ML19305C708
| ML19305C708 | |
| Person / Time | |
|---|---|
| Site: | Three Mile Island  |
| Issue date: | 03/28/1980 |
| From: | GENERAL PUBLIC UTILITIES CORP. |
| To: | |
| Shared Package | |
| ML19305C698 | List: |
| References | |
| NUDOCS 8003310290 | |
| Download: ML19305C708 (116) | |
Text
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0PERATIONAL QA PLAN r~x Introduction O
This Quality Assu'rance Plan is formatted in sucn a manner to provide all users with a functionally workable docu-ment. It is structured to descrice how the Quality Assurance Program is to be functionally implementeo witn due regard to the safety ano healtn of the puolic and tne personnel onsite. The plan contains a description of the organizations responsible for the implementation of tne Quality Assurance Program (Section 1) and an overall des-cription of- the Program (Section 2) . The remaining sec-tions are structureo in a functional manner.
The reouirements for administrative controls are generic and apply to all suosecuent sections. Control of docu-ments and records are contained in Section 3.0; contrpl of design is contained in Section 4.0; contrul of materials and services including procurement is contained in Section 5.0.
Sections 6.0 and 7.0 contain the program requirements for tnose direct and supportive activities associated with the operation and safety of the plant; construction and/or modifications associated with corrective maintenance, plant improvement, and/or repair; and the processing and transportation of radioactive wastes. Specific require-p)s
(. ments sucn as control of measurement and test eauipment, insoection, special processes, test control, and status of inspections, tests and operations are included therein.
Sections 8.0 and 9.0 again apply to all functions coverso by the scope of tnis Quality Assurance Program. Section 8.0 addresses the loentification and disposition of non-conformances associated witha 'll aspects of the program.
In addition, this section contains the management controls provided for evaluating collectively all nonconformances and determining wnat corrective actions snould ce taken to preclude their recurrence Section 9-0 contains the recuirements and administrative controls applicable to audits. Appendices A, 8, and C cc.itain additional Quality Program reouirements associat'de with the functional areas discussed in the plan.
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1.0 Organization O
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1.1 Policy It'is the policy of GPU Nuclear Corporation (GPUNC) to meet the Quality assurance require-ments of Nuclear Regulatory Commission as presented in 10 CFR 50, Appendix 8, and otner applicaole regulatory guices, cooes, ano stancards pertinent to operation of Three Mile Island Unit 1. Tnerefore GPUNC has authorizeo the establisnment of a formal and comprehen-sive Quality Assurance Program for TMI Unit 1 operation. The Program, whicn is describec in the following sections, shall oe implemented in documented approved policies, procedures and instructions wnich comply with tnis Plan and tne design specified in the license application.
1.2 Resconsibilities The structure of tne organizations responsible for the operation, maintenance, modification, repair, inservice inspection ano refueling of the TMI Nuclear Station is illustrated in Figure 1. The overall organization cnart is
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provided to illustrate the interfaces between the various departments and to ioentify tnose normally located on-site and off-site.
1.2.1 President-Met-Ed As the chief executive o f ficer, the President-Met-Ed is ultimately responsiole for QA com-mitments to the Nuclear Regulatory Commission for Unit 1 operation. The responsioliity ano autnority for assuring that_tne conduct of these activities af fecting quality are per-formed in a manner consistent with tne commit-ments of tnis Quality Assurance Program is delegated to the. 0f fice of the President-GPUNC.
1.2.2 President - GPUNC The President - GPUNC has the overall respon-sicility for the implementation and ef fective-ness o f the TMI Unit 1 Operational Quality Assurance Program. This responsiollity is Rev. 8
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adminstered through nis management staff g including:
v Executive Vice Presioent - GPUNC
-Vice President -
TMI Unit i Vice President - Tecnnical Functions Vice President - Nuclear Assurance Vice President - Administration Additionally, he is responsible to assure that management reviews on the ef fectiveness of tne Operational Quality Assurance Program are conducted and documented.
1.2.3 Executive Vice President - GPUNC The Executive Vice President-GPUNC reports directly to tne President-GPUNC and assists him in fulfilling nis respons10ilities. Por-tions of the President's responsibilities may be delegated to the Executive Vice President.
The Executive Vice President provides a focal point for coordination of project ef forts to as's ure unanimity of purpose and ef fective utilization o f resources.
1.2.4 Office of the President O
The Presloent ano the Executive Vice Presioent constitute the Of fice of the President. The two of ficers work in close cooperation and share the executive duties of GPUNC. As used in this Plan. the Office of the President means eitner the President or tne Executive Vice President.
1.2.5 Vice President - TMI Unit 1 The _Vice President - TMI Unit I reports directly to the Of fice of the President. He is responsible for the overall safety of the Unit; for ensuring that the applicable proce-dures for the management control ano Quality Assurance Program activities are implementeo in the conduct of operations, preventative and corrective maintenance, replacment, modifica-tion, re fueling, engineering support, in-service inspection, radiation protection ano control of radioactive wastes, training ano plant security; ano for ensuring that tnese activities are performed in accoroance witn the provins and limitations set forth in
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the licenses and permits of the jurisdictional agencies of Federal, State, and local govern-rm ments. He is also responsiole for ensuring
(- that the operations organization is adequately sta f fed and that the personnel are adequately trained and cualified to perform tneir assigned tasks. Additionally, the Vice Presi-dent-TMI Unit 1 is responsiole for activities such as support services ano logistics ano for the planning and scnedaling of plant opera-tions such as start-up and test, refueling and planned outages, ano productivity of the generating station.
Tne Vice. President - TMI Unit 1 gives his fullest support to the quality assurance requirements set fortn in this Operational Quality Assurance Plan, assuring compliance to the fullest degree oy his staff.
1.2.5.1 Manager-Plant Engineering The Manager-Plant Engineering is responsible for maintaining technical liaison and coordi-nation between operating snift personnel and the technical support engineering staff. Tnis is accomplished oy providing on-shift engi-p) i_
neers to the Operations staf f for direct tech-nical coverage of the plant reactor perfor-mance and associated safety systems in orcer to improve the safety of unit operations and maintenance performance. In addition, tne Manager-Plant Engineering is responsiole for in-plant engineering support in the nuclear, mechanical, instrumentation ano control, and electrical engineering areas. The Manager-Plant Engineering is also responsiole for plant chemistry, fire protection and engi-neering input for procurement of items and services important to safety.
1.2.5.2 Manager-TMI Unit i The Manager - TMI Unit 1 is responsiole for tne day-to-day operation o f Unit 1. He will nave a Shift Foreman directing the operations of eacn snif t through the Control Room Opera-tors and Auxiliary Operators. A maintenance force under the direction of a Supervisor-Maintenance, covering the areas of electrical, mecnanical and instrument control maintenance and surveillance, will'also report to thi (3
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Manager. Additionally, the Manager - TMI Unit 1 nas responsioility for the coordination of
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' start-up and test evaluations and responsi-oility for administrative control of tne training o f Unit 1 personnel.
1.2.5.3 Manaaer-Radioloolcal Controls The Manager-Radiological Controls is respon-sible for the personnel, procedures and administrative controls of tne radiation pro-tection programs. He provides the administra-tive and technical guidance applicaole to operations in the areas of radiation protec-tion, radioactive waste, respiratory protec-tion, health pnysics engineering including ALARA programs, and dosimetry control.
The Manager-Raolological Controls is respon-sible for providing and maintaining up-to-date procedures controlling tne activities of tne department, prm;iding training of all Unit personnel in the casic rules of radiation protection, providing adequate staf fs o f trained personnel to perform the duties of radiation protection, implementing tne "as low (T
as reasonably achievable" policy and making it a formal part of the Radiation Protection
(-) Program, ano assisting in the development, training and implementation of the Station Emergency Plan.
1.2.5.4 Manacer Administration and Services The Manager-Administration and Services is responsible for coordination of functions such as office management, facilities, personnel, station security, and the Station Document Center. Relative to tne activities applicaole to t'.11s Quality Assurance Plan, these rescon-sioilities include esta011sning, supervising an.a operating the Station Document Center; providing'and ma'intaining up-to-date proce-dures for controlling the distribution o f documents, and tne collection, indexing and storage of records; previoing and maintaining up-to-date procedures for controlling tne distribution of documents, and the collection, indexing *and storage of records; providing tne staf f necessary to fulfill these responsi-0111 ties, and ensuring that sta f f is ade-cuately traineo and qualified to perform tneir (m assigned tasks.
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1.2.6 Vice President-Technical Functions
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Tne Vice President-Technical Functions reports directly to the Office of the President witn responsiollity for the cetailed develop 7ent, direction and overall cooroination of all engineering, licensing and construction (nct assigned to maintenance) activities. Addi-tionally, he is responsiole for maintaining the technical configuration of the existing plant and providing technical surveillance associated with the performance of the plant.
He is responsible to assure compliance and implementation of the Quality Assurance Program requirements applicaole to tecnnical support activities. Technical support in-cludes various disciplines such as mechanical, civil, electrical and instrumentation, nuc-lear, construction, licensing and plant opera-tions. He is responsiolle to develop ano control the Quality Classification List (QCL).
Additionally, he is responsible for nuclear fuel management, nrocess computer, control anc safety analysis, and plant operational analysis.
Tne Vice Presilent-Technical Functions ano his 3
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staff give fuli support to the TMI Operatianal' Quality Assurance Program descriced herein, tnereoy assuring that all work performeo unoer their cognizance will conform to and support the requirements of the Plan.
1.2.6.1 Manager-Engineering and Design The Manager-Engineering and Design is respon-sicle for provicing technical support for the operations of the TMI Nuclear Station. He is responsible to assure compilance witn ene implementation of the Quality Assurance Program requirements applicable to angineering and design activities. He will assure tne maintenance of technical capability in the various disciplines, sucn as general mechani-cal, civil, electrical and instrumentation, and engineering mechanics. The department will review, ano where appropriate, approve the work of Architect / Engineering Organiza-tions, and will perform oasic engineering ano design for modifications. Tne department nas capaollities in the following functional areas:
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- a. Engineering Mechanics l
- o. Mechanical Systems
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- c. Mec nanical Components
- d. Electrical Power & Instrumentation
- e. Design & Drafting Additionally, he is responsible for tne iden-tification and classification of materials ano activities important to safety, and the development and control of the Quality Classi-fication List.
1.2.6.2 Manager-Systems Engineering The Manager-Systems Engineering is responsible for technical support in the areas of nuclear fuel management, process computer, control and sa fety analysis, and plant operational analy-sis. His department provides capaoliities in the following functional areas:
- a. Nuclear Analysis and Fuels
- o. Process Computers
- c. Control and Safety Analysis
- c. Plant Analysis He is responsible to assure compliance with and implementation of the Quality Assurance Program requirements applicable to Systems Engineering activities.
1.2.6.3 Project Enoineerina Manager The Project Engineering Manager is responsiole for the coordination, sta f fing and directing of engineering projects that are assigned oy the Vice President-Tecnnical Functions. These activities will vary, depending on tne scope and purpose of the assigned project. These responsiellites generally incluoe providing tne tecnnical support necessaiy "?r a study, an evaluation or a modificattan amt include the cooroination of the Depart #at.3 within Tecnnical Functions with those of Plant Opera-tions.
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1.2.6.4 Director-Environment. Health and Sa fety es The Director-Environment, Health and Sa fe ty
(_) reports directly to tne Vice President-Tecnni-cal Functions and is responsible for the development, direction and overall cooroina-tion o f the environmental, regulatory, water resoureus, of fsite radiological healtn and safety ef forts at TMI in compliance witn tne TMI Quality Assurance Program. His responsi-bilities include:
- a. Developing and implementing Environ-ment, Health and Safety procedures covering items sucn as safety evalua-tions, and others necessary to fulfill the requirements of this Plan.
O. Concurring witn important to safety Design Criteria Documents from the standpoint of naving addressed all applicaole regulatory recuirements and licensing commitments.
- c. Exercising project control of amendment recuests to the Safety and Environ-mental Technical Specifications and the FSAR in accordance with 10 CFR.
- d. Developing oio11gical monitoring programs and special studies in the Environmental Technical Specifications to quantify the impact of Unit 1 opera-tion on the environment,
- e. Performing an environmental evaluation o f proposed modifications, including puolishing o f environmental reports.
- f. Maintaining liaison between GPUNC and NRC's Project Management regarding licensing and environmental issues which are' applicable to operating facilities.
1.2.7 Vice President-Nuclear Assurance The Vice President-Nuclear Assurance nas the overall authority and direct responsiollity for Quality Assurance, Nuclear Sa fety Assess-ment, Training and Operational Safety Support
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activities as. defined in tnis Plan. These
.r ' , activities include, out are not limitec to:
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Development, dis trioution, 'ano main-tenance of tne Quality Assurance Plan
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Assessing program implementati evaluating its effectiveness, on and c.
Identification of quality proolems, d.
Initiation and recommendations rective actions problems. for cuality related of cor-e.
Evaluation of ef fectiveness of plant radiation control operations, f.
Preparation, Emergency Plans. review and approval of g.
of training for plant operations, Techn n.
Evaluation of ef fectiveness of the training programs in meeting course objectives.
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(_q / Additionally, Quality Assurance and Quality Control supp review services such as laboratory analysis, safety (Nuclear Safety Assessment),
reliaollity in formation systems. audits and The Vice President-Nuclear following management staff Assurance memoersutilitize ins tne out his responsioilities: carrying Director-Training Support and Operational Sa fet y Manager-Quality Assurance Manager-Nuclear Sa fety Assessment 1.2.7.1 Manager-Radiological Systems Control Manager-Ouality Assurance (Figure 2) has the functional authorityTne ,
n Manager-Ou (QAD)
~ mentation of the administrative ano controlsres uA-I-8 Rev. 8 i
como11ance to the cuality Assurance Program during the coerational phase of TMI Nuclear fu) m, Station. The Manager of QAD reports directly to the Vice President-Nuclear Assurance.
Additionally, ne has direct unencumoered ac-cess to the Of fice of the Presioent, and the Vice President-TMI Unit 1 with regard to cuality activities.
This reporting relationship has oeen esta-olisned to provide the Quality Assurance organization with suf ficient independence from the influence of costs and schedules to be sole to effectively assure conformance of Operational Quality Assurance Program require-ments. Figure 2 identifies the Quality Assurance Department organizational elements which function under the Quality Assurance Program. The Manager-QA0 has no cuties or responsiollities unrelated to Quality Assurance that would prevent his full atten-tion to Quality Assurance matters, and he nas authority:
- a. To evaluate the manner in wnich all activities, octn onsite and offsite are conducted, with respect to quality, oy
() means o f review, survey, audit, sur-veillance, monitoring, and inspection.
- b. To perform evaluations on a planned ano periodic basis to verify that tne Quality Assuranca Program is oeing e f fectively implemented.
- c. To identify quality proolems, and to initiate, recommend or provide solu-tions through designated channels to verify implementa tion o f resolutions,
- d. To stop work or further processing, delivery, or installation of noncon-forming m'aterial, to stop work on non-conforming activities, to initiate unit shutdown recommendations and to ootain unit shutdown with appropriate upper management concurrence as describeo in applicaole Quality Assurance procedures.
The specific responsibilities of the Manager-OAO, include tne following:
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- a. Provide for the review and acceptance r' of tne Quality Assurance Program of '
A-) contractors providing services affect-ing quality and of vendors supplying materials, parts, or components covered by tne scope of this Quality Assurance Program.
- b. Provide for review and acceptance of procedures prepared oy otner TMI organizations when these procedures control or exercise an effect upon items and activities important to safety.
- c. Provide direction and management of the QAD.
- d. Provide a working interface and commu-nication with tne TMI organizations, consultants, contractors, vendors, and otners with respect to QA matters.
Additionally, in conjunction witn the licensing organization, ne shall pro-vide a working interface and communi-cations with the NRC with respect to QA matters,
- e. Provide, as applicable, planne'd and periodic audits, monitoring, surveil-lance, and inspections of organiza-tions, contractors, and vendors per-forming work functions important to sa fety .
- f. Estaolish and assure the continuous implementation of an indoctrination and training program for QA ano QC per-sonnel and assure tnat a quality assurance indoctrination is provioed to appropriate personnel outsioe the Quality Assurance organization.
- g. Issue periodic reports to the Vice President-Nuclear Assurance and the Vice President-TMI Unit 1 on the status of ouality activities, and bring to their attention immediately any signi-ficant ouality-related proolem or defi-ciency.
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- h. Provide for quality assurance review
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T and acceptance of design and engi-neering documents, as delineated in tne detailed procedures.
- 1. Provide for Quality assurance review and acceptance of procurement documents generated for the accuisition of mate-rials and services within the scope of the program.
J. Provide for and maintain quality assurance records generated oy QAD until such time as they are turned uver to document control for storage.
The Manager-Quality Assurance shall have, as a minimum, a caccalaureate degree in Engineering or Science, with at least five years of QA experience in nuclear power plant operations or supporting activities. Additionally, tne Manager-Quality Assurance must ce knowledge-able in QA regulations, policies and standarcs.
1.2.7.l(a) Quality Assurance Design and Procurement Manager
() The Quality Assurance Design and Procurement Manager is responsiole for establisning quality programs and inspection reouirements in support of design and procurement activi-ties in compliance with the TMI Quality Assurance Program. These activities include, out are not limited to:
- a. Review and approve contractor and ven-dor quality programs for those supply-ing services or items important to safety.
- o. Reporting quality trends to nis super-visor and.to tne cognizant purcnasing or contract manager.
- c. Review and accept design control proce-dures prepared oy other TMI organiza-tions when tnese procedures control or exercise an ef fect upon systems, components, or activities important to safety.
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1.2.7.1(o) Quality Assurance Manufacturino Assurance 3 Manaaer (V
The QA Manufacturing Assurance Manager is re'sponsiole to perform tne necessary costawaro cuality-related activities in compliance with the TMI Quality Assurance Program required to assure that vendor products are designed, manufactured, tested and/or inspected in accordance with the procurement specifica-tions. These activities include post-award surveys and surveillances, and source inspec-ti6ns.
He is responsio'le for the coordination with the QA Modifications / Operations Section to assure that documentation of manufacturing discrepancies are availaole to the receiving inspectors and the cognizant purchasing or contracts manager. Additionally, he is responsible for providing tne Design and Procurement Assurance Section with the results of Manufacturing Assurance activities and recommendations relative to the acceptability of a vencor.
1.2.7.l(c) Quality Assurance Modifications /Ocerations (s-)/ Manager The Quality Assurance Modifications / Operations Manager is responsiole for monitoring the implementation and ef fectiveness o f tne Quality Assurance Program on site. These activities include the esta011shiment of ade-cuate site monitoring and inspection programs necessary to verify conformance to Quality Assurance Program requirements. In addition, he is responsiole to review site procedures from a QA/QC standpoint and to provice nondes-tructive examination support for TMI. He reports directly to the Manger of Quality
-Assurance and he. periodically reports on tne implementation and ef fectiveness of the Opera-tional Quality Assurance Program to tne Vice Presloent - TMI Unit 1. He has the authority and organizational freedom to identify quality assurance proolems, provide or recommena solu-tions, and verify implementation o f solu-tions. He nas the autnority to stop worx on all important to safety activities associated with the on site TMI Nuclear Station Opera-
,_ tional QA program. He is responsible to
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notify appropriata TMI Station management and fs the Manager of Quality Assurance immeoistely
() of any condition that warrants operational shutdown o f a nuclear unit as defined in appropriate QAD procedures. Tne Quality Assurance Modifications / Operations Manager is assisted in carrying out nis responsiollities oy an Operations Quality Assurance Supervisor, a Quality Control Manager ano tneir associated staffs located onsite.
1.2.7.l(d) Quality Assurance Methods / Operations / Audits Manager The Quality Assurance Methoas/ Operations /
Audits Manager is responsiole for coordination of activities required to maintain the Quality Assurance Plan and those OAD proceoures required to implement the plan. Additionally, the responsibility for QA training within tne department falls under this Section. He is responsible for implementing a comprehensive system of planned and documented audits to verify compliance with all aspects of the Quality Assurance Program.
T The Quality Assurance Methods / Operations /
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'~ Audits Manager maintains a full-time staf f of ouality assurance engineers and qualified ouality auditors at ooth tne corporate ano site offices. The audit activities and the results of the audits are provided to the audited organization and to the Safety Review Groups who provide the management assessments of the significance of tne audit findings ano the ef fectiveness of the Quality Assurance Program.
1.2.7.l(e) Materials Technology Manager The Materials Technology Manager directs and supervises the of fsite engineering organiza-tions which have'the responsibility for acti-vities in the establishment o f requirements for welding, inservice inspection, materials, and materials evaluations. Materials Tecnnology provides NDE and ISI program flow analysis and reporting, technical requirements
.for repair and repair program and related c corrective action recommendations to Engi-neering. Additionally, ne nas a staff func-tion to support manufacturing and tne evalua-
_ (]) tion of system materials technology proolems.
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He is directly resconsiole for the implementa-
, s. tion and compliance with the Quality Assurance T,') Program requirements applicable to his areas of responsiollity.
The specific disciplines included in the Materials Technology section are:
- o. Inservice Inspection
- c. Materiais Engineering
- d. Welding Engineering
- e. Metallurgical Analy~ sis 1.2.7.1.1 Minimum Qualifications of Quality Assurance Personnel The cualification reauirements ano experience levels for key Quality Assurance personnel are such as to assure competence commensurate with
' the responsi'oilities o f each position.
Quality managers and supervisory personnel are required to have a degree in Engineering or
(]) Science.and experience in a position having responsibility for the performance of quality activities. The degree requirement may oe waived for personnel with exceptional qualifi-cations and a minimum of seven (7) related experience.
years 1.2.7.2 Director-Training and Operatir nal Sa fety Sucoort The Director-Training and Operational Safety Support reports directly to tne Vice Presi-dent-Nuclear Assurance and has the overall authority and responsibility for technical training, emergency planning ano the system laboratory. These activities include but are not limited to:
- a. Providing tecnnical and administrative direction of training for plant opera-t'..ons in the areas o f:
o operator training o maintenance training
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o healtn pnysics~and chemistry training
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, o plant related technology o quality assurance trai'iing
- o. Evaluation o f the ef fectiveness of tne training program in meeting estaolisned course oojectives.
- c. Preparation, review and approval o f the Emergency Plan. Provide a competent staff to act as plan coordinators and evaluators.
- d. Provide management direction to the system enemistry laboratory.
1.2.7.2.1 Manaoer-System Laboratory The Manager-System Lacoratory is responsible for the administration and operation of the Environmental and Operational Chemistry Analyses Section of the System Laboratory in compliance witn the TMI Quality Assurance Program. Tnis section provides tne central-
,~s ized laooratory analyses servicet for TMI.
(_) The specific responsibilities of tne Manager--
System Lacoratory include the following:
- a. Perform analysis of water and waste-water samples suomitted Jy the generating station,
- b. Prepare calibration standards for the labs at the genera ~.ing stations,
- c. Monitor the analysis capacilities o f the laos at the generating stations through audits and independent analysis of samples,
- d. Assist station personnel in unusual operations sucn as chemical cleaning,
- e. Prcvide consultation on equipment startuo and performance, as recuested,
- f. Perform chemical analysis of fuels, looricants, insulating fluids and ion excnange resins,
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- g. Ensure tnat the lacoratory is ade-(~)
x> ouately staffed and tnat tne lacoratory personnel are adequately trained anc qualified to perform their assigneo tasks,
- b. Ensure that the System Lacoratory meets the applicaole requirements o f the Quality Assurance Program,
- 1. Develop and implement lacoratory proce-dures covering tne control of the laooratory activities and the records documenting tne results of the analysis.
J. Provide support to Materials Tecnnology regarding material specimen preparation and testing.
1.2.7.3 Manaoer-Nuclear Sa fety Assessment The Manager-Nuclear Safety Assessment is responsiole for the development, direction and supervision of the Nuclear Safety Assessment Department. The function o f this group is to maintain an overview of the oroad range of g3
(_j activities, practices and conditions whicn may have an adverse ef fect on cuality. They assess the safety significance of these conoi-tions and make recommendations to the appro-priate levels of management for corrective action to preclude repetition. The Nuclear Safety Assessment Department will have access to all documents and reports identifying conditions adverse to Quality (audit reports, nonconformance reports, surveillance /inspec-tion reports, reportaole occurrences, NRC inspections, etc.). NSAD will report, at intervals not to exceed six (6) months, the results of their evaluations to the Office of the President and the Vice President-TMI Unit
- 1. NSAD serves as an independent office of omoudsman for all members of the Corporation having a concern for nuclear safety. Addi-tionally, the Nuclear Safety Assessment Department, worxing with Systems Engineering, will evaluate the operational experience of otner nuclear power stations to improve plant operational status and derive benefit from
.otner stations experience.
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1.2.7.4 Manager - Radiological Systems Control g) k-The Manager-Radiological Systems Control reports airectly to the Vice President-Nuclear Assurance. He is responsible for provioing policy, guidance and coordination o f radio-logical control programs to oe implemented at the operating units.
1.2.8 Vice President - Administration The Vice President - Administration reports directly to the Office of the President and provides administrative and management ser-vices in the areas of:
o Materials management, including pur-chasing, contracts, ecpeoiting, receiving and warenousing.
o Fiscal management o Industrial safety o Security systems, including maintenance and security staf fing
() o Personnel and laoor relations.
He is assisted in the performance of tnese responsibilities at the site oy indiviouals with assigned responsiollity for: ,
- 1. Security
- 2. Procurement
- 3. Warehousing 1.2.8.1 y nager - Field Warehousing. TMI l
he Manager-Field #arehousing, TMI is respon-i sible for maintaining an inventory, initiating requisitions for inventory reorder, receiving oath direct turnover and inventory items, l
maintaining adeauate storage space and facili-ties, and issuance of material from storage.
1.2.8.2 Manacer - Field Procurement, TMI l
f,w The Man 1ger-Field Procurement, TMI is respon-t, ) sicle fs r all TMI purchasing and expediting activities including tne following:
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I a, the implementation of an approved procurement control process,
()- b. the receipt, review, recoroing and
. tracking of purchase reouisitions, i-
- c. the incorporation of engineering recuirements into purcnase orders,
- d. compliance and implementation of the TMI Quality Assurance Program with
- regard to nis areas of responsioliity.
l -e. the preparation and document control of all purenase orders including those for
! contracts.
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.fanager FIGURE 2 Quality Assurance
. QUALITY ASSURANCE DEPARTilENT 1laterials Methods, Site Technology Operations and Audit
!!anager Audits Supervisor llanager 6 >) QA Mod / Ops QA QA Design and Q >) !!anager }!anufacturing Procurement Assurance Manager Manager ld E@
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@ Quality Operations Site '
L Control Quality QA M Manager Supervisor Engineer
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2.0 Quality Assurance Program
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2.1.1 General The TMI Operational Quality Assurance Program has been estaolisned to provide overall cua-lity assurance of operations activities within the scope of the program. Adherence to the requirements of the TMI Operational Quality Assurance Program is mandatory for all TMI organizations and for all contractors or ven-dors providing items or services covered under the scope.
This Quality Assurance Plan is the highest level document which describes the Quality Assurance Program. Tne term " Program" as used herein includes subtier implementing policies, procedures and instructions.
2.1.2 Scoce The scope of the TMI Operational Quality Assurance Program includes all items and ac-tivities considered to be "important to fs sa fety . " This term is intended to be oroader
(,) than "sa fety-related" and encompasses struc-tures, systems, and components (including nuclear fuel and radwaste) whlen have oeen designated as Sa fety-Related, Sa fety Class, IEEE Class IE, Seismic Category 1 or Fire Prore:: ion. rha secca of the Prograir, all.
incluoe all items required by the following:
- a. Title 10, Code of Federal Regulations, Part 30. 2.pce".di" a " General C:=ign Criteria for Nuclear Power Plants"
- 0. Title 10, Code of Federal Regulations, Part 50, Appendix 8 " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants"
- c. . Title 10, Code of Federal Regulations, Part 71, Appendix E " Quality Assurance for Snipping Packages for Radioactive Material"
- d. United States Nuclear Regulatory Com-mission Regulatory Guide 1.143 " Design
! r3 V
Rev. 8
Guidance fo'r Radioactive Waste Manage-ment Systems, Structures and Components
{l Installed in Light Water Cooled Nuclear
- ower Plants"
- e. Brancn Technical Position ASB 9.5-1
" Guidelines for Fire Protection for Nuclear Power Plants",
- f. U.S. Nuclear Regulatory Commission Regulatory Guide 1.29 " Seismic Design Classification," and components wnich have impact on items important to safety.
The Program also includes certain non-safety related items wnen designated oy engineering.
Activities which are important to safety sna11 include, out not be limited to, those activi-ties covered by Appendix A o f Regulatory Guice 1.33 and ANSI NIS.7.
In addition, tne requirements of other Regula-tory Guides applicable to operations, main-tenance, modification, repair, and refueling of a nuclear power plant were considered.
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(J Met-Ed position with regard to these Regula-tory Guides is included as Appenoix C. The determination that an item or activity is, or is not, important to safety is a design deci-sion governed by approved engineering proce-dures. Items and activities determined to oe imacrtant t: :sfaty ra de floed as these 1:O r.i s on the Quality Classification List (QCL) and those activities covered by procedures wnich have been designat;d during the review cycle as "important to sa fety. "
For new design efforts, such as plant modifi-cations and new construction, the classifica-tion determination is recorded on design cri-teria documents. New items will be included in the next revision to the QCL. Documents whicn control the installation of new modifi-cations to the field wnich. nave oeen classi-fled as "important to safety" will include distinct designation as notification to all users.
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II-2 Rev. 8
2.1.3 ,0uality Assurance Pian
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K' This Quality Assurance Plan is the primary document which provides a description of the Program. The Plan is authorized by the Presi-dents of Met-Ed and GPUNC to assure that the appropriate levels of management, as desig-nated herein, are directed to implement the Program. The Plan is controlled to assure that only the latest approved revision is imple-mented. The Plan is implemented by approved detailed procedures and instructions.
The purpose of this Plan is to estaolish the principles wnich, when implemented, will pro-vide that level of quality assurance which is appropriate to each item or activity important to safety. It is recognized that the degree of management control or quality assurance to be applied varies with different systems and activities, and the degree of applicacility of any specific item in this Program will differ from item to item and activity to activity.
The degree to which the recuirements of this Plan and its implementing procedures are applied will be cased upon the following:
() a. The importance of a malfunction or failure of the item to safety;
- b. The dasign and fabrication complexity or uniqueness of the item;
- c. The need for special cc7trols and sur-veillance or monitoring of processes, equipment and operational activities;
- d. The degree to which functional com-pliance can be demonstrated by inspec-tion or test; and
- e. The. quall'ty history and degree of stan-darization of the item or activity.
The quality requirements for items important to safety will be establisned using approvec procedures cased on the " General Logic Consi-i ' derations" listed in the Appendix to ANSI-Nh5.2.13-1976. Quality requirements will ce estaolished by the responsiole Engineering Department and concurred with oy Quality ,
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II-3 Rev. 8 i
Assurance Department for those items wnich are important to sa fety.
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GPUNC is committed to a comprehensive Quality Assurance Program consisting of a three level approach to assure satisfactory and complete implementation of the program commensurate with its requirements for safety anc perfor-mance. The Program's foremoe; considerations are the protection o f the general puolic's health and sa fety. The three level approach is defined oelow:
Level 1 - activities at this level include independent inspections, cnecks and tests.
This level of activity may be performed oy Operations personnel in activities such as surveillance tests, calibration of instru-ments, radiation surveys, analyses of samples, valve line-ups, etc.; the Quality Control Section oy raccipt inspection or inspections of modification or corrective maintenance activities; or oy contractors as part of their scope o f work. In all cases, the activity is performed by indivi-deals knowladgeable of the activity oeing performed and qualified to perform the work c3 (re fer to Section 6. 2.1.1) . Checklists or (J data sheets are also used for documenting the results of the activity and for pro-viding a permanent plant record o f the performance of the activity.
In all cases where the first level activities involve independent inspection for purposes of acceptance and/or verification of modifica-tions to safety systems, the activity will be performed by the QA Department or oy organiza-tions authorized to perform those activities by the QA Department.
Level II - the activities at this level are primarily tho'se o f surveillance or moni-toring and are performea as deemed nemts-sary by the QA Modifications /Operatio.a, QA Design and Procurement or QA Manufacturing Assurance Sections. The level o f surveil-lance / monitoring applied is consistent with the importance o f the item to safety. For activities, where Quality Control is per-forming first level inspection, no second level activity will De required.
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II-4 Rev. 8
i At this level procedures and instructions are
/~T establisned and surveillance records will be completed and maintained. Such surveillance k'# /
monitoring normally includes observation of ouality control tests and inspections, ooser-vation of significant operations, review of reccrds, verifications of test reports, and direct inspection on a spot check basis. The organizations performing this activity have the levels of authority, the lines of internal and external communication for management direction, and the properiv trained personnel for implementation of these activities.
Level III - the purpose of this level of activity is to assure through a compre-hensive program of review and auditing that the first and second levels of the progrsa are properly functioning. The purpose of this level is also to establish that all other organizations including Operations, Maintenance, Engineerint Materials Manage-ment, etc. are properl- satis fying all the recuirements of the Operational Quality Assurance Program.
At this level procedures and instructions are (m) established including the use of comprehensive checklists for documentation of the audit or third level activity in accordance witn recuirements of ANSI N45.2.12. Qualified audit personnel are included that satisfy tne recuirements of 'NSI N45.2.23. Additional technical expert. from areas with administra-tive reporting outside th.e function that is oeing audited will be included as the Audit
' Team Leader deems necessary. The organiza tion performing this activity has suf ficient authority and lines of internal and external communications for obtaining the necessary management direction.
Appendix A is in~cluded to provide a comparison of the sections of the Plan with the require-ments o f 10CFR50, Appendix 8, 10CFR71, Appen-dix E, ANSI N18.7, and ANSI N45.2.
2.1.4 Quality Assurance Program Review The TMI Quality Assurance Program e f fective-ness and implementation is periodically l evaluated oy independent review groups m
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II-5 Rev. 8
reporting to GPUNC management. These groups provide safety review reports and review <
operational methods. These groups each nave
({ technical expertise necessary to support tneir areas of concern. The independent review committees and operational review groups include tne Generation Review Committee, the Plant Operations Review Committee and the Nuclear Safety Assessment Department. In addition, the Quality Assurance Department conducts activities which provide management with additional information pertaining to effectiveness and implementation. 2.1.3 Trainino The TMI Quality Assurance Program includes requirements for formal training programs for personnel performing or verifying activities important to safety. 2.2 Reouirements 2.2.1 Quality Assurance Plan The Operational Quality Assurance Plan and any significant revisions shall ce approved oy the following: (v-] Of fice of the President President Executive Vice President Vice President - TMI Unit 1 Vice President - Nuclear Assurance Manager - Quality Assurance The Plan includes a Statement of Policy whicn is signed by the Presidents - GPUNC and Metro-politan Edison. The Statement of Policy pro-vides authorization and evidence of management commitment to the Quality Assurance Program. Plan revisions which represent significant changes of a astantive nature snall oe suo-mitted to the Nuclear Regulatory Commission for approval. (~T U II-6 Rev. 8 l
Revisions to this plan shall be considered significant if they alter tne degree of com-
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(\ l pliance with committed regulatory requirements (Appendix C). Changes to the TMI-1 organiza-tion in assignment of responsiollities to tne extent described below the Vice President's level shall not oc considered significant except in the area of Quality Assurance. Changes in name or title changes with no casic change in function snall not ce considered significant. Editorial and typo's which do not change the intent of the words or scope of the program shall not be considered signifi-cant. Significant plan revisions shall be submitted to tne Nuclear Regulatory Commission for approval. Plan revisions not considered by the Manager - Quality Assurance to be significant can be issued with approval of the Manager - Quality Assurance and the Vice President - Nuclear Assurance. The Manager-Quality Assurance is responsible for notifying the NRC o f all changes to the Plan within 30 days of the change and for obtaining the required approvals prior to issuance.
/"x \_) Copies of Quality Assurance Plan may be dis-triouted as "Controlleo" or "Uncontrolleo" copies in accordance with the requirements establishec in Section 3.
2.2.2 Classification The TMI Operational Quality Assurance Program applies to all items on the QCL and activities designated as "important to safety." The QCL will be periodically updatec to include new plant modifications or construction, or any changes in classification. The list will be treated as a controlled document. The QCL will normally list systems and com-ponents, but not parts. For procurement o f spare or replacement parts, classification will be on a casa oy case oasis. Engineering will classify the parts to be ordered. QA
- concurrence is required. The determinations will not necessarily oe added to the QCL. An approved engineering evaluation shall oe docu-mented and maintained as a quality assurance record. This does not apply to those items
(>D x. II-7 Rev. 8 l
which were originally specified as commerical 7 ouality. U The Quality Assurance Department will cc ncur with the procedures used for classification, and audit tne process for implementation. Additionally, engineering classification of items "important to safety" will oe subject to independent design review mr ., gins? ring. 2.2.3 Regulatory Commitments A listing is maintained of commitments to regulatory requirements. Each new or revised USNRC Regulatory Guide will be evaluated for applicability and acceptability to TMI. The GPU Nuclear Corporation position on eacn is documented stating the method and degree o f compliance or the justification for lack of compliance. Appendix C lists those regulatory guides whicn are cuality related or affected with stated company position, exceptions and or clarifica-tions. These must be complied witn in con-junction with the QA Plan. {} 2.2.4 Safety Review Safety review groups have been establisned with primary responsibilities for review of operational phase activities. In addition to performing regulatory recuired reviews, these groups provide management with visaollity and recommendations for improved plant sa fe ty . 2.2.4.1 Generation Review Committee (GRC): The GRC is an off-site organization reporting to the Vice President - Technical Functions. This group is responsible to provide indepen-l dent safety review o f operations, nuclear I engineering, chem'istry and radiocnemistry, l matallurgy, nondestructive examination, Instrumentation and control, radiological safety, mechanical and electrical engineering, radwaste, administrative controls, cuality assurance and other appropriate fields asso-ciated witn the unique characteristics of TMI. The GRC is responsible for reviewing the following specific suojects: (v~') II-8 Rev. 8
- a. Written safety evaluations of changes in the facility as described in the
-rw) is Safety Analysis Report, cnanges in procedures as described in the Safety Analysis Report and tests or experi-ments not descrioed in the Sa fety Analysis Report wnich are completed without prior NRC approval under tne provisions o f 10 CFR 50.59(a)(1) . This review is to verify that such changes, tests or experiments did not involve a change in the technical specifications or an unreviewed safety question as de fined in 10 CFR 50.59 (a)(2).
- b. Proposed changes in procedures, pro-posed changes in the facility, or proposeo tests or experiments, any of which involves a cnange in the techni-cal specifications or an unreviewed safety auestion as defined in 10 CFR 50.59(c). Matters of this kinc snall be referred to the GRC by PORC follow-ing its review, or by otner functional organizational units within the GPU Nuclear Corporation, prior to implemen-tation.
() c. Changes in the technical specifications or license amendments relating to nuclear safety prior to submittal to the Commission for approval and prior to implementation, except in those cases where the change is identical to a previously reviewed, proposed change.
- d. Violations, deviations and reportable events which require reporting to tne NRC in writing within 24 hours, such as:
- 1. Violations of applicaole codes, regulations, orders, tecnnical specifications, license require-ments, internal procedures or instructions having safety signi-ficance.
- 2. Significant operating abnormali-ties or deviations from normal or expected performance o f plant structures, systems, or compo-nents important to safety.
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- 3. Reportable events, which require
~'. reporting to the NRC in writing (N-) withJn 24 hours, as defined in tne plant technical specifica-tions.
GRC reviews o f these items normally occur af ter tne NRC has been notified. GRC reviews shall include tne results of any investigations made and the recommendations resulting from such investigations to prevent or reduce the probability of recurrence of the event.
- e. Any other matter involving safe opera-tion of the nuclear power plant which an idependent reviewer deems appro-priate for consideration, or which is referreo to the independent reviewers by the onsite operating organization or by other functional organizational units within the TMI organization.
2.2.4.2 Plant Ooerations Review Committee (PORC): The PORC is an on-site operations review rs organization functionally reporting to the (_) Vice President-TMI Unit 1. This group screens subjects of potential concern by reviewing and/or performing preliminary investigations of suojects reouiring independent review. PORC shall provide, as part of the normal duties of plant supervisory personnel, timely and continuing monitoring of operating activi-ties to assist the Vice President - TMI Unit 1 in keeping abreast of general plant conditions and to verify tnat the day-to-day operating activities are conducted safely and in accordance with applicable administrative controls. These continuing monitoring activi-ties are considered to be an integral part of l the routine supervisory function and are l important to the safety of plant operation. The Vice President - TMI Unit 1 in carrying out his responsibility for overall safety of j t plant operations, snall oe responsiole for timely referral of appropriate matters to management and independent reviewers. i v II-10 Rev. 8
l 2.2.4.3 Nuclear Sa fety Assessment Oeoartment (NSAO): O NSAD is an independent organization reporting to the Vice President - Nuclear Assurance. It performs evaluations and investigations as assigned by Vice President - Nuclear Assurance. NSAD performs special evaluations of information from external sources for applicability to TMI. NSAD may also perform evaluations of existing hardware and sof tware systems which affect the safe, reliaole opera-tion of the plant. They interface with the QAD audit section to assure complete coverage and utilization of the audit program. 2.2.4.4 Quality Assurance Deoartment: The normal audit program conducted by the Quality Assurance Department and described in Section 9.0 also provides management witn ') assessment of program status and effectiveness. 2.2.5 Indoctrination and Trainino Indoctrination and training programs are established for oath on-site and of f-site personnel performing important to safety (\ /~T activities by the organizational units responsible for the activities. Tnese programs are implemented oy appropriate training plans and procedures which assure tnat:
- a. Personnel responsiole for performing important to safety activities are instructed as to the purpose, scope, and implementation of manuals, proce-dures, and instructions;
- b. Personnel performing important to safety activities are trained and qualified (when required oy regulatory committment or for control of special processes)-in the principles and tech-niques of the activities being per-fo rmed. Acceptance criteria will be established consistent with the impor-tance to safety of the activity reouiring qualification; l
() '
-II-11 Rev. 8 l
l
- c. Proficiency o f personnel performing important to safety activities is main-(~')
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tained oy retraining, re-examining, or recertifying;
- d. The scope, method and oojective o f the training is documented;
- e. Records of training sessions are pre-pared and maintained, including identi-fication of the content, the attendees, and the date the training was conducteo.
2.2.6 For personnel performing inspection, examina-tion, and special processes, tne qualification criteria shall oe delineated to the tecnniques of inspection or items being inspected and tne technical aoilities of the person being certi-fled will oe consistent with the assigned tasks (e.g., electrical inspection, mecnanical inspecticn, etc.)- 2.3 Resoonsibilities 2.3.1 Of fice o f the President - GPUNC The Of fice of the President - GPUNC is respon-p) s_ sible to regularly assess the scope, status, adecuacy and compliance o f the Quality Assurance Program to the requirements of 10 CFR 50, Appendix 8. This assessment shall be the combined result of:
- a. Frequent contact with Quality Assurance Program status through attendance at meetings, and review o f periodic status reports on Gie ef fectiveness ano imple-mentation o f the Quality Assurance Program.
D. Performance at least once a year of a preplanned and documented assessment of the effectiveness of the Quality Assurance Program to assure that the program meets regulatory requirements, and the policies and directives of TMI. This assessment may be performed utilizing the safety review groups, an indepentent consultant, or his own staff. Any corrective action which may ce deemed necessary as a result of ' these assessments shall be formally I l tm l V II-12 Rev. 8 l l
identified and t:2c' cad through resciu-tion. 2.3.2 VIce Presioent - Nuclear Assurance The Vice President - Nuclear Assurance has overall responsibility for estaollsnment of the Operational Quality Assurance Program. He also has overall responsibiliity for establishment and management of the Nuclear Sa fety Assessment Department and the Quality Assurance Department, including Methods / Opera-tion / Audit Section. He shall provide periodic status reports to the Office of the President on the Quality Assurance Program. 2.3.3 Manager - Quality Assurance The Manager-Quality Assurance, nas tne direct responsiollity for verifying the ef fective implementation of the Quality Assurance Program. He shall estaolisn and implement a formally documented and procedurally con-trolled program to evaluate and report to the Vice President - Nuclear Assurance on the adequacy and continued ef fectiveness of tne overall TMI Operational Quality Assurance r^ Program. Reports o f audits performed oy the (_-) Quality Assurance Department or their agents, and cuality trend analyses cased on nonconfor-mance and deficiency reports will provide the basis for this evaluation. Corrective action shall oe implemented by responsicle management as deemed appropriate when analyses reveal adverse quality trends. These actions may involve specific actions to provide compliance with the Quality Assurance Program, and may include follow-up system attrioute audits ano even revision to the TMI Operational Quality Assurance Program. Implementation and close-out of corrective actions shall be ef fectively monitored by the_ Manager-Quality Assurance to assure timely correction and compliance. The Manager-Quality Assurance is responsiole for the contents of Quality Assurance Plan and for_ ensuring that the Quality Assurance Plan is modified and updated as standards, reguia-tion, requirements and experience dictate. Proposed revisions to the Plan may oe suggested by GPU Nuclear Corporation personnel o oy submitting tne request, in writing, to tne -O II-13 Rev. 8
Manager-Ouality Assurance for review and action. The Manager-Quality Assurance is (")
responsiole for the monitoring, surveillance and auditing o f Quality Assurance Program implementation.
He is also responsible to provide tne recuireo training and qualification of Quality Assurance Department personnel. 2.3.4 Manager - Engineering & Oasign The Man. er of Engineering & Design is respon-sicle f_a development and maintenance of the QCL. He solicits input and coordinates with affected organizations to assure a uniform approach to classification of items and acti-vities important to sa fety. 2.3.5 GPU Nuclear Corocration - Management Management personnel in each department are responsiole for Quality Assurance Program , implementation. They are further responsiole for development of procedures, for scope of involvement, for activities important to safety, and for training and indoctrination o f
; personnel.
2.3.6 External Organizations Quality Assurance Programs and implementing procedures for suppliers or contractors pro-viding materials and services for the TMI Nuclear Staticn which are covereo under the scope of this Quality Assurance Program shall oe suoject, wnen required, to review and acceptance oy the Quality Assurance Department prior to the commencement o f any in.portant to sa fety activity. Procurement documents shall require, and the Quality Assurance Department shall assure, through their review and audit, that supplier and contractor Quality Assurance programs comply with the commitments of tnis document. l 2.4 Resolution of Discutes Resolution of disputes involving quality, arising from a oif ference of opinion oetween l QA/QC personnel and other organization (engi-neering, procurement, manufacturing, construc-
) tion, operation, maintenance, etc.) personnel II-14 Rev. 8 l
snall,.if'possiole, be accomolished at the level such. disputes occur ~. If tnis is not possiole the difference of opinion shall oe 5]s escalated tnrough supervisory / management , levels until resolution is acnieved. The Manager - Quality Assurance shall make tne final decision on matters concerning inspec-tion-and acceptance to estaolisned require-i ments. Tne Vice Presloent - Technical Func-- tions shall make the final decision on matters concerning interoretation o f requirements or design changes. t i r :O A Z f
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l 1 l l 3.0 Control of Documents and Records
~( 3.1 Instructions. Procedures, and Drawinos w)3-3.1.1 Poiicy The TMI Quality Assurance Program requires that activities important to safety oe pres-crioed oy documentad procedures, instructions, and/or drawings and that these quality-affect-ing activities be accomplished through the implementation of these documents. All user personnel must ce indoctrinated to the aoove prior to implementation.
3.1.2 Recuirements TMI procedures, instructions, and/or drawings which prescribe the performance of activities important to safety shall comply with reouire-ments of this Plan. To accomplisn tnis tne procedures shall:
- a. Include quantitative (sucn as dimen-sions, tolerances, and operating limits) and qualitative (suen as work-mansnip samples) acceptance criteria ps su f ficien t for determining that impor-
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tant activities have oeen satisfac-torily accomplished,
- c. Require approval of responsiole per-sonnel prior to the initiation of the quality-af fecting activity.
- c. Describe the action to De accomplished.
( d. De fine the responsiollities ano autno-9 rities of personnel performing the activity. 9 b
- e. Describe interfaces with other company 9 elements 'or otner organizations.
f. Se cistributed in a controlled manner to preclude the use of obsolete docu-ments.
- g. Be distributed with sufficient con-trolled copies to assure availability to responsiole personnel.
\.J Rev. 8 I
Aapendix 8 identifies organizational responsi-oilities for tne preparation, review, appro-([) val, concurrence ano issuance of documents important to safety. 3.1. 3' Resconsibilities 3.1.3.1 Deoartment Managers The Manager of each department performing activities important to safety is responsible for the preparation, approval and implementa-tion of procedures, instructions and/or drawings. He is responsible to assure that provisions are made for interface controls for internal and external lines of communications among participating organizations ano tecnni-cal disciplines. Additionally, he is respon-siDie to insure that the procedures reference the occuments used in their preparation ano the extent to which the procedures meet the requirements of the references. 3.1.3.2 Quality-Assurance-Deoartment 4 The QAD snall review those administrative policies, procedures, instructions and/or
/~T drawings wnich delineate the methods o f k
complying with tne recuirements o f this Plan. Procurement documents shall specify those
/
vendor documents which must ce suomitted for approval. Vendor Quality Assurance Plans / Manuals, spe-cial process procedures, and inspection and test procedures shall be reviewed and approved by QAD prior to releasing the vendor to imple-ment such documents. Contractor Quality Assurance Plans / Manuals, wor < plans, selected drawings, instructions and procecures snall ce reviewed and approved by QAD prior to releasing tne contractor to start worx. Com-pliance snall be verified by aJdit, Surveil-lance and inspection programs. 3.1.3.3 TMI Unit Management The Management of each TMI Unit is respansiole for assuring that instructions, drawings: ano procedures associateo witn tne administrative
- controls, operation, fuel hanoling, insarvice L
III-2 Rev. 8 D* ]D
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l l l inspection, calloration, maintenance, modifi-cation, repair and operational testing of
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structures, systems, and components important to safety are prepared, revieweo, approved and in accordance with approved written proceoures which conform to tne requirements o f the TMI Quality Assurance Program. All activities important to safety accomplished Dy the plant staff shall be performed in accordance with approved procedures, instructions, or drawings. 3.1.3.4 Delegated Authorities Those activities important to safety which are performed by contractors, agents, contractors, or vendors shall be delineated by documented, approved, and controlled procedures, instruc-tions or drawings. 3.2 Document-Control 3.2.1 Policy Measures shall be estaolished ano documented l to control the issuance of documents, sucn as program documents, design documents, instruc-tions, procedures, and drawings, including changes thereto, which prescribe activities (]- x important to safety. Tnese measures snall assure that documents, including changes, are reviewed for.adeauacy and approved for release oy authorized personnel and are distriouted to, and useo at, the location wnere the prescribed activity is performed. 3.2.2 Recuirements l Written document control procedures shall be estaolisned to provide for control of the j following documents as a minimum:
- a. As-built Drawings
- b. Quality Assurance Plans / Manuals, and Procedures l
l c. Operating Procedures & Instructions
- d. Maintenance Procedures & Instructions
- e. Oosign Documents (e.g., calculations, drawings, specifications, analyses)
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III-3 Rev. 8
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i l i including documents relatea to computer codes.
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s- f. Manufacturing, Construction and Installation Drawings
- g. Manufacturing, Construction Modifica-tion, Installation, Test, and Inspec-tion Procedures and Instructions
- h. Procurement Documents
- 1. FSAR and Related Design Criteria Docu-ments
- j. Nonconformance Reports
- k. Design Change Documents
- 1. Test Specifications
- m. Operating and Special Orders
- n. Eauipment & Material Control Procedures l
l o. Refueling Procedures , ,q p. OCL U
- q. Topical Reports All procedures estaolished for document control shall meet the following requirements:
- a. Review, approval and issuance criteria for documents and their revisions snall be specified to assure adequate techni-cal and quality requirements are met prior to issue.
- o. The individuals or organizations responsiole for reviewing, approving and issui'ng documents and their revision shall ce specified.
- c. Cnanges must be documented, approved and included in the revised document prior to being implemented.
- d. Revisions snal'. De revieweo and approved by the same organizations that performed tne original review and III-4 Rev. 8
approval or oy other qualified, responsiole, and designatea organiza-a tions. V
*e. Document distribution must ce suffi-cient to assure that the occuments are readily available at convenient loca-tions to plant personnel prior to com-mancement of work.
- f. Document transmittal and maintenance measures shall oe incorporated in docu-ment control systems to prevent in-advertent use of voided, superseded or oosolete documents. Holders of controlled documents are responsiole for maintaining their assigned copies in a current status. Documents dis--
tributed for information only will not ce considered a controlled copy, anc, as sucn, will not ce used in performing an activity important to safety since they will not be maintained current. Exceptions to this requirement must ce approved, in writing, by QAD.
- g. Master lists or eauivalents will o,e f- estaolished and maintained to identify
()3 the current revision numoer of instruc-tions, procedures, specifications, drawings, and procurement documents. This list will ce distriouted to pre-determined responsicle personnel to i preclude the use o f superceded docu-ments,
- n. Maintenance, modification and inspec-tion procedures shall ce reviewed and concurred with prior to implementation oy the responsible Quality Assurance organization to detert.ine:
- 1. The need for inspection, tne identification o f inspection l personnel and tne cocumentation i
of inspection results. f I
- 2. That necessary inspection re-cuirements, metnoos, and accep-tance criteria nave oeen identi-.
fled. O
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III-5 Rev. 8
- 3. That proceoures nave been pre-pared, reviewea and approved in
-(^} . accordance with estao11shed N' Quality Assurance policy ano Program controic.
3.2.3 Resoonsibilities 3.2.3.1 Manager - Management Services Responsible to approve the GPU Nuclear Corpo-ration procedures for o f f-site document con-trol. 3.2.3.2 Manager - Administration and Services Responsible for implementation of the document control system for all instructions, proce-dures, drawings and other controlled documents prepared for TMI in administration, operation, testing, maintenance, and modification of structures, systems and components important to safety. 3.2.3.3 Manager --Quality Assurance Resconsiole for the review ano approval of, g-)s (, document control proceoures for Quality assurance requirements and document control measurch- to evaluate the document control system ef fectiveness through review and aucit. 3.2.3.4 Deoartment Manaoers Responsible to ensure that documents are available when required; to procerly review and approve documents sucn as procadures, instructions, specifications, cr3 dings, etc. to ensure that changes to docunents are reviewed and approved by the same organization that performed the original review and approval o f the document; to ansure tnat approved changes'are promptly transmitted for incorporation into documents: to ensure that obsolete or superseded documents are elimi-nated ' rom the system. 3.2.3.5 Delegated Authorities venoor, contractor, ano agent QA prograr s shall be reviewed to assure :cmcliance with the requiremer,ts o f this section. i , (-)x u III-6 Rev. 8 l L
1 3.3 Qualitv Assurance Records 3.3.1 Policy (]) Quality Assurance records for items and acti-vities covered under the scope of the TMI QA Program shall De identified, documented, reviewed, retained, and retrievable. These requirements are imposed on all organizations performing activities important to safety. Quality Assurance record systems shall ce described and controlled by approved written procedures and instructions, adequately imple-mented, and verified by-QAD through inspec-tions and audits.
-3.3.2 Reauirements The procedures established for the generation, collection, storage, maintenance, ano re-trieval of the TMI Quality Assurance records shall meet tne following minimum requirements:
- a. Design specifications, procurement documents, test procedures, operational procedures, and otner documents shall specify the records to De generated,
(-)/ s-supplied and maintained by or for the owner. Typical records to de specified incluoe inspection and verificanian procedures (exclude completed cneck-lists), results of reviews, inspec-tions, tests, audits, and material analysis; monitoring o f work perfor-mance; aualification of personnel, procedures, and equipmant; and otner documentation such as calculations design verifications, orawings, speci-fications, procurement occuments, calibration procedures and reports; nonconformance reports; anc corrective action reports.
- o. Sufficient records and occumentation shall be maintained to provice evidence of tne cuality of items or activities important to sa fety. Inspection and test records shall contain tne follow-ing where soplicaole:
- 1. A description of the type of ooservation.
)
! III-7 Rev. S
- 2. T'he date and results of the inspection or test.
(-) 3. Information related td conditions adverse to quality.
- 4. Insoector or data recorder iden-tification.
- 5. Evidence as to the acceptaoility of the results.
- 6. Action taken to resolve any dis-
-crepancies noted.
- c. Documented and approved measures shall be established for complying with the requirements of codes, standards, and procurement documents regarding record transmittal, retention, and maintenance subsequent to completion of work.
- d. Record storage facilities snall be establisned and utilized to prevent i
' destruction of quality records oy fira, flooding, theft and deterioration oy environmental conditions such as tem-(')
\- perature or humidity in compliance witn tne standards, codes and regulatory guides endorsed in Appenoix C of this Plan.
3.3.3 Resoonsioilities 3.3.3.1 Manager - Quality Assurance
- a. Responsible for reviewing procedures for GPU Nuclear departments who perform activities related to tne maintenance of Quality Assurance records; esta-blishing a program for tne identifica-tion, storage, retrieval, and mainte-nance of Quality Assurance records generated oy QAD, until they are turneo over for storage, and performing planned and periodic audits to verify adequacy and implementation of Quality Assurance records reovirements oy both internal TMI organizations and external suppliers.
p) III-8 Rev. 8
3.3.3.2 Manager - Administration and Services
/^s a. Responsible for tne collection, main-kJ tenance, and storage o f records at tne plant site in accordance with approved written procedures wnich conform to tne requirements and policy of tnis section,
- o. Responsiole for providing procedures which ensure the maintenance o f records sufficient to furnish oojective evi-dence that activities affecting quality are in compliance with the standards, codes and regulatory guides endorsed in Appendix C of the TMI Quality Assurance Plan.
3.3.3.3 Manager - Management Services
- a. Responsiole for the collection,' main-tenance, and storage of records at the home office in accordance with approved written procedures whien conform to tne requirements and policy of this section.
- b. Responsiole for providing procedures g-) which ensure tne maintenance of records (s
su f ficien t to furnisn oojective evi-dence that activities af fecting Quality are in compliance with tne standards, codes and regulatory guides endorsed in Appendix C of the TMI Quality Assurance Plan. 3.3.3.4 Delecated Authorities Records generated by site contractors shall be controlled according to contractor procedures until sucn time as they are turned over to tne QAD for review, acceptance, and transmittal to the permanent records file. Purchased equip-ment records shall be retained oy the vencor until the eauipment is released for shipment. When required oy the procurement documents, contractors and vendors shall estaolish proce-dures to control Quality Assurance records. Implementation of tnese procecures snall be assured oy performance o f source surveillance oy QA0 and tnrougn audits performed by QAG. r~h V III-9 Rev. 8 L
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b
- Records to be submitted with the snipment or i 3 - .. retained oy the venoor will De specifically identified in procurement documents . These '
3 records.will be reviewed as necessary oy QAD ! to" provide the reauired degree of confiaence j '
- in the adequacy a f compli'ance o f the vendor witn the reouirements of this section.
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4.0 Desian Control (ew) '4.1 Policy )
Ieasures shall be established and documenteo to assure that the applicable specified design ; requirements, such as design bases, regulatory ' requirements, codes and standards are cor-rectly translated into specifications, draw-ings, procedures or instructions. These measures shall include provisions to assure that appropriate quality standards are speci-fled and included or referenced in design documents for design of systems and struc-tures; external design of systems and structures; and assessment of damage. The tesponsibility for establishing these require-ments belongs to engineering but is subject to Quality Assurance Department review for items which are important to safety. 4.2 Recuirements 4.2.1 Design control measures require that:
- a. The organizational structure be de-fined, and authority and responsibility t]-
\ of personnel involved in preparing, reviewing, approving and verifying design documents be delineated.
- b. The FSAR design bases, FSAR safety analysis, design regulations, codis a.'d standards and Plant Technical Specifi-cations be adhered to in design work, except where the changes will be the subject of an operating license amend-ment application.
- c. The materials, parts and processes selected by design are reviewed to assure that they are suitaole for the intended application, including compa-tibility o f materials, accessibility for inservice inspection, maintenance and repair, associated computer pro-grams, and quality standards. The review will also evaluate suitability with regard to human factors wnich may ef fec t sa fe operation.
O v Rev. 8
- d. Internal and external design interface controls, procedures, and lines of
(~T_ communication among participating k/ design organizations and across techni-cal disciplines are established and described for the review, approval, release, distribution, and revision of documents involving design interfaces,
- e. Errors and deficiencies in approved design documents, including design methods (such as computer codes) that could adversely af fect items and acti-vities important to safety shall be documented, and action shall be taken ta assure that these errors or defi-ciencies are corrected.
- f. Deviations in specified quality stan-dards shall be identified and proce-dures shall be established to assure their control.
- g. Review of s tandard "o f f the shelf" commercial materials, parts, and equip-ment for suitability of application with structures, systems, and compo-fs
(_) nents important to safety shall oe ' , conducted prior to selection. h. Design verification methods (design review, alternate calculations or qualification testing) shall be esta-blished. Guidelines shall oe esta-blished for determining the scorc0riata methods.
- 1. Design verification procedures shall ne estaolished which assure the following:
The verifier is qualified and is not directly responsible 'for the design. Verification shall be complete prior to relying upon the com-ponent, system, or structure to perform its function during plant operations. , Final tie-in j authorizations requira that app-licaule design verification be comoleted, em ( s_ IV-2 Rev. 8
Procedural control is established ,3 for design documents that re flec t q'j the commitments of the SAR. Design occuments subject to pro-cedural control include, -but are not limited to, specifications, calculations, computer programs, system descriptions, and draw-ings, including flow diagrams, piping and instrument systems for major facilities, site arrange-ments, and equipment locations. The responsibilities o f the veri-fler, the areas and features to be verified, the pertinent consi-derations to be verified, and the extent of documentation shall be l identified in procedures.
- j. When verifications may be accomplisheo by test:
l Prototype, component or feature testing shall be performed as , l early as possible prior to f' installation of plant equipment, k ') or prior to the point when the installation would become irre-versible. Verification oy test shall be performed under conditions that simulate the most adverse design conditions as determineo by analysis. l k. Procedures shall ce established to ' assure that computer codes are verified prior to use.
- 1. Design and specification changes, in-cluding field cnanges, will be suoject to design controi measures commensurate with those applied-to'the original design. Design enanges snail be reviewed and aaproveo by the organiza-tion responsible for the original design or by anctner organization with .
comparacle expertise designated to review and approve changes. O IV-3 Rev. 8
.PQ -
- m. Measures shall be provided to assure that responsiola plant personnel are
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\/ - made aware of design changes and/or
. modifications, which may affect the performance o f _ their duties.
4.3 Resconsio'ilities 4.3.1 Plant Engineerino The Plant Engineering Department is respon-sible for providing technical support to operations and maintenance personnel. This is accompl17h'i - previding cr-2hirt engincar to the operations staf f for ' direct technical coverage of the plant systems performance. In addition, Plant Engineering is responsible for in-plant fuel management and accountability, control rod programs, core calculations, pro-viding technical assistance to unit management and the preparation and maintenance of proce-dures ment. related to the activities of the depart-Plant Engineering is also responsible for engineering activities related to routine maintenance and minor plant modifications. () 4.3.2 Project Engineerino Manager The Project Engloeerino Manager is resconsidle far cooroination, staf fing ano directing o f . engineering tasks which are outside of the normal scope of activities of Plant Engi-neering. will: To fulfill these responsibilities he
- a. Maintain a listing of all identified design tasks and the person (s) or or-ganization assigned. For each outside design task, a Responsible Engineer will be identified.
O. Maintain schedule and status informa-tion for each task.
- c. Cocrdinate the ef forts of the System Engineering Department and the Engi-neering ano Design Department. Person-nel from these departments will Oe' utilized to perform tne assigned. tasks.
O v IV-4 Rev. 8 i 1
~
l 1
- d. Control and coordinate the activities
(], of A/E's providing direct engineering service.
- e. Coordinate with the engineering manage-ment personnel of contractors witn design responsibility.
- f. Review ano approve caseline design documents such as design criteria, flow diagrams, system descriptions, arrange-ment drawings, one-line diagrams and logic diagrams, as appropriate.
- g. Review and approve final design docu-ments including specifications and drawings (as required).
Note: This design review does not replace or eliminate the need for design verification by the organization who performed the design. 4.3.3 Systems Engineering Department rg The Systems Engineering Department is respon-(_/ sible for providing conceptual ano analytic ' , e'ogineering groups as required. service to other engineering They are directly respon-sible fuel-related engineering activities.of nuclear for technical administration The Systems Engineering Department is respon-sicle for implementation of the design control program for their own activities wnich are important to safety. 4.3.4 Engineering and Design Oeoartment The Engineering and Design Department provices detailed mechanical and electrical engineering as well as design service to support TM I engineering activities. They are responsible for classification of items and activities important to safety and for preparation and maintenance of the Quality Classification List (OCL). The oepartment is also responsioie for implementation o f the design control program for their own activities which are imporrant to sa fety. !~ UD IV-5 Rev. 8
4.3.5 Other Desian Oroanizations
' () All design organizations performing design activities for TMI shall have quality programs which include design control provisions equi-valant to those provided in the TMI Quality Assurance Program.
4.3.6. Quality Assurance Decartment The Manager - Quality Assurance is responsible for providing Quality Assurance review and concurrence with design and engineering docu-ments relating to items and. activities impor-tant to safety to assure that appropriate quality requirements have been included. In addition, Quality Assurance ' will perform planned and periodic audits o f responsible design organizations to verify implementation of design control measures. () - i 3 l t O IV-6 Rev. 8
5.0 Procurement and Material Control
,. 5.1 Control of Procurement 5.1.1 Policy Procurement of material, equipment ano ser-vices which are considered important to safety shall be performed in accordance with written policies, procedures and instructions. These shall establish methods for preparation, re-view approval, and control of procurement documents and shall provide measures to comply with applicable regulatory requirements.
Appropriate measures shall be established to evaluate procurament sources, monitor the activities of consultants, vendors and con-tractors, and confirm that purchased items conform to procurement document requirements. The programs of all participants shall be in accordance with the requirements of the TMI Quality Assurance Program. The general and specific requirements for tne Quality Assurance Program of all vendors and contractors, including their subvendors and subcontractors sucolying material, equipment, or services which are considered important to (~N _J safety, are delineated by procurement docu- - ments. The procurement documents impose qual-ity program requirements that are commensurate with the degree o f complexity, the uniqueness, and the importance to sa fety of the items and services being performed. Quality Assurance measures shall apply to the procurement of materials including spare parts, replacement parts, o f f-the-sneif items and consumables. Procurement of spare or replacement parts for structures, systems, and components shall be subject to current Quality Assurance Program controls and to codes, stan-dards, and technical requirements equal to, or better than, original technical requirements, or in accordance with an accroved engineering document. 5.1.2 Reouirements t/ Rev. 8
# =
5.1.2.1 Procurement Documents
'() The sequence of actions for the preparation, review, approval and control of procursment occuments shall be delineated in detailed procedures. These procedures shall delineate requirements to asssure that procurement docu-ments:
- a. Specify quality assurance requirements commensurate with the requirements of this QA Plan,
- b. Require applicable quality program requirements to be passed on to sub-vendors and subcontractors.
- c. Specify or reference design bases tech-nical requirements, including appli-cable regultory requirements, material, and component identification require-ments, drawings, specifications, codes and standards, test and' inspection requirements, and special process instructions.
- d. Identify the documentation to be pre-f]
k- pared, maintained, and submitted for ' review, approval and record information as applicable.
- e. Include an identification of those items and activities important to safety.
- f. Identify those records which vendors or contractors shall retain, maintain, and control; and those which vendors or contractors shall deliver pr'or to use or installation o f the item,
- g. Incl.ude right of access to vendors or contractors and their subtier vendor and contractor facilities and records for source inspection and/or audit.
- h. For spare or replacement parts, contain requirements at least equivalent to thSse used for the original procure-ment. The original procurement docu-ment may be used as the technical
[~~\ u l- V-2 Rev. 8 I l-
requirements for purchase of spare or replacement parts. O
\
- i. Include the provision that suppliers shall refrain from implementing proce-dures which require owner approval prior to obtaining such approval.
Measures shall be established for the review, approval, and release of procurement documents and subsequent revisions. The reviews shall assure the inclusion of'the applicable tech-nical, quality, and administrative require-ments in procurement documents prior to their use. Requisitions for professional service agreements for services covered by the scope of this Quality Assurance Program shall be reviewed by the QAD to assure inclusion of quality requirements. QA0 personnel shall review and concur with the adequacy of quality requirements to determine that they are correctly stated, inspectacle and controllaole; that there are adequate acceptace criteria; and that procurement docu-ments have been processed in accordance with established requirements.
' C) \s Review of procurement documents shall be docu-mented to provide objective evidence of their approval prior to their release.
5.1.2.2 Qualification and Selection of Sucoliers The TMI Quality Assurance Program requires documented evaluations of prospective sup-pliers which demonstrate qualifications based upon one or more of the following criteria:
- a. Review of performance histories which provide records of suppliers previous capability to provide similar products l
or servi ~ces.
- b. Review of the supplier's capability to comply with the criteria of 10 CFR 50, Appendix 8, applicable to the items or services to be supplied.
- c. A pre-award survey of supplier's faci-l 11:les and Quality Assurance croc 7. m to 1e:2cmine hi= ; .:.?. .. . . ,4 . i . .
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(O V-3 Rev. 8
i items or services that meet the design O - and quality requirements of the speci-ss fication. Procedures shall be established to accomplish the evaluation and selection of suppliers of equipment, material or services. Contracts or purchase orders for material, equipment or services covered by the scope of the Quality Assurance Program shall be awarded only to vendors or contractors who have been qualified by the QAD as having a Quality Assurance pro-gram commensurate with the equipment or ser-vices to be provided. When a supplier quality program is required, it shall be reviewed and approved prior to initiation of the activity affected by their program. For certain ser-vices, the supplier may be required, by pro-curement documents, to work under the direct control of the TMi Quality Assurance Program. In these instances, the supplier will not be required to have a separate quality assurance program, but will be required to work within the applicable requirements of this Quality Assurance Program and will require the apprcval of the Quality Assurance Depart.:snt. 5.1.2.3 Manufacturing Assurance (')% m Measures shall be established to provide con-trol of manufacturing activities of vendors. These methods shall be described in detailed written procedures. The extent to which these specific controls will be applied to vendors will be described in individual vendor inspec-tion plans. A vendor inspection plan will be prepared for each major contract within the scope of the TMI Quality Assurance Program. The attributes of the manufacturing assurance program shall include:
- a. Provisichs for the review, approval and status tracking of the vendor's draw-ings, Quality Assurance manual and selected manufacturing and quality procedures prior to fabrication. Ven-dors may not implement procedures until written , notice of approval is received,
, if applicable. ! f') v l l V-4 Rev. 8 \ . t
~
1 l l
- 6. Establisned venoor inspection plans tnat delineate, as required tne nold s and/or witness points in tne manufac-s) turing process for specified review, inspection, verification and test.
- c. Methods for resolution of nonconfor-mance where the vendor's suggested disposition is "Use-as-is" or " Repair".
Such nonconformances require approval by the responsible engineer and the concurrence of the responsiole Quality Assurance organization. QAD will also provide followup o f corrective action implementation.
- d. Planned and systematic audit and sur-veillance of vendor quality activities.
Scope of coverage and frecuency shall be determined by the criticality of the furnished items and the evaluated
~
results of vendor qualifications, in-cluoing pre-award surveys and auality procedure reviews. Revisions to sur-veillance plans shall be made as warranted by vendor performance,
- e. Control of vendor document package
()' including review for completeness and acceptability. Inadequate records snall be suf ficient cause to reject the items furnished due to their indeter-minate quality status,
- f. Assessments of vendor control of quality shall be made at a frequency and depth commensurate with the impor-tance, complexity and quantity of the items furnished. These assessments shall utilize tne qualitative and ouan-citstive informa:ian proviced oy vendor noncompliance documents; surveillance, inspection and audit reports; and receiving inspection and test records.
- g. Receiving inspection procedures assure that:
- 1. The material, component, or eauipment is clearly identifieo and that the identification and V-5 Rev. 8
qua'ntity corres,and to the infor-mation on the shipping documents (3 and quality records. LJ
- 2. The item's handling and shipping, requirements have been met by the vendor and maintaineo by the carrier.
- 3. The item's quality record package or compliance certificate is complete, and adequate.
- 4. Items delivered, which are not in compliance with requirements are documenteo in accordance with the nonconformance procedure, tagged, segregated (if possible), and prevented from being inadver-tently issued for installation or use.
- 5. Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation ,
or further work. 5.1.3 Resconsibilities 5.1.3.1 Materials Manaoement Materials Management is responsible for complying with the requirements o f this Plan and for the administration anc operation of procurement and warehousing associated with the operation of the TMI Nuclear Station. In this regard, they are responsible for assuring that the technical and quality requirements, as esta011sned by engineering, are incor-porated into procurement documents without revision. Furthermore, Materials Management is responsible for assuring that the contrac-tural, legal and commercial requirements are incorporated into the procurement documents in a manner which will not alter the technical or quality requirements. The Manager - Field Warehousing, TMI is responsible for the opera-tion and maintenance of the company warehouses and storerooms at the TMI Nuclear Station.
- r^
(S) V-6 Rev. 8
5.1.3.2 Manaaer - Cualitv Assurance r-k>S The Manager - Quality Assurance is responsible for assuring that QAD procedures for tne con-trol of purchased equipment, material, and services are established, approved, imple-mented and ef fective. He is also responsible for the approval of all TMI procedures neces-sary for the control of purchased equipment, material, and services within the scope of the TMI Quality Assurance Program. He is respon-sible for approval of suppliers' Quality Assurance Program to the extent required in the procurement documents. He is also espon-sible for review and acceptance of sup ier record packages. He is responsible for establishing and implementing an adeauat. program o f source inspection, surveillance and receipt inspection to assure supplier com-pliance with contract requirements. 5.1.3.3 Resoonsible Enoineer A responsible engineer is that engineer assigned responsibility for the design and/or procurement o f each structure, system, or item. He shall review, approve and control (-) procedures, drawings and other quality-related
- documents submitted by the supplier o f the specified equipment. He shall maintain a status reference of all documents requiring approval and distribute such information as required.
5.2 Indentification and Control o f Materials, Parts ano Comoonents 5.2.1 Policy Measures shall be established to provide for the identification and control of materials, i l parts and components important to safety. These measures 3 hall assure that incorrect or nonconforming items are identified and con-trolled in order to prevent their inadvertant installation or use at TMI. Where required by l design documents, the system established shall provide traceability of components from the receipt of material through fabrication and testing. Verification shall include review of objective evidence of inspections ano tests which demonstrate that product identification O V-7 Rev. 8
and control is maintained at various stages of manufacture, installation, or erection. Iden-ry tification requirements shall be specified in (-) - the applicable design and procurement docu-ments. 5.2.2 Recuirements
- a. Identification requirements shall be included in specifications and drawings,
- b. Material, parts, and components, including partially fabricated sub-assemblies or subdivided materials shall be identified to preclude the use of incorrect or defective items.
- c. Materials and parts important to safety shall be identified so that they can be traced to the appropriate documenta-tion, including, but not limited to:
- 1. Specifications
- 2. Drawings (including as-builts)
- 3. Procurement Documents ,,
( 4. Physical and Chemical Test Reports
- 5. Nonconformance Reports
- 6. Inspection Reports and Checklists
- 7. Storage Maintenance Instructions
- 8. NDE Reports
- 9. Vendor Certificates o f Compliance
- d. The location and method of identifica-tion shall be specified so as not to af fect the form, fit, function or quality o f the item being identified.
- e. Correct identification of materials, parts and components shall be verified prior to -release for fabrication,
- shipping, installation, and testing.
- f. Where physical identification is either impractical or insuf ficient, physical O
V-8 Rev. 8
separation, procedural control, or rm othar approvad means may be employed. kJ g. A receipt inspection at the site ware-house verifies that identification for received items is complete and accom-panied by appropriate documentation. 5.2.3 Responsibilities 5.2.3.1 Responsible Engineer
- a. Responsible for ensuring that procure-ment documents contain appropriate requirements for the identification and control of materials, parts, or compo-nents.
5.2.3.2 Manager - Quality Assurance
- a. Responsible for Quality Assurance review and concurrence of procedures for maintaining identification in accordance with the requirements of l
this section.
- b. Responsible for verification of identi-fication during receipt inspection. ',
- c. Responsible for monitoring and conduct-ing inspections, surveillances and audits to verify conformance to the requirements of this section.
5.2.3.3 Manager - Site Warehousing, TMI
- a. Responsible for maintaining identifica-tion and control of materials, parts or components received and stored at TMI in accordance with written procedures.
1 O t.J V-9 Rev. 8
6.0 Control of of Station Activities 6.1 Policy Station activities considered important to safety snall be conducted in accordance with the requirements of this Plan. These activi-ties include design changes, procurement, faorication, handling, shipping, storage, cleaning, erecting, installation, inspection, testing, operation, maintainance, repair, refueling and modification. 6.2 Recuirements The Quality Assurance requirements for station activities are contained in this Plan and include compliance with applicable USNRC Regu-latory Guides and ANSI Standards indicated in Appendix C. These requirements shall De im-plemented in appropriete TMI procedures governing station activities. The require-ments of the Plan apply to all individuals or organizations performing functions which af-fect the quality of structures, systems, com-ponents, or activities important to safety. g~ 6.2.1 Details V The following subsections discuss typical activities wnich are representative of tne broad scope of administrative controls and quality assurance requirements tnst are appli-cable to station activities. The organiza-tional structures and functional responsioi-lities governing station activities shall ce structured so that attainment of Quality As-surance Plan oojectives is accomplished oy those wno nave oeen assigned or delegated responsibility for performing the work and verification of conformance to established requirements is accomplished by qualifisc personnel who do'not have direct responsi-bility for performing or directly supervising tne work. Quality Assurance Department acti-vities such as inspection, monitoring, sur-veillance, reviews and audits are performeo to indepencently verify conformance to this plan, i j applicable station administration controls, and aoolicaole regulatory and licensing com-l mitme ts. These independent verifications are applied to station activities on a graded ([) Rev. 8
approach and to the extent necessary to pro-vide adeouate confidence that structures, f
-)
(_/ systems, components, and personnel perform satisfactorily to maintain the safety of the station. Station work functions sucn as rou-time and abnormal operations, maintenance, repair or rework, in-service inspections, technical specification compliance, f'sel handling, radwaste handling, radiation protec-tion, chemical analysis, nousekeeping and cleanliness, fire protection, security, train-ing, environmental requirements, health physics, and other activities considered im-portant to safety which are discussed in the Quality Assurance Plan are controlleo to an extent consistent with their importance to safety. 6.2.1.1 Controloof Inspection A program for inspection of activities a f fect-ing quality shall be estaolisheo and executed by, or for, the organization performing the activity to verify conformance to the docu-mented instructions, procedures, and drawings for accomplishing the activity. Design speci-fications, drawings, procedures, or instruc-tions snall include the necessary inspection (]) requirements. These requirements include acceptance criteria and reference to codes, standards, and regulatory documents. These requirements shall be further translated into inspection procedures, instructions, or check-lists which shall contain, as required, the following:
- a. Identification of cnaracteristics and activities to be inspected.
- o. Inspection methods.
- c. Identification; of organization respon-sible for performing the inspection,
- d. Acceptance and rejection criteria.
- e. Identification of applicable revisions or required procedures, orawings and speci"ications.
VI-2 Rev. 8 I
- f. Documentation of inspection results inclouing identification of tne in-T spector.
(V
-g. Listing of necessary measuring ano test eauipment including tneir accuracy requirements.
Inspectors (including NDE personnel) shall oe qualified in accordance with applicable codes, standards and TMI training programs and their qualification and certification shall be kept current and documented. Individuals performing inspections shall be other than those who performeo or directly supervised the activity oeing inspectea and shall not report directly to the immediate supervisors who are responsiole for the work activity being inspected. If tne individuals performing inspections are not part of tne responsible Quality Assurance organization, the inspection procedures and personnel quali-fication criteria shall be reviewed and con-curred with oy the responsible Quality Assurance organization prior to the initiation o f the inspection activity. Inspection of activities as defined in ANSI N45.2.10 may be (). conducted by second line supervisory personnel or be other qualified personnel not assigned first line supervisory responsibility for the conduct of work. These inspections, i.e., those performed oy individuals not assigned first lim' supervisory responsioility, are not intended to dilute or replace tne clear re-sponsibility of first line supervisors for the cuality of work performed under their super-vision. When inspections associatec witn normal operations of the plant (suen as rou-tine maintenance, surveillance and tests) are performed by individuals other tnan those wna performed or airectly supervised the work, out are witnin the same group, the following con-trols shall ce met:
- a. The quality of cne work can be demon-strated tnrougn a functional test wnen the activity involves creacning a pres-sure retaining item.
f~s V VI-3 Rev. 8
L l
- o. The cualification criteria for inspec-tion personnel are revieweo and found
'1
('# acceptacle by the Quality Assurance organization prior to initiating tne
. Inspection.
Wor < authorization documents relating to work
~
considered important to safety snall be reviewed and concurred with oy Quality As-surance Department personnel to determine tne need for: a) inspection, o) identification of inspection organization, c) identification of inspection witness and hold points, d) docu-menting inspection results. When hold points have been estaolished, either contractually by procurement or internally by plant procedures, work may not proceed until either inspection is performed or waived oy the responsible Quality Assurance organization. Inspection of modifications, repairs, ano replacements shall be by the same method and to the same criteria as the original inspec-tion or by an approved, documented, engi-neering and QA alternate. Where verification r' of inspection is being performed on previously ( >s accepted lots, sampling inspection shall be representative and only to the extent neces-sary to assure adequacy of control. The samoling plan shall be determined oy Quality Assurance. Inspection personnel shall be provided with suitaole eauipment and tools, which are calibrated as necessary, and con-trolled to assure that accuracy requirements are sati3fied and that inspections are complete. Inspection data and results snall be evaluated by designateo personnel to assure tnat the inspection oojectives have been met ano tnat items recuiring action or follow-up are iden-tified and documented. Records shall oe kept in suf ficient detail to provide adeauate confirmation of an inspection program. 6.2.1.2 Plant GA Monitoring i l- A program for QA Monitoring of activities a f fecting important to safety materials, _) s parts, components or processes shall oe estab-lisned and executed oy Quality Assurance. VI-4 Rev. 8
Monitoring is used to establish adequate confidence levels that important to safety (]) activities are being performed in accordance with Quality Assurance Program requirements and plant administrative controls. Monitoring will ce performed on a graded approaco and tne degree of monitoring performeo snail ce typi-cally based upon the status and safety importance of activities, degree of previous experience, consistency of overall coverage, unioueness of testing or operating activities and trending data. Monitors shall be qualified in accordance with a documented Quality Assurance Department procedure that insures that Monitors are know-ledgeable in the activities they are moni-toring to the extent that tney can readily verify compliance of the activity oeing performed. Monitoring reports shall contain as a minimum the following:
- a. Identification of activity being moni-tored including specific reference to the program or procedural recuirements
({'} governing the activity.
- b. Indication o f compliance.
- c. Identification of monitor
- d. Appropriate distrioution to supervisory or managerial personnel tnat have responsioility for tne performance of the activity.
- e. Identification of nonconformance docu-ment that will ootain appropriate cor-rective action, including tnat to prevent recurrence, wnen nonconfor-mances exist and are identified as a result of the monitoring.
Records shall oe kept in sufficient detail to provide adecuate confirmation of a monitoring program.
)
i , VI-5 Rev. 8 i l
6.2.1.3 -Control of Soecial Processes r~g Measures shall oe estaclisheo and documented (~) to assure tnat special processes are accom-plished under controlled conditions in accordance with applicaala codes, standards, applications criteria, and otner special reouirements including the use of qualified personnel and procedures. Special processes are tnose that require interim in process controls in addition to final inspection to assure quality including, but not limitea to, such processes as welding, heat treating, chemical cleaning, and nondestructive examina-tion. Procedures for special processes shall oe established to meet the recuirements or applicaole codes and standards, where appli-caole, or to meet the requirements of special process specifications which may oe produced i for TMI. These procedures shall provide for recording evidence of acceptacle accomplish-ment of special processes. Procecures and ' instructions for the control of special pro-cesses shall be reviewed and approved by qualified personnel. Procedures, equipment, and personnel performing special processes shall be qualified in accordance with appli-caole codes, stancards, and specifications. C)s Organizational responsibilities snail ce delineated for the cualification of special processes, equipment and personnel. Qualifi-cation records of personnel equipment and procedures associated with special processes snall be estaolisned, maintained and kept current. For special processes not covereo oy the existing codes or standaros, or when item cuality requirements exceed the requirements of estaolished codes or standards, the neces-sary cualifications of personnel, procecures and equipment shall oe de fined. 6.2.1.4 Test Control A documented test program snall oe estaolisned to assure that all testing required to demon-strate that the structure, system or component considered important to sa fety will perform j satisfactorily in service. The tests snall ce ! performed in accordance witn written, ap- a proved, and controlled test procecures wnicn incorporate or reference the requirements ano l I /~;
- U l VI-6 Rev. 8 I
l'
1 acceptance standards contained in the appli-cable design documents. The extent o f testing ([] shall be cased on the complexity of the modi-fication, replacement, or repair. Testing, including proof tests prior to installation and preoperational tests, necessary to demon-strate that structures, systems and components will perform satisfactorily in service, shall oe accomplished in accordance with written approved procedures. These procedures shall be based on requirements and acceptance limits contained in applicaole design and procurement documents. These test procedures or instruc-tions shall provide for the following as required:
- a. A description of the test objective.
- o. Instructions for performing the test, including caution or safety notes in sufficient detail to avoid operator interpretation.
- c. Test prerequisites such as calibrated instrumentation, adequate test equip-ment and instrumentation including accuracy requirements, completeness of
/~')
ks item to be tested, suitable and con-trolled environmental conditions, and trained qualified and licensed or certified personnel.
- d. Provisions for data collection and storage.
- e. Acceptance and rejection criteria as specified in design and procurement occuments.
- f. Methods of documenting or recording test data and results, in sufficient detail to prevent misinterpretation.
! g. Provisions for assuring that test pre-requisites have o'een met.
- h. Mandatory hold or witness points for inspection by TMI Quality Assurance and/or other designated personnel.
- 1. Provisions for control of jumpers, L lifted leaos and jurisdictional or
{} safety tags. VI-7 Rev. 8
J. Provisions for returning a system to normal configuration upon completion of g3 'tne test.
\.)
Test results shall be documented, evaluated, and their acceptacility determined oy a re-sponsiole individual or group. The test program sna11 cover all requirea tests including:
- 1. Tests during the preoperational period to demonstrate that plant performance is in accordance with the design intent.
- 2. Tests during the initial operational phase to demonstrate the performance of systems that could not be tested prior to operation to confirm that plant behavior conforms to design criteria.
- 3. Tests during the operational phase to provide assurance that failures or substandard performance do not remain undetected and that the required relia-
! bility of systems important to safety is maintained. (]) 4. Tests during activities' associated with plant maintenance during the opera-tional phase and to demonstrate satis-factory performance following plant maintenance or procedural enanges. Tests performed following plant repairs or replacements shall be conducted in accordance witn the original design and testing require-i ments or engineering approved, documented alternatives. Testing shall De suf ficient to confirm that the cnanges reasonaoly produce l t expected results and that the change does not reduce safety of operations. 6.2.1.5 Control of Measuring and Test Eouloment Measures shall oe establisned to assure that tools, gauges, instruments, and other measuring and testing devices used in activi-ties af fecting the function or quality of structures, systems, and components covered under tne scope of the TMI Quality Assurance Program oe properly controlled, callorated, VI-8 Rev. 8 a.- -
and acjusted at specified periods to maintain accuracy witnin specified limits. Additional 3 (/ N- measures shall oe established to ensure tne range, type and accuracy of test equipment conforms to the specified testing requirements. Requirements for each control program shall include inspection and verification of accuracy upon receipt of equipment, iden ti fi-cation of all gauges and instruments, calibra-tion and scheduled recall for calloration and traceability to an accepted Standard. These activities shall be subject to QAD monitoring and auditing. Procedures shall be estaolished to implement the following requirements:
- a. To estaolish the calibration technique and frecuency maintenance, a.nd control of all measuring and test equipment which are used in the measurement, inspection, and monitoring of compo-n e r. t s , systems, and structures coverec under the scope of the TMI Quality Assurance Program (instruments, tools, gauges, fixtures, reference and trans-fer standards, and nondestructive examination eauipment).
() b. The identification of measuring and test equipment traceable to the cali-bration test data,
- c. Installed operations measuring and test equipment requiring calibration shall be lacelled, tagged or otherwise con-trolled in accordance with written, approved procedures to assure that approved calibration intervals are not exceeded. Portable measuring and test equipment may be similarly controlled; but shall, as a minimum, ce clearly laoelled to indicate the cate en which the current calloration expires.
Portable measuring and test equipment J that has exceeded the approved calibra-tion interval shall not ce useo for measurements or tests.
- d. Establish calibration frequency for measuring and test equipment cased on requirec accuracy, purcose, degree of (m
%)
VI-9 Rev. 8
usage, stability characteristics, and/ or any other condition which may affect I~)
the measurement. A calioration recall I system shall be imolemented to assure
. recalibration within the required period for each piece of measuring and test equipment covered under the scope o f this program.
- e. Methods for determining the validity of previous inspections performed when the measuring and test equipment is found to be out of calioration. Inspections or tests are repeated on items deter-mined to be suspect. Such determina-tion is to be documented in suitaole form. If any calibration, testing or measuring device is consistently found to oe out of calibration, it shall be repaired or replaced.
- f. Calibration shall oe against standards that have an accuracy of at least four times tne required accuracy of the equipment being calibrated. When this is not possible, standards shall have an accuracy that assures the equipment being calibrated will be within
(~)T
% required tolerance and that the oasis of acceptance is documented and authorized oy the supervisor of tne calibrating organization.
- g. A status of all measuring and test eouipment under the callaration program is to oe maintained.
- n. Utilization of reference and transfer standards traceaole to nationally re-cognized standards. