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{{#Wiki_filter:'OA a t(o0 UNITED STATESNUCLEAR REGULATORY COMMISSIONa WASHINGTON. D. C. 20555April 9, 1991TO: ALL HOLDERS OF OPERATING LICENSES AND CONSTRUCTION PERMITS FORNUCLEAR POWER REACTORSSUBJECT: LICENSEE COMMERCIAL-GRADE PROCUREMENT AND DEDICATION PROGRAMS(GENERIC LETTER 91-05)This generic letter notifies the industry of the staff's pause in conductingcertain procurement inspection and enforcement activities and identifies anumber of failures in licensees' coninercial-grade dedication programsidentified during recent team inspections performed by the U.S. NuclearRegulatory Commission (NRC). The pause, which began in March of 1990, willend in late summer of 1991. The purpose of the pause is to allow licenseessufficient time to fully understand and implement guidance developed byindustry to improve procurement and commercial-grade dedication programs.This generic letter expresses staff positions regarding certain aspects oflicensee commercial-grade procurement and dedication programs which wouldprovide acceptable methods to meet regulatory requirements.During the period from 1986 to 1989, the NRC conducted 13 team inspections ofthe licensees' procurement and coniTercial-grade dedication programs. Duringthese inspections, the NRC staff identified a common, programmatic deficiencyin the licensees' control of the procurement and dedication process ofcommercial-grade items for safety-related applications. In a number of cases,the staff found that licensees had failed to adequately maintain programs asrequired by 10 CFR Part 50, Appendix 8, to assure the suitability ofcommercially procured and dedicated equipment for its intended safety-relatedapplications. In addition, the staff identified equipment of indeterminatequality installed in the licensees' facilities.Because of a decrease in the number of qualified nuclear-grade vendors, theNRC staff is aware that there has been a change in the industry's procurementpractices. Ten years ago, licensees procured major assemblies from approvedvendors who maintained quality assurance programs pursuant to Appendix B ofPart 50 of Title 10 of the Code of Federal Regulations (10 CFR). Currently,due to the reduction in the number of qualified nuclear-grade vendors,licensees are increasing the numbers of commercial-grade replacement partsthat they procure and dedicate for use in safety-related applications. Thisis a substantial change from the environment in which 10 CFR Part 50,Appendix B was promulgated. This has necessitated an increased emphasis bylicensees and the NRC staff to maintain procurement and dedication programsthat adhere to the requirements of 10 CFR Part 50, Appendix B. and thus-assurethe quality of items purchased and installed in safety-related applications.Therefore, dedication processes for commercial-grade parts have increased inimportance and NRC inspections have determined that a number of licensees havenot satisfactorily performed this procurement and dedication process.9104030126 W~&cL~c 0503AOOC-K OSOcOOCX'3.-G CI~i GENERIC LETTER 91-05-2-The industry has been made fully aware of the NRC's concerns in this programarea. In the past, escalated enforcement cases have provided notice to theaffected licensees and to the industry of NRC'S findings, concerns, andexpectations in the implementation of procurement and dedication programs.Further, the NRC staff continues to participate in numerous industry meetingsand conferences at which the NRC's positions in this area have been presented.The Nuclear Utility Management and Resources Council (NUMARC) Board of Direc-tors recently approved a comprehensive procurement initiative as described inNUMARC 90-13, "Nuclear Procurement Program Improvements," which commitslicensees to assess their procurement programs and take specific action toenhance or upgrade the program if they are determined to be inadequate. Theinitiative on the dedication of commercial-grade items, which is part ofNIUMARC 90-13, was to be implemented by January 1, 1990. The staff is monitor-ing implementation of licensee program improvements by conducting assessmentsof their procurement and commercial-grade dedication programs and maintainingclose interaction with the nuclear industry through participation in confer-ences, panels, and meetings.The staff will continue to perform reactive inspections relating to plantspecific operational events or to defective equipment and, as required, willcontinue to initiate resultant enforcement actions. In addition, the staffwill continue to perform inspections of vendors. The staff expects to resumeprocurement and dedication inspection activities in the late summer of 1991.These resumed inspections will be conducted using 10 CFR Part 50, Appendix B(not the NUMARC initiatives) as the applicable regulatory requirement.Licensee programs must assure the suitability of commercially procured anddedicated equipment for its intended safety-related application.The staff position is that the staff will not initiate enforcement action incases of past programmatic violations that have been adequately corrected. Inaddition, the staff does not expect licensees to review all past procurements.However, if during current procurement activities, licensees identifyshortcomings in the form, fit, or function of specific vendor products, or iffailure experience or current information on supplier adequacy indicates that acomponent may not be suitable for service, corrective actions are required forall such installed and stored items in accordance with Criterion XVI of 10 CFRPart 50, Appendix B. Also in accordance with Criterion XVI, licensees mustdetermine programmatic causes when actual deficiencies in several products fromdifferent vendors are identified during current procurement activities andthese deficiencies lead to the replacement of installed items as Part of thecorrective action. In such cases, a further sampling of previously procuredcommercial-grade items may be warranted.In NRC Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeitand Fraudulently Marketed Products," the staff described its perspective ongood practices in procurement and dedication and provided the NRC's conditional GENERIC LETTER 91- 05-3-endorsement of an industry standard (EPRI NP-5652) on methods of comneercia1-grade procurement and dedication. A number of recent inspection finid'n2s, asdiscussed in Enclosure 1, indicate that licensees have failed to includecertain key activities, as appropriate, in the lmplenieretatioi of the dedicationprocess. The NRC staff's positions on the successful implementation oflicensces programs for contrercial-grade dedication with respect to criticalcharacteristics and like-for-like replacements are as follows. (These are alsoincluded in Enclosure 1.)The term "critical characteristics" is not contained in Appendix B and has nospecial regulatory significance beyond its use and definition in variousindustry guides and standards. The KRC first used the term criticalcharacteristics in GL 89-02 as constituting those characteristics which need tobe identified and verified during product acceptance as part of the procurementprocess. The 1NRC has not taken the position that all design requirements mustbe considered to be critical characteristics as defined and used inEPRI flP-5652. Rather, as stated in Appendix 8, Criterion III, licensees mustassure the suitability of all parts, materials, and services for their intendedsafety-related applications (i.e., there reeds to be assurance that the itemwill perform its intended safety functior, when required). The licensee isresponsible for identifying the important design, material, and performancecharacteristics for each part, material, and service intended for safety-rel.ted applications, establishing acceptance criteria, and providingreasonable assurance of the conformance of items to these criteria.A likt-for-like replacemenit is defined as the replacement of an item with anitem that is identical. For example, the replacement item would be identicalif it was purchased at the same time from the same vendor as the item it isreplacing, or if the user can verify that there have been no changes in thedesign, materials, or Manufacturing process since procurement of the item beingreplaced. If differences from the original item are identified in thereplacement item, then the item is not identical, but similar to the item beingrepiaced, and an evaluation is necessary to determine if any changes in design,material, or the manufacturing process-could impact the functionalcharacteristics and ultimately the ci.oniponent's ability to perform its requiredsafety function. If the licensee can demonstrate that the replacement item isidentical, then the licensee need not identity the safety function or reviewand verify the design requirements and critical characteristics. Engineeringinvolvement is necessary il the above activities. Reliance on part numberverification and certification documentation is insufficient to ensure thequality of comrercially procured produLts.The other matters discussed In Enclosure I do not cnr.stitute NRC staffpositions, but provide information on inspection findings .and clarify thecharacterization of effective procurement and dedication programs previouslydescribed in GL 89-02.
{{#Wiki_filter:'OA a t(o 0 UNITED STATES NUCLEAR REGULATORY  
COMMISSION
a WASHINGTON.
 
D. C. 20555 April 9, 1991 TO: ALL HOLDERS OF OPERATING  
LICENSES AND CONSTRUCTION  
PERMITS FOR NUCLEAR POWER REACTORS SUBJECT: LICENSEE COMMERCIAL-GRADE  
PROCUREMENT  
AND DEDICATION  
PROGRAMS (GENERIC LETTER 91-05)This generic letter notifies the industry of the staff's pause in conducting certain procurement inspection and enforcement activities and identifies a number of failures in licensees'  
coninercial-grade dedication programs identified during recent team inspections performed by the U.S. Nuclear Regulatory Commission (NRC). The pause, which began in March of 1990, will end in late summer of 1991. The purpose of the pause is to allow licensees sufficient time to fully understand and implement guidance developed by industry to improve procurement and commercial-grade dedication programs.This generic letter expresses staff positions regarding certain aspects of licensee commercial-grade procurement and dedication programs which would provide acceptable methods to meet regulatory requirements.
 
During the period from 1986 to 1989, the NRC conducted  
13 team inspections of the licensees'  
procurement and coniTercial-grade dedication programs.
 
During these inspections, the NRC staff identified a common, programmatic deficiency in the licensees'  
control of the procurement and dedication process of commercial-grade items for safety-related applications.
 
In a number of cases, the staff found that licensees had failed to adequately maintain programs as required by 10 CFR Part 50, Appendix 8, to assure the suitability of commercially procured and dedicated equipment for its intended safety-related applications.
 
In addition, the staff identified equipment of indeterminate quality installed in the licensees'  
facilities.
 
Because of a decrease in the number of qualified nuclear-grade vendors, the NRC staff is aware that there has been a change in the industry's procurement practices.
 
Ten years ago, licensees procured major assemblies from approved vendors who maintained quality assurance programs pursuant to Appendix B of Part 50 of Title 10 of the Code of Federal Regulations  
(10 CFR). Currently, due to the reduction in the number of qualified nuclear-grade vendors, licensees are increasing the numbers of commercial-grade replacement parts that they procure and dedicate for use in safety-related applications.
 
