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#REDIRECT [[BVY 14-072, Submittal of the Entergy Vermont Yankee Quality Assurance Program Manual, Revision 0]]
| number = ML14308A078
| issue date = 10/30/2014
| title = Vermont Yankee - Submittal of the Entergy Vermont Yankee Quality Assurance Program Manual, Revision 0
| author name = Wamser C J
| author affiliation = Entergy Nuclear Operations, Inc
| addressee name =
| addressee affiliation = NRC/Document Control Desk, NRC/NRR
| docket = 05000271
| license number = DPR-028
| contact person =
| case reference number = BVY 14-072
| document type = Letter, Manual, Quality Assurance Program
| page count = 58
}}
 
=Text=
{{#Wiki_filter:EntrgEntergy Nuclear Operations, Inc.Vermont Yankee320 Governor Hunt RoadVernon, Vermont 05354Tel: (802) 257-7711Christopher J. WamserSite Vice PresidentBVY 14-072October 30, 2014U.S. Nuclear Regulatory CommissionATTN: Document Control DeskWashington, DC 20555-0001
 
==SUBJECT:==
 
==REFERENCES:==
Submittal of the Entergy Vermont Yankee Quality Assurance ProgramManual, Revision 0Vermont Yankee Nuclear Power StationDocket No. 50-271License No. DPR-281. Letter, USNRC to Entergy, "Safety Evaluation for the Entergy QualityAssurance Program Manual, Revisions 24 and 25 (TAC Nos. MF4071through and including MF4081)," dated August 8, 2014 (ML14210A266)2. Letter, Entergy to USNRC, "Renewal of Quality Assurance ProgramApproval for Radioactive Material Packages (No. 0907)," BVY 05-052,dated April 28, 20053. Letter, USNRC to Entergy, "Quality Assurance Program Approval forRadioactive Material Packages No. 0907, Revision 2," NVY 05-063,dated May 12, 20054. Letter, Entergy to USNRC, "Intent to use 1OCFR50 Appendix B QualityAssurance Program for Independent Spent Fuel Storage InstallationNotification Pursuant to 1OCFR72.140(d)," BVY 07-031, dated April 18,2007 (ML071140107)
 
==Dear Sir or Madam:==
In June 2003, the Vermont Yankee Nuclear Power Station (VYNPS) transitioned from theVermont Yankee Operational Quality Assurance Manual to the Entergy Nuclear QualityAssurance Program Manual (QAPM). Since that time, VYNPS has been using the EntergyQAPM to satisfy the requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10CFR 72 Subpart G.To support the implementation of ongoing quality assurance activities and the transition to adecommissioning facility, VYNPS has established a site specific Vermont Yankee (VY) QAPMfor the VYNPS using the Entergy QAPM as the basis. The VY QAPM contains the samerequirements as the current Entergy QAPM, Revision 26. Revisions 24 and 25 of the EntergyQAPM were found to be acceptable to the NRC staff in Reference 1. The changes made inRevision 26 of the Entergy QAPM involved an organizational change that was determined to not
*1~~BVY 14-072 / Page 2 of 3be a reduction in commitment in accordance with 10 CFR 50.54(a) and will be reportedpursuant to 10 CFR 50.71(e).The changes made to support this transition and allow the adoption of the Entergy QAPMinvolved administrative, reference and organizational position description changes to reflect asite-specific QAPM. This letter provides notification to the NRC of the changes and provides acopy of the VY QAPM, Revision 0.These changes were assessed using the guidance provided in 10 CFR 50.54(a)(3) and did notconstitute a reduction in commitments, therefore NRC approval is not required prior toimplementation.In Reference 2, the VYNPS requested a renewal of the NRC 10 CFR 71 Quality AssuranceProgram Approval, No. 0907, which applies to radioactive material packages. The NRC grantedthis approval in Reference 3. This letter notifies the NRC of the intention to apply the EntergyVY QAPM Revision 0 to those activities specified in the Quality Assurance Program ApprovalNo. 0907, Revision 2 at VYNPS.In Reference 4, the VYNPS notified the NRC of its intent to utilize the Entergy QAPM to satisfythe requirements of 10 CFR 72.140(d). This letter notifies the NRC of our intent to apply theEntergy VY QAPM Revision 0 to those activities associated with the design, fabrication,installation, and operation of the Independent Spent Fuel Storage Installation (ISFSI) at theVYNPS.This submittal will also serve as the biennial update of the VYNPS QAPM as required by 10CFR 50.71(e).Should you have any questions regarding this submittal, please contact Mr. Coley Chappell at(802) 451-3374.This letter contains no new regulatory commitments.I declare under penalty of perjury that the foregoing is true and correct. Executed on October30, 2014.Sincerely,[CJW/plc]
 
==Enclosure:==
: 1. Entergy VYNPS Quality Assurance Program Manual, Revision 0 BVY 14-072 / Page 3 of 3cc: Regional Administrator, Region 1U. S. Nuclear Regulatory Commission2100 Renaissance Blvd., Suite 100King of Prussia, PA 19406-2713U. S. Nuclear Regulatory CommissionATTN: Director, Office of Nuclear Reactor RegulationOne White Flint North11555 Rockville PikeRockville, MD 20852-2378NRC Senior Resident InspectorVermont YankeeU.S. Nuclear Regulatory CommissionATTN: Mr. James S. Kim, Project ManagerDivision of Operating Reactor LicensingOffice of Nuclear Reactor RegulationOWFN -Mail Stop 08D15Washington, DC 20555Mr. Christopher Recchia, CommissionerVermont Department of Public service112 State Street, Drawer 20Montpelier, VT 05620-2601
'- -EntergyVermont Yankee Nuclear PowerStationDocket No. 50-271License No. DPR-28Docket No. 72-59Quality Assurance Program ManualEffective: October 27, 2014Revision 0 QUALITY ASSURANCE PROGRAM MANUALEn tLmgPOLICY STATEMENTVermont Yankee Nuclear Power Station (VY) and Entergy Nuclear Operations, Inc. (ENOI) shallmaintain and operate VY in a manner that will ensure the health and safety of the public andworkers. The facility shall be operated in compliance with the requirements of the Code ofFederal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility OperatingLicenses, and applicable laws and regulations of the state and local governments.The Quality Assurance Program (QAP) described herein and associated implementingdocuments provide for control of activities that affect the quality of safety-related nuclear plantstructures, systems, and components. The QAP is also applied to certain quality-relatedequipment and activities that are not safety-related, but support safe plant operations, or whereother regulatory or industry guidance establishes program requirements.The Quality Assurance Program Manual (QAPM) is the top-level policy document thatestablishes the manner in which quality is to be achieved and presents our overall philosophyregarding achievement and assurance of quality. Implementing documents assign more detailedresponsibilities and requirements and define the organizational interfaces involved in conductingactivities within the scope of the QAPM. Compliance with the QAPM and implementingdocuments is mandatory for personnel directly or indirectly associated with implementation ofthe QAP.Responsibility for developing, implementing, and verifying execution of the Quality AssuranceProgram is delegated to the Chief Nuclear Officer (highest level nuclear executive) and authorityfor developing and verifying execution of the program to the Vice-President Nuclear Oversight.Revision 0
_En_ QUALITY ASSURANCE PROGRAM MANUALEtergyTABLE OF CONTENTSSECTION PAGEA. MANAGEMENT1. Methodology 12. Organization 13. Responsibility 54. Authority 55. Personnel Training and Qualification 56. Corrective Action 67. Regulatory Commitments 6B. PERFORMANCE/VERIFICATION1. Methodology 72. Design Control 73. Design Verification 84. Procurement Control 95. Procurement Verification 106. Identification and Control of Items 117. Handling, Storage, and Shipping 118. Test Control 129. Measuring and Test Equipment Control 1210. Inspection, Test, and Operating Status 1311. Special Process Control 1412. Inspection 14iiRevision 0 QUALITY ASSURANCE PROGRAM MANUALEtergyTABLE OF CONTENTSSECTION PAGEB. PERFORMANCEIVERIFICATION (continued)13. Corrective Action 1514. Document Control 1515. Records 16C. AUDIT1. Methodology 172. Performance 17D. INDEPENDENT SAFETY REVIEW1. Description 20Table 1- Regulatory CommitmentsA. Regulatory Guide 1.8 Revision 1, dated September 1975 21"Personnel Qualification and Training"B. Regulatory Guide 1.30, dated August 1972 23"Quality Assurance Requirements for the Installation, Inspection, andTesting of Instrumentation and Electric Equipment"C. Regulatory Guide 1.33 Revision 2, dated February 1978 24"Quality Assurance Program Requirements"D. Regulatory Guide 1.37, dated March 1973 28"Quality Assurance Requirements for Cleaning of Fluid Systems andAssociated Components of Water-Cooled Nuclear Power Plants"E. Regulatory Guide 1.38 Revision 2, dated May 1977 29"Quality Assurance Requirements for Packaging, Shipping, Receiving,Storage and Handling of Items for Water-Cooled Nuclear Power Plants"F. Regulatory Guide 1.39 Revision 2, dated September 1977 34"Housekeeping Requirements for Water-Cooled Nuclear Power Plants"iiiRevision 0 SEntergy QUALITY ASSURANCE PROGRAM MANUALTABLE OF CONTENTSSECTION PAGETable 1- Regulatory Commitments (continued)G. Regulatory Guide 1.58 Revision 1, dated September 1980 35"Qualifications of Nuclear Power Plant Inspection, Examination, andTesting Personnel"H. Regulatory Guide 1.64 Revision 2, dated June 1976 36"Quality Assurance Requirements for the Design of Nuclear Power Plants"I. Regulatory Guide 1.74 dated February 1974 37"Quality Assurance Terms and Definitions"J. Regulatory Guide 1.88 Revision 2, dated October 1976 38"Collection, Storage and Maintenance of Nuclear Power PlantQuality Assurance Records"K. Regulatory Guide 1.94 Revision 1, dated April 1976 40"Quality Assurance Requirements for Installation, Inspection andTesting of Structural Steel during the Construction Phase ofNuclear Power Plants"L. Regulatory Guide 1.116 Revision 0-R, dated June 1976 43"Quality Assurance Requirements for Installation, Inspection andTesting of Mechanical Equipment and Systems"M. Regulatory Guide 1.123 Revision 1, dated July 1977 44"Quality Assurance Requirements for control of Procurement of Itemsand Services for Nuclear Power Plants"N. Regulatory Guide 1.144 Revision 1, dated September 1980 47"Auditing of Quality Assurance Programs for Nuclear Power Plants"0. Regulatory Guide 1.146 Revision 0, dated August 1980 50"Qualification of Quality Assurance Program Audit Personnelfor Nuclear Power Plants"ivRevision 0
