Summary of Changes to the FirstEnergy Nuclear ... - NRC

FENOCFftst gn6qg, }\trclffi @ati6 furprlny

341 White Pond Dr.Abon, Ohio 44320

October 8, 2019L-19-177 10 CFR 50.54(a)(3)

10 cFR 71.106(b)

ATTN: Document Control DeskU.S. Nuclear Regulatory CommissionWashington, DC 20555-0001

SUBJECT:Beaver Valley Power Station, Unit Nos. 1 and 2Docket No. 50-334, License No. DPR-66Docket No. 50.412, License No. NPF-73Davis-Besse Nuclear Power StationDocket No. 50-346, License No. NPF-3Perry Nuclear Power PlantDocket No. 50-440, License No. NPF-58Summarv of Chanoes to the FirstEnergv Nuclear Operatinq Companv. QualitvAssurance Program Manual for Feav_eJ Vallev Power Station. Unit Noq. 1 and 2.Davis-Besse N,Ugl_ear Power Station. and Perry Nuclear Power Plant

ln accordancewith 10 CFR 50.54(a)(3) and 10 CFR 71.106(b), FirstEnergy NuclearOperating Company (FENOC) is submitting a summary of changes to the FENOCQuality Assurance Program Manual (AAPM) that did not reduce commitments in thequality assurance program description, and therefore, did not require NuclearRegulatory Commission (NRC) approval prior to implementation. There were nochanges to the QAPM that required NRC approval prior to implementation,

Previous submittals of the FENOC QAPM were provided as part of the Updated FinalSafety Analysis Reports (UFSAR) submitted under 10 CFR 50.71(e); however, FENOCis now submitting QAPM changes annually. To ensure a good transition and todocument the changes, FENOC is providing a summary of changes for the last fourrevisions to the QAPM. Future revisions will include a summary of changes within theQAPM. The current FENOC QAPM Revision?4 was submitted by letter dated May 14,2019 (Accession No. ML19151A181), with the Updated Final Safety Analysis Report forthe Beaver Valley Power Station, Unit No. 2. The Enclosure to this letter provides acopy of FENOC QAPM, Revision 24 for information purposes only.

Beaver Valley Power Station, Unit Nos. 1 and 2Davis-Besse Nuclear Power StationPerry Nuclear Power PlantL-19-177

The summary of the changes for Revisions 21,22,23, and 24 for the FENOC QAPM isprovided in Attachment 1 of this letter.

There are no regulatory commitments contained in this submittal. lf there are anyquestions or if additional information is required, please contact Mr. Phil H. Lashley,Acting Manager - Nuclear Licensing and Regulatory Affairs, at (330) 315-6808.

Sincerely,

L_Darin M. BenyakVice President, Nuclear Suppoft and Regulatory Affairs

Attachments:FENOC QAPM Revisions 21 , 22,23 and 24 - Summary of Changes

EnclosureFENOC QAPM Revision24 - Current Revision

cc: NRC Region lAdministratorNRC Region III AdministratorNRC Project Manager - FENOC FIeetNRC Resident lnspector (Beaver Valley)NRC Resident Inspector (Davis-Besse)NRC Resident lnspector (Perry)Director BRP/DEPSite BRP/DEP RepresentativeUtility Radiological Safety Board

Attachment 1

L-19-177

FENOC QAPM Revisions 21, 22,23 and 24 - Summary of ChangesPage 1 of 1

REVISION EFFECTIVEDATE

CHANGEDSECTIONS

DESCRIPTION OF CHANGE

24 3t4t2019 A.2.a, A.2.a.1.b The Chief Nuclear Officer (CNO) assumesthe responsibility from the executiveresponsible for operations to act as thesingular point of contact with respect to theoperation of the four FENOC power plantsand provides operationa! oversight. Thesite executives retain responsibility foroverall plant nuclear safety and operations.This change results in changes to section4.2.a and A.2.a.1.b. The change wasreviewed in accordance with 10 CFR 50.54(a)and did not reduce FENOC commitmentspreviously approved by the NRC.

23 3t13t2018 4.2.b.3,4.2.b.1.b

The management position responsible forlicensing and regulatory affairs changedfrom reporting to the Chief Nuclear Officer(CNO) to reporting to the executiveresponsible for operations. This results indeleting section A.2.b.3 and addition of newsection A.2.b.1.b. The change was reviewedin accordance with 10 CFR 50.54(a) and didnot reduce FENOC commitments previouslyapproved by the NRC.

22 il23tzo18 A.2.a, 4.2.a.1,A.2.a.1 .a), A.2.b,A.3.c

The FENOC President and Chief NuclearOffice (CNO) title is changed effective onMarch 5, 2018. The change to the QAPMdeletes reference to President and onlyretains the CNO title in sections A.Z.a,4.2.a.1, 4.2.a.1.a), A.z.b, A.3.c The changewas reviewed in accordance with 10 CFR50.54(a) and did not reduce FENOCcommitments previously approved by theNRC.

21 3t29t2017 A.2.b.3 Due to organizational changes in FirstEnergyGeneration Step A.2.b.3 was revised todelete laboratory services from themanagement position responsible forlicensing and regulatory affairs. The changewas reviewed in accordance with 10 CFR50.5a(a) and did not reduce FENOCcommitments previously approved by theNRC.

EnclosureL-19-177

FENOC QAPM Revision24 - Current Revision(36 pages follow)

FENOCFhrlErx4gr f,It4err Openting tltraponi. Qual Assurance Program Manual

Approved By:

Benver Valley Power StationUnits I &.2Docket Nos. 5G334 & 50-412Operating License Nos. DPR-66 & hIPF-?3

Davis-Besse Nuclear Power StationDocket No. 50-346Operating Licen$e No. NPF-3

Perry Nuclear Power PlantDocket No. 50440Operating License No. NPF-58

President - Fleet Oversight03/04/1 9

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TABLE OF CONTENTS

A. MANAGEMENT

1.2.3.4.DJ.6.,l,.8.9.10.I1,12.13.14.15.

MothodoloryOrganizationResponsibilityAuthorityPeroonrel Training and QualificationCorrective ActionRegulatory Commitments

MethodologrDeeign ControlDesign VerificntionProcurement ControlPro cu rement VerificationIdentification and Control of ltemsIlandling Storage, and ShippingTest ControlMensuring and Test Equipment ControlInspection, Test, and Operating StafusSpecial Process ControlInspectionCorrective ActionDocument ControlRecords

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3.4.5.6.7.

B. PERX'ORMANCE/YERIFICATION

C. ASSESSMENT

MethodoloryAudit

D. INDEPENDENT SAFETY REVIEW

l. llescription

1.2.

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TABLE OF CONTENTS (Continued)

Table I * Regulatory Commitments

Regulatory Guide 1.8 (Revision t) [September 19751,Personnel Selection and Training [ANSI NI.8.tlRegulatory Guide 130 (Revision 0) [Augu$t 19721,Sualrty Assurance Requiremenls for lhe Instalfialion,Inspectian, rnd Testing of Instramentation andElectric Equipmenr [ANSI N45.2.4]

Regulatory Guidel.3l (Revision 0) [March 19731,SuaIW Assurance Reqairements for Cleaning af FluidSyslerer and Assocified Components of Water*CooledNuclear Power Planr. IAI{SI N45.2.11

Regulatory Guide I.38 (Revision 2) [May 19771]Qur,ltp r4s s ur anc e Req uiremcnts fo r Packagin g,Shipping, Reeeiving, Storage, and Hundling of ltemsfor Water-Cooled Nuclesr Power Plants [ANSI N45.2.21

Regulatory Guide 1.39 (Revision 2) [Septcmber 19771,Houst*eeping Req uire ments for Water-Cooled NaclearPower PIanfr IANSI N45,2.31

Regulatory Guide 1.58 (Revision l) [September lg80f,Qaa{f,tcation of Nuclear Power Plant Inspection,Exartnafian and Testing Ferssnnel [ANSI N45.2.61

Regulatory Guide 1.64 (Revision 2) pune 19761,

$uiltty Assurance Requiremen$for the Design ofNuclear Power Plants IAIISI N45.2.1U

Regulatory Guide 1.74 (Revision 0) [f,'ebruary 19741,

Quality Assurance Terms and Detinitions [ANSI N45.2.10]

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Regulatory Guide 133 (Rtvisiotr 2) [February 19781,

Suatrfy Assurance Prugram Requirements (Operations) [AFISI N18.71 24

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TABLE OF COhITENTS (Continued)

Tahle I - Regulatory Commitments (Continued)

Regulatory Guide 1.88 {Revision 2) [October 1976J,Coltection, Storage and Mainlenance of Nuclear FowerPlant frual@ Assurance Records [ANSI N45.2,91

Regulatory Guide I.94 (Revision 1) [April 19761,Quality Assarfrnce Requirements for Installation,Inspection and Testing at Concrete and Structural SteelDuring the Construction Phuse of Nuclear Power Plqnts[AI{SI N45.2.51

Regulatory Guide 1.116 (Revision 0) [Mry 19771,Sualrfl Ass arance Req uirenunfr for Installation,Inspection and Testing of Mechanicul Eqaipment and,Sysferrs [AI{SI N45.2.81

Regulatory Guide 1.123 (Reviciotr I) [July 19171,Quality ,4ssarance Requirements for Control ofProcuremcnt of llems and Sewices for Nuclear PowerPlants IANSI N45.2,131

Regulatory Guide 1.144 (Revision f) [Septemher 19801,Auditing af Qadity Assurance Progranu for NuclearPower PlanB IANSI N45.2.12]

Regulatory Guide 1.146 (Revision 0) [Auguct 19801,Qualilication of Qaality Assurance Program AuditPersonneltor Nuclear Power Plants [ANSI N45.2.231

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A. MANAGEMEIIIT

l. Methodolory

The Quality Assurance Program Manual (QAPM) provides a consolidatedoverview of the quallty progrsm controls which govern the operation andmaintenance of FirstEnergy Nuclear Operating Company's (FENOC's) qualityrelated items and activities. This includes nuclear plant and FENOC fleetlocations, as well as FirstEnergy corporate locations that provide safety relatedservices. The QAPM describes the quality assurance organizational stnrctwe,functional responsibilities, levels of authority, and interfaces.

