ML18016A943
| ML18016A943 | |
| Person / Time | |
|---|---|
| Site: | Harris  |
| Issue date: | 07/07/1998 |
| From: | Hinnant C CAROLINA POWER & LIGHT CO. |
| To: | |
| Shared Package | |
| ML18016A936 | List: |
| References | |
| NGGM-PM-007, NGGM-PM-007-R01, NGGM-PM-7, NGGM-PM-7-R1, NUDOCS 9905050234 | |
| Download: ML18016A943 (115) | |
Text
CP&L NGG PROGRAM MANUAL
Title:
Quail Assurance Pro ram Manual Lead De artment: PERFORMANCE EVALUATION& REGULATORY AFFAIRS NGG Program Manual Revision Number: Effective Date:
Number:
Rev. 1 Ji lo, i998 NGGM-PM%007 Revision 1:
Sections 19.0 and 20.0 were combined into Section 19.0 to provide more detailed requirements in establishing the Graded Approach to Quality for Software. The procedures implementing the requirements of these Sections will become effective August 18, 1998, after training has been presented on the implementing procedures and the changes to the QA Program Manual. Therefore the changes to this manual will also have an effective date of August 18, 1998. In addition, Section 3.4.2 was revised to correct an error in performing design verification, and Enclosure 1, CP8 L Quality Assurance Program Policy, was added to ensure that the Quality Assurance Program Policy on the lntranet is appropriately controlled.
b/gp 4ECEIVED JUL 0 9 ~~~8
~ COpy Approved By:
Senior Vice Presi ent and Chief Nuclear Officer Date Rev. 1 Page 1 of 99 9905050234 9"70430 PDR ADOCK 05000400 P ', PDR
13.1 SCOPE 55 13.2 QUALIFICATIONS 56 13.3 REGULATORY COMMITMENTS ...... 56 13.4 GENERAL ~ ~ ~ ~ ~ ~ ~~~~~ ~o o \ ~ ~~ ~~ o 56 13.5 ADVERSE CONDITIONS ~ ~ ~ ~ ~ 56 13.6 REPORTS ...... ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ o ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 56 13.7 FOLLOW-UP ~~~~ ~ 57 14.0 QUALITYASSURANCE (QA) RECORDS AND DOCUMENT CONTROL ..........~....~... .. 57 ~
14.1 SCOPE.. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~ ~~~~~~ ~~ eo ~ 57 14.2 REGULATORY COMMITMENTS, ~ ~ ~ ~~~ ~ ~ ~ 57 14.3 QA RECORDS............ ~~~~~~~~~~~ 57 14.4 DOCUMENT CONTROL'....,.......................... ~ ~~~~~~~~~~~~~ 58 15.0 QUALITYASSURANCE (QA) PROGRAM FOR FIRE PROTECTION SYSTEMS.~........ 59 15.2 REGULATORY COMMITMENTS....~......................,...,.............~.....~.... .~..................... ~ 59 15.3 PROGRAM MANAGEMENTAND OBJECTIVES 59 15.4 DESIGN AND MODIFICATIONCONTROL AND DOCUMENTATION........................ 60 15.5 PROCEDURES AND DRAWINGS ~.........~....... ~ .~.................~.......~... 60 15.6 CONTROL OF PURCHASED MATERIALS, EQUIPMENT, AND SERVICES...~......... 60 15.7 FIRE PROTECTION SYSTEM TAGOUTS.~........~.................................,......~....~........ 61 15,8 CONDITIONS ADVERSE TO QUALITY(CATQ) ..... 62
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15.9 QUALITYCONTROL INSPECTIONS...................,......,....................................~.......... 62 15.10 FIRE PROTECTION INSPECTIONS..............,...........,...,........,.......,......................... 62 15.11 PREVENTIVE MAINTENANCE 62 15.12 TESTING .......................",. ~ ~ ~ ~ ~ ~~~~~~ ~~ ~ ~~ ~ ~ ~ ~~~ ~~ 62 1 5.13 ASSESSMENTS,. .~.............................
~ ~ . ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~ 63 1 5o 1 4 AUDITS ~~~~~~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ eo ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~ 63 15.15 RECORDS ...........,. ...63 15.16 MATERIALUPGRADING ............. 63 16.0 QUALITYASSURANCE (QA) PROGRAM FOR RADIOACTIVEWASTE MANAGEMENT SYSTEMS (HARRIS PLANT ONLY) 63 16.1 SCOPE......... 63 16.2 REGULATORY COMMITMENTS ............,............~.........,........... ~ ~........ 63 16e4 DESIGN 16.5 16.6 MATERIALCONTROL ...................,..............
AND PROCUREMENT ACTIVITIES............................................................. 63 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE) ................................ 64
~ . 64 16,7 PROCEDURES AND DRAWINGS ...........~...~...~...........,.................. 64 16.8 CORRECTIVE ACTION,...... .....64 16.9 RECORDS 64 17.0 IF-300, IRRADIATED FUEL SHIPPING CASK. .. ~ .65 17.1 SCOPE... ~ .. 65 17.2 REGULATORY COMMITMENTS 65 17.3 GENERAL .65 17.4 ORGANIZATION. ~ ~~ ~ ~~ 66 17.5 DESIGN CONTROL. ...66 NGGM-PM%007 Rev. 1 Page 4 of 99
17.6 PROCUREMENT DOCUMENT CONTROL .66 17.7 PROCEDURES AND DRAWINGS .66 17.8 DOCUMENT CONTROL...... .66 17.9 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 66 17.10 CONTROL OF SPECIAL PROCESSES .66 17.11 INSPECTIONS AND TEST CONTROL ..66 17.12 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE) ...................... 67 17.13 HANDLING, STORAGE, AND SHIPPING 67 17.14 INSPECTION, TEST, AND OPERATING STATUS . . . .... 67 ACTION......
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17.15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS ................ 67 17.16 CORRECTIVE 67 1 7.17 QA RECORDS ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~~~~~ 67 17.18 AUDITS/ASSESSMENTS 67 18.0 RADIOACTIVEMATERIALPACKAGES QUALITYASSURANCE (QA) PROGRAM ..... 67 18.1 SCOPE ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~~~~ ~~~ ~ ~ 67 18.2 REGULATORY COMMITMENTS 68 1 8.3 ORGANIZATION..........................,........... ~ ~ ~ ~ ~~ ~ ~ ~~~~~ ~ ~~~ ~ ~~~ ~ ~~ 68 18.4 DESIGN CONTROL...... ~ ~ ~ ~~~ ~~ ~~ ~ ~ ~ ~ ~~~ ~ ~ ~ oo ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~~~~~~~~~~~ 68 18.5 PROCUREMENT DOCUMENT CONTROL .....68 18.6 PROCEDURES AND DRAWINGS 68 18.7 DOCUMENT CONTROL......~................ ~ ....................... ~ ., .. 69 18.8 CONTROL OF PURCHASED MATERIALS, EQUIPMENT, AND SERVICES..........,.. 69 18.9 IDENTIFICATIONAND CONTROL OF MATERIALS, PARTS, AND COMPONENTS69 18.10 CONTROL OF SPECIAL PROCESSES . ... ........ ..... .. , 69
~ ~ ~ ~
18.11 INSPECTIONS ...,.........,.......~........ 69 18.12 TEST CONTROL,. ~ ..,...,....,...,..............,
18.13 CONTROL OF MEASURING AND TEST EQUIPMENT (M8cTE)
..~....
.................. 69 69 18.14 HANDLING, STORAGE, AND SHIPPING ...69 18.15 INSPECTION, TEST, AND OPERATING STATUS . ~................................ 69 18.16 CONDITIONS ADVERSE TO QUALITY(CATQ) AND CORRECTIVE ACTION ....... 70 18.17 QA RECORDS.......................... ~ ~ ~ ~~ 70 18.18 AUDITS/ASSESSMENTS ............................~..........~............ 70 19.0 COMPUTER SOFTWARE QUALITYASSURANCE (QA). ~ ~~ ~ ~ ~~ ~~~ ~ ~~~ ~~~ ~~ ~ ~~~ 70 1 9o1 SCOPE ~~ ~~~~~~ oo ~~~~~~~~~~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ os ~ ~ 70 19.2 REGULATORY COMMITMENTS ... ...71 19.3 RESPONSIBILITIES OF CAROLINA POWER 8 LIGHT (CP8 L) . 71 19.4 PROGRAM ......... ...71 20.0 NONSAFETY-RELATED COMPUTER SOFTWARE QUALITYASSURANCE........... . . 74 ~ ~
21.0 QUALITYASSURANCE (QA) PROGRAM REQUIREMENTS FOR QUALITYCLASS B ITEMS 74 21.1 SCOPE 74 21.2 REGULATORY COMMITMENTS 74 21.3 MANAGEMENTRESPONSIBILITIES 74 21.4 DESIGN ACTIVITIES 75 21.5 PROCUREMENT...... ~ ~~~ ~~~~~~~~~ 75 21.6 MATERIALCONTROL ....75 21.7 CONDITIONS ADVERSE TO QUALITY(CATQ). 75 NGGM-PM007 Rev. 1 Page 5 of 99
21.8 OPERATIONS CONTROL 75 21.9 CALIBRATIONCONTROL 75 21.10 MAINTENANCE ~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~ ~~ ~ ~~ 75 21.11 ASSESSMENTS/AUDITS. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 75 21.12 QA RECORDS ~ ~ ~ ~ ~ ~ ~ 75 22.0 QUALITYASSURANCE PROGRAM FOR NONSAFETY RELATED SYSTEMS AND EQUIPMENT USED TO MEET THE STATION BLACKOUT RULE ....76 2 2.1 SCOPE ~ ~~ ~~~~~~~~ \ ~ ~~ ~~~~ ~~ ~~ ~ ~ ~ ~~ ~~ ~ ~~ ~ ~ ~ o ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ o ~ ~ ~~o ~~~ ~~ ~ ~~ ~ ~ ~ 76 2P.2 REGULATORY COMMITMENTS.......................,..........................,................,....,., 76 22.3 PROGRAM MANAGEMENTAND OBJECTIVES..........~....,...~........,...~...~..... ...... . ~,., ~ ~ ~ 76 22,4 DESIGN CONTROL....~......................,......;......., ~...... ~ .,..... 76 22.5 INSTRUCTIONS, PROCEDURES AND DRAWINGS 76 22.6 PROCUREMENT DOCUMENT CONTROL AND CONTROL OF PURCHASED MATERIAL,EQUIPMENT, AND SERVICES.................,...,........................, 76 22.7 NONCONFORMING ITEMS AND CORRECTIVE ACTIONS (CONDITIONS ADVERSE T0 QUALITY) o~~~~~~~ ~ ~ ~~~ ~ ~ ~ ~ ~ ~~~~~~~~~~~~~~~~~~~ ~ ~ ~ ~~~~~~~~~~~~~~~~~~~~ ~ ~~~ ~~ ~ ~~ ~ ~ ~ ~ ~ ~ 77 2 2e8 INSPECTIONS ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~~ ~~ ~ 77 22.9 TESTING AND TEST CONTROL...................,............................~...... .,...,...... ~ .77 2 2.10 ASSESSMENTS ................................~............................................~.................... 78 22.11 RECORDS......~.... ~ 78 22.12 MATERIALUPGRADING ..........,.................................................~..................,....~..... 78 23.0 INTERPRETATIONS .............. ..... ., ~ ~ ...., 78 23.1 SCOPE ... .......
~ ~ ~ ~ ~ ~ 78 23,2 REGULATORY COMMITMENTS . 78 23.3 REQUIREMENTS. 78 23.4 CONTENTS ..79 23.5 LISTING OF INTERPRETATIONS ......... ~~ ~ ~~~ ~ ~ ~ ~~ ~ ~ ~~ ~~ ~ ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~~ ~~ ~ ~~~~~~~~~~~~ 79 ENCLOSURE 1 .. ~ .. ~ .~... ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~ ~ ~ ~ ~~ ~ ~ ~ ~~ 80 APPENDIX I ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ oo ~ ~ ~ ~ ~ eo ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~~~ ~ ~~~~ ~~~~~ ~~ ~ ~~ ~~~~~ ~~~~~~~~~~~~~~~~ 81 APPENDIX II 98 NGGM-PM%007 Rev. 1 Page 6 of 99
ACRONYMS NE - Architect-Engineer ANI - AUTHORIZED NUCLEAR INSERVICE INSPECTOR for ASME Code compliance activities and items at the site AIA - AUTHORIZED INSPECTION AGENCY for ASME Code compliance activities with which CP&L has contract for AUTHORIZED INSPECTOR coverage for each site ANSI - American National Standards Institute, Inc.
ASME - American Society of Mechanical Engineers ASTM - American Society of Testing & Material BNP - Brunswick Nuclear Plant BSEP - Brunswick Steam Electric Plant BWR - Boiling Water Reactor CMMS - Corporate Materials Management System CP&L - Carolina Power & Light Company 10CFR50- Title 10 (Atomic Energy), Code of Federal Regulations, Part 50, "Licensing of Production and Utilization Facilities."
ESR - Engineering Service Request FSAR - Final Safety Analysis Report HBRSEP - H. B. Robinson Steam Electric Plant, Unit 2 HNP - Harris Nuclear Plant INPO- Institute of Nuclear Power Operations M&TE - Measuring and test equipment NAS - Nuclear Assessment Section NIST-National Institute of Standards and Technology NDE - Nondestructive examination NED - Nuclear Engineering Department NGGM-PM%007 Rev. 1 Page 7 of 99
ACRONYMS NRC - Nuclear Regulatory Commission
~N-Stem - Official N-type symbol provided by the ASME and applied to plant items upon certification of compliance with applicable rules of the ASME Code OESD - Operations & Environmental Support Department PES - Performance Evaluation Support Unit PO- Purchase order PR - Purchase requisition PWR - Pressurized Water Reactor RFO - Released for operation RNP - Robinson Nuclear Plant SAR - Safety Analysis Report. The most recently updated collection of information pursuant to 10CFR50.34(b) and which the NRC uses to conclude that the facility may be operated without undue risk to the public health and safety, including, but not limited to, the following:
~ UFSAR and FSAR (HNP), including its text, figures, drawings, and approved changes which have not yet been incorporated,
~ Documents incorporated by reference including, but not limited to, the Emergency Plan, Security Plan, Operating License(s), Technical Specifications, and NRC Safety Evaluation Reports (SERs) (Documents merely listed as references are excluded),
and
~ Docketed correspondence related to 10CFR50.34.
SHNPP - Shearon Harris Nuclear Power Plant SNM - Special Nuclear Material SNT-TC-1A - Publications of the American Society for Nondestructive Testing which present recommended practices for qualifying and certifying personnel performing specific methods for nondestructive examination and evaluation of the examination results.
SSC - Structures, systems, and components UFSAR - Updated Final Safety Analysis Report NGGM-PM007 Rev. 1 Page 8 of 99
DEFINITIONS Certain terms are applied in the Carolina Power 8 Light Company (CP&L) Quality Assurance Program Manual (QAP Manual) with a special meaning or in a more restrictive sense than defined in a standard dictionary. The definitions listed are applicable to Nuclear Regulatory Commission (NRC) regulated activities and are generally used throughout the QAP Manual.
All items which are defined in this section will appear as boldface type throughout this manual.
ACCEPTANCE CRITERIA: A limit or limits placed on the variation permitted in the characteristics of an item expressed in definitive engineering terms such as dimensional tolerances, chemical composition limits, density and size of defects, temperature ranges, time limits, operating parameters, and other similar characteristics. (ANSI N45.2.8)
ACTIVE SAFETY-RELATED INSTRUMENT: A permanently installed instrument that has been determined to be safety-related because it provides some required signal/output in the event of an accident.
ACTIVITIES AFFECTING QUALITY:Activities that affect or reasonably could affect the safety related functions of nuclear plant structures, systems, components, and parts. Activities included are design changes, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling and modifying.
ALGORITHM COMPUTER: 1) A finite set of well-defined rules for the solution of a problem in a finite number of steps; for example, a complete specification of a sequence of arithmetic operations for evaluating sine x to a given precision. 2) Any sequence of operations for performing a specific task.
- ANNUALLY:Once per year, not to exceed 366 days.
APPROVED SUPPLIERS LIST ASL: A listing of suppliers/contractors whose quality assurance programs have been evaluated to meet applicable requirements and found capable of supplying particular items or services to specified requirements.
BASIC COMPONENT: A structure, system, or component, or part thereof that affects its safety function necessary to assure the item is safety related. (10CFR21)
BENCHMARK SOFTWARE: - See qualification
- BIANNUAL: Every 6 months, not to exceed 184 days.
- BIENNIAL: Every 2 years, not to exceed 732 days.
- BIMONTHLY: Every 2 months, not to exceed 62 days.
- BIWEEKLY: Every 2 weeks, not to exceed 14 days.
~UGB SDFIWARE:Il p dd t,t I .tl . i p 5 NGG M-P M%007 Rev. 1 Page 9 of 99
CALIBRATION: Comparison of an item of Measuring and Test Equipment (M&TE) with a reference standard or with an item of M&TE of equal or closer tolerance to detect and quantify inaccuracies and to report or eliminate the inaccuracies.
COMMERCIALGRADE: A structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. (10CFR21)
COMPLETED QUALITYASSURANCE QA RECORD: A document becomes a QA record when the last reviewer or evaluator has completed his or her review or evaluation as prescribed in procedures. Completion includes being stamped, initialed, signed, or otherwise authenticated, and dated by authorized personnel. In the case of a record package (Engineering Service Request, Equipment Qualification, and so forth) made up of several individual documents, the package will be considered to be the document for the purpose of determining when the document is complete.
COMPUTER SOFTWARE: - Computer programs, procedures, and possibly associated documentation and data pertaining to the operation of a computer system. A sequence of instructions or actions implemented by procedure or algorithm, that may or may not be taken, suitable for processing by a computer.
CONDITION ADVERSE TO QUALITY CATQ: See Section 12;0.
CONDITIONALRELEASE: A document permitting limited work progression on nonconforming items.
CONSUMABLE/EXPENDABLEITEM: Those designated items whose quality is necessary for the functional performance of safety-related structures, systems, and components and thus are subject to applicable provisions of 10CFR50, Appendix B. These designated items are purchased and controlled in accordance with plant procedures.
CONTRACT: The various documents which describe the scope of the contracted work and the conditions under which CP&L and the contractor have agreed to participate. The contract may include either the procurement of labor and/or services together with materials necessary in their performance, DESIGN BASES: That information which identifies the specific functions to be performed by a structure, system, or component of a facility and the specific values or ranges of values chosen or controlling parameters as reference bounds for design. These values may be (1) restraints derived from generally accepted state-of-the-art practices for achieving functional goals or (2) requirements derived from analysis based on calculation and/or experiments of the effects of a postulated accident for which a structure, system, or component must meet its functional goals (refer to 10CFR50.2).
CP&L has provided the following clarification to the NRC. A system's Design Basis, as defined by CP&L, consists of:
~ System and Component functional requirements (Reference 10CFR50.2),
~ Regulatory Requirements and Commitments relative to system and component design (Reference 10CFR50, Appendix B, Criterion III),
NGGM-PM007 Rev. 1 Page 10 of 99
~ Original System and Component design codes and standards of record, unless clearly superseded by a Regulatory commitment to a later code or standard (Reference 10CFR50.2)
DESIGN CHANGE OPERABILITY: The installation of a completed design change such that the affected equipment is capable of performing its intended function, when sufficient acceptance testing has been completed to verify the changes will perform as specified by the design and to fulfillany testing requirements resulting from the change, and when sufficient documentation exists to support operation.
H DESIGN DOCUMENTS: Specifications, calculations, drawings, and procedures derived from regulatory requirements and design bases that delineate item design, quality assurance and process requirements for use in'procurement, fabrication, installation, examination, and testing; and analyses and reports that substantiate design characteristics or evaluate item performance.
DESIGN INPUTS: Those criteria, parameters, bases or other design requirements, updated to reflect all approved ch'anges, upon which detailed final design is based.
