ML20029D072
| ML20029D072 | |
| Person / Time | |
|---|---|
| Issue date: | 04/26/1994 |
| From: | Zech G Office of Nuclear Reactor Regulation |
| To: | Rossi C Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9405030408 | |
| Download: ML20029D072 (27) | |
Text
4 UNITED STATES q
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S NUCLEAR REGULATORY COMMISSION Ia
'f WASHINoToN. D.C. 20566-0001
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l April 26, 1994 MEMORANDUM FOR:
Charles E. Rossi, Director Division of Reactor Inspection and Licensee Performance, NRR FROM:
Gary G. Zech, Chief Performance and Quality Evaluation Branch Division of Reactor Inspection and Licensee Performance, NRR
SUBJECT:
SUMMARY
OF A WORKING GROUP MEETING WITH NEI ON APRIL 11, 1994 ON GRADED QUALITY ASSURANCE On April 11, 1994, a Working Group meeting was held with Nuclear Energy Institute (NEI) representatives to continue discussions on graded quality assurance (QA) and to initiate discussions on the NEI draft document
" Guideline For Industry Pilot Project - Implementation of Graded, Performance-based Approach to Quality", dated April 1994, (Enclosure 1) which was formally presented by NEI at the onset of the meeting.
The staff opened the meeting by providing clarification on the organization and goal of the two separate Working Groups, and their respective Steering Groups, which were formed independently by industry and the NRC to examine the benefits of the graded allocation of QA resources to structures, systems, and components (SSCs) based on their safety significance.
The initial goal of these efforts is the formulation of a conceptual process or methodology for the development of a graded QA program by identifying the SSCs, including those within the scope of the Maintenance Rule (10 CFR 50.65),
that deserve varying or proportionate degrees of QA verification based on their relative safety significance.
The initial screening of SSCs as to their safety significance would be through individual plant Probabilistic Risk Assessment (PRA) insights, in conjunction with appropriate deterministic evaluations of their intended safety functions, and plant-specific regulatory and/or licensing commitments.
The ultimate objective of these efforts is to capitalize on the potential safety benefits that would result from allowing both the industry and regulators to concentrate their limited resources on those SSCs that are determined to be the most safety significant.
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I Charles E. Rossi April 26, 1994 NEI distributed copies of its' draft guidance document and provided an overview of its content and philosophy reiterating that it was not their intention to include explicit or prescriptive guidance on how the pilot project participants should implement the graded QA effort.
NEI stated that their draft guidance document would implement Appendix B to 10 CFR 50 based on the safety significance of SSCs. NEI added that their approach is based on the philosophy of the Maintenance Rule which allows use of Probabilistic Safety Analysis (PSA) insights as useful and important tools in helping licensees determine the safety significance of SSCs.
The staff noted that NEI's approach, which advocates the utilization of only Criterion XVI of Appendix B to 10 CFR 50, " Corrective Action", for low-safety significant safety-related SSCs, is not sufficient in and of itself to implement a graded approach to quality.
The staff stressed that the intended safety function, and the design criteria, of SSCs would have to be the determining factor in establishing the appropriate QA related measures that should be retained and applied commensurately with the safety significance of those SSCs.
The staff added that in those cases where a corrective action program, in conjunction with performance criteria, have been determined by the licensee (s) to be sufficient to provide adequate confidence that a given low-safety significant safety-related SSC will perform satisfactorily in service, including during Design Basis Events (DBEs), appropriate measures must be established to ensure that " corrective actions" comprehensively encompass all facets of Appendix B to 10 CFR 50, Criterion XVI.
The staff agrees with NEI's assertion that the pilot project effort should complement, and ultimately result in improvement of, the guidance document itself. However, the staff clarified that before the pilot effort is initiated the guidance document must be sufficiently detailed to allow assessment of the acceptability of the proposed pilot effort.
The meeting adjourned with both the staff and NEI agreeing to reconvene on April 26, 1994, when the staff will formally pre'sent the results of its initial review of NEI's draft guidelines and when the pilot project participants will meet with the staff for the first time.
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Charles E. Rossi April 26,1994 Enclosures 1 is the draft NEI guideline document, Enclosure 2 is material presented by NEI during the meeting, and Enclosure 3 is the meeting attendance list.
ORIGINAL SlGNED BY t GARY G. ZECH 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 1776 Eye Street NW Suite 300 Washington, DC 20006-3706
Enclosures:
As stated Q1STRIBUTION:
Central Files (PI-22)
EJordan, 3701 iPDR (PI-22)
RPEB R.F.
RZimmerman, 9 A2 ARamey-Smith, 10 E4 DRll R.F.
