L-19-177, Summary of Changes to the Firstenergy Nuclear Operating Company Quality Assurance Program Manual for Beaver Valley Power Station, Unit Nos. 1 and 2, Davis-Besse Nuclear Power Station, and Perry Nuclear Power Plant

Summary of Changes to the Firstenergy Nuclear Operating Company Quality Assurance Program Manual for Beaver Valley Power Station, Unit Nos. 1 and 2, Davis-Besse Nuclear Power Station, and Perry Nuclear Power Plant

ML19281A499
Person / Time
Site:	Beaver Valley, Davis Besse, Perry
Issue date:	10/08/2019
From:	Benyak D FirstEnergy Nuclear Operating Co
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
L-19-177
Download: ML19281A499 (40)

Text

FENOC 341 White Pond Dr.

Abon, Ohio 44320 Fftst gn6qg, }\trclffi @ati6 furprlny October 8, 2019 L-19-177 10 CFR 50.54(a)(3) 10 cFR 71.106(b)

ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

SUBJECT:

Beaver Valley Power Station, Unit Nos. 1 and 2 Docket No. 50-334, License No. DPR-66 Docket No. 50.412, License No. NPF-73 Davis-Besse Nuclear Power Station Docket No. 50-346, License No. NPF-3 Perry Nuclear Power Plant Docket No. 50-440, License No. NPF-58 Summarv of Chanoes to the FirstEnergv Nuclear Operatinq Companv. Qualitv Assurance 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 Nuclear Operating Company (FENOC) is submitting a summary of changes to the FENOC Quality Assurance Program Manual (AAPM) that did not reduce commitments in the quality assurance program description, and therefore, did not require Nuclear Regulatory Commission (NRC) approval prior to implementation. There were no changes to the QAPM that required NRC approval prior to implementation, Previous submittals of the FENOC QAPM were provided as part of the Updated Final Safety Analysis Reports (UFSAR) submitted under 10 CFR 50.71(e); however, FENOC is now submitting QAPM changes annually. To ensure a good transition and to document the changes, FENOC is providing a summary of changes for the last four revisions to the QAPM. Future revisions will include a summary of changes within the QAPM. The current FENOC QAPM Revision?4 was submitted by letter dated May 14, 2019 (Accession No. ML19151A181), with the Updated Final Safety Analysis Report for the Beaver Valley Power Station, Unit No. 2. The Enclosure to this letter provides a copy of FENOC QAPM, Revision 24 for information purposes only.

Beaver Valley Power Station, Unit Nos. 1 and 2 Davis-Besse Nuclear Power Station Perry Nuclear Power Plant L-19-177 Page 2 The summary of the changes for Revisions 21,22,23, and 24 for the FENOC QAPM is provided in Attachment 1 of this letter.

There are no regulatory commitments contained in this submittal. lf there are any questions 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. Benyak Vice President, Nuclear Suppoft and Regulatory Affairs Attachments:

FENOC QAPM Revisions 21 , 22,23 and 24 - Summary of Changes Enclosure FENOC QAPM Revision24 - Current Revision cc: NRC Region lAdministrator NRC Region III Administrator NRC Project Manager - FENOC FIeet NRC Resident lnspector (Beaver Valley)

NRC Resident Inspector (Davis-Besse)

NRC Resident lnspector (Perry)

Director BRP/DEP Site BRP/DEP Representative Utility Radiological Safety Board

Attachment 1 L-19-177 FENOC QAPM Revisions 21, 22,23 and 24 - Summary of Changes Page 1 of 1 REVISION EFFECTIVE CHANGED DESCRIPTION OF CHANGE DATE SECTIONS 24 3t4t2019 A.2.a, A.2.a.1.b The Chief Nuclear Officer (CNO) assumes the responsibility from the executive responsible for operations to act as the singular point of contact with respect to the operation of the four FENOC power plants and provides operationa! oversight. The site executives retain responsibility for overall plant nuclear safety and operations.

This change results in changes to section 4.2.a and A.2.a.1.b. The change was reviewed in accordance with 10 CFR 50.54(a) and did not reduce FENOC commitments previously approved by the NRC.

23 3t13t2018 4.2.b.3, The management position responsible for 4.2.b.1.b licensing and regulatory affairs changed from reporting to the Chief Nuclear Officer (CNO) to reporting to the executive responsible for operations. This results in deleting section A.2.b.3 and addition of new section A.2.b.1.b. The change was reviewed in accordance with 10 CFR 50.54(a) and did not reduce FENOC commitments previously approved by the NRC.

22 il23tzo18 A.2.a, 4.2.a.1, The FENOC President and Chief Nuclear A.2.a.1 .a), A.2.b, Office (CNO) title is changed effective on A.3.c March 5, 2018. The change to the QAPM deletes reference to President and only retains the CNO title in sections A.Z.a, 4.2.a.1, 4.2.a.1.a), A.z.b, A.3.c The change was reviewed in accordance with 10 CFR 50.54(a) and did not reduce FENOC commitments previously approved by the NRC.

