ML18331A088
Text
Quality Asgurance P rem lltanual Approvrd Berver Yrllry Power $tetion Ilnits l &,2 Docket Nos. 50-334 & 50412 Oper*iilg Lieense Nos, DPR{6 & NPF-73 Ilavis-Bessc Nuclerr Power Station Dosket No. 5&,346 Operating Licerrse No. NPF-3 Perry Nudear Power Plant flocket No. 50440 Operating License No. NPF-58 hesidetil - FlGs{
fi Revislon: 23 I of35
FEIUOC Fi !rf,,+r!t.L';:,rlr flrrl'hL..lr f.'rtlli r+at Quali Assurance Program Manual TABLE OF CONTENTS A.
MANAGEMENT 1.
2.
3.
4.
t.
6, 7.
8.
9.
10.
11.
12.
13, 14.
15.
Methodolotr Organization Reuponsihility Authority Personnel Training and Qurlification Corrective Action Regulatory Commitments Methodology Design Control Design Yerilicrtlon Procurement Control Procurement Verilication Identificafion nnd Control of Items Handling, Storagen and Shipping Test Control Measuring and Test Equipment Control Inspection, Test, and Operating Status Special Process Control Inspection Corrective Action Document Control Records 5
6II 9
9 10 1.
2.
3.
4.
t.
6.
7.
B.
PERT'ORMANCEruERIFICATION C.
ASSESSMENT Methodology Audit D.
IFTI}EPENDENT SAFETY REYIEW
- l.
Description 1.
2.
1t 1l t2 l3 L4 14 15 15 t6 L7 L7 L7 r8 18 l9 19 20 22 Revision: 23 2 of36
EEfUOG F.t r.',I!r;tt rrd,tu. ;r!. tlit'rfr.'!. (}1t15+rny Suali Assurance Program Manual 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 Installatiory Inspedion, and Testing of hrttrumentalion and Electria Equipment IAI\\til N45.2.41 Regulatory Guide 137 (Revision 0) [March 1973],
Suahty Assurance Reqairements for Cleaning ol Fluid Systems and Associated Componenls of Water-Cooled Nuclesr 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 ltems for Water-Cooled Nuclear Power Plnt fr IANSI N45.2.2I F.
Regulatory Guide 139 (Revision 2) [Septemher l9T7l, Hoasekceping Reqaberuenfr lor Water-Cooled Nuclear Power 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 of Nuclear Power Plants [Ail{SI N45.2.111 Regulatory Guidel,74 (Revision 0) [February 19741, Quality Assurance Terms and Detinitions [A1\\[SI N45,2.101 C.
Il.
Regulatory Guide 133 (Revision 2) [FebruarT 19781, SasW Assurance Progrum Requirements (Operation$/ [ANSI N18.71 24 23 23 26 G.
f[.
r.
27 28 28 29 30 Revision: 23 3 of36
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Quali Assurance Program Manual TABLE OF CONTT,NTS (Continued)
Tahle 1 - Regulatory Commitments (Continued)
Regulatory Guide l.EB (Revlston 2) [October 19161, Collection, Storage and Maintenance of Naclear Powet Plant Sualry Assarsnce Records IAI{SI N45.2.9]
Regulatory Guide 1.94 (Revision 1) [April 19761, Sasl#ry Assnra$ce Requirements for Instellatioth Inspection and Testing of Concrete and Structural Steel During lhe Consfiuction Phase of Nuclear Power Plorr*
IANSI N45.2.5I Regulatory Guide 1.116 (Revision 0) [May 19771, Sualry Assurance Requbemen# for Installatioth Inspection and Testing of Mechanical Eqaipment and
.lps/erns IAIISI N45.2.81 Regulntory Guidel.l2S (Revision 1) puly 19771, Saal@ Assurance Reqairements for Control of Procurement of ltems and Seniees tor Nuclear Power Plan# [AI{SI N45.2,131 Regulatory Guide 1,144 (Revicion 1) [September 19801, Auditing of Quality Assarance Prugrams for Nuclear Power Plants [41\\tSI N45,2,121 Regulatory Guide 1.146 (Revision 0) [August t9E0],
Qaaltfrcetion af Sualily Assursnce Prugram Audir Pertonnelfor Naclesr Power Plants [A][SI N45.2.231 J.
K 30 31 32 L.
M.
N.
33 34 36 o.
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FETUOC f,r ffr.jr1rl 1ti'. ;51r g'1;:q1*y1',,5+ {ltr;tg rr"1 Quality Assurance Program Manual A. IT{ANAGEMENT
- l.
Methodologp a.
The Quality Assruance Program Manual (QAPM) provides a consolidated overview of the quality program controls which govertr the operation and maintenance of FirstEnergy Nuclear Operating Company's (FENOC's) quality related items and activities. This includes nuclear plant and FENOC fleet locations, as well as FirstEnergy corporate locations that provide safety related services. The QAPM describes the quality assurarce organizational stnrcture, firnctional responsibilities, levels of authority, and interfaces.
- b. The requirements and commitments contained in the QAPM are mandatory and must be implemented, enforce{ and adhered to by all individuals and organizations. Employees are expected to actively participate in the continued development of the QAPM as well as its implementation. Changes are promptly cornmunicated wheu identified.
c.
The QAPM implements 10CFR50, Appendix B and applies to all activities associated with structues, systems, ffid components which are safety related.
The requirements of the QAPM arc applied to these items and activities to an extent commensurate with their importance to safety.
- d. The QAPM also applies to the packaging and fransportation of radioactive waste activities contolled by IOCFR?1, Bs the quality assurance program required by 10CFR71, Subpart H.
The QAPM also applies to the iadependent storage of spent nuclear fuel and high-level radioactive waste activities contolled by 10CFR72, as the quality a"ssurance program required by 10CFR72, Subpart G.
The QAPM sections 8.13, Corrective Actions, and 8.14, Document Control, also apply to non-safety related Stnrctures, Systems and Components subject to aging management for the period of extended operations following issuance of the renewed operating license.
Section 8.13 and the listed references also address the confirmation process described in NRC RIS 2014-09, Maintaining the Effectiveness of License Renewal Agirrg Management Programs, to ensure preventive actions are adequate and appropriate corrective actions are completed and effective.
Section 8.14 and the listed references address administrative confrols described in NRC RIS 2014-09, to ensurs forrral review and approval processe$ are provided.
e.
f.
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(,E' The applicability of the requirements of the QAPM to other items and activities is 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 unitten guidance for the confrol of quality related activities and provide for the development of documentation to provide objective evidence of compliance.
