ML20042E952
| ML20042E952 | |
| Person / Time | |
|---|---|
| Issue date: | 04/27/1990 |
| From: | Grimes B Office of Nuclear Reactor Regulation |
| To: | Rasin W NUCLEAR ENERGY INSTITUTE (FORMERLY NUCLEAR MGMT & |
| References | |
| NUDOCS 9005070013 | |
| Download: ML20042E952 (10) | |
Text
{{#Wiki_filter:- - April 27,1990 .Mr. William H. Rasin Director. Technical Division i Nuclear Managerent and Resources Council i 1776 Eye Street, NW Suite 300 Washington, DC 20006 2496
Dear Mr. Rasin:
1 A draft Generic Letter on procurement issues which announces a pause in programmatic procurement inspections and which gives our thinking on codication, critical characteristics, and corrective ection programs is enclosed. The draft Generic Letter is consistent with the staff actions 4 identified to the Comission in SECY-90-57 to better define NRC's positions in this program area. In addition, the draft Generic Letter is structured ind based on the assumption that the NUMARC Working Group initiatives will be approved and implemented by the industry. We would appreciate receiving any concents you may have on the draft Generic Letter by May 15, 1990. If you have any questions, please contact me or Bill Brach at 492 0961. Sincerely, I Brian K. Grimes Director Division of Reactor Inspection and Safeguards
Enclosure:
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b TO: ALL HOLDERS OF OPERATING LICENSES AND CONSTRUCTION i PERMITS TOR NUCLEAR POWER REACTORS
SUBJECT:
LICENSEE COMMERCIAL-GRADE PROCUREMENT AND DEDICATION PROGRAMS (GL 90-XX) During the past three years, the NRC has conducted inspections of licensees' procurement and commercial-grade dedication programs. These inspections have identified a common, programmatic deficiency in licensees' control of the procurement and dedication of commercial-grade items used in safety-related applications. In a number of cases, licensees have not maintained programs to L ensure the suitability of equiprent for use in safety-related applications as required by 10 CFR Part 50, Appendix B, Criterion Ill. In a number of instances, these inspections resulted in the identification of equipment of indeterminate quality installed in the licensee's facility. Based on past NRC inspections, it is likely that additional programmatic inspections in this area-will identify more and similar findings. The staff believes that these NRC inspection findings, in part, tre reflective of a change in industry procurenent practices and the decrease in qualified nuclear-grade vendors. Ten years ago, most licensee procurements were for major assemblies from approved vendors with Appendix B progrs:ns. Presently, licensees are increasingly procuring commercial-grade replacement parts for use in safety-related applications. This has resulted in a shift of responsibility for assuring the quality of the item purchased from the supplier to the licensee. Therefore, dedication processes for commercial-grade parts have increased in importance. l NRC inspections have determined that a number of licensees have not satis-factorily performed this dedication process, t The industry should be fully aware of the NRC's concerns in this program area. l .The past escalated enforcenent cases have provided to the affected licensee and l broadly to the industry notice of NRC's findings, concerns. and expectations in the implenientation of procurement and dedication programs. Further, NRC has participated and continues to participate in nunerous industry meetings and conferences to discuss NRC positions in this area. The indestry has a number of initiatives under development which if effectively implemented shculd markedly improve the assurance that quality components are l installed in nuclear power plants. While monitoring industry implenentation of these programs, the NRC staff is ceferring progrann,atic inspections of licensees' comercial-grade procurement and dedication programs until May of 1991 to allow utilities to have sufficient time to fully understand and implement guidance being developed by the industry which is intended to provide implementation guidance for meeting the existing quhlity requirenents of 10 CFR 50, Appendix B. However, selected inspections will be conducted to determine the progress of F9ff pul I m_.__
~ I ', "a } h.I, i UEU in'dustry implementation of current initiatives and to provide fcadback on the
- progress, inspections whi:h are of a reactive or operational nature (related to an event or to defective equipment) and resultant enforcenent actions will continue and will not be affected by the decision to cefer programatic actions in this program area. Af ter one year the NRC will resume programatic inspections.