JPage, NLS314 GMizuno, 15 B18 NRC Meeting Participants JJohnson, 16 GIS MModes, RI JMilhoan, 17 G21 JHeltemes, NLS007 WTRussell, 12 G18 AThadani, 12 G18 FJape, RII DFischer, 7 E23 GHolahan, 9112 BBurgess, RIII MDey, NLS314 4
MVirgilio, 8 E2 Wang, RIV/ Walnut Creek LReyes, 12 09 Eleeds, 12 G18 WGleaves, NL2178 CMcCracken, 8 D1 AGody, 13 E21 RVollmer, 1 F22 0Gormley, NLS217B i
RWessman, 9 A2 VMcCree, 17 G21 OfC SEND RPEB:DRIL:NRR RPEB:DRIL:NRR SAC:RPEB:DRll:NRR NRR NAME TO JPeralta:rci
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GUIDELINE FOR INDUSTRY PILOT PROJECT IMPLEMENTATION OF GRADED, PERFORMANCE-BASED APPROACH TO QUALITY NUCLEAR ENERGY INSTITUTE APRIL 1994 1
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l ii DRAFT (4/8/94)
TABLE OF CONTENTS EXECUTIVE
SUMMARY
1.0 INTRODUCTION
2.0 PURPOSE 3.0 RESTRUCTURING THE Q-LIST 3.1 Defining the Scope ofSSCs 3.2 Selection ofPlant SSCs 3.3 Establishing the Safety Significance of SSCs 3.4 Initial Categorization at the Component Level 3.5 Reviewing the Scope of Safety Significant Components 3.6 Additional Categorization of Safety Significant Components 4.0 APPLYING GRADED, PERFORMANCE-BASED QUALITY ELEMENTS 4.1 Administrative Guidance 4.2 Safety Significant SSCs 4.3 Non-safety Significant SSCs 4.4 Performance Criteria 4.4.1 Safety Significant SSCs 4.4.2 Non-safety Significant SSCs 4.4.3 Evaluation of Performance criteria 4.4.4 Changing Performance Criteria 4.5 Corrective Action Progmm 4.5.1 Resolution ofDeviations 4.5.2 Failure to meet Performance Criteria 5.0 EXAMPLES OF A GRADED, PERFORMANCE-BASED APPROACH TO QUALITY - (Output from the Pilot Project)
APPENDIX A DEFINITIONS, TERMS AND ACRONYMS 2
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EXECUTIVE
SUMMARY
This guideline provides the general framework and guidance to support a pilot project for implementing a graded, performance-based approach to quality. On completion of the pilot project, the guidance will be amended as necessary to incorporate the lessons learned. The document, together with examples from the pilot project, will be formally issued as industrywide guidance for other companies to consider the option of moving to a graded, performance-based approach to quality, following NRC staff endorsement through a Regulatory Guide.
This project builds on the momentum being established through the implementation of the Maintenance Rule towards a performance-based regulatory regime.
The continuing transition to a performance-based regime in the area of quality implementation moves the emphasis for quality from procedural programmatic compliance towards product quality and plant performance. A corrective action program is still required to adjust and cont'rol deviations from the defined performance, product criteria or specification.
The pilot project, consisting of facilities from six utilities, will implement and assess methodologies for a graded, performance-based approach to quality. The project grades the SSCs into two main categories, safety significant SSCs and non-safety significant SSCs. A performance-based approach will only be applied to SSCs oflow safety significance (non-safety significanti). The effectiveness of the quality program for this non-safety significant set of SSCs is determined by meeting a predetermined set of plant level and in some specific instances system level performance criteria.
The overall objective ofimplementing a graded, performance-based approach to quality is to effect changes that will enable the regulations to be implemented in a more efficient and effective manner. These changes will enable the NRC staff and licensees to appottion resources commensurate with safety significance to meet the current I
The term non-safety significant is used throughout this document. It equates to the term non-risk significant used in NUMARC 93-01, industry Guideline for Monitoring the EfTectiveness of Maintenance at Nuclear Power Plants I
and this document.
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DRAFT (4/8/94) regulations, taking advantage of modern quality concepts and programs for improving performance and productivity, while maintaining safety requirements.
Facilities involved in the pilot project will interact with the NRC staff through the Nuclear Energy Institute (NEI) to reach an understanding on the regulatory basis for moving to a graded, performance-based approach for implementing quality.
This guideline should not result in the development of an alternative quality assurance program. The intent is to refine and improve current quality program implementation practices, building on industry experiences while taking advantage of improved technologies and advances in analytical techniques.
The project involves the following steps:
Grade the structures, systems and components (SSCs) based on safety significance, building on the concepts and practices established in implementing the Maintenance Rule and developing the Individual Plant Examinations (IPE). In addition, SSCs excluded from the scope of the Maintenance Rule, but included in the general regulatory scope because of other regulations would also be included.
This involves combining probabilistic safety assessment and deterministic evaluations in determining the overall safety significance profile of the SSCs within the facility.
Establish two main groups, safety significant and non-safety significant (low safety significance). Both groups will be a blend of safety related and non-safety related SSCs. There is a third group, SSCs that are not within the scope of the regulations.
For the safety significant group, current quality practices and current regulatory commitments apply.
For the non-safety significant group, existing regulatory commitments associated with quality assurance would be replaced by the guidance in this document under 10 CFR 50.54(a). Quality practices and depth ofimplementation would be determined by facility management. The effectiveness of the quality practices 4
DRAFI (4/8/94) would be determined by meeting a predetermined set ofperformance criteria.
These SSCs would also be subject to a corrective action program.
As the project progresses, cost benefit and project evaluations will be performed to determine whether to adopt the concept of a graded, performance-based quality regime to the complete spectrum of company work activities as an industrywide evolution.
Adjustments will be made as the pilot project progresses based on input from the pilot participants and feedback from the NRC staff.
Appendix A provides a list of definitions, terms and acronyms to clarify and assist in understanding the concepts and guidance given in this document.
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DRAFT (4/8/94)
1.0 INTRODUCTION
The originators of 10 CFR Part 50, Appendix B, drafted the regulation in a manner that pennitted flexibility in its implementation. Further, as stated in the NRC Regulatory Review Group Report, and confirmed in the industry-NRC management interactions, the regulation language allows for the quality program to be implemented to an extent that is consistent with the importance to safety. The regulations also require a determination to be made on the effectiveness of the program and allows significant latitude in the manner in which this is determined.