_ En yQUALITY ASSURANCE PROGRAM MANUAL"En tergyA. MANAGEMENT1. Methodologya. The Quality Assurance Program Manual (QAPM) provides an overviewof the quality program controls which governs the operation andmaintenance of VY quality related items and activities. The QAPMdescribes the quality assurance organizational structure, functionalresponsibilities, levels of authority, and interfaces.b. The requirements and commitments contained in the QAPM aremandatory and must be implemented, enforced, and adhered to by allindividuals and organizations. Employees are encouraged to activelyparticipate in the continued development of the QAPM as well as itsimplementation. Changes should be promptly communicated whenidentified.c. The QAPM applies to all activities associated with structures, systems,and components that are safety related or controlled by 10 CFR 72. TheQAPM also applies to transportation packages controlled by 10 CFR 71.The methods of implementation of the requirements of the QAPM arecommensurate with the item's or activity's importance to safety. Theapplicability of the requirements of the QAPM to other items and activitiesis determined on a case-by-case basis. The QAPM implements 10 CFR50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.d. The QAPM is implemented through the use of approved procedures (e.g.,policies, directives, procedures, instructions, or other documents) whichprovide written guidance for the control of quality related activities andprovide for the development of documentation to provide objectiveevidence of compliance.2. OrganizationThe organizational structure responsible for implementation of the QAPM isdescribed below. The organizational structure consists of corporate and VYfunctions. The specific organization titles for the quality assurance functionsdescribed are identified in procedures. The authority to accomplish the qualityassurance functions described is delegated to the incumbent's staff as necessaryto fulfill the identified responsibility.1Revision 0 ft QUALITY ASSURANCE PROGRAM MANUAL"En tergyA.2. (continued)a. Corporate Organization1. The Entergy Corporation chief executive officer (CEO) is responsiblefor overall corporate policy and provides executive direction andguidance for the corporation as well as promulgates corporate policythrough the Company's senior management staff. Responsibility fordeveloping, implementing, and verifying execution of the QualityAssurance Program is delegated to the chief nuclear officer, thehighest level nuclear executive, and authority for developing andverifying execution of the program to the executive responsible fornuclear oversight.2. The chief nuclear officer, the highest level nuclear executive officer, isresponsible for providing top-level direction for the safe and reliableoperation of VY's nuclear site. The highest level nuclear executiveofficer provides guidance with regards to company quality assurancepolicy. The off-site safety review committee reports to this executive.3. The following executives report to the highest level nuclear executiveofficer and provide governance and oversight in regards toimplementing company quality assurance policy:(a) The chief operating officers, the executives responsible fornuclear operations, are responsible for implementing qualityassurance policies, goals, and objectives and theimplementation of all activities associated with the safe andreliable operation of VY.(b) The senior executive responsible for engineering and technicalservices is responsible for providing engineering services,nuclear safety, operations support, regulatory assurance, andcorporate nuclear security. Supply chain and informationtechnology are no longer a functional area exclusively within thenuclear organizational structure. However, the oversight andgovernance of these functional areas remain within the nuclearorganization through the executive position responsible forengineering and technical services.(c) The executive responsible for project management isresponsible for providing project management services,implementing major projects and modifications, andimplementing quality assurance policies, goals, and objectives.(d) The executive responsible for oversight establishes the policies,goals, and objectives of the quality assurance policy andprovides guidance and interpretation for implementing thecompany quality assurance policy and is responsible forgovernance and implementation of the quality assuranceprogram in accordance with regulatory requirements.Independent oversight groups report to this executive.2Revision 0
_ En QUALITY ASSURANCE PROGRAM MANUAL`EntergyA.2.a.3.(d) (continued)(1) The following management positions report to this executive:* A management position that is responsible for nuclearoversight activities and is independent of production.This position provides overall direction for theimplementation of the quality assurance program." A management position that is responsible for oversightand governance of the QAPM. This manager hasauthority and responsibility for establishing, controlling,and verifying the implementation and adequacy of thequality assurance program as described in this QAPMincluding activities related to vendor quality. Thisposition has the authority for Stop Work andresponsibility to escalate matters directly to the highestlevel nuclear executive officer when needed.4. The following executives reports to the senior executive responsiblefor engineering and technical services:(a) The executives responsible for engineering and technicalservices are responsible for providing engineering services,including implementing quality assurance policies, goals, andobjectives.(b) The executives responsible for operations support areresponsible for implementing quality assurance policies, goals,and objectives of Entergy's corporate support activities.(c) The executive responsible for regulatory assurance isresponsible for regulatory interfaces, licensing activities, andimplementing quality assurance policies, goals, and objectives.b. VY Site OrganizationThe following site management positions describe the typical site QAPMfunctional responsibilities, which may be delegated to others asestablished in this document. These individuals may report through anadditional layer of management, but shall maintain sufficient authority andorganizational freedom to implement the assigned responsibilities.1. The VY executive management position reports through theapplicable executive position responsible for VY. This position isresponsible for overall nuclear safety at the site, and is responsible forestablishing the policies, goals, and objectives and theimplementation of the QAPM at the VY site.3Revision 0
[ __ QUALITY ASSURANCE PROGRAM MANUALEn tergytA.2.b. (continued)2. The manager responsible for overall operations assures the safe,reliable, and efficient operation of the facility within the constraints ofapplicable regulatory requirements and the operating license.Different aspects of these responsibilities may be fulfilled by separatemanagers. The onsite safety review function reports to the managerresponsible for facility operations.3. A manager responsible for engineering is responsible for thedevelopment and maintenance of engineering programs, plant designbases, policies, and procedures and for providing engineeringservices. Different aspects of these responsibilities may be fulfilled byseparate managers.4. A manager responsible for regulatory and performance improvementis responsible for emergency planning, training, security, correctiveaction program, and records management. Different aspects of theseresponsibilities may be fulfilled by separate managers.5. The following site positions report directly to an executive positionoffsite:(a) A manager responsible for quality assurance who has overallauthority and responsibility for establishing, controlling, andverifying the implementation and adequacy of the qualityassurance program as described in this QAPM. This positionhas the authority and responsibility to escalate matters directlyto the highest level nuclear executive officer when needed. Thisposition reports to the executive responsible for nuclearoversight through the corporate management positionresponsible for nuclear oversight (offsite).(b) A manager responsible for materials, purchasing, and contractsis responsible for procurement, services, receipt, storage, andissue of materials, parts, and components. Different aspects ofthese responsibilities may be fulfilled by separate managers.This site position reports to an executive (supply chain -offsite)who has a functional interface with the executive responsible forengineering and technical services.c. The on-site and off-site safety review function independently reviewsactivities to provide additional assurance that VY is maintained inaccordance with the Operating License and applicable regulations thataddress nuclear safety.4Revision 0
___ QUALITY ASSURANCE PROGRAM MANUAL--Entergy3. Responsibilitya. VY has the responsibility for the scope and implementation of an effectivequality assurance program.b. VY may delegate all or part of the activities of planning, establishing, andimplementing the quality assurance program to others, but retains theresponsibility for the program's effectiveness.c. VY is responsible for ensuring that the applicable portion(s) of the qualityassurance program is properly documented, approved, and implemented(people are trained and resources are available) before an activity withinthe scope of the QAPM is undertaken by VY or by others.d. Individual managers are to ensure that personnel working under theirmanagement cognizance are provided the necessary training andresources to accomplish their assigned tasks within the scope of theQAPM.e. Procedures that implement the QAPM are approved by the managementresponsible for the applicable quality function. These procedures are toreflect the QAPM and work is to be accomplished in accordance withthem.4. Authoritya. When VY delegates responsibility for planning, establishing, orimplementing any part of the overall QA program, sufficient authority toaccomplish the assigned responsibilities is delegated.b. The manager responsible for quality assurance has the responsibility andthe authority to stop unsatisfactory work and control further processing,delivery, installation, or use of non-conforming items or services. Costand schedule considerations will not override safety considerations.5. Personnel Training and Qualificationa. Personnel assigned to implement elements of the quality assuranceprogram are capable of performing their assigned tasks.b. Training programs are established and implemented to ensure thatpersonnel achieve and maintain suitable proficiency.c. Personnel training and qualification records are maintained in accordancewith procedures.d. Additional details concerning Personnel Training and Qualification may befound in the Regulatory Guides and associated Standards as committedto in Section A.7 and Table 1 (e.g., Regulatory Guides 1.8, 1.58, and1.146).5Revision 0 QUALITY ASSURANCE PROGRAM MANUAL""Entergy6. Corrective Actiona. It is the responsibility of each individual to promptly identify and reportconditions adverse to quality. Management at all levels encourages theidentification of conditions that are adverse to quality.b. A corrective action program is established and implemented that includesprompt identification, documentation, and correction of conditions adverseto quality. The corrective action program for significant conditionsadverse to quality shall require cause determination and a correctiveaction plan that precludes repetition.c. Specific responsibilities within the corrective action program may bedelegated, but VY maintains responsibility for the program'seffectiveness.d. Non-conforming items are properly controlled to prevent their inadvertenttest, installation, or use. They are reviewed and either accepted, rejected,repaired, or reworked.e. Reports of conditions that are adverse to quality are analyzed to identifytrends in quality performance. Significant conditions adverse to qualityand significant trends are reported to the appropriate level ofmanagement.f. Additional details concerning corrective action activities may be found inthe Regulatory Guides and associated Standards as committed to inSection A.7 and Table 1 (e.g., Regulatory Guide 1.33).7. Regulatory Commitmentsa. Except where alternatives are identified, VY complies with the QAguidance documents listed on Table 1. If the guidance in one of thesedocuments is in conflict with the QAPM, the guidance provided in theQAPM is the controlling guidance. Additionally, the following clarificationsapply to all guidance documents listed in Table 1:1. For modifications and nonroutine maintenance, guidanceapplicable to construction-like activities is applicable tocomparable facility activities. Except that the inspection ofmodifications, repairs, rework, and replacements shall be inaccordance with the original design and inspection requirementsor a documented approved alternative.2. The definitions provided by Regulatory Guide 1.74 and associatedclarifications