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| number = ML033220524 | | number = ML033220524 | ||
| issue date = 11/12/2003 | | issue date = 11/12/2003 | ||
| title = | | title = Change to the Quality Program Description | ||
| author name = Haas K | | author name = Haas K | ||
| author affiliation = Consumers Energy | | author affiliation = Consumers Energy | ||
| addressee name = | | addressee name = | ||
Revision as of 05:04, 14 July 2019
| ML033220524 | |
| Person / Time | |
|---|---|
| Site: | Big Rock Point File:Consumers Energy icon.png (DPR-006) |
| Issue date: | 11/12/2003 |
| From: | Haas K Consumers Energy |
| To: | Document Control Desk, NRC/FSME |
| References | |
| -RFPFR | |
| Download: ML033220524 (94) | |
Text
November 12, 2003U.S. Nuclear Regulatory CommissionDocument Control Desk Washington, DC 20555-0001DOCKETS 50-155 AND 72-043 - LICENSE DPR BIG ROCK POINT PLANT - BIGROCK POINT PLANT - CHANGE TO THE QUALITY PROGRAM DESCRIPTION
References:
- 1. Letter from NMSS to Big Rock Point, Big Rock Point QualityAssurance Program Changes - Approval with Comment (L52099),
dated October 28, 2003 (ML033010274)2. Letter from Big Rock Point to NMSS, Clarification of April 15, 2003,CPC-2A Submittal, dated September 11, 2003 (ML032590552)3. Letter from Big Rock Point to NMSS, Change to the Quality ProgramDescription, Reduction in Commitment, dated April 15, 2003 (ML031120170)On October 28, 2003, Big Rock Point submittals for updating the Quality AssuranceProgram, Quality Program for Nuclear Power Plants, Part 1 - Big Rock Point Nuclear Plant, Revision 21 were conditionally approved. The condition of having a full element inspection interval every five years has been incorporated into the attached Quality Program Description. With this submittal, we accept the comment, have revised the Quality Program accordingly, and we consider the Quality Plan, Revision 21, approved under the provisions of 10 CFR 50.54(a)(4).Implementation of this plan will be effective immediately. Complete re-write of the SiteAdministrative Procedures has been undertaken. During the interim period, prior to the re-write, revision of current Administrative Procedures that implement the previous version of the Quality Program is not necessary. The scope of activities, structures, systems, and components to which the Quality Plan applies is decreasing rapidly as decommissioning and demolition are being performed. The current Administrative Procedures are more conservative than planned, re-written procedures incorporating the changes due to Revision 21 of Big Rock Point Quality Assurance Program. The following interpretations will be applied to the current Administrative Procedures, which are considered as editorial: The terms "Restoration Safety Review Committee" (RSRC) and "IndependentSafety Review Committee" (ISRC) shall be considered as equivalent.
The terms "Nuclear Performance Assessment Department" (NPAD) and"Quality Assurance Organization" shall be considered as equivalent. The terms "Safety Review Committee" (SRC) and "Safety Review" shall beconsidered equivalent.If you have any questions or concerns regarding this acceptance, please contact GregWithrow, Engineering, Operations, and Licensing Manager, at 231-547-8365.Kurt M. HaasSite General Managercc: Administrator, Region III, USNRC NRC Decommissioning Inspector - Big Rock Point NRC NMSS Project ManagerAttachment Consumers EnergyBIG ROCK POINTDocket Numbers 50-155 and 72-043Quality Program for Nuclear Power PlantsPart 1 - Big Rock Point Nuclear PlantRevision 21November 12, 200386 Pages QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 1 Date: 11/12/2003
SUBJECT:
STATEMENT OF RESPONSIBILITY AND AUTHORITY REGARDINGTHE CONSUMERS ENERGY QUALITY PROGRAM FOR THE BIGROCK POINT NUCLEAR PLANTAs President and Chief Executive Officer, Electric of Consumers Energy, I have theultimate management authority for the Consumers Energy Quality ProgramDescription for Nuclear Power Plants (Part 1) - Big Rock Point Nuclear Plant. TheQuality Program Description (QPD) complies with the quality assurance requirementscontained in Appendix B of 10 CFR 50, "Quality Assurance Criteria for Nuclear PowerPlants and Fuel Reprocessing Plants," and responds to the additional guidancecontained in ANSI N18.7, and to the ANSI N45.2 Series of Standards and corresponding Regulatory Guides within the context of applicability imposed byANSI N18.7. In addition to activities governed by 10 CFR 50 Appendix B, this QualityProgram applies to activities governed by 10 CFR 71 Subpart H "Quality Assurancefor Packaging and Transportation of Radioactive Waste", and 10 CFR 72 Subpart G"Quality Assurance for Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste".Because the Big Rock Point reactor will no longer be operated, and prior toimplementation of this revised QPD, fuel and high-level radioactive waste will bestored only at the ISFSI, application of Quality Program requirements to the in-plant structures, systems and components formerly associated with either of thesefunctions will no longer be required. Quality Program requirements will be applied tostructures, systems and components at the Independent Spent Fuel StorageInstallation (ISFSI) that are required for safe storage of spent nuclear fuel and high-level radioactive waste. Quality Program requirements will also be applied to selected activities and programs as long as they are required for decommissioning or operationof the ISFSI; for example, packaging and transportation of radioactive materials, andactivities required to achieve compliance with 10 CFR 20.I have delegated responsibility for establishing, maintaining and implementing theQuality Program Description to the Senior Vice President, Nuclear, Fossil and HydroOperations. This Quality Program Description describes the Consumers Energyorganizations responsible for implementation.The Quality Program Description contains mandatory requirements which must beimplemented and enforced by all responsible organizations and individuals._____________________________________ ________________John G. RussellDatePresident and Chief Executive Officer, Electric QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 2 Date: 11/12/2003APPROVED BY:____________________________________ __________________Senior Vice President, Nuclear, Fossil, and DateHydro Operations Robert A. Fenech QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 3 Date: 11/12/2003 CONTENTS Section Title PageStatement of Responsibility and Authority1Approval Page2 Contents 3 1.0ORGANIZATION---------...........................................................5 2.0QUALITY PROGRAM..................................................................................11 3.0DESIGN CONTROL....................................................................................16 4.0PROCUREMENT DOCUMENT CONTROL.................................................20 5.0INSTRUCTIONS, PROCEDURES AND DRAWINGS..................................22 6.0DOCUMENT CONTROL.............................................................................25 7.0CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES..27 8.0IDENTIFICATION AND CONTROL OF ITEMS............................................30 9.0CONTROL OF SPECIAL PROCESSES......................................................31 10.0INSPECTION..............................................................................................32 11.0TEST CONTROL.........................................................................................35 12.0CONTROL OF MEASURING AND TEST EQUIPMENT..............................3713.0HANDLING, STORAGE AND SHIPPING....................................................3914.0INSPECTION, TEST AND OPERATING STATUS......................................40 15.0NONCONFORMING MATERIALS, PARTS OR COMPONENTS................41 16.0CORRECTIVE ACTION..............................................................................43 17.0QUALITY RECORDS..................................................................................44 18.0AUDITS.......................................................................................................46 QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 4 Date: 11/12/2003APPENDIX A...................................................................................................................48APPENDIX B...................................................................................................................77 APPENDIX C...................................................................................................................79 APPENDIX D...................................................................................................................82APPENDIX E...................................................................................................................84FIGURE1 Consumers Energy Organization Chart for Big Rock Point Quality Program-10 QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 5 Date: 11/12/20031.0ORGANIZATION1.1REQUIREMENTSConsumers Energy is responsible for establishing and implementing the QualityProgram, as described herein, for the Big Rock Point Nuclear Plant (BRP) andits Independent Spent Fuel Storage Installation (ISFSI). Consumers Energymay delegate the authority for development and maintenance of the QualityProgram Description (QPD) and execution of certain quality assurance functions to others who are independent and qualified, such as contractors, agents orconsultants. Although authority for development and execution of some parts ofthe program may be delegated to others, Consumers Energy retains overallresponsibility.This section of the QPD identifies the responsibilities of Consumers Energy andother organizations for activities: 1) affecting radiological safety during decommissioning; 2) related to packaging and transportation of radioactivematerials; and 3) affecting safe operation of the ISFSI. It addressesresponsibilities for attaining quality objectives; for establishing and maintainingthe QPD; and for assessing the performance of activities affecting quality.Quality assessment functions, such as audits, surveillances and supplierevaluations are performed by personnel who report to the Quality AssuranceLead or by members of other organizations selected by the Quality AssuranceLead. The reporting level of the Quality Assurance Organization affordssufficient authority and organizational freedom, including sufficient indepen-dence from the cost and schedule impacts of Quality Assurance Organizationactions, to enable people in that organization to identify quality problems; toinitiate, recommend, or provide solutions; and to verify implementation ofsolutions.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations1.2.12a1.2.22g1.2.32, 2b, 2c1.2IMPLEMENTATION 1.2.1Source of AuthorityThe President and Chief Executive Officer, Electric (see Figure 1, CompanyOrganization Chart) of Consumers Energy is responsible for safedecommissioning of Big Rock Point and safe operation of the ISFSI. Authorityand responsibility for establishing and implementing the Quality Program aredelegated to the Senior Vice President - Nuclear, Fossil, and Hydro Operations (NFHO). This delegation is formalized in a STATEMENT OF RESPONSIBILITYAND AUTHORITY signed by the President and Chief Executive Officer, Electric.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 6 Date: 11/12/2003Other quality-related functions are provided by other organizations as describedherein.1.2.2Responsibility for Attaining Quality Objectives at Big Rock Pointa.Senior Vice President, Nuclear, Fossil and Hydro Operations (NFHO)The Senior Vice President, NFHO is responsible to the President and ChiefExecutive Officer, Electric for decommissioning BRP and operation of theISFSI. Managers who report to the Senior Vice President, NFHO have responsibilities as indicated for directing the performance of activities thataffect safe plant decommissioning and ISFSI operation, and/or functions ofstructures, systems and components of the ISFSI that are important tosafety in accordance with Quality Program requirements.b.Big Rock Point Site General ManagerThe BRP Site General Manager (see Figure 1) is responsible to the SeniorVice President NFHO for decommissioning BRP and operation andmaintenance of the ISFSI in a manner that achieves compliance withlicenses, applicable regulations and the Quality Program. The Site GeneralManager delegates to appropriate staff personnel in his organization responsibility for carrying out applicable controls required by the QualityProgram. Quality Program activities performed on the authority of the SiteGeneral Manager include:(1)Preparation, review, and approval of methods to identify ISFSIstructures, systems and components, and ISFSI/plant activities towhich this QPD apply, as described in Section 2.0.(2)Establishing, implementing and documenting the appropriate trainingof decommissioning and ISFSI personnel, including Quality Program indoctrination and training.(3)Accomplishing plant/ISFSI licensing activities including maintaininglicensing documents up-to-date, interfacing with the NRC, accom-plishing and/or tracking licensing commitments and coordinating internal action on NRC bulletins, generic letters, etc, and performingreviews specified in Appendix B, SAFETY REVIEW.(4)Functioning as the ISFSI design and configuration control authority forcompliance of ISFSI modifications and design changes to existingISFSI design criteria.(5)Performing the engineering, construction, inspection and testingassociated with ISFSI modification projects.(6)Procurement, including preparation, reviews and approval of purchaserequests for spare parts, replacement items, consumables, materials, items and services, and submittal of purchase requests to thepurchasing organization. Planning and execution of vendor source QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 7 Date: 11/12/2003surveillance or inspection, receiving inspection, and review of supplierquality-related documentation.(7)Preparation, review, approval and control of required procedures andinstructions.(8)Developing, maintaining and implementing security, fire protectionand emergency plans.(9)Providing for handling, storage, protection, and preservation ofidentification of purchased materials and items awaiting dispositionafter removal from service.(10)Qualification of appropriate decommissioning/ISFSI personnel,including certification of inspection personnel.(11)Performing necessary surveillance testing.
(12)Inspection of ISFSI maintenance and testing, fuel transfer operations,activities associated with packaging and transportation of radioactivematerial, and activities required to achieve compliance with10 CFR 20.(13)Control, calibration, and use of Measuring and Test Equipment(M&TE) and installed instrumentation.(14)Maintaining equipment status control.
(15)Stopping unsatisfactory work to control further processing, delivery orinstallation of nonconforming materials or items.(16)Assuring that nonconforming items are identified, segregated anddispositioned.(17)Implementing the Corrective Action process.
(18)Preparation, protection and retention of quality records.
(19)Packaging and transportation of radioactive materials.c.Responsibilities of the Quality Assurance Organization(1)The Quality Assurance Lead, (see Figure 1) is directly responsible tothe Senior Vice President, NFHO, for:(2)Assessment of the effectiveness of the Nuclear Quality Program.
(3)Supplier surveys and evaluation including review/approval of supplierQA programs, and maintenance of the Qualified Suppliers List.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 8 Date: 11/12/2003(4)Preparation, review, approval and implementation of departmentalprocedures governing nuclear assessment activities.(5)Assuring that assessments are done by personnel not directlyresponsible for the work being performed.(6)Assessment of on-site and off-site programs and activities includingfollow-up on corrective action for audit findings.(7)Review of performance trends associated with decommissioning andISFSI activities including corrective actions.(8)Analysis of new and/or changed regulatory direction, codes andstandards to determine their effect on the Quality Program.(9)Maintenance of the Quality Program Description for Nuclear PowerPlants Part 1 - Big Rock Point Nuclear Plant.(10)Reporting audit findings relative to follow-up on corrective actions andthe effectiveness of the Quality Program to Consumers EnergyManagement.(11)In fulfilling the above responsibilities, the Quality Assurance Lead mayuse a combination of Consumers Energy employees and others whoare qualified and independent, including contractors, agents orconsultants. The Quality Assurance Lead is provided with "Stop Work"authority whereby he can suspend any quality related activity or process that may, in his opinion, adversely affect public safety, thesafe decommissioning of BRP, or safe fuel storage operations. Whena Stop Work Order that would result in suspension of in-processactivities related to spent fuel transfer operations or storage operationsis given, the persons responsible for the operation in question shall ensure stored fuel is in a safe condition before stopping work.(12)The Quality Assurance Lead has no other duties or responsibilities thatwould prevent his attention to Quality Program matters, is sufficientlyfree from schedule and cost pressures to give appropriate weight to quality considerations in his decisions and recommendations, and hasdirect access to high enough levels of Management to obtainresolution of quality problems.d. Responsibilities of the Environmental and Laboratory Services DepartmentThe Manager, Environmental and Laboratory (E&LS) is responsible for:
(1) Maintaining the Company's Echelon II calibration facility for calibratingreference and secondary standards and general usage portable andlaboratory measuring and test equipment.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 9 Date: 11/12/2003(2) Controlling the calibration recall system for Portable and Laboratory(PL) - Measuring and Test Equipment (M&TE) owned by E&LS, andother departments, as requested.(3) Maintaining a Master PL-M&TE List for E&LS PL-M&TE and for otherdepartments, as requested.(4) Providing a PL-M&TE Inventory List for the ISFSI.
(5) Preparing, reviewing, approving and obtaining additional reviews andapprovals if required, of purchase requests for services, equipmentand consumables, and submitting such requests to purchasing forprocurement action.(6) Conducting performance tests on materials, equipment and systemswhen requested.(7) Performing nondestructive examination, and controlling/maintainingNon-Destructive Examination (NDE) equipment.(8) Providing qualified NDE procedures and equipment and NDEpersonnel.(9) Providing chemical and metallurgical analytical services.