As a result ofintense commercial competition, modern quality practices now being implemented outside of the commercial nuclear community reflect a general improvement on the quality practices currently employed in i nplementing 10 CFR 50 Appendix B. The general programmatic concepts have esser tially remained the same, but the measure of a satisfactory quality program has advance'. from programmatic procedural compliance to one that focuses on performance and product quality.
Utilities have already begun the transition to a performance-based quality regime.
This effort builds on these embryonic activities to implement and evaluate the generic progression to performance-based quality practices in areas oflow safety significance.
The implementation of a graded, performance-based approach to quality should enable resources to be apportioned to the more safety significant issues and concerns.
The goals of this effort are to maintain or improve current high levels of safety and to improve the economic efficiency of operating plants.
Pilot Proiect Backcround In June 1992, the chairman of the NRC, addressing the NUMARC Board of Directors, suggested that the industry should identify areas where there are significant expenditure of resources associated with marginal safety benefit. In November 1992, the NRC announced, through the FederalRegister (57 Fed. Reg. 55060), that they believed further studies should be undertaken in a number of areas to assess the benefits of a performance-based approach to implementing the regulations, including those associated with quality assurance. The studies would indicate what level of resources could be 6
DRAFT (4/8/94) apportioned to more effectively manage safety significant issues and improve the effectiveness of the regulation.
In January 1993, following the industry response to the NRC chairman's suggestion, the NRC formed the Regulatory Review Group. This group was tasked with conducting a review ofpower reactor regulations and related processes, programs, and practices, with special attention placed on the feasibility ofperformance-based concepts.
The Regulatory Review Group published their report in August 1993 and concluded that an industry-phased implementation ofspecific measures could be a practical way to improve quality practices based on a graded, performance-based concept as currently permitted by the regulations. Such an approach could ultimately result in an improved public health and safety environment.
Traditionally the structures, systems and components (SSCs) in a facility have been categorized into a number oflists, such as, non-safety related, Q-Lists, and augmented quality. In some cases, because of ease ofimplementation, or specific regulatory commitments, the full extent and requirements of Appendix B, as defined in the numerous regulatory guides, have been applied to the SSCs on the Q-List.
Today with over thirty years of operating experience, with the advances in technologies and improvements in analytical techniques, such as probabilistic safety assessments, additional evaluations can be performed to provide further insights into identifying safety significant SSCs. Application ofsuch techniques to a facility's list of SSCs can then become the basis for a graded, performance based approach to implementing quality.
Within the scope of this document, the SSCs are divided into two main groups, safety significant and non safety significant. There is an additional category of components that are not within the regulatory scope that would be subjected to quality practices, as determined by facility management, but are not part of the scope of this document. The two main groups would be a blend of the current component classifications, safety related and non-safety related structures, systems and components.
Figure 4-1 gives a graphical representation of the grading structure The quality elements would be applied in a manner and to an extent commensurate with safety significance, as permitted by the regulations.
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The foundation for such an approach has been established by two recent industry activities: the Individual Plant Examination (IPE) project defined by NRC Generic Letter 88-20, and the implementation of the Maintenance Rule (10 CFR 50.65) through the industry guidance document NUMARC 93-01, " Industry Guidelinefor Monitoring the Effectiveness ofMaintenance at Nuclear Power Plants", which has been endorsed by NRC Regulatory Guide 1.160, in December 1993, NRC management proposed a process and approach for implementing quality based on the implementation of the Maintenance Rule. Apart from tetimizing the utilization of resources, such an approach to implementing quality practices would assist in focusing both NRC and industry attention and resources on the more safety significant SSCs.
The transition to a performance-based quality regime is a three part project. This document reflects the guidance for the first part, a pilot project to implement a performance-based quality regime for components having low safety significance. The second part involves NRC review and endorsement of the approach described in this guidance, amended as necessary to reflect lessons learned from the pilot projects. The NRC endorsement would provide the regulatory acknowledgment of the option for implementing a graded, performance-based approach to quality, for areas oflow safety significance throughout the industry. The third stage, a longer term issue, is to provide the option to adopt a performance-based quality regime for the complete facility, further reducing the complexity of assessing quality practices, while improving regulatory effectiveness and stability.
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DRAFT (4/8/94) 2.0 PURPOSE The purpose of this document is to provide general guidance to a set ofpilot projects on the implementation of graded quality elements that includes:
The use of PSA and deterministic insights, consistent with NUMARC 93-01, to refine and restructure a Q-list based on the safety significance of plant SSCs; and Applying quality elements, including Appendix B criteria, to the restructured Q-list.
This guidance provides an approach for implementing graded, performance-based quality measures and is intended for the voluntary use of nuclear power plant licensees. It does not preclude the use of other approaches to implement graded, performance-based quality.
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J DRAFT (4/8/94) 3.0 RESTRUCTUltING THE O-LIST 1
This section provides guidance for a process to refine a licensee's Q-list. It begins with the SSCs that are within the general scope of the Maintenance Rule and ends with a list of SSCs that are categorized by their safety significance. The restructured Q-list will have at least two main categories of SSCs, safety significant and non-safety significant.
Optional guidance is provided on refining the scope of SSCs that reside in the two main categories. Optional guidance is also provided on grading the Q-list into more than two categories.
3.1 Defining the Scone of SSCs 1
The SSCs defined by the Maintenance Rule,10 CFR 50.65, and the SSCs i
encompassed by other regulations and licensing commitments provides the scope and the starting point for determining which plant SSCs will reside on the restructured Q-list. It includes safety-related and non-safety-related SSCs as required by the requirements of the Maintenance Rule.