The requirements and commitments contained in the QAPM are mandatory andmust be implemented, enforcedo flnd adhered to hy all individuals andorganizations. Employees axe expected to actively participate in the continueddevelopment of the QAPM as well as its implementation. Changes are promptlycommunisated when identifi ed.

c. The QAPM implements I0CFR50, Appendix B and applies to all activitiesassociated udth structures, systems, and components which are safety related.The requirements of the QAPM are applied to these items and activities to anextent conrmensurate with their importance to safety.

d. The QAPM also applies to the packaging and transportation of radioactive wasteactivities controlled by 10CFR7I, ffi the quality assurance progrim required by10CFR71, Subpart H.

The QAPM also applies to the independent storage of spent nuclear fuel andhighJevel radioactive waste activities controlled by I0CFR72, as the qualityassruance progtam required by 10CFR72, Subpart G.

The QAPM sections 8.13, Corrective Actions, and 8,14, Document Conhol, alsoapply to non-safety related Shuctures, Systems and Components subject to agrngilunag€ment for the period of extended operations following issuance of therenewed operating license.

Section B.l3 and the listed references also address the confirmation processdescribed in NRC RIS 2014-09, Maintaining the Effectiveness of LicenseRenewal Agrng Management Programs, to enstue preventive actions areadequate and appropriate corrective actions are completed and effective.

Section 8.14 and the listed references address administrative controls describedin NRC RIS 2014-09, to ensure formal review and approval processes areprovided.

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g. The applicability of the requirements of the QAPM to other items and activitiesis determined on a case-by-cas€ basis.

h. The QAPM is implemented through the use of approved procedr:res (i.e.,policies, directives, procedures, or other docunrents) which provide writtenguidance for the control of quality related activities and provide for thedevelopment of docuurentation to provide objective evidence of compliance.

2. Organization

The organieational structwe responsihle for implementation of the QAPM is describedbelow. The specific organization titles for the qualrty assurance functions described areidentified in procedures. The authority to accomplish the quality assurance functionsdescribed is delegated to the incumbent's staff as necessary to fulfill the identifiedresponsibility.

a* The ChiefNuclear Officer (CNO) is responsible for establishing expectationsand providing top level direction of all activities associated with the safe andreliable operation of FENOC's nuclear power plants and activities of corporatefunctions. The CNO provides guidance with regards to the company qualityassurance policy. The CNO provides a singular point of contact with respect tothe operation of the four FENOC power plants and provides operationaloversight of the four plants.

The executive responsible for oversight reports to the CNO and isresponsible for the audit and assessment of the quality assuranc€ progftmof FENOC's nuclear activities, both site and corporate, flrd maintainingthis QAPM in accordance udth regulatory requirements. This executive isalso responsible for establishing the quality assurance program policies,goals and objectives, for implementation of the quslfiy assurance program,and for maintaining the Quality Asswance Program Manual. Thisexecutive also has overall responsibility for the quality assurance andindependent off-site safety review committee functions, as well as supplierauditing.

a) The individual responsible for quality assurance reports to theexecutive responsible for oversight and has overall authority andresponsibillty for veriffing the implementation and adequacy of thequality assurance program (auditing) as described in this QAPM. Theindividual responsible for quality assurance has the authority andresponsibility to report matters directly to the Chief Nuclear Officerwhen needed. This individual is also responsible for the qualitycontrol fi:nction, flrrd receipt and supplier source inspections.

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b) These individuals above may be responsible for a single unit/locationor for multiple unitsflocations and may fulfill more than one firnctiondescribed. Conversely, responsibilities may be fulfilled by rnore thanone individual. Individuals m.ay be located at the nuclear plant orFirstEnergy corporate locations.

b. The follorring management positions report to the Chief Nrrclear Officer:

l. The executives responsible for overall plant nuclear safety and operationssupport at each site. These executives may report through an additionallayer of management but shall maintain sufficient authority andorganizational freedom to implement the assigned responsibilities. Theseexecutives are responsible for establishing and implementing the qualrtyasflrance program at the respective site.

2. The executive responsible for engineering is responsible for providinsengineering services at all sites.

3. A management position responsible for licensing and regulatory affairs.

The individuals fulfilling the following management functioffi report to theappropriate management position identified in Paragraphs 2.b.1 or 2.b.2 above.These individuals may report through an additional layer of management butshall maintain suffrcient authority and organizational freedom to implement theassigned responsibilities. These individuals may be responsible for a singleunit/location or for multiple unitsllocations and may fulfill more than onefunction described below. Conversely, responsibilities rnay be fulfilled by morethan one individual. The fi,rnctions descrihed below may also be implemented bynon-FENOC organizations within the FirstEnergy Corporation however, FENOCmaintains responsibility and authority.

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The individual responsible for plant operations assures the safeo reliable,and efficient operation of the plant within the constraints of applicableregulatory requirements and the operating license.

The individual responsible for plant modification provides direction,confrol, and overall supervision of the implementation of plantmodifications and assigned maintenance.

The individual responsible for training provides direction, control, ffidoverall supervision of all training of personnel required by regulations.

The individual responsible for records management provides direction,conhol, and overall supervision of the records managernent program andassociated activities.

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The individual responsible for document control provides directiortcontol, and overall supervision of the document control program andassociated activities.

The individual responsible for f,re corrective action program providesdirection, conhol, ffid overall supervision of the corrective action programand associated activities.

The individual responsible for engineering is responsible for thedevelopment and maintenance of engineering programs, policies, andprocedures and for providing engineering services.

The individual responsible for materials, purchasing, and contracts isresponsible for supplier evaluations, procurement, services, receipt, storage,and issue of materials, parts, ffid cornponents.

d. The on-site and off-site safety review cornmittees independently review activitiesto provide additional assurance that the units are operated and maintained inaccordance with the Operating License and applicable regulations which addressnuclear safety. (Refer to Table 1, Item C.2 for additional details.)

3. Responsihility

FENOC has the responsibility for the scope and implementation of an effectivequalrty assurance program.

FET-IOC may delegate all or part of the activities of planning, establishing, andirnplementing the quality assurance program to others, but retains theresponsibility for the program's effectiyene$s.

The adequacy of the QAPM's implementation is continually assessed by theindividual(s) responsible for quality assurance and the associated executive foroverall plant nuslear safety, and is reported to the executive responsible foroversight and to the Chief Nuclear Officer.

FENOC is responsible for ensuring that the applicable portion(s) of the qualityassurance program is properly documented, approved, and irnplemented (peopleare tained and resources are available) before an activity within the scope of theQAPM is undertaken by FENOC or by others.

e. Responsible individuals are to ensure that personnel working under theirmanagement cognizance are provided the necessary training and resources toaccomplish their assigned tasks within the scope of the QAPM.

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Procedures that implement the QAPM are approved by the managementresponsible for the applicable quality fuirction. These procedures are to reflectthe QAPM and work is to be accomplished in accordance with them.

4. Authority

a. When FENOC delegates responsibility for planning, establishing, orimplementing any part of the overall QA program, sufficient authority toaccomplish the assigned responsibilities is delegated.

b. The individual responsible for quality flssurfiice has the responsibility and theauthority to stop unsatisfactory work (including reactor operation through properchannels) and control further processing, delivery, installation, or use ofnon-conforming items or senrices. Cost and schedule considerations will notoverride safety considerations.

5, Personnel Training and Qualification

Personnel assigned to implement elements of the quality a.ssurance program Erecapable of performing their assigued tasks.

b. Training programs a"re established and implemented to ensure that personnelachieve and maintain suitable proficiency.

c. Personnel training and qualification records are maintained in accordance withprocedures.

d. Additional details concerning personnel naining and qualification may be foundin the Regulatory Guides and associated Standards as commiued to in SectionA.7 and Table I (e.9., Regulatory Guides 1.8, 1.58, and 1.146).