as described in Table 1 apply wherever the definedterm is used in the QAPM and associated guidance documents.3. Clarification to a guidance document applies wherever theguidance document is invoked.6Revision 0
_En_ QUALITY ASSURANCE PROGRAM MANUALEntergy"A7 (continued)4. In each of the ANSI standards, other documents (e.g., otherstandards, codes, regulations, tables, or appendices) arereferenced or described. These other documents are only qualityassurance program requirements if explicitly committed to in theQAPM. If not explicitly committed to, these documents are notconsidered as quality assurance program requirements, althoughthey may be used as guidance.5. Guidance applicable to safety related items and activities isapplicable to comparable items and activities controlled by 10CFR 72 and transportation packages controlled by 10 CFR 71.b. The NRC is to be notified of QAPM changes in accordance with 10 CFR50.54(a)(3) or 10 CFR 50.54(a)(4).B. PERFORMANCENERIFICATION1. Methodologya. Personnel performing work activities such as design, engineering,procurement, manufacturing, construction, installation, startup,maintenance, modification, operation, and decommissioning areresponsible for achieving acceptable quality.b. Personnel performing verification activities are responsible for verifyingthe achievement of acceptable quality and are different personnel thanthose who performed the work.c. Work is accomplished and verified using instructions, procedures, orother appropriate means that are of a detail commensurate with theactivity's complexity and importance to safety.d. Criteria that define acceptable quality are specified, and quality is verifiedagainst these criteria.2. Design Controla. The design control program is established and implemented to assurethat the activities associated with the design of systems, components,structures, and equipment and modifications thereto, are executed in aplanned, controlled, and orderly manner.b. The program includes provisions to control design inputs, processes,outputs, changes, interfaces, records, and organizational interfaces.c. Design inputs (e.g., performance, regulatory, quality, and qualityverification requirements) are to be correctly translated into designoutputs (e.g., specifications, drawings, procedures, and instructions).7Revision 0
' Entergy QUALITY ASSURANCE PROGRAM MANUALB.2 (continued)d. The final design output is to relate to the design input in sufficient detail topermit verification.e. The design process is to ensure that items and activities are selected andindependently verified consistent with their importance to safety to ensurethey are suitable for their intended application.f. 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 measures commensurate with those appliedto the original design and approved by the organization that performedthe original design or a qualified designee.g. Interface controls (internal and external between participating designorganizations and across technical disciplines) for the purpose ofdeveloping, reviewing, approving, releasing, distributing, and revisingdesign inputs and outputs are defined in procedures.h. Design documentation and records, which provide evidence that thedesign and design verification process was performed in accordance withthis program, shall be collected, stored, and maintained in accordancewith documented procedures. This documentation includes final designdocuments, such as drawings and specifications, and revisions theretoand documentation which identifies the important steps, including sourcesof design inputs that support the final design.Additional details concerning design control activities may be found in theRegulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.g., Regulatory Guide 1.64).3. Design Verificationa. A program is established and implemented to verify the acceptability ofdesign activities and documents for the design of items. The selectionand incorporation of design inputs and design processes, outputs, andchanges are verified.b. Verification methods include, but are not limited to, design reviews,alternative calculations, and qualification testing. The extent of thisverification will be a function of the importance to safety of the item, thecomplexity of the design, the degree of standardization, the state of theart, and the similarity with previously proven designs. Standardized orpreviously proven designs will be reviewed for applicability prior to use.c. When a test program is used to verify the acceptability of a specificdesign feature, the test program is to demonstrate acceptableperformance under conditions that simulate the most adverse designconditions that are expected to be encountered.8Revision 0 QUALITY ASSURANCE PROGRAM MANUAL"EnteyB.3 (continued)d. Independent design verification is to be completed before design outputsare used by other organizations for design work and before they are usedto support other activities such as procurement, manufacture, orconstruction. When this timing cannot be achieved, the unverified portionof the design is to be identified and controlled. In all cases, the designverification is to be completed before relying on the item to perform itsfunction.e. Individuals or groups responsible for design reviews or other verificationactivities shall be identified in procedures and their authority andresponsibility shall be defined and controlled. Design verification shall beperformed by any competent individuals or groups other than those whoperformed the original design but who may be from the sameorganization. The designer's immediate supervisor may perform thedesign verification provided:1. the supervisor is the only technically qualified individual capable ofperforming the verification,2. the need is individually documented and approved in advance bythe supervisor's management, and3. the frequency and effectiveness of the supervisor's use as adesign verifier are independently verified to guard against abuse.f. Design verification procedures are to be established and implemented toensure that an appropriate verification method is used, the appropriatedesign parameters to be verified are chosen, the acceptance criteria areidentified, the verification is satisfactorily accomplished, and the resultsare properly recorded.g. Additional details concerning design verification activities may be found inthe Regulatory Guides and associated Standards as committed to inSection A.7 and Table 1 (e.g., Regulatory Guide 1.64).4. Procurement Controla. A program is established and implemented to ensure that purchaseditems and services are of acceptable quality.b. The program includes provisions for evaluating prospective suppliers andselecting only qualified suppliers.9Revision 0
___ nQUALITY ASSURANCE PROGRAM MANUALSEn tergyB.4 (continued)c. The program includes provisions for ensuring that qualified supplierscontinue to provide acceptable products and services.d. The program includes provisions (e.g., source verification, receiptinspection, pre-installation and post-installation tests, and certificates ofconformance) for accepting purchased items and services.e. Applicable technical, regulatory, administrative, and reportingrequirements (e.g., specifications, codes, standards, tests, inspections,special processes, and 10 CFR Part 21) are invoked for procurement ofitems and services.f. The program includes provisions for ensuring that documented evidenceof an item's conformance to procurement requirements is available at thesite before the item is placed in service or used unless otherwisespecified in procedures.g. The program includes provisions for ensuring that procurement,inspection, and test requirements have been satisfied before an item isplaced in service or used unless otherwise specified in procedures.h. The procurement of components, including spare and replacement parts,is subject to quality and technical requirements suitable for their intendedservice.Appropriate controls for the selection, determination of suitability forintended use (critical characteristics), evaluation, receipt, and qualityevaluation of commercial grade items are to be imposed to ensure thatthe items will perform satisfactorily in service.j. Additional details concerning procurement control may be found in theRegulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.g., Regulatory Guides 1.33 and 1.123).5. Procurement Verificationa. A program is established and implemented to verify the quality ofpurchased items and services at intervals and to a depth consistent withthe item's or service's importance to safety, complexity, and quantity andthe frequency of procurement.b. The program is executed in all phases of procurement. As necessary,this may require verification of activities of suppliers below the first tier.10Revision 0 B.5 (continued)c. Additional details concerning procurement verification may be found inthe Regulatory Guides and associated Standards as committed to inSection A.7 and Table I (e.g., Regulatory Guides 1.123 and 1.144).6. Identification and Control of Itemsa. A program is established and implemented to identify and control items toprevent the use of incorrect or defective items.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'simportance to safety.c. Additional details concerning identification and control of items may befound in the Regulatory Guides and associated Standards as committedto in Section A.7 and Table 1 (e.g., Regulatory Guide 1.33).7. Handling, Storage, and Shippinga. A program is established and implemented to control the handling,storage, shipping, cleaning, and preserving of items to ensure the itemsmaintain acceptable quality.b. Special protective measures (e.g., containers, shock absorbers,accelerometers, inert gas atmospheres, specific moisture content levels,and temperature levels) are specified and provided when required tomaintain acceptable quality.c. Specific procedures are developed and used for cleaning, handling,storage, packaging, shipping, and preserving items when required tomaintain acceptable quality.d. Items are marked and labeled during packaging, shipping, handling, andstorage to identify, maintain, and preserve the items' integrity and indicatethe need for special controls.e. Additional details concerning handling, storage, and shipping activitiesmay be found in the Regulatory Guides and associated Standards ascommitted to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.38).11Revision 0
__ QUALITY ASSURANCE PROGRAM MANUALSEtergy8. Test Controla. A test control program is established and implemented to demonstratethat 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 beforeinstallation, pre-operational tests, post-maintenance tests, post-modification tests, and operational tests.d. Test procedures are developed that include:1. instructions and prerequisites to perform the test,2. use of proper test equipment,3. acceptance criteria, and4. mandatory inspections as required.e. Test results are evaluated to assure that test objectives and inspectionrequirements have been satisfied.f. Unacceptable test results shall be evaluated.g. Additional details concerning test control may be found in the RegulatoryGuides and associated Standards as committed to in Section A.7 andTable 1 (e.g., Regulatory Guide 1.33).9. Measuring and Test Equipment Controla. A program is established and implemented to control the calibration,maintenance, and use of measuring and test equipment. Measuring andtest equipment does not include permanently installed operatingequipment or test equipment used for preliminary checks where dataobtained will not be used to determine acceptability or be the basis fordesign or engineering evaluation. Additionally, calibration and controlmeasures are not required