DESIGN ORGANIZATION: An organization within CP&L or a contractor supporting CP&L assigned responsibility for development or revision and documentation of the design of a plant structure, system, equipment, or parts thereof.
DESIGN SPECIFICATIONS: The documerit describing the engineering and performance requirements which provide a basis for designing an item and/or the technical information necessary for purchasing an item.
DESIGN OUTPUT: Documents such as drawings, specifications, and other documents that define the technical requirements of Safety Systems and Components (SSC).
ENGINEERING EVALUATION: A documented assessment performed to disposition a concern, indeterminate condition, or other circumstance that provides a basis for the disposition and is reviewed and released as specified in procedures.
ENVIRONMENT COMPUTER: The conditions under which a program is developed or run.
This includes the type of processor, storage media, and other software-dependent hardware used, as well as the operating system used to run the program.
FIRE PROTECTION RELATED: Those fire protection systems and components that provide direct protection to safety-related items from fire or whose failure could prevent those fire protection systems and components from operating. Those components used for indication, backup, or information purposes are not considered fire protection related.
HOLDPOINT: A point beyond which work shall not proceed until mandatory verification, inspection, or approval is obtained from appropriate inspection/ verification organization(s).
INFORMATION MANAGEMENTSYSTEM: A data base or computing system containing information used to support a safety-related activity, i.e., Equipment Data Base System (EDBS).
NGGM-PM007 Rev. 1 Page 11 of 99
MEASURING AND TEST EQUIPMENT M&TE: Instrument, tools, gauges, fixtures, reference and transfer standards, and nondestructive test equipment which are used in the measurement, inspection, and monitoring of safety-related components, systems, and structures. (This includes [1] instrumentation permanently installed as required by the plant Technical Specifications, [2] instrumentation used to verify Technical Specifications but which are not specified in the Technical Specifications, and [3] active safety-related instruments.
M&TE does not include rulers, tape measures, levels, and other such devices if normal commercial practices provide adequate accuracy, or installed or portable instruments used for preliminary or qualitative checks, where accuracy is not required, such as a circuit checking multimeter.)
- MONTHLY: Once per month, not to exceed 31 days.
PORTABLE MEASURING AND TEST EQUIPMENT P-M&TE: M&TE items that are not permanently installed in the facility (e.g., test gauges, voltmeters, deadweight tester).
PURCHASE ORDER PO: A formal agreement for procurement of items and those services allowed to be obtained without a contract.
QUALIFICATION: The process of demonstrating, through test methods, a given input for the software produces the expected output..
QUALITYCLASS B ITEMS: Nonsafety related, seismically designed items as discussed in Regulatory Guide 1.29, Regulatory Positions C2 and C4, and Category 2 instruments subject to Regulatory Guide 1.97, Revision 3.
QUALITYRELEASE: A document used by a vendor or CP&L to release item(s) for shipment from a vendor's facility.
QUALITYSOFTWARE/COMPUTING SYSTEMS: Computer software and/or computing systems used to support processes that have a direct or indirect affect on nuclear safety and/or operation.
- QUARTERLY: Every 3 months, not to exceed 92 days.
RECEIPT INSPECTION: Inspection activities performed by qualified personnel during the receiving of items to determine the conformance of those items to predetermined requirements.
REFERENCE CALIBRATIONSTANDARDS: Standards (e.g., primary, secondary, working, field, and shop where appropriate) used in a calibration program. These standards establish the basic accuracy limits for the program.
REPAIR: The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still may not conform to the original requirement. (ANSI N45.2.10)
NGGM-PM%007 Rev. 1 Page 12 of 99
REWORK: The process by which a nonconforming item is made to conform to a prior specified requirement by completion, remachining, reassembling or other corrective means.
SAFETY-RELATED: A term applied to those plant features relied upon during or following a design basis event to ensure the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents which could result in off-site exposures comparable to the guideline exposures of NRC Regulation 10CFR100.
- SEMIANNUAL: Every 6 months, not to exceed 184 days.
SEMIMONTHLY: Every 2 weeks, not to exceed 16 days.
- SEMIWEEKLY: Twice per week, not to exceed 4 days.
SERVICES: The performance by a Supplier of activities such as design, fabrication, inspection, non-destructive examination, repair, or installation. (ANSI N45.2.13)
SIGNIFICANTCONDITIONADVERSETO QUALITY SCATQ: See Section12.0.
TRACEABILITY: The ability to trace the history, application, or location of an item or activity by means of recorded identification.
USE-AS-IS: A disposition which may be imposed for a nonconformance when it can be established that the discrepancy will result in no adverse conditions and that the item under consideration will continue to meet all engineering functional requirements including performance, maintainability, fit, and safety. (ANSI N45.2.10)
- WEEKLY: Every week, not to exceed 7 days.
- These frequency dependent terms are defined for application if not specifically defined in plant documents.
NGGM-PM-0007 Rev. 1 Page 13 of 99
1.0 INTRODUCTION
1.1 CP&L QUALITYASSURANCE (QA) PROGRAM - SCOPE This manual amplifies the CP&L committed 10CFR50 Appendix B Quality Assurance Program (QAP) requirements described in (U)FSAR Section 17.3 and establishes measures for assuring that organizations performing safety-related activities perform their responsibilities in a manner which results in safe nuclear power production. This manual also establishes the QA programs for the non-safety related areas of RW-Q, FP-Q, and Quality Class B. Additional QA requirements imposed on individual plants by regulations and commitments shall be considered a part of the QAP. Other QA programs are established in this manual to comply with requirements, either required by regulators, or determined to assist the company implement structured programs beneficial to the operation of the nuclear plants.
The guidance provided in this manual is not all inclusive. It is intended to be used in conjunction with Sections 1.8 and 17.3 of the (U)FSARs to develop procedures that implement the CP8L Quality Assurance Program.
1.2 SCOPE OF APPLICATION The measures described in this manual have been written to comply with the Quality Assurance requirements of certain regulatory documents identified in Sections 1.8 and 17.3 of the (U)FSARs. The applicable regulatory commitments are identified in each section.
The manual is arranged in functional sections to facilitate its use and includes additionally Appendix I which cross-references functional subjects with the applicable criteria of 10CFR50, Appendix B, and Appendix II which contains QA program regulatory guide references.
A list or system identifying items to which Sections 1.0 through 19.0 apply shall be maintained at each nuclear plant or work location. The responsibility for maintaining this list or system shall be identified in procedures or interface documents.
1.2.1 Sections 1.0 through 14.0-Scope of Application For compliance with 10CFR50, Appendix B, and 10CFR72 the provisions of Sections I.O through 14.0 shall be applied to activities associated with safety-related materials, equipment, and services.
1.2.2 Section 15.0-Scope of Application This section identifies measures for compliance with the QAP requirements for fire protection systems, components, parts, and administrative programs.
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1.2.3 Section 16.0-Scope of Application. (HNP Only)
This section identifies measures for compliance with the QAP requirements for radioactive waste systems, components, and administrative programs.
1.2.4 Section 17.0-Scope of Application This section identifies measures for compliance with the QAP requirements for the IF-300 irradiated fuel shipping cask.
1.2.5 Section 18.0-Scope of Application This section identifies measures for compliance with the QAP requirements for shipping "non LSA greater than Type A" packages, 1.2.6 Section 19.0-Scope of Application This section identifies measures for compliance with the QAP requirements for computer software for safety-related applications.
1.2.7 Section 20.0-Scope of Application This section has been deleted and the requirements incorporated into Section 19,0.
1.2.8 Section 21.0-Scope of Application (HNP only)
This section identifies QAP requirements for Class B items.
1.2.9 Section 22.0-Scope of Application (BNP and RNP only)
This section identifies QAP requirements for nonsafety related systems and equipment used to meet the Station Blackout Rule.
1.2.10 Section 23.0-Scope of Application This section identifies requirements for the issuance of interpretations of the QAP by the Manager - Performance Evaluation and Regulatory Affairs (PERAS). Interpretations issued are included in this section.
2.0 ORGANIZATION AND RESPONSIBILITIES 2.1 SCOPE This section sets forth the organizational structure and responsibilities for implementation of the Quality Assurance Program (QAP). While general managerial and supervisory responsibilities are delineated in this section, each organization performing activities described in this manual is responsible for assuring proper implementation of the applicable requirements for the activity being accomplished.
Specific duties and responsibilities should be delineated in procedures and interface documents.
NGGM-PM-0007 Rev. 1 Page 15 of 99
2.2 MANAGEMENTRESPONSIBILITIES Ultimate responsibility for operation of the nuclear plants rests with the Senior Vice President, Nuclear Generation/Chief Nuclear Officer reporting to the Executive Vice President, Energy Supply who reports to the President/Chief Executive Officer.
Nuclear Generation - The Senior Vice President/Chief Nuclear Officer reports to the Executive Vice President, Energy Supply. This position is responsible for managing the company's nuclear plants and assuring they are in compliance with applicable regulations, codes, and other requirements. There are five departments in the Nuclear Generation Group: (a) the Brunswick Nuclear Plant Department, (b) the Harris Nuclear Plant Department, (c) the Robinson Nuclear Plant Department, (d) the Nuclear Engineering Department, and (e) the Operations and Environmental Support Department. Their responsibilities are summarized below:
2.2.1. The Brunswick Nuclear Plant Department - The Vice President, Brunswick Nuclear Plant Department reports to the Senior Vice President/Chief Nuclear Officer. This position is responsible for managing all aspects of:
configuration cont'rol of the plant's design basis; services associated with the procurement, design, and modification installation; outage management; direct plant support functions; operation; and maintenance of the Brunswick Nuclear Plant. The department includes: (1) Director of Site Operations, (2)
Plant General Manager, (3) Manager - Plant Support Services, (4) Manager-Regulatory Affairs, (5) Manager - Training, (6) Manager - Brunswick Engineering Support Services, (7) Manager- Nuclear Assessment, and (8)
Manager - Environmental & Radiation Control.
2.2.2 The Harris Nuclear Plant Department - The Vice President, Harris Nuclear Plant Department reports to the Senior Vice President/Chief Nuclear Officer.
This position is responsible for managing all aspects of: configuration control of the plants design basis; services associated with the procurement, design, and modification installation; outage management; direct plant support functions; operation; and maintenance of the Harris Nuclear Plant. The department includes: (1) Director of Site Operations, (2) Plant General Manager, (3) Manager - Plant Support Services, (4) Manager - Harris Engineering Support Services, (5) Manager - Training, (6) Manager-Regulatory Affairs, (7) Manager - Nuclear Assessment and (8) Manager-Environmental & Radiation Control.
2.2.3. The Robinson Nuclear Plant Department - The Vice President, Robinson Nuclear Plant Department reports to the Senior Vice President/Chief Nuclear Officer. This position is responsible for managing all aspects of:
configuration control of the plant's design basis; services associated with the procurement, design, and modification installation; outage management; direct plant support functions; operation; and maintenance of the Robinson Nuclear Plant. The department includes: (1) Director of Site Operations, (2)
Plant General Manager, (3) Manager - Plant Support Services, (4) Manager-Regulatonj Affairs, (5) Manager- Training, (6) Manager- Robinson Engineering Support Services, (7) Manager - Nuclear Assessment and (8)
Manager - Environmental & Radiation Control.
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2.2.4. The Nuclear Engineering Department - The Vice President, Nuclear Engineering Department (NED) reports to the Senior Vice President/Chief Nuclear Officer. This position is responsible for complimenting the Plant Engineering Support Sections by providing an integrated technical, design
.control and configuration management function. The VP, NED is also responsible for engineering, procurement, and fabrication of nuclear fuel, probabilistic risk assessment (PRA) and spent fuel management services for the nuclear plants . Reporting to the Vice President - Nuclear Engineering Department are: (1) Manager - Nuclear Fuel Management and Safety Analysis, and (2) Chief Engineer.
2.2.5. The Operations and Environmental Support Department - The Director-Operations 8 Environmental Support Department reports to the Senior Vice President/Chief Nuclear Officer. This position is responsible for materials acquisition and administrative services for the Nuclear Generation Group; as well as providing analytical, chemistry, and metallurgy services; operations, maintenance, and configuration control of plant computing systems;
- environmental programs support; and radiological support for the company.
The Department consists of: (1) Manager - Material Services, (2) Manager-Environmental Services, (3) Manager - Nuclear Information Technology, and (4) Manager - Business Planning 8 Budget Services.
The Manager - Performance Evaluation and Regulatory Affairs (PERAS) reports to the Senior Vice President/Chief Nuclear Officer. This position is responsible for generic licensing, independent oversight of the plant's Nuclear Assessment Sections, and maintenance of the Quality Assurance Program Manual.
The Manager - PERAS, as necessary, is responsible for updating this manual to maintain consistency with commitments, mandatory regulations, and codes. The Manager - PERAS shall assure a review of the status and adequacy of this manual is performed at least once a year by appropriate CP&L management and submit any recommended revisions to the Senior Vice President/Chief Nuclear Officer for approval. Revisions and distribution to the QAP Manual will be in accordance with NGGM-PM-0005, Development and Approval of Documents in the NGG Document Hierarchy.
The Senior Vice President - Administrative Services reports to the President/Chief Executive Officer. This position operates through the Vice President - Corporate Services to provide procurement activities and security access for each nuclear plant.
The three plant Nuclear Assessment Sections (NAS) independently monitor and assess the Company's nuclear programs on a continuing basis. The NAS performs assessments which incorporate the previous QA audits. These evaluations are primarily performance based with emphasis on quality of the end product.
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Quarterly (approximately) a briefing of NAS activities, along with any potential issues and recommendations, shall be presented to the Senior Vice President/Chief Nuclear Officer. The Managers - NAS shall have access to the corporate management up to and including the Senior Vice President/Chief Nuclear Officer to resolve any quality or nuclear safety related concerns if the concerns cannot be resolved satisfactorily at a lower management level.
The Performance Evaluation Support Unit (PES) of PERAS is responsible to ensure that the results and effectiveness of the NAS organization and its processes in accomplishing its assigned objectives is regularly evaluated on a frequency not to exceed 24 months.
2.3 RESPONSIBILITY The primary responsibility for quality performance, including the identification and effective correction of problems potentially affecting the safe and reliable operation of the Company's nuclear facilities, resides with the line organization. The term "line organization". used in this program refers to the production organization reporting to the Senior Vice President/Chief Nuclear Officer.
The managers of functions involving engineering, modification, maintenance, nuclear fuel, and operations shall assure that their personnel are adequately trained for their jobs and they have the experience and education required to carry out their assigned responsibilities. These managers shall ensure that adequate resources and procedures are available for correctly implementing the work activities to support the QA program, Independent inspections are conducted in accordance with procedures to verify specific critical quality attributes. Individuals performing these inspections have access to necessary information to ensure that activities and equipment meet established acceptance criteria.
Procurement documents prepared in accordance with procedures require suppliers to operate in accordance with QA programs which are compatible with the applicable requirements of CP&L's QAP and procedures where their services are used in support of plant activities.
2.4 AUTHORITY.
The QAP and procedures require that the authority and duties of persons and organizations performing activities affecting quality be clearly established and delineated in writing. In addition, the QAP requires that these individuals and organizations have sufficient authority and organizational freedom to:
- 1. Identify quality, nuclear safety, and performance problems,
- 2. Order unsatisfactory work to be stopped and control further processing, delivery, or installation of nonconforming material.
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- 3. Initiate, recommend, or provide solutions for conditions adverse to quality.
- 4. Verify implementation of solutions.
3.0 OPERATING PLANT DESIGN ACTIVITYCONTROL 3.1 SCOPE This section sets forth minimum requirements for control of design activities affecting systems, components, and structures. The major areas covered by this section are design, reviews and approvals, work execution, documentation, and design interface controls.
3.2 RESPONSIBILITIES The responsibility for implementing this section is assigned to each nuclear plant department and the Nuclear Engineering Department. Responsibilities delegated to other Carolina Power 8 Light (CP8 L) departments or contractors shall be documented through approved interface documents.
3.3 REGULATORY COMMITMENTS This section used in conjunction with Regulatory Guides 1.64 and 1.33 and American National Standards Institute N45.2.11 and N18.7, as committed by Sections 1.8 and 17.3 of the (U)FSAR, establishes the requirements essential for compliance with the applicable portions of 10CFR50 Appendix B.
3.4 DESIGN PROCESS The designated design organization shall have access to pertinent background information needed to fulfillits responsibility and shall have personnel with adequate understanding of the requirements and intent of the original plant design commensurate with the scope and complexity of the design activity to be performed.
Design activities carried out to develop final design documents or to support development of final design documents shall be accomplished in accordance with procedures of a type sufficient to ensure that design input requirements are correctly applied, the activity is documented in sufficient detail to permit verification, appropriate quality standards are Identified, and the results of the activity are reviewed and approved. Design activities include such work as preparation of design input requirements, specifications, drawings, analyses, and procedures.
3.4.1 Design input requirements.
Applicable design input requirements shall be developed and documented.
The design inputs shall be specified to a level of detail sufficient to allow translation into other design documents such as specifications, drawings, analyses, procedures, etc. Changes to design requirements during the design process shall be controlled to ensure such changes are factored into other ongoing design activities.
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3.4.2 Design verification.
Sufficient design verification shall be performed by one or more methods to substantiate that the final design documents meet the appropriate design inputs. Verification activities shall be clearly documented, identifying the verifier and the results of the verification. Acceptable verification methods include but are not limited to:
3.4.2.1 Design reviews.
3.4.2.2 Alternate calculations.
3.4.2.3 Qualification testing using the most adverse specified design condition.
The design verification shall be performed by a competent individual or group of individuals, but shall not be performed by individuals who prepared the original design or the designer's immediate supervisor unless the immediate supervisor is the only one capable of verifying the design.
Gbjective evidence documenting the completion of and satisfactory resolution of any concerns raised in the design verification shall be provided with the package prior to relying on the structure system or component to perform its function. A design verification of the completed design package shall be performed to verify the following:
3.4.2.3.1 Design interface between design disciplines is adequately established.
3.4.2.3,2 Sufficient design documents and procedures are included or referenced to allow implementation to be carried out in a planned and controlled manner.
3.4.2.3.3 Adequate provisions for in-process or post-installation examinations, inspections, and testing have been specified to assure quality of work and verification that the design performs as intended.
3A.2.10.4 Adequate provisions have been provided to document installation and results of examinations, inspections, and testing within the package or documents referenced.
3.4.2.10.5 Consideration has been given to design change operability, reliability, maintainability, safety, and adherence to appropriate codes, standards, and regulatory requirements.
3.4.2.10.6 Appropriate design verification has been performed for applicable documents contained in the package.
3.4.2.10.7 Specified materials and processes are suitable for the intended application.
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3.4.2.10.8 The design is technically adequate with respect to the design bases.
3.5 DESIGN CHANGE PACKAGE For design changes that produce a physical modification to the plant, an approved design change package shall be issued. The design change package shall be prepared by the responsible design organization and shall include or reference design documents or procedures to provide for:
3.5.1 Installation of the physical change 3.5.2 Identification of required inspections and acceptance criteria.
3.5.3 Identification of required testing and acceptance criteria.
3.5.4 Identification of specified materials for installation.
3.5.5 Identification of necessary revisions to existing design documents such as design basis documents, specifications, drawings, procedures, and manuals.
3.5.6 Identification of new design documents.
3.5.7 Identification of functional quality class and boundaries.
3.5.8 Control of design change package.
The content, revisions, format, reviews and approvals, issuance control, and interface with other processes affected by the design change shall be established in procedures. The procedures shall establish controls to assure that changes to Plant Operating Manual, information management systems, or other documents important to the configuration or to work execution are identified.
3.5.9 Design change package implementation.
Implementation including installation, examinations, inspections, and tests shall be performed in accordance with the procedures provided in the design change package or procedures referenced in the design change package.
Deviations from the design change package, except where authorized in the package or referenced procedures, require an approved revision to the package prior to work execution.
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3.6 SAFETY EVALUATION Any proposed activity/change or discovered change to the facility or procedure or test or experiment as described in the applicable SAR whether permanent or temporary shall be evaluated for 10CFR50.59 applicability as described in procedures.
3.7 DESIGN CHANGE OPERABILITYAND CLOSEOUT 3.7.1 Prior to design change operability, verification of the work and a review of documentation shall be performed to assure work has been satisfactorily accomplished including examinations, inspections, and tests. Measures shall be established to document any exceptions identified by this review.
These exceptions shall be either cleared prior to design change operability or exceptions shall be approved and tracked to ensure timely completion, 3.7.2 Training to familiarize plant personnel with the hardware, procedure changes, and Technical Specification changes resulting from the implementation of the design change package shall be conducted, as appropriate.
3.7.3 As part of a declaration of design change operability, measures shall be initiated to revise documents and information management systems identified per Section 3.5,8 in accordance with approved procedures, Methods shall be implemented to ensure that potential users of affected documents are notified of outstanding changes to documents and information management systems. The controlling procedures for design change packages shall provide a documented method for declaration of design change operability.
3.7.4 Final closeout of a design change package shall not be done until all exceptions and outstanding changes to documents and information management systems have been dispositioned.
3.8 TEMPORARY DESIGN CHANGES 3.8.1 Temporary design changes to the plant to support testing shall be accomplished in accordance with procedures. The procedure shall:
3.8.1.1 Control the installation of the change.
3.8.1.2 Require removal of the change upon test completion.
If the equipment or system affected is to remain in service during the change, the following additional requirements shall apply:
3.8.1.3 Design Verification 3.8.1A 10CFR50.59 safety evaluation.
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3.8.2 Temporary design changes including temporary repairs to the plant for reasons other than test or surveillance activities shall be controlled by procedures. The procedure may be for a specific change or a controlling process for a certain type of change. In either case, the document authorizing the change shall:
3.8.2.1 Provide instructions to implement the change.
3.8.2.2 Control removal of the change.
If the system is to remain in service during the change, the following additional requirements shall apply:
3.8.2.3 Perform a Design Verification 3.8.2.4 Perform a 10CFR50.59 safety evaluation.
3.8.2.5 Designate the responsible organization for control and removal of the change.
3.8.2.6 Provide appropriate notification and instruction, if needed, to operational personnel.
3.8.2.7 Identify drawing and procedure changes to be in effect during the time the temporary design change is in place, 3.8.2.8 Identify training requirements.
Such temporary changes shall be tracked to assure removal or permanent dispositioning within a specified time limit.
3.9 DISPOSITION OF DEVIATIONS BETWEEN DESIGN DOCUMENTS AND PLANT CONFIGURATION When deviations are discovered between plant design documents and actual configuration, they shall be dispositioned in accordance with Sections 3.0, 11.0, or 12.0.
3.10 DESIGN INTERFACE CONTROL Documented interface control over design activities assigned by each nuclear plant department to other CP8 L organizations shall address the following:
3.10.1 Delegated areas of responsibility.
3.10.2 How the assistance is requested and the scope of work specified.
3.10.3 Methods of communication between the assisting organization and each nuclear plant department.
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3.10.4 Applicable procedures which govern the conduct of design activities, design change authorizations, and work execution.
3.10.5 Handling and dispositioning of documentation and Quality Assurance Records generated during the performance of the requested activity.
The interface document shall be established prior to initiation of design. The interface may be in a document specific for a given assistance request, procedures concurred with by the affected departments, or a standardized interface agreement.
4.0 PROCUREMENT CONTROL 4.1 SCOPE This section establishes requirements for controlling the activities and documents associated with procurement of items and services. It includes requirements for procurement document content and reviews, vendor selection and qualification, and surveillance after award.
4.2 RESPONSIBILITY The responsibility for implementing this section is designated to the Carolina Power &,
Light (CP&L) organization having responsibility for the project or work function that determines the need for procurement. Delegation of tasks or functions related to this responsibility shall be accomplished through approved interface documents or procedures. The CP&L organization having primary responsibility shall retain the responsibility.
4.3 REGULATORY COMMITMENTS This section used in conjunction with Regulatory Guides 1.33, 1.123, 1.144, and 1.146 and American National Standards Institute (ANSI) N45.2.12, N45.2.13, N45.2.23, and N18.7, as committed in Sections 1.8 and17.3 of the (U)FSAR, establishes the requirements for compliance with the associated portions of 10CFR50, Appendix B.
4.4 APPROVAL OF VENDORS Where procurement documents require the vendor to implement a quality assurance (QA) program that complies with 10CFR50, Appendix B, the vendor's program shall be approved by CP8 L before issuance Of the purchase order (PO) or contract.
Procurement from other nuclear plant facilities licensed for construction or operations by the NRC are exempt from this requirement. The Procurement, Dedication, and Vendor/Equipment Services Unit (PD&V/ES) of OESD shall maintain a list of approved vendors (ASL). The qualification of a vendor's QA program shall be based on an evaluation of the adequacy of the program compliance with the applicable requirements of 10CFR50, Appendix B, for the type of items or services supplied.
4.4.1 Vendor qualification shall be documented by one or more of the following methods:
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4.4.1.1 The vendor's QA capabilities as determined by a direct survey/audit of the vendor's facilities and personnel and the implementation of the QA program.
4.4.1.2 Evaluation of the vendor's history of providing a product which performs satisfactorily in actual use. The following information should be considered:
4.4.1,2.1 Experience of users in identical or similar products of the same prospective vendor.
4A.1.2.2 CP&L's records that have been accumulated in connection with previous procurement actions and product operation experience. Historical data should be representative of the vendor's current capability. If there has been no recent experience with the vendor, or the vendor is a new supplier, the prospective vendor shall be requested to submit information on a similar item or service for evidence of his current capabilities.
4.4.1.3 Evaluation of the vendor's current quality records supported by documented qualitative and quantitative information which can be objectively evaluated. This would include review and evaluation of the vendor's QA program manual and procedures, as appropriate, to ensure that the applicable requirements of 10CFR50, Appendix B, are appropriately applied and effectively implemented.
4.4.1.4 Verification that the vendor holds an active CERTIFICATE OF AUTHORIZATIONfrom the American Society of Mechanical Engineers (ASME) to supply or manufacture item(s) described in the procurement document.
4.4.1.5 Evidence that material manufacturers or material suppliers hold an ASME Quality System Certificate (Materials).
4.4.2 Where procurement documents for commercial grade items take credit for the vendor's commercial grade quality assurance program for verifying any critical characteristics for acceptance, the vendor's program shall be approved by CP&L before issuance of the purchase order. Procurement from other nuclear plant facilities licensed for construction or operations by the NRC are exempt from this requirement. PD&V/ES shall maintain a list of approved commercial grade vendors. The qualification of a vendor's commercial grade QA program shall be based on an evaluation of the ability of the program and/or manufacturing processes to provide reasonable assurance that the critical characteristics for acceptance are verified for the items or services supplied.
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4.4.2.1 Qualification of a vendor shall be documented by one or more of the following methods:
4 4.2.1.1 The vendor's QA and/or manufacturing process control capabilities as determined by a direct survey/audit of the vendor's facilities and personnel and the implementation of the QA program and/or manufacturing process controls.
NOTE: Commercial grade surveys/audit of distributors should not be employed alone unless the distributor has a commercial grade quality assurance program capable of verifying the applicable critical characteristics. Otherwise, a survey/audit of the distributor must also include a survey/audit of the original part manufacturer(s).
4.4.2.1.2 Evaluation of the vendor's history of providing a product which performs satisfactorily in actual use.
The following information should be considered:
~ Monitored performance of the item through user historicai performance and evaluated results.
~ Industry product tests.
~ Manufacture of the item(s) to national codes and standards.
~ Industry data bases on item performance.
The item performance record is required to be specific to the item and directly applicable to the item's critical characteristics and intended safety-related applications.
The vendor history method alone is not acceptable for dedication of commercial grade items and must be used in combination with supplier survey/audit, source inspection or special tests and inspection methods, provided the evaluation results are acceptable and the following are performed:
~ Receipt inspection in accordance with a documented receipt inspection plan.
~ Periodic revalidation of performance evaluation bases and results.
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4.4.3 The evaluation of the adequacy of the vendor's QA program shall be performed by PDBV/ES and updated annually. Records supporting the vendor's listing on the ASL will be maintained as described in procedures.
4.5 ITEMS AND SERVICES PROCUREMENT BY PURCHASE ORDER This subsection applies to the procurement by POs of items and services. Activities associated with the procurement process, including document preparation, reviews, approval, and changes to the PO, shall be controlled by procedures.
4.5.1 Initiation of purchase requisition (PR)
Procurement shall be initiated by preparation of a PR. The term "PR" shall apply to any document which initiates the process of procurement and is subject to the controls of this section. This may include manually processed or computer-generated documents. For computer-generated PRs, the technical and QA requirements applicable to the item being procured may be coded and recorded in a controlled data base. Text associated with technical and QA requirement codes shall be retrievable or included with the PR, as appropriate.
4.5.2 General requirements for PRs PRs shall include a description of the item or service and delivery instructions. The quality class shall be specified on each PR.
4.5.3 Requirements for PRs, except Commercial Grade This subsection applies to the procurement of items from a vendor who is required to implement an approved QA program that complies.with the applicable requirements of 10CFR50, Appendix B, for the purpose of assuring quality and compliance with the order requirements.
4.5.3.1 Technical and documentation requirements The PR shall specify:
4.5.3.1.1 The design technical requirements that adequately specify each item requirement imposed on the vendor. The requirements shall be established by:
4.5.3.1.1.1 Reference to applicable codes/standards, regulations, approved drawings, approved specifications, or other controlled documents including appropriate revision, editions, and addenda.
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4.5.3.1.1.2 Included in the PR based on requirements established in controlled engineering documents.
OR 4.5.3.1.1.3 A combination of both the above.
4.5.3.1.2 Fabrication requirements and controls essential to the item's final quality, as appropriate.
4.5.3.1.3 Required vendor inspection and tests, as appro'priate.
4.5.3.1.4 Vendor shelf-life limitations specified by the vendor, if applicable, unless they are to be established by CP8 L.
4.5.3.1.5 Packaging and shipping requirements, as appropriate.
4.5.3.1.6 Documentation submittal requirements including schedule for submittal and any limitations on work progression related to their review, if appropriate.
4.5.3.1.7 As applicable, record retention requirements by the vendor including type of records and retention time if the vendor is to retain custody of final QA Records.
4.5.3.2 QA requirements The PR shall require the vendor to:
4.5,3.2.1 Implement a documented QA program that complies with the applicable requirements of 10CFR50, Appendix B, and is approved by CP8 L.
4.5.3.2.2 Allow CP8 L and other parties authorized by CP8 L right of access to the vendor's facilities and QA Records for source inspection and QA audits.
4.5.3.2.3 Incorporate appropriate QA program requirements in subtier procurement documents.
4.5.3.2.4 Notify CP8L of nonconformances to the order requirements which consist of one or more of the following. Documented vendor notification shall include the vendor's recommended disposition and technical justification.
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4.5.3.2.4.1 Technical or material requirement is violated.
4.5.3.2.4.2 Vendor documents approved by CP&L are violated.
4.5.3.2.4.3 Nonconformance(s) cannot be corrected by continuation of the original manufacturing process or by rework.
4.5.3.2.4.4 The item does not conform to the original requirements even though the item can be restored to a condition such that the capability of the item to function is unimpaired.
4.5.3.3 Waiver of requirement for vendor-approved QA program.
The requirement for a vendor to have a CP&L-approved QA program may be waived under the following circumstances:
4.5.3.3.1 For procurement of replacement or spare parts where the original design, fabrication inspection, and test requirement are adequate; the vendor is the original equipment manufacturer; and the original specification or order did not require the vendor's QA program to be approved.
4.5.3.3.2 For procurement of items and services where CP&L is substituting its QAP, in whole or in part, in place of the vendor's normal controls. Such circumstances will require the requisition, as a minimum, to reference the documents and methods (e.g., Engineering evaluations, ESRs, modifications, etc.) which will be used to invoke CP&L's QAP on the applicable activities such that appropriate 10CFR50, Appendix B, controls are assured.
4.5.3.3.3 Special procurement in accordance with Section 4.10.
4.5.3.3.4 When there has been no recent experience with the supplier, the prospective supplier shall be evaluated by reviewing appropriate procedures, instructions, and specifications on a similar item (or service) for evidence of current capabilities.
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The requisition shall include, as appropriate, that the vendor have approved procedures for the specific work being performed, that personnel be qualified to perform the specific activity, that calibration of instrumentation shall be traceable to nationally recognized standards, and that the activity being performed shall be evaluated by CP&L, or its agent, at the supplier facility. These activities shall be in accordance with Section 4.8.
4.5.4 Determination of Commercial Grade Items.
An evaluation shall be performed in accordance with approved procedures to determine the applicability of using commercial grade items for the intended safety-related application(s) and should include:
4.5.4.1 A confirmation that the item meets the criteria as defined in the definition section.
4.5.4.2 Identification of the critical characteristics of the item to be verified. Critical characteristics are identifiable and measurable attributes/variables of the item which, once verified, provide reasonable assurance that the item received is the item specified on the PR.
4.5.4.3 Identification of methods to be employed for verification of critical characteristics including acceptance criteria.
4.5.4.4 Identification of technical and QA requirements sufficient to assure the product requirements are clearly specified to vendor.
4.5.5 Requirements for Commercial Grade PRs.
Establishment of technical requirements, quality requirements, documentation requirements, dedication methodologies, etc., for commercial grade items shall be performed in accordance with approved procedures.
4.5.6 Measuring and test equipment (M&TE) calibration service PRs A PR for M&TE calibration services shall include the following requirements:
4.5.6.1 Description of the calibration service being requested including calibration ranges; accuracy and repeatability requirements, where appropriate; and any restrictions on service, if warranted.
4.5.6.2 Traceability of calibrations to a nationally recognized standard.
Where no nationally recognized standard exists, the method and standard used in performing the calibration shall be documented by the vendor.
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4.5.6.3 Written notification to purchaser when equipment is found out of calibration, including the amount of out of calibration.
4.5.6.4 Specific documentation to be submitted.
4.5.7 PR review and approval 4.5.7.1 PRs shall be reviewed prior to release for purchase by qualified individuals knowledgeable in technical and QA requirement considerations to assure that the PRs are adequate for the intended item. The responsible organization(s) designated to perform the review(s) shall be established in procedures.
This review shall determine, as appropriate, that:
4.5.7.1.1 The PR has been prepared in accordance with procedures.
4.5.7.1.2 Adequate technical and quality requirements are specified.
4.5.7.1.3 References and attachments are appropriate for the intended item.
4.5.7.1A Adequate QA documentation requirements have been specified.
4.5.7.2 After satisfactory completion of the review(s), the reviewer(s) shall document concurrence in a manner specified in procedures. The PR is considered approved within the context of this QAP upon satisfactory completion of the review(s).
4.5.8 PR changes Once the initial PR has been reviewed by the reviewer(s), any changes to the technical and quality requirements including references or attachments of the PR shall be reviewed for adequacy. The review shall be equivalent to that performed on the initial PR and performed by the organization(s) assigned this responsibility in approved procedures.
4.5.9 Request for quotation/proposal 4.5.9.1 When required or requested, a request for quotation (RFQ) shall be prepared from an approved PR and issued to selected bidders. Items on a PR may be regrouped in the RFQ; however, each item and its requirements shall remain unchanged in transcription from the PR to the RFQ.
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4.5.9.2 Quotations received with exceptions to the technical or quality requirements of the PR shall be evaluated by the department initiating the PR. Changes to the technical or quality requirements resulting from acceptance of vendor exceptions shall be translated into a change to the PR per Section 4.5.8 prior to issuance of a PO to the selected vendor.
4.5.10 POs 4.5.10.1 POs shall be prepared from an approved PR. When required by the PR, the vendor's QA program shall be approved by CPBL prior to issuance of the PO.
4,5.10.2 POs may be issued to agents or distributors of a vendor. In such cases, the PO shall include the name and location of the approved vendor. The agent or distributor does not have to appear on the Approved Suppliers List (ASL) provided that the items are shipped directly from the approved vendor.
4.5.10.3 PR items may be regrouped in the PO to facilitate procurement; however, each item and its requirements shall remain unchanged in the transcription from the PR to the PO.
Validation of the accuracy of the PO against the approved PR will be performed in accordance with approved procedures.
4.5.10.4 Any exceptions to the PO received from the vendor involving the technical or quality requirements of the order shall be forwarded to the appropriate materials acquisition organization for evaluation. Any exceptions granted to technical and quality requirements shall be translated into a change to the initial PO as per Section 4.5.8.
4.6 PROCUREMENT BY CONTRACT This subsection applies to the procurement by contract of items and services.
Activities associated with the contract process including document preparation, review, approval, and changes to the contract document shall be controlled by procedure.
4.6.1'ontract Requisition A contract will be generated from an approved contract requisition. The requisition shall be reviewed, prior to release, by qualified individuals knowledgeable in technical and QA requirement considerations to assure the requisition is adequate for the intended scope of work.
The review shall verify, as appropriate, that:
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4.6.1.1 The requisition has been prepared in accordance with procedures.
4.6.1.2 Adequate technical and QA requirements are specified.
4.6.1.3 References and attachments are appropriate for the intended work scope.
4.6.1.4 When required, the vendor's QA program has been approved by CP8 L for the scope of work, The vendor's QA program does not have to be approved prior to issuance of a RFQ.
4.6.1.5 Appropriate QA documentation requirements have been specified.
4.6.1.6 The record of reviews shall be retained as a QA record.
4.6.2 General requirements Each contract shall specify:
4.6.2.1 Vendor's name and address.
4.6.2.2 Location where the work will be performed.
4.6.2.3 Scope of work requested.
4.6.2.4 QA requirements.
4.6.2.5 Special conditions the vendor shall comply with to be able to perform the work.
4.6.2.6 Documentation submittal requirements.
4.6,2.7 Material requirements, if applicable.
4.6.3 CP8 L designated representative The organization requesting a contract shall identify a CP&L designated representative, and the individual shall be specified by name in the contract. Changes in the assigned CP8L designated representative should be communicated to the vendor in writing. This individual will function as the contract administrator and, as such, shall be a person knowledgeable of the:
4.6,3.1 Work scope requested.
4.6.3.2 Technical and quality requirements of the work.
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4.6.3.3 Responsibilities of a designated representative in monitoring the vendor, handling changes in work scope, and processing any documentation resulting from the service.
4.6.4 Technical requirements The work scope of the contract shall clearly specify technical requirements which govern the work and establish an interface process for transmittal of requirements not identified in the work scope. Consideration shall be given to the following areas when developing the contract work scope description:
4.6.4.1 Applicable codes, standards, regulations, etc.
4.6.4.2 Methods of interface between vendor and CP&L for transmittal of design inputs and outputs, documents for review and approval, and other applicable design information.
4.6.4.3 Applicable specifications, drawings, or documents which shall be invoked.
4.6.4A Submittals required for CPBL review and approval with any limitations on work progression related to their approval by CP&L.
4.6.4.5 Reference to existing interface documents between vendor and CP8 L if the document will be used to govern the interface.
4.6.4.6 For M&TE calibration services, the requirements of Section 4.5.6 shall apply.
4.6.5 QA requirements 4.6.5.1 The contract shall identify whether the work will be performed under the controls of the vendor's QA program and resultant procedures or under the control of CP&L's QAP with work performed to CP&L procedures, For work performed under CP8 L's program, the CP8 L designated representative will be responsible for identifying applicable procedures and making available a copy of these procedures and the QAP to the vendor or vendor's personnel.
4.6.5.2 For vendors implementing their QA program the contract shall required the vendor to:
4.6.5.2.1 Implement a documented QA program that complies with the applicable requirements of 10CFR50, Appendix 8, and is approved by CP&L prior to the initiation of any work.
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4.6.5.2.2 Allow CP8 L and/or other parties authorized by CP&L right of access to the vendor's facilities, work areas, and records for the purposes of audits, surveillances, and inspections.
4.6.5.2.3 Incorporate appropriate QA requirements of the contract in subtier procurement documents.
4.6.5.2.4 Notify CP8 L's designated representative of any nonconformances to the contract or any CP8 L-approved document that results in one or more of the following. Documented vendor notification shall include the vendor's disposition and technical justification.
4.6.5.2.4.1 Technical or material requirement is violated.
4.6,5.2.4.2 Vendor documents approved by CP8 L are violated.
4.6.5.2.4.3 Nonconformance(s) that cannot be corrected by continuation of the original manufacturing process or by rework.
4.6.5.2.4.4 The item or work product does not conform to the specified requirements even though the item or work product can be restored to a condition such that the capability of the item or work product is unimpaired.
4.6.5.3 Documentation submittal requirements to CP8L shall be specified or referenced. If any QA Records are to be retained by the vendor for CP&L, the contract shall specify the records to be retained, retention period for each record, and appropriate storage requirements.
4.6.6 Contract reviews The contract shall be reviewed prior to release to assure the contract requisition requirements have been incorporated in accordance with approved procedures.
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4.6.7 Contract/contract requisitions (CR) changes Once the contract/CR has been reviewed by the reviewer(s), any changes to the technical and QA requirements including the scope, references, and attachments shall be reviewed for adequacy. The review shall be equivalent to that performed on the initial contract/CR and performed by the organization(s) assigned this responsibility in approved procedures.
4.6.8 Request for quotation/proposal 4.6.8.1 When required or requested, a RFQ shall be prepared and issued to selected bidders. The RFQ shall be reviewed for compliance with the contract requisition prior to issuance.
4.6.8.2 Quotations received with exceptions to the technical or quality requirements of the RFQ shall be evaluated by the organization responsible for the work. Changes to the technical or quality requirements resulting from acceptance of vendor exceptions shall be reflected in the final contract with final reviews perfomled per Section 4.6.7.
4.6.8.3 If the vendor's QA program is required to be approved by CP&L, qualification of the vendor's program shall be approved per Section 4.4 prior to issuance of the formal contract.
4.6.9 Approved contract A copy of the approved safety-related, FP-Q, RW-Q, 10CFR71-Q, 10CFR72-Q, or Q Class B contract including attachments shall be provided to the Procurement, Dedication and Vendor/Equipment Services Unit and the CP&L designated representative, except for contracts controlled by the Nuclear Fuel Management & Safety Analysis Section of NED.
Copies of all safety-related contracts shall be retained as QA Records.
4.7 DISPOSITION OF VENDOR NONCONFORMANCES Nonconformances reported by a vendor and the recommended disposition shall be evaluated by the responsible individual/group within the initiating department of the procurement documents. Approval of the vendor's disposition or CP8 L-selected alternate disposition shall be provided to the vendor in writing. A copy of the nonconformance report and CP&L's disposition approval shall be retained as QA Records.
4.8 VERIFICATION OF VENDOR ACTIVITIES 4.8.1 Verification activities shall be a function of relative importance, complexity, and quantity of the item or service being procured and the vendor's past quality performance.
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4' 4.8.2 Verification activities shall be documented and executed by a surveillance or audit plan for an awarded PO or contract. These plans shall include the following provisions as required:
4.8.2.1 For in-process and final source surveillance of vendor's product or activities at the vendor's facilities or facilities of subtier vendors, The source surveillance shall be documented in a report and a copy of all reports sent to the appropriate plant's materials acquisition organization.
4.8.2.2 For surveillance or audits, as necessary, to assure that vendor planning and execution of work at the work location is controlled in accordance with the procurement document requirements.
4.9 MATERIALUPGRADING Material may be upgraded providing the item complies with the specification or applicable requirements for the intended application. Upgrades shall be performed by documented engineering evaluations or in accordance with criteria established in a procedure. The results of the evaluation of intended application requirements to the actual attributes of the item to be upgraded shall be documented and auditable. The upgrade evaluation shall assess the adequacy of QA data. The upgrade process shall address the need for receipt inspection based on the circumstances of the situation.
Upon approval, the upgrade evaluation, along with the relevant vendor documentation and receipt inspection package, shall form the equivalent to a PO for item traceability.
4.10 SPECIAL PROCUREMENT Items and services may be procured from other nuclear plant facilities licensed for construction or operations by the NRC that are not on CP&L's ASL so long as the technical and quality attributes of the item or service comply with the necessary requirements of specifications or intended application. The methods to be used for procurement in such special cases shall be set forth in procedures and shall provide adequate controls to assure technical and quality requirements are met.
4.11 VENDOR AUDITS Audits, including preaward and periodic audits, are performed at the facilities of contractors providing material, parts, components, and services to CP8L. Preaward audits are performed when alternate methods of qualification are not sufficient to support the initial qualification of contractors. Periodic audits are performed when the results of periodic evaluations and the status and nuclear safety importance of items and services indicate that an audit is required. Audits shall be planned, conducted, and reported in accordance with procedures.
4.11.1 Personnel performing audits shall be appropriately trained, indoctrinated, and qualified to plan, conduct, and report audits.
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4.11.2 Personnel qualified as lead auditors shall be responsible for: leading audits; audit notification, audit agenda preparation; auditor assignments, checklist preparation, auditor orientation, leading and scheduling preaudit and postaudit meetings, audit report preparation, and audit follow-up action.
4.11,3 Audits shall be conducted using checklists as guidelines. The checklists shall be prepared to cover the scope of the contractor's QA program for the desired items and services.
4.11.4 Audit planning shall include a review of previous audit reports of contractors.
Unresolved conditions adverse to quality from previous audits shall be documented on the checklist.
4,11,5 Audits are performed to evaluate contractors'bilities to comply with the QA requirements of CP8 L's procurement documents. Audits include an evaluation of QA practices, procedures, and instructions; assessment of contractors'A programs implementation; review of work activities and processes; and review of quality-related documents and records.
4.11.6 Audit reports will include any identified findings, concerns, comments and, when appropriate, recommended corrective action. Audit reports will be maintained as QA Records.
4.11.7 Audit reports will be distributed to the appropriate CP8L and contractor management.
4.11.8 The contractor shall be requested to respond to the conditions adverse to quality. The request shall indicate the period of time required to respond to the conditions adverse to quality.
4.11.9 The lead auditor is responsible for the evaluation of corrective action. The results of this evaluation shall be documented. Follow-up audits will be planned and conducted to verify implementation of corrective action when necessary.
4.11.10 A system shall be maintained which indicates the status of nonconformances identified during audits.
5.0 MATERIALAND EQUIPMENT CONTROL 5.1 SCOPE This section establishes the requirements for controlling items which by definition include material, parts, and components. It includes requirements for the verification of identification, inspection status, handling, and storage of items. Material and equipment control assures that items used or installed in nuclear plants comply with the QAP, regulatory requirements, applicable technical requirement, and codes and standards.
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5.2 REGULATORY COMMITMENTS This section used in conjunction with Regulatory Guides 1.33, 1.38, and 1.146, and American National Standards Institute N45.2.2, N45.2.23 and N18.7, as committed in Sections 1.8 and 17.3 of the (U)FSAR, establishes the requirements for compliance with the associated portions of 10CFR50 Appendix B.
5.3 MATERIALACCEPTANCE 5.3.1 Personnel responsible for receiving material shipments shall verify that items do not exhibit shipping damage.
5.3.2 The determination of the need for, methods to be used, and acceptance criteria for material acceptance shall be determined prior to acceptance.
5.3.3 For acceptance by receipt inspection, the acceptance criteria shall be determined in accordance with guidance set forth in procedures. The following shall be considered in establishing the receipt inspection requirements and acceptance criteria:
5.3.3.1 Identification, marking, and labeling 5.3.3.2 Packaging requirements 5.3.3.3 Cleanliness 5.3.3.4 Physical attributes and electrical characteristics 5.3.3.5 Special inspections 5.3.3.6 Special environmental conditions (such as inert gas atmospheres, specific moisture content, and temperature levels) 5.3.3.7 Statistical sampling methods that may be used for receipt inspection of groups of similar items 5.3.3.8 Documentation required and the review requirements (such as legibility and completeness) 5.3.4 Results of the receipt inspection shall be documented. If the items and supporting documentation are found to be acceptable, the items shall be identified as acceptable. Acceptable items shall be released for storage or installation. Acceptable items shall indicate information that will provide traceability to procurement documents.
5.3.5 When necessary, source inspection shall be performed to verify that contractors have performed manufacturing, testing, and inspecting of items in accordance with the requirements of procurement documents. A quality release shall be prepared which authorizes contractors to ship items that are acceptable. Personnel responsible for receipt inspection shall verify NGGM-PM<007 Rev. 1 Page 39 of 99
that source-inspected items are marked, labeled, and traceable to documentation packages and that documentation packages include records required by procurement documents, as a minimum. Any inspections or tests required per Section 5.3.3 which are not performed during source inspection shall be performed by appropriately qualified personnel upon receipt of the item(s) by CP&L.
5.3.6 Measures shall be taken to assure that items, including those subdivided, are properly identified from the time of receipt to the point of installation.
Identification markings shall be applied in a manner that will not affect the function of the item.
5.3.7 The required identification and status markings shall be retained with the items or records traceable to the items. The identification of each item shall be included in the record of assembly or installation, For uninstalled items in work areas, status indicators such as markings, tags, or notations on work control documents shall be applied to show the latest status.
5.3.8 When items or required documentation for the items do not conform to requirements, the items shall be identified as nonconforming.
Nonconforming items will be identified and controlled until proper disposition is made.
5.3.9 A receipt inspection documentation package shall be prepared and will include or reference for traceability the procurement documents, receipt inspection report, special inspection reports, certifications, plant-generated documents, and contractor-furnished documents. The documentation package shall be retained as QA Records.
5.4 CONDITIONALRELEASE OF NONCONFORMING ITEMS 5.4.1 A conditional release may be initiated to permit progression of work involving a nonconforming item awaiting resolution. The request shall contain the necessary justification and limitations prior to review and approval.
5.4.2 If reasonable control and traceability can be maintained, a conditional release may be issued to permit limited use, installation, or testing of an item. The item shall be clearly tagged or otherwise traceable to show the status and the permitted actions.
5.5 MATERIALSTORAGE AND RELEASE 5.5.1 Items shall be stored in designated storage areas. Identification tags or marks and the inspection status shall be retained on items or on records which are traceable to the items, Release of accepted items shall be controlled to prevent damage, deterioration, or unauthorized storage and release.
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5.5.2 Nonconforming items shall be segregated and stored in a designated storage area, when practical, to await disposition. When it is not practical to segregate nonconforming items, they shall remain tagged and held in storage areas until properly dispositioned.
5.5.3 Items shall be controlled to assure that they are properly dispositioned at the end of their specified shelf life or qualification period.
5.5.4 The appropriate handling equipment shall be provided and controlled to assure safe and adequate handling. Designated equipment shall be periodically inspected and tested to criteria established in procedures.
5.6 STORAGE INSPECTION PROGRAM 5.6.1 Inspection shall be maintained over items in storage areas. This program shall include:
5.6.1.1 Periodic inspections to assure that items are properly controlled, maintained, and protected. Inspections shall be documented.
5.6.1.2 The identification and control of nonconforming items until proper disposition is made.
6.0 PROCEDURES AND DRAWINGS 6.1 SCOPE This section establishes requirements for preparation, review, approval, and control of procedures and drawings for activities affecting quality.
6.2 RESPONSIBILITY Each organization performing activities affecting quality is responsible for ensuring this section is properly implemented in their area of responsibility.
6.3 REGULATORY COMMITMENTS This section utilized in conjunction with Regulatory Guide 1.33 and American National Standards Institute N18.7 as committed in Sections 1.8 and 17.3 of the (U)FSAR, establishes the requirements essential to comply with the associated portions of 10CFR50 Appendix B.
6.4 PROCEDURES AND DRAWINGS 6.4.1 Appropriate procedures shall bb developed for the preparation, review, approval, and issue of procedures and drawings, 6.4.2 The accomplishment of activities affecting quality shall be in accordance with approved procedures and/or drawings which are appropriate to the circumstances.
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6.4.3 Procedures and drawings shall include the following elements in their content as applicable:
6.4.3.1 Pre requisites.
6.4.3.2 Precautions, 6.4.3.3 Qualitative/quantitative acceptance criteria.
6.4.3.4 Inspection points.
6A.3.5 Checklists.'.4.4 Measures shall be established to assure that procedures for activities affecting quality are reviewed prior to issue to ensure appropriate criteria have been specified. Appropriate criteria to be met include the Final Safety Analysis Report, Technical Specifications, operating license, commitments to regulatory agencies,- regulations, and the Quality Assurance Program.
6.4.5 The approved, current revision, of procedures and drawings shall be strictly followed in accomplishment of work and shall be available at the work location where the activity will be performed (when applicable) prior to commencing work, Measures shall be established to assure continued use of approved, current revision documents.
6.4.6 Provisions shall be made for the review of procedures (Those procedures described in Reg. Guide 1.33) as required by plant commitment by an individual knowledgeable in the area affected to determine the need for changes.
7.0 INDOCTRINATIONAND TRAINING 7.1 SCOPE This section establishes the requirements for providing indoctrination and training for personnel performing activities affecting quality.
7.2 RESPONSIBILITY Each department head responsible for activities affecting quality shall ensure the requirements of this section are implemented within his area of responsibility.
7.3 REGULATORY COMMITMENTS This section utilized in conjunction with Regulatory Guides 1.8, 1.33 and 1.58, American National Standards Institute ANSI N3.1, ANSI N18.7 and ANSI N45.2.6 as committed in Sections 1.8 and 17.3 of the (U)FSAR, establishes the requirements essential to comply with the associated portions of 10CFR50 Appendix B.
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7.4 GENERAL REQUIREMENTS 7.4.1 Training procedures shall be developed and implemented which encompass training, retraining, qualifications, and certifications of qualification, as required. Scope, method and objective of indoctrination and training shall be documented.
7.4.2 Personnel, both on-site and off-site, within the Carolina Power 8 Light (CP&L) organization performing activities affecting quality shall be indoctrinated and trained such that they are knowledgeable in the applicable quality-related procedures and requirements. Provisions to assure that these personnel remain proficient shall be made. The indoctrination and training program assures that:
7.4.2,1 Personnel responsible for performing activities affecting quality are instructed as to the purpose, scope, and implementation of the quality-related manuals and procedures.
7.4.2,2 Personnel performing/verifying activities affecting quality are trained and qualified in the principles and techniques of the activity being performed.
e 7.4.2.3 Proficiency and knowledge of personnel performing activities affecting quality is maintained by retraining, reexamining, and/or recertifying.
7.4.2A Formal training and qualification programs require documentation which includes objective, content of program, attendees, and dates of attendance.
7.4.3 Temporary personnel, both CP&L and/or contractors, are also trained in the categories in Section 7.4.2 to the extent necessary to assure safe execution of their duties.
7.4.4 Personnel within the operating organization performing duties of a licensed operator are indoctrinated, trained, and qualified as required by 10CFR55.
7.4.5 When specified in procedures, personnel performing welding, weld repair, brazing, heat treating, or other special processes shall be qualified and certified as set forth in the American Society of Mechanical Engineers Code,Section IX, and/or other applicable requirements.
7.5 TRAINING RECORDS Records of personnel qualification and certification shall be maintained as required by procedures.
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7.6 QUALIFICATIONAND CERTIFICATION OF INSPECTION AND NONDESTRUCTIVE EXAMINATION(NDE) PERSONNEL 7.6.1 Personnel performing inspection, review, examination and testing, evaluations of inspection data, and reporting of inspection and test results will be qualified and certified, based on CP8 L's commitment to Regulatory Guide 1.58.
7.6.2 Prior to certification, NDE personnel shall have satisfactorily passed an examination administered under the jurisdiction of a certified Level III in accordance with Recommended Practice SNT-TC-1A, "Personnel Qualification and Certification In Nondestructive Testing." Authority to certify CP8 L Level III NDE personnel will be specified in CP8 L's NDE procedures.
8.0 CALIBRATIONCONTROL 8.1 SCOPE This section sets forth the requirements to establish those measures which will assure that measuring and test equipment (M&TE) is properly controlled and calibrated.
8.2 RESPONSIBILITY Each organization has the responsibility for the calibration of the items in the Calibration Program. As a minimum, the following types of items shall be included in the Calibration Program:
8.2.1 Instruments and control equipment required to be calibrated by the plant Technical Specifications 8.2.2 Instruments and equipment used to verify data points required by the plant Technical Specifications 8.2.3 Active safety-related instrumentation 8.2.4 Special tools; e.g torque wrenches, micrometers, etc.
8.2.5 Portable measuring and test equipment (P-M&TE) 8.2.6 Calibration standards 8.2.7 Nondestructive examination (NDE) equipment utilized for NDE examinationslinspections. (NDE instruments used by NDE are not traceable to NIST or any other nationally recognized standard and do not fall under the chart depicted in Section 8.4.2) ~
NOTE: UT calibration blocks (used to set up ultrasonic NDE equipment); hardness test blocks (used to verify proper operation of the QC Receipt Inspection portable hardness testers); and Alloy Analyzer Test Specimens (used to verify proper operation of the QC Receipt Inspection Alloy Analyzers), are not considered as M&TE under CP8 L's QAP, and as such, are not included in the calibration program. This does not preclude controls necessary NGGM-PM<007 Rev. 1 Page 44 of 99
to assure that each block meets applicable requirements prior to their initial release for use.
The responsibility for carrying out the requirements of this section shall be established by the appropriate section manager in procedures. The following sections define the structure within which calibration shall be controlled.
8.3 REGULATORY COMMITMENTS This section utilized in conjunction with (U)FSAR Section 17.3 establishes the requirements essential to comply with the associated portions of 10CFR50 Appendix B.
8.4 GENERAL 8.4.1 Calibration frequency For those instruments and devices required to be calibrated by the Technical Specifications, the frequency shall be at least as frequent as the Technical Specification frequency. Special tools shall be calibrated at specified frequencies or prior to use. Frequency of calibration for the other items in the Calibration Program shall be based upon one or more of the following:
8.4.1.1 Required accuracy 8.4.1.2 Purpose 8.4.1.3 Degree of usage 8.4.1.4 Stability characteristics 8.4.1.5 Other conditions affecting the measurement 8.4.1.6 Manufacturer's recommendation 8.4.1.7 Governing Codes and Specifications Special calibrations shall be performed when the accuracy of either installed or calibrating equipment is questionable 8.4.2 Calibration standards Items in the Calibration Program shall have a known valid relationship to a nationally recognized standard; or where national standards do not exist, the basis for the calibration shall be documented.
The relationship between items in the Calibration Program and the devices that they are calibrated to shall be:
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NATIONALLYRECOGNIZED STANDARD Greater than Tolerance PRIMARY (SHOP)
STANDARD and/or Items in Section 8.2.6 Ratio 4:1 Tolerance FIELD (WORKING)
STANDARD and/or Items in Section 8,2.5 Greater than Tolerance Items in Sections 8.2.1, 8.2.2, 8.2.3 Equipment used both for calibration of installed instruments and to calibrate other standards shall be considered as P-M&TE.
Special tools (8.2.4) shall be calibrated to within the accuracy of the manufacturer's guarantee. Standards used in the calibration of special tools shall have a relationship to a calibrating standard which is equal to or greater than the accuracy of the special tool calibration standard.
In those cases where the given accuracy is not achievable or practicable, an evaluation shall be performed and documented to justify acceptability of the calibration accuracy in question.
8.5 CALIBRATIONPROGRAM A Calibration Program shall be developed and maintained up to date. The program will cover the type of equipment identified in Section 8.2 and, as a minimum, the program shall include:
8.5.1 Provisions for the review and approval of calibration procedures or instructions to include the review and approval of any vendor technical manual/document used in lieu of step-by-step directions for calibration.
NOTE: Procedures used by vendors on the Approved Supplier's List for calibration services have been reviewed as part of the original qualification. For specific applications, requesting organizations should ask for and review calibration procedures prior to use. This section allows a CP8 L organization to incorporate vendor instructions (after suitable review) instead of writing their own should they NGGM-PM%007 Rev. 1 Page 46 of 99
desire to perform the calibration.
8.5.2 Provisions to properly control calibrations performed by vendors and contractors. The vendor/contractor shall certify the traceability in accordance with the procurement document.
8.5.3 Provisions for performing the required calibration at the prescribed frequencies.
8.5.4 Provisions for the establishment and maintenance of a master schedule reflecting the status of planned calibrations.
8.5.5 Unique identification of each item in the Calibration Program so that traceability to the calibration data is possible. This identification shall be clearly visible on or with the equipment; e.g., Test Gauge 8, 2-CAC-AQH-l264.
8.5.6 Status of calibration for M&TE is provided for through the use of tags, stickers, labels, routing cards, computer programs, or other suitable means.
The status indicators indicate the date recalibration is due or the frequency of recalibration.
8.5.7 Provisions as to the action required if P-M&TE is out of calibration. Such action shall include a documented review to determine the validity of past calibrations, measurements, or monitored parameters.
8.5.8 Action to be taken in the case of repetitive out of calibration of any M&TE and the cause of the out-of-calibration conditions shall be determined.
Corrective action such as repair, replacing the equipment, or increasing the frequency of its calibration shall be taken to prevent recurrence.
Identification of the condition, the cause, and the corrective action taken shall be documented and reported to the appropriate foreman/supervisor.
8.5.9 Provisions to provide for the evaluation of the calibration data to ensure conformance to acceptance criteria by a responsible group or individual ~
8.5.10 Provisions to require and document corrective actions required following calibrations which do not meet the acceptance criteria.
.8.5.11 Provisions to document the permission by operating personnel to remove from service installed items to be calibrated.
8.5.12 Provisions for providing the environmental conditions required for the performance of the calibration (e.g., location, cleanliness requirements, temperature, etc.).
8.5.13 Provisions to ensure items in the Calibration Program that are calibrated by CP&L are calibrated in accordance with procedures. These procedures shall:
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8.5.13.1 Identify the item(s) to which it applies.
8.5.13.2 Contain a description of objectives.
8.5.13.3 Contain the acceptance criteria that will be used to evaluate the results.
8.5.13.4 Contain prerequisites for performing the calibration including any special conditions to be used to simulate normal or abnormal operating conditions.
8.5.13.5 Contain limiting conditions.
8.5.13.6 Specify special equipment or calibrations required to conduct the calibration.
8.5.13.7 Prescribe the appropriate documentation requirements (e.g.,
data forms to be used, test data to be recorded, etc.).
8.5.13.8 Contain step-by-step instructions in the degree of detail necessary for performing the calibration.
8.5.13.9 Require the recording of:
8.5.13.9.1 Calibration date.
8.5.13.9.2 Identification of those performing calibration.
8.5.13.9.3 As-found condition.
8.5.13.9.4 As-left condition.
8.5.13.9.5 The standard or other item of M&TE used to perform the calibration in order to maintain traceability, including the calibration date and serial number or unique instrument identification number.
8.6 RECORDS The following documents shall be filed as QA Records:
8.6.1 Out-of-calibration documentation.
8.6.2 Calibration certificates for reference standards.
8.6.3 Completed calibration document(s).
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9.0 SURVEILLANCE This section was deleted with the implementation of the assessment program.
10.0 PLANT OPERATIONS CONTROL 10.1 SCOPE This section sets forth requirements for the control of plant operations. Plant operations control assures that the quality of installed plant items is not degraded and that the quality of operations is not compromised.
10.2 REGULATORY COMMITMENTS This section utilized in conjunction with (U)FSAR Section 17.3 establishes the requirements essential to comply with the associated portions of 10CFR50 Appendix B.
10.3 OPERATIONAL CONTROL 10.3.1 Plant operations shall be controlled and conducted in accordance with procedures. These procedures shall be contained within the Plant Operating Manual and shall provide for normal and emergency plant operations including response to abnormal operating conditions and the conditions described in the emergency plan.
10.3.2 Procedures shall be developed and approved which prescribe those measures to be employed when the operating capability of plant items is restricted or limited. These conditions shall be positively identified by tagging or other controls as a means to prevent inadvertent operation or use.
10.4 OPERATING LOGS AND RECORDS Applicable logs and records shall be maintained to support the reporting and record-keeping requirements of the plant Technical Specifications. Completed logs and records relating to plant operations shall be reviewed for accuracy and completeness and maintained in accordance with Section 14.0.
10.5 INSTALLED PLANT ITEMS 10.5.1 Installed items shall be tested in accordance with procedures.
I 0.5.2 When an installed item does not conform to test, design, installation specifications, or other requirements, action shall be initiated as set forth in Sections 3.0, 11.0, or 12.0 to correct or replace the item.
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LJ 10.5.3 Whenever an installed item is inoperative, nonconforming, or malfunctioning, the system and/or item shall be tagged or otherwise identified in accordance with procedures to prevent erroneous operation and, if necessary, inadvertent use. Corrective action shall be documented in accordance with Sections 3.0, 11.0, or 12.0.
11.0 MAINTENANCECONTROL
'11.1 SCOPE This section sets forth requirements for procedures to be applied at operating plants for maintenance. This section includes re'quirements for work planning and preparation to assure that maintenance procedures are adequate, prerequisites are met, maintenance is accomplished under suitably controlled conditions, and the functional capability and quality intended by the design is maintained.
11.2 REGULATORY COMMITMENTS This section utilized in conjunction with (U)FSAR Section 17.3 establishes the requirements essential to control maintenance activities in accordance with the associated portion of 10CFR50 Appendix B.
11.3 MAINTENANCEPROCEDURES 11.3.1 Procedures shall be applied to control maintenance of safety-related items.
Maintenance procedures will include the following information, as appropriate:
11.3.1.1 Requirements for indoctrination, training, and skills.
11.3.1.2 Prerequisites for special environments, equipment, tools, and material preparation.
11.3.1.3 Provisions for data collection and reporting.
11.3.1.4 Instructions for documentation of work performed.
11.3.1.5 Requirements for verification of functional capability and quality by inspection, witnessing, examination, testing including specified mandatory holdpoints, and special processes.
11.3.1.6 Quantitative and qualitative criteria for determining that important steps or functions have been satisfactorily accomplished.
11.3.2 Certain maintenance activities which involve skills normally possessed by qualified personnel may not require detailed step-by-step delineation in a procedure. The following types of activities are among those that may not require detailed step-by-step written procedures:
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11.3.2.1 Gasket replacement.
11.3.2.2 Troubleshooting electrical circuits.
11.3.2.3 Changing chart or drive speed gears or slide wires on recorders.
11.3.2.4 Packing adjustment or replacement.
lt is the responsibility of maintenance supervision to determine if the job is within the skill of the craftsman.
11.4 CORRECTIVE MAINTENANCE 11.4.1 Maintenance activities at the plant which affect the quality of items shall be prescribed in procedures and accomplished as prescribed therein. To meet this requirement, one or more procedures are necessary for:
11,4.1.1 Processes of rework or repair that establish the functional capability or quality of items which require step-by-step delineation.
11 4.1.2 Tests and examinations that determine or verify the functional capability or quality of items.
11.4.1.3 Material protection measures that prevent damage and deterioration of items during handling, storage, and other maintenance activities.
1 1.4.1.4 Processes, tests, and handling which, unless controlled, may degrade the functional capability or quality of an item.
11.4.2 Work planning.
11 A.2.1 Maintenance programs shall prescribe the preplanning and preparation necessary to ensure the required materials and equipment are available and that work procedures are adequate.
11.4.3 Work execution.
11.4.3.1 Maintenance of items shall be accomplished as prescribed in procedures. Work execution shall include, as a minimum:
11.4.3.1.1 Assurance that prerequisites have been satisfied prior to performance.
11.4.3.1.2 The establishment of prescribed environmental conditions for accomplishing the activity such as adequate cleanliness or an inert atmosphere.
11.4.3.1.3 The use of appropriate equipment.
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11.4.3.1.4 Control and accomplishment of special processes by qualified personnel and procedures.
11.4.3.1.5 Provisions for assuring that proper item identification for traceability is maintained.
11.4.3.2 Tests shall be conducted when necessary to determine that a new, reworked, or repaired item will perform satisfactorily in service.
11.5 PREVENTIVE MAINTENANCE A preventive maintenance program shall be developed and implemented in accordance with procedures. Preventive maintenance procedures shall consider manufacturer recommendations and plant operating and maintenance experience.
'I1.6 USE OF MATERIAL Items used for maintenance shall be in accordance with requirements contained in controlled documents or as specified in a controlled information management system. If items cannot be determined to be correct for the intended application, the responsible personnel shall request engineering determination of the adequacy of the item for its intended use. This determination shall be documented and referenced on or attached to the work request, or shall be documented in accordance with approved procedures.
12.0 CONDITIONS ADVERSE TO QUALITY(CATQ) AND CORRECTIVE ACTION 12.1 SCOPE This section sets forth requirements for reporting, controlling, and dispositioning CATQ.
12.2 RESPONSIBILITY The responsibility for carrying out the requirements of this section shall be established by procedures.
12.3 REGULATORY COMMITMENTS This section utilized in conjunction with (U)FSAR Section 17.3 establishes the requirements essential to comply with the associated portions of 10CFR50 Appendix B.
12A GENERAL 12.4.1 Personnel are responsible for reporting to their supervision conditions adverse to quality (CATQ), discovered as a result of inspections, observations, surveillance, assessments, monitoring, audits, tests, checks, and review of documents.
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12.4.2 CATQ shall be documented, controlled, and dispositioned in accordance with this section. In-process control documents may be used provided:
12.4.2.1 The condition is corrected before final acceptance of the work.
12.4.2.2 Work does not go beyond a holdpoint to the point of prohibiting the required inspections.
12.4.2.3 The condition does not adversely affect work previously accepted.
12.5 IDENTIFICATION,CONTROL, AND DISPOSITION 12.5.1 Procedures to control CATQ shall provide for the following:
12.5.1.1 Identification of nonconforming items by tags, labels, or other appropriate status indicators. This status identification shall remain with the item or in records traceable to the item until the disposition is complete and accepted.
12,5.1.2 Segregation of uninstalled nonconforming items, if practical, to prevent inadvertent use pending proper disposition and/or reinspection.
12.5.1.3 Identification and prompt notification of individuals or organizations responsible for disposition of the condition.
12.5.1.4 Preparation of appropriate documents which identify and describe the condition; provide for proper evaluation; and provide for disposition including reinspection, testing, or other verification to determine the acceptability and proper implementation of the disposition.
12.5.1.5 Verification of the acceptability of rework/repair of items by reinspection or testing of the item as originally performed or by methods equivalent to the original inspection or testing methods, 12.5.1.6 Assurance that corrective action appropriate for the condition is determined and scheduled for timely implementation.
12.5.1.7 initiation of stop-work action in the event an activity or condition presents a threat to personnel safety or plant equipment.
12.5.1.8 Escalation to appropriate levels of management to obtain, resolution of disagreements between responsible organizations.
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12.5.2 Documents identifying CATQ should be reviewed in a timely manner and, if a CATQ is confirmed, evaluated for significance and issued. Guidance for this evaluation is provided in Section 12.7. Action to determine appropriate disposition and corrective measures should be initiated.
If the condition is not confirmed, the initiating document shall be canceled, the basis for cancellation noted on the document, and the document shall be placed in a permanent file.
12.5.3 For significant conditions adverse to quality (SCATQ), the root cause of the condition, corrective action, and action to preclude repetition shall be determined, documented, and reported to appropriate levels of management.
12.6 REPAIR OR USE-AS-IS DISPOSITIONS 12.6.1 When it is proposed to repair or to "use-as-is" a nonconforming item, an engineering evaluation shall be conducted before performing the repair or using the item.
12.6.2 Engineering evaluations to repair or "use-as-is" shall include documentation verifying the acceptability of the nonconforming item or condition being repaired or used as is.
12.6.3 Engineering evaluations shall be performed in accordance with procedures by personnel technically competent in the area of the nonconforming item or condition.
12.7 SIGNIFICANCE EVALUATIONGUIDANCE 12.7.1 In determining if a condition is significant, the following criteria should be considered:
12.7.1.1 Adverse condition.
A deficiency, failure, malfunction, deviation, abnormal occurrence, defective material or equipment, or nonconformance in an item or activity which has affected or reasonably could affect:
12.7.1.1.1 Nuclear safety or quality.
12.7.1.1.2 Compliance with other regulations not included in nuclear safety or quality above.
12.7.1.1.3 Personnel safety.
12.7.1.1.4 Plant reliability.
12.7.1.1.5 Commercial concerns.
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Adverse conditions may be performance-based, reliability-based, dimensional, material properties, testing, supporting documentation, etc.
12.7.1.2 CATQ.
An adverse condition associated with activities affecting the quality of structures, systems, components, programs, procedures, or documents that are subject to this QAP (I.e., Q-List, FP-Q, RW-Q, 10CFR71-Q, 10CFR72-Q, seismically qualified, equipment used to verify technical specification requirements, etc.)'2.7.1.3 SCATQ.
A CATQ which is important to the degree that action to preclude repetition is deemed appropriate by management. At a minimum, the following CATQs shall be considered SCATQs:
12.7.1.3.1 Severe or unusual plant transients.
12.7.1.3.2 A significant degradation in the ability of a safety system to perform its function.
12.7.1.3.3 Events involving nuclear safety that had a strong potential to be more severe if different conditions that could be reasonably expected had been present.
12.7.1.3.4 Discover of a deficiency in an area such as design, analysis, operation, maintenance, testing, procedures, or training that is likely to cause a SCATQ in any of the items above.
13.0 ASSESSMENTS 13.1 SCOPE The Assessment Program is designed to independently evaluate those company functions which have potential Nuclear Safety, Reliability or Quality Implications. The process is performance based using real time observation, interview and review techniques. Included in the program is the determination of each Nuclear Generation Group organization's ability to self evaluate its activities, identify needed improvements and deficiencies, and accomplish the appropriate corrective action.
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13.2 QUALIFICATIONS Personnel performing assessments shall have appropriate training and qualifications.
They shall have no direct responsibilities in the areas they assess.
13.3 REGULATORY COMMITMENTS This section used in conjunction with Regulatory Guides 1.144 and 1.146, American National Standards Institute N45.2.12, N45.2.23 and N18.7 as committed in Section 1.8 and Section 17.3.3.3, Independent Assessments, of the (U)FSAR, establishes the requirements essential for compliance with the associated portions of 10CFR50 Appendix B.
13.4 GENERAL Assessments will be performed at nuclear plants and CP8 L locations where functions affecting safety-related activities are performed. Assessments are regularly scheduled on the basis of the status and safety importance of the activity being performed. Assessments will verify compliance, determine the effectiveness, and evaluate the QAP against performance objectives and QAP requirements, Assessment frequencies are based on the Plant Technical Specifications, (U)FSAR commitments, and QAP Manual requirements and are maintained in commitment matrices by each assessment organization, Assessments shall be planned, conducted, and reported in accordance with procedures.
13.4.1 Assessments will focus on areas of potential improvement based on indicators such as previous assessment data, industry experience, regulatory sensitivity, and input from NGG Management.
13.4.2 The assessment process may include objective evaluation of line management's self assessment effectiveness, inspection of areas, observation of work activities and processes, interviews with personnel and review of documentation and procedures.
13.4.3 Assessment personnel are to maintain their independence of activities for which they are responsible for assessing. This independence should be sufficiently clear so as to avoid even the perception that they are in some way not independent. This, however, should in no way impede or dilute meaningful dialogue between assessors and assessed individuals and organizations.
13.5 ADVERSE CONDITIONS Adverse conditions identified during the assessment process will be documented in accordance with Section 12.0.
13.6 REPORTS Assessment results will be documented and distributed to appropriate levels of management.
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Each assessment report will include documentation indicating the areas assessed, the appropriate QAP Manual requirement, and the commitment met by the assessment, as appropriate.
13.7 FOLLOW-UP Follow-up is accomplished to assure that corrective action is taken as a result of the assessment and that deficient areas are reassessed, when necessary, to verify effectiveness of corrective actions.
14.0 QUALITYASSURANCE (QA) RECORDS AND DOCUMENT CONTROL 14.1 SCOPE This section establishes the requirements for accumulation, maintenance, and retention of QA Records associated with the nuclear plants and establishes requirements for control of documents relative to activities affecting quality. QA Records are those records which furnish documentary evidence of the quality of items and of activities affecting quality.
14.2 REGULATORY COMMITMENTS This section used in conjunction with American National Standards Institute N45.2.9 and N18.7, and Sections 1.8 and 17.3 as committed in the (U)FSAR establishes the requirements for compliance with the associated portions of 10CFR50 Appendix B.
14.3 QA RECORDS 14.3.1 Requirements for implementation.
As required by procurement documents, vendors and contractors shall provide for accumulation and organization of those documents generated in their work that are required to be submitted for retention as QA Records.
Upon completion of work by vendors and contractors, these records shall be transferred to Carolina Power 8 Light (CP8 L) or its agent unless, by contractual agreement, the vendor or contractor will retain the records for
. CP8 L for the required periods mutually agreed upon. Collection, storage, and maintenance of records shall be in accordance with commitments to Regulatory Guide 1.88 and/or ANSI N45.2.9 and the plant Technical Specifications.
14.3.2 QA Records accumulation, maintenance, and retention.
14.3.2.1 The responsible individual or organization shall provide for accumulation and organization of documents designated as in accordance with procedures. Documents shall be QA'ecords identifiable and retrievable.
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14.3.2.2 Documents designated for retention shall be transferred in an organized manner for filing as QA Records. The documents shall be checked to verify that they are complete, properly identified, and that required documents are included.
14.3.2.3 QA Records shall be retained as part of the records system at, the plant, unless by contractual agreement they are retained by an agent, vendor, or contractor for CPB L. QA Records may be maintained by other CP&L organizations as agents for a nuclear plant department as long as the agreement is covered by an approved document. The QA Records will be filed and maintained in facilities that prevent deterioration or damage to documents and shall be controlled to prevent loss. QA Records shall be organized and filed so that each document is identifiable, retrievable, and shall preclude deterioration of the records. QA Records shall be indexed.
14.4 DOCUMENT CONTROL 14.4.1 Appropriate document control procedures shall be established to identify those individuals or groups responsible for reviewing, approving, revising, and issuing documents.
Examples of documents which are to be controlled include:
14.4.1.1 Design documents (e.g., calculations, drawings, specifications, and analyses) including documents relating to computer codes.
14.4.1.2 Procurement documents 14.4.1.3 Quality Assurance Program Manual 14.4.1.4 Maintenance, modification, engineering, and operating procedures 14.4.1.5 Final Safety Analysis Report 14.4.1.6 Conditions adverse to quality.
14.4.1.7 Operating license/Technical Specification.
14.4.2 Procedures shall require that changes to documents be reviewed and approved prior to implementation by the same organization that performed the original review and approval or by other designated, qualified responsible organizations.
14.4.3 Procedures shall establish measures that assure current approved documents are used in accomplishment of work activities as well as in procedure and design document development or changes. Methods shall be implemented that preclude the use, or inadvertent use, of obsolete or superseded documents.
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14.4.4 Controlling procedures for document control shall specify methods for identifying the current revision and status of plant procedures, design documents, modifications and change documents. These procedures shall also provide methods for identifying outstanding changes to procedures and design documents.
15.0 QUALITYASSURANCE (QA) PROGRAM FOR FIRE PROTECTION SYSTEMS 15.1 SCOPE This section sets forth the QAP requirements for permanent plant fire protection related systems, equipment, and administrative programs.
15.2 REGULATORY COMMITMENTS The QAP delineated in this section incorporates the appropriate requirements of Branch Technical Position 9.5.-1, Appendix A; Appendix R to 10CFR50; commitments to the 1977 Nuclear Regulatory Commission "Administrative Controls for Fire Protection for Nuclear Power Plants" letter; and appropriate National Fire Protection Association codes and standards to the extent required by plant commitments. This section is to be used in conjunction with the (U)FSAR and Technical Specifications of each nuclear plant. Sections 1.0 through 14.0 of the QAP Manual apply only to the extent referenced in this section.
15.3 'ROGRAM MANAGEMENTAND OBJECTIVES 15.3.1 The Plant General Managers at the three nuclear plants are responsible for the overall administration of the Fire Protection Program and provide the plant point of control and contact for contingencies. They may delegate their authority as appropriate to others; however, they shall not delegate their responsibility. The Plant General ManagerslDirector - Site Operations shall direct a documented program of QA for items designated as fire protection related. The program shall accomplish the following:
15.3.1.1 Provide controls for inspection, installation, corrective maintenance, modifications, and material acceptance activities for designated fire protection related items.
15.3.1.2 Verify compliance with governing procedures of the Fire Protection Program.
15.3.1.3 Provide adequate QA controls for designated fire protection related items to ensure the maintenance of an effective Fire Protection Program.
15,3.2 The Fire Protection Program shall include procedures and controls to accomplish the following:
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15.3.2.1 Coordinate Fire Protection Program activities.
1 5.3.2.2 Prepare procedures and instructions which implement the Fire Protection Program.
1 5.3.2.3 Assure development and technical adequacy of training materials and sources related to fire protection related and assign qualified fire protection instructors.
15.3.2.4 Listing those fire protection items which are subject to the Fire Protection Program.
15.3.2,5 Periodic monitoring of fire protection related activities.
15.3.2.6 Assure that corrective maintenance and modifications of the fire protection related systems comply with Technical Specifications and as appropriate, applicable NFPA Codes and Standards; 10CFR50A8; and 10CFR50, Appendix R Sections III.G, III.J, and III.O.
1 5.3.2.7 Coordinate the arrangements for off-site fire company support and training.
15.3.2.8 Schedule and implement the Fire Drills Program.
15.3.2.9 Establish and maintain minimum equipment for the fire brigade teams.
15.3.2.10 Assign personnel to fire brigade teams.
15.4 DESIGN AND MODIFICATIONCONTROL AND DOCUMENTATION Design activities shall be accomplished in accordance with procedures that assure the applicable design requirements are included and that appropriate reviews are conducted. Design change of fire protection related items shall be prepared, approved, accomplished, and documented in accordance with Section 3.0.
15.5 PROCEDURES AND DRAWINGS Activities such as design, installation, inspection, tests, maintenance, and modification of fire protection related systems shall be accomplished in accordance with procedures and drawings controlled in accordance with Sections 6.0 and 14.0.
15.6 CONTROL OF PURCHASED MATERIALS, EQUIPMENT, AND SERVICES Control of plant purchased materials, equipment, and services with respect to fire protection related items shall be accomplished in accordance with the following for procurement, receiving, and storage:
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15.6.1 Procurement.
Procurement documents for fire protection related items shall be completed in accordance with plant procedures. These procedures shall require:
15.6.1.1 Items to be either Underwriters Laboratories, Inc., listed and/or Factory Mutual approved or accepted, or accepted by American Nuclear Insurance, formerly NEL-PIA or Nuclear Mutual Limited.
or:
15.6.1.2 The item(s) technical and quality requirements are established during the review and approval process for the purchase requisition.
15.6.2 Receiving.
15.6.2.1 Fire protection related items shall be receipt inspected in accordance with procedures, noting in particular; 15.6.2.1.1 Any damage to the item.
15.6.2.1.2 Item identification and marking.
15.6.2.1.3 Any required vendor-supplied documentation.
15.6.2.1.4 Conformance with purchase requirements/
specifications.
15.6.2.2 A receipt inspection report shall be completed for received fire protection related items. Noted deficiencies shall be documented in accordance with Section 12.0.
1 5.6.2.3 Fire protection related items shall be tagged in accordance with procedures.
15.6.3 Storage.
Fire protection related items shall be stored in accordance with plant procedures.
15.7 FIRE PROTECTION SYSTEM TAGOUTS Fire protection related system tagouts shall be accomplished in accordance with procedures.
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15.8 CONDITIONS ADVERSE TO QUALITY(CATQ)
CATQ of fire protection related items shall be identified, reported, dispositioned, and corrected in accordance with Section 12.0.
15.9 QUALITYCONTROL INSPECTIONS A documented program of quality control inspections is required when rework or design changes to those items can impair the ability of the system, equipment, component, or installation to accomplish its intended function.
15.10 FIRE PROTECTION INSPECTIONS The Plant General Manager is responsible for implementing a documented program of periodic inspections which verifies compliance with governing procedures for the following fire protection related activities:
15.10.1 Housekeeping.
15.10.2 Surveillance tests of the fire protection related systems.
15.10.3 Control of ignition sources.
15.10.4 Use of fire watches.
15.10.5 Control of combustibles.
15.10.6 Fire protection related training documentation.
15.10.7 Preventive Maintenance Program.
15.11 PREVENTIVE MAINTENANCE A Preventive Maintenance Program for designated fire protection related items shall be established and implemented in accordance with Section 11.0.
15.12 TESTING Corrective maintenance which affects the function of designated fire protection related items requires post-maintenance testing except where such testing would be destructive. The specific test requirements shall be delineated in accordance with procedures and applicable NFPA codes and standards.
Design changes to fire protection related items require testing to demonstrate that design criteria and the function of the modification are met. The specific test requirements will be delineated in accordance with procedures.
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15.13 ASSESSMENTS Assessments shall be conducted in accordance with Section 13.0.
15.14 AUDITS Fire protection related audits will be performed in accordance with plant Technical Specification.
15.15 RECORDS Those records required to verify compliance with criteria of the Fire Protection Program shall be identifiable and retrievable and shall be assigned retention requirements.
15.16 MATERIALUPGRADING Items not originally procured for application in fire protection related systems shall be evaluated for the intended use prior to installation in accordance with procedures.
16.0 QUALITYASSURANCE (QA) PROGRAM FOR RADIOACTIVEWASTE MANAGEMENTSYSTEMS (Harris Plant Only) 16.1 SCOPE This section establishes the QAP requirements for radioactive waste management systems for use at the Harris Nuclear Plant only.
Maintenance and operation of radioactive waste management systems shall be in accordance with procedures to assure the original design requirements or evaluated alternatives are not compromised.
16.2 REGULATORY COMMITMENTS This section establishes the QAP requirements of Regulatory Guide 1.143 for radioactive waste management systems. These requirements should be applied for design, installation, and initial testing of new radioactive waste management systems when specified by the design organization.
16.3 RESPONSIBILITIES The responsibility for implementation of these requirements is assigned to the applicable department head unless specified in an interface agreement.
16.4 DESIGN AND PROCUREMENT ACTIVITIES 16.4.1 Design and procurement activities shall be accomplished in accordance with procedures. These procedures shall assure that the applicable design requirements are included in design and procurement documents and that appropriate reviews of these documents are conducted. Design changes shall be prepared, approved, accomplished, and documented in accordance NGGM-PM007 Rev. 1 Page 63 of 99
with Section 3.0.
16 4.2 Procurement procedures shall include measures for evaluation of the supplier to assure an appropriate QA system is in place for the items or services to be provided. As an alternative to such a system for American Society of Mechanical Engineers (ASME), Section Vill, or American National Standards Institute (ANSI) B31.1 items, the supplier shall only be required to have a QA system which satisfies the requirements of the ASME Boiler and Pressure Vessel Code, Section Vill, or ANSI B31.1 for boiler external piping.
16.5 MATERIALCONTROL 16.5.1 Material purchased for radioactive waste management systems shall be receipt inspected to assure conformance to technical and QA requirements of the procurement document.
16.5.2 Measures shall be established to control handling, storage, and preservation of material to prevent damage or deterioration.
16.5.3 Measures shall be established to provide for identification of material which has satisfactorily passed required inspections or tests. These measures may include tags, labels, stamps, computer programs, or other suitable means.
16.5.4 Material not originally purchased for radioactive waste management systems may be used providing appropriate evaluations and inspections are performed in accordance with procedures.
16.6 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE)
Control of M&TE used to support activities described in this section shall be in accordance with Section 8.0.
16.7 PROCEDURES AND DRAWINGS Activities described in this section shall be accomplished in accordance with procedures and drawings. These procedures and drawings shall be controlled in accordance with Sections 6.0 and 14.0.
16.8 CORRECTIVE ACTION Conditions adverse to quality shall be identified, reported, dispositioned, and corrected in accordance with Section 12.0.
16.9 RECORDS Measures shall be established to assure sufficient records are maintained to furnish evidence that the activities described in this section are being implemented. These records shall be identifiable and retrievable.
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17.0 IF-300, IRRADIATED FUEL SHIPPING CASK 17.1 SCOPE This section specifies the quality assurance (QA) requirements for the IF-300 irradiated fuel shipping cask.
17.2 REGULATORY COMMITMENTS This section provides for the implementation of the IF-300 Irradiated Fuel Shipping Cask QA program criteria required to comply with the "QA Program Approval for Radioactive Material Packages," Docket 71-0345 which complies with the QA Program requirements of 10CFR71 Subpart H.
17.3 GENERAL 17.3.1 Classification of cask components The following components and parts are 10CFR71 "Important to Safety" and are classified as safety-related. They are subject to QA program requirements contained in this section.
17.3.1.1 Containment
- Cavity End Plate - BWR Head End Plate
- Inner Shell - BWR Head Liner Ring
- Vent Pipe Assembly - BWR Sleeve Nuts
- Locating Key - PWR Sleeve Nuts
- Body Flange - Studs
- PWR Head Forging - Cavity Globe Valves.
- PWR Head Subassembly - Valve Pipe Cap or Plug
- BWR Head Forging - Valve Hardware
- BWR Head Liner - Grayloc Seal Ring
- Trunnion Assembly - Fins
- Valve Boxes - Cavity Drain Line Assembly
- Rupture Disk Device 17.3.1.2 Nuclear shielding:
Uranium shield (cask barrel, closure head, bottom, basket shield), neutron shield (corrugated barrel, valve boxes, expansion tank, piping, valves, blind flanges, liquid).
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17.3.1.3 Criticality control:
- BWR basket
- PWR basket 17A ORGANIZATION Organization and responsibilities are as described in Section 2.0.
17.5 DESIGN CONTROL Design control shall be controlled as required by Section 3.0.
17.6 PROCUREMENT DOCUMENT CONTROL The procurement of safety-related items and services shall be per the requirements of Section 4.0. To the extent necessary, suppliers are required to implement a QA program that meets Appendix 8 to 10CFR50 or Subpart H, 10CFR71. Safety-related parts shall be inspected, stored, and handled in accordance with plant procedures which meet Section 5.0.
17.7 PROCEDURES AND DRAWINGS Cask loading, unloading, tests, and inspections are performed in accordance with procedures and drawings which are approved in accordance with Section 6.0. These procedures and drawings shall implement the requirements of the cask Certificate of Compliance.
17.8 DOCUMENT CONTROL Documents relative to IF-300 activities shall be controlled as required by Section 14.0.
17.9 IDENTIFICATIONAND CONTROL OF MATERIALS, PARTS, AND COMPONENTS The identification and control of materials, parts, and components for the IF-300 cask shall be as described in Section 5.0.
17.10 CONTROL OF SPECIAL PROCESSES Special processes shall be performed per the requirements of Section 11.0.
17.11 INSPECTIONS AND TEST CONTROL Inspections and tests required by the IF-300 Certificate of Compliance shall be performed in accordance with the applicable portions of Section 11.0.
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17.12 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE)
M&TE used for the IF-300 shall be calibrated and controlled as required by Section 8.0.
17.13 HANDLING, STORAGE, AND SHIPPING Shipping of the IF-300 shall be in accordance with 49CFR and 10CFR71. Handling and storage shall be performed in accordance with procedures.
17.14 INSPECTION, TEST, AND OPERATING STATUS Prior to placing the IF-300 cask in operation, certain preliminary tests shall be performed in accordance with procedures. These functional tests are designed to meet the requirements of the Certificate of Compliance for the IF-300 and Carolina Power 8 Light administrative controls.
Routine inspection of cask systems and components shall be accomplished in accordance with procedures. Where applicable, the manufacturer's recommended inspection intervals should be followed.
17.15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS Conditions adverse to quality (CATQ) shall be controlled and dispositioned in accordance with Section 12.0.
17.16 CORRECTIVE ACTION CATQ shall be controlled and dispositioned in accordance with Section 12.0.
17.17 QA RECORDS Measures shall be established to assure sufficient records to furnish evidence that the activities described in this section are being implemented and records required by 10CFR71 are maintained in accordance with Section 14.0.
17.18 AUDITS/ASSESSMENTS Audits/Assessments of the IF-300 cask activities shall be conducted in accordance with Sections 4.0 & 13.0.
18.0 RADIOACTIVEMATERIALPACKAGES QUALITYASSURANCE (QA) PROGRAM 18.1 SCOPE This section establishes the QA requirements for activities associated with the procurement, testing, maintenance, repair, and use of "non LSA greater than Type A" packages as required by 10CFR71, Subpart H, other than the IF-300. The Quality Assurance Program (QAP) for the If-300 is provided in Section 17.0 of the QAP Manual. This section also provides for management-controlled audits as required by 10CFR20.311.
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18.2 REGULATORY COMMITMENTS This section provides the implementation criteria required to comply with the "QA Program Approval for Radioactive Material Packages," Docket 71-0345 which complies with the QA Program requirements of 10CFR71 Subpart H.
18.3 ORGANIZATION Organization and responsibilities are provided in Section 2.0.
18.4 DESIGN CONTROL Design control shall be the responsibility of the package owner or manufacturer in the case of packages that are purchased by CP8 L.
18.5 PROCUREMENT DOCUMENT CONTROL Procurement documents:
Procurement documents shall:
~ Require the package owner/manufacturer/ to have a Nuclear Regulatory Commission (NRC) approved QA program that meets the requirements of 10CFR71, Subpart H.
~ Require the owner/manufacturer to submit current documentation attesting that the packaging was designed, procured, fabricated, assembled, tested, modified, repaired, and maintained in accordance with an NRC-approved quality assurance program.
~ Designate other pertinent documentation to be furnished with the packaging (e.g., certificate of compliance, as-built drawings, photographs, sketches, use and maintenance manuals)
A royal of Vendors Where procurement documents require the vendor to implement a quality assurance (QA) program that complies with 10CFR71, Subpart H, approval of this program by the NRC shall be confirmed prior to issuance of the purchase order or contract.
Monitoring of supplier performance and continued qualification shall be documented in accordance with procedures. In the event replacement parts for the packagings are required, procurement of the parts shall be made by the packaging owner in accordance with the packaging owner's QA program.
18.6 PROCEDURES AND DRAWINGS Package loading, unloading, filling, and inspections are performed in accordance with procedures and drawings which are approved in accordance with Section 6.0 and comply with the package Certificate of Compliance, NGGM-PM007 Rev. 1 Page 68 of 99
18.7 DOCUMENT CONTROL Documents relative to activities performed by Carolina Power 8 Light (CP&L) shall be controlled as required by Section 14.0.
18.8 CONTROL OF PURCHASED MATERIALS, EQUIPMENT, AND SERVICES Inspections shall be performed upon receipt of packaging to verify compliance with procurement documents. The criteria for acceptance of each of these inspections and the action to be taken if noncompliance is encountered is established in applicable plant procedures.
18.9 IDENTIFICATIONAND CONTROL OF MATERIALS, PARTS, AND COMPONENTS Reference Section 18.5.
18.10 CONTROL OF SPECIAL PROCESSES Special processes required shall be performed by the package owner.
18.11 INSPECTIONS While packages are at CP&L facilities, inspections required by the Certificate of Compliance and by the package owner/manufacturer will be performed in accordance with Section 11.0. Packages owned by CP8 L shall be inspected and maintained in accordance with procedures and drawings that are approved in accordance with Section 6.0.
18.12 TEST CONTROL Tests required by the Certificate of Compliance shall be performed by the package owner/manufacturer in accordance with their NRC-approved QA program while the package is in their physical possession. Prior to a shipment, CP8L shall perform tests as required by the Certificate of Compliance and 10CFR71.
'I8.13 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE)
M&TE used by CP&L shall be calibrated and controlled as required by Section 8.0.
18.14 HANDLING, STORAGE, AND SHIPPING Shipping of packages shall be in accordance with 10CFR71. Handling shall be performed in accordance with procedures. In the event CP8 L stores a package, storage shall be in accordance with the package owner instructions.
'I8.15 INSPECTION, TEST, AND OPERATING STATUS While a package is located on CP8 L property, the status of the package shall be in accordance with the applicable sections of the QAP Manual.
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18.16 CONDITIONS ADVERSE TO QUALITY(CATQ) AND CORRECTIVE ACTION CATQ identified while on CP&L property shall be controlled and dispositioned in accordance with Section 12.0.
18.17 QA RECORDS Those records required by 10CFR71 which are generated by CP&L shall be retained in accordance with Section 14.0.
18.18 AUDITS/ASSESSMENTS Audits/Assessments of the Radioactive Material Packaging Program including the package contractor's activities shall be conducted in accordance with Sections 4.0 and 13.0.
19.0 SOFTWARE QUALITYASSURANCE (QA) PROGRAM 19.1 SCOPE 19.1.1 This section provides detailed requirements which establish the Graded Approach to Quality for Software. The purpose of this section is to prescribe software configuration control requirements, define controls applicable to quality software/computing systems, and identify software life cycle requirements that establish the Nuclear Generation Group (NGG) Software Quality Assurance Program. Procedures that meet the requirements delineated in this section for quality software/computing systems shall be used to implement these controls. Controls are applied in a graded manner to software/computing systems which are outside safety related processes.
19.1.2 Items which have "self contained" digital processors or software (i.e. components that do not rely upon or interface with other software) that are periodically verified and validated are exempted from the scope of this program. This includes the following examples:
Digital instrumentation and control equipment (e.g. digital transmitters) subject to technical specification surveillance testing or periodic testing (e.g. periodic maintenance route).
Measuring and Testing Equipment (MBTE) which has in-process calibration to recognized standards or is in a site's calibration program.
- 3. Laboratory instruments utilizing software recognized as a national standard.
Changes to the simulator computer are exempted from this program because they are controlled by direct regulatory commitments.
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19.1.3 Industry guidance documents on software quality assurance such as IEEE, ANSI, ANS, ASME, NUSMG, and NIRMA may be used for reference purposes.
19.2 REGULATORY COMMITMENTS None.
19.3 RESPONSIBILITIES OF CAROLINA POWER & LIGHT (CP&L)
The responsibility for implementing this section is assigned to each nuclear organization that procures, develops, tests, verifies, uses, changes, maintains or retires quality software/computing systems. All quality software/computing systems shall be developed, tested, verified, used, and maintained under controlled conditions as appropriate based upon its importance to nuclear safety. A list of quality software/computing systems that support safety related work shall be maintained.
19.4 PROGRAM 19A.1 Graded Approach to Software Quality Level Determination The Software Quality Level is commensurate with the software's importance to nuclear safety. The most rigid controls are applied to quality software/computing systems based on the need for compliance with regulations, equipment reliability, or other factors. These controls are applied to the Software Life Cycle, which is the systematic approach to software development, maintenance, use, and,retirement. The extent to which the individual requirements are applied depends upon the importance of software/computing systems as explained by Software Quality Assurance Program implementing procedures.
19.4.2 Software Life Cycle Procurement Procurement of quality software/computing systems shall be in accordance with Section 4.0 of this manual as specified in the Software Quality Assurance Program implementing procedures.
- 2. Development Phase
- a. Baseline software life cycle documents are produced during the Development Phase in accordance with the Software Quality Assurance Program implementing procedures.
