ML14342A693

Quality Assurance Program Manual, Revision 19

ML14342A693
Person / Time
Site:	Davis Besse
Issue date:	11/21/2014
From:	FirstEnergy Nuclear Operating Co
To:	Office of Nuclear Reactor Regulation
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Download: ML14342A693 (36)

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fiffiff##Quality Assurance Program fulanual Approved By: Beaver Valley Po\yer Station Units I &Lz Docket Nos. 50-334 &,50-412 Operating License Nos. DPR-66

& hlPF-73 Ilavis-Besse Nuclear Potyer Station Docket No, 50-346 Operating License No. NPF-3 Perry Nuclear Polver Plant Docket No, 50 -440 Operating Licerlse No, NPF-58 Datel Vice President - Fleet OversightRevisiott: 19 Fffiru##Quality Assurance Prograrn Manual frclEnergy Nuclear Oprating Company TABLE OF CONTENTS A. I\,TANAGBN,IEN'T l.2.3.4.5.6.7, l.2, 3, 4, ,J 5.6, 7, 8.9.10.11.12.13, 14, 15.C.ASSESSMtrNT IVlcthodology Organization Responsibility Authority Personnel Trnining and Qualification Corrective ActionRegu la tory Comnritments N'Iethodology Design Control Dcsign Verification Procurenlent Control Pro cu rerlren t Verific ation Identification and Control of ltelns Handling, Storager and Shipping Test Control Measul'ing and Test trquipnlent Control Inspection, Test, and Operating Stattrs Special Proccss ControlI nspection Col'r'ective r\ction Document Control Recor'(ls 5 5 I I 9 9 l0 B, PER FORMA NCE/VERIFI C AT I ON l0 l1 l2 13 l4 t4 l4 l5 l6 1',l t7 tl l8 18 19 l.2, h{ethodologl, Audit 19 20 D.INDtr,PENDENT SAFETY RtrVItrW Desu'ilrtion 1.Revision:

192 of36 ffiffiru##

Ouality Assurance Program Manual f' : t 5 l f 1 1 g 1 a1 / r\tu.a lr' ii i O p e At, il g (\, m p an yTABLE OF CONTENTS (Continued)

Table 1 - Regulatory Commitrnents I. Regulatory Guide 1.74 (Revision

0) [February 19741, Quality Assursnce Terms and Definilrons

[ANSI N45.2.101 A.B.C, D,Regulatory Guide 1.8 (Revision

1) [Septernber 1975], Personnel Selectiort and Trainir,tg

[ANSI Nl8.1]Regrrlatory Guidc 1.30 (Revision

0) lAngust 19721, Quality Assurauce Requirements for the hrstullation, Inspectiorr, enrl Testing of Instrunrentstlon andElectric Equipment

[ANSI N45.2.4]Regulatory Guide 1.33 (Revision

2) [February 19781, Quolity Assurfl,tce Program Requirenrcnts (Operatiotts)

[ANSI NI8.71Regulatory Gulde 1.37 (Revision

0) [March l973l, Quality Assurance Requirentents for Cleaning of Fluid Sys/err.s ttnd Assoclated Components of lYater-Cooled Nilcleur Power Plants IANSI N45.2.11 Regulatory Guide 1,38 (Revision

2) [May 19771, Qualitl, Assurance Requirements for Packaging, Shtpping, Receidng, Storuge, snd Hsndlirtg of ltems for lYater-Cooled Nuclear Power Plants [ANSI N45,2,21Regrrlatory Guide 1.39 (Revision

2) [Sepfember 19771,Housekeeping Requirements for Wuter-Cooletl Nuclear Power Plsnts IANSI N45.2.31Regulatory Guide 1.58 (Revision

1) [September 1980], Qualdication of Nuclesr Power Plant Inspection, Examineilion and Testing Personnel

[ANSI N45.2,6]Regulatot'y Guide 1,64 (Revision

2) [June 19761, Quality Assurnrrce Requirentents for the Design of htucleur Poner Phnls IANSI N45,2,111 24 li.F.G, I-I.Revision:

193 of36 Fffiru##Quality Assurance Prograrn Manual TABLE OF CONTENTS (Continrred)Table I - Regulatory Comrnitrnents (Continued)

Regrrlatory Guide I .88 (Revision

2) [October I97 61]Collectiort, Storage and Mnintennnce of Nuclesr Powrer Plant Quality Assururrce Recorrls IANSI N45.2,9J Regulator.y Guide 1.94 (Revision l) [April 19761, Quality A.r.sr{r's ilce Requirent ents for Instnllution, Inspectiort fifid Testing of Concrete unel Structurtil Steel During the Construction Plrese of Nuclesr Power Plunts IANSI N45,2.5J Regnlatorv Guide 1.116 (Revision

0) [N{ay 1977], Qu al ity.rlsslrr iln ce Requirent e nts for Instcrllati ort, Inspectiort and Testing of Mecherticcrl Equiprnent snrl Systenls [ANSI N45,2.81Regrrlatory Guide 1,123 (Revision l) [Jul1' 19771, QualiU, Assnrsnce Requirenrents for Control of Procurenrent o_f ltems snd Seryices for Ntclear Pow,er Plants IANSI N45,2,131 Regulatory Guide 1.144 (Revision l) [Septerrtber 19801, Auditirtg of Quality Assut'$ttce Progrutrts fo,' Nrtcleur Power Plunrs [AI'{SI N45,2.121 Regulatotl' Guicle I ,146 (Revision

0) [August 1980J, Qualificstlon of Quality Assur(tnce Progrfint Audit Personnel for Nuclesr Power Plsrtts IANSI N45 ,7,231 J.K.L.h{.N.o.Revision:

19d of36 Fffru##Quality As$urance Program Manual A. NIANAGBMtrNT Nlethodology The Quality Assurance Progam Manual (QAPM) provides a consolidated overview of the quality plogram controls which govern the operation and maintenance of FirstEnelgy Nuclear Operating Company's (FENOC's) quality related items and activities. This includes nuclear plant and FENOC fleet locations, as well as FirstEnergy colporate locations that provide safety related seryices.

The QAPM describes the quality assurance organizational structure, fi.rnctional responsibilities, levels of authority, and interfaces.

The requiremenfs and commitments contained in the QAPM are mandatory and must be implemented, enfolced, and adhered to by all individuals andorganizations. Employees are expected to actively participate in the continued developrnent of the QAPM as well as its irnplementation. Changes are promptly communicated when identified.

c. The QAPM implernents l0CFR50, Appendix B and applies to allactivities associated with structures, systems, and components which are safety related.The requirernents of the QAPM are applied to these items and activities to an extcnt connnensurate with their irnportance to safety, The QAPM also applies to the packaging and transportation of radioactive waste activities controlled by 10CFR71, as the quality assurance ploglam required by lOCFR7I, SubpartH.The QAPM also applies to the irrdependent storage of spent nuclear fuel and high-level radioactive rvaste activities controlled by l0CFR72, as the qualityassurance prog'am required by l0CFR72, Subpart G.The applicability of tlre requirenrents of the QAPM to other items and activities is deterrnined on a case-by-case basis, The QAPM is irnplernented through the use of approved procedures (i.e., policies, direotives, procedures, or other documents) which provide written guidance for the contlol of quality related activities and provide for the developnrent of documentation to provide objective evidence of compliance, OrganizationThe orgarrizational stlucture resporrsible for implementation of the QAPM is described belou,. The specific organization titles fol the quality assurance functions described are identified in ptocedures.