- 2. Organization The organizational stnrcture responsible for implementation of the QAPM is described below. The specific orgnnization titles for the qunhty a$surance firnctions described are identified in procedures. The authority to accomplish the qnality assurance fimctions described is delegated to the incumbenfs staffas necessary to fulfill the identifiod responsibility.
The Chief Nuclear Officer (CNO) is responsible for establishing expectations and providing top level direction of all activities associated with the safe and reliable operation of FENOC's nuclear power plants and activities of corporate firnctions. The CNO provides guidance with regards to the company quality assurance policy.
a.
I The executive responsible for oversight reports to the CNO and is responsible for the audit and assessment of the quality assurance program of FENOC's nuclear activities, both site and corporate, ffid maintaining this QAPM in accordauce with regulatory requirements. This executive is also 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. This executive also has overall responsibility for the quality assurance and independent off-site safety review cornnrittee firnctions' as well as supplier auditing.
a) The individual responsible for quality assurance reports to the executive responsible for oversight and has overall authority and responsibility for veriffing 1fos implementation and adequacy of the quality assurance program (auditing) as described in this QAPM. The individual responsible for quahty assurance has the authority and responsibility to report matters directly to the Chief Nuclear Officer when needed. This individual is also responsible for the quality control fimction, and recetpt and supplier source inspections.
b) These individuals above may be responsible for a single unit/location or for multiple unitsflocations and may fulfill more than one fuirction Revision: 23 6 of36
FETUOC Frr ilSi.+frr,t:r.. ;:-}d (Ia+\\.ih',Lr ffrrl\\idrr Quali Assurance Program Manual described. Conversely, responsibilities may be fulfilled by more than one individual. Individrrals may be located at the nuclear plant or FirstEnergy corporate locations.
- b. The following management positions report to the Chief Nuclear Officr:
- 1. The executive responsible for operatious provides a singular point of contact with respect to the operation of the four FENOC polyr plants, and provides operational oversight of the foru plants.
- a. The executive$ responsible for overall plant nuclear safety and operations support at each site re,port to the executive respotrsible for operations.
These executives may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities. These executive$ are responsible for establishing and implementing the quality assurance program at the respective site.
- b. Also reporting to the executive responsible for operations is a management position responsible for licensing and regulatory affairs.
- 2. The executive responsible for engineering is responsible for providing engineering services at all sites.
The individuals fulfilling the following maragement functions report to the appropriate management position identified in Paragraphs 2.b.1.a or 2.b.2. above.
These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities. These individuals may be responsible for a single unit/location or for multiple unitsflocations and may fulfill more than one function described below. Conversely, responsibilities may be fulfilled by more than one individual. The functions described below may also be implemented by non-FENOC organizations within the FirstEnergy Corporation however, FENOC maintains 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 applicable regulatory requirements and the operating license.
- 2. The individual responsible for plant modification provides direction, control, and overall supenrision of the implementation of plant modifications and assigned maintenance.
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EETIIOC F,r +'f t, e gr, rL r. ir rr dtI t\\.rl..Lr CrtItI rrtr Quality Assurance Program Manual The individual responsible for trainiug provides direction, control, and overall 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 and as sociated activitie s.
The individual responsible for document control provides direction, conffol, and overall supervision of the document confol program and as sociated activitie s.
- 6. The iudividual responsible for the corrective action progftun provides direction, control, ffid overall supervision of the corrective action program and associated activities.
The individual responsible for engineering is reqponsible for the development and maintenance of engineering programs, policies, and procedures and for providing engineering services.
The individual responsible for materials, purchasing, and contracts is responsible 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 activities to provide additional assurance that the units are operated and maintained in accordance with the Operating License and applicable regulations which address nuclear safety. (Refer to Table 1, Item C.2 for additional details.)
- 3. ResponsibiHty FENOC has the responsibilrty for the scope and implementation of an effective quallty assurance program.
- b. FENOC may delegate all or part of the activities of planning, establishing, and implementing the quality asflrance program to others, but retains the responsibility for the program's effectivenes$.
The adequacy of the QAPM's implementation is continually assessed by the individual(s) responsible for quality assurance and the associated executive for overall plant nuclear safety, and is reported to the executive responsible for oversight and to the Chief Nuclear Officer.
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7 8.
a.
c.
- d. FENOC is responsible for ensuring that the applicable portion(s) of the quality assurance program is properly doeumented, approved, and implemented (people Revision: 23 I of36
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are trained and resources are available) before an activity within the scope of the QAPM is undertaken by FENOC or by others.
Responsible individuals are to ensure that personnel working under their management cognizance are provided the necessary training and resources to accomplish their assigned tasks within the scope of the QAPM.
Procedures that implement the QAPM are approved by the management responsible for the applicable quality firnction. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them.
- 4. Authority a.
a.
\\Uhen FENOC delegates responsibility for plnnning, estahlishing, or implementing any part of the overall QA program, sufficient authority to accomplish the assigned responsibilities is delegated.
- b. The individual responsible for quality assurance has the responsibility and the authority to stop unsatisfactory work (including reactor operation through proper channels) and contol ftirther processiug, delivery installatiou, or use of non-conforming items or services, Cost and schedule considerations will not override safety considerations.
- 5. Personnel Training and Qualilication Personnel assigned to implement eleme,rrts of the quality assurance pro$am af,e capable of performing their assigned tasks.
Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency.
c.
Personnel training and qualification records are maintained in accordance with procedures.
- d. Additional details concerring personnel training and qualification may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.9., Regulatory Guides 1.8, 1.58, aud 1.146).
- 6. Corrective Action It is the responsibility of each individual to promptly identiff and report conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.
b a.
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- b. A corrective action progranr is established and implemented that includes prompt identification, documentatioq significailce evaluation, ffid correction of conditions adverse to quality. For significant conditions adverse to quality, the caruie is determined and corrective action to preclude repetition is identified and tracked 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.
c.
f.
- d. Non-conforming 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 are anallzed to identiff trends in quallty performance. Siguificant conditions adverse to quality and siguificant trends are reported to the appropriate level of management.
e.
Additional details concerning corrective action activities may be found in Section 8.13 and the Regulatory Guides and associated Standards as coillmitted to 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 guidance documents listed ou Table [. 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 documents listed in Table 1:
- l.
For modifications and nonroutine maintenance, guidance applicable to construction-like activities is applicable to comparable plant activities, except that the inspection of modifications, repairs, rework, and replacements shall be in accordance with the original desigu and inspection requirements or a docunented approved alternative.