Extractfrom 10 CFR S0.65:
- 1. Safety-related SSCs that are relied upon to remainfunctional during andfollowing design basis events to ensure the integrity ofthe reactor coolantpressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, and the capability to prevent or mitigate the consequences ofaccidents that could result in potential ofsite exposure comparable to the 10 CFRpart 100 guidelines.
- 2. Non-safety-relatedSSCs:
That are relied upon to mitigate accidents or transients or are used in plant emergency operatingprocedures (EOPs); or Whosefailure couldprevent safety-related SSCsfromfulfilling their safety-related fimclion: or Whosefailure could cause a reactor scram or actuation ofa safety-relatedsystem.
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DRAFT (4/8/94) 3.2 Selection of Plant SSCs NUMARC 93-01, Section 8.2.1, Selection ofPlant SSCs, provides guidance on determining the SSCs that are within the scope of the Maintenance Rule. These same SSCs will reside on the restructured Q-list.
It is expected that most of the SSCs that comprise current utility Q-lists will be determined to be within the scope of the Maintenance Rule. Ifsome of these SSCs are not within the Maintenance Rule scope, they should be evaluated as a separate category of SSCs to determine whether there is a basis for including them within the scope.
3.3 Establishing the Safety Significance of SSCs NUMARC 93-01, Section 9.3.1, Establishing Risk Criteria, provides guidance on establishing the safety significance of SSCs. The guidance involves a blend of both probabilistic and deterministic methods to appropriately identify the safety significance of SSCs. This approach is intended to capitalize on the insights gained from plant-specific PSAs as well as the operating experience and expertise ofplant personnel. For example, when probabilistic methods are used to determine the safety significance of SSCs, a panel ofindividuals experienced with the plant PSA, operations and maintenance should be employed to supplement the probabilistic results with their own expertise. The expert panel should compensate for limitations associated with applying PSA methods to establish the safety significance of SSCs.
There is one important difference to note here regarding the guidance provided in NUMARC 93-01 to establish the safety significance of SSCs. In using PSA importance measures 2 to gain insights into the safety significance of SSCs, pertinent failure modes, whether they are maintenance related or not, should be considered. The guidance in NUMARC 93-01 appropriately excludes consideration of failure modes that are not related to maintenance. Given that quality measures are applied to a spectrum of functional areas other than maintenance, it is necessary to consider the pertinent failure modes in those areas and related activities that would impact the safety function.
2 Imponance measures are those defined in NUMARC 93-01, risk reduction worth risk achievement worth and core damage frequency contribution.
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r DRAFT (4/8/94)
The methods described above to identify the safety significance of SSCs were employed by several utilities during the development of NUMARC 93-01. The results of those efforts were published in NUMARC 93-02, A Report on the Verification and
{
Validation ofNUMARC 93-01, Draft Revision 2A, Industry Guidelinefor Monitoring the Effectiveness ofMaintenance at Nuclear Power Plants. The results indicated that the utilities generally identified the safety significance of SSCs within the scope of the Maintenance Rule at the system level. This step serves as the first cut at categorizing the systems based on the safety significance of the systems. Figure 3-1 illustrates the concepts discussed thus far in Section 3.2 and this section.
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+ Reg. Scope = Maint. Rule Scope + Other SSCs from Other Regulations and Licensing Committments FIGURE 3-1 3.4 Initial Categorization at the Component Level The next step involves a component level categorization. This section discusses the initial breakdown of the safety significant and non-safety significant systems into two main categories on the restructured Q-list, safety significant components and non-safety significant components.
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DRAFT (4/8/94)
Within the systems identified as safety significant, all components in these systems should be initially categorized as safety significant components. Within the systems identified as non-safety significant, all components should be initially categorized as non-safety significant components. Figure 3-2 illustrates this concept. One could use this initial categorization as the foundation for implementing graded quality practices.
However, it should be noted that there may be several components within the system that are not safety significant (i.e., that are not necessary for the system to perform its safety function) and could be categorized as such. The next section addresses this topic.
Safety Safety Significant Significant Systems Components Non-Safety Non-Safety Significant Significant Systems Components Restructured Q-list (initial Categorization)
FIGURE 3-2 3.5 Reviewing the Scope of Safety Significant Components The section provides optional gmdance that further refines the scope of the components that reside in the two categories, safety significant and non-safety significant.
Up to this point, components have been categorized based upon the safety significance of the system of which they are a part. The review at this stage is intended to provide 13 yl'
DRAFT (4/8/94) greater focus on truly safety significant components by determining the component's contribution to the system's safety significance.
The primary factor to consider in this review is the safety function of the system.
If the component is necessary for the performance of the system safety function, it should remain in the safety significant category. If the component is not necessary for the performance of the system safety function, is should be moved to the non-safety significant category.
There are a number of acceptable methods to determine a component's contribution to system safety function. In genemi, these methods consist of either deterministic or probabilistic criteria (or a blend of the two) to evaluate component safety significance.
A deterministic approach may be used to identify system safety function through a review of documents such as system descriptions or design basis documents. The role of an individual component in achieving or supporting achievement of that safety function could then be determined by knowledgeable personnel in assessing the ability to achieve the system safety function in light of component failure.