6. Corrective Action

It is the responsibility of each individual to promptly identiff and reportconditions adverse to quality. Management at all levels encourages theidentification of conditions that are adverse to quality.

b. A corrective action program is established and implemented that includes promptidentification, documentation, signifi cance evaluation, and correction ofconditions adverse to quality. For significant conditions adverse to quality, thecause is determined and comective action to preclude repetition is identified andtracked until it is completed and verified.

Specific responsibilities within the corrective action progftrm may be delegat€d,but FENOC maintains responsibility for the program's effectiveness.

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d. Non*conforming items are properly confrolled to prevent their inadvertent test,installation, or use, They are reviewed and either accepted, rejected, repaired, orreworked.

Reports of conditions that are adverse to quality are analyzed to identiff uends inqualrty performance. Significant conditions adverse to quallty and significanttrends are reported to the appropriate level of management.

Additional details concerning corrective action activities may be found inSection B.13 and the Regulatory Guides and associated Standards as coilrmittedto in Section A.7 and Table I (e,g., Regulatory Guides 1,33 and 1.144).

7. Regulatory Commitments

Except where alternatives are identified, FENOC complies with the QA guidancedocuments listed on Table l. If the guidance inany ofthese doctrments is in conflictwith the QAPM, the gurdance provided in the QAPM is the contolling guidance.Additionally, the following clarifications apply to all guidance documents listed inTable l:l. For modifipations and nonroutine maintenance, guidance applicable to

construction-like activities is applicable to comparable plant activities,except that the inspection of modifications, repairs, rework, andreplacements shall be in accordance with the original design and inspectionrequirements or a documented approved alternative.

2. The definitions provided by Regulatory Guide 1 .74 apply wherever thedefined term is used in the QAPM and associated guidance documents.

3. Clarifications and alternatives to a guidance document apply wherever theguidance document is invoked.

4. In each of the ANSI Standards, other documents (e.9., other Standards,Codes, Regulationso tables, or appendices) are referenced or described.These other documents are only quality assurance program requirements ifexplicitly committed to in the QAPM. If not explicitly committed to, thesedocuments are not considered as quality assurance program requirements,although they may be used as guidance.

5. Regulatory guidance originally intended to apply to design or constuctionphase activities will be applied to activities during the operations phase thatare comparahle in nature and extent to constnrction phase activities.

b. The NRC is to be notified of QAPM changes in accordance with 10CFR50,54(a).

In cases where license requirements differ from the QAPM, the most stringentrequirements apply.

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B. PERFORMANCE/VERIFICATION

L Methodolory

Personnel performing work activities such as design, engineering, procurement,manufacturing, construction, installation, starilrp, maintenance, modification,operation, ffid decommissioning are responsible for achieving acceptable quality.

b. Personnel performing verification activities iue responsible for veriffing theachievement of acceptable quality.

c. Work is accomplished and verified using instnrctions, procedwes, or otherappropriate means that are of a detail commensurate with the activity'scomplexity and importance to safety.

d. Criteria that define acceptable quality are specified, and qualrty is verifiedagainst these criteria.

2. Design Control

The design control prograrn is established and implemented to assure that theactivities associated with the desigu of systems, components, structures, andequipment and modifications thereto, are executed in a planned, controlled, andorderly manner.

b. The program includes provisions to conhol design inputs, prooesses, outputs,changes, interfaces, records, and organizational interfaces.

g. Design inputs (e.g., performanco, regulatory, quality, and quality verificationrequirements) are to be correctly translated into design outputs (e.g.,specifi cations, drawings, procedures, and instructions).

d. The final design output is to relate to the design input in sufficient detail topermit verification,

The design process is to ensure that items and activities are selected andindependently verified consistent with their importance to safety to ensure theyare suitable for their intended application.

Changes to final desigus (including field changes and modifications) anddispositions of non-conforrning items to either use-as-is or repair are to besubjected to design conffol measures commensurate with those applied to theoriginal design and approved by the organization that perforrned the originaldesign or a qualified designee.

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Interface controls (intemal and extemal benueen participating designorganizations and across technical disciplines) for the purpose of developing,reviewing, approving, releasing, distributing, and revising design inputs andoutputs are defined in procedures.

h. Design documentation and records, which provide evidence that the design anddesign verification process was performed in accordance with this program, shallbe collected, stored, ffid maintained in accordance with docuurented procedures.This documentation includes final desigu documents, such as drawings andspecifications, and revisions thereto and documentation which identifies theimportant steps, including sources of design inputs that support the final design.

Additional details concerning design control activities may be found in theRegulatory Guides and associated Standards as cornmitted to in Section A.7 andTable 1 (e.g., Regulatory Guide 1.64).

3. Desigu Verilication

A prograrn is established and implernented to verifu the acceptability of designactivities and documents for the design of items. The selection and incorporationof design inputs and design processes, outputs, and changes are verified.

Verification rnEthods include, but are not limited to, design reviews, altemativecalculations, and qualification testing. The extent of this verification will be afunction of the importance to safety of the item, the complexity of the design, thedegree of standardization, the state of the artn and the similarity with previouslyproven desigus. Standardized or previously proven desigrrs will be reviewed forapplicability prior to use.

c. When a test program is used to veriff the acceptability of a specific designfeature, the test program is to demonstrate acceptable performance underconditions that simulate the most adverse design conditions that are expected tobe encountered.

d. Independent design verification is to be completed before design outputs are usedby other organizations for design work and before they are used to support otheractivities such as procuremsnt, manufacture, or construction. When this timingcannot be achieved, the unverified portion of the design is to be identified andcontrolled. h all cases, the design verification is to be cornpleted before relyingon the item to perform its function.

e. Individuals or groups responsible for design reviews or other verificationactivities shall be identified in procedures and their authority and responsibilityshall be defined and controlled. Design verification shall be performed by sny

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cornpetent individuals or groups other than those who performed the originaldesign but who may be from the same organization. The designer's immediatesupenrisor may perform the design verification provided: the supervisor is theonly technicatly qualified individual capable of performing the verification, theneed is individually documented and approved in advance by the supervisor'smanagement, and the frequency and effectiveness of the supervisor's use as adesign verifier are independently verified to guard against abuse.

f, Design verification procedures are to be established and implemented to ensurethat an appropriate verification method is used, the appropriate design parametersto be verified are chosen, the acceptance criteria are identified, the verification issatisfactorily accomplished, and the results are properly recorded.

Additional details concerning design verification activities may be found in theRegulatory Guides and associated Standards as committed to in Section A.7 andTable 1 (e.9., Regulatory Cuide 1.64).

4. Procurement Control

A program is established and implemented to ensure that purchased items andserices are of acceptable quality.

b. The program includes provisions for evaluating prospective suppliers andselecting only qualified suppliers.

The program includes provisions for ensuring that qualified suppliers sontinue toprovide acceptable products and services.

d. The program includes provisions (e.g., source verifisation, receipt inspectionnpre-installation and post-installation tests, and certificates of conformance) foraccepting purchased items and services.

Applicable technical, regulatory, administrative, and reporting requirements(e.9., specifications, codes, standards, tests, inspections, special processes, andl0CFR2l) are invoked for procurement of items and services.

The program includes provisions for ensuring that documented evidence of anitem's conformance to procurement requirements is available at the site beforethe item is placed in service or used unless otherwise specified in procedures.

The program includes provisions for ensuring that procurement, inspection, andtest requirements have been satisfied before an item is placed in servie,e or usedunless otherwise specified in procedures.

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FETUOCFrrBlF-rrEEy luroJsrr Og{i.al/f,8 fuff pfif Quality Assurance Program Manual

h. The procurement of components, including spare and replacement parts, issubject to quality and technical requirements suitable for their intended serviee.

t. Appropriate controls for the selection, determination of suitability for intendeduse (critical characteristics), evaluation, receipt, and quality evaluation ofcommercial grade items are to be imposed to ensure that the items will performsatisfactorily in senrice.

J Additional details concerning procurement control may be forrnd in theRegulatory Guides and associated Standards as committed to in Section A.7 andTable I (e.9., Regulatory Guides 1.33 and 1.123).

5. Procurement Yerifiention

A program is established and implemented to verifr the quality of purchaseditems and services at intervals and to a depth consistent with the item's orseryice's importance to safety, complexity, and quantity and the frequency ofprocurement.

b. The program is executed in all phases of procurement. As nese$sary, this mayrequire verification of activities of suppliers below the first tier.

Additional details concerning procurement verification may be found in theRegulatory Guides and associated Standflxds as corrmitted to in Section A.7 andTable I (e.9., Regulatory Guides 1.123 and 1.144).