- 2. The definitions provided by Regulatory Guide 1.74 apply wherever the defined term is used in the QAPM and associated guidance documents.
- 3. Clarifications and alternatives to a gurdance document apply wherever the guidance 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 if explicitly committed to in the QAPM. If not explicitly committed to, these documents are not considered as quality assurance program requirements, although they may be used as guidance.
a.
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- 5. Regulatory guidance originally intended to apply to design or consffuction phase activities will be applied to activities during the operations phase that are comparable in nature and extent to consffuction phase activities.
- b.
The NRC is to be notified of QAPM changes in accordance with 10CFR50.5a(a).
c.
In cases where license requirements differ from the QAPM, the most stringent reguirements 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 the achievement of acceptable quality.
c.
Work is accomplished and verified using instnrctions, procedures, or other appropriate means that are of a detail coilrmensurate with the activity's complexity and importance to safety.
- d. Criteria that define acceptable qualrty are specifie4 and qualrty is verified against these criteria.
- 2. Ilesign Control The design confrol program is established and implemented to assure that the activities associated with the design of systems, componentsn structures, and equipment and modifications thereto, ffe executed in a planned controlled, and orderly 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 verification requirements) 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 to permit verification.
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The design process is to ensure that items and activities are selected and independently verified consistent $.ith their importance to safefy to ensure they are suitable for their intended application.
Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to be subjected to design control mea$urss commensurate with those applied to the original design and approved by the organizatiou that performed the original design or a qualified designee.
Interface controls (internal and external between particrpating design organizations and across technical disciplines) for the purpose of developing, reviewing, approving, releasing, distributing, and revising design inputs and outputs are defined in procedures.
Verification methods include, but are not limited to, design reviews, alternative calculations, and qualification testing. The extent of this verification will he a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the art, and the similadfy with previously proven designs. Standardized or previously proven designs will be reviewed for applicability prior to use.
When a test program is used to veriff the acceptability of a specific design feature, the test program is to demonstrate acce,ptable perforurance under conditions that simulate the most adverse design eonditions that are expected to be encountered.
Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with this program, shall be collected stored, and maintained in accordance with documented proceftres.
This documentatiou includes final design docume,nts, such as drawings and specifications, and revisions thereto and documentation which identifies the important steps, including sources of design inputs that support the final desrgR.
t.
Additional details concenring design contol activities may be forrnd in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9., Regulatory Guide 1.64).
- 3. Ilesign Verification A program is established and implemented to veriff the acceptahility of design activities and documents for the design of items. The selection and incorporation of design inputs and design processes, outputs, and changes are verified.
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- d. Independent design verification is to be completed before desip outputs are used by other organizations for desrgu work and before they are used to support other activities such as prusurement, manufactureo or constnrction. Whe,n this timing sannot be achieved, the unverified portion of the desrgn is to be identified and controlled. In all cases, the design verification is to be completed before relyiug on the item to perform its firnction.
e.
Individuals or groups responsible for design reviews or other verification activities shall be identified iu procedures and their authority and responsibility shall be defined and controlled. Design verifisation shall be performed by any competent individuals or groups other than those who performed the original design but who may be from the same organization. The designer's immediate supenrisor may perform the design verification provided: the supervisor is the only technically qualified individual capable of perfonrring the verification, the need is individually documented and approved in advance by the strpervisor's management, and the frequency and effectiveness of the supervisor's use as a destgn verifier are independently verified to guard against abuse.
Design verificatiotr procedrues are to be established and implemented to ensure that an appropriate verification method is use{ the appropriate design parameters to be verified are chosenn the acceptance criteria are identified, the verification is satisfactorily accomplished, and the results are properly recorded.
- g. Additional details concerning design verification activities may be found in the Regulatory Guides and associated Standards a$ commiued to in Section A.7 and Table I (e.9., Regulatory Guide 1.64).
- 4. Procurement Control A program is established and implemented to ensure that purchased items and services are of acceptable quality.
- b.
The program includes provisions for evaluating prospective suppliers and selecting only qualified suppliers.
c.
The program includes provisions for ensuring that qualiflred suppliers continue to provide 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) for accepting purchased iterns and services.
e.
Applicable technical, regulatory, adminisfrative, and reporting requirements (e.9., specifications, codes, standards, tests, inspections, special processes, and 10CFR21) are invoked for procurement of items and services.
f.
a.
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FETIIOC F;t :.8,:tgrtr,.!'"..,:rr tTryrfiitt frrn5.f"r Qual Assurance Program Manual The program includes provisions for ensruing that documented evidence of an item's confonnance to procurement requirements is available at the site before the item is placed in service or used unless otherurise specified in procedures.
The program includes provisions for ensuring that procurement, inspection, and test requirements have been satisfied before an item is placed in service or used unless othenrise specified in procedures.
- h. The procr:rement of components, including spare and replacement parts, is subject to quality and technical requirements suitable for their intended service.
1.
Appropriate controls for the selection, determination of suitability for intended use (critical characteristics), evaluation, receip, and quality evaluation of commercial grade items are to be imposed to snnre that the items will perform satisfactorily in service.
Additional details concerning procurement contol may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9,, Regulatory Guides 1.33 and 1.123).
- 5. Procurement Verification A program is established and implemented to veriff the quality of purchased items and services at intervals and to a depth consistent with the item's or service's importance to safety, complexity, and quantity and the frequency of lnocurement.
- b. The program is executed in all phases of procurement. As necessary, this may require verification of activities of suppliers below the first tier.
c.
Additional details concernitrg procurement verification may be found in the Regulatory Guides and associated Standards as cornmitted to in Section A.7 and Table 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 to prevent the use of incorrect or defective items.
f.
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a.
a.
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 to safety.
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Additional details concenring identification and confiol of items may be found in the Regulatory Guides and assosiated Standards as committed to in $ection A.7 and Table I (e.g., Regulatory Guide 1.33).
- 7. Ilandling Storagg and Shipping a.
A program is established and implemented to contol the handliag, storage, shippingn cleaning, and presenring of items to ensure the items maintain acce,ptable quality.
- b.
Special protective measures (e.9., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levelsn and temperature levels) are specified and provided when required to maintain acceptable quality.
c.
Specific procedures are developed and used for cleaning, handling, storage, packaglng, shipping, and preserving items when required to maintain acceptable quality.
- d. Items are marked and labeled &ring packagmg, shipping, handling, and storage to identiff, maintain, ffid preserve the items'integrity and indicate the need for special eonffols.