A probabilistic approach may be used to determine component safety significance through application of the plant IPE. Since the system has already been determined safety significant, it would be necessary to delve more deeply into the IPE model to identify those system components which are modeled in the IPE. Because components in the IPE models are often " super-components" which represent two or more system components, it may be necessary to identify the multiple components which constitute a modeled IPE component. Having done this, those system components which do not contribute to modeled IPE components should be moved to the non-safety significant category.
The probabilistic approach can then employ a final step to determine component safety significance. So far, the only criterion applied to components is to determine if the component has been modeled in the IPE. Those components which have been modeled, and therefore remain in the safety significant category, can now be assessed to determine their contribution to plant risk. Components whose failure is determined to have no risk 14 i
DRAFT (4/8/94) significance or negligible risk significance should also be moved to the non-safety significant category.
By employing deterministic or probabilistic criteria to identify and retain those components that are relied upon to carry out the system safety function, the scope of components in the safety significant category would become more focused. Figure 3-3 illustrates this concept.
l It is recognized that after completing this review, both the safety significant and non-safety significant groups will contain a mixture of safety related and non-safety related components. To improve consistency between the component classification and safety significant categorization, the facility could consider reclassification of the safety related and non-safety related components. Section 4 contains additional information on -
implementing quality practices for these categories. In this case, Appendix B would be implemented,
Components needed to perform Safety Safety safety functions Significant i
SIDnificant Components Components 4
Non-Safety Components not needed Significant Non-Safety to perform safety Components Significant functions Components Restructured Q-list Restructured Q-list (initial Categorization)
FIGURE 3-3 i
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' 3.6 Additional Categorization of Safety Significant Componenta l
t This section provides optional guidance on further subdit.
g the safety significant component category of the restructured Q-list into additional categories. It '
should be emphasized that the decision to proceed with implementation of this optional.
guidance would be based on cost benefit determinations, and would vary from facility to facility. This decision should be based on whether the savings from implementing a graded, performance-based approach over the life of the facility outweigh the cost of further categorizing the SSCs.
The additional categorization is primarily based on identifying the functional failure modes of the components residing in the safety significant category. This.
approach would require additional use of the plant-specific PSA to identify the risk rignificant failure mode of the component. Components would then be categorized based:
on the significsut e of their functional failure modes. Appropriate quality elements would -
then be applied to address the particular failure mode of that category of components.
Figure 3-4 illustrates this concept.
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Safety Co ponen Further Grading of Safety Significant Components Based On FFMs Non-Safety Non-Safety Significant Significant Components
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4.0
~ APPLYING GRADED. PERFORMANCE-BASED OUALITY ELEMENTS Figure 4-1 gives a graphical representation of the general process being described i
in this document.
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GRADED APPROACH TO IMPLEMENTING QUALITY a
A Assessment &
Safety significant implementation per (Safety related &
non safety related)
Regulatory u -
Scope per n
Maint. Rule +
Non-safety significant a ed compliance (safety related &
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& corrective action program) '
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Other SSCs i
+ Reg. Scope = Maint. Rule Scope + Other SSCs from Other Regulations & Licensing Commitments Fig 4 - 1 This poject will result in a number of adjustments to current quality practices that are applied to facility SSCs. While past performance and safety significance are insights by which to apply quality elements, adjustments should also consider design engineering.
specifications and other regulatory requirements, including environmental factors, seismic fire protection and radiological considerations.
4.1 Administrative Guidance The specific details, including the extent of adjustments to the implementation procedures, practices and instructions would be determined by each facility and company.
A panel of facility personnel experienced in the specific functional work area, the design, 18 i
DRAFT (4/8/94) the pertinent SSCs under consideration, quality assurance and, if applicable, PSA, would determine the extent and depth of any amendments and adjustments of existing programs.
Input from other experienced facility personnel would be solicited, as required, and as determined by the facility management and the panel. This panel could be the same as that described in Section 3, but the task associated with the assessment, determination and adjustment of quality elements would probably be undertaken in a different time frame to that of categorizing the facility SSCs. It is also recognized that a person could fulfill more than one function, e.g. knowledgeable of the functional work area and the pertinent SSC.
The panel should take into account a number of factors when developing or assessing the need to adjust the programs, controls, procedures or instructions associated with a SSC, or adjust the level of detail associated with implementing specific quality elements. The main factors that the panel should consider are listed below. They are not in any order of priority and, include:
Existing work practices and instructions Past plant performance history Environmental design specifications and conditions Facility, division, department or section past performance history Training, professional development and certification programs Experience of the work force and use of outside contractors / consultants Health and safety implications Cost oflabor, materials and parts Impact on plant performance The panel should also take into consideration how implementation might be effected, using "on-line" examples from a SSC within the safety significant and non-safety significant group. In addition, the panel should assess how adjustments to the proposed quality practices might affect performance, and the quality of the SSC or service, including the potential impact on the performance criteria.
Each company will make its own determination on the functional work areas for implementing a graded, performance-based approach to quality, as well as the degree and depth ofimplementing these processes.
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The list of functional work areas described below is a provisional list, developed by the NEI Appendix B working group. There are other functional work areas that may benefit from adopting a graded approach. The list is not in order of priority, or ranked in order of anticipated cost benefits.
Procurement Warehouse receipt inspection QC inspections Maintenance Design process, including verification and change process Configuration control Records and documentation Material control and traceability Audits / assessments Independent verification Procedure development Work control processes, (bolting, cable pulling....)