21 3t29t2017 A.2.b.3 Due to organizational changes in FirstEnergy Generation Step A.2.b.3 was revised to delete laboratory services from the management position responsible for licensing and regulatory affairs. The change was reviewed in accordance with 10 CFR 50.5a(a) and did not reduce FENOC commitments previously approved by the NRC.

Enclosure L-19-177 FENOC QAPM Revision24 - Current Revision (36 pages follow)

FENOC FhrlErx4gr f,It4err Openting tltraponi. Qual Assurance Program Manual Benver Valley Power Station Units I &.2 Docket Nos. 5G334 & 50-412 Operating License Nos. DPR-66 & hIPF-?3 Davis-Besse Nuclear Power Station Docket No. 50-346 Operating Licen$e No. NPF-3 Perry Nuclear Power Plant Docket No. 50440 Operating License No. NPF-58 Approved By: 03/04/1 9 President - Fleet Oversight Revision: 24 I of16

FENOC FrstEn ery y Nw I d u @cratfiry tarp eny Quali Assurance Program Manual TABLE OF CONTENTS A. MANAGEMENT

1. Mothodolory 5

t. Organization 6

3. Responsibility I

4. Authority 9

5. Peroonrel Training and Qualification 9

6. Corrective Action I

7. Regulatory Commitments l0 B. PERX'ORMANCE/YERIFICATION

1. Methodologr 11

2. Deeign Control 11

3. Design Verificntion L2

4. Procurement Control t3 J. Pro cu rement Verification I4 D

6. Identification and Control of ltems l4

,l

,. Ilandling Storage, and Shipping l5

8. Test Control l5

9. Mensuring and Test Equipment Control 16

10. Inspection, Test, and Operating Stafus t7 I1, Special Process Control t7

12. Inspection t7

13. Corrective Action 18

14. Document Control l8

15. Records l9 C. ASSESSMENT

1. Methodolory t9

2. Audit 20 D. INDEPENDENT SAFETY REVIEW

l. llescription 77 Revision: 24 2 of36

FENOC FnstErd4gy I*rcJeer A,faury Bmryny Quality Assurance P rogram Manual TABLE OF CONTENTS (Continued)

Table I

• Regulatory Commitments A. Regulatory Guide 1.8 (Revision t) [September 19751, Personnel Selection and Training [ANSI NI.8.tl 23 B. Regulatory Guide 130 (Revision 0) [Augu$t 19721, Sualrty Assurance Requiremenls for lhe Instalfialion, Inspectian, rnd Testing of Instramentation and Electric Equipmenr [ANSI N45.2.4] 23 C. Regulatory Guide 133 (Rtvisiotr 2) [February 19781, Suatrfy Assurance Prugram Requirements (Operations) [AFISI N18.71 24 D. Regulatory Guidel.3l (Revision 0) [March 19731, SuaIW Assurance Reqairements for Cleaning af Fluid Syslerer and Assocified Components of Water*Cooled Nuclear Power Planr. IAI{SI N45.2.11 26 E. Regulatory Guide I.38 (Revision 2) [May 19771]

Qur,ltp r4ss ur anc e Req uiremcnts fo r Packagin g, Shipping, Reeeiving, Storage, and Hundling of ltems for Water-Cooled Nuclesr Power Plants [ANSI N45.2.21 27 F Regulatory Guide 1.39 (Revision 2) [Septcmber 19771, Houst*eeping Req uire ments for Water-Cooled Naclear Power PIanfr IANSI N45,2.31 28 G Regulatory Guide 1.58 (Revision l) [September lg80f, Qaa{f,tcation of Nuclear Power Plant Inspection, Exartnafian and Testing Ferssnnel [ANSI N45.2.61 28 H. Regulatory Guide 1.64 (Revision 2) pune 19761,

$uiltty Assurance Requiremen$for the Design of Nuclear Power Plants IAIISI N45.2.1U 29 I. Regulatory Guide 1.74 (Revision 0) [f,'ebruary 19741, Quality Assurance Terms and Detinitions [ANSI N45.2.10] 30 Revision: 24 3 of36

FENOC FirstEne4gy Ali.r3,sa r Dpaathg C$1pany Quality Assurence P rogram Manual TABLE OF COhITENTS (Continued)

Tahle I - Regulatory Commitments (Continued)

J. Regulatory Guide 1.88 {Revision 2) [October 1976J, Coltection, Storage and Mainlenance of Nuclear Fower Plant frual@ Assurance Records [ANSI N45.2,91 30 K. Regulatory Guide I.94 (Revision 1) [April 19761, Quality Assarfrnce Requirements for Installation, Inspection and Testing at Concrete and Structural Steel During the Construction Phuse of Nuclear Power Plqnts

[AI{SI N45.2.51 31 L. 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 32 M. Regulatory Guide 1.123 (Reviciotr I) [July 19171, Quality ,4ssarance Requirements for Control of Procuremcnt of llems and Sewices for Nuclear Power Plants IANSI N45.2,131 33 N. Regulatory Guide 1.144 (Revision f) [Septemher 19801, Auditing af Qadity Assurance Progranu for Nuclear Power PlanB IANSI N45.2.12] 34

o. Regulatory Guide 1.146 (Revision 0) [Auguct 19801, Qualilication of Qaality Assurance Program Audit Personneltor Nuclear Power Plants [ANSI N45.2.231 36 Revision: 24 4 of36