6. Identification and Control of Items

A program is established and implemented to identiff aod confrol items toprevent the use of incorrect or defective items.

b. Identification of each item is maintained throughout fabrication, erection,installation, and u$o so that the itern can be traced to its documentation.Traceability is maintained to an Extent consistent with the itern's importanse tosafety.

c. Additional details concerning identification and control of items may be found inthe Regulatory Guides and associated Standards as committed to in Section A.7and Table 1 (e.g., Regulatory Guide 1.33).

7, Handling, Storage, nnd Shipping

A program is established and implemented to conffol the handling, storage,shipping, cleaning, and preserving of items to ensure the items maintainacceptable quality.

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Special protective measures (e.9., containers, shock absorbers, accelerometers,inert gas atnospheres, speeific moistr-ue content levels, and temperature levels)are specified and provided when required to maintain acceptable quality.

Specific procedures are developed and used for cleaning, handling, storage,packaging, shipping, and preserving items when required to maintain acceptablequality.

d. Items are marked and labeled during packaging, shipping, handli*g, and stor4geto identiff, maintain, and preserve the items' integrity and indicate the need forspecial controls.

Additional details concerning handling, storage, and shipprng activities may befound in the Regulatory Guides and associated Standards as coilrmitted to inSection A.7 and Table I (e.9., Regulatory Guide l.3S).

L Test Control

a. A test control program is established and implEmented to demonstrate that itemswill perform satisfactorily in seryice.

b. Criteria are defined that specify when testing is required.

c. The test control program includes, as appropriate, proof tests before installation,pre-operational tests, post-maintenance tests, post-modification tests, andoperational tests.

d. Test procedures are developed that include:

f . instructions and prerequisites to perforrr the test,

2. use of proper test equipment,

3. acceptance criteria, and

4. rnandatory inspections as required.

e. Test results are evaluated to assure that test objectives and inspectionrequirements have been satisfied.

f. Unacceptable test results shall be evaluated.

b

c.

e.

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g. Additional details concerning test control may be found in the Regulatory Guidesand associated Standards as conrmitted to in Section A.7 and Table I (e.g.,Regulatory Guide 1.33).

9. Measuring and Test Equipment Control

a. A program is established and implemented to conhol the calibration,maintenance, and use of measuring and test equipment. Measruing and testequipment does not include perrranently installed operating equipment or testequipment used for preliminary checks where data obtained will not be used todetermine acceptabihty or be the basis for design or engineering evaluation.Additionally, calibration and control mea$ures are not required for rulers, taperneasures, Ievels and other such devices if normal commercial manufacturingpractices provide adequate accuracy.

b. The types of equipment covered by the program (e.g., instruments, tools, gages,and reference and transfer standards) are defined in procedurcs.

c. Measuring and test equipment is calibrated at specified intervals or irnmediatelybefore use on the basis of the item's required accurasy, intended use, frequencyof use, and stability characteristics and other sonditions affecting itsperformance.

d. Measruing and test equipment is labeled, tagged, or otherwise controlled toindicate its calibration status and to ensure its naceability to calibration test data.

Measuring and test equipment is calibrated against standards that have anaccuracy of at least four times the required accuracy of the equipment beingcalibrated or, when this is not possible, have an accuracy that ensures theequipment being calibrated will be within the required tolerance.

If nationally recognized standards exis! calibration standards are to be traceableto them. Except where calibration standards with the same accuracy as theinstruments being calibrated are shown to be adequate for the requirements,calibration standards are to have a greater accuracy than the standards beingcalibrated.

Measuring and test equipment found out of calibration is tagged or segregated.The acceptability shall be determined of items measured, inspected, or testedwith an out-of-calibration device.

e

f,

oE.

h. Additional details concerning measuring and test equipment control may befound in the Regulatory Guides and associated Standards as committed to inSection A.7 and Table I (e.9., Regulatory Guides 1.30, 1.33, 1.94, 1.116, and1.123).

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10. Inspection, Test, and Operating Status

The status ofrequired inspections and tests and the operating status of items isverified before release, fabrication, receipt installation, test, and use, asapplicable. This verification is to preclude inadvertent bypassing of inspectionsand tests and to prevent inadvertent operation of controlled equipment.

b. The application and removal of inspection, test, and operating status indicatorsare controlled in accordance with procedues.

Additional details concerning inspection, test, and operating status contol maybe found in the Regulatory Guides and associated Standards as committed to inSection A.7 and Table I (e.9., Regulatory Ouide 1.33).

I l. Special Process Control

A program is established and implemented to ensure that special processes areproperly controlled.

The criteria that establish which processes ile special are described inprocedures.

Special proctrsses are accomplished by qualified personnel, using appropriateequipment, and procedures in accordance with applicable codes, standards,specifications, criteria, and other special requirements.

d. Additional details concerning special process control may be found in theRegulatory Guides and associated Standards as commiued to in Section A.7 andTable 1 (e.9., Regulatory Guide 1.33).

12. Inspection

A program is established and irnplemented for inspections of activities in orderto veriff conformance to the documented instructions, procedures and drawingsfor accomplishing the activity. The inspection program may be implemented byor for the organization perforrning the activrty to be inspected.

b. Provisions to ensure inspection planning is properly accomplished are to beestahlished. Planning activities are to identiff the characteristics and activities tobe inspected, the inspection techniques, the acceptance criteri4 and theorganization responsible for perfonning the inspection.

Provisions to identiff inspection hold points, beyond which work is not toproceed without the consent of the inspection organization, are to be defined.

a.

c.

a.

b

c.

i.

c.


FENOCFtslftr*gy l&nlear Opatrting fuirpxty Quality Assurance Program Manual

Inspection results are to he docunrented by the inspector and reviewed byqualified personnel.

Unaeceptable inspection results shall be evaluated and resolved in accordancewith procedures.

Inspections are performed by qualified personnel other than those whoperformed or directly supervised the work being inspected. While performingthe inspestion activity the inspectors functionally report to the associatedindividual responsible for quality control or an individual responsible formaterials, purchasing, and contracts as appropriate.

g. Additional details concerning inspections may be found iu the Regulatory Guidesand associated Standards as committed to in Section A.7 and Table I (e.g.,Regulatory Guides 1.33 and 1.58).

13. Corrective Action

Procedures shall provide for identification, evaluation, and resolution ofconditions adverse to quality.

Reworked, repaired, and replacement items are to be inspected and tested inaccordance with the original inspection and test requirements or specifiedalternatives.

Additional details conserning corrective action activities may be found inSection A.6, $ection A.1.f, and the Regulatory Guides and associated Standardsas committed to in Section A.7 and Table I (e.g., Regulatory Guides 1.33 andr.144).

14. Document Control

A program is established and implemented to control the development, review,approval, issue, use, and revision of documents.

b. The document control program shall be applied to docurnents that prescribeactivities affecting quality of safety-related strrctures, systems or components.Such activities include design, procurement, material control, installation,inspection, testing, maintenance, modifi cation, operation, refueling anddecommissioning.

d.

o.

f.

a,

b

c.

a.


FENOCfi rs lEn eryy l'tueJ an CI#ralhq Conq- ilt y Quali Assurance Program Manual

c Revisions of contolled documents are reviewed for adequacy and approved forrelease by the same organization that originally reviewed and approved thedocuments or by a designated organization that is qualified and knowledgeable.

d. Controlled documents are available to and used by the person performing theactivity.

The distribution of new and revised controlled documents is in accordance withprocedures. Superseded documents are controlled to prevent inadvertent use.

e.

f. Additional details concerning document contol may be found in Section A.l.fand the Regulatory Guides and associated Standards as committed to in SectionA.7 and Table I (e.9., Regulatory Guide 1.33).

15. Records

A prograrn is estahlished and implemented to ensure that sufficient records ofitems and activities (e.9., design, engineering, procurement, manufacfuring,construction, inspestion and test, installation, preoperation, startup, operations,rnaintenance, modification, decommissiodog, and audits) are generated andmaintained to reflect completed work.

b. The program provides provisions for the administration, receipt, storage,preservation, safekeeping, retrieval, ffid disposition of records.

Additional details conceming record requirernents may be found in theRegulatory Guides and associated Standards as comrnitted to in Section A.7 andTable I (e.9., Regulatory Guide 1.88).

C. ASSESSMENT

I. Methodology

Personnel responsible for carrying out audits are maintained cognizant ofday+o-day activities by the ongoing involvement in the qualrty assuranseprogram requirements so that they can act in a management advisory function.

b. Organizations performing audits are to be technically and performance orientedcoutmensurate with the activity being reviewed.

Personnel performing audits have no direct responsibilities in the area they areassessing.

Audits are acsomplished using procedures, or other appropriate means that are ofa detail coilImenswate with the activity's complexity and importance to safety.

a.

c.

a.

c

d


FENOCfirstEna ryy ltkr, lot ope:at/llig CDffDtiy Quality Assurance Program Manual

2. Audit

a.

I

A program ofplanned and periodic audits is established and implemented toconfirm that activities affecting quality comply with the QAPM and that theQAPM has been implemented effectively. Audits will be conducted as requiredby the applicahle Code of Federal Regulations, Technical Specifications, safetyanalysis reports, and comminnents by various correspondence to the NRC.Audits will be conducted at a frequency in accordance with either Section C.2.a.lor Section C.2.a.2 below.