The authority to accomplish the quality assurance functions 1.a.b.d, 9.g.2.Revision:

195 of36 Fffru##Quality Assurance Program Manualdescribed is delegated to the incumbent's staff as necessary to fulfill the identified responsibility.

a. The President FENOC and chief nuclear officer (CNO) is responsible for establishing expeclations and providing top level direction of all activitiesassociated rvith the safe and reliable operation of FENOC's nucleat power plantsand activities of corporate functions. The FENOC President and CNO provides guidance with regards to the company quality assurancs policy, 1. The executive responsible for oversight reports to the President FEG FENOC and chief nuclear officer and is responsible for the audit andassessment of the quality assurance progtam of FENOC's nuclear activities, both site and corporate, and maintaining this QAPM inaccordance with regulatory requirements. This executive is also responsible for establishing the quality assurance program policies, goals and objectives, for implementation of the quality assurance program, and for maintaining the Quality Assurance Program Manual. This executivo also has overall responsibility for the quality assurance and independent off-sitesafety review committee functions, as well as suppliel auditing, a)The individual responsible for quality assurance repofis to theexecutive responsible for oversight and has overall authority and responsibility for verifying the implementation and adequacy of the quality assurance program (auditing) as described in this QAPM. The individual responsible for quality assulance has the authority andresponsibility to report matters dilectly to the president and chief nuclear officer when needed. This individual is also responsible for the quality control ftlnction, and receipt and suppliet source inspections.These individuals above may be responsible for a single unit/location or for multiple units/locations and may fulfill more than one function described.

Conversely, responsibilities may be flrlfilled by more than one individual, Individuals may be located at the nuclear plant or FirstEnergy corporate locations.

b)b.The following management positions repofi to the President FENOC and chicf nuclear officer: l. Tlie executive responsible for operations 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, a, The executives rcsponsible for overall plant nuclear safety and operations support at each site report to the executive responsible for operations' Revision:

196 of 36 ffiffru##li r s I f n <..

t g yrYuc,tr'ar O per a! tn gC*p", Quality Assurance Program Manual c.These executives may report through an additional layer of management but shallmaintain sufficient authority and organizational fi'eedom to implement the assigned responsibilities, These executives are responsible for establishing and irnplernenting the quality assul'ance proglam at the respective site.2. The executive responsible for engineering is responsible for providing engineering services at all sites, 3. A managetnent position responsible for licensing and regulatory affairs.The individuals fulfilling the following management functions report to the appropriatemanagement position identified in Paragraphs 2.b.1 ,aor2,b.2, above.

These individuals may report through an additional layer of management butshall maintain sufficient authority and organizational freedom to implernent theassigned responsibilities. These individuals may be responsible for a single uniVlocation or for rnultiple units/locations and may fulfill more than one function described below. Conversely, responsibilities may be fulfilled by morethan one individual, The functions described below may also be implemented by non-FENOC organizations rvithin the FitstEnelgy Corporation however, FENOCrnaintains responsibility and authority.

The individual responsible for plant operations assures the safe, 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, control, and overall supervision of the implernerrtation of plant modifi cations and assigned naintenance.

3. The individual responsible for training provides directiott, control, and ovcrall supervision of all training of personnel required by regulations.

4. The individual responsible for records rnanagement provides directiort, control, and overall supervision of the records management progtam and associated activities.

5. The individual responsible fol docurnent contrnl prnvides direction, control, and overall supervision of the document control program and associated activities.

6. The individual responsible for the con'ective action program provides direction, contlol, and overall supewision of the corrective action plogramand associated activities.

l.2,Rcvision: 197 af 36 Fffff##t"t Quality Assurance Prograrn Manual d, 7. The individual responsible for engineedng is responsible for the development and maintenance of engineering prograrns, policies, and procedures and for providing engineering services.

8. The individual responsible for materials, purchasing, and contracts is responsible for supplier evaluations, procurement, services, receipt, storage, and issue of rnaterials, parts, and components.The on-site and off-site safety review committees independently review astivities to provide additional assurance that the units are operated and maintained in accordance with the Operating License and applicable regulations which addressnuclear safety. (Refer to Table 1, Item C.2 for additional details.)Rcspon$ibilityFENOC has the responsibility for the scope and implernentation of an effective quality assurance proglam.FENOC may delegate all or part of the activities of planning, establishing and implernenting the quality assurance proglam to others, but retains the responsibility for the program's effectiveness.

The adequacy of the QAPM's inrplementation is continually assessed by the individual(s) responsible for quality assurance and the associated executive for overall plant nuclear safety, and is reported to the executive responsible for oversight and to the prcsident and chiefnuclear officer.FENOC is responsible for ensuring that the applicable portion(s) of the qualityassulance ploglam is properly documented, approved, and implernented (people are trained and resources al'e available) before an activity lvithin the scope of the QAPM is undertaken by FENOC or by others.Responsible individuals are to ensure that personnel workirrg under their management cognizanlce are provided the necessary training and resources to accomplish their assigned tasks within the scope of the QAPM, f. Procedures that irnplernent the QAPM are apploved by the rnanagement responsible for the applicable quality fuirction. These procedures are to reflect the QAPM and work is to be accornplished in accordance with thern.Authorifv 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.

3.a.b.c.d, g.4, Revision:

19I of 36 Fffff##Quality Assurance Program Manual 5.b. The individual responsible for quality assurance has the responsibility and theauthority to stop unsatisfaetory work (including reactor operation through properchannels) and coutrol further processing, delivery, installation, or use of non-conforming items or serices. Cost and schedule considerations will not overide safety considerations.Personncl Training and Qualification Personnel assigncd to irnplement elements of the quality assurallce proglam are capable of performing their assigned tasks, Training plograms are established and implemented to ensure that personnel achieve and maintain suitable proficiency.Personnel training and qualification records are maintained in accordance with procedures, Additional details concerning personnel training and qualification may be found in the Regulatory Guides and associated Standards as committed to in SectionA.7 and Table I (e.g., Regulatory Guides 1.8, 1.58, and 1.146).6.Cor't'ectiye Action It is the responsibility of each individual to promptly identify and reportconditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.A coilective action program is established and implernented that includes prompt identiftcation, docurnentation, significance evaluation, and conection of conditions adverse to quality, For significant conditions adverse to qualitS the cause is deteurrined and comective action to preclude repetition is identified andtracked until it is completed and verified.Specific responsibilities within the corrective action progl'am may be delegated, but FENOC maintains responsibility for the program's effectiveness.Non-conformiug items are properly controlled to prevent their inadvertent test, installation, or use. They are reviewed and either accepted, rejected, repaired, or reworked.Reports of conditions that are adverse to quality ale analyzed to identify trends in quality perforrnance. Significant conditions adverse to quality and significant trends are reported to the appropriate level of rnanagement.

a.b, c.d.a.b, c.d, g.Revision:

19 9 of36 Fffru##Quality Assurance Program Manual 7, Additional details concerning conective action activities may be found in Section B.l3 and the Regulatory Guides and associated Standards as comrnitted to irr Section A.7 and Table I (e.9., Regulatory Guides 1.33 and 1.144).Regul atory ConrmitmetrtsExcept where alternatives are identified, FENOC complies with the QA guidance documents listed on Table l, If the guidance in any of these documents is in conflict with the QAPM, the guidance provided in the QAPM is the controlling guidance.Additionally, the following clarifications apply to all guidance doeuments listed inTable l: l. Fol rnodifications and nonroutine maintenance, guidance applicable to construction-like activities is applicable to comparable plant activities, except that the inspection of rnodifications, repairs, rework, and replacememts 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 wherevsr the defined term is used in the QAPM and associated guidance documents.

