quality asgurance rem lltanual - nrc

Quality Asgurance P rem lltanual

Approvrd

Berver Yrllry Power $tetionIlnits | &,2Docket Nos. 50-334 & 50412Oper*iilg Lieense Nos, DPR{6 & NPF-73

Ilavis-Bessc Nuclerr Power StationDosket No. 5&,346Operating Licerrse No. NPF-3

Perry Nudear Power Plantflocket No. 50440Operating License No. NPF-58

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TABLE OF CONTENTS

A. MANAGEMENT

1.2.3.4.t.6,7.8.9.10.11.12.13,14.15.

MethodolotrOrganizationReuponsihilityAuthorityPersonnel Training and QurlificationCorrective ActionRegulatory Commitments

MethodologyDesign ControlDesign YerilicrtlonProcurement ControlProcurement VerilicationIdentificafion nnd Control of ItemsHandling, Storagen and ShippingTest ControlMeasuring and Test Equipment ControlInspection, Test, and Operating StatusSpecial Process ControlInspectionCorrective ActionDocument ControlRecords

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1.2.3.4.t.6.7.

B. PERT'ORMANCEruERIFICATION

C. ASSESSMENT

MethodologyAudit

D. IFTI}EPENDENT SAFETY REYIEW

l. Description

1.2.

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TABLE OF CONTENTS (Continued)

Tahle 1 - Regulatory Commitmenh

A. Regulatory Gutde l.t (Revision 1) [September 19?51,Perconnel Selecfion and Training [ANSI N18.U

B. Regulatory Gutde 130 (Revision 0) lAugust 19721,Qaality Assaranee Requiremenfr for lhe InstallatioryInspedion, and Testing of hrttrumentalion andElectria Equipment IAI\til N45.2.41

Regulatory Guide 137 (Revision 0) [March 1973],Suahty Assurance Reqairements for Cleaning ol FluidSystems and Associated Componenls of Water-CooledNuclesr Power Plants [ANSI N45.2.U

E. Regulatory Guide 138 (Revision 2) [May 19771,Suahfy Assarance Requiremen# for Paclcaging,Shfuing, Receiving, Storage, and Handling of ltemsfor Water-Cooled Nuclear Power Plnt fr IANSI N45.2.2I

F. Regulatory Guide 139 (Revision 2) [Septemher l9T7l,Hoasekceping Reqaberuenfr lor Water-Cooled NuclearPower Plaws [41\lSI N45.2.3]

Regulatory Guide 1.58 (Revision 1) [September 1980],Qualifieation af Nuclcar Power Plant Inspection,Exeminstion and Testing Personnel [AI{SI N45,2,6]

Regulatory Guide 1.64 (Revision 2) pune 19761,Suahty Assarance Reqairements for the Design ofNuclear Power Plants [Ail{SI N45.2.111

Regulatory Guidel,74 (Revision 0) [February 19741,Quality Assurance Terms and Detinitions [A1\[SI N45,2.101

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Regulatory Guide 133 (Revision 2) [FebruarT 19781,SasW Assurance Progrum Requirements (Operation$/ [ANSI N18.71 24

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TABLE OF CONTT,NTS (Continued)

Tahle 1 - Regulatory Commitments (Continued)

Regulatory Guide l.EB (Revlston 2) [October 19161,Collection, Storage and Maintenance of Naclear PowetPlant Sualry Assarsnce Records IAI{SI N45.2.9]

Regulatory Guide 1.94 (Revision 1) [April 19761,Sasl#ry Assnra$ce Requirements for InstellatiothInspection and Testing of Concrete and Structural SteelDuring lhe Consfiuction Phase of Nuclear Power Plorr*IANSI N45.2.5I

Regulatory Guide 1.116 (Revision 0) [May 19771,Sualry Assurance Requbemen# for InstallatiothInspection and Testing of Mechanical Eqaipment and.lps/erns IAIISI N45.2.81

Regulntory Guidel.l2S (Revision 1) puly 19771,Saal@ Assurance Reqairements for Control ofProcurement of ltems and Seniees tor Nuclear PowerPlan# [AI{SI N45.2,131

Regulatory Guide 1,144 (Revicion 1) [September 19801,Auditing of Quality Assarance Prugrams for NuclearPower Plants [41\tSI N45,2,121

Regulatory Guide 1.146 (Revision 0) [August t9E0],Qaaltfrcetion af Sualily Assursnce Prugram AudirPertonnelfor Naclesr Power Plants [A][SI N45.2.231

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A. IT{ANAGEMENT

l. Methodologp

a. The Quality Assruance Program Manual (QAPM) provides a consolidatedoverview of the quality program controls which govertr the operation andmaintenance of FirstEnergy Nuclear Operating Company's (FENOC's) qualityrelated items and activities. This includes nuclear plant and FENOC fleetlocations, as well as FirstEnergy corporate locations that provide safety relatedservices. The QAPM describes the quality assurarce organizational stnrcture,firnctional responsibilities, levels of authority, and interfaces.

b. The requirements and commitments contained in the QAPM are mandatory andmust be implemented, enforce{ and adhered to by all individuals andorganizations. Employees are expected to actively participate in the continueddevelopment of the QAPM as well as its implementation. Changes are promptlycornmunicated wheu identified.

c. The QAPM implements 10CFR50, Appendix B and applies to all activitiesassociated with structues, systems, ffid components which are safety related.The requirements of the QAPM arc applied to these items and activities to anextent commensurate with their importance to safety.

d. The QAPM also applies to the packaging and fransportation of radioactive wasteactivities contolled by IOCFR?1, Bs the quality assurance program required by10CFR71, Subpart H.

The QAPM also applies to the iadependent storage of spent nuclear fuel andhigh-level radioactive waste activities contolled by 10CFR72, as the qualitya"ssurance program required by 10CFR72, Subpart G.