(10) Providing necessary corrective action processing and status reportingfor assigned corrective action documents.e.Responsibility for Attaining Quality Objectives Outside Nuclear, Fossil, andHydro OperationsCertain functions that constitute part of the Nuclear Quality Program maybe performed by Consumers Energy organizational units outside theNuclear, Fossil and Hydro Operations Department. However, when off-siteorganizations perform quality activities in support of Big Rock Point, they doso under the provisions of this Quality Program Description, and theactivities or services performed are subject to acceptance by the Site General Manager or designate.
.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 10 Date: 11/12/2003Figure 1 - Consumers Energy Organization for Big Rock Point Quality ProgramChairman and CEO - CMS Energy andChairman Consumers EnergyPresident and Chief ExecutiveOfficer, ElectricSenior Vice PresidentNuclear, Fossil, and HydroOperationsSiteGeneralManagerBig RockPointManagerEnvironmental andLaboratory ServicesIndependentSafetyReviewCommitteeQualityAssuranceLead QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 11 Date: 11/12/20032.0QUALITY PROGRAM2.1REQUIREMENTSPolicies that define and establish the Consumers Energy Quality Program forNuclear Power Plants (Part 1) - Big Rock Point Nuclear Plant are stated in theindividual sections of this document. The program is implemented throughprocedures and instructions responsive to provisions of the QPD and will becarried out for the life of BRP and its associated ISFSI. Plant/ISFSI life is definedas the period covered by a valid license under 10 CFR 50 and/or 10 CFR 72.Quality controls apply to activities affecting the quality of structures, systems andcomponents, to an extent based on the importance of those structures, systems,or components to safety. Such activities are performed under suitably controlledconditions, including the use of appropriate equipment, maintenance of properenvironmental conditions, assignment of qualified personnel and assurance thatall applicable prerequisites have been met.Quality Program status, scope, adequacy and compliance with 10 CFR 50,Appendix B, 10 CFR 71 Subpart H, and 10CFR 72 Subpart G are regularlyreviewed by Consumers Energy Management through reports, meetings andreview of audit results.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations2.2.321a, 21.b2.2.519a2.2.61, 19a, 21a, 21b2.2.92j, 4a, 5a, 5b, 6a, 7b, 10a, 11a, 12a, 12b, 12c, 12d, 13a, 17e2.2.102e, 2f2.2IMPLEMENTATION2.2.1The President and Chief Executive Officer, Electric, has stated in a formalSTATEMENT OF RESPONSIBILITY AND AUTHORITY, signed by him, that it iscorporate policy to comply with the provisions of applicable legislation andregulations pertaining to quality assurance as defined by 10 CFR 50, AppendixB, 10 CFR 71 Subpart H, and 10 CFR 72, Subpart G, as they apply to plantdecommissioning and operation of the ISFSI. The statement makes this QPDand the associated implementing procedures and instructions mandatory and requires compliance by all responsible organizations and individuals. It identifiesthe Management positions in the Company vested with responsibility andauthority for implementing the Quality Program and assuring its effectiveness.2.2.2The Quality Program at Consumers Energy consists of controls exercised byorganizations responsible for attaining quality objectives and by organizations QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 12 Date: 11/12/2003responsible for quality assessment functions (See Section 1.0,ORGANIZATION.)2.2.3The effective dates and applicability of this QPD are as follows:a.Effective Dates(1) For Big Rock Point, the QPD became effective on April 1, 1982, withfull implementation on January 1, 1983.(2) By letter dated February 1, 2002, the Nuclear RegulatoryCommission notified Consumers Energy Company that NRC hadapproved the Big Rock Point Plant Quality Assurance Program forRadioactive Material Packages. The NRC indicated that the QAProgram approval contained in their February 1, 2002 letter satisfiedthe approval requirements of 10 CFR 71.101(c).(3) In accordance with 10 CFR 72.4, the NRC Spent Fuel Project Officewas notified by letter dated February 17, 2000 of ConsumersEnergy's intent to apply this Quality program to the ISFSI and spentfuel storage cask activities as required by 10 CFR Part 72.140.(4) The Quality Program described in this Quality Program Descriptionis intended to apply for the life of BRP and its associated ISFSI.b. ApplicabilityBecause the Big Rock Point reactor will no longer be operated, and prior toimplementation of this revised QPD, fuel and high-level radioactive waste willbe stored only at the ISFSI, application of Quality Program requirements tothe in-plant structures, systems and components formerly associated witheither of these functions will no longer be required. Quality Program requirements will be applied to structures, systems and components at theISFSI that are defined in the Quality List as being required for safe storage ofspent nuclear fuel and high-level radioactive waste. Quality Programrequirements will also be applied to selected activities and programs definedin the Quality List as being required for decommissioning or operation of the ISFSI; for example, packaging and transportation of radioactive materials,and activities required to achieve compliance with 10 CFR 20.2.2.4This QPD, organized to present the Consumers Energy Quality Program forNuclear Power Plants (Part 1) in the order of the 18 criteria of 10 CFR 50,Appendix B, states Consumers Energy requirements for each of the criteria anddescribes how the controls pertinent to each are carried out. Any changes made to this QPD that do not reduce the commitments previously accepted by theNRC must be submitted to the NRC as specified by 10 CFR 50.71.e. Anychanges made to this QPD that do reduce the commitments previously acceptedby the NRC must be submitted to the NRC and receive NRC approval prior toimplementation in accordance with the requirements of 10 CFR 50.54(a)(4).
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 13 Date: 11/12/2003Appendix A to this QPD lists the ANSI Standards and Regulatory Guides towhich Consumers Energy commits. Appendix A also describes necessaryexceptions and clarifications to the requirements of those documents.The program described in this QPD will not be changed in any way that wouldprevent it from meeting the criteria of 10 CFR 50, Appendix B.2.2.5Documents used for implementing the provisions of the QPD include thefollowing:a.Administrative procedures specify the standard methods of accomplishingquality program activities. Because the Quality Program is an integral partof these activities, the methods for implementing Quality Program controlsare integrated into these documents.b.When Contractors perform work under their own quality assuranceprograms, these programs are reviewed for compliance with the requirements of 10 CFR 50, Appendix B, 10 CFR 71 Subpart H and10 CFR 72 Subpart G, as applicable; and the contract, and are approved byConsumers Energy prior to the start of work.c.Applicable elements of the Quality Program are applied to the emergency,security, and fire protection plans and radiation protection procedures fordecommissioning and ISFSI operation. These plans describe qualitycontrols applicable to associated equipment and activities.2.2.6Provisions of the Quality Program for Nuclear Power Plants (Part 1) apply toactivities affecting the quality of structures, systems, components and relatedconsumables that are within the scope of the program. Consumers Energyuses the following criteria in the selection of structures, systems, components,and activities to which the Quality Program is applied. Application of the QualityProgram assures that such structures, systems, components, and activities are monitored and controlled in a manner sufficient to provide reasonable assurancethat they are capable of fulfilling their intended functions.a.The Quality Program shall be applied to structures, systems, components,and activities selected based on evaluations that use quality classification criteria of the FuelSoultionsŽ Storage System Final Safety Analysis Reportand FuelSoultionsŽ W74 Canister Final Safety Analysis Report (SARs)(documents WSNF-220 and WSNF-223) to determine those items andactivities whose function is important to safe operation of the ISFSI. Theseitems and activities are commonly referred to as "Important to Safety."b. The Quality Program shall be applied to radiation protection requirementsthat are required to meet the Technical Specifications and applicableregulations.c.The Quality Program shall be applied to activities related to packaging andtransportation of radioactive material.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 14 Date: 11/12/2003Application of these criteria in performing an evaluation of an activity or an item'sfunction results in its classification and identification as being either subject ornot subject to the Quality Program. Identification may be via a "Q List",electronic database, or other controlled means. Identification is maintainedcurrent as conditions change. This information is available for inquiry by individuals involved in site activities. The extent to which controls specified inthe Quality Program are applied is determined for each item considering itsrelative importance to the above criteria. Such determinations are based oninformation in such documents as the Defueled Technical Specifications, DryFuel Storage Technical Specifications, the Updated Final Hazards Summary Report (UFHSR), and the Storage System and Canister SARs.2.2.7Activities affecting quality of items within the scope of this Program are accom-plished under controlled conditions. Preparations for such activities includeconfirmation that prerequisites have been met, such as:a.Assigned personnel are qualified.
b.Work has been planned to the proper revisions of applicable engineeringand/or technical specifications.c.Specified equipment and/or tools, if any, are on hand to be used.
d.Materials and items are in an acceptable status.
e.Systems, components, or structures on which work is to be performed arein the proper condition for the task.f.Authorized current instructions/procedures for the work are available for use.g.Items and facilities that could be damaged by the work have beenprotected, as required.h.Provisions have been made for special controls, processes, tests andverification methods.2.2.8Development, control, and use of computer programs affecting design andoperation of the ISFSI and activities important to quality are subject to qualityprogram design control.2.2.9Responsibility and authority for planning and implementing indoctrination andtraining are designated in Section 1.0, ORGANIZATION.a.The training and indoctrination program provides for ongoing training andperiodic refamiliarization with this QPD.b.Personnel who perform inspection and examination functions are qualifiedin accordance with requirements of Regulatory Guide 1.58, SNT TC-1A, or the ASME Code, or Section 10.2.3 of this QPD, as applicable.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 15 Date: 11/12/2003c.Personnel who lead audits are qualified in accordance with RegulatoryGuide 1.146. Others are either qualified to ANSI N45.2.23 or have detailedexpertise in the area being audited.d.Personnel assigned duties such as special cleaning processes, welding,etc, are qualified in accordance with applicable codes, standards andregulatory guides.e.The training/qualification program for personnel leading audits includesprovisions for retraining, reevaluation and recertification to ensure that proficiency is maintained.f.Training and qualification records including documentation of objectives,content of program, attendees and dates of attendance are maintained atleast as long as the personnel involved are performing activities to whichthe training/qualification is relevant.g.Personnel responsible for performing activities that affect quality areinstructed as to the requirements identified in applicable quality relatedmanuals, instructions and procedures.2.2.10Status and adequacy of the Quality Program are regularly assessed byConsumers Energy Management. The following activities constitute formal ele-ments of that assessment:a. Audit reports, including follow-up on corrective action accomplishment andeffectiveness, are distributed to appropriate levels of Management (see Section 18.0, AUDITS).b. The Independent Safety Review Committee assesses nuclear safetyperformance as described in Appendix C. Conclusions andrecommendations are reported to the Senior Vice President, NFHO.c. Corrective actions in response to recommendations are tracked in thecorrective action tracking system (see Section 16.0, CORRECTIVEACTION).
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 16 Date: 11/12/20033.0DESIGN CONTROL3.1REQUIREMENTSModifications to structures, systems and components to which this Programapplies according to Section 2.0, QUALITY PROGRAM, are accomplished inaccordance with approved designs. Activities to develop such designs arecontrolled. Depending on the type of modification, these activities includedesign and field engineering; the performance of physics, seismic, stress,thermal, hydraulic, and radiation analyses; UFHSR and Storage System and Canister SAR accident analyses; the development and control of associatedcomputer programs; studies of material compatibility; accessibility for inspectionand maintenance; and determination of quality standards. The controls apply topreparation and review of design documents, including the correct translation ofapplicable regulatory requirements and design bases into design, procurementand procedural documents.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations3.19a, 13b3.2.915a3.2.1013d3.2IMPLEMENTATION3.2.1Authority and responsibility for modification activities are described in Section1.0, ORGANIZATION. This authority and responsibility includes the preparation,review, approval and verification of the following design documents: a)Equipment descriptions in the Storage System and Canister SARs; b) Designinput and criteria; c) Drawings and specifications; and d) Engineering analyses and associated computer programs.3.2.2Errors and deficiencies in approved design documents or in design methods(such as computer codes) that could adversely affect structures, systems andcomponents are documented. Action is taken to assure that the errors and deficiencies are corrected.3.2.3Materials, parts and processes that are essential to functions that are importantto safety are selected and specified, based on the requirements of applicablecodes and standards or on known, successful use under similar conditions. Thisincludes standard commercial materials, parts and processes. Alternatively,materials, parts and processes may be qualified for use through qualification testing (see Item 3.2.8). The adequacy of the selected materials, parts andprocesses is assured through the required design verifications or approvals.3.2.4Exceptions and waivers to or deviations from the engineering (quality) standards(i.e., the required dimensions, material properties, features and other characteristics specified for modifications) are required by procedure and bycontract, when applicable, to be documented and controlled. (See, also, Section QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 17 Date: 11/12/200315 concerning the approval of "repair" or "use as is" dispositions ofnonconformances.) 3.2.5When modifications involve design interfaces between internal or externaldesign organizations or across technical disciplines, these interfaces are controlled. Procedures are used for the review, approval, release, distributionand revision of documents involving design interfaces to ensure that structures,systems and components are compatible geometrically, functionally and withprocesses and environment. Lines of communication are established forcontrolling the flow of needed design information across design interfaces, including changes to the information as work progresses. Decisions andproblem resolutions involving design interfaces are made by the ConsumersEnergy organization having responsibility for engineering direction of the designeffort.3.2.6Checks are performed and documented to verify the dimensional accuracy andcompleteness of design drawings and specifications (i.e., the products of a design process).3.2.7Modification design document packages are reviewed to assure that thedocuments that they contain have been prepared, verified, reviewed andapproved in accordance with Company procedures and that they contain the necessary quality requirements. These requirements include the inspection andtest requirements, quantitative and/or qualitative acceptance criteria and therequirements for documenting inspection and test results.3.2.8The extent of and methods for design verification are documented. The extentof design verification performed is a function of the importance of the item tosafety, design complexity, degree of standardization, the state-of-the-art andsimilarity with previously proven designs. Methods for design verification includeevaluation of the applicability of standardized or previously proven designs,alternate calculations, qualification testing and design reviews. These methods may be used singly or in combination, depending on the needs for the designunder consideration.When design verification is done by evaluating standardized or previouslyproven designs, the applicability of such designs is confirmed. Any differences from the proven design are documented and evaluated for the intendedapplication.Qualification testing of prototypes, components or features is used when theability of an item to perform an essential function that is important to safetycannot otherwise be adequately substantiated. This testing is performed beforeplant equipment installation where possible, but always before reliance upon the item to perform a function that is important to safety. Qualification testing isperformed under conditions that simulate the most adverse design conditions,considering all relevant operating modes. Test requirements, procedures andresults are documented. Results are evaluated to assure that test requirementshave been satisfied. Modifications shown to be necessary through testing are made, and any necessary retesting or other verification is performed. Scaling QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 18 Date: 11/12/2003laws are established and verified, when applicable. Test configurations areclearly documented.Design reviews are performed by multi-organizational or interdisciplinary groupsor by single individuals. Criteria are established to determine when a formal group review is required and when review by an individual is sufficient.Unless otherwise stated, the verification of design addresses all informationconveyed by the design document. When the verification is limited to certainareas or features, the scope or extent and any limitations on the verification are documented.3.2.9Persons representing applicable technical disciplines are assigned to performdesign verifications. These persons are qualified by appropriate education orexperience but are not directly responsible for the design. The designer'simmediate supervisor may perform the verification, provided that:a. He is the only technically qualified individual available, andb. He has not specified a singular design approach, ruled out certain designconsiderations or established the design inputs for the particular designaspect being verified, andc. His review is either:(1) Approved in advance by the supervisor's management, withdocumentation of the approval included in the design package, or(2) Controlled by a procedure that provides specific limitationsregarding the types of design work that may or may not be verifiedby a designer's supervisor, and shall provide for cleardocumentation that the supervisor performed the design verification.Independent audits by the Quality Assurance Organization cover the frequency,effectiveness, and technical adequacy of the use of supervisors as designverifiers to guard against abuse.3.2.10When designs must be released for use before they have been fully completedor before they have been verified, the incomplete or unverified parts of thedesign and the hold point to which work may proceed are identified. This holdpoint occurs before the work becomes irreversible or before the item is relied onto perform a function that is important to safety. Justification for such earlyrelease is documented.3.2.11Computer codes used in design are appropriately documented, verified, certifiedfor use and controlled. Their use is specified.3.2.12Changes to design output documents, including field changes, are controlled ina manner commensurate with that used for the original design. Such changes are evaluated for impact. Those that affect fit, form, or function are reviewedand approved by the same, or equivalent, organizations that approved the QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 19 Date: 11/12/2003original design. Information on approved changes is transmitted to all affectedorganizations.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 20 Date: 11/12/20034.0PROCUREMENT DOCUMENT CONTROL4.1REQUIREMENTSProcurement documents for structures, systems, components and services towhich this Program applies according to Section 2.0, QUALITY PROGRAM,define the characteristics of item(s) to be procured, identify requirements ofapplicable regulatory and industry codes and standards and specify supplierquality assurance program requirements to the extent necessary to assureadequate quality.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations4.2.117c, 17d4.2.32l, 17a, 17b 4.2.517d4.2IMPLEMENTATION 4.2.1Responsibilities and authorities for procurement planning and for preparation,review and approval of procurement documents are described in Section 1.0,ORGANIZATION.Procurement request packages are reviewed and approved prior to submittal tothe Purchasing and Materials Department. Review includes verification that the necessary quality requirements are specified.Bids are evaluated by an individual or organization having appropriateknowledge related to the item or service being procured.4.2.2Supplier selection is described in Section 7.0, CONTROL OF PURCHASEDMATERIALS, EQUIPMENT, AND SERVICES.4.2.3The content of a procurement document varies according to the item or servicebeing purchased and its function. Provisions of this QPD are considered for application to suppliers. As applicable, procurement documents include:a.Scope of work to be performed.