Clalifications and alternatives to a guidance document apply wherever the guidance document is invoked.In each of the ANSI Standards, other docurnents (e.g., other Standards,Codes, Regulations, tables, or appendices) are referenced or described, These other documents are only quality assurance program requirements if explicitly cornmitted to in the QAPM. If not explicitly cornmitted to, these documents are not considered as quality assurance progl'am requirernents, although they may be used as guidance.Regulatory guidance originally intended to apply to design or construclion phase activities will be applied to activities during the opelations phase that are comparable in nature and extent to construction phase activities.The NRC is to be notified of QAPM changes in accordance i.r,ith 10CFR50.54(a).In cases where license requirements differ fiom the QAPM, the most stringent requirements apply.a.3.4.5.b.c.B.PtrRFORM AN Ctr/\/ERI F'ICATION 1, h{ethodologv ReYision:

l9l0 of36 Fffff##Quality As$urance Prograrn Manual a.b.c.cl.Personnel pelforming work activities such as design, engineering, pl'ocurement,manufacturing, constluction, installation, startup, maintenance, rnodification, opemtion, and decommissioning are l'esponsible for achieving acceptable quality.Personnel perfolming verification activities are responsible for verifying theachievement of acceptable quality.Wor* is accomplished and verified using instructions, procedures, or otherappropriate lneans that are of a detail comrnensurate with the activity's complexity and impoltance to safety.Criteria that define acceptable quality are specified, and quality is verified against these cliteria.

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

b. The program includes provisions to control design inputs, procssses, outputs, chan ges, intelfaces, records, and organ izational interfaces.

c. Design inputs (e.g., perfonnance, regulatory, quality, and quality verificationrequirements) are to be correctly translated into design outputs (e.g.,specifi cations, drawings, procednres, and instructiorrs).

The final design output is to relate to the design input in sufficient detail to pennit verification.

The design ploccss is to ensure that iterns and activities are selected and independently velified consistent with their importance to safety to ensure theyare suitable for their intended application.

Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to be subjected to design control lneasures comnlensurate with those applied to theoliginal design and approved by the organization that perfouned the original design or a qualified designee.g. Interface controls (internal and external betrveen participating design organizations and across technical disciplines) for the pulpose of developing, 2.a.d.e.Revision:

19 11 of36 Fffff##Quality Assurance Program Manuaff F y [: n.1 l gy il'uc.lea r O ptraling Crvnparrl.

h.reviewing, approving, releasing, distributing, and revising design inputs and outputs are defined in procedures.Design documentation and records, which provide evidence that the desigtr and design verification plocess was perfonned in accordance with this proglam, shall be collected, stored, and maintained in accordance with documented procedurrs.

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

Additional details concerning design control Regulatory Guides and associated Standards Table 1 (e,g,, Regulatory Guide 1.64), activities may be fbund in the as committed to in section A.7 and 3.Design Verification A program is established and irnplemented to velify the acceptability of design activities and documents for the design of items. The selection and incorporation of desigr inputs and design processes, outputs, and changes are verified.Verification methods include, but are not limited to, design teviews, altetnative 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 desigrr, the degree of standardization, the state of the art, and the sirnilarity with previously pl'oven designs. Standatdized or previously proven designs will be reviewed for applicability prior to use.When a test progranr is used to veriff the acceptability of a specific design feature, the test program is to demonstrate acceptable pelfonnance underconditions that simulate the most adverse design conditions that are expected to be encountered.

Independent design verification is to be completed before desigrt outputs are used by other organizations for design work and before they are used to suppolt otheractivities such as procurement, manufacture, or construction. When this timing cannot be achieved, the unverified portion of the design is to be identified andcontrolled. In all cases, the design verifiqation is to be completed before relying on the iteln to perform its ftinction.

Individuals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibilityshall be defined and conholled. Design verification shall be performed by anycompetent individuals or groups other than those who perfonned the original a.b.c.d.g.Revision:

l9 12 of 36 Fffiru##Quality As$urance Program Manual desigrr but who rnay be fiom the same organization. The designer's immediate supervisor may perforrn the design verification provided: the supervisor is the only technically qtralified individual capable of perforrnirrg the verification, the need is individually documented and approved in advance by the supeivisors management, and the frequency and effectiveness of the superuisor's use as a design verifier are independently verified to guard against abuse.Design velificatiorr procedures are to be established and irnplemented to ensure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance cliteria are identified, the verification is satisfactorily accomplished, and the results are properly recorded.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 I (e.9., Regulatory Guide 1.64), 4.Pro cure rlrent Corrtrol A program is established and implemented to ensure that purchased items and seruices are of acceptable quality.The progtam includes provisions for evaluating prospective suppliers and selecting only qualifi ed suppliers.

c. The program includes provisions for ensuring that qualifred suppliers continue to provide acceptable products and seryices.The prnglam includes provisions (e.g,, source verification, receipt inspection, pre-installation and post-installation tests, and certificates of conformance) for accepting purchased items and services.Applicable teclmical, regulatory, admirristrative, and reporling requirements (e,g., specifications, codes, standards, tests, inspections, special processes, and 10CFR2l ) are invoked for procurernent of items and selices.The program ittcludes provisions for ensuring that docurnented evidence of an item's conformance to procurement requirements is available at the site beforethe itern is placed in service or used unless otherwise specified in procedures.The prograrn includes provisions fbr ensuring that procurenent, inspection, andtest requirements have been satisfied befole an item is placed in service or used unless otherwise specified in procedures.

h. The procurement of components, including spare and replacemetrt pafis, is subject to quality and technical requirements suitable for their intended service.g, a.b, d.e.g.Revision:

19 13 of 36 Fffiff##Quality Assurance Prograrn rulanual j.Appropriate controls for the selection, detennination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items are to be irnposed to ensure that the items rvill performsatisfactorily in service, Additional details concerning procurement control may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 andTable I (e,g., Regulatory Guides 1.33 and 1.123).5, Pro clt l'ernent Verific ati ona. A program is established and irnplemented to verify the quality of purchased items and services at intervals and to a depth consistent with the item's or serice's impofiance to safety, cornplexity, and quantity and the frequency of procurement.

The prograrn is executed in all phases ofprocurement.

As necessary, this may tequire verification of activities of suppliers below the first tier.Additional details concerning procurement verification may be found in the Regulatory Guides and associated Standards as committed to in Sectiou A.T and Table 1 (e.9., Regulatory Guides 1.123 and 1,144), Identification and Control of Items A program is established and implemented to identify and control items to prevcnt the use ol incon'ect or defective items.Identification of each item is rnaintained throughout fhbrication, erection, installation, and use so that the item can be traced to its documentation.

Traceability is maintained to an extent consistent with the item's importance to safety.Additional details concerning identification and control of items may be found in the Regulatory Guides and associated Standards as comrtritted to in Section A.7 and Table I (".9., Regulatoly Guide L33).7, Handling, Storag*, and Shiltping A program is established and impletnented to control the handling, storage, shipping, cleaning, and preserving of items to ensure the iterns maintain acceptable quality.6.b, c, a, b.c.a, Revision:

19 l4 of 36 fiffff##f ttglfnElglr rTucft:ar Opc.raLrrg a*O"h Quality Assurance Prograffi Manual b. Special protective measures (e.g., containers, shock absorbers, accelerometerc, inelt gas atmospheres, specific moisfure content levels, and temperafure levels) are specified and provided when requiled to maintain acceptable quality.c. Specific procedures are developed and used for cleaning, handling, stolage, packaging, shipping, quality.d. Iterns are lnal'ked and to idettti fy, maintain, special controls.and preserving iterns when required to rnaintain acceptable

e. Additional details concelning handling, storage, and shipping activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9., Regulatoly Guide 1.38).8.Test ControlA test conhol prog'am is established and irnplemented to demonstrate that iterns will perform satisfactorily in service, Criteria are defined that specify when testing is required.The test control program includes, as appropriate, proof tests before installation, pre-operational tests, post-rnaintenance tests, post-modification tests, and operational tests.Test procedures are developed that include: instructiotts and prerequisites to perfbrnr the test, use of proper test equiplneltt, acceptance criteria, arlcl iltandatory inspections as required.Test results are evaluated to assule that test objectives and inspection requirements have been satisfied.Unacceptable test results shall be evaluated.

labeled duling packaging, shipping, handling, and storage and preserve the items' integrity and inclicate the need for a, b.c.d.l.2.3.4, e.Revision l 1915 of 36 FTff##Quality Assurance Prograrn Manual 9.g. Additional details concerning test conh'ol rnay be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9.,Regulatory Guide 1.33).Nleasrrring and Test Equipnrent Colrtrol a. A prograrn is established and irnplemented to control the calibration, nraintenance, and use of measuring and test equipment.