The QAPM sections 8.13, Corrective Actions, and 8.14, Document Control, alsoapply to non-safety related Stnrctures, Systems and Components subject to agingmanagement for the period of extended operations following issuance of therenewed operating license.

Section 8.13 and the listed references also address the confirmation processdescribed in NRC RIS 2014-09, Maintaining the Effectiveness of LicenseRenewal Agirrg Management Programs, to ensure preventive actions areadequate and appropriate corrective actions are completed and effective.

Section 8.14 and the listed references address administrative confrols describedin NRC RIS 2014-09, to ensurs forrral review and approval processe$ areprovided.

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(,E' The applicability of the requirements of the QAPM to other items and activitiesis determined on a case-by-case basis.

h. The QAPM is implemented through the use of approved procedures (i.e.,policies, directives, procedures, or other documents) which provide unittenguidance for the confrol of quality related activities and provide for thedevelopment of documentation to provide objective evidence of compliance.

2. Organization

The organizational stnrcture responsible for implementation of the QAPM is describedbelow. The specific orgnnization titles for the qunhty a$surance firnctions described areidentified in procedures. The authority to accomplish the qnality assurance fimctionsdescribed is delegated to the incumbenfs staffas necessary to fulfill the identifiodresponsibility.

The Chief Nuclear Officer (CNO) is responsible for establishing expectationsand providing top level direction of all activities associated with the safe andreliable operation of FENOC's nuclear power plants and activities of corporatefirnctions. The CNO provides guidance with regards to the company qualityassurance policy.

a.

I The executive responsible for oversight reports to the CNO and isresponsible for the audit and assessment of the quality assurance programof FENOC's nuclear activities, both site and corporate, ffid maintainingthis QAPM in accordauce with regulatory requirements. This executive isalso responsible for establishing the qualrty assurance program policies,goals and objectives, for impleme,ntation of the quahty assurance program,and for maintaining the Quality Assruance Program Manual. Thisexecutive also has overall responsibility for the quality assurance andindependent off-site safety review cornnrittee firnctions' as well as supplierauditing.

a) The individual responsible for quality assurance reports to theexecutive responsible for oversight and has overall authority andresponsibility for veriffing 1fos implementation and adequacy of thequality assurance program (auditing) as described in this QAPM. Theindividual responsible for quahty assurance has the authority andresponsibility to report matters directly to the Chief Nuclear Officerwhen needed. This individual is also responsible for the qualitycontrol fimction, and recetpt and supplier source inspections.

b) These individuals above may be responsible for a single unit/locationor for multiple unitsflocations and may fulfill more than one fuirction

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described. Conversely, responsibilities may be fulfilled by more thanone individual. Individrrals may be located at the nuclear plant orFirstEnergy corporate locations.

b. The following management positions report to the Chief Nuclear Offic€r:

1. The executive responsible for operatious provides a singular point of contactwith respect to the operation of the four FENOC poly€r plants, and providesoperational oversight of the foru plants.

a. The executive$ responsible for overall plant nuclear safety and operationssupport at each site re,port to the executive respotrsible for operations.These executives may report through an additional layer of managementbut shall maintain sufficient authority and organizational freedom toimplement the assigned responsibilities. These executive$ are responsiblefor establishing and implementing the quality assurance program at therespective site.

b. Also reporting to the executive responsible for operations is amanagement position responsible for licensing and regulatory affairs.

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

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

c.

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

2. The individual responsible for plant modification provides direction,control, and overall supenrision of the implementation of plantmodifications and assigned maintenance.

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The individual responsible for trainiug provides direction, control, andoverall supenrision of all training of personnel required by regulations.

4. The individual responsible for records management provides dirwtion,confrol, and overall supenrision of the records management program andas sociated activitie s.

The individual responsible for document control provides direction,conffol, and overall supervision of the document confol program andas sociated activitie s.

6. The iudividual responsible for the corrective action progftun providesdirection, control, ffid overall supervision of the corrective action programand associated activities.

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

The individual responsible for materials, purchasing, and contracts isresponsible for supplier evaluations, proflrement, senrices, receipt, storage,and issue of materials, parts, and components.

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

3. ResponsibiHty

FENOC has the responsibilrty for the scope and implementation of an effectivequallty assurance program.

b. FENOC may delegate all or part of the activities of planning, establishing, andimplementing the quality asflrance program to others, but retains theresponsibility for the program's effectivenes$.

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

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d. FENOC is responsible for ensuring that the applicable portion(s) of the qualityassurance program is properly doeumented, approved, and implemented (people

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are trained and resources are available) before an activity within the scope of theQAPM is undertaken by FENOC or by others.

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

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

4. Authority

a.

a.

\Uhen FENOC delegates responsibility for plnnning, estahlishing, orimplementing any part of the overall QA program, sufficient authority toaccomplish the assigned responsibilities is delegated.

b. The individual responsible for quality assurance has the responsibility and theauthority to stop unsatisfactory work (including reactor operation through properchannels) and contol ftirther processiug, delivery installatiou, or use ofnon-conforming items or services, Cost and schedule considerations will notoverride safety considerations.

5. Personnel Training and Qualilication

Personnel assigned to implement eleme,rrts of the quality assurance pro$am af,ecapable of performing their assigned tasks.

Training programs are established and implemented to ensure that personnelachieve and maintain suitable proficiency.

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

d. Additional details concerring personnel training and qualification may be foundin the Regulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.9., Regulatory Guides 1.8, 1.58, aud 1.146).

6. Corrective Action

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

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b. A corrective action progranr is established and implemented that includes promptidentification, documentatioq significailce evaluation, ffid correction ofconditions adverse to quality. For significant conditions adverse to quality, thecaruie is determined and corrective action to preclude repetition is identified andtracked until it is completed and verified.