FENOC FnstEneryy MrcJear Opraring Col,rpcny Qual Assurance Program lUlanual A. MANAGEMEIIIT

l. Methodolory

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

b The requirements and commitments contained in the QAPM are mandatory and must be implemented, enforcedo flnd adhered to hy all individuals and organizations. Employees axe expected to actively participate in the continued development of the QAPM as well as its implementation. Changes are promptly communisated when identifi ed.

c. The QAPM implements I0CFR50, Appendix B and applies to all activities associated udth structures, systems, and components which are safety related.

The requirements of the QAPM are applied to these items and activities to an extent conrmensurate with their importance to safety.

d. The QAPM also applies to the packaging and transportation of radioactive waste activities controlled by 10CFR7I, ffi the quality assurance progrim required by 10CFR71, Subpart H.

e. The QAPM also applies to the independent storage of spent nuclear fuel and highJevel radioactive waste activities controlled by I0CFR72, as the quality assruance progtam required by 10CFR72, Subpart G.

f. The QAPM sections 8.13, Corrective Actions, and 8,14, Document Conhol, also apply to non-safety related Shuctures, Systems and Components subject to agrng ilunagment for the period of extended operations following issuance of the renewed operating license.

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

Section 8.14 and the listed references address administrative controls described in NRC RIS 2014-09, to ensure formal review and approval processes are provided.

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FENOC FirxEn*gy lt.ur,laar Qpreling f.fipery Qual Assurance Program Manual

g. The applicability of the requirements of the QAPM to other items and activities is 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 written guidance for the control of quality related activities and provide for the development of docuurentation to provide objective evidence of compliance.

2. Organization The organieational structwe responsihle for implementation of the QAPM is described below. The specific organization titles for the qualrty assurance functions described are identified in procedures. The authority to accomplish the quality assurance functions described is delegated to the incumbent's staff as necessary to fulfill the identified responsibility.

a* The ChiefNuclear Officer (CNO) is responsible for establishing expectations and providing top level direction of all activities associated with the safe and reliable operation of FENOC's nuclear power plants and activities of corporate functions. The CNO provides guidance with regards to the company quality assurance policy. The CNO provides a singular point of contact with respect to the operation of the four FENOC power plants and provides operational oversight of the four plants.

I The executive responsible for oversight reports to the CNO and is responsible for the audit and assessment of the quality assuranc progftm of FENOC's nuclear activities, both site and corporate, flrd maintaining this QAPM in accordance udth regulatory requirements. This executive is also 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. This executive also has overall responsibility for the quality assurance and independent off-site safety review committee functions, as well as supplier auditing.

a) The individual responsible for quality assurance reports to the executive responsible for oversight and has overall authority and responsibillty for veriffing the implementation and adequacy of the quality assurance program (auditing) as described in this QAPM. The individual responsible for quality assurance has the authority and responsibility to report matters directly to the Chief Nuclear Officer when needed. This individual is also responsible for the quality control fi:nction, flrrd receipt and supplier source inspections.

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FENOC FrstEnergy l*tclaar O,f,tttttg cotmany Qual Assurance Program Manual b) These individuals above may be responsible for a single unit/location or for multiple unitsflocations and may fulfill more than one firnction described. Conversely, responsibilities may be fulfilled by rnore than one individual. Individuals m.ay be located at the nuclear plant or FirstEnergy corporate locations.

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

l. The executives responsible for overall plant nuclear safety and operations support at each site. These executives may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities. These executives are responsible for establishing and implementing the qualrty asflrance program at the respective site.

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

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

c The individuals fulfilling the following management functioffi report to the appropriate management position identified in Paragraphs 2.b.1 or 2.b.2 above.

These individuals may report through an additional layer of management but shall maintain suffrcient authority and organizational freedom to implement the assigned responsibilities. These individuals may be responsible for a single unit/location or for multiple unitsllocations and may fulfill more than one function described below. Conversely, responsibilities rnay be fulfilled by more than one individual. The fi,rnctions descrihed below may also be implemented by non-FENOC organizations within the FirstEnergy Corporation however, FENOC maintains responsibility and authority.

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

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

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

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

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FENOC FvsErutry I'LfrEer (J4,ralirg Contfrirl, Qual Assurance Program Manual 5 The individual responsible for document control provides directiort contol, and overall supervision of the document control program and associated activities.

6 The individual responsible for f,re corrective action program provides direction, conhol, ffid overall supervision of the corrective action program and associated activities.

7 The individual responsible for engineering is responsible for the development and maintenance of engineering programs, policies, and procedures and for providing engineering services.

I The individual responsible for materials, purchasing, and contracts is responsible 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 activities to provide additional assurance that the units are operated and maintained in accordance with the Operating License and applicable regulations which address nuclear safety. (Refer to Table 1, Item C.2 for additional details.)