b.Technical requirements, with applicable drawings, specifications, codes andstandards identified by title, document number, revision, and date.Required procedures, such as special process instructions, will be identified.c.Regulatory, administrative and reporting requirements.
d.Quality requirements appropriate to the complexity and scope of the work,including necessary tests and inspections.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 21 Date: 11/12/2003e.A requirement for a documented Quality Program, subject to ConsumersEnergy review and written concurrence prior to the start of work.f.A requirement for the supplier to invoke applicable quality requirements onsubtier suppliers.g.Provisions for access to supplier and subtier supplier facilities and recordsfor inspections, surveillances and audits.h.Identification of documentation to be provided by the supplier, identificationof documents to be compatible with the records system, the schedule ofsubmittals and identification of documents requiring Consumers Energyapproval.4.2.4Trained, qualified personnel perform and document reviews of procurementrequest packages to assure that:a.Quality requirements (see 4.2.3 of this Section) are correctly stated,inspectable, and controllable.b.Adequate acceptance and rejection criteria are included.c.The procurement documents have been prepared, reviewed, and approvedper Quality Program requirements.4.2.5Changes to the technical or quality requirements in procurement documents arecontrolled in a manner commensurate with that used for the original requirements. Those changes that could affect fit, form, function or assurance ofquality are reviewed and approved by the same, or equivalent, organizationsthat approved the original procurement request packages.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 22 Date: 11/12/20035.0INSTRUCTIONS, PROCEDURES AND DRAWINGS5.1REQUIREMENTSActivities affecting the quality of structures, systems and components to whichthis Program applies according to Section 2.0, QUALITY PROGRAM, areaccomplished using instructions, procedures and drawings appropriate to thecircumstances that include acceptance criteria for determining if an activity hasbeen satisfactorily completed.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations5.19a, 13b5.2, item 52r, 2s, 8a 5.2, item 106b5.2IMPLEMENTATIONThe authority and responsibility for performing activities affecting the quality ofstructures, systems and components are described in Section 1.0,ORGANIZATION. Management personnel assigned these responsibilitiesassure that the instructions, procedures, and drawings necessary to accomplishthe activity are prepared and implemented.Instructions, procedures and drawings incorporate (1) a description of theactivity to be accomplished and (2) appropriate quantitative acceptance criteria,such as tolerances and operating limits, and/or qualitative acceptance criteria,such as workmanship standards, sufficient to determine that the activity hasbeen satisfactorily accomplished.Temporary procedures may be issued to provide management instructions thathave short-term applicability. Temporary procedures include a designation ofthe time period during which they may be used.The procedures used by Consumers Energy to control its activities include thefollowing:1.Administrative Procedures.
2.Procedures as needed to describe operation of ISFSI equipment.3.Process monitoring procedures that provide for monitoring systemperformance and which, as appropriate, identify limits for significantprocess parameters.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 23 Date: 11/12/20034.Spent fuel management procedures that provide for activities such as:a.Fuel accountabilityb.Preparation of fuel for transportationc.Nuclear safety measures d.Fuel transfer operations 5.Maintenance procedures that provide for:a.Preparation for maintenance b.Performance of maintenancec.Post-maintenance and operability checks and testsd.Use of supporting maintenance documents 6.Radiation control procedures that provide for:a.Implementation of the radiation control program including theacquisition of radiation datab.Identification of equipment for performing radiation surveys c.Measurement, evaluation and assessment of radiation hazards7.Calibration and test procedures that provide for:a.Periodic calibration and testing of instrumentation and control systemsb.Calibration of portable measuring and test equipment used in activitiesaffecting safety8.Chemical-radiochemical control procedures that provide for activitiesincluding:a.Control of deleterious agents b.Control, treatment and management of radioactive wastesc.The control of radioactive calibration sources9.Emergency Plan Implementing Procedures 10.Inspection, test and examination procedures that identify:a.Objectives QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 24 Date: 11/12/2003b.Acceptance criteriac.Prerequisite and special conditionsd.Limiting conditionse.Test or inspection instructions
- f. Any required special equipment or calibration g.Hold and Witness points, as appropriate11.Modification procedures that provide for:a.Administrative control and technical support during ISFSI modificationsb.The basis for a consistent method of performing recurring engineering,construction and quality activitiesc.Control of the interfaces between Consumers Energy and its suppliersd.Control of onsite quality-related modification activities that assure theQuality Program is implemented and its effectiveness is assessed andreported12.Decommissioning procedures when needed to provide for controlleddismantlement of BRP and restoration of the plant site.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 25 Date: 11/12/20036.0DOCUMENT CONTROL6.1REQUIREMENTSDocuments controlling activities within the scope defined in Section 2.0,QUALITY PROGRAM, are issued and changed according to establishedprocedures. Documents such as instructions, procedures and drawings,including changes thereto, are reviewed for adequacy, approved for releaseprior to implementation by authorized personnel and are distributed and used atthe location where a prescribed activity is performed.Changes to controlled documents are reviewed and approved by the sameorganizations that performed the original review and approval or by otherqualified, responsible organizations specifically designated in accordance withthe procedures governing these documents.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations6.12h6.2.32h, 2s, 12b6.2IMPLEMENTATION 6.2.1The authority and responsibility for the control of documents are described inSection 1.0, ORGANIZATION.6.2.2Controls are established for approval, issue and change of documents in thefollowing categories:a.Design documents (e.g., calculations, drawings, specifications, analyses)including documents related to computer codesb.As-built drawings (record drawings) and related documentsc.Procurement documentsd.Instructions and procedures for activities such as fabrication, construction,modification, installation, inspection, test, ISFSI maintenance andoperation, and decommissioning which implement the Quality Program.e.UFHSR f.BNFL FuelSolutionsŽ Storage System and W74 Canister SARs, WSNF-220 and WSNF-223, and the associated Dry Fuel Storage ExceptionsDocument.g.Reports of nonconformances QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 26 Date: 11/12/2003h.Defueled Technical Specificationsi.Dry Fuel Storage Technical Specifications6.2.3The review, approval, issue and change of the above documents are controlledby:a.Establishment of criteria to ensure that adequate technical and qualityrequirements are incorporated.b.Identification of the organizations responsible for review, approval, issueand revision.c.Review of changes to documents by the organizations designated inaccordance with the procedure governing the review and approval ofspecific types of documents, including quality aspects.6.2.4Controlled documents are issued and distributed so that:a.The documents are available at the work location prior to commencingwork.b.Obsolete or superseded documents are removed from work areas andreplaced by applicable revisions in a timely manner.6.2.5Master lists or equivalent controls are used to identify the current revision ofinstructions, procedures, specifications, drawings and procurement documents.
When master lists are used they are updated and distributed to designatedpersonnel who are responsible for maintaining current copies of the lists.6.2.6Accurate as-built drawings (record drawings) and related documentation areprepared in a timely manner.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 27 Date: 11/12/20037.0CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES7.1REQUIREMENTSActivities that implement approved procurement requests for material,equipment and services used in systems, structures, and components to whichthis Program applies according to Section 2.0, QUALITY PROGRAM, arecontrolled to assure conformance with procurement document requirements.Controls include a system of supplier evaluation and selection, source inspection, examination and acceptance of items and documents upon delivery,and periodic assessment of supplier performance. Objective evidence of qualitythat demonstrates conformance with specified procurement documentrequirements is available prior to reliance on equipment, material or services.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations7.12i7.2.216d 7.2.37b, 17e7.2.52m, 7e, 17f7.2.62m, 9b, 13c, 13d, 17f7.2IMPLEMENTATION 7.2.1Authority and responsibility for implementing the controls outlined herein aredescribed in Section 1.0, ORGANIZATION.7.2.2Consumers Energy qualifies suppliers by performing a documented evaluationof their capability to provide items or services specified by procurementdocuments. To remain qualified, suppliers involved in active procurements areevaluated continuously and are audited triennially. If an audit is acquired froman external source, the audit is evaluated prior to its use.Supplier evaluation and triennial audits are not necessary when the items orservices supplied are all of the following:a.Relatively simple and standard in design, manufacture and test, and b.Adaptable to standard or automated inspections or tests of the end productto verify quality characteristics after delivery, andc.Such that receiving inspection does not require operations that couldadversely affect the integrity, function or cleanness of the item.In the above cases, source and/or receipt inspection provides the necessaryassurance of an acceptable item or service.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 28 Date: 11/12/20037.2.3Supplier activities that affect quality are verified in accordance with writtenprocedures. These procedures provide the method of verifying (such as audit,surveillance or inspection) and documenting that the characteristics orprocesses meet the requirements of the procurement document. Forcommercial "off-the-shelf" items where the requirements for a specific quality assurance program appropriate for nuclear applications cannot be imposed in apractical manner, source verification is used to provide adequate assurance ofacceptability unless the quality of the item can be adequately verified uponreceipt.7.2.4Spare and replacement parts are procured in such a manner that theirperformance and quality are at least equivalent to those of the parts that will bereplaced.a.Specifications and codes referenced in procurement documents for spareor replacement items are at least equivalent to those for the original itemsor to properly reviewed and approved revisions.b.Parts intended as spares or replacements for "off-the-shelf" items, or otheritems for which quality requirements were not originally specified, areevaluated for performance at least equivalent to the original.c.Where quality requirements for the original items cannot be determined,requirements and controls are established by evaluation performed byqualified individuals. The evaluation assures there is no adverse effect oninterfaces, interchangeability, safety, fit, form, function, or compliance withapplicable regulatory or code requirements. Evaluation results are documented.d.Any additional or modified design criteria, imposed after previousprocurement of the item(s), are identified and incorporated.7.2.5Receipt inspections are performed to verify that items are undamaged andproperly identified, that they conform to procurement requirements notpreviously verified by source surveillance or inspection and that requiredsupplier furnished documentation is available. Items inspected are identified asto their acceptance status prior to their storage or release for installation.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 29 Date: 11/12/20037.2.6Suppliers are required to furnish the following records:a.Applicable drawings and related engineering documentation that identifythe purchased item and the specific procurement requirements (e.g., codes,standards, and specifications) met by the item.b.Documentation identifying any procurement requirements that have notbeen met.c.A description of those nonconformances from the procurementrequirements dispositioned "accept as is" or "repair."d.Quality records as specified in the procurement requirements.
The acceptability of these documents is evaluated during source and/or receiptinspection.7.2.7 Supplier's certificates of conformance are periodically evaluated by audits,independent inspections, or tests to assure that they are valid. The results ofthese evaluations are documented.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 30 Date: 11/12/20038.0IDENTIFICATION AND CONTROL OF ITEMS8.1REQUIREMENTSMaterials, parts and components (items) used in structures, systems, andcomponents to which this Program applies according to Section 2.0, QUALITYPROGRAM, are identified and controlled to prevent their inadvertent use.Identification of items is maintained either on the items, their storage areas orcontainers, or on records traceable to the items.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations8.2.27d, 7g8.2.37a8.2IMPLEMENTATION 8.2.1Controls are established that provide for the identification and control ofmaterials (including consumables), parts and components, (including partiallyfabricated assemblies). Authority and responsibility for the identification andcontrol of items are described in Section l.0, ORGANIZATION.8.2.2 Items are identified by physically marking the item, its storage area or itscontainer or by maintaining records traceable to the item. The method ofidentification is such that the quality of the item is not degraded.8.2.3Items are traceable to applicable drawings, specifications, or other pertinentdocuments to ensure that only correct and acceptable items are used.
Verification of traceability is performed and documented prior to release forfabrication, assembly, or installation.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 31 Date: 11/12/20039.0CONTROL OF SPECIAL PROCESSES9.1REQUIREMENTSSpecial processes affecting structures, systems, and components to which thisProgram applies according to Section 2.0, QUALITY PROGRAM, are controlledand are accomplished by qualified personnel using qualified procedures andequipment in accordance with applicable codes, standards, specifications,criteria, and other special requirements.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations9.2.16c, 13e9.2 IMPLEMENTATION9.2.1Processes subject to special process controls are those for which full verificationor characterization by direct inspection is impossible or impractical. Suchprocesses include welding, heat treating, chemical cleaning, application of protective coatings, concrete placement, and nondestructive examination.9.2.2Authority and responsibility for implementation of special processes and forqualification of procedures, personnel, and equipment used to perform specialprocesses are described in Section 1.0, ORGANIZATION.9.2.3Special process procedures are prepared by personnel with expertise in thediscipline involved. The procedures are reviewed for technical adequacy byother personnel with the necessary technical competence, and are qualified bytesting, as necessary.9.2.4Special process personnel qualification is determined by individuals authorizedto administer the pertinent examinations. Certification is based on examinationresults. Personnel qualification is kept current by performance of the specialprocess and/or reexamination at time intervals specified by applicable codes, specifications, and standards. Unsatisfactory performance or, where applicable,failure to perform within the designated time intervals requires recertification.9.2.5For special processes that require qualified equipment, such equipment isqualified in accordance with applicable codes, standards and specifications.9.2.6Qualification records are maintained in accordance with QPD Section 17.