Additional details concerning handling, storage, ffid shipping activities may be found in the Regulatory Guides and associated Standards as corlmitGd to in Section A.7 and Table I (e.g., Regulatory Guide 1.38),
- 8. Test Control A test control pro$am is established and implemented to demonstate that items will 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, and operational 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 e
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- 4. marrdatory inspections as required.
Test results are evaluated to assure that test objectives and iuspection requirements have been satisfied.
- f.
Unacceptable test results shall be evaluated.
- g. Additional details coucerniug test confrol may be found in the Regulatory Guides and associatd Standards as cornmittcd to in Section A.7 and Table I (e.g.,
- 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 test equipment does not include permanently installed operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptability or be the basis for design or engineering evaluation.
Additionally, calibration and conffol measures are not required for rulers, tape measures, levels and other such devices if nonnal commercial manufacturing practices 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 immediately before use on the basis of the item's required accuracy, intended use, frequetrcy ofuse, and stability characteristics and other conditions affecting its performance.
- d. Measuring and test equipment is labeled, tagged, or othenrise confiolled to indicate its calibration status and to ensure its traceability to calibration test data.
Measuring and test equipment is calibrated against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated or, when this is not possible, have an accuracy that ensures the equipment being calibrated will be within the required tolerance.
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c e.
f.
If nationally recognized standards exist, calibration standards axe to be traceable to them. Except where calibration standards with the same accuracy as the instruments being calibrated are shoum to be adequate for the requirements, calibration standards are to have a greater accnracy than the standards being calibrated.
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Measrrring and test equipment found out of calibration is tagged or segregakd.
The acceptability shall be determined of items measure{ inspected, or tested with an out-of-calibration device.
- h. Additional details concerning measuring and test equipment confrol may be found in the Regulatory Guides and associated Standards as corrmitted to in Section A.7 and Table I (e.9., Regulatory Guides 1.30, I.33, I.94, l. I 16, and 1.123).
10, Inspection, Test, and Operating Status The stahrs of required inspectious and tests and the operating status of items is verified beforo release, fabrication, receipt, installation, test, and use, as applicable. This verification is to preclude inadvertent blpassing of inspections and tests and to prevent inadvertent operation of conholled equipment.
- b. The application and removal of inspection, test and operating status indicators are controlled in accordance with procedures.
Additional details concerning inspection, test, and operating status contol may be found in the Regulatory Guides and associated Staldards as committed to in Section 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 axe properly confiolled.
- b. The criteria that establish which processes axe special are described in procedures.
c.
Special processes are accomplished by qualified personnel, using appropriate equipment, 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 the Regulatory Guides and associated Standards as cortmitted to in Section 4.7 and Table I (e.9., Regulatory Guide 1.33).
- 12. Inspection A program is established and implemented for inspections of activities in order to veriff conformance to the documented inskuctions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization performing the activity to be inspected.
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- b. Provisions to ensure inspection plenning is properly accomplished are to be estahlished. 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.
c.
Provisions to identiff inspection hold points, beyond which work is not to proceed without the consent of the inspection organization, are to be defined.
- d. Inspection results are to be documented by the inspector and reviewed by qualified personnel.
Unacceptable inspection results shall be evaluated and resolved iu accordance with procedures.
Inspections are performed by qualified personnel other than those who performed or directly supervised the work being inspected. While performing the inspection activity the inspectors firnctionally report to the associated iudividual responsible for quality control or an individual responsible for materials, purchasing, and contacts as appropriate.
Additional details concerning inspections may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.9.,
Regulatory Guides 1.33 and 1.58).
- 13. Corrective Action Procedures shall provide for identificationo evahration, and resolution of conditions adverse to quality.
Reworked repaired, and replacement items are to be inspected aud tested iu accordance with the original inspection and test requirements or specified alternatives.
Additional details concerning corrective action activities may be found in Section A.6, Section A.l.f, and the Regulatory Guides and associated Standards as courmitted to in Section A.7 and Tab1e I (e.9., Regulatory Guides 1.33 and 1.144).
- 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. The document control program shall be applied to documents that prescribe activities 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 and decommissioning.
Revisions of controlled docurrents are reviewed for adequacy and approved for release by the sams organization that originally reviewed and approved the documents or by a designated organization that is qualified and knowledgeable.
Confrolled documents are available to and used by the person perfonning the activity.
The distribution of new and revised controlled documents is in accordance urith procedures. Superseded documents are contolled to prevent inadvertent use.
Additional details concerning document contol may be found in Section A.l.f and the Regulatory Guides and associated Standaxds as corlmitted to in Section A.7 and Table I (e.9., Regulatory Guide 1.33).
- 15. Records A program is estahlished and implemented to ensure that sufficient records of items and activities (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, prsoperation, startup, operations, maintenancen modification, decommissioning, and audits) are generated and maintained 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 the Regulatory Guides and associated Standards as corrmitted to in Section A.7 and Table 1 (e.9., Regulatory Guide 1.88).
C. ASSESSMENT
- l.
Methodology Personnel responsible for carrying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the quahty assurance program 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 oriented cofirmensurate with the activity being rsyiewed.
Persotrnel performing audits have no direct reqponsibilities in the area they are assessing.
c.
- d. Audits axe accomplished using procedures, or other appropriate meen$ that are of a detail courmensurate with the activity's complexrty and importance to safety.
- 2. Audit A program of planned and periodic audits is established and implemented to confirm that activities affecting qualrty cornply with the QAPM and that the QAPM has been implemented effectively. Audits will be conducted as required by the applicable Code of Federal Regulations, Tecbnical Specifications, safety analysis reports, and commitrnents by various coffespondence to the NRC.
Audits will be conducted at a freEreucy in accordance with either Section C.Z.a.l or Sectio n C.2.a.2 below.
Audit frequencies will be determined in accordance with a perfonnance based audit scheduling program. The scheduling program, through an expert panel, uses assessment indicators to identiff and schedule audits based on performance rezults and importance of the activity relative to safety. Potential audit subject areas are periodically assessed against appropriate performance criteria. From these reviews a determination is made in regard to the depth, scope, and scheduling of specific audits.
Functional areas important to safety are asse$sed annually (t 25%) to identiff shengths and wealmesses (if applicable) to determine the level and focus of independent oversight activities for the upcoming year. The basis for the assessment shall include the results of audits and surveillance, NRC inspectionso LERs, self-assessments, and applicable conditions reports (e.9., non-confonnance and corrective action reports). Personnel changes, change/increase in functional area responsibilities, indusby operating experience, and INPO evahrations will also be considered. Each area will be assigned a rating with a comparison to previous yeaxs. This assessment will be documented, reviewed, and approved by quality assurance management.