for rulers, tape measures, levels and othersuch devices if normal commercial manufacturing practices provideadequate accuracy.b. The types of equipment covered by the program (e.g., instruments, tools,gauges, and reference and transfer standards) are defined in procedures.12Revision 0
_ En yQUALITY ASSURANCE PROGRAM MANUALREntergyB.9 (continued)c. Measuring and test equipment is calibrated at specified intervals orimmediately before use on the basis of the item's required accuracy,intended use, frequency of use, and stability characteristics and otherconditions affecting its performance.d. Measuring and test equipment is labeled, tagged, or otherwise controlledto indicate its calibration status and to ensure its traceability to calibrationtest data.e. Measuring and test equipment is calibrated against standards that havean accuracy of at least four times the required accuracy of the equipmentbeing calibrated or, when this is not possible, have an accuracy thatensures the equipment being calibrated will be within the requiredtolerance.f. If nationally recognized standards exist, calibration standards are to betraceable to them. Except where calibration standards with the sameaccuracy as the instruments being calibrated are shown to be adequatefor the requirements, calibration standards are to have a greater accuracythan the standards being calibrated.g. Measuring and test equipment found out of calibration is tagged orsegregated. The acceptability shall be determined of items measured,inspected, or tested with an out-of-calibration device.h. Additional details concerning measuring and test equipment control maybe found in the Regulatory Guides and associated Standards ascommitted to in Section A.7 and Table 1 (e.g., Regulatory Guides 1.30,1.33, 1.94, 1.116, and 1.123).10. Inspection, Test, and Operating Statusa. The status of required inspections and tests and the operating status ofitems is verified before release, fabrication, receipt, installation, test, anduse, as applicable. This verification is to preclude inadvertent bypassingof inspections and tests and to prevent inadvertent operation of controlledequipment.b. The application and removal of inspection, test, and operating statusindicators are controlled in accordance with procedures.13Revision 0
_ En yQUALITY ASSURANCE PROGRAM MANUAL%En tergyB.10 (continued)c. Additional details concerning inspection, test, and operating status controlmay be found in the Regulatory Guides and associated Standards ascommitted to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.33).11. Special Process Controla. A program is established and implemented to ensure that specialprocesses are properly controlled.b. The criteria that establish which processes are special are described inprocedures. The following are special processes:1. welding,2. heat-treating,3. NDE (Non-Destructive Examination),4. chemical cleaning, and5. unique fabricating or testing processes that require in-processcontrols.c. Special processes are accomplished by qualified personnel, usingappropriate equipment, and procedures in accordance with applicablecodes, standards, specifications, criteria, and other special requirements.d. Additional details concerning special process control may be found in theRegulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.g., Regulatory Guide 1.33).12. Inspectiona. A program is established and implemented for inspections of activities inorder to verify conformance to the documented instructions, proceduresand drawings for accomplishing the activity. The inspection program maybe implemented by or for the organization performing the activity to beinspected.b. Provisions to ensure inspection planning is properly accomplished are tobe established. Planning activities are to identify the characteristics andactivities to be inspected, the inspection techniques, the acceptancecriteria, and the organization responsible for performing the inspection.14Revision 0
___ EQUALITY ASSURANCE PROGRAM MANUAL"En tergyB.12 (continued)c. Provisions to identify inspection hold points, beyond which work is not toproceed without the consent of the inspection organization, are to bedefined.d. Inspection results are to be documented by the inspector and reviewed byqualified personnel.e. Unacceptable inspection results shall be evaluated and resolved inaccordance with procedures.f. Inspections are performed by qualified personnel other than those whoperformed or directly supervised the work being inspected. Whileperforming the inspection activity the inspectors functionally report to theassociated manager responsible for quality assurance.g. Additional details concerning inspections may be found in the RegulatoryGuides and associated Standards as committed to in Section A.7 andTable 1 (e.g., Regulatory Guides 1.33 and 1.58).13. Corrective Actiona. Procedures shall provide for identification, evaluation, and resolution ofconditions adverse to quality.b. Reworked, repaired, and replacement items are to be inspected andtested in accordance with the original inspection and test requirements orspecified alternatives.c. Additional details concerning corrective action activities may be found inSection A.6 and the Regulatory Guides and associated Standards ascommitted to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.33).14. Document Controla. A program is established and implemented to control the development,review, approval, issue, use, and revision of documents.15Revision 0 B.14 (continued)b. The scope of the document control program includes:1. safety analysis report,2. design documents,3. procurement documents,4. Technical Specifications,5. procedures, manuals, and plans,6. corrective action documents, and7. other documents as defined in procedures.c. Revisions of controlled documents are reviewed for adequacy andapproved for release by the same organization that originally reviewedand approved the documents or by a designated organization that isqualified and knowledgeable.d. Copies of controlled documents are distributed to and used by the personperforming the activity.e. The distribution of new and revised controlled documents is inaccordance with procedures. Superseded documents are controlled.f. Additional details concerning document control may be found in theRegulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.g., Regulatory Guide 1.33).15. Recordsa. A program is established and implemented to ensure that sufficientrecords of items and activities (e.g., design, engineering, procurement,manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification,decommissioning, and audits) are generated and maintained to reflectcompleted work.b. The program provides provisions for the administration, receipt, storage,preservation, safekeeping, retrieval, and disposition of records.16Revision 0 QUALITY ASSURANCE PROGRAM MANUAL'En tergB.15 (continued)c. The program includes provisions for the use of various record storagemedia to maintain QA records. Procedures are developed to implementthe regulatory guidance associated with the media used. The NRCGeneric Letter 88-18 "Plant Record Storage on Optical Disk" isimplemented for optical disk media. The Regulatory Issue Summary2000-18 "Guidance on Managing QA Records in Electronic Media" isimplemented for electronic media.d. Additional details concerning record requirements may be found in theRegulatory Guides and associated Standards as committed to in SectionA.7 and Table 1 (e.g., Regulatory Guide 1.88).C. AUDIT1. Methodologya. Personnel responsible for carrying out audits are maintained cognizant ofday-to-day activities by the ongoing involvement in the quality assuranceprogram requirements so that they can act in a management advisoryfunction.b. Organizations performing audits are to be technically and performanceoriented commensurate with the activity being reviewed.c. Personnel performing audits have no direct responsibilities in the areathey are assessing.d. Audits are accomplished using instructions, procedures, or otherappropriate means that are of a detail commensurate with the activity'scomplexity and importance to safety.2. Performancea. A program of planned and periodic audits is established and implementedto confirm that activities affecting quality comply with the QAPM and thatthe QAPM has been implemented effectively. Audit frequencies will beimplemented as required by the applicable Code of Federal Regulations,safety analysis report, and commitments by various correspondences tothe NRC. Audits will be conducted at a frequency in accordance witheither Section C.2.a. 1 or Section C.2.a.2 below. Audits of stand aloneIndependent Spent Fuel Storage Installations (ISFSls) (e.g. those notsited with an operating nuclear power plant) may be conducted inaccordance with Section C.2.a.4.17Revision 0
_En_ QUALITY ASSURANCE PROGRAM MANUALEtergyC.2 (continued)1. Audit frequencies will be determined in accordance with aperformance based audit-scheduling program. The schedulingprogram, through an expert panel, uses assessment indicators toidentify and schedule audits based on performance results andimportance of the activity relative to safety. Potential audit subjectareas are periodically assessed against appropriate performancecriteria. From these reviews a determination is made in regard to thedepth, scope, and scheduling of specific audits. Functional areasimportant to safety are assessed annually (+/- 25%) to identifystrengths and weaknesses (if applicable) to determine the level andfocus of independent oversight activities for the upcoming year. Thebasis for the assessment shall include the results of audits andsurveillance, NRC inspections, LERs, self-assessments, andapplicable conditions reports (e.g., non-conformance and correctiveaction reports). Personnel changes, change/increase in functionalarea responsibilities, industry operating experience, and INPOevaluations (if performed) will also be considered. Each area will beassigned a rating with a comparison to previous years. Thisassessment will be documented, reviewed, and approved by qualityassurance management.This document is considered a quality assurance record and will beavailable for NRC review. Audit subject areas of Section C.2.a.2shall continue to be audited on the frequencies designated unlessexpert panel judgment, based on performance results, determinessuch an audit to be unnecessary. In such cases the expert panelbasis shall be documented.2. Audit schedules assure that the following areas are audited at theindicated frequencies, or more frequently as performance dictates.a. The conformance of each unit's operation to provisionscontained within the Technical Specifications and applicablelicense conditions is audited at least once every 24 months.b. The performance, training, and qualifications of the entirestaff are audited at least once every 24 months.18Revision 0 QUALITY ASSURANCE PROGRAM MANUAL"EntergyC.2 (continued)c. The results of actions taken to correct deficiencies occurringin unit equipment, structure, systems, or method of operationthat affect nuclear safety is audited at least once every 24months.d. The performance of activities required by the QAPM to meetthe criteria of 10 CFR 50, Appendix B is audited at least onceevery 24 months.e. The Offsite Dose Calculations Manual and Process ControlProgram and implementing procedures are audited at leastonce every 24 months.f. The radiological environmental monitoring program and theresults thereof is audited at least once every 24 months.g. A fire protection and loss prevention program inspection andaudit shall be performed using either off-site licenseepersonnel or an outside fire protection firm at least onceevery 24 months.h. The fire protection program and implementing proceduresaudit shall be performed at least once every 24 months.A fire protection and loss prevention program inspection andaudit shall be performed using an outside fire consultant atleast once every 36 months.3. A grace period of 90 days may be applied to the 24-monthfrequency for internal audits. For activities deferred in accordancewith the 90-day grace period, the next performance due date willbe based on their originally scheduled date.4. The audit schedule for stand alone ISFSIs may combine audits tocover the areas defined in section C.2.a.2 that are invoked by theISFSI technical specifications.b. Audits shall provide an objective evaluation of quality related practices,procedures, instructions, activities, and items and a review of documentsand records, as applicable.c. Audits shall be performed in accordance with approved writtenprocedures or checklists. Items from previous audits shall be reviewedand reaudited, as appropriate. The checklists are used as guides to theauditor.19Revision 0