9.2.7The Quality Assurance Organization assesses special process activities,including qualification activities to assure they are satisfactorily performed.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 32 Date: 11/12/200310.0INSPECTION10.1REQUIREMENTSActivities affecting the quality of structures, systems, and components to whichthis Program applies according to Section 2.0, QUALITY PROGRAM, areinspected to verify their conformance with requirements. Inspections areaccomplished by independent verification or process monitoring as necessary.Verification points are used as necessary to ensure that inspections are ac-complished at the correct points in the sequence of work activities.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations10.2.22p, 2q10.2.32j, 6a10.2.72j, 6a10.2.102j10.2IMPLEMENTATION 10.2.1Authority and responsibility for inspections are described in Section 1.0,ORGANIZATION.10.2.2Inspections are applied to procurement, maintenance, modification, testing, fueltransfer operations, and decommissioning to verify that items and activitiesconform to specified requirements. Work authorizing documents (e.g.;procedures, instructions, maintenance work orders) are reviewed in accordancewith established criteria to do the following as necessary:a.Determine the need for inspection(s).b.Identify the inspection organization or personnel.
c.Identify independent verification points.
d.Determine how and when the inspections are to be performed.
e.Specify measuring and test equipment of the necessary accuracy forperforming inspection.f.Provide for documentation of inspection results to provide adequateobjective evidence of acceptability.Independent verification is performed at each operation where it is necessary toverify conformance with requirements.Process monitoring is used in whole or in part where direct inspection alone isimpractical or inadequate.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 33 Date: 11/12/200310.2.3Training and qualification programs for personnel who perform inspections,including nondestructive examination, are established, implemented, anddocumented in accordance with Section 2.0, QUALITY PROGRAM, and onsiteor offsite procedures. These programs meet the requirements of applicable codes and standards. The Site General Manager is responsible for review andconcurrence with training and qualification programs that are under his directresponsibility.Training and qualification programs for Environmental and Laboratory Services(E&LS) personnel who perform inspections, including nondestructiveexamination, are documented in E&LS procedures.Qualifications and certifications of inspection and NDE personnel aremaintained.10.2.4Inspection requirements are specified in procedures, instructions, drawings orchecklists and are either provided or concurred with by the organization thatperforms the inspection planning. The procedures, instructions, drawings orchecklists provide for the following as appropriate:a.Identification of applicable revisions of required procedures, instructions,drawings and specifications.b.Identification of characteristics and activities to be inspected.
c.Inspection methods (independent verification or process monitoring).
d.Specification of measuring and test equipment having the necessaryaccuracy.e.Identification of personnel responsible for performing the inspection.
f.Acceptance criteria.
g.Recording of the inspection results and the identification of the inspector.10.2.5Independent verification points are designated when confirmation is needed thatcritical characteristics are acceptable before the work can be allowed to proceedfurther. Independent verifications are performed and work is released for furtherprocessing or use by assigned verification personnel. Independent verificationpoints may be waived only by the organization that performs the inspectionplanning.10.2.6Independent verifications are performed and documented in accordance with thewritten instructions provided. The results are evaluated by designated personnelin order to ensure that the results substantiate the acceptability of the item orwork. Evaluation and review results are documented.Independent verification should be designated when the activity/task beingverified is necessary to ensure critical characteristics are in conformance with QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 34 Date: 11/12/2003requirements and/or the verification is the result of codes, standards, regula-tions, or commitments.10.2.7Independent verification may be performed by individuals in the sameorganization as that which performed the work provided:a.Qualifications of the independent verifier are equal to or better than theminimum qualifications for persons who can be authorized to perform thetask; andb.The work is within the skills of Consumers Energy personnel and/or isaddressed by Consumers Energy procedures.c.If work involves breaching a pressure retaining item, the quality of the workcan be demonstrated through a functional test.When a, b, and c are not met, inspections will be carried out by individualscertified in accordance with ANSI N45.2.6.The verification is performed by individuals other than the person(s) performingor directly supervising the work.10.2.8For independent verification, when acceptance criteria are not met, correctedareas are to be reverified. Results of independent verification are documentedand retained for the purposes of performance trending and analysis.10.2.9The independent verifier has the authority to stop work if inspection criteria arenot met. Resolution of disagreements between the verifier and worker isresolved by site management.10.2.10Contractors may be used as independent verifiers in accordance with Section10.2.7 provided:a.The work is performed using procedures.
b.Individuals are trained and qualified in accordance with Section 10.2.3.Otherwise, contractors must be certified to ANSI N45.2.6 to perform inspections.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 35 Date: 11/12/200311.0TEST CONTROL11.1REQUIREMENTSTesting is performed in accordance with established programs to demonstratethat structures, systems, and components to which this Program appliesaccording to Section 2.0, QUALITY PROGRAM, will perform satisfactorily inservice. The testing is performed in accordance with written procedures thatincorporate specified requirements and acceptance criteria. The test programincludes qualification (as applicable), acceptance, surveillance, and maintenance tests. Test parameters, including any prerequisites,instrumentation requirements and environmental conditions are specified andmet. Test results are documented and evaluated.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations11.2.22k, 17g11.2IMPLEMENTATION 11.2.1Authority and responsibility for testing are described in Section 1.0,ORGANIZATION.11.2.2Tests are performed in accordance with programs, procedures, and criteria thatdesignate when tests are required and how they are to be performed. Suchtesting includes the following:a.Qualification tests, as applicable, to verify design adequacy in accordancewith Section 3.0, DESIGN CONTROL.b.Acceptance tests of equipment and components to assure their properoperation prior to delivery or to pre-operational tests.c.Surveillance tests to assure continuing proper and safe operation ofsystems and equipment.d.Maintenance tests after preventive or corrective maintenance.11.2.3Test procedures and instructions include provisions for the following, as applicable:a.The requirements and acceptance limits contained in applicable design andprocurement documents.b.Test prerequisites such as calibrated instrumentation, adequate testequipment, and instrumentation including accuracy requirements, completeness of the item to be tested, suitable and controlledenvironmental conditions, and provisions for data collection and storage.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 36 Date: 11/12/2003c.Instructions for performing the test.d.Mandatory inspection hold points for witness by the appropriate authority.e.Acceptance and rejection criteria.f.Methods of documenting or recording test data and results.
g.Assuring that test prerequisites have been met.
h.Verification of completion of modification activities.
Test procedures and instructions are reviewed for technical content and qualityaspects, by the site engineering organization, or an offsite technical supportorganization, as applicable.When acceptance criteria are not met, corrected areas are to be retested.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 37 Date: 11/12/200312.0CONTROL OF MEASURING AND TEST EQUIPMENT12.1REQUIREMENTSMeasuring and testing equipment used in activities affecting the quality ofstructures systems, and components to which this Program applies according toSection 2.0, QUALITY PROGRAM, are properly identified, controlled, calibrated,and adjusted at specified intervals to maintain accuracy within necessary limits.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations12.2.32o, 9c12.2.42o, 9c12.2.510c 12.2.810b12.2IMPLEMENTATION 12.2.1Authority and responsibility for the control of measuring and test equipment aredescribed in Section 1.0, ORGANIZATION.12.2.2Procedures are established for measuring and test equipment utilized in themeasurement, inspection and monitoring of structures, systems andcomponents. These procedures describe calibration technique and frequency and maintenance and control of the equipment.12.2.3Measuring and test equipment is uniquely identified and is traceable to itscalibration source.12.2.4Consumers Energy uses a system of labels to be attached to measuring andtest equipment to display the next calibration due date. Where labels cannot beattached, a control system is used that identifies to potential users anyequipment beyond the calibration due date.12.2.5Measuring and test equipment (M&TE) and installed instrumentation arecalibrated at specified intervals based on the required accuracy, purpose,degree of usage, stability characteristics, and other conditions affecting themeasurement.Calibration of M&TE is against standards that have an accuracy of at least fourtimes the required accuracy of the equipment being calibrated or, when this is not possible, have an accuracy that assures the equipment being calibrated willbe within required tolerance and the basis of acceptance is documented andauthorized by responsible management.Calibration standards used for installed instrumentation shall normally havegreater accuracy than the instrumentation being calibrated. Standards with thesame accuracy may be used when shown to be adequate for specific calibration QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 38 Date: 11/12/2003requirements. The basis for this acceptance is documented and is approved byresponsible management.12.2.6Calibrating standards have greater accuracy than standards being calibrated.Calibrating standards with the same accuracy may be used if it can be shown to be adequate for the requirements and the basis of acceptance is documentedand authorized by responsible management.12.2.7Reference and transfer standards are traceable to nationally recognizedstandards; where national standards do not exist, provisions are established to document the basis for calibration.12.2.8When measuring and testing equipment used for inspection and test is found tobe outside of required accuracy limits at the time of calibration, evaluations areconducted to determine the validity of the results obtained since the most recentcalibration. The results of evaluations are documented. Retests orreinspections are performed on suspect items.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 39 Date: 11/12/200313.0HANDLING, STORAGE AND SHIPPING13.1REQUIREMENTSActivities with the potential for causing contamination or deterioration that couldadversely affect the ability of an item (to which this Program applies according toSection 2.0, QUALITY PROGRAM) to perform its intended safety functions, andactivities necessary to prevent undetected or uncorrectable damage areidentified and controlled. These activities include cleaning, packaging,preserving, handling, shipping, and storing. Controls are effected through the use of appropriate procedures and instructions implemented by suitably trainedpersonnel.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations13.2.27a, 7d, 7f, 7g, 7h13.2IMPLEMENTATION13.2.1Authority and responsibility for material cleaning, handling, storing, packaging,preserving, and shipping activities are described in Section 1.0,ORGANIZATION.13.2.2Procedures are used to control the cleaning, handling, storing, packaging,preserving, and shipping of materials, components and systems in accordancewith design and procurement requirements. These procedures include, but arenot limited to, the following functions:a.Cleaning, to assure that required cleanliness levels are achieved andmaintained.b.Packaging and preservation, to provide adequate protection againstdamage or deterioration. When necessary, these procedures provide forspecial environments such as inert gas atmospheres, specific moisture content levels, and temperature levels.c.Handling, to preclude damage or safety hazards.
d.Storing, to minimize the possibility of loss, damage to or deterioration ofitems in storage, including consumables such as chemicals, reagents, andlubricants. Storage procedures also provide methods to assure that specified shelf lives are not exceeded.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 40 Date: 11/12/200314.0INSPECTION, TEST AND OPERATING STATUS14.1REQUIREMENTSOperating status of structures, systems, and components to which this Programapplies according to Section 2.0, QUALITY PROGRAM, is indicated by taggingof valves and switches, or by other specified means, in such a manner as toprevent inadvertent operation. The status of inspections and tests performed onindividual items is clearly indicated by markings and/or logging under strictprocedural controls to prevent inadvertent bypassing of such inspections and tests.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations14.12r14.2.52i14.2IMPLEMENTATION14.2.1Authority and responsibility for identifying inspection, test and operating statusare described in Section 1.0, ORGANIZATION.14.2.2For modification activities, including item fabrication, installation and test,procurement documents, service contracts, and procedures specify the degree of control required for the indication of inspection and test status of structures,systems, and components.14.2.3Application and removal of inspection and welding stamps and of such statusindicators as tags, markings, labels, etc, are controlled by procedures.14.2.4The sequence of inspections, tests and other operations important to safety arecontrolled by procedures. Changes in the approved sequence are subject to thesame review and approval as the original, or as specified in administrativeprocedures if the original organization no longer exists.14.2.5The status of nonconforming, inoperable or malfunctioning structures, systems,and components is clearly identified and documented to prevent inadvertent use.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 41 Date: 11/12/200315.0NONCONFORMING MATERIALS, PARTS OR COMPONENTS15.1REQUIREMENTSMaterials, parts, or components for structures, systems and components towhich this Program applies according to Section 2.0, QUALITY PROGRAM, thatdo not conform to requirements are controlled in order to prevent theirinadvertent use. Nonconforming items are identified, documented, segregatedwhen practical, and dispositioned. Affected organizations are notified ofnonconformancesThe following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations15.12i15.2IMPLEMENTATION 15.2.1Items, services, or activities that are deficient in characteristic, documentation, orprocedure that render the quality unacceptable or indeterminate, are identified as nonconforming and any further use is controlled. Nonconformances aredocumented and dispositioned, and notification is made to affectedorganizations. Personnel authorized to disposition, conditionally release, andclose out nonconformances are designated. The authority and responsibility forthe implementation of activities related to the processing and control of noncon-forming materials, parts, or components are described in Section 1.0,ORGANIZATION.a.Nonconforming items are identified by marking, tagging, or segregating orby documented administrative controls. Documentation describes the nonconformance, the disposition of the nonconformance and the inspectionrequirements. It also includes signature approval of the disposition.b.The original inspection planning authority reviews the disposition ofnonconformances, and documents concurrence with the acceptance, conditional release or repair of a nonconforming item.c.Items that have been repaired or reworked are inspected and tested inaccordance with the original inspection and test requirements oralternatives that have been documented as acceptable and concurred withby the original inspection planning authority.d.Items that have the disposition "repair" or "use as is" require documentationjustifying acceptability. Any changes made are recorded to denote the as-built condition.15.2.2Dispositions of conditionally released items are closed out before the items arerelied upon to perform functions that are important to safety.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 42 Date: 11/12/200315.2.3Prior to the initiation of preoperational testing on an item, all nonconformancesare corrected or dispositioned and evaluated for impact upon the item or thetesting program.15.2.4Nonconformance reports are analyzed to identify quality trends. Trend reports,which highlight significant results, are issued periodically to upper managementfor review and assessment.