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

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

Reports of conditions that are adverse to quality are anallzed to identiff trends inquallty performance. Siguificant conditions adverse to quality and siguificanttrends are reported to the appropriate level of management.

e.

Additional details concerning corrective action activities may be found inSection 8.13 and the Regulatory Guides and associated Standards as coillmittedto in Section A.7 and Table I (e.9., Regulatory Guides 1.33 and 1.144).

7. RegulatoryCommitments

Except where altematives axe identified, FENOC complies with the QA guidancedocuments listed ou Table [. If the guidance in any of these documents is in conflictwith the QAPM, the guidance provided in the QAPM is the controlling guidance.Additionally, the following clarifications apply to all guidance documents listed inTable 1:

l. For modifications and nonroutine maintenance, guidance applicable toconstruction-like activities is applicable to comparable plant activities,except that the inspection of modifications, repairs, rework, andreplacements shall be in accordance with the original desigu and inspectionrequirements or a docunented approved alternative.

2. The definitions provided by Regulatory Guide 1.74 apply wherever thedefined term is used in the QAPM and associated guidance documents.

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

4. [n each of the A]ISI Standards, other documents (e.9., other Standards,Codes, Regulations, tables, or appe,ndices) are referenced or described.These other documents are only quahty assurance program requirements ifexplicitly committed to in the QAPM. If not explicitly committed to, thesedocuments are not considered as quality assurance program requirements,although they may be used as guidance.

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5. Regulatory guidance originally intended to apply to design or consffuctionphase activities will be applied to activities during the operations phase thatare comparable in nature and extent to consffuction phase activities.

b. The NRC is to be notified of QAPM changes in accordance with l0CFR50.5a(a).

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

B. PERFORMANCEfiTERIFICATION

l. Methodology

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

a.

b. Personnel performing verification activities are responsible for verifying theachievement of acceptable quality.

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

d. Criteria that define acceptable qualrty are specifie4 and qualrty is verifiedagainst these criteria.

2. Ilesign Control

The design confrol program is established and implemented to assure that theactivities associated with the design of systems, componentsn structures, andequipment and modifications thereto, ffe executed in a planned controlled, andorderly manner.

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

Design inputs (e.9., performance, regulatory, quality, and qualrty verificationrequirements) are to be correctly translated into design outputs (e.9.,specifications, drawiogs, procedures, and instnrctions).

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

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

Changes to final designs (including field changes and modifications) anddispositions of non-conforming items to either use-as-is or repair are to besubjected to design control mea$urss commensurate with those applied to theoriginal design and approved by the organizatiou that performed the originaldesign or a qualified designee.

Interface controls (internal and external between particrpating designorganizations and across technical disciplines) for the purpose of developing,reviewing, approving, releasing, distributing, and revising design inputs andoutputs are defined in procedures.

Verification methods include, but are not limited to, design reviews, alternativecalculations, and qualification testing. The extent of this verification will he afunction of the importance to safety of the item, the complexity of the design, thedegree of standardization, the state of the art, and the similadfy with previouslyproven designs. Standardized or previously proven designs will be reviewed forapplicability prior to use.

When a test program is used to veriff the acceptability of a specific designfeature, the test program is to demonstrate acce,ptable perforurance underconditions that simulate the most adverse design eonditions that are expected tobe encountered.

Design documentation and records, which provide evidence that the design anddesign verification process was performed in accordance with this program, shallbe collected stored, and maintained in accordance with documented proceftres.This documentatiou includes final design docume,nts, such as drawings andspecifications, and revisions thereto and documentation which identifies theimportant steps, including sources of design inputs that support the final desrgR.

t. Additional details concenring design contol activities may be forrnd in theRegulatory Guides and associated Standards as committed to in Section A.7 andTable I (e.9., Regulatory Guide 1.64).

3. Ilesign Verification

A program is established and implemented to veriff the acceptahility of designactivities and documents for the design of items. The selection and incorporationof design inputs and design processes, outputs, and changes are verified.

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d. Independent design verification is to be completed before desip outputs are usedby other organizations for desrgu work and before they are used to support otheractivities such as prusurement, manufactureo or constnrction. Whe,n this timingsannot be achieved, the unverified portion of the desrgn is to be identified andcontrolled. In all cases, the design verification is to be completed before relyiugon the item to perform its firnction.

e. Individuals or groups responsible for design reviews or other verificationactivities shall be identified iu procedures and their authority and responsibilityshall be defined and controlled. Design verifisation shall be performed by anycompetent individuals or groups other than those who performed the originaldesign but who may be from the same organization. The designer's immediatesupenrisor may perform the design verification provided: the supervisor is theonly technically qualified individual capable of perfonrring the verification, theneed is individually documented and approved in advance by the strpervisor'smanagement, and the frequency and effectiveness of the supervisor's use as adestgn verifier are independently verified to guard against abuse.

Design verificatiotr procedrues are to be established and implemented to ensurethat an appropriate verification method is use{ the appropriate design parametersto be verified are chosenn the acceptance criteria are identified, the verification issatisfactorily accomplished, and the results are properly recorded.

g. Additional details concerning design verification activities may be found in theRegulatory Guides and associated Standards a$ commiued to in Section A.7 andTable I (e.9., Regulatory Guide 1.64).

4. Procurement Control

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

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

c. The program includes provisions for ensuring that qualiflred suppliers continue toprovide acceptable products and senrices.

d. The program includes provisions (e.g., source verification, rmeip inspection,pre-installation and post-installation tests, and certificates of conformance) foraccepting purchased iterns and services.

e. Applicable technical, regulatory, adminisfrative, and reporting requirements(e.9., specifications, codes, standards, tests, inspections, special processes, and10CFR21) are invoked for procurement of items and services.

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

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

h. The procr:rement of components, including spare and replacement parts, issubject to quality and technical requirements suitable for their intended service.