Measuring and test equiprnent does not include permanently installed operating equipment or test equipment used forprelirninary chec.ks where data obtained will not be used to detetmine acceptability or be the basis for design or engineering evaluation.

Additionally, calibration and control measures are not required for rulers, tape measures, levels and other such devices if normal commercial manufacturing ptactices provide adequate accuracy.b. The types of equipment covered by the pl'oglan (e.g., instruments, tools, gages'and refererrce and tmnsfer standards) are defined in procedures.

c. Measuring and test equipment is calibrated at specified intervals or immediatelybefole use on the basis of the item's required accuracy, intended use, frequency of use, arrd stability characteristics and other conditions affecting its perfonnance.d. Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and to ensure its traceability to calibration tost data.e. Measuring and test equipment is calibrated against standards that have an accuracy of at least four times tlre required accuracy of the equipment being calibrated or, wlren this is not possible, have an accuracy that ensures the equipment beirrg caliblated will be within the required tolcrance.If nationally recognized standards exist, calibration standards ate to be traceableto them. Except rvhere 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.

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

The acceptability shall be detennined of items measured, inspected, or tested rvith arr out-o f:caliblation clevice.g.h. A{lditional details coltcenring lneaslfring alld test equipmellt founcl in the Regulatoly Guides and associated Standards as Section A.7 and Table I (e.9., Regulatory Gtlides 1.30, I,33, 1.123).cotrtrol rnay be colnrnitted to in r,94, Lll6,and Revision:

1916 of 36 Fffru##f r s tE n e r g yA'uClt'z ar O pe rati n gA*pon Quality Assurance Program Manual 10.Inspection, Tesf, and OperRting StatusThe status of required 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 inspectionsand tests and to prevent inadvertent operation of controlled equiprnent.

The application and rernoval of inspection, test, and operating status indicators arc conholled in accordance with procedules.

c. Additional details concerning inspection, test, and operating status coutrol may be found in the Regulatory Guides and associated Standards as committed to in Section A,7 and Table I (e.9., Regulatory Guide I.33).

11, Special Process Control a, b.a, b.A program is established and implemented to ensure that special processes are properly controlled.

The critelia that establish lvhich ploccsses are special are described in procedures.

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

c.d.Additional details concerning special process control 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).I rtspection A program is established and implemented for inspections of activities in otder'to verify confonnarrce to the documented instructions, procedules and drawingstbr acconrplishing the activity. The inspection program may be implemented by or for the organization performing the activity to be inspected.

Provisiotrs to ensure inspection planning is properly accomplished are to be established.

Planning activities are to identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspection.

12.a, b.Revision:

19 17 of 36 Fffru##t- "' $F r s I E t t e ry y rYuclcrnr O pc r alin g Crgp.l rl1'Quality Assurance Program Manualc. Provisions to identifr inspection hold points, beyond which work is not to ptoceed without the consent of the inspection organization, are to be defined, Inspection results are to be docurnented by the inspector and reviewed by quali{ied personnel.

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

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

g. Additional details concerning inspections may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.9., Regulatory Guides 1.33 and 1.58).13, Col'l'ective Actiolr d.e.a.b.Procedures shall provide for identitication, conditions aclrrerse to quality.Rervorked, r'epaired, alld replacemeut itetns accordance with the ortgirlal inspection and alternatives.

evallratiott, and resolution of are to be inspected and tested in test requit'errtents or specified Additional details concerning corrective action activities may be found in Section A.6 and the Rcgulatory Guides and associated Standards as committed to irr Section A.7 and Table I (e.g., Regulatory Guides 1.33 and 1.144).14, Docunlenf Control a. A program is established and implemented to corrtrol the development, revierv, approval, issue, use, attd revision of documents, b. The document control program shall be applied to docurnents that prescribe activities affecting quality of safety-related structures, systems or components, Such activities include design, procurenrent, material control, installation, inspection, testing, nraintenance, rnodifi cation, operatiorr, refueling and decommissioning.

g.Revisionl l9 18 of 36 fiffiff##f trslErttrg,f Nuclcar Operali,ro ar-Ooh Quality Assurance Program Manual c. Revisions of controlled docunrents are reviewed fol adequacy and approvecl for' release by the same organization that originally leviewed and approved the documents or by a designated organization that is qualified and knowledgeable.

d.e.Controlled docurnents al'e available activity.The distribution of nerv and revised pl'ocedtrres, Superseded documents to and used by the person perforrning the controlled doctrntents is irr accordallce witlr are controlled to prevent inadvertent use,Additional details concerning document control may be found in the RegulatoryGuides and associated Standards as comrnitted to in Section A.7 and Table I (e.g., Regulatory Guide l.33).

15, Records a. A prograrn is established and implernented to ensure that sufficient records ofitems and activities (e.g., design, engineering, procurement, manufacturingconstruction, inspection and test, installation, preoperation, startup, operations,maintenance, modification, decommissioning, and audits) are generated andmaintained to reflect cornpleted work.The proglarn provides provisions for the adrninistration, receipt, stotage, preselation, safekeepirrg, retrieval, and disposition of records, b.c.Additional details concerning record requirernents may be found in theRegulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9., Regulatory Guide 1.88).

C, ASSESSI\{ENT l.l'Iethoclologp' a,Pelsonnel responsible for canying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the quality assurance plogram requirements so that they can act in a tnanagement advisory function.Organizations performing audits are to be technically and perfotmance oriented cotnmensurate with the activity being reviewed.

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

b.c.Revisiolr

1919 of 36 fiffiru##F t sl fn e rgy il'uc/ear Op+ra l'rU O-rtpoh Quality Assuranse Prograrn Manuaf d. Audits are accomplished using procedures, or other appropriate means that are ofa detail cotnmellsurate with the activity's cornplexity and importance to safety.

2.Audit A prograrn of planned and periodic audits is established and implemented toconfirm that activities affecting quality cornply with ths QAPM and that the QAPM has becrr inrplemented effectively.

Audits will be conducted as lequired by the applicable Code of Federal Regulations, Technical Specifications, safety analysis repofts, and commitments by various correspondencs to the NRC.Audits will be conducted at a fi'equency in accordance with either Section C.2,a.l or Section C.2.a,2 below.1, Audit frequencies will be determined in accordance with a performance based audit scheduling program. The scheduling plogram, through an expert panel, uses assessrnent indicators to identiff and schedule auditsbased on performance results and irnportance of the activity relative to safety. Potential audit subject areas are periodically assessed against appropriate perfomrance criteria. From these reviews a determination is rnade in regard to the deptlr, scopq and scheduling of specific audits.Functional areas important to safety are assessed annually (+ 25%) to identify 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, NRCinspections, LERs, self-assessments, and applicable conditions reports (e.g,, non-conformance and corrective action reporls).

Personnel changes, change/increase in flinctional area responsibilities, industry operating experience, and INPO evaluations will also be considered. Each area willbe assigned a rating with a comparison to previous years. This assessment rvill be documented, reviewed, and approved by quality assurance management.

This docurnent is considered a quality assurance record and will be available for NRC review. Audit subject areas of Section C.2.a.2 shall continue to be audited on the fi'equencies designated unless expefi paneljudgment, based on performance results, detemrines snch an audit to be unnecessary.

In strch cases the expert panelbasis shall be docurnented.