3. Responsihility

a. FENOC has the responsibility for the scope and implementation of an effective qualrty assurance program.

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

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

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

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

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FENOC FvulEnergy l*Ebt @atitq Cantpury Quality Assurance P rogram fillanual

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

4. Authority

a. When FENOC delegates responsibility for planning, establishing, or implementing any part of the overall QA program, sufficient authority to accomplish the assigned responsibilities is delegated.

b. The individual responsible for quality flssurfiice has the responsibility and the authority to stop unsatisfactory work (including reactor operation through proper channels) and control further processing, delivery, installation, or use of non-conforming items or senrices. Cost and schedule considerations will not override safety considerations.

5, Personnel Training and Qualification

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

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

c. Personnel training and qualification records are maintained in accordance with procedures.

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

6. Corrective Action a- It is the responsibility of each individual to promptly identiff and report conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.

b. A corrective action program is established and implemented that includes prompt identification, documentation, signifi cance evaluation, and correction of conditions adverse to quality. For significant conditions adverse to quality, the cause is determined and comective action to preclude repetition is identified and tracked until it is completed and verified.

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

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FENOC FrstEnergry f(rcJcar Opratl/lg CdJ4,gf,,y Quality Assurance P rogram Manual

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

e. Reports of conditions that are adverse to quality are analyzed to identiff uends in qualrty performance. Significant conditions adverse to quallty and significant trends are reported to the appropriate level of management.

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

7. Regulatory Commitments

a. Except where alternatives are identified, FENOC complies with the QA guidance documents listed on Table l. If the guidance inany ofthese doctrments is in conflict with the QAPM, the gurdance provided in the QAPM is the contolling guidance.

Additionally, the following clarifications apply to all guidance documents listed in Table 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, and replacements shall be in accordance with the original design and inspection requirements or a documented approved alternative.

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

3. Clarifications and alternatives to a guidance document apply wherever the guidance 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 if explicitly committed to in the QAPM. If not explicitly committed to, these documents 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 constuction phase activities will be applied to activities during the operations phase that are 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).

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

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FENOC FnstErta4gy frlr.rclee r Apraling Culpty Quali Assurance Program Manual B. PERFORMANCE/VERIFICATION L Methodolory

a. 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 the achievement of acceptable quality.

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

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

2. Design Control

a. The design control prograrn is established and implemented to assure that the activities associated with the desigu of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly 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 verification requirements) 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 to permit verification,

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

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

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FENOC FfslEn$tgy t*&lad Opdi.ailfig funry8dty Quality Assurance Prograrn Manual

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

h. Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with this program, shall be collected, stored, ffid maintained in accordance with docuurented procedures.

This documentation includes final desigu documents, such as drawings and specifications, and revisions thereto and documentation which identifies the important steps, including sources of design inputs that support the final design.

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

3. Desigu Verilication

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

b Verification rnEthods include, but are not limited to, design reviews, altemative calculations, and qualification testing. The extent of this verification will be a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the artn and the similarity with previously proven desigus. Standardized or previously proven desigrrs will be reviewed for applicability prior to use.

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

d. Independent design verification is to be completed before design outputs are used by other organizations for design work and before they are used to support other activities such as procuremsnt, manufacture, or construction. When this timing cannot be achieved, the unverified portion of the design is to be identified and controlled. h all cases, the design verification is to be cornpleted before relying on the item to perform its function.

e. Individuals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibility shall be defined and controlled. Design verification shall be performed by sny Revision: 24 12 of36

FENOC FvsEn&rgy t*.Ebar #clatl/,,d" tunp'f,,y Quality Assurance P rogram illanual cornpetent individuals or groups other than those who performed the original design but who may be from the same organization. The designer's immediate supenrisor may perform the design verification provided: the supervisor is the only technicatly qualified individual capable of performing the verification, the need is individually documented and approved in advance by the supervisor's management, and the frequency and effectiveness of the supervisor's use as a design verifier are independently verified to guard against abuse.

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

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

4. Procurement Control

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

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

c The program includes provisions for ensuring that qualified suppliers sontinue to provide acceptable products and services.

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

6 Applicable technical, regulatory, administrative, and reporting requirements (e.9., specifications, codes, standards, tests, inspections, special processes, and 10CFR2l) are invoked for procurement of items and services.

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

g. The program includes provisions for ensuring that procurement, inspection, and test requirements have been satisfied before an item is placed in servie,e or used unless otherwise specified in procedures.

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

t. Appropriate controls for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items are to be imposed to ensure that the items will perform satisfactorily in senrice.

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

5. Procurement Yerifiention

a. A program is established and implemented to verifr the quality of purchased items and services at intervals and to a depth consistent with the item's or seryice's importance to safety, complexity, and quantity and the frequency of procurement.

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

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

6. Identification and Control of Items

a. A program is established and implemented to identiff aod confrol items to prevent 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 to safety.

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

7, Handling, Storage, nnd Shipping

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

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FENOC FtrslEwrgy t fucldar @eraliry Cmtpany Quality Assurance P rogram Manua!

b 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.