1. Appropriate controls for the selection, determination of suitability for intendeduse (critical characteristics), evaluation, receip, and quality evaluation ofcommercial grade items are to be imposed to snnre that the items will performsatisfactorily in service.

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

5. Procurement Verification

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

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

c. Additional details concernitrg procurement verification may be found in theRegulatory Guides and associated Standards as cornmitted to in Section A.7 andTable 1 (e.9., Regulatory Guides 1.123 and 1.144).

6. Identilication and Control of ftems

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

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b Identification of each item is maintained throughout fabrication, 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 tosafety.


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c. Additional details concenring identification and confiol of items may be found inthe Regulatory Guides and assosiated Standards as committed to in $ection A.7and Table I (e.g., Regulatory Guide 1.33).

7. Ilandling Storagg and Shipping

a. A program is established and implemented to contol the handliag, storage,shippingn cleaning, and presenring of items to ensure the items maintainacce,ptable quality.

b. Special protective measures (e.9., containers, shock absorbers, accelerometers,inert gas atmospheres, specific moisture content levelsn and temperature levels)are specified and provided when required to maintain acceptable quality.

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

d. Items are marked and labeled &ring packagmg, shipping, handling, and storageto identiff, maintain, ffid preserve the items'integrity and indicate the need forspecial eonffols.

Additional details concerning handling, storage, ffid shipping activities may befound in the Regulatory Guides and associated Standards as corlmitGd to inSection A.7 and Table I (e.g., Regulatory Guide 1.38),

8. Test Control

A test control pro$am is established and implemented to demonstate that itemswill perform satisfactorily in service.

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

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

d. Test procedures are developed that include:

f . instructions and prerequisites to perform the test,

2. use of proper test equipment,

3. acceptance criteria, and

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4. marrdatory inspections as required.

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

f. Unacceptable test results shall be evaluated.

g. Additional details coucerniug test confrol may be found in the Regulatory Guidesand associatd Standards as cornmittcd 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 control the calibration,maintenance, and use of measuring and test equipment. Measuring and testequipment does not include permanently installed operating equipment or testequipment used for preliminary checks where data obtained will not be used todetermine acceptability or be the basis for design or engineering evaluation.Additionally, calibration and conffol measures are not required for rulers, tapemeasures, levels and other such devices if nonnal commercial manufacturingpractices provide adequate acfltracy.

b. The tlpes of equipment covered by the program (e.9., instume,nts, tools, gages'and reference and tansfer standards) are defined iu procedures.

Measuring and test equipment is calibrated at specified intervals or immediatelybefore use on the basis of the item's required accuracy, intended use, frequetrcyofuse, and stability characteristics and other conditions affecting itsperformance.

d. Measuring and test equipment is labeled, tagged, or othenrise confiolled toindicate its calibration status and to ensure its traceability to calibration test data.

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

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f. If nationally recognized standards exist, calibration standards axe to be traceableto them. Except where calibration standards with the same accuracy as theinstruments being calibrated are shoum to be adequate for the requirements,calibration standards are to have a greater accnracy than the standards beingcalibrated.

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g. Measrrring and test equipment found out of calibration is tagged or segregakd.The acceptability shall be determined of items measure{ inspected, or testedwith an out-of-calibration device.

h. Additional details concerning measuring and test equipment confrol may befound in the Regulatory Guides and associated Standards as corrmitted to inSection A.7 and Table I (e.9., Regulatory Guides 1 .30, I .33, I .94, l. I 16, and1.123).

10, Inspection, Test, and Operating Status

The stahrs of required inspectious and tests and the operating status of items isverified beforo release, fabrication, receipt, installation, test, and use, asapplicable. This verification is to preclude inadvertent blpassing of inspectionsand tests and to prevent inadvertent operation of conholled equipment.

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

Additional details concerning inspection, test, and operating status contol maybe found in the Regulatory Guides and associated Staldards as committed to inSection A.7 and Table 1 (e.9., Regulatory Guide 1.33).

ll, Special Process Control

A program is established and implemented to ensure that special processes axeproperly confiolled.

b. The criteria that establish which processes axe special are described inprocedures.

c. Special processes are accomplished by qualified personnel, using appropriateequipment, ffid procedures in accordance with applicable codes, standards,specifications, criteriao and other speeial requirements.

d. Additional details concerning special process control may be found in theRegulatory Guides and associated Standards as cortmitted to in Section 4.7 andTable I (e.9., Regulatory Guide 1.33).

12. Inspection

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

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b. Provisions to ensure inspection plenning is properly accomplished are to beestahlished. Planning activities are to identify the characteristics and activities tobe inspected, the inspection techniques, the acceptance criteria, and theorganization responsible for performing the inspection.

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

d. Inspection results are to be documented by the inspector and reviewed byqualified personnel.

Unacceptable inspection results shall be evaluated and resolved iu accordancewith procedures.

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

Additional details concerning inspections may be found in the Regulatory Guidesand associated Standards as committed to in Section A.7 and Table I (e.9.,Regulatory Guides 1.33 and 1.58).

13. Corrective Action

Procedures shall provide for identificationo evahration, and resolution ofconditions adverse to quality.

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

Additional details concerning corrective action activities may be found inSection A.6, Section A.l.f, and the Regulatory Guides and associated Standardsas courmitted to in Section A.7 and Tab1e I (e.9., Regulatory Guides 1.33 and1.144).

14. Ilocument Control

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

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b

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b. The document control program shall be applied to documents that prescribeactivities affecting quality of safety-related structures, systems or components.Such activities include design, procruement, material confroln installation,inspection, te sting, maintenance, modifi cation, operation, refueling anddecommissioning.

Revisions of controlled docurrents are reviewed for adequacy and approved forrelease by the sams organization that originally reviewed and approved thedocuments or by a designated organization that is qualified and knowledgeable.

Confrolled documents are available to and used by the person perfonning theactivity.