- b. Vendor supplied life cycle documents for quality software/computing systems shall meet the requirements of this section.
NGGM-PM007 Rev. 1 Page 71 of 99
- 3. Installation Phase Installation of quality software/computing systems shall be controlled by Software Quality Assurance program implementing procedures.
- a. Operation and Maintenance Phase a, During the Operation and Maintenance Phase the software has been approved for operational use and the computing environment is established.
- b. Maintenance (changes to quality software/computing systems) to remove latent errors, to respond to new or revised requirements, or to adapt to changes in the operating environment shall be performed under the established change control process as defined by Software Quality Assurance program implementing procedures.
- 5. Retirement Phase
- a. During the Retirement Phase the support for a software product is terminated, and the routine use of the software is prevented.
- b. The software is de-installed from CPUs, Servers, etc. and returned to the software librarian who controls software. Diskettes, tapes and other media shall be labeled "RETIRED".
19.4.3 Configuration Management Configuration management refers to the controls for hardware and software items that constitute a system. This includes the release and change of those items throughout the system life cycle including the documentation of modification activities.
- 2. The baseline version of quality soffware/computing systems, source code and life cycle documentation shall be stored per Records Management procedures and Software Quality Assurance Program implementing procedures.
- 3. Error notification, evaluation and resolution information shall be controlled for quality software/computing systems used in NGG.
- 4. Life Cycle Baseline documentation requirements shall be imposed upon modification of the existing product.
- 5. Quality software/computing systems that exist and are in production prior to the effective date of this program shall be included on a controlled list. Minimal information shall be software name, version, software quality level, software quality level justification and software owner name.
NGGM-PM007 Rev. 1 Page 72 of 99
- 6. Each organization utilizing quality software/computing systems shall keep track of safety-related work resulting from the use of such software, including version numbers or issue date of the software. If significant errors are later determined, safety-related work can be reviewed to determine any impact of software errors.
19.4.4 Qualification Requirements Qualification is the process of demonstrating that for a given input which may be defined in an Acceptance Test Plan, Benchmark Test Case or Calibration Test Procedure, the software produces the expected output
- 1. Acceptance Test Requirements Plant computer systems shall undergo acceptance testing per applicable plant procedures to demonstrate required performance over the range of operation of the controlled function or process. The results of tests that are Quality Assurance or Vital records shall be designated and stored in Records Management in accordance with procedures.
- 2. Calibration and Control Test Requirements Computer based calibration and control equipment shall be calibrated, adjusted, and maintained at prescribed intervals or prior to use per applicable plant procedures. The results of tests that are Quality Assurance or Vital records shall be designated and stored in Records Management as required by procedures.
- 3. Benchmark Test Requirements The benchmark test process is typically used to demonstrate design analysis software products perform as expected. This includes development of appropriate test cases to access the software functionality and execution of these test cases. The benchmark test proves, for a given input, a known result is obtained.
19.4.5 Error Management A method of describing user-identified errors or problems to the developer or the owner of the software shall be established. Errors for quality software/computing systems shall be identified and documented per Software Quality Assurance Program implementing procedures.
- 2. A list of errors, error reports to users, resulting evaluation and corrections, error impact statement, and error resolutions shall be maintained in a controlled manner.
NGGM-PM007 Rev. 1 Page 73 of 99
- 3. Impact on NGG shall be determined and appropriate corrective action taken with any related errors introduced into NGG and with the software source code, if appropriate. In case of misuse, the causes of misuse shall be clarified and positive action taken to prevent future misuse.
Error reports shall document error impact and will be identified as a Quality Assurance or Vital records upon error resolution. These records shall be designated and stored in Records Management as required by procedures.
19.4.6 Self Assessment Self assessments of the Software Quality Assurance Program shall be performed.
19.4.7 Records Management Documentation resulting from the development, modification or use of quality software/computing systems shall be maintained as QA records as required in procedures.
20.0 NONSAFETY-RELATED COMPUTER SOFTWARE QUALITYASSURANCE.
THE CONTENTS OF THIS SECTION HAVE BEEN INCLUDED IN SECTION 19.0.
21.0 QUALITYASSURANCE (QA) PROGRAM REQUIREMENTS FOR QUALITYCLASS B ITEMS 21.1 SCOP E This section sets forth the QA requirements for quality Class B items and activities.
Items subject to these requirements shall be identified in appropriate plant procedures.
Sections 1.0 through 14.0 of the QAP Manual apply only to the extent referenced in this section.
21.2 REGULATORY COMMITMENTS This section is to be utilized in conjunction with Regulatory Guides 1.29 and 1.97 as committed in Section 1.8 of the (U)FSAR.
21.3 MANAGEMENTRESPONSIBILITIES Each department head has responsibility for determining if this section applies to plant activities being performed, for implementation of these requirements, and for establishing the necessary interfaces with other organizations.
NGG M-PM-0007 Rev. 1 Page 74 of 99
21.4 DESIGN ACTIVITIES Design change activities shall be accomplished in accordance with Section 3.0. (Not applicable to BNP/RNP) 21.5 PROCUREMENT Preparation, review, and approval of procurement documents shall be in accordance with Section 4.0 or acceptable alternatives delineated in procedures.
21.6 MATERIALCONTROL P
Receiving inspection, storage, and equipment control shall be in accordance with Section 5.0. (For BNP and RNP, these items are not required to be stored in specifically designated storage areas.)
21.7 CONDITIONS ADVERSE TO QUALITY(CATQ)
CATQ shall be identified, reported, dispositioned, and corrected in accordance with Section 12.0.
21.8 OPERATIONS CONTROL Plant operations of these items shall be in accordance with Section 10.0.
21.9 CALIBRATIONCONTROL Calibration activities shall be in accordance with Section 8.0.
21.10 MAINTENANCE Maintenance activities shall be in accordance with Section 11.0. (Not applicable to BNP or RNP.)
2'I.11 ASSESSMENTS/AUDITS Assessments/Audits may be conducted in accordance with Sections 4.0 & 13.0.
21.12 QA RECORDS Measures shall be established to assure sufficient records are maintained to furnish evidence that the activities described in this section are being implemented. These records shall be identifiable and retrievable. These records shall be maintained in accordance with Section 14.0.
NGGM-PM%007 Rev. 1 Page 75 of 99
22.0 QUALITYASSURANCE PROGRAM FOR NONSAFETY RELATED SYSTEMS AND EQUIPMENT USED TO MEET THE STATION BLACKOUTRULE 22.1 SCOPE This section sets forth the QAP requirements for nonsafety related systems and equipment used for meeting the Station Blackout (SBO) Rule (10CFR50.63) which are not otherwise covered by a quality assurance program.
22.2 REGULATORY COMMITMENTS The QAP delineated in this section incorp'orates the appropriate requirements of 10CFR50.63 and Reg. Guide 1.155. Sections 1.0 through 14.0 of the QAP Manual apply only to the extent referenced in this section.
22.3 PROGRAM MANAGEMENTAND OBJECTIVES The Plant General Manager is responsible for the overall administration of the Station Blackout Quality Assurance Program and provides the plant point of control and contact for contingencies. He may delegate his authority as appropriate to others; however, he shall not delegate his responsibility.
22A DESIGN CONTROL Design activities shall be accomplished in accordance with procedures that assure the applicable design requirements are included and that appropriate reviews are conducted. Design changes of Station Blackout items shall be prepared, approved, accomplished, and documented in accordance with Section 3.
22.5 INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities such as design, installation, inspection, tests, maintenance, and modification of non-safety systems used to meet the Station Blackout Rule shall be accomplished in accordance with instructions, procedures and drawings in accordance with Section 6.
22.6 PROCUREMENT DOCUMENT CONTROL AND CONTROL OF PURCHASED MATERIAL,EQUIPMENT, AND SERVICES Control of plant purchased materials, equipment, and services with respect to nonsafety related systems and equipment used to meet the SBO rule (SBO Items) shall be accomplished in accordance with the following for procurement, receiving, and storage:
22.6.1 Procurement Procurement documents for SBO items shall be completed in accordance with plant procedures. These procedures shall require the item(s) technical and quality requirements be established during the review and approval process for the purchase requisition.
NGGM-PM007 Rev. 1 Page 76 of 99
If')'4 22.6.2 Receiving 22.6.2.1 Material, equipment and services, including spare and replacement parts for the nonsafety related systems and equipment used to meet the Station Blackout Rule shall be inspected, stored, issued, and controlled in accordance with procedures, noting in particular:
22.6.2.1.1. Any damage to the item.
22.6.2.1.2 Item identification and marking.
22.6.2.1.3 Any required vendor-supplier documentation.
22.6.2.1.4 Conformance with purchase requirement/specification.
22.6.2.2 A receipt inspection report shall be completed for received SBO Items. Noted deficiencies shall be documented in accordance with Section 12.
22.6.2.3 SBO Items shall be tagged in accordance with procedures.
22.6.3 Storage SBO Items shall be stored in accordance with plant procedures.
22.7 NONCONFORMING ITEMS AND CORRECTIVE ACTIONS (CONDITIONS ADVERSE TO QUALITY)
Conditions Adverse To Quality (CATQ) of SBO items shall be identified, reported, dispositioned, and corrected in accordance with Section 12, 22.8 INSPECTIONS Independent inspections of activities will be performed in accordance with procedures to verify compliance with documented installation drawings and test procedures for accomplishing activities related to the Station Blackout program.
22.9 TESTING AND TEST CONTROL Testing will be performed and verified by inspection to demonstrate conformance with design and system readiness requirements. These tests will be performed; test results properly evaluated, and appropriate action taken in accordance with plant procedures.
NGGM-PM-0007 Rev. 1 Page 77 of 99
22.10 ASSESSMENTS Assessments shall be conducted in accordance with Section 13.0.
22.11 RECORDS Those records required to verify compliance with criteria of the Station Blackout program shall be identifiable and retrievable and shall be assigned retention requirements.
22.12 MATERIALUPGRADING Items not originally procured for application in SBO systems shall be evaluated for the intended use prior to installation in accordance with procedures.
23.0 INTERPRETATIONS 23.1 SCOPE This section sets forth requirements for issuing official CP8 L Quality Assurance Program interpretations by the Manager - Performance Evaluation and Regulator Affairs (PERAS). These interpretations are issued on an as-needed basis for the purposes of clarifying Company policy in areas pertaining to this program. It includes requirements for the issuance, control, and removal of interpretations and a listing of current interpretations.
23.2 REGULATORY COMMITMENTS None 23.3 REQUIREMENTS Interpretations shall be requested and issued in accordance with the following requirements:
23.31 Requests. for interpretation shall require the signature of a section manager or above.
23.3.2 The Manager - PERAS is the sole authority for determining whether a response to a request for interpretation is to be included in this section.
23.3.3 A request for an interpretation will be responded to regardless of whether or not it will be included in this section.
23.3.4 Current and historical interpretations shall be listed in Section 23.5 by sequential number and by subject.
NGGM-PM007 Rev. 1 Page 78 of 99
23.3.5 Interpretations, once issued, shall remain a part of this section until the manual is revised. After manual revision, interpretation will be withdrawn and a line added to the listing in Section 23.4 identifying that portion of the manual revised to incorporate that interpretation or noted for clarification only.
23A CONTENTS The following is a listing of interpretations contained in Section 23.4. Both current and historical interpretations are included by number and subject line. Historical interpretations can be found in the historical files.
23.5 LISTING OF INTERPRETATIONS Current and Historical INTERPRETATIO N SUBJECT DATE STATUS NUMBER 23.5.1 Interpretation of Inspector 7/1 9/89 Deleted by Qualification/Independence Requirements Revision 18 23.5.2 Interpretation of UT Block Calibration 1/1 5/90 Incorporated Requirements (QAP Manual Sections 4.5.6 into Section 8.0
& 8.0) for clarification only in Revision 18 23.5.3 Interpretations to Commitments to ANSI 1/6/92 Deleted by 18.7 via Final Safety Analysis Reports- Revision 18 (Requirements for Inspection By Other Than Quality Control Personnel)
(QAP Manual Section 7.6) for clarification only 23.5.4 Interpretation of the QAP Manual, 1/1 7/92 Canceled Paragraph 6.4.7 of the Procedures and Section Drawings Section 6.4.7 Deleted 23.5.5 Interpretation of Calibration 9/2/93 Incorporated in accuracy requirements for M&TE Rev. 17 (QAP Manual Section 8.4)
NGGM>>PM<007 Rev. 1 Page 79 of 99
Enclosure 1 (Note: This policy statement is a reprint of the CP&L Quality Assurance Program Policy statement on the lntranet. Any changes to this document requires the policy statement to be revised on the Intranet).
Document btle CP8 L Quality Assurance Program Policy Document number REG-CPL-000 Keywonh Policy; CPL; Regulatory; Quality Assurance; Program It is the policy of Carolina Power 8 Light Company to operate and maintain nudear power plants to safeguard the health and safety of its employees and the public. gabe operation of nuclear power plants is in accordance with the facility operating license issued by the Nuclear Regulatory Commission (NRC). A Quality Assurance (QA) program is implemented and updated as necessary to assure that systems used for generating electricity using nuclear fuel are designed, constructed, and operated in a safe manner. Deviations from the requirements of this program are permitted only with written authority from the corporate management position which originally approved the program or implementing procedures.
CP&L's QA Program ensures compliance with NRC regulations specified in Title 10 of the US Code of Federal Regulations. The CP&L QA Program for 10CFR50 Appendix B requirements is established by and defined in Sections 1.0-1 4.0 of NGGM-PM4007, Quality Assurance Pegram Manual. A description of this program is also contained in Section 17.3 of each nuclear plant's (U)FSAR. implementing procedures are contained in the Plant Operating Manuals (POMs). CP&L QA programs for Fire Protection Systems, Radioactive Waste Management Systems, IF-300 Shipping Cask, Radioactive Material Packages, Computer Software, Quality Class B items, and Station Blackout are also contained in the NGGM-PM-0007.
The Senior Vice President - Nuclear Generation/Chief Nuclear Officer has the ultimate company responsibility for the safe operation of the nuclear power plants. Plant Vice Presidents and the Manager - Performance Evaluation and Regulatory Affairs (PERAS), have the responsibility and authority to identify and correct quality problems and are responsible for monitoring the effectiveness of quality assurance activities through a system of planned assessments and inspections. Plant Vice Presidents and the Manager - PERAS effect this responsibility by maintaining a strong self evaluation culture in the line organization supplemented with independent monitoring and systematic assessments performed by the Nuclear Assessment Sections and Performance Evaluation Support.
The Manager - PERAS is responsible for maintaining and monitoring the overall effectiveness of QA Program implementation and communicates directly with Senior Management up to and including the President/Chief Executive Officer, and if appropriate, with the Board of Directors, to resolve any quality concerns which cannot be resolved satisfactorily at a lower management level.
PES and NAS Managers review the effectiveness of the QA Program on a regular basis with the Senior Vice President - Nuclear Generation/Chief Nuclea'r Officer.
Although specific position and responsibilities are delineated in this policy statement the achievement of quality is the responsibility of each individual involved in nuclear generation.
W. S. Orser Executive Vice President - Energy Supply NGGM-PM%007 Rev. 1 Page 80 of 99
APPENDIX I This Appendix provides a cross-reference between the QAP Sections I.O through 14.0 and Title IO, Code of Federal Regulations, Part 50, Appendix B (IOCFR50, Appendix B), titled, "Quality Assurance Criteria for Nuclear Power Plants."
The references to the QAP contained in this appendix are limited to those that have a direct connection, or describe the immediate activity addressed by IOCFR50, Appendix B. The program references are identified by paragraph number, indicating a description of implementation somewhere within the text of the referenced paragraph. References to the 18 criteria of IOCFR50, Appendix B, are identified by roman numerals. Sentences within each Appendix B criterion are further subdivided by Arabic numbers and aspects of each sentence by lower case letters.
NGGM-PM-0007 Rev. 1 Page 81 of 99
APPENDIX I 10CFR50 APPENDIX B CP&L QA PROGRAM MANUAL I. ORGANIZATION
- 1. The applicant shall be responsible for:
- a. Establishment of the QA Program.
- b. Execution of the QA Program. 1.1, 1.2, 2.1
- 2. The applicant may delegate to others, such as contractors, agents, or consultants the work (or any part thereof) of:
- a. Establishing the QA Program. 2.2
- b. Executing the QA Program. 1.1, 2.1, 2.2 But the applicant shall retain responsibility therefore.
- 3. The authority and duties of persons 2.2 and organizations performing activities affecting the safety-related functions of structures, systems, and components shall be clearly established and delineated in writing.
- 4. These activities include both the 2.2, 2.3, 2.4 performing functions of attaining quality objectives and the quality assurance functions.
5., The QA functions are those of:
- a. Assuring that an appropriate 1.3, 2.2, 4.11, QA Program is established and 13.1 effectively executed.
- b. Verify, such as by checking, 2.2, 4.11, 13.1 auditing, and inspection, that activities affecting the safety-related functions have been correctly performed.
NGGM-PM%007 Rev. 1 Page 82 of 99
The persons and organizations performing QA functions shall have sufficient authority and organizational freedom to:
- a. Identify quality problems. 2.2, 4.1 1, 13.1
- b. To initiate, recommend, or 2.2, 4.11.6, provide solutions. 13.5 C. To verify implementation of 2,2, 4.11.8, solutions. 13.7
- 7. Such persons and organizations 2.2 performing quality assurance functions shall report to a management level such that this required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations are provided.
- 8. Because of the many variables involved, 2.2 such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the QA Program may take various forms provided that the persons and organizations assigned the QA functions have this required authority and organizational freedom.
Irrespective of the organizational 2.2 structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the QA Program at any location where activities subject to this Appendix are being performed shall have direct access to such levels of management as may be necessary to perform this function.
QUALITYASSURANCE PROGRAM The applicant shall establish at the 1.1, 1.2, 2.2 earliest practical time, consistent with the schedule for accomplishing the activities, a QA Program which complies with the requirements of NGGM-PM%007 Rev. 1 Page 83 of 99
this Appendix.
- 2. This Program shall be:
- a. Documented by written policies, 2.2 procedures or instructions.
- b. Carried out throughout plant 2.2, 6.0 life in accordance with those policies, procedures or instructions.
- 3. The applicant shall identify:
- a. The structures, systems and 1,2 components to be covered by the QA Program.
- b. The major organizations 2,2 participating in the Program, together with the designated functions of these organizations.
- 4. The QA Program shall provide control 1.2 over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety.
- 5. Activities affecting quality shall be 5.3, 6.4, 8,5, 10.3, accomplished under suitably 11.1, 11.3 controlled conditions,
- 6. Controlled conditions include:
- a. The use of appropriate equipment. 5.2, 6.3, 8.4, 10.2, 11 1, 11,3
~
- b. The use of suitable environmental 5.3, 6.4, 8.5, 10.3 conditions for accomplishing the 11.1, 11.3 activity, such as adequate cleanliness.
- c. Assurance that all prerequisites 4.9, 4.1 1, 5.3, 6.4, for the given activity have been 8.5, 13.1 satisfied.
NGGM-PM<007 Rev. 1 Page 84 of 99
- 7. The Program shall take into account the need for:
- a. Special controls. 5.3, 5.5, 10.3, 11.3
- b. Processes. 10.3, 10.5, 11.3, 11,4
- c. Test equipment. 8.2
- d. Tools. 5.4, 8.2
- e. Skills to attain the required 7.0 quality.
- f. Verification of quality by 4.5, 4.6, 5.3, 5,5, inspection. 11.3, 11.4
- g. Verification of quality by 3.4, 3.5, 4.5, 11.3
- test.
- 8. The Program shall provide for:
- a. Indoctrination. Section 7.0
- b. Training. Section 7.0 Of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.
9 The applicant shall regularly review 1.3 the status and adequacy of the QA Program.
- 10. Management of other organizations 2.1, 2.2 participating in the QA Program shall regularly review the status and adequacy of that part of the QA Program which they are executing.