It is anticipated that action will not be t6 ken on past pro-grammatic violations prior to May 1991 unless the licensee failed to take appropriate corrective actions as part of implementing industry guidance for its commercial-grade procerement and dedication program. NRC Generic Letter 89-02, " Actions To improve the Detection of Counterfeit and Fradulently Marketed Products," described NRC observations on good practices in procurement and provided conditional NRC endorsement of an industry standard (EPRI NP-5652) on methods of commercial-grade procurement and dedication. Further discussion of NRC staff views on licensees' implenentation and programs for cammercial-grade dedication processes, critical characteristics and corrective action programs with respect to 1C CFR Part 50, Appendix B is provided in Enclosure 1. The staff has discussed their views, as summarited in inclosure 1, with representatives of NUMARC and at meetings of industry representatives in relation to the NUMARC Working Group on nuclear plant equipnent procurement initiatives. Enclosure 2 lists a number of recent inspection findings which illustrate the need for substantial program improve-ments. We will continue to meet with the industry to assure a common under-standing of implementation issues in this area. Although no response to this letter is required, if you have any questions regarding this matter, please contact the persons listed below. Sincerely, James G. Partlow Associate Director for Projects Office of Nuclear Reactor Regulation
Enclosures:
1. Characteristics of Effective Commercial-Grade Procurement and Dedication Programs 2. Recent NRC Inspection Findings in Commercial-Grade Procurement and Dedication 3. List of Recently Issued Generic Letters Technical Contacts: E. William Brach, NRR (301)492-0961 Ulcis Pot
- s, NRR (301) 492 ~ o4 Richard McIntyre, NRR (301)492-3215 s
ENCLOSURE 1 J Characteristics of Effective Commercial-Grade Procurement and Dedication Procrams s
Background
1 NRC's regulations for procurement quality assurance (QA) and quality control (QC) for products to be used in safety-related applications are established in Appendix B to 10 CFR Part 50, and further guidance is provided in Regulatory Guides 1.28, 1.33, and 1.123. These requirements are structured to assure suitability of equipment, includino commercial-grade items for use in safety-related systems. CriterionIllofAppendixBrequireslicenseestoselectandreview for suitability of application materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components. Criterion IV requires that applicable requirements necessary to ensure functional performance are specified in procurement documerts. Criterion VII requires licensees to assure that source evaluation and selection, objective evidence of quality, inspection of the source, and examination of-products upon delivery are sufficient to identify whether specification require-ments for the purchased roterial and equipment have been met. The process used to satisfy these requiremerds when upgrading commercial-grade items for use in I safety-related applications is commonly called dedication. The process of ensuring compliance with 10 CFR Part 50, Appendix B must include all those activities necessary to establish and confirm the quality and suitability of those items to be installed in safety-related applications. Sone of the dedication activities may occur early(Note that 10 CFR Part 21 has a morein the procurem i is accepted from the manufacturer. i restricted definition of commercial-grade item dedication related to respon-sibility for evaluation and reporting of defects). GenericLetter(GL)89-02, " Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products," discussed commercial-grade dedication in terms of engineering involvemtent in the procurement process, product acceptance, and the dedication process as identified in the EPRI NP-5652 guidelines. This generic letter is intended to expand on GL 89-02 by defining the essential elements of an acceptable program for dedicating and ensuring suitability of commercial-grade products for safety-related applications. A. Commercial-Grade Dedication Process The staff believes that licensees who implement th dedication methods described in the EPRI-565? guidelines, as conditionally endorsed by NRC + in Generic Letter 89-02, can establish a basis for satisfying existing l requirements of Appendix B to 10 CFR Part 50 as they apply to the dedication process for commercial-grade items. Listed in the paragraph l below are salient points from the EPRI guidelines that the staff believes l are fundamental to an effective dedication program. i An effective commercial-grade dedication program should include provisions to demonstrate that a dedicated item is suitable for use in a safety-related l application. For a licensee to adequately demonstrate suitability, there are certain key activities that must be performed as part of the dedication i process. \\ 1 UIMII e m
DRAFT (1) Identify and document the safety function (s) the commercial-grade item must perform and the design requirements which must be met. (2) Identify and document those characteristics that are critical to the l performance of the safety functions identified in nanber 1 above, and establish acceptance criteria for those critical characteristics. (3) Determine the nethods to be used to verify the critical characteristics identified in nun.ber 2 above. These methods may include a combination of traceability, source audits, receipt inspection, receipt testing. and functional testing. 2 (4) Verify and document that the critical characteristics meet the acceptance criteria. (5) Perform and document the dedication process using applicable QA and QC requirements to verify the suitability of the item for its intended safety-related appliC6 tion. Engineering involvenent is essential in the above activities. The v. tent of this involvenent is dependent on the nature, complexity, and use of the items to be dedicated. Engineering should be part of the procurement process, as well as product acceptance, including developing purchase specifications, determination of specific testing requirements applicable to the products; and tvaluation of the test results. Reliance on part number verification snd certification documentation is insufficient to ensure the quality of counercially procured products. Effective product 4 acceptance programs include receipt / source inspection, appropriate testing criteria, effective vendor audits (including witness / hold points), special tests and inspections, and post-inst 611ation-tests in their programs. B. Critical Characteristics NRC staff has met on several occasions with NUMARC and licensee representatives to discuss " critical characteristics" as that term is used in the context of consercial-p'rade procurenant and dedicatico. The term " critical characteristics 1: not contained in Appendix 6 and has r.o special regulatory significance beyond its use and definition in various industry guides / standards. NRC has not taken the position that "all" important design requirements must be considered to be critical characteristics as that term is defined and used in EPRI NP-5652. Rather, NRC has always taken the pcMtion as stated in Appendix B, Criterion 111, that licensees must assure sne suitability of all parts, materials, and services for their intended safety-related application (i.e., there needs to be assurance that the item will carry out its intended safety function when called upon). The licensee is responsible for identifying the important design, material, and performance characteristics for each part, materini, and service intended for safety-related application, establishing 2