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

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

15. Records

A program is estahlished and implemented to ensure that sufficient records ofitems and activities (e.g., design, engineering, procurement, manufacturing,construction, inspection and test, installation, prsoperation, startup, operations,maintenancen modification, decommissioning, and audits) are generated andmaintained to reflect completed work.

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

Additional details concerning record requirements may be found in theRegulatory Guides and associated Standards as corrmitted to in Section A.7 andTable 1 (e.9., Regulatory Guide 1.88).

C. ASSESSMENT

l. Methodology

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

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b. Organizations performing audits are to be technically and perfonnance orientedcofirmensurate with the activity being rsyiewed.

Persotrnel performing audits have no direct reqponsibilities in the area they areassessing.

c.

d. Audits axe accomplished using procedures, or other appropriate meen$ that are ofa detail courmensurate with the activity's complexrty and importance to safety.

2. Audit

A program of planned and periodic audits is established and implemented toconfirm that activities affecting qualrty cornply with the QAPM and that theQAPM has been implemented effectively. Audits will be conducted as requiredby the applicable Code of Federal Regulations, Tecbnical Specifications, safetyanalysis reports, and commitrnents by various coffespondence to the NRC.Audits will be conducted at a freEreucy in accordance with either Section C.Z.a.lor Sectio n C.2.a.2 below.

Audit frequencies will be determined in accordance with a perfonnancebased audit scheduling program. The scheduling program, through anexpert panel, uses assessment indicators to identiff and schedule auditsbased on performance rezults and importance of the activity relative tosafety. Potential audit subject areas are periodically assessed againstappropriate performance criteria. From these reviews a determination ismade in regard to the depth, scope, and scheduling of specific audits.Functional areas important to safety are asse$sed annually (t 25%) toidentiff shengths and wealmesses (if applicable) to determine the level andfocus of independent oversight activities for the upcoming year. The basisfor the assessment shall include the results of audits and surveillance, NRCinspectionso LERs, self-assessments, and applicable conditions reports(e.9., non-confonnance and corrective action reports). Personnel changes,change/increase in functional area responsibilities, indusby operatingexperience, and INPO evahrations will also be considered. Each area willbe assigned a rating with a comparison to previous yeaxs. This assessmentwill be documented, reviewed, and approved by quality assurancemanagement.

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

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2. Audit schedules assure that the following areas are audited at the indicatedfrequencies, or more frequently as perfoflnance dictates.

a. The conformance of uuit operation to provisions contained within 1fosTechnical Specifications and applicable license conditions at leastonce per 24 months.

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

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

d. The performance of activities required by the QAPM to meet therequirements of 10CFR50, Appendix B at least once per 24 months.

e. The firs protection program contols and implementing procedures atleast once per 24 months.

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

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

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

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

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

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

4. Audits shall provide an objective evaluation of quality related practices,procedures, inshrrctions, activities, ild items and a review of documentsand records, as applicable.

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

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

Scheduling is dpamic and resources are supplemented when theeffectiveness of the quality assurance program is in doubt.

Audit reports are written and disffibuted to the appropriate levels ofmenagernent for review. Follow-up astion can be accomplished throughuritten courmunioation, re-audit, or other appropriate means, as deemednecessary.

Implementation of delegated portions of the quality a$surance program isassessed.

10. Audits are conducted using predetermined acceptance sriteria, which arethe individual requirements within the QAPM, applicable RegulatoryGuides and AI.ISI Standards, procedrues, and documents that are used toperform the audited activity or process.

11. Additional details conceming audits may be found in the RegulatoryGuides and associated Standards as coilrmitted to in Section A.7 and Table1 (e.9., RegulatoryGuides 1.33 and 1.144).

D. INI}EPENDENT SAFETY BE\IIEW

I. Description

lndependent safety review is performed to meet the individual unit'scommitment to perform the functions describsd in NUREG-0737, SectionI.B. 1 .2, "Independent Safety Engineering Gtoup."

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Table I - Regulatory Commitments

A. Regulatory Guide 1.8 (Revision 1) [September 19751, Personnel Selcclion and Trairtng

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

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

2. FENOC commits to the requirements of AI.ISI N18.1-1971 as modified by plant-specificTechnical Specifications.

B. Regulatory Guide 1.30 (Revision 0) [August 19721, $uilW Assurance Reqairewents forthe Installation, Inspeetion, and Testing of lwtrumenlation and Electric Equipment

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

2. FENOC commits to the requirements of AI.ISI N45.2.4-1972 urith the followingclarifications:

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

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


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c. Section 3 requires that records of protective measures maintained furing storage forconformance to storage requirements be checked to veriff that items are insatisfactory condition for installation. This check shall be made only if equipmentrequires special storage or handling as specified in procureme,lrt documents.

d. Sections 5.2 and 6.2 list the tests which are to be conducted during constnrction andpost-construction activities. In lieu of these tests, FENOC shall conduct only thosetests necessary to veriff that work activities specified by work contolling documeutshave been satisfactorily accomplished furing maintenance or modification activities.The requiremeuts of Sections 5.2 and 6.2 of AI.ISI N45.2.4 shall be used as guidelinesin determining these testing requirements.

e. Seetion 6.2.1states in part that *Items requiring calibration shall be tagged or labeledon completion indicating date of calibration and identity of person that performed thecalibration." fn lieu of this requirement, FENOC may altematively implementprograms that require the equipment to be suitably marked to indicate the date of thenext calibration and the identity of the percon that performed the calibration. Inaddition, installed plant equipment that is used as measuring and test equipment(M&TE) may be controlled to indicate its calibration status and to ensure taceabilityto calibration test data hy alternate means in lieu of physically tagging or labeling(e.g., preventive maintenance program).