Audit frequencies will be deterulined in accordance with a performancebased audit scheduling program. The scheduling prograrrl through anexpert panel, uses asssssment indicatons to identifu and schedule auditsbased on perforrranss results and importance ofthe activity relative tosafety. Potential audit subject areas are periodically assessed againstappropriate perfonnflnce criteria. From these reviews a determination ismade in regard to the depth, scope, and scheduling of specific audits.Functional axeas important to safety are assessed annually (t 25%) toidentiff strengths and weaknesses (if applicable) to determine the level andfocus of independent oversight activities for the upcoming year. The basisfor the assessment shall include the results of audits and surveillance, NRCinspections, LERs, self-assessments, and applicable conditions reports(e.g., non-conformance and corrective action reports). Personnel changes,change/increase in functional area responsibilities, industry operatingexperience, and INPO evaluations will also be considered. Each area willbe assigned a rating with a comparison to previous years. This assessmentwill be documentedn reviewed, and approved by qualrty assurancemanagement.

This document is considered a quality assurance record and will be available forNRC review. Audit subjectareas of Section C.2.a.2 shall continue to be audited onthe frequencies designated unless expert panel judgment, based on performanceresults, determines such an audit to be unnecessary. In such cases the expert panelbasis shall be documented.

Audit schedules assure that the following axeas are audited at the indicatedfrequencies, or more frequently as performanee dictates.

a. The conformance of unit operation to provisions contained within theTechnical Specifications and applicable license conditions at leastonce per 24 months.

b. The perfonnance, training and qualification of the station staffat leastonce per 24 months.

2

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c. The results of actions taken to correct deficiencies occuning in unitequipment, structures, systems or method of operation that affectnuclear safety at least once per 24 months.

d. The performancs of astivities required by the QAPM to meet therequirements of I0CFR50, Appendix B at least once per 24 months.

e. The fire protection program controls and implementing procedures atleast once per 24 months.

f. The fire protection equipment and program irnplementation at leastonce per 24 months utilizing either qualified licensee personnel or anoutside fire protection consultant.

g. The fire protection equipment and program implementation at leastonce per 36 months utilizing a qualified outside fire protectionconsultant.

h. The Radiological Environmental Monitoring Program (REMP) andradiological effluents monitoring activities and implementingprocedures at least once pvr 24 months.

i. The Offsite Dose Calculation Manual and implementing proceduresat least once per 24 months.

j. The Process Control Program and implementing procedures forprocessing and packaging of radioactive wastes at least once per 24months.

A grace period of 90 days may be applied to the 24 month frequency forinternal audits. For activities deferred in accordarce with the 90 day graceperiod, the next performance due date will be based on their originallyscheduled date.

Audits shall provide an objective evaluation of quality related practices,procedures, instrrrctions, activities, ood items and a review of docurnentsand records, as applicable,

Audits shall be performed in accordance with approved written proceduresor chEcklists. Items from previous audits shall be reviewed and reaudited,as appropriate. The checklists are used as guides to the auditor.

6. Scheduling and resource allocation are based on the status and safetyimportance of the activity or process being assessed.

Scheduling is dynarnic and resources are supplemented when theeffectiveness of the quality assuranee program is in doubt.

3

4

5

7


FEIUOCfirstEnargy ttwtear @eftttng funpeny Qual Assurance Program Manual

Audit reports are written and distributed to the appropriate levels ofmanagement for review. Follow-up action can be accomplished throughuryitten cofirmunication, re-audit, or other appropriate means, as deemednecessary.

Implementation of delegated portions of the quality assurance program isassessed.

10. Audits are conducted using predetermined acceptance criteria, which arethe individual requirements within the QAPM, applicable RegulatoryGuides and ANSI Standards, procedures, and documents that are used toperform the audited activity or procoss.

I l. Additional details concerning audits may be found in the RegulatoryCuides and associated Standards as committed to in Section A,7 and Table1 (e.9., Regulatory Guides 1.33 and I.144).

D. INDEPENDENT SAF'ETY REVIEW

l. Description

Independent safety review is perforrred to meet the individual unit'scornrnitment to perform the functions described in NUREG-0737, SectionI.B. 1 .2, "lndependent Safety Engineering Group. "

I

I

a.


FENOCFtrslEnargy NwEa,. Ope{etlng Cunpurl, Quality Assurance Program Manual

Table I -Regulatory Commitments

A. Regulatory Guide 1.8 (Revision l) [September 19751, Personnel Selection and Training

l. FENOC commits to the regulatory position of this Guide with the followingclarifications:

L. Regulatory Guide 1.8 states "The RPM should have a bachelor's degree or theequivalent in a science or engineering subject including some formal training inradiation protection and at least 5 years of professional experipnce in appliedradiation protection." It is FENOC's position that equivalent as used in thisRegulatory Guide for the bachelor's degree means (a) four years of post secondaryschooling in science or engiueering, or (b) four yeaf,s of applied experience at anuclear facility iu the area for which qualification is sought, or (c) four years ofoperational or technical experience or training in nuclear power, or (d) anycombination of the above totaling four years. The years of experiencs used to meetthe education requirements as allowed by this exception shall not be used to also meetthe experience requirements.

2. FENOC commits to the requirements of ANSI N18.1-1971 as modified by plant-specificTechnical Spebifi cations.

B. Regulatory Guide 1.30 (Revision 0) [Augurt 19721, Qualily Assursnce Requirements forthe Installation, Inspection, and Testing of Instrunrentation and Electric Eqaipment

l. FENOC commits to the regulatory position of this Guide.

2. FENOC commits to the requirements of ANSI N45.2.4-1972 with the followingclarifications:

a. Section 1.1 specifies equipment to which this Standard applies. In lieu of this,requirements of this Standard shall apply to those systems and components that arewithin the scope of the QAPM. Each plant maintains a list of equiprnent subject toQAPM requirements. This Standard is also applied to other systems and componentswhen required by approved procedures, engineering specifications, or other workcontrol I ing documents.

b. Section 2.2 requires that evidence of compliance by the manufacfurer with purchaserequirements, including qualrty assurance requirements, be available at the site priorto applying the requirements of ANSI N45.2.4. In lieu of this requirement,installarion, inspection, and testing activities of equipment lacking its qualitydocumentation may proceed provided that this equipment has been identified andreleased in accordance with non-conforming material procedures and that all requiredquality documentation has heen received and accepted prior to the item being placedin service.


FENOCFtrstfrteryy l*rclcar Oparatiry funpuy Qual Assurance Program Manual

c. Section 3 requires that records of protective measures maintained during storage forconformanffi to storage requirements be checked to verifr that items are insatisfactory condition for installation. This check shall be made only if equipmentrequires special storage or handling as specified in procurement documents.

d. Sections 5.2 and 6.2 list the tests which are to be conducted dtuing construction andpost-construction activities. ln lieu of these tests, FENOC shall conduct only thosetests neses$ary to veriff that work activities specified by rvork controlling documentshave been satisfactorily accomplished during maintenance or rnodification activities.The requirements of Sections 5.2 and 6.2 of AI.{SIN45.2.4 shall be used as guidelinesin determining these testing requirements.

e. Sestion 6.2.1 states in part that "Items requiring calibration shall be tagged or labeledon completion indicating date of calibration and identity of person that perforrred thecalibration." tn lieu of this requirement, FENOC may alternatively implementprogftrms that require the equipment to be suitably marked to indicate the date of thenext calibration and the identity of the person that performed the calibration. Inaddition, installed plant equipment that is used as measuring ard test equipment(M&TE) may be controlled to indicate its salibration status and to ensure haceabilityto calibration test data by alternate means in lieu of physically tagging or labeling(e. g., preventive maintenance program).

C. RegulatorX Guide 1.33 (Revision 2) [February 19781, Qualily Assurance ProgramReq ubements (Operations)

I. FENOC commits to the regulatory position of this Guide with the following alternatives:

a. Regqlatory Position C.4 specifies audit frequencies for several audit topics. QAPMSection C.2 (Audit) describes altematives to these frequencies.