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

d. Items are marked and labeled during packaging, shipping, handli*g, and stor4ge to identiff, maintain, and preserve the items' integrity and indicate the need for special controls.

e. Additional details concerning handling, storage, and shipprng activities may be found in the Regulatory Guides and associated Standards as coilrmitted to in Section 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 items will 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, and operational 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 inspection requirements have been satisfied.

f. Unacceptable test results shall be evaluated.

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FENOC FnsEtsrfry ffiJclaa t Oryathg Cffitfiny Qual Assurance Program Manual

g. Additional details concerning test control may be found in the Regulatory Guides and 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 test equipment does not include perrranently installed operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptabihty or be the basis for design or engineering evaluation.

Additionally, calibration and control mea$ures are not required for rulers, tape rneasures, Ievels and other such devices if normal commercial manufacturing practices 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 irnmediately before use on the basis of the item's required accurasy, intended use, frequency of use, and stability characteristics and other sonditions affecting its performance.

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

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

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

o E. Measuring and test equipment found out of calibration is tagged or segregated.

The acceptability shall be determined of items measured, inspected, or tested with an out-of-calibration device.

h. Additional details concerning measuring and test equipment control may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9., Regulatory Guides 1.30, 1.33, 1.94, 1.116, and 1.123).

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10. Inspection, Test, and Operating Status

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

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

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

I l. Special Process Control

a. A program is established and implemented to ensure that special processes are properly controlled.

b The criteria that establish which processes ile special are described in procedures.

c. Special proctrsses are accomplished by qualified personnel, using appropriate equipment, 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 the Regulatory Guides and associated Standards as commiued to in Section A.7 and Table 1 (e.9., Regulatory Guide 1.33).

12. Inspection

i. A program is established and irnplemented for inspections of activities in order to veriff conformance to the documented instructions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization perforrning the activrty to be inspected.

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

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

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

o. Unaeceptable inspection results shall be evaluated and resolved in accordance with procedures.

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

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

Regulatory Guides 1.33 and 1.58).

13. Corrective Action a, Procedures shall provide for identification, evaluation, and resolution of conditions adverse to quality.

b Reworked, repaired, and replacement items are to be inspected and tested in accordance with the original inspection and test requirements or specified alternatives.

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

14. Document Control

a. 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 prescribe activities affecting quality of safety-related strrctures, systems or components.

Such activities include design, procurement, material control, installation, inspection, testing, maintenance, modifi cation, operation, refueling and decommissioning.

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FENOC fi 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 for release by the same organization that originally reviewed and approved the documents or by a designated organization that is qualified and knowledgeable.

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

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

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

15. Records

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

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

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

C. ASSESSMENT I. Methodology

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

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

c Personnel performing audits have no direct responsibilities in the area they are assessing.

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

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FENOC firstEna ryy ltkr, lot ope:at/llig CDffDtiy Quality Assurance P rogram Manual

2. Audit

a. A program ofplanned and periodic audits is established and implemented to confirm that activities affecting quality comply with the QAPM and that the QAPM has been implemented effectively. Audits will be conducted as required by the applicahle Code of Federal Regulations, Technical Specifications, safety analysis reports, and comminnents by various correspondence to the NRC.

Audits will be conducted at a frequency in accordance with either Section C.2.a.l or Section C.2.a.2 below.

I Audit frequencies will be deterulined in accordance with a performance based audit scheduling program. The scheduling prograrrl through an expert panel, uses asssssment indicatons to identifu and schedule audits based on perforrranss results and importance ofthe activity relative to safety. Potential audit subject areas are periodically assessed against appropriate perfonnflnce criteria. From these reviews a determination is made in regard to the depth, scope, and scheduling of specific audits.

Functional axeas important to safety are assessed annually (t 25%) to identiff strengths and weaknesses (if applicable) to determine the level and focus of independent oversight activities for the upcoming year. The basis for the assessment shall include the results of audits and surveillance, NRC inspections, LERs, self-assessments, and applicable conditions reports (e.g., non-conformance and corrective action reports). Personnel changes, change/increase in functional area responsibilities, industry operating experience, and INPO evaluations will also be considered. Each area will be assigned a rating with a comparison to previous years. This assessment will be documentedn reviewed, and approved by qualrty assurance management.

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

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

a. The conformance of unit operation to provisions contained within the Technical Specifications and applicable license conditions at least once per 24 months.

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

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

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

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

f. The fire protection equipment and program irnplementation at least once per 24 months utilizing either qualified licensee personnel or an outside fire protection consultant.

g. The fire protection equipment and program implementation at least once per 36 months utilizing a qualified outside fire protection consultant.

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

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

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

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

4 Audits shall provide an objective evaluation of quality related practices, procedures, instrrrctions, activities, ood items and a review of docurnents and records, as applicable, 5 Audits shall be performed in accordance with approved written procedures or 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 safety importance of the activity or process being assessed.

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

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FEIUOC firstEnargy ttwtear @eftttng funpeny Qual Assurance Program Manual I Audit reports are written and distributed to the appropriate levels of management for review. Follow-up action can be accomplished through uryitten cofirmunication, re-audit, or other appropriate means, as deemed necessary.