This is a substantial change from the environment in which 10 CFR Part 50, Appendix B was promulgated.
 
This has necessitated an increased emphasis by licensees and the NRC staff to maintain procurement and dedication programs that adhere to the requirements of 10 CFR Part 50, Appendix B. and thus-assure the quality of items purchased and installed in safety-related applications.
 
Therefore, dedication processes for commercial-grade parts have increased in importance and NRC inspections have determined that a number of licensees have not satisfactorily performed this procurement and dedication process.9104030126 W~&cL~c 0503 AOOC-K OSOcOOCX'3.-G  
CI~i GENERIC LETTER 91-05-2-The industry has been made fully aware of the NRC's concerns in this program area. In the past, escalated enforcement cases have provided notice to the affected licensees and to the industry of NRC'S findings, concerns, and expectations in the implementation of procurement and dedication programs.Further, the NRC staff continues to participate in numerous industry meetings and conferences at which the NRC's positions in this area have been presented.
 
The Nuclear Utility Management and Resources Council (NUMARC) Board of Direc-tors recently approved a comprehensive procurement initiative as described in NUMARC 90-13, "Nuclear Procurement Program Improvements," which commits licensees to assess their procurement programs and take specific action to enhance or upgrade the program if they are determined to be inadequate.
 
The initiative on the dedication of commercial-grade items, which is part of NIUMARC 90-13, was to be implemented by January 1, 1990. The staff is monitor-ing implementation of licensee program improvements by conducting assessments of their procurement and commercial-grade dedication programs and maintaining close interaction with the nuclear industry through participation in confer-ences, panels, and meetings.The staff will continue to perform reactive inspections relating to plant specific operational events or to defective equipment and, as required, will continue to initiate resultant enforcement actions. In addition, the staff will continue to perform inspections of vendors. The staff expects to resume procurement and dedication inspection activities in the late summer of 1991.These resumed inspections will be conducted using 10 CFR Part 50, Appendix B (not the NUMARC initiatives)  
as the applicable regulatory requirement.
 
Licensee programs must assure the suitability of commercially procured and dedicated equipment for its intended safety-related application.
 
The staff position is that the staff will not initiate enforcement action in cases of past programmatic violations that have been adequately corrected.
 
In addition, the staff does not expect licensees to review all past procurements.
 
However, if during current procurement activities, licensees identify shortcomings in the form, fit, or function of specific vendor products, or if failure experience or current information on supplier adequacy indicates that a component may not be suitable for service, corrective actions are required for all such installed and stored items in accordance with Criterion XVI of 10 CFR Part 50, Appendix B. Also in accordance with Criterion XVI, licensees must determine programmatic causes when actual deficiencies in several products from different vendors are identified during current procurement activities and these deficiencies lead to the replacement of installed items as Part of the corrective action. In such cases, a further sampling of previously procured commercial-grade items may be warranted.
 
In NRC Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products," the staff described its perspective on good practices in procurement and dedication and provided the NRC's conditional GENERIC LETTER 91- 05-3-endorsement of an industry standard (EPRI NP-5652) on methods of comneercia1- grade procurement and dedication.
 
A number of recent inspection finid'n2s, as discussed in Enclosure  
1, indicate that licensees have failed to include certain key activities, as appropriate, in the lmplenieretatioi of the dedication process. The NRC staff's positions on the successful implementation of licensces programs for contrercial-grade dedication with respect to critical characteristics and like-for-like replacements are as follows. (These are also included in Enclosure  
1.)The term "critical characteristics" is not contained in Appendix B and has no special regulatory significance beyond its use and definition in various industry guides and standards.
 
The KRC first used the term critical characteristics in GL 89-02 as constituting those characteristics which need to be identified and verified during product acceptance as part of the procurement process. The 1NRC has not taken the position that all design requirements must be considered to be critical characteristics as defined and used in EPRI flP-5652.
 
Rather, as stated in Appendix 8, Criterion III, licensees must assure the suitability of all parts, materials, and services for their intended safety-related applications (i.e., there reeds to be assurance that the item will perform its intended safety functior, when required).  
The licensee is responsible for identifying the important design, material, and performance characteristics for each part, material, and service intended for safety-rel.ted applications, establishing acceptance criteria, and providing reasonable assurance of the conformance of items to these criteria.A likt-for-like replacemenit is defined as the replacement of an item with an item that is identical.
 
For example, the replacement item would be identical if it was purchased at the same time from the same vendor as the item it is replacing, or if the user can verify that there have been no changes in the design, materials, or Manufacturing process since procurement of the item being replaced.
 
If differences from the original item are identified in the replacement item, then the item is not identical, but similar to the item being repiaced, and an evaluation is necessary to determine if any changes in design, material, or the manufacturing process-could impact the functional characteristics and ultimately the ci.oniponent's ability to perform its required safety function.
 
If the licensee can demonstrate that the replacement item is identical, then the licensee need not identity the safety function or review and verify the design requirements and critical characteristics.
 
Engineering involvement is necessary il the above activities.
 
Reliance on part number verification and certification documentation is insufficient to ensure the quality of comrercially procured produLts.The other matters discussed In Enclosure I do not cnr.stitute NRC staff positions, but provide information on inspection findings .and clarify the characterization of effective procurement and dedication programs previously described in GL 89-02.