Surveillances, including ISI/IST within code allowables Oversight process Testing The application of quality elements for the safety significant SSCs would be more comprehensive than the non-safety significant SSCs. In addition, the company's corrcetive action program would be used to implement adjustments to a facility's programs and practices. Adjustments might include broadening or reducing the scope, level of detail, or implementation of quality activities, on account of an identified need to l
refine quality activities.
i i
The quality practices for the non-safety significant group should be based on existing non-safety related working practices, instructions or procedures, or on the programs associated with other non-nuclear areas within the company. Comparisons and, if necessary, evaluations of these programs would be performed to determine if the j
existing quality practices for the non-safety significant safety related quality practices 1
could be refined. The objective is to provide adequate confidence that the performance criteria will be met. Facility monitoring programs and periodic performance criteria evaluations would determine whether the improvements have beeri effective.
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DRAFT (4/8/94)
The changes in the quality program associated with the 10 CFR 50, Appendix B and identified through by this project would be implemented through 10 CFR 50.54(a).
For the non-safety significant, safety related SSCs, the current regulatory quality assurance commitments and ancillary programs would be replaced by the general guidance described in this document. The quality program's effectiveness would be assessed by meeting a set ofpredetermined performance criteria similar to that used for implementing the Maintenance Rule.
It should be noted that individual facility business plans may require additional emphasis on specific quality elements for non-safety significant SSCs on account of their importance (economic, or operational aspects). The necessity for additional emphasis or detailed quality practices based on business plans and not safety is outside of the scope of this document.
4.2 Safety Significant SSCs For those safety-significant SSCs that were on the original Q-list (i.e., safety-related SSCs), the current 10 CFR 50, Appendix B quality program would continue to be applied in a manner commensurate with safety significance. The regulatory commitments described, or referenced in the FSAR would still apply to these SSCs.
The work procedures and instructions for the SSCs in this category should not be impacted by this project, unless the facility management desires to further refine and improve the quality regime for implementing Appendix B, consistent with the regulations and the facility's existing regulatory commitments associated with quality assurance.
1 For those safety significant SSCs that were not on the previous Q-list (i.e., non-safety-related SSCs), the applicable criteria of the Appendix B would apply. The level of detail ofimplementation would be commensurate with the safety significance of the SSC or activity. The Appendix B requirements for this group of SSCs would be applied in a forward-looking manner, not retroactive. The panel of experienced facility personnel would assess past performance and current quality practices and make adjustments as necessary to reflect the safety significance of the SSC.
l 1
21
' DRAFT (4/8/94) 4.3 Non-safety Sienifierut SSCs For the non-safety significant group of SSCs, the major refinement is the assessment of the effectiveness of the quality program through performance based concepts by meeting a set of predetermined performance criteria. The performance criteria and the evaluation of compliance with the performance criteria would be in a manner similar to that developed for the implementation of the Maintenance Rule.
Section 4.4 provides additional guidance on performance criteria.
A panel of experienced facility personnel would determine the practices that will be employed for this group of SSCs to assure that the performance criteria are met.
For the non-safety significant SSCs that were on the original Q-list (i.e., safety related SSCs), the regulatory commitments to regulatory guides and specific quality assurance practices referenced, or described in the FSAR, or current QA Topical Report for the facility no longer apply. A company corrective action program (Criterion XVI of 10 CFR 50 Appendix B) should be applied commensurcte with its safety significance. In
~
addition, plant level, and in specific instances, system level performance criteria would be established by the panel of experienced facility personnel based on past performance and PSA insighs. The degree of documentation should be sufficient to provide input into the performance criteria evaluations should a deviation occur. Section 4.4 and 4.5 provide additional guidance on the performance criteria and corrective action program.
If the safety related classification of these SSCs has been changed, the basis of the change should be documented. If the SSC is still subject to regulatory oversight, i.e.
subject of a regulation, such as within the scope of the Security or Fire Protection rules etc., it would remain part of the non-safety significant group of SSCs. If the SSC is not subject to other regulatory requirements, it would become part of the SSCs that are outside of the regulatory scope, and not part of the scope of this document.
4.4 Performance Criteria 4.4.1 Safety Significant SSCs For the pilot project, the assessment of quality program effectiveness for the safety significant group would be that defined by current Appendix B implementation practices.
22 4
DRAFT (4/8/94) 4.4.2. Non-safety Significant SSCs The benchmark for determining the effectiveness of the quality programs in the non-safety significant group is meeting a predetermined set of performance criteria.
These performance criteria would be derived in the same manner as that described in NUMARC 93-01, Section 9, Establishing Risk andPerformance Criteria /Goa! Setting andMonitoring. It should be noted that in the case ofperformance-based quality, the performance criteria and evaluations would take into account all failures, not just those associated with maintenance preventable failures. A panel of experienced facility personnel would review the performance criteria and the process to be used in evaluating the performance criteria. Additional information is also provided in Section 3 of this document.
In general, for a graded, performance-based approach to quality, the performance criteria for the non-safety significant SSCs will be plant level. The performance criteria should be similar, and in many instances identical, to the performance criteria developed during the implementation of the Maintenance Rule, e.g. availability, reliability, or condition. The performance criteria could be quantified to a single value or range of values, such as the industrywide plant performance indicators.
For non-safety significant systems, classified as safety related, and considered standby systems, the effectiveness of the applicable quality programs would be based on meeting system level performance criteria.
Ifperfonnance criteria cannot be practically monitored by plant level criteria, other performance criteria should be established, as appropriate (e.g., repetitions of safety function failures).
As stated in NUMARC 93-01, performance criteria should consider specific equipment performance histories, whether at the plant level or, as for the standby non-safety significant systems, at the system level. The establishment of performance criteria for the standby systems should include a review of surveillance tests and actual demands.
