurement, design change process, etc.)
- 5. Adjustas necessary h
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Steps for Selecting QA Requirements
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Step 1
- Maintenance Ruin IPE Results Detennine Risk Importance of SSCs NUMARC Guldance for Grading Risk Significant Non-Risk Significant
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Step 4 Evaluate Nature and Complexityof the Work y
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Determine Appropriate Level con de 11 ns DetermineAppropriate ofQA Levelof QA
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Step 6 Apply to Appendix B Process (es)
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HowIs Quality Assurance Graded Now?
Several grades currently exist, e.g.,
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Safety-related (SR)
= Quality-augmentedgroup Non-safety related Other grading schemes exist relevant to QA (e.g., ASME
+
code)
Now most SSCs are in the top grade whereas risk models
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suggest the opposite QA requirements applied to the augmented grade are not
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clearly defined (tendency is to treat these grades nearly the same as the top grade) g,,
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Graded QA Approach Effect on Q-List Current Quality Grades "New" Risk Based Quality Grades Risk Significant-Safety n
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Non-Q-List Non Risk Significant, includes:
-commercially important SSC
> -non risk significant safety Non Safety Related barriers i:i
-SSC of minorImportance Q
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p, Selected Discussion issues
+ Risk-significant components from otheriPEs
+ Extent of regulatory review (i.e., interpretation of 10CFR50.54) prioritization methodology and criteria application of methodology to Q-List ranking V
- use of re-ranked Q-List in various Appendix B processes ffik
+ How to overcome institutional resistance to change in current QA practices both at utilities and within NRC staff w((j
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Future Plans s
+
Complete opportunity screening and prioritization study
+
Complete grading methodology development
+ Define the risk-significant SSCs (at the Q-List level of detail) l for Grand Gulf
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+ Evaluate acceptability of re-ranked Q-List under 10CFR50.54
- submit for NRC approval as necessary v
+ Pilot the utilization of the new risk-significant SSC list in one or two example areas at Grand Gulf W
Candidate areas include:
h Procurement Design verification
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Records
- Graded corrective actions 9
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= QCinspection
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NRC Regulatory Framework For A Graded Application Of Quality Assurance (12/16/93) o 10 CFR 50 Provisions for Graded QA Programs I
o Regulatory Guidance Provisions o
Applicable industry Codes and Standards o
Graded QA for Procurement o
Typical QA Program Descriptions o
Conclusions i
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10 CFR 50 Provisions for Graded QA o 10 CFR 50 Accendix A Criterion 1 Structures, systems, and components (SSCs) important to safety are designed, fabricated, and tested to quality standards commensurate with importance of safety functions performed.
o 10 CFR 50 Anoendix 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 safety-related functions of those SSCs.
o 10 CFR 50 Accendix B, Criterion 11 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.
2
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Regulatorv Guidance Provisions Standard Review Plan o SRP 17.1 (Acceotance Criteria 2B3)
The QA organization and the necessary technical organizations participate early in the QA program definition stage to determine and identify the extent GA controls are to be applied 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 17.3 (Acceolance 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
1 Regulatorv Guidance Provisions Rea_ulatorv. Guides o
Regulatorv Guide 1.26
- Four quality groups t
o Regulatorv Guide 1.33 i
- Audits commensurate with safety significance i
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Regulatorv Guide 1.68 i
- Test Program based on importance to safety
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APPLICABLE INDUSTRY CODES AND STANDARDS o
- 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
NOA-1
- Control consistent with importance o
ASME Code
- Graded fabrication controls and examination O
- Operational QA l
o Ai4SI N45.2.2-72
- Four protective measures levels o
- Five cleanliness levels 5
Graded QA for Procurement i
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- QA based on safety significance or complexity 1
o Factors of Consideration
-Importance of malfunction to plant safety i
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- Need for special controls and surveillance over process
- Quality history
- Suitability of end-product testing o
Engineering iufgement 6
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TYPICAL QA PROGRAM DESCRIPTIONS o
SSCs generally specified for full Appendix B treatment or none o
Some non-safety systems on Q-lists for some olants
- SSC associated with liquid, gaseous and solid radioactive waste.
- SSC associated with Fire Protection.
- SSC not required to function following a seismic event.
- Radiation Protection (ALARA)
- Emergency Planning
- Security
- Fire Protection
- Environmental Monitoring 7
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.3 Conclusions I'
i 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 i
achieve a graded application.
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- o Regulatorv Review Group Quality Assurance Aspects o
Graded Application of QA
- Use of FRA 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
1
';#,, o Technical Specifications Administrative Controls NRC interactions with Owners Groups o
- 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 i
O Impact of Regulatory Review Group Recommendations 1
l
- Re-evaluating what controls are necessary for items relocated to the QA program 10
'