C. Regulatory Guide 1.33 (Revision 2) [FebruarT 19781, SuaIW Assarance ProgrumRe q uir em enl s ( Op ernfio ns)

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

a. Regulatory Position C.4 specifies audit frequencies for several audit topics. QAPMSection C.2 (Audi$ describes alternatives to these frequencies.

2, FENOC eommits ts the requirements of AI.ISI N18.7-1976/ANS 3.2 with the followingclarifications and alte,matives :

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

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

c. Section 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 members of the


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plant staffknowledgeable in the areas affected by the procedure. At least one 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, incorporatedinto the uext revision of the affected procedure. In lieu of these requiremffih,FENOC commits to the following:

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

2) Temporary changes to procedures will be approved by two knowledgeable members ofthe plant staffprior to implementatiou. At least one of these persons will be a memberof supervision. If the change affects operations procedures, at least one of thesepersons will hold a senior reactor operator license for the unit affected. Prior toimFlementation, the OSC (PORC) shall review and rrcommend 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.

d. Section 5.2.6 requires that a log be maintained to identiff the current status ofternporary modifications such as blpass lines, electrical jumpers, lifted electricalleads, and temporary trip point settings. FENOC takes exception to this requirementwhen the installation and removal of such temporary modifications is specificallyaddressed in approved procedures. These procedures ersure that the circuitry isretumed to its original configuration whe,n the operation is completed.

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

f. Section 5.2.13 (l) establishes the requirement for identitn g quality assurancopro$am requirements applicable to the items or services being procured. Whenpurchasing commercial grade services from certain accredited calibrationlaboratories, the procurement documents are not required to impose a qualityassurance program consistent with AI'ISI N18.7. Alternative requirements described


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in this QAPM for Regulatory Guide 1.L23 may be implemented in lieu of imposing aquality asflranc€ program consistent urith AI.ISI N18.7.

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

l) Implement process confrols that ensure procedrues iue reviewed for possiblerevision upon identification of new or revised sorrrce material potentially affectingthe intent of procedures.

2) Implement process controls related to procedure review, a maximum six yearreyiew period and biennial audits of opemting organizations that include a reviewof their procedures to assure that confrols result in timely procedure rwision inresponse to operations experience deficiencies and procedure deficienciesidentified by users.

h. Section 4.3.4 (3) discusses the requirement for the on-site and off+ite independentreview bodies to review license amendments and technical specification changes. Asan altemative to the requirements for the off-site review body to review licenseamendments and technisal speeification changes, FENOC will utilize the on-sitereview body for these reviews. To ensure that the on-site review body maintainsindependence during these reviews, any voting member that has a potential conflict ofinterest in a change uuder review will be replaced by another member to achieve aquorum. In addition, the off-site review body will review on-site review bodymeeting minutes and independent oversight (QA) audit and assessment results of ou-site review body activities to evaluate their effectiveness.

fl, Regulatory Guide 1.37 (Revision 0) [March 19731, Qualrty Assurance Requirements forCleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear PowerPlants

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

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

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


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alloys or compounds. Maximum allowable levels of water leachable chloride ions,total halogens and sulfur compounds shall be defined and imposed on theaforementioned materials. These materials will be conffolled through administrativeprocedues that are, in pafr, designed to minimize their effects on intergranularcrackiug or stess corrosion cracking.

2. FENOC commits to the requirements of AhISI N45.2.1-1973 with the followingclarifications:

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

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

E. Regulatory Guide I.38 (Revision 2) [May 19771, SaaW Assurance Requirements forPaclraging, Shipping, Receiving, Storage, and Handl@ of ltems for Water-CooledNuclew Power Plants

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

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

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

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

c. Section 5.5 provides for o'rework" and'trse-as-is" dispositions for nonconformingitems. As an alternative, the "repah" disposition (as defined by AI.{SI N45.2.10-1973) may also be used.

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

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appropriate storage area and move the equipment to the plant arsas for staging only insuffrcient time to support its installation. Within the planf, the equipment shall bestaged at locations which provide equivale,nt environmental couditions uuder which itis designed to operate. Materials placed in staging areas shall be stored in accordancewith the applicable requirements of Paragraphs 6.1, 6.3 and 6.4.2 of AI.ISI N45.2.2.

e. Various Sections of AI.ISI N45.2.2 address the use of non-halegenated materialswhen in contact with austenitic stainless steel or nickel-based alloys. The exceptionsapplicable to Regulatory Guide 1.37 regarding this subject also apply to ATISIN45.2.2.

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

F Regulatory Guide 1.39 (Revision 2) [Septemher 19771, Housekeqting Requiremen# forWaler-Cooled Naelear Power Planfr


2. FENOC commits to the requirements of AIIISI N45.2.3-1973 with the follouringalternative.

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

G. Regulatory Guide 1.58 (Revision 1) [September 19801, Qaalifrcation of Naelear PowerPlqnt lrcpectiory Examinatian and Testing Personnel

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

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

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

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

2) Quality assurance and staff personnel responsible for the review of documents forclarity and completeness.

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3) Test personnel utilizing gas test methods for informatiotr or data collectiouactivities (this includes those personnel performing local leak rate testing (LLRT)as stated in 10CFR50 Appendix I). The qualifications of these personnel shallconform to the requirements of Regulatory Guide 1.8.

4) Plant operation personnel corcemed with day-to-day operation, maintenance, andcertain technical seroices (the qualifications of these personnel shall conform tothe requirements of Regulatory Guide 1,8).

c. Regulatory Position C.2 indicates that SNT-TC-1A-1975 is to be used for thequalification of nondestnrctive examination (lt{DE) peffionnel who apply variousNDE methods. It also iudicates that personnel perfomring nondeshrctiveexaminations required by Section Itr and Section XI of the ASME Code should bequalified to SNT-TC-1A-19?5 as well as additional provision of the Code. For thequalification of NDE personnel, FENOC commits to the ASME Section XIreErirements specified within the applicable code year edition(s) as defined by10CFR50.55a. This altemative may be applied regardless of whether exafirinationsare of a q/pe required by the Code.