Consideration should be given to using industrywide operating experience, if applicable and appropriate.
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DRAFT (4/8/94)
For inherently reliable SSCs, such as raceways, pressure vessels, jet shields, etc.,
that are associated with non-safety significant standby systems, specific component reliability may not be a practical measure of performance. In these instances, performance criteria would be associated with the ability of the pertinent system to perform its safety function i.e., system level performance criteria. For inherently reliable SSCs that are associated with other non-safety significant systems, the plant level performance criteria would not be the appropriate measure of the applicable quality program effectiveness.
Guidance on the action to be taken in the event of failing to meet one or more of the performance criteria is given in Section 4.5, Corrective Action Program, and in NUMARC 93-01, Sections 9.3 and 9.4.
4.4.3 Evaluation of Performance Criteria Each facility should develop a process for assessing plant data and for determining the specific plant level performance criteria associated with this program. In many cases the process could be the same as 'for the implementation of the Maintenance Rule.
However, the implementation of a graded, performance-based quality regime is broader than the implementation of the Maintenance Rule. It involves assessments and evaluations of deviations in all applicable areas including those associated with maintenance activities. These assessments should also assist facility management in determining whether additional managerial assessments or program improvements should be implemented.
The frequency of these performance criteria evaluations should be consistent with the frequency of the evaluations established for implementing the Maintenance Rule. In nearly every case the process will be the same and involve the same data inputs. In addition, facility management may determine, at its discretion, to undertake additional evaluations into whether the performance criteria are being sustained based on specific events, recommendations from oversight reports or general trending reports.
4.4.4 Changing Performance Criteria Facility management may make changes to the performance criteria based on new information oeviations defects or as a result of quality assessments. The basis for 1
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DRAFT (4/8/94) changing the plant level, or in specific instances system level or component level performance criteria, should be documented.
4.5 Corrective Action Program A corrective action program is an essential element of any quality program, nuclear or non-nuclear. It is through this process that improvements are initiated and deficiencies are evaluated and resolved.
s Measures should be established to assure that deviations from the performam:e criteria are identified and communicated to the appropriate levels ofmanagement in a timely manner regardless of the cause of the deviation. Controls and processes should be available to stop work while the appropriate level of management resolves the deviation or concern. Satisfactory accomplishment of corrective actions must be confirmed.
Corrective action programs take many forms, from informal and rough defect logs and front line technician / supervisor / foreman interactions, to formal divisional and departmental interactions, with d'etailed engineering evaluations and formal data bases.
Each method has its benefits and disadvantages. The important factors are that the programs are structured in a manner that can be readily understood, implemented by the work force in the most effective way, and provide reasonable assurance that deviations are resolved. These informal or formal corrective action determinations should take into consideration the experience, training and qualification ofpersonnel involved in the corrective action activities. In addition, the past personnel performance involved in the corrective action activities should also be taken into account when determining the level of detail and specificity of the corrective action plan's procedures, instructions and directions.
Management would determine the extent and degree ofimplementing correction action and base its action on the safety significance of the SSC. The objective is to take the necessary action to provide adequate confidence that the performance criteria would be met. Ifit is determined that the performance criteria are not practical or valid, management should change the criteria as described in Section 4.4.3.
Where there is disagreement on the corrective action plan's resolution, a process should be established for raising the issue to the appropriate level of management for 25
DRAFT 4
(4/8/94) resolution. If necessary, the ultimate decision resides with the senior company executive that is responsible for the operation of the facility.
Section 4.4.3 of this document, Changing Performance Criteria and Sections 9.3 and 9.4 ofNUMARC 93-01 provide additional guidance on changing performance criteria.
4.5.1 Resolution of Deviations Documented deviations shall be resolved by the responsible organizations to an extent, and in a manner, that is consistent with the safety significance of the structure, system, component or activity. Activities associated with correcting deviations should continue until the performance criteria have been satisfied, or until appropriate levels of managementjustify and authorize changes to the original performance criteria.
Satisfactory accomplishment of corrective actions should be confirmed and, for significant deviations, documented.
4.5.1.1 Safety Significant SSCs The method and subsequent corrective actions for deviations would be the same as for current 10 CFR 50, Appendix B practices.
Management would confirm the satisfactory resolution ofsignificant deviations in the safety significant group in the same manner as the resolution of deviations are confirmed for current safety related components.
4.5.1.2 Non-safety Significant SSCs The same type ofpractices for resolving deviations in this group would apply, as for the safety significant group, but the deviations would not necessarily have to be formally documented, or reviewed in the same manner, or necessarily involve the same level of management involvement as they are for the current safety related SSCs. The corrective action process should raise more significant issues to higher managerial levels for resolution and for providing input into the performance criteria evaluations.
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DRAFT (4/8/94)
There may be instances where the predetermined perfomiance criteria may have to be amended as a result ofidentified deviations. Management would make the determination on the degree ofincreased monitoring and assessment that is necessary to confirm that the deviation has been satisfactorily resolved. Additional information on changing performance criteria is given in Section 4.4.3.
4.5.2 Failure to meet Performance Criteria Documented deviations from the performance criteria should be evaluated commensurate with the safety significance of the deviation. This evaluation should consider the cause of the deviation, the significance, extent, and identified deficiencies in the work activity, with input from the appropriate personnel associated with the activity in which the deviation was identified. For deviations with safety implications, management should review the results of the evaluations. Actions should be taken and documented to minimize the potential of recurrence.