==BACKFIT DISCUSSION==
==BACKFIT DISCUSSION==
:Based or. past inspection findings and the resulting enforcement actions, the11RC staff has determined that licensee coirnercial-grade procurement and GENERIC LETTER 91-05-4-Iedication prograr's needed to be improved to comply with the existing NRCrequirements as described in 10 CFR Part 50, Appendix B, Criterion III (DesignControl), IV (Procurement Document Control), VII (Control of PurchasedMaterial, Equipment and Services), and XVIIH (Audits). Specifically, licenseeshave failed to adequately niaintain programs to assure the suitability ofcommiercially procured and dedicated equipment fur its intended safety-relatedapplication. Since the generic letter presents staff positions regardingimplementation of existing regulatory requirements, as contained in Appendix Eto 10 CFR Part 50, the staff has coricluded, that this is a compliance backfitdrd has prepdred the generic letter in accordance with 10 CFR 50.109 (a)(4)(i).In light of the inadequacies identified in the procurement and dedicationprograms of a large number of licensees, the issuance of this generic letter isnecessary to express the staff's position on the key element that licenseesmust incluce as part of the dedication process, specifically that commercial-grade procurement and dedication programs mrust assure the suitability ofequipment for its intended safety-related application. This generic letter isalso intended to clarify the elements of effective procurement andconmmercial-grade dedication programs that were previously provided to licenseesin GL 69-02. Since licensees' procurement and dedication programs may containprogrammatic deficiencies, the staff has irncluded in the generic letter thenecessary licensee corrective action to address shortcomings identified inspecific vendor products or components that directly lead to the component notbeing suitable for safety-related service.Although no response to this letter is required, if you have any questionsregarding this matter, please contact the persons listed below.Sincerely,Jes G. PartlowA sociate Director for ProjectsOffice of Nuclear Reactor RegulationEnclosures:1. Characteristics of Effective Conviercial-GradeProcurement and Dedication Programs.List of Recently Issued Generic LettersTechnical Contacts: Richard P. McIntyre, NRR(301) 492-3215Uldis Potapovs, URR(301) 492-0959 Enclosure 1CHARACTERISTICS OF-EFFECTIVE COMMERCIAL-GRADEPROCUREMENT AND DEDiCATION PROGRAMSBackgroundAppendix B to 10 CFR Part 50 contains the NRC's regulations for procurementquality assurance (QA) and quality control (QC) for products to be used insafety-related applications. In addition, the NRC has provided further -guidance in Regulatory Guides 1.28, 1.33, and 1.123. These requirements andguides, if properly implemented, provide a measure of assurance for thesuitability of equipment, including commercial-grade 'ims for use insafety-related systems. Criterion III of Appendix B 1ires licensees toselect and review for suitability of application materials, parts, equipment,and processes that are essential to the safety-related functions ef thestructures, systems, and components. Criterion IV requires that procurementdocuments specify the applicable requirements necessary to ensure functionalperformance. Criterion VII requires licensees to assure that the following aresufficient to identify whether specification requirements for the purchasedma.terial and equipment have been met: source evaluation and selection,objective evidence of quality, inspection of the source, and examination ofproducts upon delivery. The process used to satisfy these requirements whenupgrading commercial-grade items for safety-related applications is commonlycalled "dedication.* The process of ensuring compliance with 10 CFR Part S0,Appendix B, must include all those activities necessary to establish andconfirm the quality and suitability of commercially procured and dedicatedequipment for its intended safety-related application. Some of the dedicationactivities may occur early in the procurement cycle before the item isaccepted from the manufacturer. Generic Letter (GLi 89-02, "Actions to Improvethe Detection of Counterfeit and Fraudulently Marketed Products, discussedcommercial-grade dedication in terms of engineering involvement in theprocurement process, product acceptance, and the dedication process asidentified in the EPRI NP-5652 guidelines. This enclosure further-discussesthe characteristics of effective procurement and dedication programs previouslydiscussed in GL 89-02 and provides examples of specific failures by licenseesto effectively implement these characteristics for dedicating and ensuring thesuitability of commercial-grade products for safety-related applications.Appropriate implementation of these characteristics would have avoided many ofthe failures to meet 10 CFR Part 50, Appendix B requirements in licenseeprocurement and commercial-grade dedication programs which were identifiedduring past NRC inspections.Inspection Observations and FindingsFrom 1986 to 1989, headquarters and regional personnel conducted 13 teaminspections of licensees' procurement and dedication programs. These inspec-tions have identified a common, broad programmatic deficiency in licensees'control over the process of procurement afld dedication of commercial-grade  
:
-2-items. In a number of cases, licensees have not Maintained programs to ensurethe suitability of equipment for use in safety-related applications asrequired by 10 CFR Part 50, Appendix B, Criterion III. These 13 ir.spectionsresulted in findings with significant safety implications. The staff identifiedeight findings that were considered to be Severity Level III violations andthree findings that were Severity Level IV violations. At one plant, the staffdid not assign a severity level to individual violations. Instead, the staffconsidered the entire group to be a Severity Level III problem and used enforce-ment discretion, as provided under the enforcement pclicy, based on thelicensee's corrective actions (see 10 CFR Part 2, Appendix C, Section V.G.2).Only one of the plants that were inspected did not receive violations in thisprogram area.In GL 89-02, the NRC has conditionally endorsed the dedication methodsdescribed in EPRI NP-5652 guidelines. The staff believes that licensees whoimplement these dedication methods, in accordance with the NRC's endorsement,can establish a basis for satisfying the existing requirements of Appendix Bto 10 CFR Part 50 as these requirements apply to the dedication process forcommercial-grade items. An effective conmiercial-grade dedication programmust include provisions to demonstrate that a dedicated item is suitable forsafety-related applications. For a licensee to adequately establish suitabil-ity, certain key activities must be performed, as appropriate, as part of thededication process. This generic letter is intended to clarify the dedicationapproaches described in GL 89-02.During each of the 13 inspections, the staff iderntified a couaimon element ineach of the inspection findings. This element was the failure of the licenseeto assure that a commercially procured and dedicated item was suitable for theintended safety-related application. A dedicated commercial-grade item mustbe equivalent in its ability to perform its intended safety function to thesame item procured under a 10 CFR Part 50, Appendix B QA program. The follow-ing is a list of the 13 licensees inspected and the inspection report numbers.A sunciary of the general inspection findings and NRC observations on thesefindings follows the list of licensee inspections.LICENSEE and PLANT INSPECTION REPORT NO.1. Tennessee Valley Authority (Sequoyah) 50-327/86-6150-328/86-612. Southern California Edison (San Onufre) 50-206/87-0250-361/87-0350-362/87-043. Alabama Power (Farley) 50-348/87-1150-364/87-114. Louisiana Power and Light (Waterford)50-382/87-19  
Based or. past inspection findings and the resulting enforcement actions, the 11RC staff has determined that licensee coirnercial-grade procurement and GENERIC LETTER 91-05-4-Iedication prograr's needed to be improved to comply with the existing NRC requirements as described in 10 CFR Part 50, Appendix B, Criterion III (Design Control), IV (Procurement Document Control), VII (Control of Purchased Material, Equipment and Services), and XVIIH (Audits).  
-3-INSPECTION REPORT NO.LICENSEE and PLANT5. Sacramento Municipal Utility District (Rancho Seco)6. Maine Yankee Atomic Power (Maine Yankee)7. Northern States Power (Prairie Island)8. Portland General Electric (Trojan)9. Connecticut Yankee Atomic Power (Haddam Neck)'O. washington Public Power Supply System (WHP-2)II. Florida Power (Crystal River)12. Gulf States Utilities (River Bend)13. Connonwealth Edison (Zion)50:312/88-02* 50-309/88-20050-282188-20150-306/88-20150-344188-3950-344/88-4650-213/89-20050-397/89-2150-397/89-2850-302/89-20050-458/89-20050-295/89-20050-304/89-2001. Inspection Findingsa. Failure to identify the methods and acceptance criteria for verify-ing the critical characteristics, such as during receipt inspection,dedication process, or post-installation testing.b. Failure to establish verifiable, documented traceability of complexcommercial-grade items to their original equipment manufacturers inthose cases where the dedication program cannot verify the criticalcharacteristics.c. Failure to recognize that some commercial-grade items cannot befully dedicated once received on site. Certain items are manufac-tured using special processes, such as welding and heat treating.Dedication testing of these items as finished products would destroythem. For these items, licensees may need to conduct vendor sur-veillances or to witness certain activities during the manufacturingprocess.DiscussionThe NRC staff has met on several occasions with NUMARC and licenseerepresentatives to discuss "critical characteristics' as used. in-thecontext of commercial-grade procurement and dedication. The term "criti-cal characteristics" is not contained in Appendix B and has no specialregulatory significance beyond its use and definition in various industry  
Specifically, licensees have failed to adequately niaintain programs to assure the suitability of commiercially procured and dedicated equipment fur its intended safety-related application.
-4-guides and standards. The NRC first used the term critical characterls-tics in GL 89-02 as constituting those characteristics which nbed to beidentified and verified during product acceptance as part of theprocurement process. The ARC has not taken the position that all-designrequirements must be considered to be critical characteristics as definedand used in EPRI NP-5652. Rather, as stated in Appetidix S, Criterion 11!,licensees must assure the suitability of all parts, Materials, andservices for their intended safety-related applications (i.e., there needsto be assurance that the item will perform its intended safety functionwhen required). The licensee is responsible for identifying the importantdesign, material, and performance characteristics for each part, material,and service intended for safety-related applirations, establishingacceptance criteria, and providing reasonable assurance of the conformanceof items to these criteria. There is no nilniun. or maximum number ofcritical characteristics that need to be verified. Further, the criticalcharacteristics for an item may vary from application to applicationdepending on the design and performance requirements unique to eachapplication.A licensee may take different approaches for the verification of thecritical characteristics, depending on the complexity of the item. Innmany cases, the licensee can verify the critical characteristics of eac'hitem during receipt inspection testing. However, for a complex itemwith internal parts which receive special processing during Manufacturing,the licensee may need to conduct a source verification of the manu-facturer during production to verify the critical characteristicsidentified as necessary for the item to perform its safety function. Whenthese methuds cannot verify the critical characteristics related tospecial processes and tests, certification by the original equipmentmanufacturer nay be an acceptable alternative provided documented,verified traceability to the original equipment manufacturer has beet.established and the purchaser has vecrified by audit or survey that theoriginal equipment manufacturer has itaiplemented adequate quality controlsfor the activity being certified.For items with critical characteristics that can be verified forthe most severe or limiting plant application, the licensee might preferto identify and verify the item's critical characteristics to qualify thatitem for all possible plant applications. For complex items that would bepurchased for specific plant applications it may be appropriate toaddress the acceptance criteria for each item individually. Engineeringinvolvement is important in either method because the technical evaluationwill identify the critical characteristics, acceptance criteria, and themiethods to be used for verification.Inspection Findingsa. Failure to demonstrate that a like-fur-like replacement iteml isidentical in form, fit, and function to the item it is replacing.Part number verification is not sufficient because of the probabilityof undocumented changes in the design, material, or fabricationof commercial-grade items using the same part number.
 
Since the generic letter presents staff positions regarding implementation of existing regulatory requirements, as contained in Appendix E to 10 CFR Part 50, the staff has coricluded, that this is a compliance backfit drd has prepdred the generic letter in accordance with 10 CFR 50.109 (a)(4)(i).
In light of the inadequacies identified in the procurement and dedication programs of a large number of licensees, the issuance of this generic letter is necessary to express the staff's position on the key element that licensees must incluce as part of the dedication process, specifically that commercial- grade procurement and dedication programs mrust assure the suitability of equipment for its intended safety-related application.
 
This generic letter is also intended to clarify the elements of effective procurement and conmmercial-grade dedication programs that were previously provided to licensees in GL 69-02. Since licensees'  
procurement and dedication programs may contain programmatic deficiencies, the staff has irncluded in the generic letter the necessary licensee corrective action to address shortcomings identified in specific vendor products or components that directly lead to the component not being suitable for safety-related service.Although no response to this letter is required, if you have any questions regarding this matter, please contact the persons listed below.Sincerely, Jes G. Partlow A sociate Director for Projects Office of Nuclear Reactor Regulation Enclosures:
1. Characteristics of Effective Conviercial-Grade Procurement and Dedication Programs.List of Recently Issued Generic Letters Technical Contacts:  
Richard P. McIntyre, NRR (301) 492-3215 Uldis Potapovs, URR (301) 492-0959 Enclosure  
1 CHARACTERISTICS
OF-EFFECTIVE  
COMMERCIAL-GRADE
PROCUREMENT
AND DEDiCATION  
PROGRAMS Background Appendix B to 10 CFR Part 50 contains the NRC's regulations for procurement quality assurance (QA) and quality control (QC) for products to be used in safety-related applications.
 
In addition, the NRC has provided further -guidance in Regulatory Guides 1.28, 1.33, and 1.123. These requirements and guides, if properly implemented, provide a measure of assurance for the suitability of equipment, including commercial-grade  
'ims for use in safety-related systems. Criterion III of Appendix B 1 ires licensees to select and review for suitability of application materials, parts, equipment, and processes that are essential to the safety-related functions ef the structures, systems, and components.
 
Criterion IV requires that procurement documents specify the applicable requirements necessary to ensure functional performance.
 
Criterion VII requires licensees to assure that the following are sufficient to identify whether specification requirements for the purchased ma.terial and equipment have been met: source evaluation and selection, objective evidence of quality, inspection of the source, and examination of products upon delivery.
 
The process used to satisfy these requirements when upgrading commercial-grade items for safety-related applications is commonly called "dedication.*  
The process of ensuring compliance with 10 CFR Part S0, Appendix B, must include all those activities necessary to establish and confirm the quality and suitability of commercially procured and dedicated equipment for its intended safety-related application.
 