This document is considered a quality assurance record and will be available for NRC review. Audit subject axeas of Section C.2.a.2 shall continue to he audited on the frequencies designated unless expert panel judgment, based on performance results, determines such an audit to be unnecessary. In such cases the expert panel basis shall be documented.
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- 2. Audit schedules assure that the following areas are audited at the indicated frequencies, or more frequently as perfoflnance dictates.
- a. The conformance of uuit operation to provisions contained within 1fos Technical Specifications and applicable license conditions at least once per 24 months.
- b.
The performance, training and qualification of the station staffat least once per 24 months.
- c.
The results of actions taken to correct deficiencies occurring in unit equipment, stnrctures, systems or method of operation that affect nuclear safety at least once per 24 months.
- d. The performance of activities required by the QAPM to meet the requirements of 10CFR50, Appendix B at least once per 24 months.
- e. The firs protection program contols and implementing procedures at least once per 24 months.
- f.
The fire protection equipment and program implementation at least once per 24 months utilizing either qualified licensee personnel or an outside fire protection consultant.
- g. The fire protection equipment and program implementation at least once per 36 months utilizing a qualified outside fire protection consultant.
- h.
The Radiological Environmental Monitoring Program (REMP) and radiological effluents monitoring activities and implementing procedures at least once per 24 months.
- i.
The Offsite Dose Calculation Manual and implementing procedures at least onse per 24 months.
- j.
The Process Control Program and implementing procedures for processing and packaging of radioactive wastes at least once per 24 months.
A grace period of 90 days may be applied to the 24 month frequency for internal audits. For activities deferred in accordance with the 90 day grace period, the next performance due date will be based on their originally scheduled date.
- 4. Audits shall provide an objective evaluation of quality related practices, procedures, inshrrctions, activities, ild items and a review of documents and records, as applicable.
Audits shall be performed in accordance with approved written procedures or 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 safety importance of the activity or process being assessed.
Scheduling is dpamic and resources are supplemented when the effectiveness of the quality assurance program is in doubt.
Audit reports are written and disffibuted to the appropriate levels of menagernent for review. Follow-up astion can be accomplished through uritten courmunioation, re-audit, or other appropriate means, as deemed necessary.
Implementation of delegated portions of the quality a$surance program is assessed.
- 10. Audits are conducted using predetermined acceptance sriteria, which are the individual requirements within the QAPM, applicable Regulatory Guides and AI.ISI Standards, procedrues, and documents that are used to perform the audited activity or process.
- 11. Additional details conceming audits may be found in the Regulatory Guides and associated Standards as coilrmitted to in Section A.7 and Table 1 (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's commitment to perform the functions describsd in NUREG-0737,Section I.B. 1.2, "Independent Safety Engineering Gtoup."
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Qual Assurance Program Manual 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 following clarifications:
- a. Regulatory Guide 1.8 states'oThe RPM strould have a bachelor's degree or the equivalent in a science or engineering subject including some formal fraining in radiation protection and at least 5 years ofprofessional experience in applied radiation protection." It is FENOC's position that equivalent as used in this Regulatory Guide for the bachelor's degree mearrc (a) forr years of post secondary schooling in science or engineering, or (b) four yeaxs of applied experience at a nuclear facility in the area for which qualification is sought, or (c) four years of operational or technical experience or training in nuclear power, or (d) any combination of the above totaling four years. The years of experience used to meet the education requiremeuts as allowed by this exception shall not be used to also meet the experience requirements.
- 2. FENOC commits to the requirements of AI.ISI N18.1-1971 as modified by plant-specific Technical Specifications.
B. Regulatory Guide 1.30 (Revision 0) [August 19721, $uilW Assurance Reqairewents for the Installation, Inspeetion, and Testing of lwtrumenlation and Electric Equipment
- l. FENOC commits to the regulatory position of this Guide.
- 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 are within the scope of the QAPM. Each plant maintains a list of equipment subject to QAPM requirements. This Standard is also applied to other systems and components when required by approved procedures, engineering specifications, or other work contolling documents.
- b. Section 2.2 requires that evidence of compliance by the manufacturer with purchase requirements, including quality assurance requirementso be available at the site prior to applying the requirements of AI.ISI 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 aocordance with non-conforming material procedures and that all required quality documentation has been received and accepted prior to the item being placed in senrice.
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- c. Section 3 requires that records of protective measures maintained furing storage for conformance to storage requirements be checked to veriff that items are in satisfactory condition for installation. This check shall be made only if equipment requires 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 and post-construction activities. In lieu of these tests, FENOC shall conduct only those tests necessary to veriff that work activities specified by work contolling documeuts have 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 guidelines in determining these testing requirements.
- e. Seetion 6.2.1states 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." fn lieu of this requirement, FENOC may altematively implement programs that require the equipment to be suitably marked to indicate the date of the next calibration and the identity of the percon that performed 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 taceability to 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 Progrum Re 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. QAPM Section 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 following clarifications and alte,matives :
- a.Section I requires that this Standard "apply to all activities affecting the safety-related functions of nuclear power plant structures, systems, and components." FENOC shall apply the requirements of this Standard to those structures, systems, and components identified as safety-related in the respective plant's USAR.
- b. Section 5.1 states in part that "a srunmary document should be compiled by each owner organization to identiff the sources, to index such sources to the requirements of this Standard, ffid to provide a consolidated base for the description of the program." In lieu of this requirement, a method of cross-referencing these requirements to the implementiug procedures will be maintained.
- c. Section 5.2.2 requires that'temporary changes which clearly do not change the intent of the approved procedure shall, as a minimum, be approved by two members of the Revision: 23 24 of36
FEIUOC Il' i'E.t,*,tr.,.!,,..,"br f:riltfl.,$ Cirry rra Quali Assurance Program Manual plant staffknowledgeable in the areas affected by the procedure. At least one of these shall be the supervisor in charge of the shift and hold a senior operating license on the unit affected." Such changes shall be documented and if appropriate, incorporated into the 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 approved procedrue shall be approved for imFlementatiou 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 procedrrres which may involve a change in intent of the procedure, the original approval authority shall approve the change prior to implementation. OR
- 2) Temporary changes to procedures will be approved by two knowledgeable members of the plant staffprior to implementatiou. At least one of these persons will be a member of 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 to imFlementation, the OSC (PORC) shall review and rrcommend approval of temporary changes to procedures which require a 10CFR50.59 safety evaluation. Within 14 days of implementation, temporary changes will be reviewed by an independent qualified reviewer and approved by the Responsible Discipline Manager or his designee.