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 43 Date: 11/12/200316.0CORRECTIVE ACTION16.1REQUIREMENTSConditions adverse to quality of structures, systems, components, or activities towhich this Program applies according to Section 2.0, QUALITY PROGRAM,such as failures, malfunctions, deficiencies, deviations, defective material, andequipment and nonconformances, are identified promptly and corrected as soonas practical.For significant conditions adverse to quality, the cause of the condition isdetermined and corrective action is taken to preclude repetition. In these cases,the condition, cause and corrective action taken is documented and reported toappropriate levels of management for review and assessment.16.2IMPLEMENTATION16.2.1The responsibility and authority for the control of corrective action are describedin Section 1.0, ORGANIZATION.16.2.2Controls are established to assure that conditions adverse to quality areidentified and documented and that appropriate remedial action is taken.16.2.3For significant conditions adverse to quality, necessary corrective action ispromptly determined and recorded. Corrective action includes determining thecause and extent of the condition, and taking appropriate action to precludesimilar problems in the future. The controls also assure that corrective action is implemented in a timely manner.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 44 Date: 11/12/200317.0QUALITY RECORDS17.1REQUIREMENTSRecords that furnish evidence of activities affecting the quality of structures,systems and components to which this Program applies according to Section2.0, QUALITY PROGRAM, are maintained. They are accurate, complete andlegible and are protected against damage, deterioration or loss. They areidentifiable and retrievable.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations17.114b17.2.514c 17.2.814a, 14c17.2IMPLEMENTATION 17.2.1Authority and responsibility for the identification and control of Quality recordsare described in Section 1.0, ORGANIZATION.17.2.2Documents that furnish evidence of activities affecting quality are generated andcontrolled in accordance with the procedures that govern those activities. Uponcompletion, these documents are considered records. These records include:a.Results of reviews, inspections, surveillances, tests, audits, and materialanalysesb.Qualification of personnel, procedures, and equipment c.Operating and decommissioning logs d.Maintenance and modification procedures and related inspection resultse.Reportable occurrencesf.Records required by Appendix E of this QPD g.Nonconformance reports h.Corrective action reports i.Other documentation such as drawings, specifications, procurementdocuments, calibration procedures, and reports QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 45 Date: 11/12/200317.2.3Inspection and test records contain the following where applicable:a.A description of the type of observation b.The date and results of the inspection or test c.Information related to conditions adverse to quality d.Inspector or data recorder identificatione.Evidence as to the acceptability of the resultsf.Action taken to resolve any discrepancies noted17.2.4When a document becomes a record, it is designated as permanent ornonpermanent and then transmitted to file. Nonpermanent records havespecified retention times. Permanent records are maintained for the life of the item. Appendix E identifies retention periods for certain specific records.17.2.5Temporary storage of completed documents during processing to becomerecords is in rated fire-resistant file cabinets.17.2.6Only authorized personnel may issue corrections or supplements to records.17.2.7Traceability between the record and the item or activity to which it applies isprovided.17.2.8Records are stored in remote, dual facilities to prevent damage, deterioration, orloss due to natural or unnatural causes. Records that can only be stored asoriginals, such as radiographs and some strip charts are retained in a four-hourfire-rated facility.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 46 Date: 11/12/200318.0AUDITS18.1REQUIREMENTSA comprehensive system of audits is carried out to provide independentassessment of performance and effectiveness of the Quality Program to achievenuclear safety, including those elements of the program implemented bysuppliers and contractors. Audits are performed in accordance with writtenprocedures or checklists by qualified personnel not having direct responsibility inthe areas audited. Audit results are documented and are reviewed by management. Follow-up action is taken where indicated.The following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/Interpretations18.2.23a, 3b, 3c, 16a, 16b18.2.316c18.2.92e18.2IMPLEMENTATION 18.2.1Responsibility and authority for the audit program are described in Section 1.0,ORGANIZATION.18.2.2Internal audits are performed in accordance with established schedules thatreflect the status and importance to safety of the activities being performed.Audits are conducted in accordance with frequencies stated in Appendix D,Audit Frequencies.18.2.3Audits of suppliers and contractors are scheduled based on the status andsafety importance of the activities being performed as well as performance of thesuppliers and contractors and are initiated early enough to assure effectivequality during design, procurement, manufacturing, construction, installation,inspection, and testing.18.2.4Principal contractors are required to audit their suppliers based on performanceand on a schedule based on the status and safety importance of the activitiesbeing performed. Such audits shall be initiated early enough to assure aneffective Quality Program on the part of their suppliers.18.2.5Regularly scheduled audits are supplemented by special audits when significantchanges are made in the Quality Program, when it is suspected that quality is in jeopardy or when an independent assessment of program effectiveness isconsidered necessary.18.2.6Audits include an objective evaluation of quality-related practices, procedures,instructions, activities and items, and review of documents and records to confirm that the Quality Program is effective and properly implemented.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 47 Date: 11/12/200318.2.7Audit procedures and the scope, plans, checklists, and results of individualaudits are documented.18.2.8Personnel selected for auditing assignments have experience or are giventraining commensurate with the needs of the audit and have no direct responsibilities in the areas audited.18.2.9Audit data are analyzed by the Quality Assurance Organization. The resultingaudit reports identify any quality deficiencies and assess the effectiveness of theQuality Program in the area audited. The reports are distributed to the responsible management of both the audited and auditing organizations.18.2.10Management of the audited organization identifies and takes appropriatecorrective action to correct observed deficiencies and to prevent recurrence ofany significant conditions adverse to quality. Follow-up for internal audits isperformed by the Quality Assurance Organization to ensure that appropriatecorrective action is taken and is effective. Such follow-up includes re-audits when necessary. For vendor audits, such follow-up shall be performed by theorganization performing the audit.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 48 Date: 11/12/2003APPENDIX A, PART 1REGULATORY GUIDE AND ANSI STANDARD COMMITMENTSThe Consumers Energy Quality Program complies with the regulatory position of theRegulatory Guides referenced in this appendix as modified by the exceptions stated inPart 2.1. Appendix B to 10 CFR, Part 50, Quality Assurance Criteria for Nuclear PowerPlants and Fuel Reprocessing Plants.2. 10 CFR 72, Subpart F - General Design Criteria.3. Regulatory Guide 1.8 - (9/80 Draft) - Personnel Qualification and Training -Endorses ANSI/ANS 3.1 - (12/79 Draft) (application limited as described in exceptions 4a and 5a of Appendix A, Part 2).4. Regulatory Guide 1.30 (Safety Guide 30) - (8/11/72) - Quality AssuranceRequirements for the Installation, Inspection, and Testing of Instrumentation andElectrical Equipment - Endorses ANSI N45.2.4.5. Regulatory Guide 1.33 - (2/78, Rev 2) - Quality Assurance Program Requirements(Operation) - Endorses ANSI N18.7 - 1976.6. Regulatory Guide 1.37 - (3/16/73) - Quality Assurance Requirements for Cleaningof Fluid Systems and Associated Components of Water-Cooled Nuclear PowerPlants - Endorses ANSI N45.2.1 - 1973.7. Regulatory Guide 1.38 - (5/77, Rev 2) - Quality Assurance Requirements forPackaging, Shipping, Receiving, Storage, and Handling of Items for water-Cooled Nuclear Power Plants - Endorses ANSI N45.2.2 - 1972.8. Regulatory Guide 1.39 - (9/77, Rev 2) - Housekeeping Requirements for water-Cooled Nuclear Power Plants - Endorses ANSI N45.2.3 - 1973.9. Regulatory Guide 1.58 - (9/80, Rev l) - Qualification of Nuclear Power PlantInspection, Examination, and Testing Personnel - Endorses N45.2.6 1978.10. Regulatory Guide 1.64 - (6/76, Rev 2) - Quality Assurance Requirements for theDesign Of Nuclear Power Plants - Endorses N45.2.11 - 1974.11. Regulatory Guide 1.74 - (2/74) - Quality Assurance Requirements Terms andDefinitions - Endorses ANSI N45.2.10 - 1973.12. Regulatory Guide 1.88 - (10/76, Rev 2) - Collection, Storage, and Maintenance ofNuclear Power Plant Quality Assurance Records - Endorses N45.2.9 - 1974.13. Regulatory Guide 1.94 - (4/76, Rev 1) - Quality Assurance Requirements forInstallation, Inspection, and Testing of Structural Concrete and Structural Steel QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 49 Date: 11/12/2003During the Construction Phase of Nuclear Power Plants -Endorses ANSI N45.2.5 -
1974Property "ANSI code" (as page type) with input value "ANSI N45.2.5 -</br></br>1974" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..14. Regulatory Guide 1.116 - (5/77) - Quality Assurance Requirements for Installation,Inspection, and Testing of Mechanical Equipment and Systems - Endorses ANSI N45.2.8 - 1975.15. Regulatory Guide 1.123 - (7/77, Rev 1) - Quality Assurance Requirements forControl of Procurement of Items and Services for Nuclear Power Plants - EndorsesN45.2.13 - 1976.16. Regulatory Guide 1.144 - (9/80, Rev l) - Auditing of Quality Assurance Programsfor Nuclear Power Plants - Endorses N45.2.12 - 1977.17. Regulatory Guide 1.146 - (8/80) - Qualification of Quality Assurance Program AuditPersonnel for Nuclear Power Plants - Endorses N45.2.23 -1978.18. ANSI/ANS 3.1-1987, Selection, Qualification, and Training of Personnel for NuclearPower Plants (application limited as described in Appendix C of this document).
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 50 Date: 11/12/2003APPENDIX A, PART 2CONSUMERS ENERGY EXCEPTIONS TO OPERATING PHASE STANDARDSAND REGULATORY GUIDES1.GeneralRequirementCertain Regulatory Guides invoke or imply Regulatory Guides and standards inaddition to the standard each primarily endorses.Certain ANSI Standards invoke or imply additional standards.
Exception/InterpretationThe Consumers Energy commitment refers to the Regulatory Guides and ANSIStandards specifically identified in Appendix A, Part 1. Additional RegulatoryGuides, ANSI Standards, and similar documents implied or referenced in thosespecifically identified are not part of this commitment.Imposition of these Regulatory Guides on Consumers Energy suppliers and subtiersuppliers will be on a case-by-case basis depending upon the item or service to beprocured.2. N18.7 GeneralException/InterpretationAs permitted by 4.3.3 of ANSI N18.7, Consumers Energy has established anorganizational unit, the Independent Safety Review Committee, (ISRC) to performindependent review activities.The standard numeric and qualification requirements may not be met by the ISRC.Procedures will be established to specify how the ISRC will acquire necessaryexpertise to carry out its review responsibilities in accordance with Appendix C,Independent Safety Review Committee.2a.N18.7, Sec 3.4.2Requirement"The Plant Manager shall have overall responsibility for the execution of theadministrative controls and quality assurance program at the plant to assure safety."Exception/InterpretationSince Consumers Energy has more than one organization providing services toBRP/ISFSI, overall responsibility cannot be centralized in a single on-site position.Instead, responsibilities are as designated within the QPD.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 51 Date: 11/12/20032b.N18.7, Sec 4.3.1Requirement"Personnel assigned responsibility for independent reviews shall be specified in bothnumber and technical disciplines and shall collectively have the experience andcompetence required to review problems in the following areas:..."Exception/InterpretationThe ISRC will not have members specified by number or by technical disciplinesand its members may not have the experience and competence required to reviewproblems in all areas listed in this section; however, the ISRC will function as descri-bed in Appendix C, Independent Safety Review Committee, and will acquire theservices of personnel having such experience and competence as necessary.2c.N18.7, Sec 4.3.4Requirement"The following subjects shall be reviewed by the independent review body:"Exception/InterpretationSubjects requiring review will be as specified in Appendix C, Independent SafetyReview Committee.2d.N18.7, Sec 4.3.4(3)RequirementChanges in the Technical Specifications or license amendments relating to nuclearsafety are to be reviewed by the independent review body prior to implementation,except in those cases where the change is identical to a previously reviewedproposed change.Exception/InterpretationThe ISRC will not review Technical Specification Changes after NRC approval priorto implementation. The basis for this position is that all Technical Specificationchanges are reviewed prior to submittal to the NRC.2e.N18.7, Sec 4.5RequirementWritten reports of audits specified in ANSI N18.7 shall be reviewed by theindependent review body and by appropriate members of Management includingthose having responsibility in the area audited.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 52 Date: 11/12/2003Exception/InterpretationThe ISRC shall review or arrange for reviews of those audits over which it hascognizance, in accordance with Appendix C, Independent Safety ReviewCommittee.Some audits required during decommissioning and ISFSI operation are in areasother than those requiring independent review in accordance with ANSI N18.7,Section 4.3.4.2f.N18.7, Sec 4.5RequirementPeriodic review of the audit program shall be performed by the independent reviewbody or by a management representative at least semiannually to assure that auditsare being accomplished in accordance with requirements of technical specifications and of this standard.Exception/InterpretationAudits of nuclear facility activities are performed under the cognizance of the ISRCas described in Appendix C, Independent Safety Review Committee.2g.N18.7, Sec 5.2.1Requirement"The responsibilities and authorities of the plant operating personnel shall bedelineated."Exception/InterpretationOn-site personnel not directly associated with operating activities, as defined inANSI N18.7, Section 2.2, are not considered to be operating personnel.2h.N18.7, Sec 5.2.2Requirement"Temporary changes, which clearly do not change the intent of the approvedprocedure, shall as a minimum be approved by two members of the plant staffknowledgeable in the areas affected by the procedures. At least one of theseindividuals shall be the supervisor in charge of the shift and hold a senior operators license on the unit affected."Exception/InterpretationConsumers Energy considers that this requirement applies only to procedures iden-tified in Plant Technical Specifications and to Security Plan and Emergency Plan QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 53 Date: 11/12/2003implementing procedures. Temporary changes to these procedures may be madeprovided:a.The intent of the original procedure is not altered;b.The change is approved by an individual designated by the Site GeneralManager; andc.The change is documented, reviewed by a safety reviewer as described inAppendix B within 30 days of initial approval, and approved by the Site General Manager.2i.N18.7, Sec 5.2.6Requirement"In cases where required documentary evidence is not available, the associatedequipment or materials must be considered nonconforming in accordance withSection 5.2.14. Until suitable documentary evidence is available to show theequipment or material is in conformance, affected systems shall be considered to beinoperable and reliance shall not be placed on such systems to fulfill their intendedsafety functions."Exception/InterpretationConsumers Energy initiates appropriate corrective action when it is discovered thatdocumentary evidence does not exist for a test or inspection which is required to verify equipment acceptability. This action includes a technical evaluation of theequipment's operability status.2j.N18.7, Sec 5.2.7RequirementThe following standards contain useful guidance concerning design andconstruction-related activities associated with modifications and shall be applied tothose activities that are comparable in nature and extent to related activities occurring during initial plant design and construction: American National StandardInstallation, Inspection and Testing of Instrumentation and Electric EquipmentDuring the Construction of Nuclear Power Generation Station, N45.2.4-1972 (IEEE336-1972) [6]; American National Standard Supplementary Quality AssuranceRequirements for Installation, Inspection and Testing of Structural Concrete andStructural Steel During the Construction Phase of Nuclear Power Plants, N45.2.5-1974 [7]; American National Standard Qualifications of Inspection, Examination and Testing Personnel for the Construction Phase of Nuclear Power Plants N45.2.6-1973 [5]; American National Standard Supplementary Quality AssuranceRequirements for Installation, Inspection and Testing of Mechanical Equipment andSystems for Construction Phase of Nuclear Power Plants, N45.2.8-1975 [8];American National Standard Quality Assurance Requirements for the Design of Nuclear Power Plants, N45.2.11 1974 [9]; and American National Standard QualityAssurance for Protective Coating Applied to Nuclear Facilities N101.4-1972 [10].