DRAFT acceptance criteria, and for assuring the conforniance of items to these criteria. There is no minimum or maximum number of critical characteristics which need to be verified. Further, the critical characteristics for en item may vary from application to application depending on the design and performance requirements unique to each application. A licensee may take different approaches for the verification of the critical characteristics, depending on the complexity of the item. For items which are relatively simple, with critical characteristics that can be vcrified for the most severe or limiting plant application, a broad dedication program approach might be the preferred method for the identification and verifica-tion of the items' critical characteristics to qualify that item for all potential plant applications. For complex items that would tend to be purchased for specific plant applications, identific3* ion of safety func-tions, critical characteristics, and acceptance crin:ria for these items generally need to be addressed on an individual basis. Engineering involve-ment is essential in either method used since the technical evaluation will identify the critical characteristics, acceptance criteria, and the methods to be used for verification. The definition of critical characteristics contained in the EPRI NP-5652 guidelines is adequate. This is based on NRC's understanding that the intent of the EPRI Guideline is not to permit the purchaser to order a commercial-grade part by the catalogue number, to verify acceptability by i comparing the item to the catalogue description and concluding that "the item received is the item specified" and, on that basis to consider that l part suitable for safety-related service. Thetechnicalspecificationfor an item as used in the above example should include those critical characteristics that the licensee has determined essential for assuring suitability of the item to perform its safety function._ This specifi-cation may or may not become a part of the purchase order, depending on how the licensee's dedication program provides for verification of the specification, but the critical characteristics need to be verified as netting the acceptance criteria as a part of the overall dedir.ation process. The verification of these critical characteristics may be accomplished using one, or a combinetion of the methods described in the EPRI NP-5652 pd delines, as conditionally endorsed by Generic Letter 89-02. This becorres increasingly irrportant when dedicating comercial-grade items in which all m critical characteristics cannot be easily verified. In such cases, tuo licensee l needs to consider alternatives such as procuring the item from a safety-related vendor with an Appendix B QA progr a. C. LicensteCorrectiveActio3 The commerical-grade dedication approaches discussed in Sections A and B do not constitute new NRC requirements or positions, but are intended to provide specific implementetion guidance to meet 10 CFR Part 50 Appendix B. NRC is not requiring licensees to review all past procurements. However, DRA?T 3 i __-....-,a.--.
~ DRAFT if a licensee identifies items installed in safety-related applications I without adequate dedication or, if a licenree determines that there are i significant programmatic weaknesses in its dedication program that causes a licensee to question the suitability of installed items, then appropriate corrective action is to be taken. These corrective actions should include a sampling program which is keyed to identified past programmatic i ceficiencies in connercial-grade dedication and a look back for specific con,ponents where identified shortcomings, f ailure experience or current information on supplier adequecy indicate that a component rey not be suitable for safety-related service. Licensee actions in this regarc should follow the existing requirements for correctivt action and followup contained in Criterion XVI of 10 CFR Part 50, Appendix B. P 1 l i DRAFT 4 l ' 4 ,,-.---w-w- y y
DRAFT l "=2 Recent H,RC. Inspection Findings in Connercial-Grade Procurement ar.d Dedication Recent NRC inspections have identified several examples of connon weaknesses in licensees' connercial-grade procurement and dedication programs. The 4.- following examples and discussion are illustrative of problems NRC and licensees 'have found in assuring the quality and suitability for use of dedicated items in safety-related applications. Failure to demonstrate that the dedicated commercial-grade item is equivalent to the same item procured under a 10 CFR Part 50, Appendix B, i QA program with respect to tie item performing its intended safety function. t Failure to demonstrate that a like-for-like item is identic_al in form, fit, and function to the item it is replacing. Part number verifi-cation is not sufficient because of the likelihood of undocumented design, material, or fabrication changes in connercial-grade items usirg the same part number. Failure to evaluate design, material, and/or manufacturing process changes for the impact on safety function performance (particularly under design basis event conditions) of replacement items that are similar as opposed to _ identical to the items being replaced. An unverified certificate of conTdrmance from a commercial-grade vendor is not sufficient. Failure to verify the validity of certificates of conformance iaceived l l-from vendors not on the licensee's approved vendors / suppliers list. Failure to identify the methcds and acceptance criteria for verifying the critical characteristics, such as during receipt insp ction 'ir post-installation testing. Failure to assure items will function under all design requirements; on some occations licensees only assured that the connercial-grade item would f unction under normal operation conditions. Failure to establish verifiable, documented traceability of complex commercial-grade items to their original equipment manufacturers in those cases where the dedication program cannot verify the critical character-istics. For example, meaningful destructive testing of product line samples cannot be performed by the licensee on connercial-grade components of unknown source and uniformity. Failure to recognize that some connerical-grade items cannot be fully. dedicated once received on site, items which are manufacturec Jsing special processet, such as welding and heat treatment, may require the licensee to conduct vendor surveillances or witness certain activities h ring the manufacturing process where finished product dedication l testi19 would result in destructior of the product. 5 L DRAFT
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