Audit schedules assul'e that the following areas are audited at the indicatedfrequencies, or rnore fi'equently as perfonnance dictates.

^. The conformance of unit operation to provisions contained within the Technical Specifications and applicable license conditions at least once per 24 months.a.2.Revision I 1920 of 36 Fffff##Ouality Assurance Program fulanual F t sl E n e qy A'uclea r O pualing Conpany.b, c.The perfonnance, training and qualification of the station staff at least once per 24 rnonths,Tlte tesults of actions taken to corlect deficiencies occun'ittg in unitequipurent, sttuctures, systems or method of operation that affect nuclear safety at least once per 24 rnonths.The performance of activities required by the QAPM to meet the requirements of 10CFR50, Appendix B at least once per 24 months.The fire protection proglam controls and implementing procedures atleast once per 24 months.The fire protection equipment and program implernentation at least once per 24 months utilizing either qualified licensee personnel or anoutside fi re protection consultant.

The fire protection equiprnent and prograrn irnplementatiott at least once per 36 months trtilizing a qualified outside fire protection consultant.

The Radiological Environmental Monitoring Program (REMP) andradiological effl uents monitoring activities and implementing ptocedures at least once per'24 months.The Offsite Dose Calculation Manual and implernenting procedures at least once per 24 months, The Process Control Prograrn and inrplementing ptocedures for processing and packaging of radioactive wastes at least once per 24 months.d.9.g.h.3.A grace period of 90 days may be applied to the 24 rnonth frequency for internal audits. For activities defered in accordance with the 90 day grace period, the next performance due date will be based on their originallyscheduled date.

1.j.Auclits shall procedures, and records.Audits shallor checklists.as appropriate.

4, provide an objectirre evaluation of quality related practices, instructions, activities, and iterns and a review of docuutents as applicable.

be perfonned in accorclallce u'ith approved written procedures Items fi'om pre\/ious audits shall be reviewed and reaudited,The checklists are ussd as guides to the attditor.

5.6. Scheduling

and resource allocation are based on the status and safety importance of the activity or process being assessed.

7. Scheduling is dynamic and resources are supplemented when theeffectiveness of the quality assurance proglam is in doubt.Revision: l9 21 of 36 FHru##Quality Assurance Program Manualf rslfrcrgy rYuf/c-ar Operaling (lrwpartt.

8. Audit repofis are written and distributed to the appropriate levels of management for review. Follow-up action can be accornplished through written communication, re-audit, or other appropriate means, as deemed necessal'y, Implementation of delegated portions of the quality assurance program is assessed.Audits are conducted using predetermined acceptance criteria, which are the individual requirements within the QAPM, applicable Regulatory Guides artd ANSI Standards, procedures, and documents that are used to perform the audited activity or process.Additional details concerning audits may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.g., Regulatory Guides 1,33 and 1.144).

D.IN DtrPENDIINT SAFETY Rtr\/Itr\\/

Descriptiona. Independent safety review is performed to meet the individual unit's commitment to perform the functions described in NUREG-0737, SectionLB. I,2, "Independent Safety Engineering Group." 9.10.ll.l,Revisiotr: 1922 tf 36 ffffff##Quality Assurance Prograrn Manual A.Table 1 - Regulatory Conrmitnrents Regulatory Guide 1.8 (Revision

1) [Septcmber 19751, Personnel Selection and Training l. FENOC cornmits to the regulatory position of this Guide with the following clarifications:a. 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 ofprofessional experience in appliedradiation protection." It is FENOC's position that equivalent as used in this Regulatory Guide for the bachelor's degtee Ineans (a) four years of post secondaryschooling in science or engineering, or (b) four years of applied experience at a nuclear facility in the area for which qualification is sought, or (c) four years of opemtional or technical expertence or training in nuclear power, or (d) any cornbination of the above totaling four yeals. The years of experience 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 NI8,1-1971 as modified by plant-specific Teclrnical Specifications.

Regulatory Guide 1.30 (Revision

0) [August l9T2L Quality Assurance Requil'ementsfor the Installatiott,Irtspectiort, and Testitrg of Instrumenftilion sttd Electric Eqaipment FENOC comrnits to the regulatory position of this Guide.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 tltis, requiretnents of this Standard shall apply to those systems and components that are within the scope of the QAPM. Each plant maintains a list olequiprnent subject to QAP\4 requirements.

This Standard is also applied to other systems and components u,hen required by approved plocedures, engineeriug specifications, or other workcontlolling docunrents.b. Section 2.2 requires that evidence of compliance by the rnanufacturer with purchase requirements, including quality assurance requirements, be available at the site priorto applying the requirements of ANSI N45.2.4. In lieu of this requirement,installation, 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 been received and accepted plior to the item being placedin service.

B, 1.2, Revision:

l9 23 sf36 Fffru##Quality As$uranee Program Manual

c. Section 3 requires that records of protective lneasures maintained during storage for conformance to storage requirements be checked fo verify that iterns are in satisfactory condition for installation.

This check shall be made only if equiprnent requires special stot'age or handling as specified in procurement documents, Sections 5.2 and 6.2 list the tests which are to be conducted during construction and post-construction activities, In lieu ofthese tests, FENOC shall conduct only thosetests necessary to verify that work activities specified by work controlling docurnents have been satisfactorily accomplished during maintenance or modification activities.

The requirenrents of Sections 5.2 and 6.2 of ANSI N45,2.4 shall be used as guidelinesin deterrnining these testing requirements.

Section 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 performed the calibration." In lieu of this requirement, FENOC may alternatively irnplement programs that require the equipment to be suitably marked to indicate the date of the next calibration and the identity of the person that perfonned the calibration.

In addition, installed plant equipment that is used as measuring and test equipment (M&TE) may be controlled to indicate its calibration status and to ensure traceabilityto calibration test data by alternate rnearls in lieu ofphysically taggingor labeling (e.g., preventive maintenance prograrn).

Rcgulator.y Guide 1.33 (Revision

2) [Februar.y 19781, Qutrlity Assurance ProgramR eq u ire nrc n ls (Operatiotts)1. FENOC commits to the regulatory position of this Guide r,vith the following alternatives:

a, Regulatory Position C.4 specifies audit fi'equencies for several audit topics. QAPMSection C.2 (Audit) describes alternatives to these fiequencies,2. FENOC commits to the requirements of ANSI NI8.7-1976IANS 3,2 with the follorving clarifi catious and alternatives :a. Sectiorr l requires that this Standard "apply.to all activities affecting the safety-related functions of nuclear power plant stitrctures, 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 summary document should be cornpiled by each owner organization to identify the sources, to index such sources to the requirementsof this Standard, and to provide a consolidated base fol the description of the plogr4rn." In lieu of this requirement, a nrethod of cross-referencing these requirements to the irnplernenting ptocedures will be rnaintained.c. Secti<lrr 5.2.2 requires that "temporary changes which clearly do not change the intentof the approved procedure shall, as a minimum, be approved by two tnembers of the d.e.C, Revision3 19 24 of 36 fiffiru##fi r s I fn e r gyrTuctea

r. O per a t ingO*Or, Quality Assurance Program Manual d.plant staff knowledgeable in the areas affected by the procedure.

At least otte of theseshall be the supervisor in charge of the shift and hold a senior operating license on theunit affected." Such changes shall be documented and if appropriate, incorporated into the next revision of the affected procedure.

In Iieu of these requirements, FENOC cotnmits to the following:l) Ternporary 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 involvea change in intent of the procedure, the original approval authority shall approve the change priol to irnplernentation.

OR 2) Tcmporary changes to procedures rvill be apptoved by two knowledgeable membets of the plant staff prior to irnplementation. At least one of these persotls will be a memberof supervision. If the change affects operations procedures, at least one of these persons will hold a senior reactor operator license for the unit affected.