Some of the dedication activities may occur early in the procurement cycle before the item is accepted from the manufacturer.
 
Generic Letter (GLi 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products, discussed commercial-grade dedication in terms of engineering involvement in the procurement process, product acceptance, and the dedication process as identified in the EPRI NP-5652 guidelines.
 
This enclosure further-discusses the characteristics of effective procurement and dedication programs previously discussed in GL 89-02 and provides examples of specific failures by licensees to effectively implement these characteristics for dedicating and ensuring the suitability of commercial-grade products for safety-related applications.
 
Appropriate implementation of these characteristics would have avoided many of the failures to meet 10 CFR Part 50, Appendix B requirements in licensee procurement and commercial-grade dedication programs which were identified during past NRC inspections.
 
Inspection Observations and Findings From 1986 to 1989, headquarters and regional personnel conducted  
13 team inspections of licensees'  
procurement and dedication programs.
 
These inspec-tions have identified a common, broad programmatic deficiency in licensees'
control over the process of procurement afld dedication of commercial-grade  
-2-items. In a number of cases, licensees have not Maintained programs to ensure the suitability of equipment for use in safety-related applications as required by 10 CFR Part 50, Appendix B, Criterion III. These 13 ir.spections resulted in findings with significant safety implications.
 
The staff identified eight findings that were considered to be Severity Level III violations and three findings that were Severity Level IV violations.
 
At one plant, the staff did not assign a severity level to individual violations.
 
Instead, the staff considered the entire group to be a Severity Level III problem and used enforce-ment discretion, as provided under the enforcement pclicy, based on the licensee's corrective actions (see 10 CFR Part 2, Appendix C, Section V.G.2).Only one of the plants that were inspected did not receive violations in this program area.In GL 89-02, the NRC has conditionally endorsed the dedication methods described in EPRI NP-5652 guidelines.
 
The staff believes that licensees who implement these dedication methods, in accordance with the NRC's endorsement, can establish a basis for satisfying the existing requirements of Appendix B to 10 CFR Part 50 as these requirements apply to the dedication process for commercial-grade items. An effective conmiercial-grade dedication program must include provisions to demonstrate that a dedicated item is suitable for safety-related applications.
 
For a licensee to adequately establish suitabil-ity, certain key activities must be performed, as appropriate, as part of the dedication process. This generic letter is intended to clarify the dedication approaches described in GL 89-02.During each of the 13 inspections, the staff iderntified a couaimon element in each of the inspection findings.
 
This element was the failure of the licensee to assure that a commercially procured and dedicated item was suitable for the intended safety-related application.
 
A dedicated commercial-grade item must be equivalent in its ability to perform its intended safety function to the same item procured under a 10 CFR Part 50, Appendix B QA program. The follow-ing is a list of the 13 licensees inspected and the inspection report numbers.A sunciary of the general inspection findings and NRC observations on these findings follows the list of licensee inspections.
 
LICENSEE and PLANT INSPECTION  
REPORT NO.1. Tennessee Valley Authority (Sequoyah)  
50-327/86-61
50-328/86-61
2. Southern California Edison (San Onufre) 50-206/87-02
50-361/87-03
50-362/87-04
3. Alabama Power (Farley) 50-348/87-11
50-364/87-11
4. Louisiana Power and Light (Waterford)
50-382/87-19  
-3-INSPECTION  
REPORT NO.LICENSEE and PLANT 5. Sacramento Municipal Utility District (Rancho Seco)6. Maine Yankee Atomic Power (Maine Yankee)7. Northern States Power (Prairie Island)8. Portland General Electric (Trojan)9. Connecticut Yankee Atomic Power (Haddam Neck)'O. washington Public Power Supply System (WHP-2)II. Florida Power (Crystal River)12. Gulf States Utilities (River Bend)13. Connonwealth Edison (Zion)50:312/88-02
* 50-309/88-200
50-282188-201
50-306/88-201
50-344188-39
50-344/88-46
50-213/89-200
50-397/89-21
50-397/89-28
50-302/89-200
50-458/89-200
50-295/89-200
50-304/89-200
1. Inspection Findings a. Failure to identify the methods and acceptance criteria for verify-ing the critical characteristics, such as during receipt inspection, dedication process, or post-installation testing.b. 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 characteristics.
 
c. Failure to recognize that some commercial-grade items cannot be fully dedicated once received on site. Certain items are manufac-tured using special processes, such as welding and heat treating.Dedication testing of these items as finished products would destroy them. For these items, licensees may need to conduct vendor sur-veillances or to witness certain activities during the manufacturing process.Discussion The NRC staff has met on several occasions with NUMARC and licensee representatives to discuss "critical characteristics'  
as used. in-the context of commercial-grade procurement and dedication.
 
The term "criti-cal characteristics" is not contained in Appendix B and has no special regulatory significance beyond its use and definition in various industry  
-4-guides and standards.
 
The NRC first used the term critical characterls- tics in GL 89-02 as constituting those characteristics which nbed to be identified and verified during product acceptance as part of the procurement process. The ARC has not taken the position that all-design requirements must be considered to be critical characteristics as defined and used in EPRI NP-5652. Rather, as stated in Appetidix S, Criterion  
11!, licensees must assure the suitability of all parts, Materials, and services for their intended safety-related applications (i.e., there needs to be assurance that the item will perform its intended safety function when required).  
The licensee is responsible for identifying the important design, material, and performance characteristics for each part, material, and service intended for safety-related applirations, establishing acceptance criteria, and providing reasonable assurance of the conformance of items to these criteria.
 
There is no nilniun. or maximum number of critical characteristics that need to be verified.
 
Further, the critical characteristics for an 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. In nmany cases, the licensee can verify the critical characteristics of eac'h item during receipt inspection testing. However, for a complex item with internal parts which receive special processing during Manufacturing, the licensee may need to conduct a source verification of the manu-facturer during production to verify the critical characteristics identified as necessary for the item to perform its safety function.
 
When these methuds cannot verify the critical characteristics related to special processes and tests, certification by the original equipment manufacturer nay be an acceptable alternative provided documented, verified traceability to the original equipment manufacturer has beet.established and the purchaser has vecrified by audit or survey that the original equipment manufacturer has itaiplemented adequate quality controls for the activity being certified.
 
For items with critical characteristics that can be verified for the most severe or limiting plant application, the licensee might prefer to identify and verify the item's critical characteristics to qualify that item for all possible plant applications.
 
For complex items that would be purchased for specific plant applications it may be appropriate to address the acceptance criteria for each item individually.
 
Engineering involvement is important in either method because the technical evaluation will identify the critical characteristics, acceptance criteria, and the miethods to be used for verification.
 
Inspection Findings a. Failure to demonstrate that a like-fur-like replacement iteml is identical in form, fit, and function to the item it is replacing.
 
Part number verification is not sufficient because of the probability of undocumented changes in the design, material, or fabrication of commercial-grade items using the same part number.
 
-5-b. Failure to evaluatc changes in the design' on&terial, or manufactur- ing process fur the effect of these chances on safety function perforLMIce (particularly under design. basis event condltions)
of replacement items that are similar as opposed to identical to the items being replaced.c. Failure to ensure that itemrs will function under all design require-meents. On some occasions, licensees only ensured thbt the commercil-,grade item would function ui.der normal operation cor.ditions.
 
d. Failure to verify the validity of certificates of conformarnce received from vendors not on the licensee's list of approved vendors/suppliers.
 
An unverified certificate of conformance from a commercial- gradc vetdur is not sufficient.
 
Discussion A like-for-like replacement is defined as the replacement of an item with uri itein that is identical.
 
For example, the replacement item would be identical if it was purchased at the same time from. the same vendor as the item it is replacing, or if the user can verify that there have been no changes in the design, materials, or manufacturiqg process since procurement of the item being replaced.
 
If differences from the original ite.i iare identified in the replacement item, then the item is rot identical, but similar to the item being replaced, and evaluation is necessary to determine if any changes in design, material, or the n.anufacturing process could impact the functional characteristics and ultimately the com.ponent's ability to perform its required safety func-tion. If the licersee can demonstrate that the replacement item is identical, then the licensee need not identify the safety function or review and verify the design requirements and critical characteristics.
 
Engineering involvement is necessary ill the above activities.
 
The extent uf this Involvement.
 
is lependent on the nature, conmplexity, and use of the items to be dedicated.
 
Participation of engineering personnel is appropriate in the procurement process, and product acceptance, to develop purchase rpecificaticns, determine specific testing requirements applicable to the products, and evaluate the test results. When engi-reering personnel specify design requirements for inclusion on the purchase documents for replacement components, they need not reconstruct and reverify design adequacy for procurement purposes, but need only ensure that the existing design requirements (which may reference the original design basis) are properly translated into the purchase order.Reliance on part number verification and certification documentation is insufficient to ensure the quality of coniercially procured products.Effective product acceptance programs have as elements, receipt and source inspection, appropriate testinS criteria, effective vendor audits Ltd surveillances (including witness/hold points as appropriate), special tests and inspections, and post-installation tests. Procedures and adequ:te qualificatio!Is and training for implementing personnel are also r.ecessory factors in successful implenmentationr.
 