I Implementation of delegated portions of the quality assurance program is assessed.

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

I l. Additional details concerning audits may be found in the Regulatory Cuides and associated Standards as committed to in Section A,7 and Table 1 (e.9., Regulatory Guides 1.33 and I.144).

D. INDEPENDENT SAF'ETY REVIEW

l. Description

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

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FENOC FtrslEnargy 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 following clarifications:

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

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

B. Regulatory Guide 1.30 (Revision 0) [Augurt 19721, Qualily Assursnce Requirements for the 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 following clarifications:

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 are within the scope of the QAPM. Each plant maintains a list of equiprnent subject to QAPM requirements. This Standard is also applied to other systems and components when required by approved procedures, engineering specifications, or other work control I ing documents.

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

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c. Section 3 requires that records of protective measures maintained during storage for conformanffi to storage requirements be checked to verifr that items are in satisfactory condition for installation. This check shall be made only if equipment requires 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 and post-construction activities. ln lieu of these tests, FENOC shall conduct only those tests neses$ary to veriff that work activities specified by rvork controlling documents have 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 guidelines in determining these testing requirements.

e. Sestion 6.2.1 states in part that "Items requiring calibration shall be tagged or labeled on completion indicating date of calibration and identity of person that perforrred the calibration." tn lieu of this requirement, FENOC may alternatively implement progftrms that require the equipment to be suitably marked to indicate the date of the next calibration and the identity of the person that performed the calibration. In addition, installed plant equipment that is used as measuring ard test equipment (M&TE) may be controlled to indicate its salibration status and to ensure haceability to 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 Program Req 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. QAPM Section C.2 (Audit) describes altematives to these frequencies.

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

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

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

c. Section 5.2.? requires that'temporary changes which clearly do not change the intent of the approved procedure shall, as a minimum, be approved by two members of the Revisiou: 24 24 of36

FENOC Fns,Enaryy f,twl w Op?dell ng C dl?4- vty Quali Assurence Program Manual plant staffknowledgeable in the areas affected by the procednre. At least one of these shall be the supenrisor in charge of the shift and hold a senior operating license on the unit affected." Such changes shall be documented and if appropriate, incorporated into 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 approved procedure shall be approved for implementation by two members of the plant management staff, at least one of whom holds a Senior Reactor Operating License for the unit affected. The temporary procedures shall be approved by the original approval authority within 14 days. For changes to procedures which may involve a change in intent of the procedure, the original approval authority shall approve the change prior to implementation. OR

2) Temporary changes to procedures will be approved by two knowledgeable members of the plant staffprior to implementation. At least one of thes persons will be a member of superuision, tf the change affects operation$ procedures, at least one of these persons will hsld a senior reactor operator lisense for the unit affected. Prior to implementation, the OSC (PORC) shall review and recommend approval of temporary changes to procedures ruhich require a 10CFR50.59 safety evaluation. Within 14 days of implementation, temporary changes will be reviewed by an independent qualified reviewer 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 of temporary modifications such as bypass lines, electrical jumpers, lifted electrical leads, and temporary trip point settings. FENOC takes exception to this requirement when the installation and removal of sush temporary rnodificatious is specifically addressed in approved procedures. These procedures ensrue that the circuitry is returned to its original configuration when the operation is eompleted.

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

f. Sestion 5.?.13 (l) establishes the requirement for identiffing quality assurance program requirements applicable to the items or ssrvices being procrued. When purchasing commercial grade services from certain accredited calibration laboratories, the procurement documents are not required to irnpose a quality assurance program consistent with AIISI N18.7. Alternative requirements described Revision; 24 25 of36

FENOC FvslErangy ltirr.tcar Op*altng fullparry Qual Assurance Program Manual in this QAPM for Regulatory Guide 1.123 may be implemented in lieu of imposing a quality assurance program consistent with AhISI N18.7.

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

1) Implement process controls that ensrre procedures axe reviewed for possible revision upon identification of new or revised souce material potentially affecting the intent of procedures.

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

h. Section 4.3.4 (3) discusses the requirement for the on-site and off-site independent review bodies to review license amendments and technical specification changes. As an alternative to the requirements for the offisite review hody to review license amendments and technical specification changes, FENOC will utilize the on-site review body for these reviews. To ensure that the on-site review body maintains independsnce during these reviews, any voting rneruber that has a potential conflict of interest in a change under review will be replaced by another member to achieve a quonrm. In additiono the off-site review body will review on-site review body meeting 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 for Cleaning of Fluid Sysfems and Associated Components of Water-Cooled Nuclesr Power Plants

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

a. Regulatory Position C.3 requires that water quality for final flushes of fluid systems and associated components be at least equivalent to the quality required for nornnal operation. This requirement is not applied to dissolved oxygen or nitrogen nor does it infer 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 to intergranular cracking or stress corrosion cracking should not be used with austenitic stainless steel and nickel-based alloys. It is FENOC's position that materials such as inks, temperature indicating crayons, labels, wrapping materials (other than polyethylene), water soluble materials, desiccants, lubricants, and NDE penetrant materials and couplants, which contast stainless steel or nickel-based alloy rnaterial surfaces contain no rnore than trace amounts of lead zinc, copper, or lower melting Revision; 24 26 of36

FENOC F[ntEwtgy l{t*lear Oocrafh1g Mnpany Qual Assurance Program Manual alloys or compounds. Maximum allowable levels of water leachable chloride ions, total halogens and sulfur compounds shall be defined and imposed on the aforementioned materials. These materials will be controlled through administative procedues that are, in part, designed to minimize their effects on intergranular cracking or stress corrosion cracking.