Prior toirnplementation, the OSC (PORC) shall review and recomrnend approval of temporarychanges to procedures which 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.Section 5.2,6 requires that a log be maintained to identify the current status of temporary rnodifisations such as bypass lines, electrical jumpers, lifted electricalleads, and temporary trip point settings. FENOC takes exception to this requitementrvhcn tlie installation and removal of such ternpolary rnodifications is specifically addrcssed in approved procedules.

These procedures ensure that the circuitry is returned to its original configuration when the operation is cornpleted,Section 5.2.7 - Since certain emergency situations could arise which might prevent preplanning activities, FENOC complies with an altemative to the first sentence inthe second paragtaph as follows: "Except under emergency or abnonnal operating conditions where irnmediate actions are required to protect the health and safety of the public, to protect equiprnent or personnel, ot'to prevent the deterioration of plant conditions to a possibly unsafe or unstable level, maintenance or modification of equipment shall be preplanned and performcd irt accordance with approved procedures. When written procedures would be required and are not used, the activities that are accomplished are documented after-the-fact and receive the same clegrec of reviews as if they had been preplanned." Section 5,2.13 (1) establishes the requirernent for identifying quality assuranceprogl'am requirements applicable to the items or selices being procured.

Whenpurchasing commercial grade services from certain accredited calibration laboratories, the procurement documents are not required to impose a quality assurance program consistent with ANSI N18.7. Alternative requirements described g.Revisiott:

l925 of 36 Fffff##Quality Assurance Program Manual D.in tlris QAPM for Regulatory Guide 1.123 may be inplemented in lieu of irnposing a quality assurance proglarn consistent with ANSI N18.7, g. Sectiorr 5.2.15 contains a requirement for biennial revierv of plant procedures.

In lieu of this requirement, FENOC may use one of the following rnethods as alternatives:

l) Impletnent process controls that ensure procedures are revierved for possible revisiotr upon identification of nerv or rcvised source rnaterial potentially affecting the intent of procedures.2) Iuplement process controls related to procedure review, a maximum six year review period and biennial audits of operatingorganizations that include a reviewof their procedurcs to assure that controls result in tirnely procedure revision in response 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 independent review bodies to review license amendments and technical specification changes. As an alternative to the requirements for the off-site review body to review license arnendments and techuical specification changes, FENOC will utilize the on-siteLcvie,w body for these reviews. To ensure that the on-site review body maintains independence during these reviews, any voting member that has a potential conflict of interest in a change uuder review will be replaced by another member to achieve a quorum. In addition, the off-site review body will review on-site review body meeting minutes and independent oversight (QA) audit and assesunent results of on-site review body activities to evaluate their effectiveness.

Regulatory Guide 1.37 (Revision

0) [March 1973), Quality Assw'ance Requirernentsfor Cleaning of Fluid Systems and Associated Contponents of llater-Cooled Nuclear Power PIantsl . FENOC commits to the regulatory position of this Guide with the following clarifications:

a. Regulatory Position C.3 requiles that water quality for final flushes of fluid systems and associated components be at least equivalent to the quality"required for normal operation. This requirement is not applied to dissolved oxygen or nitrogen nor does it infer that additives rrotmally in the system rvatel 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 austeniticstainless steel and nickel-based alloys, It is FENOC's position that materials such as inks, temperatule indicating crayons, labels, wrapping materials (other than polyethylene), water soluble materials, desiccants, lubricants, and NDE penetrantmaterials and couplants, which contact stainless steel or nickel-based alloy materialsulfacss contain no more than trace amounts of lead, zinc, copper, or lower rnelting Revision:

1926 of 36 fiffffffi#

Quality As$urance Prograffi Manual E, alloys or compounds.

Maximurn allowable levels of water leachable chloride ions, total halogens and sulfur cornpounds shall be defined and imposed on theaforementioned rnaterials. Thcse matedals will be controlled through administrative procedures that are, in part, designed to rnirrimize their effects on intergranularcracking or stress conosion cracking.2. FENOC commits to the requirements of ANSI N45.2,1-1973 with the following clarifications:

a. During maintenance and modification activities, FENOC shall control the opening of clean systems and shall conduct inspections to verify that affected system clearliness levels shall not be adversely affected by the maintenance or modification activity, Wren system cleanliness is affected, specific cleaning procedures which incorporatethe applicable portions of this Standard shall bs developed and irnplemented tomairrtairr systclx cleanliness.

b. Section 2.4 requires that personnel wlto pelform 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 alternatively be qualified in accordance with Regulatory Guide 1.8.Regulatory Guide 1.38 (Revision

2) [May 19771, Quality Assurance Requirementsfor Packaging, Shipping, Receivittg, Storage, and Handling of Itemsfor ll/ater-Cooled Nuclesr Power Plants FENOC cotnrnits to the regulatory position of this Guide.FENOC conrmits to the requirements of ANSI N45.2.2-1978 with the following clarifications:Sections 3 and 4 specify a four level classification system for the packaging and shipping of items. In lieu of these requirements, cornmercial gtade items shall be packaged and shipped in accordance with standard commercial practices.

Section 5.2.1 requires preliminary visual inspection or examination for shipping damage to be performed prior to unloading. In lieu of this requirement, visualinspection shall be performed during unloading and unpacking.Section 5,5 provides for'"rewor*" and "use-as-is" dispositions for nonconfot'tning iterns. As an altelnative, the "repair" disposition (as defined by ANSI N45.2.10-1973) tnay also be used.

Section 6.5 requires that items released from 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 Standard and other applicable Standards.

In lieu of this requirement, FENOC shall, whenevet feasible, store items within their'L)A.b.C.d,Revisfort t 19 27 oI 36 Fffff##Quality Assurance Prograrn Manual F.appropriate storage area and move the equiprnent to the plant areas for staging only in sufficient tirne to suppolt its installation, Within the plant, the equiprnent shaH be staged at locations which provide equivalent envirorunental conditions under which itis designed to operate.

Materials placed in staging areas shall be stored in accotdance with the applicable requirements of Paragraphs 6.1, 6.3 and 6.4.2 of ANSI N45.2.2.Various Sections of ANSI N45.2,2 addrrss the use of non-lralegenated materials when in contact with austenitic stainless steel or nickel-based alloys. The exceptionsapplicable to Regulatory Guide 1.37 regarding this subject also apply to ANSI N45,2.2.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 static gas blankets in order to provide adequate protection due to difficulty of providing aleak-proof banier. In these cases, a positive pressure purge flow may be used as an altemative to a leak-proof barrier.Regulatory Guide 1.39 (Revision

2) [September 19771, Housekeeping Requirementsfor Wa.ter-Cooled Nuclear Power Plants FENOC commits to the regulatoly position of this Guide.FENOC commits to the requirements of ANSI N45.2.3-1973 with the following alternative.

a. The ANSI five level zone designation systern may not be utilized, but the intent of thestandard will be met for the areas of housekeeping, plant and personnel safety, and fire plotection.

Regulatory Guide 1.58 (Revision

1) [September 1980], Qualification of Nuclear Power Plant Inspection, Exentinotion and Testing Personnell. FENOC commits to the regulatory position of this Cuide rvith the following clarifications:a, The guidance of this Regulatory Guide shall be followed as it pertains to the qualification of personnel who verify confonnance of wor* activities to quality requirements.

b, Personnel will not be certified as stated in this Guide in the follolving areas: 1) Individuals that handle test results ol perfonn document control activities, 2) Quality assurance and staff personnel responsible for tlre review of documents for clarity and cornpleteness.

l.2.G, Revision:

19 28 of 36 Fffiff##t"t Ouality Assurance Program Manual 3) Test persorutel utilizing gas test methods for infonnation or data collection activities (this includes those personnel perfor'rning local leak rate testing (LLRT)as stated in 10CFR50 Appendix J). The qualifications of these personnel shall conform to the requirements of Regulatory Guide 1.8.