Enclosure
2 LIST OF RECENTLY ISSUED GENERIC LETTERS Generic Date of Letter No. Subject Issuance Issued To 91-04 CHARGES IN TECHNICAL
SPECI lCATM N SUR- ALL HOLDERS OF OL V VEILLANCE
INTERVALS
TO ACCOMMODATE
A 24- OR CONSTRUCTION
PER-I MONTH FUEL CYCLE (GENERIC LETTER 91-04) MITS FOR NUCLEAR POWER REACTORS 91-03 91-02 91-01 91-01 90-09 REPORTING
OF SAFEGUARDS
03/06/91 EVENTS REPORTING
MISHAPS INVOLVING
12/28/90 LLW FORMS PREPARED FOR DISPOSAL REMOVAL-OF
THE SCHEDULE FOR 01/04/91 THE WITHDRAWAL
OF REACTOR VESSEL MATERIAL SPECIMENS FROM TECHNICAL
SPECIFICATIONS
ALTERNATIVE
REQUIREMENTS
FOR 12/11/90 SNUBBER VISUAL INSPECTION
INTERVALS
AND CORRECTIVE
ACTIONS CONSIDERATION
OF THE RESULTS 10/25/90 OF NRC-SPONSORED
TESTS OF MOTOR-OPERATED
VALVES SIMULATION
FACILITY 08/10/90 EXEMPTIONS
OPERATOR LICENSING
NATIONAL 08/10/90 EXAMINATION
SCHEDULE AVAILABILITY
OF PROGRAM 08/03/90 DESCRIPTIONS
ALL HOLDERS OF OLs OR CPs FOR NUCLEAR POWER REACTORS AND ALL OTHER LICENSED -ACTIVITIES
INVOLVING A FORMULA QUANTITY OF SPECIAL NUCLEAR.MATERIAL (SNM)ALL OPERATORS
OF LOW-LEVEL
RADIO-ACTIVE WASTE (LLW)DISPOSAL SITES, WASTE PROCESSORS,& ALL HOLDERS OF LICENSES FOR NUCLEAR FUELS, NUCLEAR MATERIALS
& NUCLEAR POWER REACTORS ALL HOLDERS OF OLs OR CPs FOR NUCLEAR POWER PLANTS ALL LIGHT-WATER
REACTOR LICENSEES AND APPLICANTS
ALL LICENSEES
OF OPERATING
NUCLEAR POWER PLANTS AND HOLDERS OF CONSTRUC-TION PERMITS FOR NUCLEAR POWER PLANTS ALL HOLDERS OF OPERATING
LICENSES OR CONSTRUCTION
PERMITS FOR NUCLEAR POWER REACTORS ALL POWER REACTOR LICENSEES
AND APPLICANTS
FOR AN OPERATING
LICENSE ALL LICENSEES
OF OPERATING
NPPs AND HOLDERS OF CPs FOR NPIPs 89-10 SUPP. 3 90-08 90-07 89-10 SUPP. 2 GENLRIC LETTER 91- 05-4-dedication proranms needed to be improvetd to comppy with the existing DRC recuirements as described in 10 CFR Part 50, Appendix 6, Criterion I.I-(Design Control;-, IV (Procurement Docunient Control), VII (Control of Purchased Imattrii'l, Equipment anoa Services), and XVIII (Audits).
Specifically, licensees hac failed to adtquately maintain programsto assure the suitability of cornpercilily procured and dedicated equiprent for its intended safety-related
3".icatiofl.


-5-b. Failure to evaluatc changes in the design' on&terial, or manufactur-ing process fur the effect of these chances on safety functionperforLMIce (particularly under design. basis event condltions) ofreplacement items that are similar as opposed to identical to theitems being replaced.c. Failure to ensure that itemrs will function under all design require-meents. On some occasions, licensees only ensured thbt the commercil-,grade item would function ui.der normal operation cor.ditions.d. Failure to verify the validity of certificates of conformarncereceived from vendors not on the licensee's list of approved vendors/suppliers. An unverified certificate of conformance from a commercial-gradc vetdur is not sufficient.DiscussionA like-for-like replacement is defined as the replacement of an item withuri itein that is identical. For example, the replacement item would beidentical if it was purchased at the same time from. the same vendor as theitem it is replacing, or if the user can verify that there have been nochanges in the design, materials, or manufacturiqg process sinceprocurement of the item being replaced. If differences from the originalite.i iare identified in the replacement item, then the item is rotidentical, but similar to the item being replaced, and evaluation isnecessary to determine if any changes in design, material, or then.anufacturing process could impact the functional characteristics andultimately the com.ponent's ability to perform its required safety func-tion. If the licersee can demonstrate that the replacement item isidentical, then the licensee need not identify the safety function orreview and verify the design requirements and critical characteristics.Engineering involvement is necessary ill the above activities. The extentuf this Involvement. is lependent on the nature, conmplexity, and use ofthe items to be dedicated. Participation of engineering personnel isappropriate in the procurement process, and product acceptance, todevelop purchase rpecificaticns, determine specific testing requirementsapplicable to the products, and evaluate the test results. When engi-reering personnel specify design requirements for inclusion on thepurchase documents for replacement components, they need not reconstructand reverify design adequacy for procurement purposes, but need onlyensure that the existing design requirements (which may reference theoriginal design basis) are properly translated into the purchase order.Reliance on part number verification and certification documentation isinsufficient to ensure the quality of coniercially procured products.Effective product acceptance programs have as elements, receipt and sourceinspection, appropriate testinS criteria, effective vendor audits Ltdsurveillances (including witness/hold points as appropriate), specialtests and inspections, and post-installation tests. Procedures andadequ:te qualificatio!Is and training for implementing personnel are alsor.ecessory factors in successful implenmentationr.
Since the ierQeric letter presents staft positions regarding ir-tplenfleritction of existing regulaory requirements, as contained in Appexdix b to 10 CFR Pirt 5G, the '.taff has conckded, that this is a compliance backfit:.:d has prerared the gti.Lric letter in accordance with 10 CFR 50.109 (a)(4)(i).
ir. light of the inadequ'Lies identified in the procurement and dedication pruyrar.,.  
Lf a lar;e n1upter of licensees, the issuance of this generic letter is necessary Itl vxpress the staff's position on the key element that licensees ritL5 includc as part of the dedication process, specifically that cowtmercial- Srade pruLcureifent and &ctication prograns must assure the suitabilit)  
of cuipelnt f 'r its interded safety-rclated application.


Enclosure 2LIST OF RECENTLY ISSUED GENERIC LETTERSGeneric Date ofLetter No. Subject Issuance Issued To91-04 CHARGES IN TECHNICAL SPECI lCATM N SUR- ALL HOLDERS OF OLV VEILLANCE INTERVALS TO ACCOMMODATE A 24- OR CONSTRUCTION PER-I MONTH FUEL CYCLE (GENERIC LETTER 91-04) MITS FOR NUCLEARPOWER REACTORS91-0391-0291-0191-0190-09REPORTING OF SAFEGUARDS 03/06/91EVENTSREPORTING MISHAPS INVOLVING 12/28/90LLW FORMS PREPARED FORDISPOSALREMOVAL-OF THE SCHEDULE FOR 01/04/91THE WITHDRAWAL OF REACTORVESSEL MATERIAL SPECIMENSFROM TECHNICAL SPECIFICATIONSALTERNATIVE REQUIREMENTS FOR 12/11/90SNUBBER VISUAL INSPECTIONINTERVALS AND CORRECTIVEACTIONSCONSIDERATION OF THE RESULTS 10/25/90OF NRC-SPONSORED TESTS OFMOTOR-OPERATED VALVESSIMULATION FACILITY 08/10/90EXEMPTIONSOPERATOR LICENSING NATIONAL 08/10/90EXAMINATION SCHEDULEAVAILABILITY OF PROGRAM 08/03/90DESCRIPTIONSALL HOLDERS OF OLsOR CPs FOR NUCLEARPOWER REACTORS ANDALL OTHER LICENSED -ACTIVITIES INVOLVINGA FORMULA QUANTITYOF SPECIAL NUCLEAR.MATERIAL (SNM)ALL OPERATORS OFLOW-LEVEL RADIO-ACTIVE WASTE (LLW)DISPOSAL SITES,WASTE PROCESSORS,& ALL HOLDERS OFLICENSES FOR NUCLEARFUELS, NUCLEARMATERIALS & NUCLEARPOWER REACTORSALL HOLDERS OF OLsOR CPs FOR NUCLEARPOWER PLANTSALL LIGHT-WATERREACTOR LICENSEESAND APPLICANTSALL LICENSEES OFOPERATING NUCLEARPOWER PLANTS ANDHOLDERS OF CONSTRUC-TION PERMITS FORNUCLEAR POWER PLANTSALL HOLDERS OFOPERATING LICENSESOR CONSTRUCTIONPERMITS FOR NUCLEARPOWER REACTORSALL POWER REACTORLICENSEES ANDAPPLICANTS FOR ANOPERATING LICENSEALL LICENSEES OFOPERATING NPPs ANDHOLDERS OF CPs FORNPIPs89-10SUPP. 390-0890-0789-10SUPP. 2 GENLRIC LETTER 91- 05-4-dedication proranms needed to be improvetd to comppy with the existing DRCrecuirements as described in 10 CFR Part 50, Appendix 6, Criterion I.I-(DesignControl;-, IV (Procurement Docunient Control), VII (Control of PurchasedImattrii'l, Equipment anoa Services), and XVIII (Audits). Specifically, licenseeshac failed to adtquately maintain programsto assure the suitability ofcornpercilily procured and dedicated equiprent for its intended safety-related3".icatiofl. Since the ierQeric letter presents staft positions regardingir-tplenfleritction of existing regulaory requirements, as contained in Appexdix bto 10 CFR Pirt 5G, the '.taff has conckded, that this is a compliance backfit:.:d has prerared the gti.Lric letter in accordance with 10 CFR 50.109 (a)(4)(i).ir. light of the inadequ'Lies identified in the procurement and dedicationpruyrar.,. Lf a lar;e n1upter of licensees, the issuance of this generic letter isnecessary Itl vxpress the staff's position on the key element that licenseesritL5 includc as part of the dedication process, specifically that cowtmercial-Srade pruLcureifent and &ctication prograns must assure the suitabilit) ofcuipelnt f 'r its interded safety-rclated application. This generic letter isalso irt;e.LUd to clarify the elenents of effective procuremuent andcorr.erciel -jrade cedic~.ition proSrams that were previcusly provided to licensees.bL 8§-02. Since licersees' procurement and dedicatiot1 programs -ay containprr(drarnatc deficiencies, the staff has incluaed in the gereric letter thenecessary .icensee corrective action to address shortcot..ings identified inspjL'l''c vender products or components that directly lead to the component rLotbei-c suitable fc,r .Ltety-rclated service.rt,...;UCh no resr ctise tu this letter is required, if )uu have any questionsreourdinc this .c.;ttr, plebsE contact thb personIs listed below.Sincerel),ORIGINAL SIGNED BY:%lmes G. PartlobAssociate sirector for ProjectsOffice of Nuclear Reactor RegulatiiunF. rc cf Eftfe: .tC Coribercial-Gradteuit;.ren~ei.t and ~Jedicatiunl Progru~s7. List, of Fie..evty :edGeneric Litttrslectii,(Lal Ccortlact,.: Pichaire P. cIcntyre, NF~R11cL2l 492-3215DISTRIBUTION:enetriFr 0i esNRC PDRVIB ReadingRMcIntyre-" E L i r. LV ' L L '.I ICF -, I Q : '.' : L.Lk' # : U?,. ;y.' j: LA' I -2 / I 4 / 1 *?Pr~ta poy :7£ditvI V-C f?a1I001nA/UP,KU: C:Orr. :UI A C E C I i~t7Fkf' :1 /'7 /9-I /- IC ED E4(y..9104030126  
This generic letter is also irt;e.LUd to clarify the elenents of effective procuremuent and corr.erciel -jrade cedic~.ition proSrams that were previcusly provided to licensees.bL 8§-02. Since licersees'  
}}
procurement and dedicatiot1 programs -ay contain prr(drarnatc deficiencies, the staff has incluaed in the gereric letter the necessary .icensee corrective action to address shortcot..ings identified in spjL'l''c vender products or components that directly lead to the component rLot bei-c suitable fc,r .Ltety-rclated service.rt,...;UCh no resr ctise tu this letter is required, if )uu have any questions reourdinc this .c.;ttr, plebsE contact thb personIs listed below.Sincerel), ORIGINAL SIGNED BY:%lmes G. Partlob Associate sirector for Projects Office of Nuclear Reactor Regulatiiun F. rc cf Eftfe: .tC Coribercial-Gradte uit;.ren~ei.t and ~Jedicatiunl Progru~s 7. List, of Fie..evty  
:edGeneric Litttrs lectii,(Lal Ccortlact,.:  
Pichaire P. cIcntyre, NF~R 11cL2l 492-3215 DISTRIBUTION:
enetriFr 0i es NRC PDR VIB Reading RMcIntyre-" E L i r. LV ' L L '.I I CF -, I Q : '.' : L.Lk' # : U?,. ;y.' j:  
LA' I -2 / I 4 / 1 *?Pr~ta poy :7£ditv I V-C f?a1I 001nA/UP, KU: C:Orr. :UI A C E C I i~t 7 Fk f' :1 /'7 /9-I /- IC ED E 4 (y..9104030126}}