2. FENOC commits to the requirements of AI.ISI N45.2.6-1978 as modified by thecommitme,nts to Regulatory Guide 1.58 with the following clarifications:

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

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

c. Section 2.3 of this Standard dissusses evaluating personnel who have not perforrredinspection activities for more than a yeax. A 90 day grace period is applied to thisevaluation.

H, Regulatory Guide 1.64 (Revision 2) [June 1976], Saal@ Assurance Requirementsfor theDesign of Nuclear Power Plants

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


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a. Regulatory Position C.2(1) addresses the use of a supernisor in design verification.If, in exceptional cirsumstances, the supervisor is the only technically qualifiedindividual available, the desrgn verification or checking shall be conducted by thesupervisor with the following provisions:

1) The otherrequirements of Regulatory Position C.2 of this Guide shall be met.

2) The justification shall be individually docunented and approved by the next levelof supervision.

3) Qualtty assurance audits shall include review of frequency and effectiveness ofthe use of the imrnediate supe,rrisor to assure that this provision is used only inexce,ptional circumstances.

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

2. FENOC commits to the requirements of ATISI N45.2.1l-1974 with the clarifications asnoted ahove for the use of an immediate supervisor for design verification activities andconduct of group verification activities.

I. Regulatory Guide 1.74 (Revision 0) [Februar] 19741, SuaW Assurance Terms andDefinitiorc


2. FENOC commits to the requirements of AI{SI N45.2.10-19?3.

J, Regulatory Guide 1.88 (Revision 2) [October 19761, Collection, Storage andMaintenance of Nuclear Power Plant Sutlity Assurence Records


2. FENOC commits to the requirements of A}'{SI N45.2.9 -1974 with the followingalternatives:

a. Section 5.6 addresses records storage facilities. In lieu of this, the design andconstruction of quality assurance record storage facilities will follow the guidance ofAI.ISVASME NQA-I-1983, Supplement l7S-1, Section 4.4. When temporarystorage of records is required, the guidance of ASME NQA-I-1989, Supplement 17S-l, Section 4.4.3 will be followed. For storage of special processed records (such asradiographs and microfilm), humidity and temperature confrols shall be provided soas to maintain an environmental condition as prescribed in Paragraph 6.1.1 of AIIISIPH 1 .43-L979 (Also required by Section 5.4).


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b. Appendix A of A].ISI N45.2.9, requires that records of measuring and test equipmentcalibration be maintained 'tntil recalibration." This implies that the full storagerequirements of this Standard apply rmtil the equipment is recalibrated. In lieu of thisrequirement, FENOC may store measuring and test equipmmt calibration records inone-hour fire rated containers. This exception does not apply to records of calibrationrequired by the Technical Specifications.

c. For managtng QA records in electonic media FENOC commits to the guidance ofRIS-2000-018. This NRC Regulatory Issue Srrmmary (RIS) endorses:

. NIRMA Technical Guide (TG) I l-1998, Authentication of Records and Media

NIRMA TG 15-1998, Management of Electonic Recordsa

NIRMA TG 16-1998, Softrrare Configuration Management and QualityAssurance

NIRMA TG 2l-1998, Electronic Records Protection and Restoration

K Regulatory Guide 1.94 (Revision 1) [April 1976], Qaality Assurance RequtrementsforInstallation, Inspection and Testing of Structural Concrete and Stractural Steel Duringthe Constraction Phase of Nuclear Power Plants


2. FENOC commits to the requirements of AI.ISI N45.2.5-1974 with the followingclarifi cations and alternatives:

a. Section 2.2 requires that installation, inspection, and test procedures be kept currentwith the latest information. This Standard was written to address requirementsassociated with construction phase activities. However, during the operations phase,activities associated with installation, inspectiono and testing of structural concreteand shrrcfural steel are very minor in frequency and extent. Consequently, proceduresfor these activities shall only be reviewed or updated prior to commencing theactivity. The procedures for structural coucrete and stnrctural steel installation,inspection, and testing activities will be developed using the provisions of AIIISIN45.2.5 * 1974.

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

a

a


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c. Section 4.9.1 discusses the qualification requirements for mechanical (cadweld) spliceoperators. In lieu of this, Davis-Besse and Beaver Valley urill comply withqualification requiremeuts of ASME Section trI, 1995 Edition, subparagraph CC-4333.4.

d. Section 4.9.3 discusses tensile testing of mechanical (cadweld) splices. In lieu of this,Davis-Besse and Beaver Valley will comply with the requirements of ASME SectionItr, 1995 Edition, subparagraph CC4333.5.2.

e. Section 4.9.4 discusses tensile testing frequency. In lieu of this, Davis-Besse andBeaver Valley will comply with ASME Section Itr, 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 m, 1995 Edition, zubparagraph CC-4333.5.2.

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

h. The mechanical splice personnel qualification, testing and testing frequencyrequirements for mechanical (cadweld) splices addressed in K.2.c through K.2.f applyto other full positive connection technologies that meet the design code of record. Thefrequency of shear screw and sleeve splice testing shall meet ths same requirementsas swaged splices.

L. Regulatory Guide l.116 (Revision 0) [May l977l,$aalW Assurance ReqairementsforInstallation, Inspection and Testing of Meehanical Eqaipment and Systems

l FENOC commits to the regulatory position of this Guide.

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

a. Sections 2.4 and 2.6 require that procedwes define system restoration requirements asneeded to prevent contamination after cleanliness class is achieved in accordance withcommitments to AI{SI N45.2.1 and ANSI N45.2.3.

b. Section 2.9 requires that evidence of compliance by the manufacflrer with purchaserequirements, including quallty assurance requirements, be available at the site priorto applyrng the requirements of this Standard. In lieu of this requirement, section 8.4(Procurement Control) of this manual describes the contols for equipment lackingquahty documentation.