4) Plant opelation personnel concenred with day-to-day operation, maintenance, and ccftain technical serices (the qualifications of these personnel shall confonn to the requirements of Regulatory Guide 1.8).c. Regulatory Position C,2 indicates that SNT-TC'IA-1975 is to be used for the qualification of nondestructive examination (NDE) pelsonnel who apply various NDE rnethods. It also indicates that personnel performing nondestructive examinations required by Section III and Section XI of the ASME Code should be qualified to SNT-TC-lA-1975 as well as additionalprovision of the Code. For the qualification ofNDE personnel, FENOC commits to the ASME Section XI requirements specified within the applicable code year edition(s) as defined by l0CFR50.55a, This alterlative rnay be applied regardless of whether examinations are of a type required by the Code.2. FENOC comrnits to the requirernents of ANSI N45,2.6-1978 as modified by thecomrnitments to Regulatory Guide 1.58 with the following clarifications:

Section 2.5 of this Standard discusses special physical characteristics.

FENOC cotnmits to the following: Examinations to verify that personnel have the requiled physical characteristics will be schecluled on an amual basis with a maximum allowable extension of 90 days.Section 3.5 of this Standard discusses education and experience.

FENOC commits to thc following: The initial qualifications of individuals to Level I, II, or III r.vill generally be to the education and experience recommendations in the Standard.However, in certain instances as determined by appropriate management, qualifications may be altematively determined through test results and/or denonstration of capabilities.

For Level I, FENOC lvill also accept a four year college degree plus one month of related experience or equivalent inspection, exarnination or testing activities. Individual requalification will meet or exceed the recollnlellclation of this Standard.c. Section 2.3 of this Standald discusses evaluating personnel who have not pelfornred inspection activities for more than a year. A 90 day grace period is applied to this evaluation, Regulatory Guide 1.64 (Revision

2) Uune 79761, Quality Assurilflce Retluirementsfor the Design of Nuclear Power Plants 1, FENOC commits to the legulatory position of this Guide with the following clarificatiotrs:

a.b.H.Revision:

l9 29 of 36 ffiffff##Itslf Quality Assurance Prograrn Manual I.a. Regulatory Position C.2( l ) addresses the use of a snpetvisor in design verification.If, in exceptional circumstances, the supervisor is the only technically qualified individual available, the design verification or checking shall be conducted by the supelisor with the following provisions:

1) 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 supervision.

3) Quality assurance audits shall include review of fiequency and effectiveness of the use of the immediate supervisor to assure that this provision is used only in exceptional circumstances.

b. An individual who contributed to a given design rnay participate in a group verification of that design provided that the individual who contributed to the designdoes not (l) verify his contribution to the design, ot (2) selve as chairman or leader of the group verification activity.2. FENOCcommitstotherequirementsofANSIN45,2.ll-l974withtheclarificationsas noted above for the use of an immediate supelvisor for design verification activities andconduct of group verification activities.Regufatory Guide 1.74 @evision 0) [February 19741, Quallty Assurance Terms and DeJinitions FENOC cornmits to the regulatory position of this Guide, FENOC commits to the requirenlellts of ANSI N45.2,10-19J3.Regulatory Guide 1.88 (Revision

2) [Octobcr 19761, Collection, Storage ond Maintenance of Nuclear Power Plant Quality Assursnce RecordsL FENOC conimits to the legulatory position of this Guide, 2. FENOC commits to the requirements of ANSI N45.2,9-1974 with the following altemalives:

a. Section 5.6 addresses records storage facilities. In lieu of this, the design and construction of quality assurance record storage facilities will follow the guidance of ANSI/ASMENQA-l-1983, Supplement l7S-1, Section 4.4. When temporary storage of records is required, the guidarrce of ASME NQA-l - 1989, Supplement l7S-I , Section 4.4,3 will be followed. For storage of special processed records (such asradiographs and rnicrofihn), hurnidity and temperature controls shall be plovided soas to rnaintain an environnrental condition as pl'escribed in Paragraph 6.1.1 of ANSI PH 1.43-1979 (Also required by Section 5.4).l.2.J, Revision:

19 30 of 36 fiffiff##Auality As$urance Program Manual K, b' Appendix A of ANSI N45.2,9, tequires that records of measuring and test equiprnent calibration be rnaintairted "until recalibration." This irnplies thaf the full stoiage tequiremenfs of this Standard apply until the equiprnent is r.ecalibrated. In lieu of this requirement, FENOC may store measuring and test equiprnent calibration rBcords in otre-hour Iire rated containers.

This exception does not apply to records of calibration required by the Technical Specifications.

c. For managing QA recotds in electronic media FENOC commits to the guidance of RIS-2000-018, This NRC Regulatory Issue summary (RIS) endorses: NIRMA Technical Guide (Tc) 1l-1998, Authentication of Records and Media NIRMA TG l5-1998, Management of Electronic Records NIRMA TG l6-1998, Software co'figuration Management and euality Assurance NIRMA TG 2l-1998, Electronic Records protection and Restoration Regulatory Guide 1.94 (Revision

1) [Aprit 19761, Quatity Assuruntce Requirementsfor Installation,Inspection anl Testing of Structnral Concrete and Structural Steel During the Construction Phase of Nuclenr Power Plants 1, FENOC commits to theregulatoryposition of this Guide.

2. FENOC comtnits to the requirements of ANSI N45,2.5-1974 with the followingclarifi cations and altcmatives:

Section 2.2 requires that installation, inspection, and test procedures be kept cun'ent with the latest infolmation, This Standard was lvritten to address requirements associated with construction phase activities. However, during the operations phase, activities associated with installation, inspection, and testing of structural corrcrete and structural steel are very minor in frequency and extent. Consequently, plocedures for these activities shall only be reviewed or updated prior to commencing the activity.

The procedures for structnral concrete and structural steel installation, inspection, and testirrg activities rvill be developed using the provisions of ANSI N4s.2.5 - 1974.Altelnatives to lhis Standard are taken with respect to fi'equency of calibration of impact wreuches and bolt projection criteria.

Impact and torque wrenches shall be checked at least once daily per shift, and at least one full thread of all bolts shall project beyond the nut of all tightened corurections.

These criteria comply with the recommendations of the Research Council on Riveted and Bolted Structural Joints.a.b.Rcvision:

l9 31 of 36 fiffff##Quality Assurance Program Manualc. Sectiorr

4.9.1 discusses

the qualification requirements for rnechanical (cadweld) splice operators.

In lieu of this, Davis-Besse 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 cornply with the requirernents of ASME SectionIII, 1995 Edition, subparagraph CC-4333.5.2.

e. Section 4.9.4 discusses tensile testing fi'equency.

In lieu of this, Davis-Besse and Beaver Valley will cornply with ASME Section III, 1995 Edition, subparagmph CC-4333.5.3.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.s.2.g, Section 5.5 discusses inspection of structural steel welding. In lieu of this, Davis-Besse and Beaver Valley will cornply rvith inspection requirements of the applicablewelding codes and any exceptions.

h. Thc nrecharrical splice personnel qualification, testing and testing frequency requircments for mechanical (cadlveld) splices addressed in K,2.c through K.2.f applyto other full positive connection technologies that meet the design code of record, Thefi'equency of shear scrsw and sleeve splice testing shall meet the same requirementsas swaged splices, Regulatory Guide 1.116 (Revision

0) [May 1977], QualiE Assurance Requirementsfor Installatiott,Inspection and Testing of Mechanical Equipnrent and Systems FENOC conrnits to the regulatory position of this Guide.FENOC commits to the requirements of ANSI N45.2.8-1975 with the following claritications:a. Sections 2.4 and 2.6 require that procedures define system restoration requirements as needed to prevent contarnination after cleanliness class is achieved in accordamce witlt commitments to ANSI N45.2.1 and ANSI N45.2.3, b. Section 2.9 t'equires that evidence of compliance by the manufacturer with purchase requirements, including quality 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 lacking quality docurnentation.