_En_ QUALITY ASSURANCE PROGRAM MANUALEntergyC.2 (continued)d. Scheduling and resource allocation are based on the status and safetyimportance of the activity or process being assessed.e. Scheduling is dynamic and resources are supplemented when theeffectiveness of the quality assurance program is in doubt.f. Audit reports are written and distributed to the appropriate levels ofmanagement for review. Follow-up action, including re-look at deficientareas, is initiated as deemed appropriate.g. Implementation of delegated portions of the quality assurance program isassessed.h. Audits are conducted using predetermined acceptance criteria.Additional details concerning audits may be found in the RegulatoryGuides and associated Standards as committed to in Section A.7 andTable 1 (e.g., Regulatory Guides 1.33 and 1.144).D. INDEPENDENT SAFETY REVIEW1. Descriptiona. Independent safety review is performed to meet VY's commitment toNUREG-0737, Section I.B.1.2, "Independent Safety Engineering Group,"as described in the unit's safety analysis report.20Revision 0 is QUALITY ASSURANCE PROGRAM MANUAL"EntergyTable 1Regulatory CommitmentsA. Regulatory Guide 1.8 Revision 1, dated September 1975Clarification/Exception1. General VY is committed to Sections 1 -4 of ANSI/ANS 3.1-1978 withfollowing clarifications and exceptions.Qualification requirements for personnel shall meet ANSI/ANS 3.1-1978 except the following:a. The radiation protection manager shall meet or exceed thequalifications of Regulatory Guide 1.8, Revision 2, 1987.b. Managers required to hold an SRO license are specifiedin the applicable unit's Technical Specifications.c. Licensed Operators shall be qualified in accordance with therequirements of 10 CFR 55.Individuals filling positions who met the previous commitment at thetime of implementation of this commitment can be considered tomeet any more restrictive aspects of the requirements of thiscommitment for that position without further review anddocumentation.2. General The following qualifications may be considered equivalent to abachelor's degree:a. 4 years of post-secondary schooling in science or engineering,b. 4 years of applied experience at a nuclear facility in the area forwhich qualification is sought,c. 4 years of operational or technical experience/training innuclear power, ord. any combination of the above totaling 4 years.Years of experience used to meet the education requirements asallowed by this exception shall not be used to also meet theexperience requirements.21Revision 0
___ EQUALITY ASSURANCE PROGRAM MANUAL"En tergy,Table 1Regulatory CommitmentsA. Regulatory Guide 1.8 (continued)3. ANSI/ANS 3.1Section 44. ANSI/ANS 3.1Section 4.4.55. ANSI/ANS 3.1Section 5Individuals assigned to professional-technical comparable positionsshall have the authority and specified qualifications to accomplishthe functional responsibilities of the position.Individuals who do not possess the formal education and minimumexperience requirements for the manager responsible for qualityassurance should not be eliminated automatically when otherfactors provide sufficient demonstration of their abilities. Theseother factors are evaluated on a case-by-case basis and approvedand documented by senior management. As a minimum, theSpecial Requirements of ANSI/ANS 3.1-1993 Section 4.3.7 must bemet if the manager responsible for Quality Assurance does notmeet the requirements of section 4.4.5 of ANSI/ANS 3.1-1978.VY will maintain a training program for the unit staff that meets theapplicable regulations and either a) is accredited by the NationalNuclear Accrediting Board (NNAB) or b) meets the standards ofsection 5 of ANSI/ANS 3.1-1978.22Revision 0 Table 1Regulatory CommitmentsB. Regulatory Guide 1.30, dated August 1972Clarification/Exception1. ANSI N45.2.4General2. ANSI N45.2.4Section 33. ANSI N45.2.4Section 5.24. ANSI N45.2.4Section 6.2.1ANSI N45.2.4 identifies various tests to be performed. Theapplicability of these tests will be determined as discussed in QAPMSection B.8 and based upon the significance of change ormodification.Documented routine inspections and audits of the storage area maybe performed instead of the requirements of this Section.In some cases, testing requirements may be met by post-installation surveillance testing in lieu of a special post-installationtest.The last sentence of this section states: "Items requiring calibrationshall be tagged or labeled on completion indicating date ofcalibration and identity of the person that performed the calibration."Instead of requiring the tagging or labeling of all equipment thisstatement is changed to require the equipment to be suitablymarked to indicate the date of the next required calibration and theidentity of the person that performed the calibration.23Revision 0 S EntW QUALITY ASSURANCE PROGRAM MANUAL-~EtergyTable IRegulatory CommitmentsC. Regulatory Guide 1.33 Revision 2, dated February 1978Clarification/Exception1. Section C.12. Section C.43. ANSI N18.7Section 14. ANSI N18.7Section 4.3.15. ANSI N18.7Section 4.3.2.3VY will provide procedures for the guide's Appendix A activities asdiscussed. However, VY does not consider all activities listed to be"safety-related" (e.g., activities in 7.e).This section establishes minimum 2-year audit frequency for all safetyrelated functions and recommends audit frequencies specific toCorrective Action, Facility Operation, and Staff Performance,Training, and Qualifications. VY will perform audits at frequencies asdiscussed in QAPM Section C.2.a instead of this section.Sentences 4 and 5 state, "However, applicable sections of thisstandard should be used as they apply to related activities. Activitiesincluded are: Design Changes, Purchasing, Fabricating..." Withregard to radioactive material transportation activities, VY will onlyimplement the requirements associated with those activitiesconducted in accordance with the applicable NRC Quality AssuranceProgram Approval for Radioactive Material Packages.The specific areas of experience described in this section are notapplicable to the on-site safety review committee but the committeemust be comprised of site operating or engineering supervisorypersonnel. Additionally, the off-site safety review committee needcontain experience in only a majority of the areas.The statement that "no more than a minority of the quorum shall haveline responsibility for the operation of the plant" is not applicable tothe on-site safety review committee.24Revision 0
__ EyQUALITY ASSURANCE PROGRAM MANUALm6vEn tergyTable IRegulatory CommitmentsC. Regulatory Guide 1.33 (continued)Clarification/Exception6. ANSI N18.7Section4.3.4.(1) & (2)7. ANSIN18.7Section 4.3.4(2)8. ANSI N18.7Section 4.3.4(3)9. ANSI N18.7Section 4.3.4(4)10. ANSI N18.7Section 4.3.4(5)11. ANSI N18.7Section 4.512. ANSI N18.7Section 4.510 CFR 50.59 was revised through Federal Register Notice19991001 R1 N3150-AF94 eliminating the terms "safety evaluation"and "unreviewed safety question." The term "safety evaluation" hasbeen replaced with 10 CFR 50.59 "evaluation." The term"unreviewed safety question," as defined in the previous version of 10CFR 50.59 (a)(2), was replaced by criteria provided in 50.59(c)(2) todetermine if a license amendment pursuant to 50.90 is required priorto implementing the change, test, or experiment.Reviews associated with changes to the technical specifications willbe performed in accordance with Section 4.3.4(3) instead of thissection.Revision to proposed Technical Specification changes only requiresreview in accordance with this section when the revision involves asignificant change to the technical basis for the proposed change.The independent review body discussed in this section is the on-sitesafety review committee. Voting members having a potential conflictof interest refrain from voting on documents under review.In place of the requirements of this section, the on-site and off-sitesafety review committees shall review facility operations to detectpotential nuclear safety hazards and all reports made in accordancewith 10 CFR 50.73.An example of the matters reviewed by the on-site safety reviewcommittee in accordance with this section is a change to theEmergency Plan (except editorial changes).This section establishes minimum 2-year audit frequency for all safetyrelated functions. VY will perform audits at frequencies as discussedin QAPM Section C.2.a instead of this section.The independent review body discussed in this section is the off-sitesafety review committee.25Revision 0
_En_ QUALITY ASSURANCE PROGRAM MANUALEtergyTable IRegulatory CommitmentsC. Regulatory Guide 1.33 (continued)ClarificationlException13. ANSI N18.7Section 5.114. ANSIN18.7Section 5.2.215. ANSI N18.7Section 5.2.216. ANSI N18.7Section 5.2.617. ANSI N18.7Section 5.2.618. ANSI N18.7Section 5.2.7.1Instead of the requirements of this section to have a summarydocument, a method of cross-referencing these requirements to theimplementing procedures will be maintained.The person who holds a senior reactor operators license for theaffected unit and approves a temporary change to a procedure is notrequired to be in charge of the shift.In addition to the temporary procedure change process described forchanges which clearly do not change the intent of a procedure,temporary procedure changes which may change the intent of aprocedure may be made following the process described in thissection. Except that the person normally responsible for approvingrevisions to the procedure is the approval authority for the change.Instead of the requirements of this section concerning non-conforming conditions, non-conforming conditions will be evaluatedand controlled in accordance with the corrective action program.The requirement of the fifth paragraph of this section to have a log ofthe status of temporary modifications is not applicable to temporarymodifications for routine tasks installed in accordance withprocedures. These procedures shall provide assurance thatapprovals are obtained, temporary modification activities areindependently verified by an individual cognizant of the purpose andthe effect of the temporary modification, and that activities areadequately documented to indicate the status of the temporarymodification.This section will be implemented by adding the words 'Wherepractical" in front of the first and fourth sentences of the fifthparagraph. For modifications where the requirements of the fourthsentence are not considered practical, a review in accordance withthe provisions of 10 CFR 50.59 will be conducted.26Revision 0