If necessary, facility management would review the evaluation of the cause of the deviation and the recommended disposition. In addition, if applicable and appropriate, facility management would determine whether more stringent performance criteria should be set, or whether changes to specific quality programs need to be implemented, or whether the engineering, design, and procurement specifications need to be amended.
The facility would amend programs, as necessary, to provide adequate assurance that the performance criteria will be met.
In view of the importance and implications associated with a failure to meet the performance criteria, it is important to document the corrective action activities, changes to any quality elements, including the assessment of the cause of the deviation, and pertinent technical evaluations and recommendations.
Repetitive failures should be identified and result in additional management involvement. The degree and level of managerial involvement would be commensurate with the safety significance of the failure or deviation. NUMARC 93-01, Sections 9.3.4 and 9.4 provides additional guidance.
27
'g l
DRAFT l
. (4/8/94).
n APPENDIX A I
=1 DEFINITIONS. TERMS AND ACRONYMS The following definitions and terms are provided to assist in understanding the terms used in the document.
Assessments:- A collective term covering reviews, monitoring, tests, surveillances, inspections, audits or examinations.
Deviation:- A departure from a specified requirement or performance criteria.
Industrywide operating experience:- Information included in NRC, industry, and vendor equipment information that are applicable and available to the nuclear industry with the intent of minimizing adverse plant conditions or situations through shared experiences.
Y Expert panel:- A group of expeiienced facility personnel. Facility management would determine the experience requirements' for each of the positions.
As appropriate, the expert panels should include personnel with experience in the following areas: functional work areas, the pedinent design disciplines, the pertinent SSCs or activity under consideration, quality assurance and, if applicable, PSA. The panel for categorizing the SSCs and the performance criteria should also include a 1
member experienced in implementing the Maintenance Rule in the specific facility. It is -
possible that one person would be able to cover more than one of these categories.
Performance monitoring:- Continuous or periodic tests, inspections, measurement or trending of the performance or physical characteristics of a SSC to indicate current or future performance and potential failures.
Performance criteria:- In the context of this document, unless otherwise stated, the
. term performance criteria, or predetermined performance criteria relate to plant level, or in specific instances, system level performance criteria. The term is used in the same -
manner as used in NUMARC 93-01. The term does not relate to specific component, -
28
F DRAFT (4/8/94) quality criteria or manufacturing or activity process criteria as used in some other publications.
Performance-based approach:- An approach that focuses on the end results that directly contribute to safe and reliable plant operation. Meeting a predetermined set of goals, limits or perfonnance criteria based upon the operating history of equipment, components and organizations, allowing the licensee flexibility to determine how the results will be achieved and adjust quality practices, as necessary.
Q-List:- The list of SSCs required by Criterion II of 10 CFR 50, Appendix B.
Restructured Q-List:- List of SSCs that are part of the overall regulatory scope as defined by the scope of the Maintenance Rule and other NRC regulations.
QA Topical Report:- A general report and description of the facility's Appendix B quality program and the accompanying standards. It represents the quality assurance licensing commitments associated with implementing 10 CFR 50, Appendix B.
Safety significant SSCs:- This term equates to the term risk significant SSCs used in NUMARC 93-01. It relates to those SSCs that are significant contributors to safety and risk as determined through a blend of PSA and deterministic assessments and insights.
Non-safety significant SSCs:- This term equates to the term non-risk significant SSCs used in NUMARC 93-01. It relates to those SSCs that have low safety significance as determined by probabilistic and deterministic assessments and insights.
I Standby system or train:- A system or train that is not normally operating and only performs its intended safety function when initiated by either an automatic or manual demand signal.
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DRAFT (4/8/94)
O List of Acronyms CFR Code ofFederal Regulations EOPs Emergency Operating Procedures FSAR Final Safety Analysis Report IPE Individual Plant Examination ISI Inservice Inspection IST Inservice Testing NRC Nuclear Regulatory Commisrian NEI Nuclear Energy Institutes NUMARC Nuclear Management and Resources Council (amalgamated into NEI)
PSA Probabilistic Safety Assessment I
i 30
.i j
Enclosure:
.2-GRADED. PERFORMANCE-BASED APPROACH TO IMPLEMENTING QUALITY t
n n
Assessment &
Safety significant implementation per (Safety related &
non-safety related).
Regulatory 1r Scope per
~
n Maint. Rule +
Performance-Non-safety significant based compliance (safety related &
(performance criteria non-safety related)
& corrective action program)
U
- y i
Other SSCs
+ Reg. Scope = Maint. Rule Scope + Other SSCs from Other Regulations & Licensing Commitments Fig 4 - 1
l o c s
Page 1 of I Meeting Attendance List NAME ORGANIZATION Richard Correia NRR/DRIL/RPEB Frank Jape NRR/DRS/RII Angel L. Coello Spanish Assignee - NRC NRR/DRIL/RPEB Bob Gramm NRR/DRIL Juan Peralta NRR/DRIL Gil Millman NRC/RES/DE James W. Johnson NRC/NRR/SPSB Gene Imbro NRR/DRIL Ernie Rossi NRR/DRIL Robert M. Latta NRR/DRIL/RPEB Gary G. Zech NRR/DRIL Alex Marion NEI Adrian Heymer NEI Tony Pietrangelo NEI Hans Renner.
NUS Corp.
Hector Barbeito Bechtel/SERCH Barry B. Scott Raytheon Engrs. & Cont., Inc.
Mark D. Lombard MDM Engineering Corp.
Roger Huston TVA James J. Raleigh STS Michael Knapik McGraw-Hill