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Revision as of 12:40, 31 August 2018

NRC Generic Letter 1991-005: Licensee Commercial-Grade Procurement and Dedication Programs
ML031140508
Person / Time
Site: Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Washington Public Power Supply System, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant, Clinch River  Entergy icon.png
Issue date: 04/09/1991
From: Partlow J G
Office of Nuclear Reactor Regulation
To:
References
GL-91-005, NUDOCS 9104030126
Download: ML031140508 (11)


'OA a t(o 0 UNITED STATES NUCLEAR REGULATORY

COMMISSION

a WASHINGTON.

D. C. 20555 April 9, 1991 TO: ALL HOLDERS OF OPERATING

LICENSES AND CONSTRUCTION

PERMITS FOR NUCLEAR POWER REACTORS SUBJECT: LICENSEE COMMERCIAL-GRADE

PROCUREMENT

AND DEDICATION

PROGRAMS (GENERIC LETTER 91-05)This generic letter notifies the industry of the staff's pause in conducting certain procurement inspection and enforcement activities and identifies a number of failures in licensees'

coninercial-grade dedication programs identified during recent team inspections performed by the U.S. Nuclear Regulatory Commission (NRC). The pause, which began in March of 1990, will end in late summer of 1991. The purpose of the pause is to allow licensees sufficient time to fully understand and implement guidance developed by industry to improve procurement and commercial-grade dedication programs.This generic letter expresses staff positions regarding certain aspects of licensee commercial-grade procurement and dedication programs which would provide acceptable methods to meet regulatory requirements.

During the period from 1986 to 1989, the NRC conducted

13 team inspections of the licensees'

procurement and coniTercial-grade dedication programs.

During these inspections, the NRC staff identified a common, programmatic deficiency in the licensees'

control of the procurement and dedication process of commercial-grade items for safety-related applications.

In a number of cases, the staff found that licensees had failed to adequately maintain programs as required by 10 CFR Part 50, Appendix 8, to assure the suitability of commercially procured and dedicated equipment for its intended safety-related applications.

In addition, the staff identified equipment of indeterminate quality installed in the licensees'

facilities.

Because of a decrease in the number of qualified nuclear-grade vendors, the NRC staff is aware that there has been a change in the industry's procurement practices.

Ten years ago, licensees procured major assemblies from approved vendors who maintained quality assurance programs pursuant to Appendix B of Part 50 of Title 10 of the Code of Federal Regulations

(10 CFR). Currently, due to the reduction in the number of qualified nuclear-grade vendors, licensees are increasing the numbers of commercial-grade replacement parts that they procure and dedicate for use in safety-related applications.

This is a substantial change from the environment in which 10 CFR Part 50, Appendix B was promulgated.

This has necessitated an increased emphasis by licensees and the NRC staff to maintain procurement and dedication programs that adhere to the requirements of 10 CFR Part 50, Appendix B. and thus-assure the quality of items purchased and installed in safety-related applications.

Therefore, dedication processes for commercial-grade parts have increased in importance and NRC inspections have determined that a number of licensees have not satisfactorily performed this procurement and dedication process.9104030126 W~&cL~c 0503 AOOC-K OSOcOOCX'3.-G

CI~i GENERIC LETTER 91-05-2-The industry has been made fully aware of the NRC's concerns in this program area. In the past, escalated enforcement cases have provided notice to the affected licensees and to the industry of NRC'S findings, concerns, and expectations in the implementation of procurement and dedication programs.Further, the NRC staff continues to participate in numerous industry meetings and conferences at which the NRC's positions in this area have been presented.

The Nuclear Utility Management and Resources Council (NUMARC) Board of Direc-tors recently approved a comprehensive procurement initiative as described in NUMARC 90-13, "Nuclear Procurement Program Improvements," which commits licensees to assess their procurement programs and take specific action to enhance or upgrade the program if they are determined to be inadequate.

The initiative on the dedication of commercial-grade items, which is part of NIUMARC 90-13, was to be implemented by January 1, 1990. The staff is monitor-ing implementation of licensee program improvements by conducting assessments of their procurement and commercial-grade dedication programs and maintaining close interaction with the nuclear industry through participation in confer-ences, panels, and meetings.The staff will continue to perform reactive inspections relating to plant specific operational events or to defective equipment and, as required, will continue to initiate resultant enforcement actions. In addition, the staff will continue to perform inspections of vendors. The staff expects to resume procurement and dedication inspection activities in the late summer of 1991.These resumed inspections will be conducted using 10 CFR Part 50, Appendix B (not the NUMARC initiatives)

as the applicable regulatory requirement.

Licensee programs must assure the suitability of commercially procured and dedicated equipment for its intended safety-related application.

The staff position is that the staff will not initiate enforcement action in cases of past programmatic violations that have been adequately corrected.

In addition, the staff does not expect licensees to review all past procurements.

However, if during current procurement activities, licensees identify shortcomings in the form, fit, or function of specific vendor products, or if failure experience or current information on supplier adequacy indicates that a component may not be suitable for service, corrective actions are required for all such installed and stored items in accordance with Criterion XVI of 10 CFR Part 50, Appendix B. Also in accordance with Criterion XVI, licensees must determine programmatic causes when actual deficiencies in several products from different vendors are identified during current procurement activities and these deficiencies lead to the replacement of installed items as Part of the corrective action. In such cases, a further sampling of previously procured commercial-grade items may be warranted.

In NRC Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products," the staff described its perspective on good practices in procurement and dedication and provided the NRC's conditional GENERIC LETTER 91- 05-3-endorsement of an industry standard (EPRI NP-5652) on methods of comneercia1- grade procurement and dedication.

A number of recent inspection finid'n2s, as discussed in Enclosure

1, indicate that licensees have failed to include certain key activities, as appropriate, in the lmplenieretatioi of the dedication process. The NRC staff's positions on the successful implementation of licensces programs for contrercial-grade dedication with respect to critical characteristics and like-for-like replacements are as follows. (These are also included in Enclosure

1.)The term "critical characteristics" is not contained in Appendix B and has no special regulatory significance beyond its use and definition in various industry guides and standards.