- d. Section 5.2.6 requires that a log be maintained to identiff the current status of ternporary modifications such as blpass lines, electrical jumpers, lifted electrical leads, and temporary trip point settings. FENOC takes exception to this requirement when the installation and removal of such temporary modifications is specifically addressed in approved procedures. These procedures ersure that the circuitry is retumed to its original configuration whe,n the operation is completed.
- e. Section 5.2.7 - Since certain emergency situations could arise which might prevent preplanning activities, FENOC complies with an alternative to the first sentence in the second paragraph as follows: *'Excep under emergency or abnormal operating conditions where immediate actions are required to protect the health and safety of the public, to protect equipment or personnel, or to prevent the deterioration of plant conditions to a possibly unsafe or unstable level, maintenance or modification of equipment shall be preplanned and performed in 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 degree of reviews as if they had been preplanned."
- f. Section 5.2.13 (l) establishes the requirement for identitn g quality assuranco pro$am requirements applicable to the items or services being procured. When purchasing commercial grade services from certain accredited calibration laboratories, the procurement documents are not required to impose a quality assurance program consistent with AI'ISI N18.7. Alternative requirements described Revision: 23 25 of36
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Quality Assurance Program Manual in this QAPM for Regulatory Guide 1.L23 may be implemented in lieu of imposing a quality asflranc program consistent urith AI.ISI N18.7.
- g. Section 5.2.15 coutains a requirement for biennial review of plant procedures. In lieu of this requirement, FENOC may use one of the following methods as alternatives:
l) Implement process confrols that ensure procedrues iue reviewed for possible revision upon identification of new or revised sorrrce material potentially affecting the intent of procedures.
- 2) Implement process controls related to procedure review, a maximum six year reyiew period and biennial audits of opemting organizations that include a review of their procedures to assure that confrols result in timely procedure rwision in response to operations experience deficiencies and procedure deficiencies identified by users.
- h. Section 4.3.4 (3) discusses the requirement for the on-site and off+ite independent review bodies to review license amendments and technical specification changes. As an altemative to the requirements for the off-site review body to review license amendments and technisal speeification changes, FENOC will utilize the on-site review 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 assessment results of ou-site review body activities to evaluate their effectiveness.
fl, Regulatory Guide 1.37 (Revision 0) [March 19731, Qualrty Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. Regulatory Position C.3 requires that water quality for final flushes of fluid systems and associated components be at least equivalent to the quahty required for normal operation. This requirement is not applied to dissolved oxygen or nitrogen nor does it infer 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 to intergranular cracking or stress corrosion cracking should not be used with austenitic stainless steel and niskel-based alloys. It is FENOC's position that materials such as inks, temperature indicating crayons, labels, wrapping materials (other than polyethylene), water soluble materials, desiccants, lubricants, and NDE penetant materials and couplants, which contact stainless steel or nickel-based alloy material surfaces contain no more than trace amounts of lead, zirrc, copper, or lower melting Revision: 23 26 of36
FEIUOC F.r $s.q{rr,,\\r..,r}r t:I$df !fiirlr lirry6ry Quali Assurance Program Manual alloys or compounds. Maximum allowable levels of water leachable chloride ions, total halogens and sulfur compounds shall be defined and imposed on the aforementioned materials. These materials will be conffolled through administrative procedues that are, in pafr, designed to minimize their effects on intergranular crackiug or stess corrosion cracking.
- 2. FENOC commits to the requirements of AhISI 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 veriff that affected system cleanliness levels shall not be adversely affected.by the maintenance or modification activrty.
When system cleanliness is affected, specific cleaning procedures which incorporate the applicable portions of this Standard shall be developed and implemented to maintain system cleanliness.
- b. Section 2.4 requires that psrsonnel who perform inspection, examination or testing activities required by this Standard be qualified in accordance with ANSI N45.2.6. Er lieu of this, personnel who perform cleanliness inspections may alternatively be qualified in accordance with Regulalory Guide 1.8.
E. Regulatory Guide I.38 (Revision 2) [May 19771, SaaW Assurance Requirements for Paclraging, Shipping, Receiving, Storage, and Handl@ of ltems for Water-Cooled Nuclew Power Plants
- 1. FENOC commits to the regulatory position of this Guide.
- a. Sections 3 and 4 specify a four level classification system for the packagiug and shipping of items. In lieu of these requirements, commercial grade items shall be packaged and shipped in accordance with standard corrmercial practices,
- b. Section 5.2.1 requires preliminary visual inspection or examination for shipping damage to be performed prior to unloading. In lieu of this requirement, visual inspection shall be performed during unloading and unpacking.
- c. Section 5.5 provides for o'rework" and'trse-as-is" dispositions for nonconforming items. 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 final locations within the power plant be inspected and cared for in accordance with the requirements of Section 6 of this Standard and other applicable Standards. In lieu of this requirement, FENOC shall, whenever feasible, store items within their Revision: 23 27 oJt6
FETIIOG f,r,1.f r.6"'11',L'r; r!)j ilIr\\,}t i$ (irNiar"1' Quali Assurance Program Manual appropriate storage area and move the equipment to the plant arsas for staging only in suffrcient time to support its installation. Within the planf, the equipment shall be staged at locations which provide equivale,nt environmental couditions uuder which it is designed to operate. Materials placed in staging areas shall be stored in accordance with the applicable requirements of Paragraphs 6.1, 6.3 and 6.4.2 of AI.ISI N45.2.2.
- e. Various Sections of AI.ISI N45.2.2 address the use of non-halegenated materials when in contact with austenitic stainless steel or nickel-based alloys. The exceptions applicable to Regulatory Guide 1.37 regarding this subject also apply to ATISI N45.2.2.
- f. Section A.3.4.2 addresses inert gas blankets. There may be cases involving large or complex shapes for which an inert or dry air purge flow is provided rather than static gas blankets in order to provide adequate protection due to difficulty of providing a leak-proof barrier. In these cases, a positive pressure pttrge flow may be used as ail alternative to a leak-proof barrier.
F Regulatory Guide 1.39 (Revision 2) [Septemher 19771, Housekeqting Requiremen# for Waler-Cooled Naelear Power Planfr
- l. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of AIIISI N45.2.3-1973 with the follouring alternative.