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

a. During maintenanse and modification activities, FENOC shall control the opening of clean systems and shall conduct inspections to veriff that affected system cleanliness levels shall not he adversely affected by the maintenance or modification activrty.

When system cleanliness is affected, specifi.c cleaning procedures which incorporate the applicable portions of this Standard shall be developed and implemented to maintain system cleanliness.

b. Section 2.4 requires that personnel who perform inspection, examination or testing activities required by this Standard be qualified in accordance with ANSI N45.2.6. In lieu of this, personnel who perform cleanliness inspections may altematively be qualified in accordance with Regulatory Guide 1.8, E. Regulatory Guide 1.38 (Revision 2) [May l}Tflr Eual@ Assurnnce Requirementsfor Pac*agtng, Shipping, Receiving, Storage, and Handling of ltems for Water-Cooled Nuclear 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 following clarifications:

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

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

c. Section 5.5 provides for "rework" and 'ouse-a.s-is" dispositions for nonconforming

• repair" items. As an altemative, the 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 final locations within the power plant be inspected and cared for in accordance with the requirernents of Section 6 of this $tandard and other applicable Standards. In lieu of this requirement, FENOC shall, whenever feasible, store items within their Revision: 24 27 of36

FENOC Frsl&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 in sufficient time to support its installation. Within the plant, the equipment shall be staged at locations which provide equivalent environmental conditions under which it is designed to operate. Materials placed in staging areas shall be stored in accordance with 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 materials when in contact with austenitic stainless steel or nickel-based alloys. The exceptions applicable to Regulatory Guide 1.37 regarding this subject also apply to ANSI N45.2.2.

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

f,'. Regulatory Guide 1,39 (Revision 2) [Septemher 19771, Househeeping Requiremcn# tor Water-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*ing altemative.

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

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

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

a. The guidance of this Regulatory Guide shall be followed as it pertains to the qualification of personnel who verify conformance of work activities to quality requirements.

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 for clarity and completeness.

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

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

c. Regulatory Position C.2 indicates that SNT-TC-l A-1975 is to be used for the qualification of nondestructive examination (NDE) personnel who apply various NDE methods. It also indicates that personnel perforrning nondestrustive exarninations required by Section III and Section XI of the ASME Code should be qualified to SNT-TC-IA-1975 as well as additional provision of the Code. For the qualification of NDE personnel, FENOC comurits to the ASME Section )il requirernents specified within the applicable code year edition(s) as defined by 10CFR50.55a. This altenrative may be applied regardless of whether exarninations are of a type required by the Code.

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

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

b. Section 3.5 of this Standard dissusses education and experience. FENOC commits to the following: The initial qualifications of individuals to Level I, il, or III will generally 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/or demonstration of capabilities. For Level I, FENOC will also accept a four year college degree plus one month of related experience or equivalent inspection, examination or testing activities. Individual requalification will meet or exceed the recommendation of this Standard.

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

H. Regulatory Guide 1.64 (Revision 2) [June 19761 , SuaW Assurance Requirements for the Design of Nuclear Power Planfr I . FENOC comrnits to the regulatory position of this Guide with the following clarifications:

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FENOC FvstEnetgy l,lt'lr,larrr Oryralhg Con4ny Quality Assurance P rogram Manual

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 qualified individual available, the design verification or checking shall be conducted by the superrrisor 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 level of supenrision.

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

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

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

r. Regulatory Guide 1.74 (Revision 0) [F'obmary 1974lr $uahty Assurance Terms and Detinitinns

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

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

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

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

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

a. Section 5.6 addresses records storage facilities. In lieu of this, the design and sonstruction of quallty assurimce record storage facilities will follow the guidance of ANSVASME NQA-I-1983, Supplement l7S-1, Section 4.4. When temporary storage 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 as radiographs and microfilm), humidity and ternperature controls shall be provided so as to maintain an environmental condition fls prescribed in Paragraph 6.1 .1 of AIISI PH 1.43-1979 (Also required by Section 5.4).