DESIGN CONTROL Measures shall be established to assure 3.3, 3.4 that applicable regulatory requirements and the design bases, as defined in IOCFR50.2 and as specified in the license application for those structures, systems, and components to which this Appendix applies, are correctly translated into NGGM-PM<007 Rev. 1 Page 85 of 99
specifications, drawings, and instructions.
- 2. These measures shall include provisions to assure that appropriate quality standards:
- a. Are specified and included in design 3.3, 3.4 documents.
- b. Deviations from such standards are 3.3, 3.4, 3.9 controlled.
- 3. Measures shall also be established for:
- a. Selection. 3.4, 3.5
- b. Review. 3.4, 3.5 For suitability of. application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.
- 4. Measures shall be established for the 3.10 identification and control of design interfaces and for coordination among participating design organizations.
- 5. These measures shall include the establishment of procedures among participating design organizations for.
- a. Review of documents involving design 3.10 interfaces.
- b. Approval of documents involving design 3.10 interfaces.
- c. Release of documents involving design 3.10 interfaces.
- d. Distribution of documents involving design3.10 interfaces.
- e. Revision of documents involving design 3.10 interfaces.
- 6. The design control measures shall provide for verifying or checking the adequacy of design, such as by one or more of the following means:
NGGM-PM007 Rev. 1 Page 86 of 99
- a. Performance of design reviews. 3.4, 3.5, 3.6
- b. Use of alternate or simplified 3.4, 3.5, 3.6 calculational methods.
- c. Performance of a suitable testing 3.4, 3.5, 3.6 program.
- 7. The verifying or checking process 3.4, 3.5 shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization.
- 8. Where a test program is used to 3.3, 3.4, 3.5 verify the adequacy of a specific design feature in lieu of other verifying or checking process, it shall include suitable qualification testing of a prototype unit under the most adverse design conditions.
- 9. Design control measures shall be 3.3, 3.4, 3.5 applied to items such as the following: reactor physics; stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for in-service inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and tests.
10, Design changes, including field changes, shall be:
- a. Subject to design control measures 3.5 commensurate with those applied to the original design.
- b. Approved by the organization that 3.5 performed the original design unless the applicant designates another responsible organization.
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IV. PROCUREMENT DOCUMENT CONTROL Measures shall be established to assure 4.5 that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or references in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its Contractors or Subcontractors,
- 2. To the extent necessary, procurement 4.4 documents shall require Contractors or subcontractors to provide a QA Program consistent with the pertinent provisions of this Appendix.
V. INSTRUCTIONS PROCEDURES AND DRAWINGS Activities affecting quality shall be:
- a. Prescribed by documented instructions, 6.0 procedures or drawings of a type appropriate to the circumstances.
- b. Accomplished in accordance with these 6.0 instructions, procedures or drawings.
- 2. Instructions, procedures, or drawings 6.0 shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
VI. DOCUMENT CONTROL Measures shall be established to 6.1, 6.34, 14.4 control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto, which prescribe all activities affecting quality.
- 2. These measures shall assure that documents, including changes:
- a. Are reviewed for adequacy. 6.4, 14A NGGM-PM%007 Rev. 1 Page 88 of 99
- b. Approved for release by 6.4, 14.4 authorized personnel.
- c. Distributed to the location 6.4, 14.4 where the prescribed activity is performed.
- d. Used at the location where the 6.4, 14.4 prescribed activity is performed.
- 3. Changes to documents shall be reviewed 6A, 14.4 and approved by the same organization that performed the original review and approval unless the applicant designates another responsible organization.
Vll. CONTROL OF PURCHASED MATERIAL EQUIPMENT AND SERVICES Measures shall be established to assure 4.8, 5.3 that purchased material, equipment, and services, whether purchased directly or through Contractors and Subcontractors, conform to the procurement documents.
- 2. These measures shall include provisions, as appropriate, for:
- a. Source evaluation and selection. 4.4, 4.8
- b. Objective evidence of quality 4.4, 4.8 furnished by the Contractor or Subcontractor.
- c. Inspection at the Contractor or 4.4, 4.8 Subcontractor source.
- d. Examination of products upon delivery. 5.3 Documentary evidence that material and 5.5 equipment conform to the procurement requirements shall be available at the nuclear power plant site prior to installation or use of such material and equipment.
NGGM-PM%007 Rev. 1 Page 89 of 99
4, This documentary evidence shall be:
- a. Retained at the nuclear power plant 5.3 site.
- b. Sufficient to identify the specific 5.3 requirements, such as codes, standards, or specifications, met by the purchased material and equipment.
- 5. The effectiveness of the control of quality by 22 Contractors and Subcontractors shall be 4.8, 4.11 assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.
Vill IDENTIFICATIONAND CONTROL OF MATERIALS,
~
PARTS AND COMPONENTS Measures shall be established for the 5.3, 5.4, 5.5 identification and control of materials, parts, and components, including partially fabricated assemblies,
- 2. These measures shall assure that 3.5, 3.7, 5.3, 5.4 identification of the item is maintained 5.5, 10,5 by heat number, part number, serial number or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, erection, installation, and use of the item.
3, These identification and control measures 5.3, 5,4, 5.5, 10.3, shall be designed to prevent the use of 1 1.4, 1 1.6 incorrect or defective material, parts, and components.
IX. CONTROL OF SPECIAL PROCESSES Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing are:
- a. Controlled. 7.4, 11.3 NGGM-PM007 Rev. 1 Page 90 of 99
- b. Accomplished by qualified personnel 7.4, 11.3 using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.
X. INSPECTION
- 1. A program of inspection of activities affecting quality shall be:
- a. Established. 2.2, 5.3, 5,6
- b. Executed by or for the organization 2.2, 5.3, 5.6 performing the activity to verify conformance with the documented instructions, procedures and drawings for accomplishing the activity.
- 2. Such inspection shall be performed by 2.2, 5.3 individuals other than those who performed the activity being inspected.
- 3. Examinations, measurements, or tests of 2.2, 3.4, 4.5, 4.6, 4.8, material or products processed shall be 5.3, 5.5, 6.4 performed for each work operation where necessary to assure quality.
- 4. If inspection of processed material or 2.2, 4.4, 4.8, 5.3, products is impossible or disadvantageous, 5.6 indirect control by monitoring processing methods, equipment, and personnel shall be provided.
- 5. Both inspection and process monitoring 2,2, 4.4, 4,8, 5.3, shall be provided when control is 5.6, 6.4 inadequate without both.
- 6. If mandatory inspection holdpoints, which require witnessing or inspecting by the applicant's'esignated representative are required:
- a. Work shall not proceed beyond 2.2, 3.4, 3.7 these holdpoints without the consent of the designated representative.
NGGM-PM007 Rev. 1 Page 91 of 99
- b. Specific holdpoints shall be 3.4, 4.5 indicated in appropriate documents.
XI. TEST CONTROL
- 1. A test program shall be established to assure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is:
- a. Identified. 3.4, 3.7, 4.5
- b. Performed in accordance with 3.4, 3.7, 4.5 written test procedures which incorporate the requirements and acceptance limits contained in applicable design documents.
- 2. The test program for structures, systems and components shall include, as appropriate:
- a. Proof tests prior to installation. 3.4, 3.7, 4.5, 11.3
- b. Preoperational tests. 3.4, 3.7, 4.5, 11.3
- c. Operational tests during nuclear 3.4, 3.7, 4.5, 11.3 power plant operation.
- 3. Test procedures shall include provisions for assuring that:
- a. All prerequisites for the given 3.4, 3.7, 4.5, 11.3 test have been met.
- b. Adequate test instrumentation is 3.4, 3.7, 4.5, 11.3 available and used..
- c. The test is performed under 3.4, 3.7, 4.5, 11.3 suitable environmental conditions.
- 4. Test results shall be:
- a. Documented. 3.4, 3.7, 4.5, 11.3
- b. Evaluated to assure that test 3.4, 3.7, 4,5, 11.3 requirements have been satisfied.
NGGM-PM007 Rev. 1 Page 92 of 99
XII. CONTROL OF MEASURING AND TEST EQUIPMENT Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly:
- a. Controlled. 8.4, 8.5
- b. Calibrated and adjusted at specified 8.4, 8.5 periods to maintain accuracy within necessary limits.
XIII HANDLING STORAGE AND SHIPPING
~
Measures shall be established to 5.3, 5.5, 5.6 control the handling, storage, shipping, cleaning and preservation of material and equipment in accordance with work and inspection instructions to prevent damage or deterioration.
- 2. When necessary for particular products, 5.3, 5.5, 5.6 special protective environments, such as inert gas,atmosphere, specific moisture content levels, and temperature levels, shall be specified and provided.
XIV. INSPECTION TEST'ND OPERATING STATUS Measures shall be established to 5.3, 5.4, 5,5, 5.6 indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the nuclear power plant.
- 2. These measures shall provide for the 5.3, 5A, 5.5, 5.6 identification of items which have satisfactorily passed required inspection and tests, where necessary to preclude inadvertent bypassing of such inspections and tests.
NGGM-PM%007 Rev. 1 Page 93 of 99
Measures shall also be established for 5.3, 5.4, 5.5, 5.6 indicating the operating status of structures, systems, and components of the nuclear power plant, such as by tagging valves and switches, to prevent inadvertent operation.
XV. NONCONFORMING MATERIALS PARTS OR COMPONENTS Measures shall be established to 12.4, 12.5, 12.6, control materials, parts, or 12.7 components which do not conform to requirements in order to prevent their inadvertent use or installation.
- 2. These measures shall include, as appropriate, procedures for.
- a. Identification. 12.4, 13.5
- b. Documentation. 12.5
- c. Segregation. 12.5
- d. Disposition. 12.5
- e. Notification to affected organizations. 12.5
- 3. Nonconforming items shall be:
- a. Reviewed. 5.3.8, 12.4, 12.5, 12.7
- b. Accepted or rejected. 5.3.8, 1 2.4, 12.5, 12.7
- c. Repaired or reworked in accordance 5.3.8, 12.4, 12.5, 12.7 with documented procedures.
XVI. CORRECTIVE ACTION Measures shall be established to assure 12.4, 12.5 that conditions adverse to quality such as failures, malfunctions, deviations and defective material and equipment are promptly identified and corrected.
- 2. ln the case of significant conditions 12.4, 12.5 adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken NGGM-PM%007 Rev. 1 Page 94 of 99
to preclude repetition.
- 3. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be:
- a. Documented. 2.4, 12.5, 12.7
- b. Reported to appropriate levels of 12.4, 12.5, 12.7 management, XVII. QUALITYASSURANCE RECORDS Sufficient records shall be maintained 14.3 to furnish evidence of activities affecting quality.
The records shall include at least the following:
- a. Operating logs, 14.3, 14.4
- b. Results of reviews. 14.3, 14.4
- c. Inspections. 14.3, 14.4
- d. Tests. 14.3, 14.4
- e. Audits. 14.3, 14.4
- f. Monitoring of work performance. 14.3, 14.4
- g. Material analyses. 14.3, 14.4
- 3. The records shall also include 5.2, 7.4, 14.3, 14.4 closely-related data such as qualifications of personnel, procedures, and equipment.
- 4. Inspection and test records shall, as a minimum, identify:
- a. The inspector or data recorder. 5.2, 14.3, 14.4
- b. The type of observation. 5.2, 14.3, 14.4
- c. The results. 14.3
'. The acceptability. 14.3 NGGM-PM007 Rev. 1 Page 95 of 99
- e. The action taken in connection with 14.3 any deficiencies noted.
- 5. Records shall be identifiable and 14.3 retrievable.
- 6. Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as:
- a. Duration. 14.3, 14.4
- b. Location. 14.3, 14.4
- c. Assigned responsibility. , 14.3, 14.4 XVIII.AUDlTS
- 1. A comprehensive system of planned and periodic audits shall be carried out to:
- a. Verify compliance with all aspects 4.11, 13.1, 13.4 of the QA Program.
- b. Determine the effectiveness of 4.11, 13.1, 13.4 the Program.
- 2. The audits shall be performed:
- a. In accordance with written procedures 4.11, 13.1, 13A or checklists.
b, By appropriately trained personnel 4.11, 13,2, 13.4 not having direct responsibilities in the areas being audited.
- 3. Audit results shall be:
- a. Documented. 4.11, 13.6
- b. Reviewed by management having 4.11.7, 13.6 responsibility in the area audited.
- 4. Follow-up action, including reaudit of 4.11, 13.7 deficient areas, shall be taken where indicated.
NGGM-PM%007 Rev. 1 Page 96 of 99
APPENDIX II This appendix provides a matrix of specific plant commitments to QA Program related Regulatory Guides and referenced documents and is included in this manual as a "quick reference". This appendix is not intended to be all inclusive of all commitments and has no specific relationship with the other sections of this manual ~
It must be noted that the information depicted in the appendix reflects only those commitments found in Section 1.8 of each plant's (U) FSAR. It must also be noted that exceptions/clarifications taken by CP8 L to these Regulatory Guides are not indicated in the reference and must be obtained from the applicable plant (U)FSARs.
Regulatory Guides are listed by number, title, and revision applicable to each plant.
The document primarily endorsed by each Regulatory Guide are also listed with revision or date of issue, where applicable, for each plant. If a Regulatory Guide and/or an endorsed document is not applicable to a particular plant, it is so noted as "N/A" in the appropriate Commitment columns. In cases where Regulatory Guides do not endorse specific documents, "none" appears in the corresponding Primary Endorsed Documents column.
NGG M-P M%007 Rev. 1 Page 97 of 99
CP&L COMMITMENTMATRIX APPENDIX II Reg. Commitments Regulatory Guide Primary Endorsed Commitments Guide Documents Reg. Guide Rev. Document Rev SHNPP BSEP HBR SHNPP BSEP HBR 1.8 R2 3/71 9/75 Personnel Selection and Training ANSI N18.1 N/A N/A N/A 2/79 ANSI 3.1 9n9 N/A N/A Draft 1.29 R3 R3 R3 Seismic Design Classification None 1.30 RO sn2 sn2 QA Requirements for the Installation and Testing of ANSI N45.2.4 3/72 3/72 3/72 Instrumentation and Electrical Equipment 1.33 R2 11/72 2/78 QA Program Requirements (Operation) ANSI N18.7
'.37 RO 3/73 3/73 QA Requirements for Cleaning Fluid Systems and Associated ANSI N45.2.1 Com onents of Water-Cooled Nuclear Power Plants 1.38 R2 - 3/73 3/73 QA Requirements for Packaging, Shipping, Receiving, Storage ANSI N45.2.2 12/72 12/72 12/72 and Handlin of Items for Water-Cooled Nuclear Power Plants 1.39 R2 3f73 3/73 Housekeeping Requirements for Water-Cooled Nuclear Power ANSI N45.2.3 3/73 3/73 3/73 Plants 1.54 RO 6fl3 Quality Assurance Requirements for Protective Coatings ANSI N101.4 1972 A lied to Waterwooled Nuclear Power Plants 1.58 R1 9/80 9/80 Qualification of Nuclear. Power Plant Inspection, Examination ANSI N45.2.6 sns 8/78 8/78 and Testin Personnel 1.64 R2 10/73 10/73 QA Re uirements for the Desi n of Nuclear Power Plants ANSI N45.2.11 en4 en4 en4 1.74 RO 2/74 2/74 QA Terms and Definitions ANSI N45.2.10 5/73 5/73 5/73 NGGM-PM-0007 REV. 1 Pgryo QA nf AA
CP8cL COMMITMENTMATRIX APPENDIX II Commitments Commitments Reg. Primary Endorsed Guide Regulatory Guide Documents Reg. Guide Rev. Document Rev SHNPP BSEP HBR SHNPP BSEP HBR 1.88 R2 sn4 N/A Collection, Storage, and Maintenance of Nuclear Power Plant ANSI N45.2.9 6n4 6n4 5/79 QA Records 1.94 R1 N/A 4n6 QA Requirements for Installation, Inspection, and Testing of ANSI N45.2.5 m4 m4 Structural Concrete and Structural Steel During the (Std.
Construction Phase of Nuclear Power Plants Onl 1.116 RO-R QA Requirements for Installation, Inspection, and Testing of ANSI N45.2.8 sns sns sns Mechanical Equipment and Systems (Std. (Std.
Onl Onl 1.120 N/A N/A N/A Fire Protection Guidelines for Nuclear Power Plants None 1.123 R1 N/A N/A QA Requirements for Control of Procurement of Items and ANSI N45.2.13 2/76 Draft 2 Draft 2 Services for Nuclear Power Plants Rev. 4 Rev. 4 an4 4n4 1.143 R1 N/A Design Guidance for Radioactive Waste Management None Systems, Structures, and Components Installed in Light Water-Cooled Nuclear Power Plants 1.144 RO 1/79 1/79 Auditing of QA Programs for Nuclear Power Plants ANSI N45.2.12 11/77 11/77 11n7 1.146 RO RO RO Qualification of Quality Assurance Program Audit Personnel ANSI N45.2.23 4/78 ans 4/78 8/80 8/80 8/80 for Nuclear Power Plants NGGM-PM-0007 REV. 1 pano QQ nf Qq 5 to Serial HNP-99-069 QA Program - Pertinent Quality Control. Procedures for Implementation (1) List of Mechanical Modification Procedures (1 page)
(2) Index of Corporate Welding Manual Procedures (2 pages)
(3) Index of Corporate NDE Manual Procedures (7 pages)
g 1
5 to Serial: HNP-99-069 HNP Mechanical Modification Procedures A licable to Com letion of S ent Fuel Pool Coolin S stems:
MMP-002 Installation of Piping and Piping Components MMP-003 Instrumentation MMP-004 Installation of Pipe Supports MMP-006 Installation of Structural Steel and Electrical, Instrumentation, and HVAC Supports MMP-007 Mechanical Equipment Installation MMP-012 Hydrostatic and Pneumatic Testing of Piping Systems
CORPORA 7E WELDING MANUAL TABLE OF CONTENTS Does Not Contain Plant Procedure Change Notices (PCNs) Per NW-i Paragraph 5.3.3 NW-i Manual Administrative Controls Rev. 8 PART 1: GENERAL PROCEDUMK NW-01 Qualification of Welding and Brazing Procedures Rev. 6 NW-02 Qualification of Welders and Welding Operators Rev. 7 NW-03 Welding Material Control Rev. 6 NW-04 Permanent Marking of Plant Materials, Rev. 7 Components, and Weld Joints NW-05 General Welding Procedure for Structural Welding Rev. 6 NW-06 General Welding Procedure for Carbon and Low Alloy Rev. 7 Steels, Stainless Steels, and Nonferrous Alloys NW-07 Weld Data Reports Preparation, and Use Rev. 6 NW-08 Post-Weld Heat Treatment Rev. 4 NW-09 Repair of Base Material and Weldments Rev. 6 NW-10 Assigning CP&L Welder Symbols Rev.
3'ev.
NW-11 General Welding Procedures for Sheet Metal Components 4 NW-12 Deleted - Superseded in September 1993 by Specification CP&L-XXXX-W-04 NW-13 General Welding Procedures for Studs and Pins Rev. 2 NW-14 Care and Maintenance of Welding Machines and Equipment Rev. 4 NW-15 General Brazing Procedure Rev. 4 NW-16 Identification of Base Metals For Welding Applications Rev. 1 NW-17 Welder Safety Rev. 0 NGGM-PM-0003 Rev. 51 Page 2 of 3
CORPORA TE WELDING MANUAL TABLE OF CONTENTS PART 2: WELDING PROCEDURE SPECIFICATIONS Welding Procedure Cross Reference Table Rev. 1 WPS/BPS Index (Welding/Brazing Procedure Specifications) Rev. 37 Procedure Specifications (WPSs)
I'elding Brazing Procedure Specifications (BPSs)
PART 3: WELD JOINT DETAILS Weld Joint Detail Index Rev. 0 APPENDICES:
Appendix A Standard Welding Symbols NGGM-PM-0003 Rev. 51 Page 3 of 3