- a. The AI.ISI five level zone desiguation system may not be utilized but the intent of the standard will be met for the areas of housekeeping, plant and personnel safety, and fire protection.
G. Regulatory Guide 1.58 (Revision 1) [September 19801, Qaalifrcation of Naelear Power Plqnt lrcpectiory Examinatian and Testing Personnel
- l. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. The guidance of this Regulatory Guide shall be followed as it pertains to the qualification of personnel who verifu conformance of work activities to quality requirements.
- b. Personnel will not be certified as stated in this Guide in the following areas:
- 1) Individuals that handle test results or perform document control activities.
- 2) Quality assurance and staff personnel responsible for the review of documents for clarity and completeness.
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- 3) Test personnel utilizing gas test methods for informatiotr or data collectiou activities (this includes those personnel performing local leak rate testing (LLRT) as stated in 10CFR50 Appendix I). The qualifications of these personnel shall conform to the requirements of Regulatory Guide 1.8.
- 4) Plant operation personnel corcemed with day-to-day operation, maintenance, and certain technical seroices (the qualifications of these personnel shall conform to the requirements of Regulatory Guide 1,8).
- c. Regulatory Position C.2 indicates that SNT-TC-1A-1975 is to be used for the qualification of nondestnrctive examination (lt{DE) peffionnel who apply various NDE methods. It also iudicates that personnel perfomring nondeshrctive examinations required by Section Itr and Section XI of the ASME Code should be qualified to SNT-TC-1A-19?5 as well as additional provision of the Code. For the qualification of NDE personnel, FENOC commits to the ASME Section XI reErirements specified within the applicable code year edition(s) as defined by 10CFR50.55a. This altemative may be applied regardless of whether exafirinations are of a q/pe required by the Code.
- 2. FENOC commits to the requirements of AI.ISI N45.2.6-1978 as modified by the commitme,nts to Regulatory Guide 1.58 with the following clarifications:
- a. Section 2.5 of this Standard discusses special physical characteristics. FENOC commits to the follorring: Examinations to verify that personnel have the required physical characteristics will be scheduled on an annual basis with a maximum allowable extension of 90 days.
- b. Section 3.5 of this Standard discusses edusation and experience. FENOC commits to the following: The initial qualifications of individuals to [rvel I, U, or Itr will generally 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/or demonstration of capabilities. For Level I, FENOC will also accept a four year college degree plus one month of related experience or equivalent inspection, examination or testing activities. Individual requalification will meet or exceed the recommendation of this Standard.
- c. Section 2.3 of this Standard dissusses evaluating personnel who have not perforrred inspection activities for more than a yeax. A 90 day grace period is applied to this evaluation.
H, Regulatory Guide 1.64 (Revision 2) [June 1976], Saal@ Assurance Requirementsfor the Design of Nuclear Power Plants
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
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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 qualified individual available, the desrgn verification or checking shall be conducted by the supervisor 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 level of supervision.
- 3) Qualtty assurance audits shall include review of frequency and effectiveness of the use of the imrnediate supe,rrisor to assure that this provision is used only in exce,ptional circumstances.
- b. Ar individual who contributed to a given design may participate in a group verification of that design provided that the individual who confributed to the desrgn does not (l) veriff his contribution to the design, or (2) serve as shairman or leader of the group verification activity.
- 2. FENOC commits to the requirements of ATISI N45.2.1l-1974 with the clarifications as noted ahove for the use of an immediate supervisor for design verification activities and conduct of group verification activities.
I.
Regulatory Guide 1.74 (Revision 0) [Februar] 19741, SuaW Assurance Terms and Definitiorc
- 1. FENOC commits to the regulatory position of this Guide.
- 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 and Maintenance of Nuclear Power Plant Sutlity Assurence Records
- 1. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of A}'{SI N45.2.9 -1974 with the following alternatives:
- 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 AI.ISVASME NQA-I-1983, Supplement l7S-1, Section 4.4. When temporary storage 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 as radiographs and microfilm), humidity and temperature confrols shall be provided so as to maintain an environmental condition as prescribed in Paragraph 6.1.1 of AIIISI PH 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 equipment calibration be maintained 'tntil recalibration." This implies that the full storage requirements of this Standard apply rmtil the equipment is recalibrated. In lieu of this requirement, FENOC may store measuring and test equipmmt calibration records in one-hour fire rated containers. This exception does not apply to records of calibration required by the Technical Specifications.
- c. For managtng QA records in electonic media FENOC commits to the guidance of RIS-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 Records a
NIRMA TG 16-1998, Softrrare Configuration Management and Quality Assurance NIRMA TG 2l-1998, Electronic Records Protection and Restoration K
Regulatory Guide 1.94 (Revision 1) [April 1976], Qaality Assurance Requtrementsfor Installation, Inspection and Testing of Structural Concrete and Stractural Steel During the Constraction Phase of Nuclear Power Plants
- 1. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of AI.ISI N45.2.5-1974 with the following clarifi cations and alternatives:
- a. Section 2.2 requires that installation, inspection, and test procedures be kept current with the latest information. This Standard was written to address requirements associated with construction phase activities. However, during the operations phase, activities associated with installation, inspectiono and testing of structural concrete and shrrcfural steel are very minor in frequency and extent. Consequently, procedures for these activities shall only be reviewed or updated prior to commencing the activity. The procedures for structural coucrete and stnrctural steel installation, inspection, and testing activities will be developed using the provisions of AIIISI N45.2.5
- 1974.
- b. Alternatives to this Standard are taken with respect to frequency of calibration of impact wrenches and bolt projection criteria. Impact and torque wrenches shall be checked at least once daily per shift, ffid at least one full thread of all bolts shall project beyond the nut of all tightened connections. These criteria comply with the recommendations 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) splice operators. In lieu of this, Davis-Besse and Beaver Valley urill comply with qualification 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 Section Itr, 1995 Edition, subparagraph CC4333.5.2.
- e. Section 4.9.4 discusses tensile testing frequency. In lieu of this, Davis-Besse and Beaver Valley will comply with ASME Section 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 applicable welding codes and any exceptions.
- h. The mechanical splice personnel qualification, testing and testing frequency requirements for mechanical (cadweld) splices addressed in K.2.c through K.2.f apply to other full positive connection technologies that meet the design code of record. The frequency of shear screw and sleeve splice testing shall meet ths same requirements as swaged splices.
L. Regulatory Guide l.116 (Revision 0) [May l977l,$aalW Assurance Reqairementsfor Installation, Inspection and Testing of Meehanical Eqaipment and Systems l FENOC commits to the regulatory position of this Guide.