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

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

a NIRMA Techdcal Guide (TC) I l -1998, Authentication of Records and Media a NIRMA TG 15-1998, Management of Electronic Records a NIRMA TG 16-1998, Software Configuration Management and Quality Assurance I NIRMA TG 21-1998, Electronic Records Protection and Restoration K. Regulatory Guide 1.94 (Revision 1) [April 19761, Saahly Assurance Requtrementsfor Instullation, Inspection and Testing af Structural Concrete and Stractural Steel During the Construction Phase of Nuclear Power Plants

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

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

a" Section 2.2 rcqaires that installation, inspection, and test procedures be kept current with the latest information. This Standard was rnritten to address requirements associated with construction phase activities. However, during the operations phase, activities associated with installation, inspection, and testing of stnrcfural concrete and structural steel are very minor in frequency and extent. Consequently, procedures for these activities shall only be reviewed or updated prior to commencing the activity. The procedures for structural concrete and structtral steel installation, inspection, and testing activities will be developed using the provisions of ANSI N45.2.5 - 1974.

b. Alternatives to this Standard are taken with respect to frequency of calibration of impact wrenches and bolt projection criteria. Impact and torque wrenches shall be checked at least once daily per shift, ffid at least one full thread of all bolts shall project beyond the nut of all tightened connections. These criteria cornply with the reconrmendations 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) splice operators. In lieu of this, Davis-Bfisse and Beaver Valley will comply with qualification 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 Section ilI, 1995 Edition, subparagraph CC-4333.5.2.

e. Section 4,9.4 discusses tensile testing frequency. In lieu of this, Davis-Besse and Beaver 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 applicable welding codes and any exceptions.

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

L. Regulatory Guide l.116 (Revision 0) [May L977l,8uahty Assurance Requiremenfrfor Inslallalion, 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 following clarifications:

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

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

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

M. Regulatory Guide 1.123 (Revision 1) puly 19771 , SuaW Assurance Reqniremcn# for Control 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 following clarifications, exceptions and alternatives :

a. Subsection 3.2.3 discusses quality assurance program requirements for procurement documents. For the purchasing of commercial grade calibration services from domestic calibration laboratories accredited by a nationally recognized accrediting body, the procurement documents are not required to impose a quality assuranoe progftrm consistent with AIISI Nl8,7.

In such cases, accreditation may be acceptable in lieu of the purchaser imposing a QA program 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 following accrediting hodies, which are recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement {MRA};

- National Yoluntary Laboratory Accreditation Program (NVLAP), administered by 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 the needed measurement parameters' ranges, and unceftainties.

4) The purchase documents impose additional technical and administrative requiremsnts, as neces$flry, to satisfu FENOC QA Program and technical requirements. This will include requiring that the supplier identiff the laboratory equipment/standards used and the as-found and as-left data in the calibration certificate/report.

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

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b. The alternative method is applicable to sub-suppliers of calibration service supplierso provided 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 Assurance Program for which there are no quallty assurance program or quality documentation requirements, the requirements of this Section need not be adhered to. However, the procurement documents shall speciff requirements specific to the item being procured, sufficient to provide adequate certification or other records to ensure that items and activities meet the specified requirernents.

d. Sestion 8.2 provides requirements for the control of nonconformances. Suppliers qualified by FENOC as design agents in accordance with Regulatory Guides 1.64 and I .123 may he permitted under specific conhactual provisions to disposition nonconformancs as o'use-as-is" or o'repair" on behalf of FENOC. All nonconformances dispositioned'trse-as-is" or'orepair" by suppliers qualified by FENOC as design agents on behalf of FENOC are required to be submitted to FENOC for engineering approval at the time equipment is received on site. If FENOC determines that a disposition has been incorrectly made, a nonconformance report 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 be an authorized and responsible employee of the supplier and shall be identified by the supplier.

N, Regulatory Guide 1.144 (Revision U [September l980lrAudifing of Quality,4ssarance Prugramstor 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 evaluations of suppliers. A 90 day grace period may be applied to these activities. For triennial audits and annual evaluations that are deferred, the next performance due date will he based on the originally scheduled date.

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

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

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

- National Voluntary Laboratory Accreditation Program (NVLAP), administered by 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 the needed 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 evaluations of suppliers. Instead of documenting evaluations of suppliers on an annual basis, FENOC may document evaluations of suppliers on an ongoing basis, using the guidance of Section C.3.b of this Regulatory Guide. The results of these ongoing evaluation$ are reviewed and appropriate corrective actions taken. Adverse findings resulting from these evalu,ations are periodically reviewed in order to deterrnine if, as a whole, they result in a significant condition adverse to qualrty and to provide input to support supplier audit activities conducted by the licensee or a third party auditing entity.

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

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

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 qualrty assurance or when requested by the audited organization.

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d. Section.4.4 discusses audit reporting. Audit reports shall be issued within thirfy working days after the last day of the audit. The last day of an audit shall be considered to be the day of the post-audit conference. If a post-audit conference is not held hecause it was deemed unnecessily, the last day ofthe audit shall be considered to be the date the post-audit conference was deemed unnecessary as documented in the audit report.

O. Regulatory Guide 1.146 (Revicion 0) [August 19801, Qualificarion of Suality Assurance Progrom 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 following altematives.

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

b. Section 2.1.4 discusses audit participation. Prospective lead auditors shall demonstrate their ability to effectively implernent the audit process and lead an audit team. They shall have participated in at least one nuclear audit within the year preceding the individual's effective date of qualification. Upon successful dernonstration of the ability to effectively lead audits, licensee managernent rnay designate a prospective lead auditor as a lead auditor.

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

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

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