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 54 Date: 11/12/2003Considerable care is required in assessing which operational phase activities arecomparable in nature and extent to activities normally associated with design andconstruction.Exception/ClarificationWork that is within the skills of Consumers Energy personnel and is covered byConsumers Energy procedures may be inspected by independent verifiers qualifiedin accordance with Section 10.2.3 and 10.2.7 and 10.2.10 of this QPD, rather thanANSI N45.2.6.2k.N18.7, Sec 5.2.8Requirement"A surveillance testing and inspection program...shall include the establishment of amaster surveillance schedule reflecting the status of all planned in-plant surveillance tests and inspections."Exception/InterpretationSeparate master schedules may exist for different programs such as storage caskinspection, Defueled Technical Specification surveillance requirements, and DryFuel Storage Technical Specification surveillance requirements.2l.N18.7, Sec 5.2.13.1Requirement"To the extent necessary, procurement documents shall require suppliers to providea quality assurance program consistent with the pertinent requirements of ANSIN45.2 - 1971."Exception/InterpretationTo the extent necessary, procurement documents require that the supplier have adocumented quality assurance program consistent with the pertinent requirements of ANSI N45.2 or other nationally recognized codes and standards.2m.N18.7, Sec 5.2.13.2RequirementANSI N18.7 and N45.2.13 specify that where required by code, regulation, orcontract, documentary evidence that items conform to procurement requirementsshall be available at the nuclear power plant site prior to installation or use of suchitems.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 55 Date: 11/12/2003Exception/InterpretationThe required documentary evidence is available at the site prior to use, but notnecessarily prior to installation. This allows installation to proceed while any missingdocuments are being obtained, but precludes dependence on the item for safetypurposes.2n.N18.7, Sec 5.2.15RequirementPlant procedures shall be reviewed by an individual knowledgeable in the areaaffected by the procedure no less frequently than every two years to determine ifchanges are necessary or desirable.Exception/InterpretationThe exception taken to this section of ANSI N18.7 has been deleted.2o.N18.7, Sec 5.2.16RequirementRecords shall be made and equipment suitably marked to indicate calibration status.Exception/InterpretationSee Item 9c.2p.N18.7, Sec 5.2.17RequirementFor modifications and non-routine maintenance, inspections shall be conducted in amanner similar (frequency, type, and personnel performing such inspections) to that associated with construction phase activities (see also Section 5.2.7)Exception/InterpretationMaintenance and modification activities that are within the skills of ConsumersEnergy maintenance personnel and are carried out using Consumers Energyprocedures may be inspected by independent verifiers qualified in accordance with Sections 10.2.3, 10.2.7, and 10.2.10 of this program description.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 56 Date: 11/12/20032q.N18.7, Sec 5.2.17RequirementIf mandatory inspection hold points are required, the specific hold points shall beindicated in appropriate documents. Information concerning inspection shall beobtained from the related design drawings, specifications, and/or other controlleddocuments.Exception/InterpretationConsumers Energy uses the terminology "independent verification point" asequivalent to a hold point.2r.N18.7, Sec 5.3.5(3)RequirementInstructions shall be included, or referenced (in maintenance procedures), forreturning the equipment to its normal operating status.Exception/InterpretationAt Consumers Energy, equipment is returned to its normal operating status, i.e.,declared operable, by qualified personnel. Verification of equipment operability willbe by line-up verification or appropriate functional testing, and will be documented.2s.N18.7, Sec 5.3.5(4)RequirementThis section requires that where sections of documents such as vendor manuals,operating and maintenance instructions, or drawings are incorporated directly or byreference into a maintenance procedure, they shall receive the same level of reviewand approval as operating procedures.Exception/InterpretationSuch documents are reviewed by appropriately qualified personnel prior to use toensure that, when used as instructions, they provide proper and adequateinformation to ensure the required quality of work. Maintenance procedures whichreference these documents receive the same level of review and approval asoperating procedures.2t.N18.7, Sec 3.4.2RequirementThis section requires that the onsite operating organization include individualsknowledgeable in nuclear power plant operation, nuclear power plant mechanical, QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 57 Date: 11/12/2003electrical and electronic systems, nuclear engineering, chemistry andradiochemistry, radiation protection, and quality assurance.Exception/InterpretationWhen needed to support ISFSI operations, Consumers Energy Company will retainor contract persons knowledgeable in ISFSI operations, ISFSI structural, andelectronic systems, nuclear engineering, radiation protection, and quality assurance.For ISFSI operations, chemistry and radiochemistry controls do not apply afterloaded casks have been placed on the ISFSI pad. There are no mechanical or electrical systems directly associated with dry fuel storage casks.2u.N18.7, Sec 5.1RequirementIf source documents are not compiled in one master document, a summarydocument shall be compiled to identify the sources, to index the source documentsto the requirements of ANSI N18.7 and to provide a consolidated base fordescription of the program.Exception/InterpretationAppendix A of this QPD is the compilation of source documents that apply to thetotal program for providing administrative controls and quality assurance duringdecommissioning and ISFSI operation.2v.N18.7, Sec 5.2.1Requirement5.2.1(1), (2) and (3) require identification of authority and responsibilities related toreactor shutdown, reactor trip or unexplained operation, and reactor restart.Exception/InterpretationBecause these reactor events are no longer possible at the Big Rock Point site, theauthority and responsibilities associated with these events will not be addressed insite procedures.2w.N18.7, Sec 5.3.4RequirementThis section (5.3.4.1 through 5.3.4.10) requires procedures for the integratedoperation of a plant.Exception/interpretationSome of the procedures, for example, those required by 5.3.4.1, 5.3.4.2 and 5.3.4.3,apply only to reactor operation and will not be developed for ISFSI operations. The QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 58 Date: 11/12/2003procedures required by 5.4.3.4 through 5.3.4.10 will be developed and will addressconditions applicable to ISFSI operation.2x.N18.7, Sec. 4.3.1Requirement"Personnel assigned responsibility for independent reviews shall-collectively havethe experience and competence required to review problems in the following areas:"(1)Nuclear power plant operations(2)Nuclear engineering(3)Chemistry and radiochemistry(4)Metallurgy(5)Nondestructive testing(6)Instrumentation and control(7)Radiological safety (8)Mechanical and electrical engineering(9)Administrative controls and quality assurance practices(10)Other appropriate fields associated with the unique characteristics of thenuclear power plant involved.Exception/interpretationPersonnel assigned responsibility for independent reviews shall collectively have thecompetence to identify problems in the areas specified. When competence toperform a thorough review of a problem area is identified, such competence will be made available to the independent review group.(1) Nuclear power plant operations no longer apply; in lieu of this item,competence to review ISFSI operations will be required.(2) In lieu of specifying "Nuclear Engineering", "Engineering" will be the requiredcompetency to have represented in ISRC membership. It is reasonable toexpect that the person representing the engineering competency will be ableto identify when competency in nuclear engineering is needed. Oneindividual may satisfy both the nuclear and metallurgical competencyrequirement.(3) There are no specifications for chemistry control or sampling in either the DryFuel Storage Technical Specifications or the Storage System or CanisterSARs, nor are there any chemically induced hazards identified in either SAR.As a result, there is no need to specify review competence in this discipline.(4) In lieu of specifying "Metallurgy", "Engineering" will be the requiredcompetency to have represented in the ISRC membership. It is reasonableto expect that the person representing the engineering competency will be able to identify when competency in metallurgy is needed. One individualmay satisfy both the nuclear and metallurgical competency requirement.(5) Nondestructive testing is not performed on casks, canisters or baskets afterthey have been placed on the ISFSI pad. Therefore, there is no need tospecify review competence in this discipline.(6) Instrumentation for the cask storage system consists of temperaturemonitoring, which has been classified as "Not Important to Safety" in the QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 59 Date: 11/12/2003SAR. The instrumentation is sufficiently simple in design as to not warrantreview expertise. There are no control systems associated with the fuelstorage casks. Therefore, there is no need to specify review competence inthis discipline.(7) No exception taken.
(8) There are no mechanical or electrical systems associated with the fuelstorage casks, therefore, competency in either of these disciplines will not berequired.(9) No exception taken.(10) Competence to review items related to the uniqueness of the Big Rock PointISFSI will be specified when the need for such competence is identified.3a.RG 1.33, Sec C4aRequirementThe results of actions taken to correct deficiencies that affect nuclear safety andoccur in facility equipment, structures, systems, or method of operation are to beaudited at least once per six months.Exception/InterpretationPerformance trends are reviewed by the ISRC. In addition, the corrective actionsystem is audited in accordance with Appendix D, Audit Frequencies.3b.RG 1.33, Sec C4bRequirementThe conformance of facility operations to provisions contained within the TechnicalSpecifications and applicable license conditions-at least once per 12 months.Exception/Interpretationa.Consistent with NRC Safety Evaluation, Amendment 106, for Millstone NuclearPower Station Unit 1 (ADAMS Accession Number ML993330283), and NRCTransmittal QA1-99-221 dated November 18, 1999 (ADAMS Accession Number ML993310022) and NRC Administrative Letter 95-06 dated December12, 1995, Consumers Energy interprets the commitment to audit TechnicalSpecification/license conditions contained in 18.2.2 of this QPD, and inAppendix D, Audit Frequencies, as follows:Consumers Energy maintains a matrix that identifies all applicable TechnicalSpecification line items to be audited. Prior to each audit, the matrix is reviewed and updated as required to conform to approved TechnicalSpecification changes. During each 24-month period, a selected sample of lineitems is audited.The items to be audited during each 24-month period are selected from thefollowing sections of the Defueled Technical Specifications and Dry FuelStorage Technical Specifications:
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 60 Date: 11/12/2003Defueled Technical Specifications: Limiting Conditions for Operation and Surveillance Requirements Administrative ControlsDry Fuel Storage Technical Specifications: Functional and Operating Limits Limiting Conditions for Operation and Surveillance Requirements Administrative Controlsb.The previously approved quality plan required that Technical Specificationaudits be scheduled so that all line items are covered within a maximum periodof five years. This interval was noted to be consistent with guidance presented in NRC letters dated March 29, 1983 (RLSpessard to JMTaylor) and January30, 1984 (JGPartlow to RLSpessard), and was accepted by the NRC in anNRC letter dated August 2, 1989 (Geoffrey C. Wright to David P. Hoffman).Audits are scheduled so that all line items are covered within a maximumperiod of 5 years. The audit period for any of the above elements may bereduced depending on Technical Specification compliance history.3c.RG 1.33, Sec C4cRequirementThe performance, training, and qualifications of the facility staff (should be audited)- - at least once per 12 months.Exception/InterpretationConsistent with NRC Safety Evaluation, Amendment 106, for Millstone NuclearPower Station Unit 1 (ADAMS Accession Number ML993330283), and NRCTransmittal QA1-99-221 dated November 18, 1999 (ADAMS Accession NumberML993310022) and NRC Administrative Letter 95-06 dated December 12, 1995,Consumers Energy interprets the commitment to audit performance, training, and qualifications of the facility staff contained in 18.2.2 of this QPD, and in AppendixD, Audit Frequencies, as once per 24 months.4a.ANS 3.1, GeneralException/InterpretationThe commitment to ANS 3.1 (12/79, draft) is limited to the requirements that applyto the training and qualification of persons performing independent quality assurance functions, except for Lead Auditors. Lead auditors are trained andqualified to Regulatory Guide 1.146 (8/80)/ANSI 45.2.23-1978. Other personnel QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 61 Date: 11/12/2003are trained and qualified as designated in the Defueled Technical Specificationsand the Dry Fuel Storage Technical Specifications.5a.RG 1.8, C.3.1, GeneralException/InterpretationThe commitment to Regulatory Guide 1.8 (9/80, draft) is limited to the requirementsthat apply to the training and qualification of persons performing independentquality assurance functions, except for Lead Auditors. Lead Auditors are trained and qualified to Regulatory Guide 1.146 (8/80)/ ANSI N45.2.23-1978. Otherpersonnel are trained and qualified as designated in the Defueled TechnicalSpecifications and the Dry Fuel Storage Technical Specifications.5b.RG 1.8, C1.2.2Requirement"When an individual is hired to temporarily function as a plant employee, such asfor contracted services, evidence of previous education, experience, and trainingshould be provided and reviewed by the appropriate professional-technical groupleaders. The appropriate group leaders should then determine the content for that individual's training, including plant-specific training. As a minimum, eachindividual should receive General Employee Training."Exception/InterpretationConsumers Energy understands that this requirement applies both to ConsumersEnergy employees from another site and to contract personnel who are temporarilyassigned to BRP either as replacements for regular employees or to augment thestaff. Consumers Energy employees so assigned possess the requiredqualifications as a prerequisite to the assignment and the review is waived. The qualifications of contract personnel are reviewed and arrangements made for anynecessary training. Temporarily assigned personnel requiring unescorted accessreceive the site general orientation as embodied in General Employee Training.6a.N45.2.1, Sec 2.4RequirementThose personnel who perform inspection, examination, or testing activities requiredby this standard shall be qualified in accordance with ANSI N45.2.6 Qualificationsof Inspection, Examination and Testing Personnel for the Construction Phase ofNuclear Power Plants.Exception/InterpretationConsumers Energy certifies its inspectors in accordance with Paragraphs 10.2.3,10.2.7 and 10.2.10 of this QPD unless the work is comparable in nature and extent to original construction (See Item 2j).
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 62 Date: 11/12/20036b.N45.2.1, Sec 3.1RequirementN45.2.1 establishes criteria for classifying items into "cleanness levels," andrequires that items be so classified.Exception/InterpretationInstead of using the cleanness level classification system of N45.2.1, the requiredcleanness for specific items and activities is addressed on a case-by-case basis.Cleanness is maintained, consistent with the work being performed, so as to preventthe introduction of foreign material. As a minimum, cleanness inspections areperformed prior to system closure. Such inspections are documented.6c.N45.2.1, Sec 5Requirement"Fitted and tack-welded joints (which will not be immediately sealed by welding)shall be wrapped with polyethylene or other non-halogenated plastic film until the welds can be completed."Exception/InterpretationConsumers Energy sometimes uses other non-halogenated material, compatiblewith the parent material, since plastic film is subject to damage and does not alwaysprovide adequate protection.7a.N45.2.2, GeneralRequirementN45.2.2 establishes requirements and criteria for classifying items subject to thisprogram into protection levels.Exception/InterpretationInstead of classifying items subject to this program into protection levels, controlsover the packaging, shipping, handling, and storage of such items are establishedon a case-by-case basis with due regard for the item's complexity, use, andsensitivity to damage. Prior to installation or use, the items are inspected andserviced as necessary to assure that no damage or deterioration exists which could affect their function.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 63 Date: 11/12/20037b.N45.2.2, Sec 2.4Requirement"...Offsite inspection, examination or testing shall be audited and monitored bypersonnel who are qualified in accordance with N45.2.6."Exception/InterpretationOffsite inspection, examination, or testing activities are audited or inspected bypersons qualified and certified in accordance with ANSI N45.2.23-1978, asendorsed by Regulatory Guide 1.146, or by personnel meeting the requirements ofparagraphs 10.2.3, 10.2.7 or 10.2.10. Monitoring activities not involving audit orinspection may be conducted by persons trained and qualified to effectively carryout such tasks, but not necessarily certified to either ANSI N45.2.23, N45.2.6 orParagraph 10.2.7.7c.This exception/interpretation no longer applies and has been deleted.7d.N45.2.2, Sec 3.9 and Appendix A 3.9Requirement"The item and the outside of containers shall be marked."
(Further criteria for marking and tagging are given in the appendix.)Exception/InterpretationThese requirements were originally written for items packaged and shipped toconstruction projects. Full compliance is not always necessary in the case of itemsshipped to operating plants and may, in some cases, increase the probability of damage to the item. The requirements are implemented to the extent necessary toassure traceability and integrity of the item.7e.N45.2.2, Sec 5.2.2Requirement"The inspections shall be performed in an area equivalent to the level of storage."