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c. Section 4.5.1 provides requirements for the cleaning, flushiug, flfld conditioning ofinstalled systems. FENOC's position on Regulatory Guide 1.37 and AI-ISI N45.2.1also apply to this Section and take precedenco over the rquirements of ANSIN45.2.8 when conflicts exist.

M. Regulatory Guide 1.123 (Revlslon l) puly 19711, SadW Assurance Re4uirements forControl of Prueanement of ltcms and Semices tot Nuelear Poww Plants


2. FENOC commits to the requirements of AI'{SI N45.2.13-1976 with the followingclarification$, exceptions and altematives :

a. Subsection 3.2.3 discusses quality assurance program requirements for procrrementdocuments. For the pnrchasing of commercial grade calibration senrices fromdomestic calibration laboratories accredited by a nationally recogni"ed accreditingbody, the procurement documents are not requirefl[1s imFose a quality a$$uranceprogram consistent with AI.ISI N18.7.

In such cases, accreditatiotr may be acceptable in lieu of the purchaser imposing a QAprogram consistent udth AIISI N18.7, provided all the following are met:

1) The accreditation is to ISO/IEC 17025.

2) The calibration laboratory holds a domestic accreditation by one of the follovringaccrediting bodies, whish are recognized by the International LaboratoryAccreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA):

- National Voluntary Laboratory Accreditation Program (NVLAP), administeredby NIST- American Association for Laboratory Accreditation (A2LA)- ACLASS Accreditation Senrices (ACLASS)- International Acsreditation Service (IAS)- Laboratory Accreditation Bureau (L-A-B)

3) The published scope of accreditation for the calibration laboratory covers theneeded measurement parameters, rangeso and uncertainties.

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

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


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b. The altemative method is applicable to sub-suppliers of calibration service suppliers,provided the above conditions are met.

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

d, Section 8.2 provides requirements for the contol of nonconformances. Suppliersqualified by FENOC as design agents in accordance with Regulatory Guides 1.64 and1.L23 may be permified under specific confractual provisions to dispositionnonconforrrances as 'lrse-as-is" or'tepair" on behalf of FENOC. Atlnonconformances dispositioned '1rse-as-iso' or 'tepair" by suppliers qualified byFENOC as design agents on behalf of FENOC are required to be submitted toFENOC for engineering approval at the time equipment is received on site. IfFENOC determines that a disposition has been incorrectly made, a nonconformancereport is generated on site to document the problem and effect resolution.

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

N. Regulatory Guide 1.144 (Revision 1) [September 1980], Auditing of Qualily AssuraneePrograms for Nuelear Pswer Plants

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

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

b. Section C.3,b (2) outlines the requirements for triennial audits and annual evaluationsof suppliers. lVhen purchasing commercial grade calibration services from domesticcalibration laboratories accredited by a nationally recognized accrediting body, theaccreditation process and accrediting body may be credited with carrying out aportion of the prnchaser's duties of verifuing acceptability and effectiveimplementation of the calibration service supplier's quality assurance program.

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

Revision; 23 34 of36

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1) The accreditation is to ISOIIE;C 17025.

2) The calibration laboratory holds a domestic accreditation by one of the followingaccrediting bodies, which are recognized by the Intemational LaboratoryAccreditation Cooperation (ILAC) Mutual Recognition Arrangement (MR at):

- National Voluntary l,aboratory Accreditation Program O[VLAP), administeredby the National Institute of Standards and Technology (NIST)- American Association for Laboratory Accreditation (A2LA)- ACLASS Accreditation Services (ACLASS)- International Accreditation Service (IAS)- Laboratory Accreditation Bweau (LA-B/

3) The published scope of accreditation for the calibration laboratory covers theneeded measurement parametersn ranges, and uncertainties,

c. The altemative method is applicable to sub-suppliers of calibration service suppliers,provided the above conditions af,e met.

d. Section C.3.b (2) outlines the requirements for triennial audits and annual evaluationsof suppliers. Instead of docrrnenting evaluatiorc of supplierc on an annual basis,FENOC may document evaluations of suppliers on an ongoing basis, using theguidnnce of Section C.3.b of this Regulatory Guide. The results of these ongolngevaluations are reviewed and appropriate corrective actions taken. Adverse furdingsresulting from these evaluations are periodically reviewed in order to determiue if, asa whole, they result in a significant condition adverse to quality and to provide inputto support supplier audit activities conducted by the licensee or a third party auditingentity.

2. FENOC commits to the requirements of AI.ISI N45.2.L2-1977 with the followingclarification:

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

b. Sections 4.3.1 and 4.3.3 of this Standard discuss pre-audit and post-audit conferences.Pre-audit and post-audit conferences may be 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 conferencss are only held when deemed necessary by qualrtyassurance or when requested by the audited organization.


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

O. Regulatory Guide 1.146 (Revision 0) IAugust 1980], Qauliftr;ation of Qaality AssurarrcePrugrum Afiit Personnelfor Nuclear Power Plan*


2. FENOC commits to the requirements of AIttSI N45.2.23-1978 with the followingalternatives.

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

b. Section 2.3.4 discusses audit participation. Prospective lead auditors shalldemonstrate their ability to effectively imFlement the audit process and lead an auditteam. They shall have participated in at least one nuclear audit within the yearpreceding the individual's effective date of qualification. Upon successfuldemonstration of the ability to effectively lead audits, licensee management maydesignate a prospective lead auditor as a lead auditor.

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

d. Section 5.3 requires that records for lead auditors be maintained and updatedannually. A 90 day grace period may be applied to the annual update. For thoseupdates that are deferre{ the next performance due date will be based on theoriginally schedule date.


quality asgurance rem lltanual - nrc

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