___ QUALITY ASSURANCE PROGRAM MANUALEntergyTable IRegulatory CommitmentsC. Regulatory Guide 1.33 (continued)ClarificationlException19. ANSI N18.7Section 5.2.820. ANSI N18.7Section 5.2.921. ANSI N18.7Section5.2.13.122. ANSI N18.7Section 5.2.1423. ANSI N18.7Section 5.2.1524. ANSI N18.7Section 5.2.1525. ANSI N18.7Section 5.3.926. ANSI N18.7Section 5.3.9.3In lieu of a "master surveillance schedule," the following requirementshall be complied with: "A surveillance testing schedule(s) shall beestablished reflecting the status of all in-plant surveillance tests andinspections."The requirements of the Physical Security Plan shall be implementedin place of these general requirements.Consistent with ANSI N45.2.11 Section 7.2, minor changes todocuments, such as inconsequential editorial corrections, or changesto commercial terms and conditions may not require that the reviseddocument receive the same review and approval as the originaldocuments.Where marking, tagging, or physical separation of the non-conformingitem is not feasible, the non-conforming item may be controlled by theuse of appropriate documentation.Required procedure reviews following the occurrences discussed inSection 5.2.15, paragraph 3, sentence 3, are determined andcontrolled in accordance with the QAPM Section A.6 instead of thissection.This section requires plant procedure review by an individualknowledgeable in the area affected by the procedure no lessfrequently than every two years to determine if changes arenecessary or desirable. Instead of this review, controls are in effectto ensure that procedures are reviewed for possible revision uponidentification of new or revised source material potentially affectingthe intent of procedures.Instead of the requirements of this section, the format and content ofthe emergency operating procedures follow the applicable NRCapproved format for the specific unit.VY's NRC accepted Emergency Plan will be implemented in lieu ofthe requirements in this section.27Revision 0
___ QUALITY ASSURANCE PROGRAM MANUAL"EntergyTable 1Regulatory CommitmentsD. Regulatory Guide 1.37, dated March 1973Clarification/Exception1. General2. Section C.33. Section C.44. ANSI N45.2.1Section 5Instead of using the cleanliness level classification system ofANSI N45.2.1, the required cleanliness for specific items and activitiesis addressed on a case-by-case basis. Cleanliness is maintained,consistent with the work being performed to prevent introduction offoreign material. As a minimum, cleanliness inspections are performedprior to system closure and such inspections are documented.The water quality for final flushes of fluid systems and associatedcomponents is at least equivalent to the quality of the operating systemwater, except for the oxygen and nitrogen content.As an alternate to the requirements of this section, contamination levelsin expendable products may be based upon safe practices andindustrial availability with documented engineering evaluations.Contaminant levels are controlled such that subsequent removal bystandard cleaning methods results in the achievement of finalacceptable levels that are not detrimental to the materials.Any nonhalogenated material may be used which is compatible with theparent material not just plastic film.28Revision 0
_Entergy QUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory CommitmentsE. Regulatory Guide 1.38 Revision 2, dated May 1977Clarification/Exception1. ANSI N45.2.2Section 3.22. ANSI N45.2.2Section 3.23. ANSI' N45.2.2Section 3.7.14. ANSI N45.2.2Section 3.7.25. ANSI N45.2.2Section 4.3.46. ANSI N45.2.2Section 5.2.1Storage of an item in a higher-level storage area meets the lower levelstorage requirements.As an alternate to the requirements in Section 3.2.1 items (4), (5), and7, Section 3.2.2, Section 3.2.3 item (1), and Section 3.2.4 item (2), thestorage atmosphere may be controlled such that it is free of harmfulcontaminants in concentration that could produce damage to thestored item and protecting weld end preparations and threads bycontrolling the manner in which the item is stored.Cleated, sheathed boxes may be used up to 1000 lb. rather than 500lb. as specified in 3.7.1(1). Special qualification testing may berequired for loads over 1000 lb.Skids and runners will normally be fabricated from a minimum 2 X 4inch nominal lumber size and laid flat except where this is impracticalbecause of the small dimensions of the container. If forklift handling isrequired, minimum floor clearance for forklift tines will be provided.Inspections of packages and/or preservative coatings are madeimmediately prior to loading rather than after loading.Warehouse personnel will normally visually scrutinize incomingshipments for damage of the types listed in this section, this activity isnot necessarily performed prior to unloading. Separatedocumentation of the shipping damage inspection is not necessary.Release of the transport agent after unloading and the signing forreceipt of the shipment provides adequate documentation ofcompletion of the shipping damage inspection. Any non-conformances noted will be documented and dispositioned. Personsperforming the visual scrutiny during unloading are not considered tobe performing an inspection function as defined under Reg. Guide1.74; therefore, while they will be trained to perform this function, theymay not be certified (N45.2.6) as an inspector.29Revision 0
[_Entergy QUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory CommitmentsE. Regulatory Guide 1.38 (continued)Clarification/Exception7. ANSI N45.2.2Section 5.2.2The second division of this subsection requires six additionalinspection activities if an item was not inspected or examined at thesource. VY will consider that a source inspection has beenconducted if the supplier of the item is required to comply with ANSIN45.2.2 for the purchased item and if the supplier's program hasbeen audited and found acceptable in the area (i.e., the supplierperforms a source inspection of his supplier or conducts a receiptinspection that includes, as applicable, the six additional items listed).Instead of the requirement that receiving inspections be performed inan area equivalent to the level of storage required for the item,receiving inspections will be performed in a manner and in anenvironment which does not endanger the requisite quality of an item.The receiving inspection's location environmental controls may beless stringent than storage environmental requirements for that item;however, the short time spent in the less stringent receivinginspection area shall be of such duration that it will not adverselyaffect the item being received.The "Special Inspection" procedure is not required to be attached tothe item or container but shall be readily available to inspectionpersonnel.Items which fall within the Level D classification of the standard willbe stored in an area which may be posted to limit access, but otherpositive controls such as fencing or guards may not be provided.The sentence is replaced with the following: "The use or storage offood, drinks, and salt tablet dispensers in any storage area shall becontrolled and shall be limited to designated areas where such use orstorage is not deleterious to stored items."8. ANSI N45.2.2Section 5.2.39. ANSI N45.2.2Section 6.2.110. ANSI N45.2.2Section 6.2.430Revision 0
__ EyQUALITY ASSURANCE PROGRAM MANUAL% En tergyTable IRegulatory CommitmentsE. Regulatory Guide 1.38 (continued)Clarification/Exception11. ANSI N45.2.2Section 6.2.512. ANSI N45.2.2Section 6.3.313. ANSI N45.2.2Section 6.4.214. ANSI N45.2.2Section 6.515. ANSI N45.2.2Section 6.6The sentence is replaced with the following: "Exterminators or otherappropriate measures shall be used to control animals to minimizepossible contamination and mechanical damage to stored material. Ifevidence of animal activity is detected, a survey or inspection will beutilized to determine the extent of the damage."An alternate to the stated requirement is the following: "Hazardouschemicals, paints, solvents, and other materials of a like nature shallbe stored in approved cabinets or containers which are not in closeproximity to installed systems required for safe shutdown."Care of items in storage shall be exercised in accordance with thefollowing: "Types of components that could require maintenancewhile in storage shall be identified and evaluated for specificmaintenance requirements. Maintenance activities 6.4.2 (6) through6.4.2 (8) listed in this requirement shall be considered during thisevaluation and any deviations shall be justified and documented."The last sentence of this section is not applicable to the operationsphase.VY will comply with this section's requirements with the clarificationthat, for record purposes, only the access of personnel without keycards into indoor storage areas shall be recorded. Unloading orpickup of material shall not be considered "access," nor shallinspection by NRC or other regulatory agents, nor shall tours by non-licensee employees who are accompanied by licensee employees.31Revision 0 QUALITY ASSURANCE PROGRAM MANUAL"~En tergyTable 1Regulatory CommitmentsE. Regulatory Guide 1.38 (continued)ClarificationlException16. ANSI N45.2.2Section 7.317. ANSI N45.2.2Appendix (A-3)Section A.3.4.118. ANSI N45.2.2Appendix (A-3)Section A.3.4.219. ANSI N45.2.2Appendix (A-3)Section A.3.5.120. ANSI N45.2.2Appendix (A-3)Section A.3.5.2Re-rating hoisting equipment will be considered only whennecessary. Prior to performing any lift above the load rating, theequipment manufacturer must be contacted for his approval anddirection. The manufacturer must be requested to supply adocument granting approval for a limited number of lifts at the newrating and any restrictions involved, such as modifications to bemade to the equipment and the test lift load. At all times, the codesgoverning re-rating of hoisting equipment must be observed.During printing of the standard, a transposition occurred betweenthe last sentence of A3.4.1(4) and A3.4.1(5). The correctrequirements are: (4) "However, preservatives for inaccessibleinside surfaces of pumps, valves and pipe systems containingreactor coolant water shall be the water flushable type." (5) "Thename of the preservative used shall be indicated to facilitate touchup."There may be cases involving large or complex shaped items forwhich an inert or dry air purge is provided, rather than a static gasblanket, in order to provide adequate protection due to difficulty ofproviding a leak proof barrier. In these cases, a positive pressurepurge flow may be utilized as an alternate to a leak-proof barrier.Instead of the requirement for non-metallic plugs and caps to bebrightly colored, non-metallic plugs and caps shall be anappropriately visible color.This paragraph limits halogen and sulfur content of tape. The useof tapes containing greater amounts of halogens than thoseidentified will be allowed after appropriate evaluation; however, thequantities shall not be such that harmful concentrations could beleached or released by breakdown of the compounds underexpected environmental conditions.32Revision 0
_QUALITY ASSURANCE PROGRAM MANUALSEn tergyTable 1Regulatory CommitmentsE. Regulatory Guide 1.38 (continued)ClarificationlException21. ANSI N45.2.2Appendix (A-3)Section A.3.7.122. ANSI N45.2.2Appendix (A-3)Section A.3.923. ANSI N45.2.2,Appendix (A-3)Section A.3.924. ANSI N45.2.2,Appendix (A-3)Section A.3.925. ANSI N45.2.2Appendix (A-3)Section A.3.9In lieu of A.3.7.1(3) and (4), VY will comply with the following:Fiberboard boxes shall be securely closed either with a waterresistant adhesive applied to the entire area of contact between theflaps, or all seams and joints shall be sealed with not less than 2-inch wide, water resistant tape.Instead of the requirement that container markings appear on aminimum of two sides of the container, preferably on one side andone end, VY will comply with the following: Containers areadequately marked for storage, identification, and retrieval.Multiple marking requirements are imposed, where necessary.Instead of the requirement that container markings be no less than3/4" high, VY will comply with the following: Container markingsare of a size which permits easy recognition.Instead of the specific container marking requirements, VY willcomply with the following: The information required in containermarking is evaluated on a case-by-case basis.The last paragraph of A.3.9 could be interpreted as prohibiting anydirect marking on bare austenitic stainless steel and nickel alloymetal surfaces. As a alternate, paragraphs A.3.9.