The KRC first used the term critical characteristics in GL 89-02 as constituting those characteristics which need to be identified and verified during product acceptance as part of the procurement process. The 1NRC has not taken the position that all design requirements must be considered to be critical characteristics as defined and used in EPRI flP-5652.

Rather, as stated in Appendix 8, Criterion III, licensees must assure the suitability of all parts, materials, and services for their intended safety-related applications (i.e., there reeds to be assurance that the item will perform its intended safety functior, when required).

The licensee is responsible for identifying the important design, material, and performance characteristics for each part, material, and service intended for safety-rel.ted applications, establishing acceptance criteria, and providing reasonable assurance of the conformance of items to these criteria.A likt-for-like replacemenit is defined as the replacement of an item with an item that is identical.

For example, the replacement item would be identical if it was purchased at the same time from the same vendor as the item it is replacing, or if the user can verify that there have been no changes in the design, materials, or Manufacturing process since procurement of the item being replaced.

If differences from the original item are identified in the replacement item, then the item is not identical, but similar to the item being repiaced, and an evaluation is necessary to determine if any changes in design, material, or the manufacturing process-could impact the functional characteristics and ultimately the ci.oniponent's ability to perform its required safety function.

If the licensee can demonstrate that the replacement item is identical, then the licensee need not identity the safety function or review and verify the design requirements and critical characteristics.

Engineering involvement is necessary il the above activities.

Reliance on part number verification and certification documentation is insufficient to ensure the quality of comrercially procured produLts.The other matters discussed In Enclosure I do not cnr.stitute NRC staff positions, but provide information on inspection findings .and clarify the characterization of effective procurement and dedication programs previously described in GL 89-02.

BACKFIT DISCUSSION

Based or. past inspection findings and the resulting enforcement actions, the 11RC staff has determined that licensee coirnercial-grade procurement and GENERIC LETTER 91-05-4-Iedication prograr's needed to be improved to comply with the existing NRC requirements as described in 10 CFR Part 50, Appendix B, Criterion III (Design Control), IV (Procurement Document Control), VII (Control of Purchased Material, Equipment and Services), and XVIIH (Audits).

Specifically, licensees have failed to adequately niaintain programs to assure the suitability of commiercially procured and dedicated equipment fur its intended safety-related application.

Since the generic letter presents staff positions regarding implementation of existing regulatory requirements, as contained in Appendix E to 10 CFR Part 50, the staff has coricluded, that this is a compliance backfit drd has prepdred the generic letter in accordance with 10 CFR 50.109 (a)(4)(i).

In light of the inadequacies identified in the procurement and dedication programs of a large number of licensees, the issuance of this generic letter is necessary to express the staff's position on the key element that licensees must incluce as part of the dedication process, specifically that commercial- grade procurement and dedication programs mrust assure the suitability of equipment for its intended safety-related application.

This generic letter is also intended to clarify the elements of effective procurement and conmmercial-grade dedication programs that were previously provided to licensees in GL 69-02. Since licensees'

procurement and dedication programs may contain programmatic deficiencies, the staff has irncluded in the generic letter the necessary licensee corrective action to address shortcomings identified in specific vendor products or components that directly lead to the component not being suitable for safety-related service.Although no response to this letter is required, if you have any questions regarding this matter, please contact the persons listed below.Sincerely, Jes G. Partlow A sociate Director for Projects Office of Nuclear Reactor Regulation Enclosures:

1. Characteristics of Effective Conviercial-Grade Procurement and Dedication Programs.List of Recently Issued Generic Letters Technical Contacts:

Richard P. McIntyre, NRR (301) 492-3215 Uldis Potapovs, URR (301) 492-0959 Enclosure

1 CHARACTERISTICS

OF-EFFECTIVE

COMMERCIAL-GRADE

PROCUREMENT

AND DEDiCATION

PROGRAMS Background Appendix B to 10 CFR Part 50 contains the NRC's regulations for procurement quality assurance (QA) and quality control (QC) for products to be used in safety-related applications.

In addition, the NRC has provided further -guidance in Regulatory Guides 1.28, 1.33, and 1.123. These requirements and guides, if properly implemented, provide a measure of assurance for the suitability of equipment, including commercial-grade

'ims for use in safety-related systems. Criterion III of Appendix B 1 ires licensees to select and review for suitability of application materials, parts, equipment, and processes that are essential to the safety-related functions ef the structures, systems, and components.

Criterion IV requires that procurement documents specify the applicable requirements necessary to ensure functional performance.

Criterion VII requires licensees to assure that the following are sufficient to identify whether specification requirements for the purchased ma.terial and equipment have been met: source evaluation and selection, objective evidence of quality, inspection of the source, and examination of products upon delivery.

The process used to satisfy these requirements when upgrading commercial-grade items for safety-related applications is commonly called "dedication.*

The process of ensuring compliance with 10 CFR Part S0, Appendix B, must include all those activities necessary to establish and confirm the quality and suitability of commercially procured and dedicated equipment for its intended safety-related application.

Some of the dedication activities may occur early in the procurement cycle before the item is accepted from the manufacturer.

Generic Letter (GLi 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products, discussed commercial-grade dedication in terms of engineering involvement in the procurement process, product acceptance, and the dedication process as identified in the EPRI NP-5652 guidelines.

This enclosure further-discusses the characteristics of effective procurement and dedication programs previously discussed in GL 89-02 and provides examples of specific failures by licensees to effectively implement these characteristics for dedicating and ensuring the suitability of commercial-grade products for safety-related applications.

Appropriate implementation of these characteristics would have avoided many of the failures to meet 10 CFR Part 50, Appendix B requirements in licensee procurement and commercial-grade dedication programs which were identified during past NRC inspections.

Inspection Observations and Findings From 1986 to 1989, headquarters and regional personnel conducted

13 team inspections of licensees'

procurement and dedication programs.

These inspec-tions have identified a common, broad programmatic deficiency in licensees'

control over the process of procurement afld dedication of commercial-grade

-2-items. In a number of cases, licensees have not Maintained programs to ensure the suitability of equipment for use in safety-related applications as required by 10 CFR Part 50, Appendix B, Criterion III. These 13 ir.spections resulted in findings with significant safety implications.

The staff identified eight findings that were considered to be Severity Level III violations and three findings that were Severity Level IV violations.

At one plant, the staff did not assign a severity level to individual violations.

Instead, the staff considered the entire group to be a Severity Level III problem and used enforce-ment discretion, as provided under the enforcement pclicy, based on the licensee's corrective actions (see 10 CFR Part 2, Appendix C, Section V.G.2).Only one of the plants that were inspected did not receive violations in this program area.In GL 89-02, the NRC has conditionally endorsed the dedication methods described in EPRI NP-5652 guidelines.

The staff believes that licensees who implement these dedication methods, in accordance with the NRC's endorsement, can establish a basis for satisfying the existing requirements of Appendix B to 10 CFR Part 50 as these requirements apply to the dedication process for commercial-grade items. An effective conmiercial-grade dedication program must include provisions to demonstrate that a dedicated item is suitable for safety-related applications.

For a licensee to adequately establish suitabil-ity, certain key activities must be performed, as appropriate, as part of the dedication process. This generic letter is intended to clarify the dedication approaches described in GL 89-02.During each of the 13 inspections, the staff iderntified a couaimon element in each of the inspection findings.

This element was the failure of the licensee to assure that a commercially procured and dedicated item was suitable for the intended safety-related application.

A dedicated commercial-grade item must be equivalent in its ability to perform its intended safety function to the same item procured under a 10 CFR Part 50, Appendix B QA program. The follow-ing is a list of the 13 licensees inspected and the inspection report numbers.A sunciary of the general inspection findings and NRC observations on these findings follows the list of licensee inspections.

LICENSEE and PLANT INSPECTION

REPORT NO.1. Tennessee Valley Authority (Sequoyah)

50-327/86-61

50-328/86-61

2. Southern California Edison (San Onufre) 50-206/87-02

50-361/87-03

50-362/87-04

3. Alabama Power (Farley) 50-348/87-11

50-364/87-11

4. Louisiana Power and Light (Waterford)

50-382/87-19

-3-INSPECTION

REPORT NO.LICENSEE and PLANT 5. Sacramento Municipal Utility District (Rancho Seco)6. Maine Yankee Atomic Power (Maine Yankee)7. Northern States Power (Prairie Island)8. Portland General Electric (Trojan)9. Connecticut Yankee Atomic Power (Haddam Neck)'O. washington Public Power Supply System (WHP-2)II. Florida Power (Crystal River)12. Gulf States Utilities (River Bend)13. Connonwealth Edison (Zion)50:312/88-02

  • 50-309/88-200

50-282188-201

50-306/88-201

50-344188-39

50-344/88-46

50-213/89-200

50-397/89-21

50-397/89-28

50-302/89-200

50-458/89-200

50-295/89-200

50-304/89-200

1. Inspection Findings a. Failure to identify the methods and acceptance criteria for verify-ing the critical characteristics, such as during receipt inspection, dedication process, or post-installation testing.b. 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 characteristics.

c. Failure to recognize that some commercial-grade items cannot be fully dedicated once received on site. Certain items are manufac-tured using special processes, such as welding and heat treating.Dedication testing of these items as finished products would destroy them. For these items, licensees may need to conduct vendor sur-veillances or to witness certain activities during the manufacturing process.Discussion The NRC staff has met on several occasions with NUMARC and licensee representatives to discuss "critical characteristics'

as used. in-the context of commercial-grade procurement and dedication.

The term "criti-cal characteristics" is not contained in Appendix B and has no special regulatory significance beyond its use and definition in various industry

-4-guides and standards.