L.l.)Revision:

1932 of 36 fiffiff##Quality Assurance Program Manualc. 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. Regrrlatory Guide 1.123 (Revision

1) [July 1977], Quality Assuyance Requirementsfor Control of Procurement of ltems and Services for Nuclew Power Plantsl. FENOC commits to the regulatory position of this Guide, 2, FENOC commits to the requirements of ANSI N45.2.13-1976 with the followingclarifications, exceptions and alternatives:

a. Subsection

3.2.3 discusses

quality assurance progl aln requircments for procurement docurnents, For the purchasing of cornmercial grade calibration seryices from dornestic calibration laboratories accredited by a nationally recognized accreditingbody, the ptocurernent documents are not required to impose a quality assul'ance pr'ogram consistent with ANSI N18.7.

In such cases, accreditation may be acceptable in lieu of the purchaser imposing a QA program consistent with ANSI N18.7, provided all the following are met:1) The accreditation is to ISO/IEC 17025.

2) The calibration laboratory holds a donrestic accreditation by one of the following accrediting bodies, which are recognizedby the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Anangement (MRA):- National Volnnfary Laboratory Accreditation Proglam (NVLAP), administeredby NIST- American Association for Laboratory Accreditation (A2LA)- ACLASS Accreditation Services (ACLASS)- International Accreditation Service (IAS)- Laboratory Accreditation Bureau (L-A-B)3) The published scope of accreditation for the calibration laboratory covers the needed measurement parametels, ranges, and uncertainties.4) The purchase documents impose additional technical and adrninistlative requiretnents, as ncccssary, to satisfy FENOC QA Progranr and technical rcquiremelrts.

'fhis u'ill include requiring that the supplier identify the laboratory equiprnent/standards nsed and the as-found and as-left data in the caliblation certificate/r'epofi.

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

Revision:

1933 of 36 fiffiruff#

Quality Assurance Program Manual N.b, The altenrative method is applicable to sub-suppliers of calibration selice suppliers, provided the above conditions are met, c. Section 4 provides for the selection ofprocurernent sources. For "commercial grade" items and for non-safety related iterns within the scope of the Quality Assurance Program for which there are no quality assurance program or quality dosumentation requilements, the requirernents of this Section need not be adhered to.

However, the procurement docurnents shall specify requirements specific to the item being ptocured, sufficient to provide adequate cerlification ol other records to ensure that iterns and activities meet the specified requirements, d. Section 8.2 provides requirements for the conhol of nonconfol'mances. Suppliers qualified by FENOC as design agents in accordance with Regulatory Guides 1,64 and 1.123 ntay be permitted under specific contractual provisions to disposition nonconfonnances as "use-as-is" or "repair" on behalf of FENOC, All nonconformances dispositioned "use-as-is" or "repair" by suppliers qualified by FENOC as design agents on behalf of FENOC are required to be submitted to FENOC for engineering approval at the tirne equipment is received on site, If FENOC detennines that a disposition has been incorrectly made, a nonconformance leport is generated on site to document the problem and effect resolution, e. Section 10,2.d is interpreted as follorvs: The person attesting to a certificate shall be an authorized and responsible ernployec of the supplier and shall be identified by the supplier.Regrrlatory Guide 1.144 (Revision

1) [Septenrber 19801, Auditing of QualityAssurance Programs for Nuclear Power Plailts l. FENOC commits to the regulatoly position of this Guide with the following alternatives:

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 triennial audits and annual evaluations that are defeued, the next performance due date will be based on the originally schcduled date.Section C.3.b (2) outlines the requirements for triennial audits and anrtual evaluations of suppliers. When purchasing comrnercial grade calibration services fi'om domestic calibration laboratories accredited by a nationally recognized accrediting body, the accreditation process and accrediting body may be credited with carlying out a porlion of the purchaser's duties of verifying acceptability and effective impleinentation of the calibration service supplier's quality assurance prograrn.In lieu of perfonning an audit, accepting an audit by another licensee, or performing a commercial grade survey, a documented revierv of the supplier's accreditation shall be perfonned by the pulchaser. This review shall include, at a minimum, all of the follorving:

a, b.Rcvision l 7934 of 36 Fffff##Quality As$urance Program Manual 2)I ) Tlre accreditation is to ISO/IEC 17Q25.The calibration laboratory holds a dornestic acsreditation by one of the following accrediting bodies, which are recognized by the International Laboratory Accredi tation Cooperation (ILAC) Mutual Recognition Aruangement (MRA);- National Voluntary Laboratory Accreditation Program (NVLAP), adrninistered by the National Institute of Standards and Technology ( NIST)- American Association for Laboratory Accreditation (AZLA)- ACLASS Accreditation Services (ACLASS)- Intemational Accreditation Service (IAS)- Laboratory Accreditation Bureau (L-A-B/The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncefiainties.

3)The alterlative method is applicable to sub-suppliers of calibration service suppliers, provided the above conditions are mct.Section C.3.b (2) outlines the requirernents for triennial audits and annual evaluationsof suppliers. Instead of documenting evaluations of suppliers on an annual basis,FENOC tnay 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 evaluations are reviewed and appropriate comective actions taken.

Adverse findings resulting from these evaluations are periodically reviewed in order to determine if, as a whole, they result in a significant condition adverse to quality and to provide input to support supplier audit activities conducted by the licensee or a third party auditing entity.2, FENOC comrnits to the requirernents of ANSI N45.2.12-1977 with the following clarification:

Section 4.5.1 of this Standard discusses fbllow-up arrd con'ective actions. FENOC may utilize the provisions of the conective action program outlined in Section A.6instead of these requirements, as long as the approptiate time limits are applied to significant conditions adverse to quality. Also, no additional documentation is necessary if needed con'ective actions are taken and verified prior to audit report issuance.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 be fulfilled by a variety of comtnunications, such as telephone convcrsation, c. Section 4.3. I and 4.3.3 of tliis Stanclard discuss pre-audit and post-audit conferences, Pre-audit and post-audit conferences are only hcld when deemed necessary by qualityassurance or when requested by the audited organization.

c.d.a.b.Revision:

19 35 of 36 Fffff##Quality Assurance Program Manual O.d. Section 4.4 discusses audit reporting. Audit reports shall be issued within thirty wor*ing days after the last day of the audit. The last day of arr audit shallbe considered to be the day of the post-audit conference.

If a post-audit conference isrrot held because it was deemed unnecessary, the last day of the audit shall be considered to be the date the post-audit conference was deemed unneeessary as documented in the audit report.

Regulatory Gulde 1,146 (Revision

0) [August 1980J, QuuliJication of Quulity Assuronce Program Audit Personnelfor Nuclear Power Plants I, FENOC commits to the regulatory position of this Guide.

2. FENOC comnrits to the lequirenrents of ANSI N45,2.23-1978 with the following alternatives.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 and may be awarded two credits.Section 2.3.4 discusses audit participation, Prospective lead auditors shalldemonstrate their ability to effectively implement the audit process and lead an auditteam. They shall have parlicipated in at least one nuclear audit within the year preceding the individual's effective date of qualification.

Upon successful demonstration of the ability to effectively lead audits, licensee management may designate a prospective lead auditor as a lead auditor.c, Section 3.2 requires an annual evaluation of lead auditors. A 90 day gl'ace periodrnay be applied to the annual evaluation. For those evaluations that are deferred, the next performance due date will be based ou the originally schedule date.d. Section 5.3 requires that records for lead auditors be maintained and updated annually. A 90 day grace period rnay be applied to tlre annual update, For those updates that are defened, the next performance due date will be based on the originally schedule date.

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