(1) and (2) maybe used to control marking on the surface of austenitic stainlesssteels and nickel base alloys based on documented engineeringevaluations. Contamination levels are controlled such that thematerial used for marking is not detrimental to the materialsmarked.33Revision 0 QUALITY ASSURANCE PROGRAM MANUAL"En tergyTable 1Regulatory CommitmentsF. Regulatory Guide 1.39 Revision 2, dated September 1977Clarification/Exception1. ANSI N45.2.3General2. ANSI N45.2.3Section 3.13. ANSI N45.2.3Section 3.2.34. ANSI N45.2.3Section 3.35. ANSI N45.2.3Section 3.46. ANSI N45.2.3Section 3.5The ANSI five level zone designation system may not be utilized, butthe intent of the standard will be met for the areas of housekeeping,plant and personnel safety, and fire protection.This section is not applicable.The Fire Protection Program shall be used in lieu of the generalrequirements in this section.The first paragraph is not applicable to the operations phase.This section is not applicable.Subparagraph (1) is not applicable to the operations phase; (2), (3),and (4) will be implemented.34Revision 0 SEnQUALITY ASSURANCE PROGRAM MANUAL`EnterfgyTable 1Regulatory CommitmentsG. Regulatory Guide 1.58 Revision 1, dated September 1980Clarification/Exception1. General2. General3. ANSI N45.2.6Section 1.24. ANSI N45.2.6Section 1.25. ANSI N45.2.6Section 2.36. ANSI N45.2.6Section 2.57. ANSI N45.2.6Section 3.5VY may choose not to apply the requirements of this guide to thosepersonnel who are involved in day-to-day operations, surveillance,maintenance, and certain technical and support services whosequalifications are controlled by the Technical Specifications or otherQAPM commitment requirements.General certification of inspectors in accordance with this guide isapproved by a manager responsible for quality.Paragraph 4 requires that the standard be imposed on personnelother than licensee employees; the applicability of this standard tosuppliers will be documented and applied, as appropriate, inprocurement documents for such suppliers.The requirements of this standard do not apply to personnel usinglater editions of ASNT contained within 1 OCFR50.55a approvedASME editions or addenda.This section requires, in part, that any person who has notperformed inspection, examination, or testing activities in hisqualified area for a period of one year shall be re-evaluated. A 90-day grace period may be applied to this activity. For activitiesdeferred in accordance with the 90-day grace period, the nextperformance due date will be based on their originally scheduleddate.This section's requirements are clarified with the stipulation that,where no special physical characteristics are required, none will bespecified. The converse is also true: if no special physicalrequirements are stipulated, none are considered necessary.VY reserves the right to use personnel who do not meet theseexperience requirements but have shown capability through trainingand testing or capability demonstration.35Revision 0
___ QUALITY ASSURANCE PROGRAM MANUAL--EntergyTable 1Regulatory CommitmentsH. Regulatory Guide 1.64 Revision 2, dated June 1976ClarificationlException1. ANSI N45.2.11Section 5.2.4For the documentation of inter-disciplinary design reviews, there mustbe documented evidence of the acceptability of design documents, orportions thereof, prior to release (material, stress, physics,mechanical, electrical, concrete, etc.). Indication of the positiveconcurrence of those who determine the design acceptability relativeto their respective disciplinary area of concern should be on thedocument or on a separate form traceable to the document. Adocument that indicates the reviewer's comments need not beretained.36Revision 0
___ QUALITY ASSURANCE PROGRAM MANUAL`-En tergyTable IRegulatory CommitmentsI. Regulatory Guide 1.74, dated February 1974Clarification/Exception1. ANSI N45.2.10,Section 2Definitions for "Certificate of Conformance" and "Certificate ofCompliance" will be exchanged based upon the guidance in ANSIN45.2.13 Section 10.2.37Revision 0
___ .QUALITY ASSURANCE PROGRAM MANUALEntergyTable 1Regulatory CommitmentsJ. Regulatory Guide 1.88 Revision 2, dated October 1976ClarificationlException1. RG 1.88Section C2. ANSI N45.2.9Section 1.43. ANSI N45.2.9Section 3.2.24. ANSI N45.2.9Section 5.4.2VY will meet the requirements of NFPA No. 232-1975, "Standards forthe Protection of Records", as allowed by the Regulatory Guide 1.88 -1976 or ANSI/ ASME NQA-1 -1983, Supplement 17S-1 Section 4.4 inlieu of N45.2.9 Section 5.6 or the discussions in this section forRecords Storage Facilities with the clarification that penetrationsproviding fire protection, lighting, temperature/humidity control, orcommunications are acceptable as long as the penetration maintainsthe required fire resistance.Except that as an altemate to these requirements non-permanentrecords (e.g., 3 years retention records) may be stored andmaintained by the originating organization in one-hour minimum firerated file cabinets located in environmentally controlled facilities thathave suitable fire protection. Suitable fire protection is provided byeither an automatic sprinkler system or a combination of two or moreof the following: 1) automatic fire alarms, 2) hose stations, or 3)portable extinguishers.Documents are considered completed when they are "completely filledout" (i.e., when sufficient information is recorded to fulfill the record'sintended purpose) and the adequacy of the document (e.g., legibility)has been accepted by the document control or records managementorganizations or designees.The requirements for an index discussed in this section areconsidered to only require that a method of retrieving the record andcontrolling the identified information be established.Instead of the requirements of this section, VY will comply with thefollowing: Records shall not be stored loosely. They shall be securedfor storage in file cabinets or on shelving in containers. Methods otherthan binders, folders, or envelopes (e.g., dividers or boxes) may beused to organize records for storage. This section is not applicable tospecial processed records controlled in accordance with Section 5.4.3when the requirements of this section are not appropriate for therecord type.38Revision 0
_ En QUALITY ASSURANCE PROGRAM MANUALEn ter gTable 1Regulatory CommitmentsJ. Regulatory Guide 1.88 (continued)ClarificationlException5. ANSI N45.2.9Section 5.4.36. ANSI N45.2.9Section 5.57. ANSI N45.2.9Section 5.6Instead of the requirements of this section, VY will comply with thefollowing: Provisions shall be made for special processed recordssuch as radiographs, photographs, negatives, microfilm, and magneticmedia to prevent damage from excessive light, stacking,electromagnetic fields, temperature, and humidity as appropriate tothe record type with appropriate consideration of packaging andstoring recommendations as provided by the manufacturer of thesematerials.Routine general office and nuclear site security systems and accesscontrols are provided; no special security systems are required to beestablished for record storage areas.VY will meet the requirements of NFPA No. 232 -1975, "Standardsfor the Protection of Records", as allowed by the Regulatory Guide1.88 -1976 or ANSI/ASME NQA-1 -1983, Supplement 17S-1 Section4.4 in lieu of this section for Records Storage Facilities with theclarification that penetrations providing fire protection, lighting,temperature/humidity control, or communications are acceptable aslong as the penetration maintains the required fire resistance.Except that as an alternate to these requirements non-permanentrecords (e.g., 3 years retention records) may be stored andmaintained by the originating organization in one-hour minimum firerated file cabinets located in environmentally controlled facilities thathave suitable fire protection. Suitable fire protection is provided byeither an automatic sprinkler system or a combination of two or moreof the following: 1) automatic fire alarms, 2) hose stations, or 3)portable extinguishers.39Revision 0
___ yQUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory CommitmentsK. Regulatory Guide 1.94 Revision 1, dated April 1976Clarification/Exception1, ANSI N45.2.5Section 2.5.22. ANSI N45.2.5Section 4.5The last sentence requires that all items inspected with maintenanceand test equipment, which is found to be out of calibration, shall beconsidered unacceptable. VY will comply with QAPM Section B.9.g asan alternate. QAPM Section B.9.g requires an evaluation to determinethe validity of previous measurements.When using ACI-305-72 and ACI-306-66, VY may apply the followingrequirements:PLACING TEMPERATURES OF CONCRETEA. During hot weather concreting, placing temperatures of concrete willbe limited to the following: 1) Concrete members less than 3 feet inleast dimension will not exceed 90'F; 2) Concrete members from3 feet to 6 feet in least dimension will not exceed 70°F; and 3)Concrete members more than 6 feet in least dimension will haveplacing temperature as near 50°F as can be obtained by use of ice asnecessary up to 100 percent of adding mixing water; and by shadingaggregate and sprinkling the coarse aggregate the day it is to be used.Care will be taken so that no unmelted ice remains in the concrete atthe end of the mixing period.B. During cold weather concreting: In heating the water andaggregate, live steam to heat the fine and coarse aggregate shall notbe used. The permissible range for concrete temperature shall be asfollows: 1) Sections less than 3 feet in least dimensions 55°F to 75°F;and 2) Mass concrete 3 feet or more in least dimension 450F to 650F.The mixing water and aggregate will be purchased as required. Thematerials will be free of ice, snow and frozen lumps before they enterthe mixer.As an alternate to daily testing grout for compressive strength, forprepackaged shelf item, non-shrink grout, the grout's compressivestrength tests may be performed once on each batch of non-shrinkgrout received, rather than each day grout is placed.3. ANSI N45.2.5Table B40Revision 0
_ En yQUALITY ASSURANCE PROGRAM MANUAL%En tefg yTable 1Regulatory CommitmentsK. Regulatory Guide 1.94 (continued)Clarification/Exception4. ANSI N45.2.5 For the performance of correlation tests, the requirements of thisSection 4.8 standard may be modified as discussed below:Table B, REINFORCING STEEL: In-process testing of reinforcingsteel will include the mechanical properties of yield strength, tensilestrength and percent elongation on full size specimens for each barsize for each 50 tons or fraction thereof from each mill heat. Bendtests are performed during material qualification testing only, except asnoted below for bar sizes #14 through #18.Table A, "Required Qualification Tests" as applied to reinforcing steelwill include bend tests as required by ASTM A615 and summarized inthe following: a) For bar sizes #3 through #11, one full size specimenfrom largest bar size rolled from each mill heat, unless material fromone heat differs by three or more designation numbers. When thisoccurs, one bend test shall be made from both the highest and lowestdesignation number of the deformed bars rolled; b) For bar sizes #14through #18, Supplementary Requirements S1 of ASTM A615 will beapplied, i.e., one fullsize specimen for each bar size for each mill heat.If supplementary requirements are not followed for mill tests, they willbe applied as in-process tests.In-process test specimens may be selected at the rebar fabricationshop, pror to start of fabrication of the rebar from the heat or fractionthereof represented by the test specimen.Acceptance criteria for any failed test (qualifications as well as in-process) may be the same as that for tensile tests specified inSubarticle CC-2331.2 of ASME Section III, Div. 2 Code (1975). Thisstates that if a test specimen fails to meet the specified strengthrequirements, two (2) additional specimens from the same heat and ofthe same bar size would be tested, and if either of the two additionalspecimens fails to meet the specified strength requirements, thematerial represented by the tests would be rejected for the specifieduse. Alternative use of rejected material under strict control may besubject to evaluation by engineering.41Revision 0