The NRC first used the term critical characterls- tics in GL 89-02 as constituting those characteristics which nbed to be identified and verified during product acceptance as part of the procurement process. The ARC has not taken the position that all-design requirements must be considered to be critical characteristics as defined and used in EPRI NP-5652. Rather, as stated in Appetidix S, Criterion

11!, licensees must assure the suitability of all parts, Materials, and services for their intended safety-related applications (i.e., there needs to be assurance that the item will perform its intended safety function when required).

The licensee is responsible for identifying the important design, material, and performance characteristics for each part, material, and service intended for safety-related applirations, establishing acceptance criteria, and providing reasonable assurance of the conformance of items to these criteria.

There is no nilniun. or maximum number of critical characteristics that need to be verified.

Further, the critical characteristics for an 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. In nmany cases, the licensee can verify the critical characteristics of eac'h item during receipt inspection testing. However, for a complex item with internal parts which receive special processing during Manufacturing, the licensee may need to conduct a source verification of the manu-facturer during production to verify the critical characteristics identified as necessary for the item to perform its safety function.

When these methuds cannot verify the critical characteristics related to special processes and tests, certification by the original equipment manufacturer nay be an acceptable alternative provided documented, verified traceability to the original equipment manufacturer has beet.established and the purchaser has vecrified by audit or survey that the original equipment manufacturer has itaiplemented adequate quality controls for the activity being certified.

For items with critical characteristics that can be verified for the most severe or limiting plant application, the licensee might prefer to identify and verify the item's critical characteristics to qualify that item for all possible plant applications.

For complex items that would be purchased for specific plant applications it may be appropriate to address the acceptance criteria for each item individually.

Engineering involvement is important in either method because the technical evaluation will identify the critical characteristics, acceptance criteria, and the miethods to be used for verification.

Inspection Findings a. Failure to demonstrate that a like-fur-like replacement iteml is identical in form, fit, and function to the item it is replacing.

Part number verification is not sufficient because of the probability of undocumented changes in the design, material, or fabrication of commercial-grade items using the same part number.

-5-b. Failure to evaluatc changes in the design' on&terial, or manufactur- ing process fur the effect of these chances on safety function perforLMIce (particularly under design. basis event condltions)

of replacement items that are similar as opposed to identical to the items being replaced.c. Failure to ensure that itemrs will function under all design require-meents. On some occasions, licensees only ensured thbt the commercil-,grade item would function ui.der normal operation cor.ditions.

d. Failure to verify the validity of certificates of conformarnce received from vendors not on the licensee's list of approved vendors/suppliers.

An unverified certificate of conformance from a commercial- gradc vetdur is not sufficient.

Discussion A like-for-like replacement is defined as the replacement of an item with uri itein that is identical.

For example, the replacement item would be identical if it was purchased at the same time from. the same vendor as the item it is replacing, or if the user can verify that there have been no changes in the design, materials, or manufacturiqg process since procurement of the item being replaced.

If differences from the original ite.i iare identified in the replacement item, then the item is rot identical, but similar to the item being replaced, and evaluation is necessary to determine if any changes in design, material, or the n.anufacturing process could impact the functional characteristics and ultimately the com.ponent's ability to perform its required safety func-tion. If the licersee can demonstrate that the replacement item is identical, then the licensee need not identify the safety function or review and verify the design requirements and critical characteristics.

Engineering involvement is necessary ill the above activities.

The extent uf this Involvement.

is lependent on the nature, conmplexity, and use of the items to be dedicated.

Participation of engineering personnel is appropriate in the procurement process, and product acceptance, to develop purchase rpecificaticns, determine specific testing requirements applicable to the products, and evaluate the test results. When engi-reering personnel specify design requirements for inclusion on the purchase documents for replacement components, they need not reconstruct and reverify design adequacy for procurement purposes, but need only ensure that the existing design requirements (which may reference the original design basis) are properly translated into the purchase order.Reliance on part number verification and certification documentation is insufficient to ensure the quality of coniercially procured products.Effective product acceptance programs have as elements, receipt and source inspection, appropriate testinS criteria, effective vendor audits Ltd surveillances (including witness/hold points as appropriate), special tests and inspections, and post-installation tests. Procedures and adequ:te qualificatio!Is and training for implementing personnel are also r.ecessory factors in successful implenmentationr.

Enclosure

2 LIST OF RECENTLY ISSUED GENERIC LETTERS Generic Date of Letter No. Subject Issuance Issued To 91-04 CHARGES IN TECHNICAL

SPECI lCATM N SUR- ALL HOLDERS OF OL V VEILLANCE

INTERVALS

TO ACCOMMODATE

A 24- OR CONSTRUCTION

PER-I MONTH FUEL CYCLE (GENERIC LETTER 91-04) MITS FOR NUCLEAR POWER REACTORS 91-03 91-02 91-01 91-01 90-09 REPORTING

OF SAFEGUARDS

03/06/91 EVENTS REPORTING

MISHAPS INVOLVING

12/28/90 LLW FORMS PREPARED FOR DISPOSAL REMOVAL-OF

THE SCHEDULE FOR 01/04/91 THE WITHDRAWAL

OF REACTOR VESSEL MATERIAL SPECIMENS FROM TECHNICAL

SPECIFICATIONS

ALTERNATIVE

REQUIREMENTS

FOR 12/11/90 SNUBBER VISUAL INSPECTION

INTERVALS

AND CORRECTIVE

ACTIONS CONSIDERATION

OF THE RESULTS 10/25/90 OF NRC-SPONSORED

TESTS OF MOTOR-OPERATED

VALVES SIMULATION

FACILITY 08/10/90 EXEMPTIONS

OPERATOR LICENSING

NATIONAL 08/10/90 EXAMINATION

SCHEDULE AVAILABILITY

OF PROGRAM 08/03/90 DESCRIPTIONS

ALL HOLDERS OF OLs OR CPs FOR NUCLEAR POWER REACTORS AND ALL OTHER LICENSED -ACTIVITIES

INVOLVING A FORMULA QUANTITY OF SPECIAL NUCLEAR.MATERIAL (SNM)ALL OPERATORS

OF LOW-LEVEL

RADIO-ACTIVE WASTE (LLW)DISPOSAL SITES, WASTE PROCESSORS,& ALL HOLDERS OF LICENSES FOR NUCLEAR FUELS, NUCLEAR MATERIALS

& NUCLEAR POWER REACTORS ALL HOLDERS OF OLs OR CPs FOR NUCLEAR POWER PLANTS ALL LIGHT-WATER

REACTOR LICENSEES AND APPLICANTS

ALL LICENSEES

OF OPERATING

NUCLEAR POWER PLANTS AND HOLDERS OF CONSTRUC-TION PERMITS FOR NUCLEAR POWER PLANTS ALL HOLDERS OF OPERATING

LICENSES OR CONSTRUCTION

PERMITS FOR NUCLEAR POWER REACTORS ALL POWER REACTOR LICENSEES

AND APPLICANTS

FOR AN OPERATING

LICENSE ALL LICENSEES

OF OPERATING

NPPs AND HOLDERS OF CPs FOR NPIPs 89-10 SUPP. 3 90-08 90-07 89-10 SUPP. 2 GENLRIC LETTER 91- 05-4-dedication proranms needed to be improvetd to comppy with the existing DRC recuirements as described in 10 CFR Part 50, Appendix 6, Criterion I.I-(Design Control;-, IV (Procurement Docunient Control), VII (Control of Purchased Imattrii'l, Equipment anoa Services), and XVIII (Audits).

Specifically, licensees hac failed to adtquately maintain programsto assure the suitability of cornpercilily procured and dedicated equiprent for its intended safety-related

3".icatiofl.

Since the ierQeric letter presents staft positions regarding ir-tplenfleritction of existing regulaory requirements, as contained in Appexdix b to 10 CFR Pirt 5G, the '.taff has conckded, that this is a compliance backfit:.:d has prerared the gti.Lric letter in accordance with 10 CFR 50.109 (a)(4)(i).

ir. light of the inadequ'Lies identified in the procurement and dedication pruyrar.,.

Lf a lar;e n1upter of licensees, the issuance of this generic letter is necessary Itl vxpress the staff's position on the key element that licensees ritL5 includc as part of the dedication process, specifically that cowtmercial- Srade pruLcureifent and &ctication prograns must assure the suitabilit)

of cuipelnt f 'r its interded safety-rclated application.

This generic letter is also irt;e.LUd to clarify the elenents of effective procuremuent and corr.erciel -jrade cedic~.ition proSrams that were previcusly provided to licensees.bL 8§-02. Since licersees'

procurement and dedicatiot1 programs -ay contain prr(drarnatc deficiencies, the staff has incluaed in the gereric letter the necessary .icensee corrective action to address shortcot..ings identified in spjL'lc vender products or components that directly lead to the component rLot bei-c suitable fc,r .Ltety-rclated service.rt,...;UCh no resr ctise tu this letter is required, if )uu have any questions reourdinc this .c.;ttr, plebsE contact thb personIs listed below.Sincerel), ORIGINAL SIGNED BY:%lmes G. Partlob Associate sirector for Projects Office of Nuclear Reactor Regulatiiun F. rc cf Eftfe: .tC Coribercial-Gradte uit;.ren~ei.t and ~Jedicatiunl Progru~s 7. List, of Fie..evty

edGeneric Litttrs lectii,(Lal Ccortlact,.:

Pichaire P. cIcntyre, NF~R 11cL2l 492-3215 DISTRIBUTION:

enetriFr 0i es NRC PDR VIB Reading RMcIntyre-" E L i r. LV ' L L '.I I CF -, I Q : '.' : L.Lk' # : U?,. ;y.' j:

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