- a. Sections 2.4 and 2.6 require that procedwes define system restoration requirements as needed to prevent contamination after cleanliness class is achieved in accordance with commitments to AI{SI N45.2.1 and ANSI N45.2.3.
- b. Section 2.9 requires that evidence of compliance by the manufacflrer with purchase requirements, including quallty assurance requirements, be available at the site prior to applyrng the requirements of this Standard. In lieu of this requirement, section 8.4 (Procurement Control) of this manual describes the contols for equipment lacking quahty documentation.
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- c. Section 4.5.1 provides requirements for the cleaning, flushiug, flfld conditioning of installed systems. FENOC's position on Regulatory Guide 1.37 and AI-ISI N45.2.1 also apply to this Section and take precedenco over the rquirements of ANSI N45.2.8 when conflicts exist.
M. Regulatory Guide 1.123 (Revlslon l) puly 19711, SadW Assurance Re4uirements for Control of Prueanement of ltcms and Semices tot Nuelear Poww Plants
- 1. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of AI'{SI N45.2.13-1976 with the following clarification$, exceptions and altematives :
- a. Subsection 3.2.3 discusses quality assurance program requirements for procrrement documents. For the pnrchasing of commercial grade calibration senrices from domestic calibration laboratories accredited by a nationally recogni"ed accrediting body, the procurement documents are not requirefl[1s imFose a quality a$$urance program consistent with AI.ISI N18.7.
In such cases, accreditatiotr may be acceptable in lieu of the purchaser imposing a QA program 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 follovring accrediting bodies, whish are recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA):
- National Voluntary Laboratory Accreditation Program (NVLAP), administered by 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 the needed measurement parameters, rangeso and uncertainties.
- 4) The purchase documents impose additional technical and administrative requirements, as necessary, to satisff FENOC QA Program and technical requirements. This will include requiring that the supplier identiff the laboratory equipment/standards used and the as-found and as-left data in the calibration certificate/report.
- 5) The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.
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- b. The 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 Assurance Program for which there are no quality assurance program or quality documentation requiremffih, the requirements of this Section need not be adhered to. However, the procurement documents shall speciff requirements specific to the item being procured, sufficient to provide adequate certification or other records to ensure that items and activities meet the specified requirements.
d, Section 8.2 provides requirements for the contol of nonconformances. Suppliers qualified by FENOC as design agents in accordance with Regulatory Guides 1.64 and 1.L23 may be permified under specific confractual provisions to disposition nonconforrrances as 'lrse-as-is" or'tepair" on behalf of FENOC. Atl nonconformances dispositioned '1rse-as-iso' or 'tepair" by suppliers qualified by FENOC as design agents on behalf of FENOC are required to be submitted to FENOC for engineering approval at the time equipment is received on site. If FENOC determines that a disposition has been incorrectly made, a nonconformance report is generated on site to document the problem and effect resolution.
- e. Section 10.2.d is interpreted as follows: The person attesting to a certificate shall be an authorized and responsihle employee of the supplier and shall be identified by the supplier.
N. Regulatory Guide 1.144 (Revision 1) [September 1980], Auditing of Qualily Assuranee Programs 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 evaluations of suppliers. A 90 day grace period may be applied to these activities. For triennial audits and annual evaluations that are deferred, the next perfonnance due date will be based on the originally scheduled date.
- b. Section C.3,b (2) outlines the requirements for triennial audits and annual evaluations of suppliers. lVhen purchasing commercial grade calibration services from domestic calibration laboratories accredited by a nationally recognized accrediting body, the accreditation process and accrediting body may be credited with carrying out a portion of the prnchaser's duties of verifuing acceptability and effective implementation of the calibration service supplier's quality assurance program.
In lieu of performing an audit, accepting ar audit by another licensee, or performing a commercial grade survey, a documented review of the supplier's accreditation shall be performed by the purchaser. This review shall include, at a minimum, all of the following:
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- 1) The accreditation is to ISOIIE;C 17025.
- 2) The calibration laboratory holds a domestic accreditation by one of the following accrediting bodies, which are recognized by the Intemational Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MR at):
- National Voluntary l,aboratory Accreditation Program O[VLAP), administered by 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 the needed 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 evaluations of suppliers. Instead of docrrnenting evaluatiorc of supplierc on an annual basis, FENOC may document evaluations of suppliers on an ongoing basis, using the guidnnce of Section C.3.b of this Regulatory Guide. The results of these ongolng evaluations are reviewed and appropriate corrective actions taken. Adverse furdings resulting from these evaluations are periodically reviewed in order to determiue 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.
- a. Section 4.5.1 of this Standard discusses follow-up and corrective actions. FENOC may utilize fhe provisions of the corrective action program outlined in Section A.6 instead of these requirements, as long as the appropriate time limits are applied to significant conditions adverse to quality. Also, no additional documentation is necessary if needed corrective actions are taken and verified prior to audit report issuance.
- b. Sections 4.3.1 and 4.3.3 of this Standard discuss pre-audit and post-audit conferences.
Pre-audit and post-audit conferences may 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 qualrty assurance or when requested by the audited organization.
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- d. Section 4.4 discusses audit reporting. Audit reports shall be issued within thirty working days after the last day of the audit. The last day of an audit shall be considered to be the day of the post-audit conference. If a post-audit conference is not held becarse it was deemed unnecessary, the last day of the audit shall be considered to be the date the post-audit conference was deemed unneces$ary as documented in the audit report.
O. Regulatory Guide 1.146 (Revision 0) IAugust 1980], Qauliftr;ation of Qaality Assurarrce Prugrum Afiit Personnelfor Nuclear Power Plan*
- l. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of AIttSI N45.2.23-1978 with the following alternatives.
- a. Section 2.3.1.3 discusses other credentials of professional competence. Holders of NRC issued Reactor Operator/Senior Reactor Operator Licenses comply with the requirements of this section and may be awarded trro credits.
- b. Section 2.3.4 discusses audit participation. Prospective lead auditors shall demonstrate their ability to effectively imFlement the audit process and lead an audit team. They shall have participated in at least one nuclear audit within the year preceding the individual's effective date of qualification. Upon successful 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 grace period may be applied to the annual evaluation. For those evaluatious that are deferred, ttre next performance due date will be based on the origrnally schedule date.
- d. Section 5.3 requires that records for lead auditors be maintained and updated annually. A 90 day grace period may be applied to the annual update. For those updates that are deferre{ the next performance due date will be based on the originally schedule date.
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