[ Entergy" QUALITY ASSURANCE PROGRAM MANUALTable IRegulatory CommitmentsK. Regulatory Guide 1.94 (continued)Clarification/Exception5. ANSI N45.2.5Section 4.96. ANSI N45.2.5Section 5.5VY may interpret the terms "horizontal, vertical and diagonal bars" toapply respectively to the following types of splice positions: a.Horizontal, including 100 to horizontal; b. Vertical, including 10° tovertical; and c. 450 angle, including 100 to 80' angle. The words"splicing crew" are interpreted to refer to all project members that areactively engaged in preparing and assembling cadweld mechanicalsplices at the final splice location. Separate test cycles will beestablished for each bar size and each splice position.VY will comply with inspection requirements of the applicable weldingcodes and any exceptions instead of this section.42Revision 0
__ EnQUALITY ASSURANCE PROGRAM MANUAL"En tergyTable IRegulatory CommitmentsL. Regulatory Guide 1.116 Revision O-R, dated June 1976Clarification/Exception1. ANSI N45.2.8Section 3Documented routine inspections and audits of the storage area maybe performed instead of the requirements of this section.43Revision 0
_Entergy QUALITY ASSURANCE PROGRAM MANUALTable IRegulatory CommitmentsM. Regulatory Guide 1.123 Revision 1, dated July 1977Clarification/Exception1. RG 1.123Paragraph C.6.e2. ANSI N45.2.13Section 1.2.23. ANSI N45.2.13Section 1.34. ANSI N45.2.13Section 3.15. ANSI N45.2.13Section 3.1This paragraph shall be implemented as originally written inN45.2.13 (i.e., with the verb "should" instead of the verb "shall").VY retains the ultimate responsibility for performance ofpurchased equipment. The appropriate engineering disciplinewill exercise this management/engineering prerogative withrespect to the final decision on post installation testrequirements.Item c is an option which may be used to assure quality;however, any option given in 10 CFR 50 Appendix B, CriterionVII as implemented by the QAPM may also be used.Instead of the definition provided for QA Program Requirements,VY will comply with the following: "Those individualrequirements of the QAPM which, when invoked in total or inpart, establish quality assurance program requirements for theactivity being controlled. Although not specifically used in theQAPM, ANSI N45.2 may be imposed upon suppliers."The "same degree of control" is stipulated to mean "equivalentlevel of review and approval." The changed document may notalways be reviewed by the originator; however, at least anequivalent level of management/supervision shall review andapprove any changes.Changes to procurement documents which are changes inquantity, estimated price, cost codes, taxes, format or editorialchanges that do not affect the quality of the item or service donot require an equivalent level of review and approval as theoriginal document.44Revision 0
[ Enltrgy QUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory CommitmentsM. Regulatory Guide 1.123 (continued)Clarification/Exception5a. ANSI N45.2.13Section 3.2When purchasing commercial-grade (as defined in 10CFR21)calibration services from NVLAP or A2LA accredited calibrationlaboratories, procurement documents are not required to imposea quality assurance program consistent with ANSI N45.2-1971.In such cases, accreditation may be accepted in lieu of thePurchaser imposing a QA Program consistent with ANSI N45.2-1971, provided all the following are met:* The accreditation is to ANSI/ISO/IEC 17025.* The accrediting body is either NVLAP A2LA.* The published scope of accreditation for the calibrationlaboratory covers the needed measurement parameters,ranges, and uncertainties.* The purchase documents require calibration/report toinclude identification of the laboratory equipment/standardsused.* The purchase documents require reporting as-foundcalibration data when calibrated items are found to be out-of-tolerance.The requirements of the QAPM will be implemented instead ofthis section.Supplier evaluations may be performed any time prior to placingthe purchased item in service.Non-conformance notices for conditions described in this sectionare only required to be submitted to VY when the non-conformance could adversely affect the end use of an itemrelative to safety, interchangeability, operability, reliability,integrity or maintainability.6. ANSI N45.2.13Section 3.47.ANSI N45.2.13Section 4.28. ANSI N45.2.13Section 8.2Item b45Revision 0
[ Et e QUALITY ASSURANCE PROGRAM MANUAL`- En teryTable 1Regulatory CommitmentsM. Regulatory Guide 1.123 (continued)ClarificationlException9. ANSI N45.2.13Section 10.2Item dThe section states that the certificate should be attested to by aperson who is responsible for this QA function whose functionand position are described in the Purchaser's/Supplier's QAprogram. As an alternate to this requirement, VY will use thefollowing: "The person attesting to a certificate shall be anauthorized and responsible employee of the supplier, and shallbe identified by the supplier."46Revision 0 Table 1Regulatory CommitmentsN. Regulatory Guide 1.144 Revision 1, dated September 1980Clarification/Exception1. RG 1.144Section C.3.a.(2)2. RG 1.144Section C.3.b.(2)3. RG 1.144Section C.3.b.(2)4. RG 1.144Section C.3.b.(2)This section is not applicable.In addition to the requirements of this section, previously evaluatedand approved active suppliers for which auditing is not the selectedmethod of source verification should be evaluated concurrent withthe award of a contract. Regardless of the evaluation results,active suppliers (except those excluded under C.3.b(1)) are sourceverified (audit, surveillance or inspection) within two years prior toaward of a contract or have source verification performed. Inactivesuppliers are evaluated prior to supplying items or services. Anaudit shall be conducted if required to determine the acceptability ofprocured items or services (i.e., acceptability cannot be determinedby receipt inspection or another method allowable under 10 CFR 50Appendix B, Criterion VII).This section requires that supplier audits be performed on atriennial basis. A 90-day grace period may be applied to thisactivity. For activities deferred in accordance with the 90-day graceperiod, the next performance date will be based on their originallyscheduled date.Instead of the annual documented evaluation of suppliersdiscussed in this section, an ongoing evaluation of supplierperformance is conducted which takes into account, whereapplicable, the other considerations of this section and paragraph ofthe Regulatory Guide.47Revision 0
___ EQUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory CommitmentsN. Regulatory Guide 1.144 (continued)Clarification/Exception4a. RG 1.144Section C.3.b.(2)For suppliers of commercial-grade (as defined in 10CFR21)calibration services with accreditation by NVLAP or A2LA, adocumented review of the supplier's accreditation by the purchasermay be used in lieu of performing an audit, accepting an audit byanother licensee, performing a commercial-grade survey,inspecting or testing following delivery, or performing in-processsurveillances during performance of the service. This review shallinclude, at a minimum, verification of all the following:* The accreditation is to ANSI/ISO/IEC 17025." The accrediting body is either NVLAP A2LA." The published scope of accreditation for the calibrationlaboratory covers the needed measurement parameters,ranges, and uncertainties.Pre-audit and post-audit conferences may be fulfilled by a variety ofcommunications, such as telephone conversation.Pre-audit and post-audit conferences are only held when deemednecessary by quality assurance or when requested by the auditedorganization.This subsection could be interpreted to limit auditors to the reviewof only objective evidence; sometimes and for some programelements, no objective evidence may be available. VY will complywith an alternate sentence which reads: 'When available, objectiveevidence shall be examined for compliance with QAPMrequirements. If subjective evidence is used (e.g., personnelinterviews) then the audit report must indicate how the evidencewas obtained."5. ANSI N45.2.12Section 4.3.16. ANSI N45.2.12Section 4.3.17. ANSI N45.2.12Section 4.3.2.248Revision 0
__ EyQUALITY ASSURANCE PROGRAM MANUAL"EntergyTable 1Regulatory CommitmentsN. Regulatory Guide 1.144 (continued)Clarification/Exception8. ANSI N45.2.12Section 4.3.39. ANSI N45.2.12Section 4.3.310. ANSI N45.2.12Section 4.411. ANSI N45.2.12Section 4.5.1Pre-audit and post-audit conferences are only held when deemednecessary by quality assurance or when requested by the auditedorganization.Pre-audit and post-audit conferences may be fulfilled by a variety ofcommunications, such as telephone conversation.Instead of the last sentence of the last paragraph of the section, VYwill comply with the following: The audit report shall be issuedwithin thirty working days after the last day of the audit. The lastday of an audit shall be considered to be the day of the post-auditconference. If a post-audit conference is not held because it wasdeemed unnecessary, the last day of the audit shall be consideredto be the date the post-audit conference was deemed unnecessaryas documented in the audit report.The QAPM Section A.6 corrective action program may be usedinstead of these requirements as long as the appropriate time limitsare applied to significant conditions adverse to quality. Also, noadditional documentation is necessary if needed corrective actionsare taken and verified prior to audit report issuance.49Revision 0 QUALITY ASSURANCE PROGRAM MANUALTable 1Regulatory Commitments0. Regulatory Guide 1.146 Revision 0, dated August 1980Clarification/Exception1. ANSI N45.2.23Section 2.3.1.32. ANSI N45.2.23Section 2.3.43. ANSI N45.2.23Sections 3.2 and5.3Holders of NRC-issued Reactor Operator/Senior Reactor OperatorLicenses comply with the requirements of this section and may beawarded two credits.Prospective lead auditors shall demonstrate their ability to effectivelyimplement the audit process and lead an audit team. They shall haveparticipated in at least one audit within the year preceding theindividual's effective date of qualification. Upon successfuldemonstration of the ability to effectively lead audits, licenseemanagement may designate a prospective lead auditor as a "leadauditor".These sections require that an annual assessment be performed ofeach lead auditor's qualification and that each lead auditor's recordsbe updated annually. A 90-day grace period may be applied to theseactivities. For activities deferred in accordance with the 90-day graceperiod, the next performance due date will be based on their originallyscheduled date.50Revision 0}}

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