2. FENOC comrnits to the requirements of ANSI Nl8.7-1976/ANS 3.2 with the followingclarifications and alternatives:

a. Section I requires that this Standard "apply to all activities affesting the safety-relatedfunctions of nuclear power plant structures, systems, and components." FENOC shallapply the requirements of this Standard to those structures, systems, and componentsidentified as safety-related in the respective plant's USAR,

b. Section 5.1 states in part that "a swnmary document should be compiled by eachowner organization to identiff the sources, to index such sources to the requirementsof this Standard, ffid to provide a consolidated base for the description of theprogram." In lieu of this requirement, a method of cross-referencing theserequirements to the implementing procedures will he maintained.

c. Section 5.2.? requires that'temporary changes which clearly do not change the intentof the approved procedure shall, as a minimum, be approved by two members of the

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plant staffknowledgeable in the areas affected by the procednre. At least one of theseshall be the supenrisor in charge of the shift and hold a senior operating license on theunit affected." Such changes shall be documented and if appropriate, incorporatedinto the next revision of the affected procedure. In lieu of these requirements,FENOC sommits to the followiug;

1) Temporary changes to procedures which do not change the intent of the approvedprocedure shall be approved for implementation by two members of the plantmanagement staff, at least one of whom holds a Senior Reactor Operating Licensefor the unit affected. The temporary procedures shall be approved by the originalapproval authority within 14 days. For changes to procedures which may involvea change in intent of the procedure, the original approval authority shall approvethe change prior to implementation. OR

2) Temporary changes to procedures will be approved by two knowledgeable members ofthe plant staffprior to implementation. At least one of thes€ persons will be a memberof superuision, tf the change affects operation$ procedures, at least one of thesepersons will hsld a senior reactor operator lisense for the unit affected. Prior toimplementation, the OSC (PORC) shall review and recommend approval of temporarychanges to procedures ruhich require a 10CFR50.59 safety evaluation. Within 14 daysof implementation, temporary changes will be reviewed by an independent qualifiedreviewer and approved by the Responsible Discipline Manager or his designee.

d. Section 5.2.6 requires that a log be maintainEd to identifiy the crurent status oftemporary modifications such as bypass lines, electrical jumpers, lifted electricalleads, and temporary trip point settings. FENOC takes exception to this requirementwhen the installation and removal of sush temporary rnodificatious is specificallyaddressed in approved procedures. These procedures ensrue that the circuitry isreturned to its original configuration when the operation is eompleted.

e. Section 5.2.7 - Since certain emergency situations could arise which might preventpreplanning activities, FENOC complies with an alternative to the first sentence inthe second paragraph as follows: ooExcept under emergency or abnormal operatingconditions where immediate actions af,e required to protect the health and safety ofthe public, to protect equipment or personnel, or to prevent the deterioration of plantconditions to a possibly unsafe or unstable level, maintenarce or modification ofequipment shall be preplanned and perfonned in accordance with approvedprocedwes. When written procedures would be required and are not used, theactivities that are accomplished are documented after-the-fact and receive the samedegree of reviews as if they had been preplanned."

f. Sestion 5.?.13 (l) establishes the requirement for identiffing quality assuranceprogram requirements applicable to the items or ssrvices being procrued. Whenpurchasing commercial grade services from certain accredited calibrationlaboratories, the procurement documents are not required to irnpose a qualityassurance program consistent with AIISI N18.7. Alternative requirements described

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in this QAPM for Regulatory Guide 1.123 may be implemented in lieu of imposing aquality assurance program consistent with AhISI N18.7.

g. Section 5.2.15 contains a requirement for biennial review of plant procedures. In lieuof this requirement, FENOC may use one of the following methods as alternatives:

1) Implement process controls that ensrre procedures axe reviewed for possiblerevision upon identification of new or revised souce material potentially affectingthe intent of procedures.

2) Implement process contols related to procedrre review, a matrimum six yearreview period and biennial audits of operating organizations that include a reviewof their procedures to assure that controls result in timely procedure revision inresponse to operations experience deficiencies and procedure deficienciesidentified by users.

h. Section 4.3.4 (3) discusses the requirement for the on-site and off-site independentreview bodies to review license amendments and technical specification changes. Asan alternative to the requirements for the offisite review hody to review licenseamendments and technical specification changes, FENOC will utilize the on-sitereview body for these reviews. To ensure that the on-site review body maintainsindependsnce during these reviews, any voting rneruber that has a potential conflict ofinterest in a change under review will be replaced by another member to achieve aquonrm. In additiono the off-site review body will review on-site review bodymeeting minutes and independent oversight (QA) audit and assessment results of on-site review body activities to evaluate their effectiveness.

D. Regulatory Guide 1.37 (Revision 0) [March l]731, Quality Assurance Requirements forCleaning of Fluid Sysfems and Associated Components of Water-Cooled Nuclesr PowerPlants

l. FENOC commits to the regulatory position of this Guide with the followingclarifications:

a. Regulatory Position C.3 requires that water quality for final flushes of fluid systemsand associated components be at least equivalent to the quality required for nornnaloperation. This requirement is not applied to dissolved oxygen or nitrogen nor does itinfer that additives norrrally in the system water shall be added to the flush water.

b. Regulatory Position C.4 requires that chemical components that could contribute tointergranular cracking or stress corrosion cracking should not be used with austeniticstainless steel and nickel-based alloys. It is FENOC's position that materials such asinks, temperature indicating crayons, labels, wrapping materials (other thanpolyethylene), water soluble materials, desiccants, lubricants, and NDE penetrantmaterials and couplants, which contast stainless steel or nickel-based alloy rnaterialsurfaces contain no rnore than trace amounts of lead zinc, copper, or lower melting

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alloys or compounds. Maximum allowable levels of water leachable chloride ions,total halogens and sulfur compounds shall be defined and imposed on theaforementioned materials. These materials will be controlled through administativeprocedues that are, in part, designed to minimize their effects on intergranularcracking or stress corrosion cracking.

2. FENOC commits to the requirements of ANSI N45.2. l-1973 with the follo*ingclarifications:

a. During maintenanse and modification activities, FENOC shall control the opening ofclean systems and shall conduct inspections to veriff that affected system cleanlinesslevels shall not he adversely affected by the maintenance or modification activrty.When system cleanliness is affected, specifi.c cleaning procedures which incorporatethe applicable portions of this Standard shall be developed and implemented tomaintain system cleanliness.

b. Section 2.4 requires that personnel who perform inspection, examination or testingactivities required by this Standard be qualified in accordance with ANSI N45.2.6. Inlieu of this, personnel who perform cleanliness inspections may altematively bequalified in accordance with Regulatory Guide 1.8,

E. Regulatory Guide 1.38 (Revision 2) [May l}Tflr Eual@ Assurnnce RequirementsforPac*agtng, Shipping, Receiving, Storage, and Handling of ltems for Water-CooledNuclear Power Plants

1. FENOC comurits to the regulatory position of this Guide.

2. FENOC commits to the requirements of ANSI N45.2.2-1978 with the followingclarifications:

a. Sections 3 and 4 specifr a four level classification system for the packaging andshipping of items. In lieu of these requirements, commercial grade items shall bepackaged and shipped in accordance with standard conrmercial practices.

b, Section 5.2.1 requires preliminary visual inspection or examination for shippingdamage to be performed prior to unloading. In lieu of this requirement, visualinspection shall he performed during unloading and unpacking.

c. Section 5.5 provides for "rework" and 'ouse-a.s-is" dispositions for nonconformingitems. As an altemative, the *repair" disposition (as defined by ANSI N45.2.10-1973) may also be used.

d. Section 6.5 requires that items released frorn storage and placed in their finallocations within the power plant be inspected and cared for in accordance with therequirernents of Section 6 of this $tandard and other applicable Standards. In lieu ofthis requirement, FENOC shall, whenever feasible, store items within their


FENOCFrsl&re4gy l*rcleer O#taling CotlEi,rty Qual Assurance Program Manuel

appropriate storage area and move the equipment to the plant areas for staging only insufficient time to support its installation. Within the plant, the equipment shall bestaged at locations which provide equivalent environmental conditions under which itis designed to operate. Materials placed in staging areas shall be stored in accordancewith the applicable requirements of Paragraphs 6.1, 6.3 and 6.4.2 of ANSI N45.2.2.

e, Various Sections of ANSI N45,2.2 address the use of non-halegenated materialswhen in contact with austenitic stainless steel or nickel-based alloys. The exceptionsapplicable to Regulatory Guide 1.37 regarding this subject also apply to ANSIN45.2.2.

f. Section A.3.4.2 addresses inert gas blankets. There may be cases involving large orcomplex shapes for which an inert or dry air purge flow is provided rather than staticgas blankets in order to provide adequate protection due to diffrculty of providing aleak-proof barrier. In these sa$es, a positive pres$we purge flow may be used a$ analternative to a leak-proof barrier.

f,'. Regulatory Guide 1,39 (Revision 2) [Septemher 19771, Househeeping Requiremcn# torWater-Cooled Naclear Power Plsnts

1- FENOC commits to the regulatory position of this Guide.

2. FENOC sonrmits to the requirements of ANSI N45.2.3-1973 with the follo*ingaltemative.

a. The ANSI five level zone designation system may not he utilized, but the intent of thestandard will be met for the areas of housekeeping, plant and personnel safety, andfire protection.

G. Regulatory Guide I.58 (Revision 1) [September 19801, Qualifwation of Nuclear PowerPlont Inspection, Examination and Testing Personnel

l. FENOC comrnits to the regulatory position of this Guide with the followingclarifications:

a. The guidance of this Regulatory Guide shall be followed as it pertains to thequalification of personnel who verify conformance of work activities to qualityrequirements.

b. Personnel will not be certified as stated in this Guide in the following areas:

1) Individuals that handle test results or perform document sontrol activities.

2) Qualtty assurance and staff per$onnel responsible for the review of documents forclarity and completeness.


FENOCFtrslfttargy Nl*.teu Opaatiog fuinpdtly Quali Assurance Program Manual

3) Test personnel utilizing gas test methods for information or data collectionactivities (this includes those personnel performing local leak rate testing (LLRT)as stated in 10CFR50 Appendix O. The qualifications of these p€r$onnel shallconform to the requirements of Regulatory Guide 1.8.

4) Plant operation personnel concerned with day-to-day operition, maintenance, andcertain technical services (the qualifications of these personnel shall conform tothe requirements of Regulatory Guide 1.8).

c. Regulatory Position C.2 indicates that SNT-TC-l A-1975 is to be used for thequalification of nondestructive examination (NDE) personnel who apply variousNDE methods. It also indicates that personnel perforrning nondestrustiveexarninations required by Section III and Section XI of the ASME Code should bequalified to SNT-TC-IA-1975 as well as additional provision of the Code. For thequalification of NDE personnel, FENOC comurits to the ASME Section )ilrequirernents specified within the applicable code year edition(s) as defined byl0CFR50.55a. This altenrative may be applied regardless of whether exarninationsare of a type required by the Code.

2. FENOC commits to the requirements of A}.ISI N45.2.6-1978 as modified by thecommitnents to Regulatory Guide 1.58 with the following clarifications:

a, Section 2.5 of this Standard discusses special physical characteristics. FENOCcommits to the following: Examinations to veriff that personnel have the requiredphysical characteristics will be scheduled on an annual basis with a maximumallowahle extension of 90 days.

b. Section 3.5 of this Standard dissusses education and experience. FENOC commits tothe following: The initial qualifications of individuals to Level I, il, or III willgenerally be to the education and experience recoilrmendations in the Standaxd.However, in certain instances as determined by appropriate management,qualifications may be alternatively determined through test results and/ordemonstration of capabilities. For Level I, FENOC will also accept a four yearcollege degree plus one month of related experience or equivalent inspection,examination or testing activities. Individual requalification will meet or exceed therecommendation of this Standard.

c. Section 2.3 of this Standard discu$ses evaluating personnel who have not performedinspection activities for more than a year. A 90 day grace period is applied to thisevaluation.

H. Regulatory Guide 1.64 (Revision 2) [June 19761 , SuaW Assurance Requirements for theDesign of Nuclear Power Planfr

I . FENOC comrnits to the regulatory position of this Guide with the followingclarifications:


FENOCFvstEnetgy l,lt'lr,larrr Oryralhg Con4ny Quality Assurance Program Manual

r.

J

a. Regulatory Position C.2(l) addresses the use of a supervisor in design verification.If, in exceptional circumstances, tlre supervisor is the only technically qualifiedindividual available, the design verification or checking shall be conducted by thesuperrrisor with the following provisions:

U The other requirements of Regulatory Position C.2 of this Guide shall be met.

2) The justification shall be individually documented and approved by the next levelof supenrision.

3) Quality assurarce audits shall include review of frequency and effectiveness ofthe use of the immediate superuisor to assure that this provision is used only inexcepti onal circumstance s.

b. An individual who contributed to a given design may participate in a groupverification of that design provided that the individual who contributed to the designdoes not (l) veriff his contribution to the design, or (2) serve as chaifinan or leader ofthe group verification activity.

?. FENOC commits to the requirements of AI.{SI N45.2.1l-1974 with the clarifications asnoted above for the use of an immediate supervisor for design verification activities andconduct of group verification activities.

Regulatory Guide 1.74 (Revision 0) [F'obmary 1974lr $uahty Assurance Terms andDetinitinns

1. FENOC commits to the regulatory position of this Ouide.

2. FENOC commits to the requirements of ANSI N45.2.10-1973.

Regulatory Guide 1.88 (Revision 2) [October 19761, Collection, Storage andlllaintenance of Nucleor Power Plsnt Qaahfy Assurance Records


2. FENOC commits to the requirements of ANSI N45.2.9-1974 with the follo*ingaltematives:

a. Section 5.6 addresses records storage facilities. In lieu of this, the design andsonstruction of quallty assurimce record storage facilities will follow the guidance ofANSVASME NQA-I-1983, Supplement l7S-1, Section 4.4. When temporarystorage of records is required, the guidance of ASh,{E NQA-1-1989, Supplement l7S-1, Section4.4.3 will be followed. For storage of special processed records (such asradiographs and microfilm), humidity and ternperature controls shall be provided soas to maintain an environmental condition fls prescribed in Paragraph 6.1 .1 of AIISIPH 1.43-1979 (Also required by Section 5.4).


FENOCFrsi6ltargy tluctaar Oprdiq hnpmy Quality Assurance Program Manual

b. Appendix A of ANSI N45.2.9, re4uires that records of measuring and test equipmentcalibration be maintained "rurtil recalibration." This implies that the full storagerequirements of this Standard apply until the equipment is recalibrated. In lieu of thisrequirement, FENOC may store measuring and test equipment calibration records inone-hour fire rated containers. This exception dops not apply to records of calibrationrequired by the Technical Specifications.

c, For managing QA records in electronic media FENOC commits to the guidance ofRIS-2000-018. ThisNRC Regulatory Issue Summary (RIS) endorses:

NIRMA Techdcal Guide (TC) I l -1998, Authentication of Records and Media

NIRMA TG 15-1998, Management of Electronic Records

NIRMA TG 16-1998, Software Configuration Management and QualityAssurance

NIRMA TG 21-1998, Electronic Records Protection and Restoration

a

a

a

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K. Regulatory Guide 1.94 (Revision 1) [April 19761, Saahly Assurance RequtrementsforInstullation, Inspection and Testing af Structural Concrete and Stractural Steel Duringthe Construction Phase of Nuclear Power Plants


2. FENOC commits to the requirements of ANSI N45.2,5 -1974 with the follo*ingclarifications and altematives :

a" Section 2.2 rcqaires that installation, inspection, and test procedures be kept currentwith the latest information. This Standard was rnritten to address requirementsassociated with construction phase activities. However, during the operations phase,activities associated with installation, inspection, and testing of stnrcfural concreteand structural steel are very minor in frequency and extent. Consequently, proceduresfor these activities shall only be reviewed or updated prior to commencing theactivity. The procedures for structural concrete and structtral steel installation,inspection, and testing activities will be developed using the provisions of ANSIN45.2.5 - 1974.

b. Alternatives to this Standard are taken with respect to frequency of calibration ofimpact wrenches and bolt projection criteria. Impact and torque wrenches shall bechecked at least once daily per shift, ffid at least one full thread of all bolts shallproject beyond the nut of all tightened connections. These criteria cornply with thereconrmendations of the Research Council on Riveted and Bolted Structural Joints.

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c. Section 4.9.1 discusses the qualification requirements for meshanical (cadweld) spliceoperators. In lieu of this, Davis-Bfisse and Beaver Valley will comply withqualification requirements of ASME Section III, 1995 Edition, subparagraph CC-4333.4.

d. Section 4.9.3 discusses tensile testing of rnechanical (cadweld) splices. In lieu of this,Davis-Besse and Beaver Valley will comply with the requirements of ASME SectionilI, 1995 Edition, subparagraph CC-4333.5.2.

e. Section 4,9.4 discusses tensile testing frequency. In lieu of this, Davis-Besse andBeaver Valley will comply with ASME Section III, 1995 Edition, subparagraph CC-4333.5.3.

f. Section 4.9.4 discusses testing of both production and sister mechanical (cadweld)splices. In lieu of this, Davis-Besse and Beaver Valley will test sister mechanical(cadweld) splices as described in ASME Section III, 1995 Edition, subparagraph CC-4333.5.2.

g. Section 5.5 discusses inspection of structural steel welding. In lieu of this, Davis-Besse and Beaver Valley will comply with inspection requirements of the applicablewelding codes and any exceptions.

h. The rnechanical splice personnel qualification, testing and testing frequencyrequirements for mechanical (cadweld) sptices addressed in K.Z.c through K.z.f applyto other full positive connection technologies that meet the design code of record. Thefrequency of shear screw and sleeve splice testing shall meet the same requirementsas swaged splices.

L. Regulatory Guide l.116 (Revision 0) [May L977l,8uahty Assurance RequiremenfrforInslallalion, Inspection and Testing of Mechanical Equipm,ent and,Systerrs

t. FENOC commits to the regulatory position of this Guide.

2. FENOC cornmits to the requirements of AI.ISI N45.2.8-1975 with the followingclarifications:

a. Sections 2.4 and 2.5 require that procedures define system restoration requirements asneeded to prevent contamination after cleanliness class is achieved in accordance withcommitnents to AI.{SI N45.2.1 and ANSI N45.2.3.

b. Section 2.9 requires that evidence of compliance by the manufacturer with purchaserequirernents, including qualrty assurance requirements, be available at the site priorto applying the requirements of this Standard. In lieu of this requirement, section 8.4(Procurement Control) of this manual describes the controls for equipment lackingquality documentati on.


FENOCFrilft e4y l*rl*ar Oryating Coa4ny Quality Assurance Program Manual

c. Section 4.5.1 provides requirements for the cleaning, flushing, and conditioning ofinstalled systems. FENOC's position on Regulatory Guide 1.37 and ANSI N45.2.1also apply to this Section and take precedence over the requirements of ANSIN45.2.8 when conflicts exist.

M. Regulatory Guide 1.123 (Revision 1) puly 19771 , SuaW Assurance Reqniremcn# forControl of Procaremcnt of ltems and Services tor Nuclear Power Planfr

l, FENOC commits to the regulatory position of this Guide.

2. FENOC com:nits to the requirements of ANSI N45.2.13-1976 with the followingclarifications, exceptions and alternatives :

a. Subsection 3.2.3 discusses quality assurance program requirements for procurementdocuments. For the purchasing of commercial grade calibration services fromdomestic calibration laboratories accredited by a nationally recognized accreditingbody, the procurement documents are not required to impose a quality assuranoeprogftrm consistent with AIISI Nl8,7.

In such cases, accreditation may be acceptable in lieu of the purchaser imposing a QAprogram consistent with AI.ISI NI8.7, provided all the following are met:

l) The accreditation is to ISOIIEC 17025,

2) The calibration laboratory holds a domestic acsreditation by one of the followingaccrediting hodies, which are recognized by the International LaboratoryAccreditation Cooperation (ILAC) Mutual Recognition Arrangement {MRA};- National Yoluntary Laboratory Accreditation Program (NVLAP), administeredby NIST- American Association for Laboratory Accreditation (A2LA)- ACLASS Accreditation Services (ACLASS)- International Accreditation Service (IAS)- Laboratory Acmeditation Bureau (L-A-B)

3) The published scope of accreditation for the calibration laboratory covers theneeded measurement parameters' ranges, and unceftainties.

4) The purchase documents impose additional technical and administrativerequiremsnts, as neces$flry, to satisfu FENOC QA Program and technicalrequirements. This will include requiring that the supplier identiff the laboratoryequipment/standards used and the as-found and as-left data in the calibrationcertificate/report.

5) The purchase documents require reporting as-found calibration data whencalibrated items are found to be out-of-tolerance.


FENOCFrxtEnegy l,ltxbil C4,arathg CaWfiy Quality Assurance Program Manual

b. The alternative method is applicable to sub-suppliers of calibration service suppliersoprovided the above conditions are met.

c. Section 4 provides for the selection of procurement sources. For "commercial grade"items and for non-safety related items within the scope of the Quality AssuranceProgram for which there are no quallty assurance program or quality documentationrequirements, the requirements of this Section need not be adhered to. However, theprocurement documents shall speciff requirements specific to the item beingprocured, sufficient to provide adequate certification or other records to ensure thatitems and activities meet the specified requirernents.

d. Sestion 8.2 provides requirements for the control of nonconformances. Suppliersqualified by FENOC as design agents in accordance with Regulatory Guides 1.64 andI .123 may he permitted under specific conhactual provisions to dispositionnonconformanc€s as o'use-as-is" or o'repair" on behalf of FENOC. Allnonconformances dispositioned'trse-as-is" or'orepair" by suppliers qualified byFENOC as design agents on behalf of FENOC are required to be submitted toFENOC for engineering approval at the time equipment is received on site. IfFENOC determines that a disposition has been incorrectly made, a nonconformancereport is generated on site to document the problem and effect resolution.

e. Section 10.2.d is interpreted as follows: The peffion attesting to a certificate shall bean authorized and responsible employee of the supplier and shall be identified by thesupplier.

N, Regulatory Guide 1.144 (Revision U [September l980lrAudifing of Quality,4ssarancePrugramstor Naclear Power Planfr

1. FENOC commits to the regulatory position of this Guide with the following alternatives:

a. Section C.3.b (2) outlines the requirements for triennial audits and annual evaluationsof suppliers. A 90 day grace period may be applied to these activities. For triennialaudits and annual evaluations that are deferred, the next performance due date will hebased on the originally scheduled date.

b. Section C.3.b (2) outlines the requirements for friennial audits and annual evaluationsof suppliers. When purchasing commencial grade calibration senrices from domesticcalibration laboratories accredited hy a nationally recognized accrediting body, theaccreditation process and accrediting body may he credited with carrying out aportion of the purchaser's duties of verifoing acceptability and effectiveimplementation of the calibration service supplier's qualrty assurance program.

In lieu of performing an audit, accepting an audit by another licensee, or performing acoillmercial grade survey, a documented review of the supplier's accreditation shallbe performed by the purchaser. This review shall include, at a minimum, all of thefollowing:


FENOCFnstEnergy llt rr,laa t Wwatiry cr'7,,pf}y Quality Assurance Program Manual

l) The accreditation is to ISOflEC 17025.

2) The calibration laboratory holds a domestic acueditation by one of the followingaccrediting bodies, urhich Elre recognized by the International LaboratoryAccreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA):

- National Voluntary Laboratory Accreditation Program (NVLAP), administeredby the National Institute of Standards and Technology (NIST)- Arnerican Association for Laboratory Accreditation (A2LA)- ACLASS Accreditation Sen ices (ACLASS)- Intemational Accreditation Service (IAS)- Laboratory Accreditation Bureau (L-A-BJ

3) The published ssope of accreditation for the calibration laboratory covers theneeded measurement parameters, ranges' and uncertainties.

c. The alternative method is applicable to sub-suppliers of calibration service suppliers,provided the above conditions axe met.

d. Section C.3.b (2) outlines the requirements for fiiennial audits and annual evaluationsof suppliers. Instead of documenting evaluations of suppliers on an annual basis,FENOC may document evaluations of suppliers on an ongoing basis, using theguidance of Section C.3.b of this Regulatory Guide. The results of these ongoingevaluation$ are reviewed and appropriate corrective actions taken. Adverse findingsresulting from these evalu,ations are periodically reviewed in order to deterrnine if, asa whole, they result in a significant condition adverse to qualrty and to provide inputto support supplier audit activities conducted by the licensee or a third party auditingentity.

2. FENOC commits to the requirements of ANSI N45 .2.12-1977 with the followingclarification:

a. Section 4.5.1 of this Standard discusses follow-up and corrective actions. FENOCmay utilize the provisions of the corrective action program outlined in Section A.6instead of these requirements, as long as the appropriate time limits are applied tosignificant conditions adverse to quality. Also, no additional documentation isnecessary if needed corrective actions are taken and verified prior to audit reportissuance.

b. Sections 4.3.1 and 4.3.3 of this Standard discuss pre-audit and post-audit conferences.Pre-audit and post-audit conferences may he fulfilled by a variety of communications,such as telephone conversation.

c. Section 4.3.1 and 4.3.3 of this Standard discuss pre-audit and post-audit conferences.Pre-audit and post-audit conferenses are only held when deemed necessary by qualrtyassurance or when requested by the audited organization.

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FENOCFtt,rEt?E,tgy lgl/E,l$t Oprating Cunpury Quality Assurance P rogram Manual

d. Section.4.4 discusses audit reporting. Audit reports shall be issued within thirfyworking days after the last day of the audit. The last day of an audit shall beconsidered to be the day of the post-audit conference. If a post-audit conference isnot held hecause it was deemed unnecessily, the last day ofthe audit shall beconsidered to be the date the post-audit conference was deemed unnecessary asdocumented in the audit report.

O. Regulatory Guide 1.146 (Revicion 0) [August 19801, Qualificarion of Suality AssuranceProgrom Aadit Perssnnelfor Nuclear Powu Plnnts

1. FENOC commits to the regulatory position of this Guide.

2. FENOC commits to the requirements of ANSI N45.2.23-1978 with the followingaltematives.

a. Section 2.3.1.3 discusses other credentials of professional competence. Holders ofNRC issued Reactor Operator/Senior Reactor Operator Licenses comply with therequirements of this section aud may be awarded two credits.

b. Section 2.1.4 discusses audit participation. Prospective lead auditors shalldemonstrate their ability to effectively implernent the audit process and lead an auditteam. They shall have participated in at least one nuclear audit within the yearpreceding the individual's effective date of qualification. Upon successfuldernonstration of the ability to effectively lead audits, licensee managernent rnaydesignate a prospective lead auditor as a lead auditor.

c. Section 3.2 requires m annual evaluation of lead auditors. A 90 day grace periodmay be applied to the annual evaluation. For those evaluations that are deferred, thenext performance due date will be based on the originally schedule date.

d. Section 5.3 requires that records for lead auditors be rnaintained and updatedannually. A 90 day grace period rnay be applied to the annual update. For thoseupdates that are defened, the next perfomrance due date will be based on theoriginally schedule date.

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Summary of Changes to the FirstEnergy Nuclear ... - NRC

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