Exception/InterpretationReceiving inspection area environmental controls may be less stringent than storageenvironmental requirements for an item. However, such inspections are performedin a manner and in an environment that do not endanger the required quality of theitem.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 64 Date: 11/12/20037f.N45.2.2, Sec 6.2.4Requirement"The use or storage of food, drinks, and salt tablet dispensers in any storage areashall not be permitted."Exception/InterpretationPackaged food for emergency or extended overtime use may be stored in materialstock rooms. The packaging assures that materials are not contaminated. Food willnot be "used" in these areas.7g.N45.2.2, Sec 6.3.4Requirement"All items and their containers shall be plainly marked so that they are easilyidentified without excessive handling or unnecessary opening of crates and boxes."Exception/InterpretationSee N45.2.2, Section 3.9 (Exception 7d).7h.N45.2.2, Sec 6.4.1Requirement"Inspections and examinations shall be performed and documented on a periodicbasis to assure that the integrity of the item and its container...is being maintained."Exception/InterpretationThe requirement implies that all inspections and examinations of items in storageare to be performed on the same schedule. Instead, the inspections andexaminations are performed and documented in accordance with material storageprocedures that identify the characteristics to be inspected and include the required frequencies. These procedures are based on technical considerations thatrecognize that inspections and frequencies needed vary from item to item.8a.N45.2.3, Sec 2.lRequirementCleanness requirements for housekeeping activities shall be established on thebasis of five zone designations.Exception/InterpretationInstead of the five-level zone designation system referenced in ANSI N45.2.3,Consumers Energy bases its controls over housekeeping activities on a QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 65 Date: 11/12/2003consideration of what is necessary and appropriate for the activity involved. Thecontrols are effected through procedures or instructions which, in the case ofmaintenance or modifications work, are developed on a case-by-case basis.Factors considered in developing the procedures and instructions includecleanliness control, personnel safety, fire prevention and protection, radiation control, and security. The procedures and instructions make use of standardjanitorial and work practices to the extent possible. However, in preparing theseprocedures, consideration is also given to the recommendations of Section 2.l ofANSI N45.2.3.9a.N45.2.4, Sec 2.2RequirementSection 2.2 establishes prerequisites that must be met before the installation,inspection, and testing of instrumentation and electrical equipment may proceed.These prerequisites include personnel qualification, control of design, conforming and protected materials, and availability of specified documents.Exception/InterpretationDuring the decommissioning phase, this requirement is considered to be applicableto modifications and initial start-up of electrical equipment. For routine or periodicinspection and testing, the prerequisite conditions will be achieved as necessary.9b.N45.2.4, Sec 2.2(5)RequirementSection 2.2(5) of ANSI N45.2.4 lists documents that are to be available at theconstruction site.Exception/ClarificationAll of the documents listed are not necessarily required at the plant site forinstallation and testing. Consumers Energy assures that they are available to thesite as necessary.9c.N45.2.4, Sec 6.2.lRequirement"Items requiring calibration shall be tagged or labeled on completion, indicating dateof calibration and identity of person that performed the calibration."Exception/InterpretationIf the physical size or location of installed instrumentation prevents calibration labelsor tags from being affixed to the instrument, each instrument is uniquely identified and is traceable to its calibration record.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 66 Date: 11/12/2003A scheduled calibration program assures that each instrument's calibration iscurrent.10a.N45.2.5, Sec 2.4Requirement"Persons charged with engineering managerial responsibility of the inspection andtesting organization at the site in either a resident or non-resident capacity shall becertified for Level III capability."Exception/InterpretationThis standard (N45.2.5) was written for the construction phase of nuclear powerplants; as such, it presumes significant activity in the areas of concrete andstructural steel that do not generally occur at an Independent Spent Fuel StorageInstallation or decommissioning site. At Consumers Energy, persons having engineering managerial responsibility for inspections and tests 1 may be certified toLevel III, or may meet other qualification criteria established for the position,including, but not limited to, nuclear power and management experience. For majormodifications involving significant concrete or structural steel work, the services of aproperly qualified Level III individual will be obtained in at least an advisory capacity.10b.N45.2.5, Sec 2.5.2Requirement"When discrepancies, malfunctions, or inaccuracies in inspection and testingequipment are found during calibration, all items inspected with that equipmentsince the last previous calibration shall be considered unacceptable until anevaluation has been made by the responsible authority and appropriate actiontaken."Exception/InterpretationConsumers Energy uses the requirements of N18.7, Section 5.2.16, rather thanN45.2.5, Section 2.5 2. The N18.7 requirements are more applicable to ISFSI operation and a plant undergoing decommissioning.10c.N45.2.5, Sec 5.4Requirement"Hand torque wrenches used for inspection shall be controlled and must becalibrated at least weekly and more often if deemed necessary. Impact torquewrenches used for inspection must be calibrated at least twice daily."Exception/Interpretation
1Within the scope of N45.2.5.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 67 Date: 11/12/2003Torque wrenches are controlled as measuring and test equipment in accordancewith ANSI Nl8.7, Section 5.2.16. Calibration intervals are based on use andcalibration history rather than N45.2.5.11a.N45.2.6, Sec 1.2Requirement"The requirements of this standard apply to personnel who perform inspections,examinations, and tests during fabrication prior to and during receipt of items at the construction site, during construction, during preoperational and start-up testing, andduring operational phases of nuclear power plants."Exception/InterpretationSee Exception/Interpretation 2j for those inspectors who must be certified toANSI N45.2.6. Others are qualified to Paragraphs 10.2.3, 10.2.7 and 10.2.10 of this QPD.Qualification of plant personnel who are involved with testing associated with plantoperation is provided in specific plant specifications. In addition, personnelparticipating in inspection or testing who take data or make observations, where special training is not required to perform this function, need not be qualified inaccordance with ANSI N45.2.6 but need only be trained to the extent necessary toperform the assigned function.12a.RG 1.58. Sec C.1Requirement"However, for qualification of personnel (1) who approve preoperational, start-upand operational test procedures and test results and (2) who direct or supervise the conduct of individual preoperational, start-up and operational tests, the guidelinescontained in Regulatory Guide 1.8, Personnel Selection and Training, should befollowed in lieu of the Guidelines of ANSI N45.2.6 - 1978."Exception/InterpretationConsumers Energy endorses this position, as also stated in 11a, above, except thatoffsite support organizations involved in testing may apply ANSI N45.2.6. Some ofthese departments have already developed their qualification programs based onANSI N45.2.6, and provide services throughout decommissioning of BRP andoperation of the ISFSI.12b.RG 1.58, Sec C.5Requirement"In addition, the individual should be capable of reviewing and approving inspection,examination and testing procedures and of evaluating the adequacy of suchprocedures to accomplish the inspection, examination and test objectives."
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 68 Date: 11/12/2003Exception/InterpretationWhile a Level III individual should be capable of reviewing and approving inspection,examination and testing procedures and of evaluating the adequacy of such procedures to accomplish the inspection, examination and test objectives, this is notconstrued by Consumers Energy as requiring personnel who review, approve orevaluate such procedures to be certified as Level III personnel.12.c.RG 1.58, Sec C.6Requirement"Since only one set of recommendations is provided for the education andexperience of personnel, a commitment to comply with the regulatory position of thisguide in lieu of providing an alternative to the recommendations of the standardmeans that the specified education and experience recommendations of the standard will be followed."Exception/InterpretationThe content of the Consumers Energy qualification and certification program isbased upon the recommendations of ANSI N45.2.6, and satisfactory completion ofcapability testing is required prior to certification. Therefore, it is our position that acandidate should not be required to be a high school graduate or have earned theGED equivalent.12.dRG 1.58, Sec C.10Requirement"Use of the measures outlined in these actions to establish that an individual has therequired qualifications in lieu of required education and experience should result indocumented evidence (i.e., procedure and record of written test) demonstrating thatthe individual indeed does have comparable or equivalent competence to that whichwould be gained from having the required education and experience."Exception/InterpretationWe will maintain documented objective evidence that demonstrates that anindividual does have "comparable" or "equivalent" competence to that which wouldbe gained from having the required education and experience. However, this maytake the form of documentation other than "procedures and records of written test"such as documentation of oral tests and on-the-job performance demonstrations.13a.N45.2.8, Sec 2.7RequirementSection 2.7 requires that personnel performing inspection and test activities bequalified according to ANSI N45.2.6.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 69 Date: 11/12/2003Exception/InterpretationSee Exception/Interpretation 2j, 11a, and 12a. Test personnel who are part of theplant staff need not be certified to N45.2.6, provided they meet applicable qualification criteria of the Technical Specifications.13b.N45.2.8, Sec 2.9RequirementSection 2.9 establishes prerequisites that must be met before the installation,inspection and testing of mechanical equipment may proceed. These prerequisitesinclude personnel and procedure qualification, control of design, material selectionand fabrication, and availability of specified documents.Exception/InterpretationDuring the decommissioning phase, this requirement is considered to be applicableto modifications of mechanical equipment. For routine or periodic inspection andtesting, the prerequisites will be achieved as necessary.13c.N45.2.8, Sec 2.9eRequirementSection 2.9e of N45.2.8 lists documents relating to the specific stage of installationactivity which are to be available at the construction site.Exception/InterpretationAll of the documents listed are not necessarily required at the plant site forinstallation and testing. Consumers Energy assures that they are available to thesite as necessary.13d.N45.2.8, Sec 2.9eRequirementEvidence that engineering or design changes are documented and approved shallbe available at the construction site prior to installation.Exception/InterpretationEquipment may be installed before final approval of engineering or design changes.However, the system is not declared operable until such changes are documentedand approved.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 70 Date: 11/12/200313e.N45.2.8, Sec 4.5.1Requirement"Installed systems and components shall be cleaned, flushed, and conditionedaccording to requirements..." (Requirements are given for chemical conditioning,flushing and process controls.)Exception/InterpretationSystems and components are cleaned, flushed and conditioned as determined on acase-by-case basis. Measures are taken to help preclude the need for cleaning,flushing, and conditioning through good practices during maintenance ormodification activities.14a.N45.2.9, Sec 5.4, Item 2RequirementRecords shall not be stored loosely. They shall be firmly attached in binders orplaced in folders or envelopes for storage on shelving in containers. Steel cabinetsare preferred.Exception/InterpretationRecords are suitably stored in steel file cabinets or on shelving in containers.Methods other than binders, folders or envelopes (for example, dividers or electronic media) may be used to organize the records for storage.14b.N45.2.9, Sec 6.2Requirement"A list shall be maintained designating those personnel who shall have access to thefiles."Exception/InterpretationRules are established governing access to and control of files as provided for inANSI N45.2.9, Section 5.3, Item 5. These rules do not always include a requirementfor a list of personnel who are authorized access. It should be noted that duplicatefiles and/or microforms exist for general use and backup.14c.RG 1.88, C2Requirement"Two methods of protection of quality assurance records from the hazards of fire aredescribed in Subdivision 5.6 of ANSI N45.2.9-1974. NFPA No 232-1975...also contains provisions for records protection equipment and records handlingtechniques that provide protection from the hazards of fire. This standard, within its QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 71 Date: 11/12/2003scope of coverage, is considered by the NRC staff to provide an acceptablealternative to the fire protection provisions listed in Subdivision 5.6...When NFPA232-1975 is used, quality assurance records should be classified as NFPA Class 1records...."Exception/InterpretationConsumers Energy adheres to ANSI N45.2.9-1974, Subdivision 5.6 for the facilityfor permanent storage of non-duplicated records. Temporary storage of documentsafter completion and during processing as records is in file cabinets selected in accordance with provisions of NFPA 232-1975 for Class 1 records (usually NFPAClass C, 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> or UL-Class 350).15a.RG 1.64, C2Requirement"Regardless of their title, individuals performing design verification should not (1)have immediate supervisory responsibility for the individual performing thedesign...."Exception/InterpretationConsumers Energy follows the requirements of ANSI N45.2.11-1974, Section 6.1,and the guidance of Section 3E4(a) of the Standard Review Plan, with the exceptionthat use of supervisors as design verifiers may be controlled by a procedure insteadof individually approved in advance in each case (see Section 3.2.9, herein). This approach is necessary to allow small organizational units (having limited numbers oftechnically qualified staff, or having the only technically qualified staff available in theCompany) the flexibility needed to most effectively accomplish their assigned tasks.16a.RG 1.144, Sec C3a(1)RequirementThis section requires that for operational phase activities, RG 1.33 "QualityAssurance Program Requirements (Operations)" are to be followed. One of the RG 1.33 requirements is that the results of actions taken to correct deficiencies thataffect nuclear safety and occur in facility equipment, structures, systems, or methodof operation are to be audited at least once per six months.Exception/InterpretationSee Item 3a for the exception to this requirement.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 72 Date: 11/12/200316b.RG 1.144, Sec C3a(2)RequirementApplicable elements of an organization's quality assurance program (for "design andconstruction phase activities") should be audited at least annually or at least oncewithin the life of the activity, whichever is shorter.Exception/InterpretationSince most modifications are straightforward, they are not audited individually.Instead, selected controls over modifications are audited periodically.16c.RG 1.144, Sec C3b(1)RequirementThis section identifies procurement contracts that are exempted from being audited.
Exception/InterpretationIn addition to the exemptions of RG 1.144, Consumers Energy considers thatAuthorized Inspection Agencies, National Institute of Standards and Technology orother State and Federal Agencies which may provide services to Consumers Energyare not required to be audited.16d.RG 1.144, Sec C.3.b(2), second paragraphRequirementA documented evaluation of the supplier should be performed annually. Whereapplicable, this evaluation should take into account (1) review of supplier-furnished documents such as certificates of conformance, non-conformance notices, andcorrective actions, (2) results of previous source verifications, audits and receivinginspections, (3) operating experience of identical or similar products furnished by thesame supplier, and (4) results of audits from other sources (e.g., customer, ASME orNRC Audits).Exception/InterpretationConsumers Energy will review the information described in the second paragraph ofsection C.3.b(2) of Regulatory Guide 1.144, Revision 1, 1980, as it becomesavailable through the Company's ongoing receipt inspection, operating experience,and supplier evaluation programs, in lieu of performing a specific evaluation on an annual basis. The results of the reviews are promptly considered for effect on asupplier's continued qualification and adjustments made as necessary (includingcorrective actions, adjustments of supplier audit plans, and input to third partyauditing entities as warranted). In addition, results are reviewed periodically todetermine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 73 Date: 11/12/200317a.N45.2.13, Sec 3.2.2RequirementN45.2.13 requires that technical requirements be specified in procurementdocuments by reference to technical requirement documents. Technicalrequirement documents are to be prepared, reviewed and released under the requirements established by ANSI N45.2.11.Exception/InterpretationFor replacement parts and materials, Consumers Energy follows ANSI N18.7,Section 5.2.13, Subitem 1, which states: "Where the original item or part is found tobe commercially 'off the shelf' or without specifically identified QA requirements,spare and replacement parts may be similarly procured, but care shall be exercisedto ensure at least equivalent performance."17b.N45.2.13, Sec 3.2.3Requirement"Procurement documents shall require that the supplier have a documented qualityassurance program that implements portions of ANSI N45.2 as well as applicablequality assurance program requirements of other nationally recognized codes andstandards."Exception/InterpretationRefer to Item 2l.17c.N45.2.13, Sec 3.3(a)RequirementReviews of procurement documents shall be performed prior to release for bid andcontract award.Exception/InterpretationDocuments may be released for bid or contract award before completing thenecessary reviews. However, these reviews are completed before the item orservice is put into service or before work has progressed beyond the point where itwould be impractical to reverse the action taken.17d.N45.2.13, Sec 3.3(b)Requirement"Changes made in the procurement documents as a result of the bid evaluations orprecontract negotiations shall be incorporated into the procurement documents.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 74 Date: 11/12/2003The review of such changes and their effects shall be completed prior to contractaward."Exception/InterpretationThis requirement applies only to quality related changes (i.e., changes to theprocurement document provisions identified in ANSI N18.7, Section 5.2.13.l,Subitems 1 through 5.) The timing of reviews will be the same as for review of theoriginal procurement document.17e.N45.2.13, Sec 7.5Requirement"Personnel responsible for performing verification activities shall be qualified inaccordance with ANSI N45.2.6 as applicable."Exception/InterpretationConsumers Energy qualifies audit personnel according to N45.2.23. Thus,personnel performing source verification audits may not be certified according toN45.2.6. Personnel performing inspection as part of source verification will be certified to N45.2.6 or qualified in accordance with Paragraphs 10.2.3, 10.2.7, or10.2.10. However, personnel performing source surveillances may not be certifiedto any of those requirements.17f.N45.2.13, Sec 10.lRequirement"Where required by code, regulation or contract requirement, documentary evidencethat items conform to procurement documents shall be available at the nuclear power plant site prior to installation or use of such items, regardless of acceptancemethods."Exception/InterpretationRefer to Item 2m.17g.N45.2.13, Sec 10.3.4 (as modified by RG 1.123, C6e)Requirement"Post-installation test requirements and acceptance documentation shall be mutuallyestablished by the purchaser and supplier."Exception/InterpretationIn exercising its ultimate responsibility for its Quality Program, Consumers Energyestablishes post-installation test requirements, giving due consideration to supplierrecommendations.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 75 Date: 11/12/200318a.ANSI N45.2.23-1978, Section 2.3.4RequirementThe prospective lead auditor shall have participated in a minimum of five (5) qualityassurance audits within a period of time not to exceed three (3) years prior to thedate of qualification, one audit of which shall be a nuclear quality assurance auditwithin the year prior to his qualification.Exception/InterpretationThe prospective lead auditor shall demonstrate his ability to properly implement theaudit process defined by this Standard and Consumers Energy program/procedure,to effectively lead an audit team, and to effectively organize and report results,including participation in at least one nuclear quality assurance audit within the yearpreceding date of certification.19a.RG 1.26, GeneralRequirementRG 1.26 establishes a system for classifying pressure boundary items into fourquality groups, which are then correlated with ASME B&PV Code and ANSIStandards requirements.Exception/InterpretationRegulatory Guide 1.26 is not useful for determining the quality classification of ISFSIstructures, systems and components and will no longer be utilized for any qualityprogram activities at Big Rock Point. However, Table 2.1-1 of the Storage SystemSAR, WSNF-220, does provide quality classifications for dry fuel storage system structures, systems, components (SSCs), and support equipment. Some ISFSISSCs are not classified in Table 2.1-1, but are classified within individual sections ofWSNF-220. For example, the quality classification of the concrete ISFSI pad isprovided in Section 1.2 of WSNF-220. WSNF-223, W74 Canister SAR, alsoprovides quality classification information.WSNF-220 and WSNF-223 will be used as the basis for determining the qualityclassification of ISFSI structures, systems, components, and support equipment.20a.This exception/interpretation no longer applies and has been deleted 21a.RG 1.29, Sec C, Regulatory PositionRequirementThe Regulatory Position states that the identified structures, systems, andcomponents are to be designated Seismic Category 1 and should be designed to withstand the SSE.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 76 Date: 11/12/2003Exception/InterpretationRegulatory Guide 1.29 is not useful for determining seismic criteria to apply tostructures, systems and components at the ISFSI, and will no longer be used for thispurpose. The Storage System and Canister SARs, WSNF-220 and WSNF-223, respectively, provide the seismic criteria to which the dry fuel storage systemstructures, systems and components have been designed. These documents alsoshow compliance to regulatory requirements, such as those contained in10 CFR 72.102(f), and indicate the extent to which applicable regulatory guidancedocuments have been followed. As a result, the Storage System and Canister SARs will be used to identify applicable seismic design criteria.21b.RG 1.29, GeneralRequirementApply pertinent Quality Assurance requirements of 10 CFR 50, Appendix B.
Exception/InterpretationThe pertinent quality requirements for ISFSI systems, structures and componentswill be determined in a graded manner using documents such as the Dry Fuel Storage SARs and Technical Specifications, and other docketed analyses todetermine the degree to which Appendix B of 10 CFR 50 and Subpart G of10 CFR 72 apply.22.ANSI/ANS 3.1 - 1987Exception/InterpretationThe commitment to ANSI/ANS 3.1-1987 is limited to requirements that apply topersons performing the independent safety review function as specified in Appendix C to this QPD.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 77 Date: 11/12/2003APPENDIX BSAFETY REVIEWB1.FUNCTION Safety Reviewers shall function to advise the Site General Manager on all mattersimportant to nuclear safety.B2.COMPOSITIONThe Site General Manager shall assign Safety Reviewers in writing. SafetyReviewers shall be competent in the activity under review and shall not review theirown work.B3.QUALIFICATIONSSafety Reviewers shall be knowledgeable in the subject area being reviewed.B4.MEETING FREQUENCYMeetings are not required for performance of Safety Review functions described inthis appendix.B5.QUORUMSafety Reviews are to be performed by at least one Safety Reviewer.B6.RESPONSIBILITIESSafety Reviewers shall be responsible for nuclear safety review of:a.All procedures and programs specified by the Technical Specifications andchanges thereto, and any other procedures or changes thereto as determinedby the Site General Manager to affect nuclear safety; all proposed tests orexperiments that affect nuclear safety; and all proposed changes ormodifications to the ISFSI that affect nuclear safety.b.All proposed changes to Operating License, the ISFSI License, TechnicalSpecifications, and the Spent Fuel Storage System Certificate of Compliance.c.Results of investigations of all violations of the Technical Specifications. (Areport shall be prepared covering evaluation and recommendations to preventrecurrence and be forwarded to the Vice President, NFHO, the QualityAssurance Lead, and the ISRC).d.ISFSI operations to detect potential safety hazards.
e.Reports of special reviews and investigations as requested by the Site GeneralManager, the Quality Assurance Lead, or ISRC.f.Site Emergency Plan and implementing procedures.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 78 Date: 11/12/2003g.Reportable events defined by 10 CFR 50.72, 50.73, 71.95, 72.74, and 72.75h.Review of any accidental, unplanned or uncontrolled radioactive releaseincluding the preparation of reports covering evaluation, recommendations and disposition of the corrective action to prevent recurrence and the forwarding ofthese reports to the Site General Manager, the Quality Assurance Lead, andISRC.B7.AUTHORITYa.Safety Reviewers shall:1.Recommend in writing to the Site General Manager approval or disapprovalof items considered under B6.a, b and f.2.Render determinations in writing whether or not items considered underB6.a, b, and f require prior NRC approval; alternatively, if the Site GeneralManager meets the qualification requirements of B3, this determination maybe made by the Site General Manager prior to Site General Managerapproval of the item.b.The Site General Manager shall:1.Provide written notification within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the Senior Vice President,NFHO, the Quality Assurance Lead, and ISRC of any disagreementbetween the recommendation of a Safety Reviewer and the decision of the Site General Manager; however the Site General Manager shall haveauthority for resolution of such disagreements.B8.RECORDSWritten records of Safety Reviews shall be maintained; these records shall contain oridentify any documents reviewed, and shall be available for ISRC review.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 79 Date: 11/12/2003APPENDIX CINDEPENDENT SAFETY REVIEW COMMITTEEThe following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/InterpretationsC1.2, 2xC22, 22 C32, 2b, 22C4.12cC4.1(c)2dC4.1(g)2e, 2fC1.FUNCTIONThe Independent Safety Review Committee (ISRC) shall collectively havecompetence in the disciplines specified below, although the ISRC may obtainadditional expertise as provided for in C3.a.ISFSI operationsb.Packaging of spent nuclear fuel for transportationc.Engineeringd.Radiation protectione.Quality assurance and administrative controlsC2.COMPOSITIONThe ISRC shall report to the Senior Vice President, NFHO and shall consist of aChairman and members appointed by the Senior Vice President - NFHO. ISRCmembers shall meet or exceed the qualifications described in Section 4.7 of ANSI/ANS 3.1-1987. The ISRC members shall have no direct responsibility foractivities subject to their review.C3.SUPPORT PERSONNELIf sufficient expertise is not available within the ISRC to review particular issues, theISRC shall have the authority to utilize consultants or other qualified organizationsfor expert advice. Support personnel shall meet or exceed the qualificationsdescribed in Section 4.7 of ANSI/ANS 3.1-1987. Support personnel shall have nodirect responsibility for activities they review.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 80 Date: 11/12/2003C4.RESPONSIBILITIESC4.1Review RequirementsThe ISRC shall provide independent review of:a. Written 10 CFR 50.59 evaluations and Big Rock Point initiated 10 CFR 72.48written evaluations of changes in the facility as described in the Safety AnalysisReports, changes in procedures as described in the Safety Analysis Reports,and tests or experiments not described in the Safety Analysis Reports that have been performed without prior NRC approval under the provisions of10 CFR 50.59 or 10 CFR 72.48.This review, includes a review of a sample of the written 10 CFR 50.59,10 CFR 50.82 and 10 CFR 72.48 screening evaluations, to verify that none ofthe sample evaluations required evaluation under the provisions of 10 CFR50.59 or 10 CFR 72.48. This sampling verifies that the process for screening 10 CFR 50.59 and 10 CFR 72.48 evaluations is effective.ISRC shall review all 10 CFR 50.59 and Big Rock Point Plant initiated10 CFR 72.48 determinations that screen into the evaluation process.b.Activities that require prior NRC approval pursuant to 10 CFR 50.59 or 10 CFR72.48. Such reviews shall be performed prior to implementation of the changeto the facility, change to a procedure, or the test or experiment.c.Proposed changes to the Operating License or Defueled TechnicalSpecifications prior to the proposed change being submitted to the NRC.d.Violations, deviations and reportable events requiring written notification to theNRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or having nuclear safety significance, such as:(1)Violations of applicable codes, regulations, orders, TechnicalSpecifications, license requirements, Cask Storage System Certificate ofCompliance, or of internal procedures or instructions requiring writtennotification to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or having nuclear safetysignificance.(2)Significant operating abnormalities or deviations from normal andexpected performance of ISFSI equipment that affect nuclear safety.(3)Events requiring written notification to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or havingnuclear safety significance.e.Reports of audits performed as specified in Appendix D.f.Any other matter involving safe operation of the ISFSI that an ISRC memberdeems appropriate for consideration, or that is referred to the ISRC by theonsite operating organization or by the Quality Assurance Organization.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 81 Date: 11/12/2003C4.2Review Methodology and Meeting RequirementsISRC review of the subjects in C4.1 shall be performed by members or supportpersonnel selected on the basis of technical expertise relative to the subject beingreviewed. If the assigned reviewer determines the need for interdisciplinary review, a committee consisting of the ISRC Chairman, or his designate, and at least oneother ISRC member or qualified support personnel shall be assigned. Thecommittee shall meet as conditions requiring interdisciplinary review arise, but notless than annually.C5AUTHORITYThe ISRC shall report to and advise the Senior Vice-President, NFHO of significantfindings associated with the reviews specified in C4.1 and Appendix D, AuditFrequencies.C6RECORDSRecords of ISRC activities shall be maintained. Reports shall be prepared anddistributed as indicated below:a.The results of reviews performed pursuant to C4.1 shall be reported to theSenior Vice-President, NFHO, following each meeting of the ISRC. Significantfindings with respect to reviews performed in accordance with C4.1 shall bereported immediately to the Senior Vice-President, NFHO, with written follow-up not later than the following meeting report.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 82 Date: 11/12/2003APPENDIX DAUDIT FREQUENCIESThe following exceptions/interpretations in Appendix A, Part 2, are relevant toimplementation of the requirements of this section of the QPD:ParagraphExceptions/InterpretationsD1.3a, 3b, 3c, 16aD1.AUDITSAudits of decommissioning activities and ISFSI operations subject to this Programare performed by the Quality Assurance Organization under the cognizance of theISRC. These audits encompass:a.The conformance of plant operation to provisions contained within theTechnical Specifications, applicable license conditions, and the Spent FuelStorage Cask System Certificate of Compliance at least once per 24 months.b.The performance, training and qualifications of those members of the facilitystaff who perform quality activities defined in this QPD at least once per 24 months.c.The performance of activities required by the QPD for Nuclear Power Plants(CPC-2A) to meet the criteria of 10 CFR 50, Appendix B at least once per 24months.d.The Site Emergency Plan and implementing procedures:
(1)At intervals not to exceed 12 months or,(2)As necessary, based on an assessment by the Quality AssuranceOrganization against performance indicators, and as soon as reasonablypracticable after a change occurs in personnel, procedures, equipment, orfacilities that potentially could adversely affect emergency preparedness,but no longer than 12 months after the change. In any case, all elementsof the emergency preparedness program must be reviewed at least once every 24 months.e. The Site Security Plan and implementing procedures shall be audited atintervals specified in the Security Plan.f. Any other area of decommissioning or ISFSI operation considered appropriateby the Quality Assurance Organization or the Senior Vice President, NFHO.g.The plant Fire Protection Program and implementing procedures at least onceper 24 months.h.Radiological environmental monitoring program and the results thereof at leastonce per 24 months.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 83 Date: 11/12/2003i.The OFFSITE DOSE CALCULATION MANUAL and implementing proceduresat least once per 24 months.j.The PROCESS CONTROL PROGRAM and implementing procedures forprocessing and packaging of radioactive wastes at least once per 24 months.Audit reports encompassed by D1shall be forwarded to the Quality Assurance Leadand Management positions responsible for the areas audited within thirty (30) daysafter completion of the audit.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 84 Date: 11/12/2003APPENDIX ERECORD RETENTIONE1.In addition to the applicable record retention requirements of Title 10, Code ofFederal Regulations, the following records shall be retained for at least the minimumperiod indicated. Where 10CFR 72 or the Part 72 license conditions do not specifya retention period for a record, the records shall be retained until the NRCterminates the license.E2.The following records shall be retained for at least five years:a.Records and logs of facility operation covering time interval at each powerlevel.b.Records and logs of principal maintenance activities, inspections, repair andreplacement of principal items of equipment related to nuclear safety.c.All reportable events as defined in 10 CFR 50.72, 50.73, 72.74, and 72.75.
d.Records of surveillance activities, inspections and calibrations required byPlant Technical Specifications.e.Records of changes made to the procedures required by Plant TechnicalSpecifications.f.Records of radioactive shipments.
g.Records of sealed source leak tests and results.
h.Records of annual physical inventory of all source material of record.E3.The following records shall be retained for the duration of the Facility 10 CFR 50 orPart 72 License:a.Record and drawing changes reflecting facility design modifications made tosystems and equipment described in the BRP UFHSR.b.Records of new and irradiated fuel inventory, fuel transfers and assemblyburnup histories.c.Records of quarterly radiation exposure for all individuals entering radiationcontrol areas.d.Records of gaseous and liquid radioactive material released to the environs.e.Records of transient or operational cycles for those facility componentsdesigned for a limited number of transients or cycles.f.Records of in-service inspections performed pursuant to Plant TechnicalSpecifications.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 85 Date: 11/12/2003g.Records of Quality Assurance activities required by the QPD.h.Records of reviews performed for changes made to procedures or equipment,or reviews of tests and experiments pursuant to 10 CFR 50.59,10 CFR 50.82 and 72.48.i.Records of reviews performed by Safety Reviewers and the ISRC, according toAppendices B and C.j.Records of monthly facility radiation and contamination surveys.k.Records for environmental qualifications that are covered under the provisionsof 10 CFR 50.49.l.Records of training and qualifications for members of the plant staff.m.Records of reactor tests and experiments.n.Records of reviews performed for changes made to the OFFSITE DOSECALCULATION MANUAL and the PROCESS CONTROL PROGRAM.E4.The following records shall be retained as long as the associated material is storedand for a period of five years after the material is transferred out of the ISFSI:a.Records of receipt, inventory (including location), disposal, acquisition, andtransfer of all spent fuel and high level waste in storage.E5.The following records shall be retained until the NRC terminates the 10 CFR Part 72General License for the ISFSI:a.Records of the current inventory of all spent fuel and high-level waste.
- c. Current material control and accounting procedures.
- d. ISFSI and Cask Storage System records pertaining to the design, fabrication,erection, testing, maintenance, and use of structures systems and components important to safety.E6.The following records shall be retained and forwarded to the appropriate NRCRegional Office prior to the ISFSI General License termination:a.Records of spills or other unusual occurrences involving the spread ofcontamination in and around the facility, equipment or site. These records may be limited to instances when contamination remains after any clean-upprocedures or when there is a reasonable likelihood that contaminants mayhave spread to inaccessible areas as in the case of possible seepage intoporous materials such as concrete. The records must include any knowninformation on identification of involved nuclides, quantities, forms, and concentrations.
QUALITY PROGRAM DESCRIPTION FOR NUCLEAR POWER PLANTSPART 1 - BIG ROCK POINT NUCLEAR PLANTPage 86 Date: 11/12/2003b.As-built drawings and modifications of structures and equipment in restrictedareas where radioactive materials are used and/or stored, and of locations ofpossible inaccessible contamination such as buried pipes which may besubject to contamination. If required drawings are referenced, each relevantdocument need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available informationconcerning these areas and locations.c. A list contained in a single document and updated no less than every 2 years ofthe following:(1) All areas designated and formerly designated as restricted areas asdefined under 10 CFR 20.1003; and(2) All areas outside of restricted areas that require documentation under10 CFR 72.30(d)(1).d. Records of the cost estimate performed for the decommissioning funding plan orof the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.e. Records of the results of measurements and calculations used to evaluate therelease of radioactive effluents to the environment. This includes those recordsof the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment under the standards for protectionagainst radiation in effect prior to January 1, 1994.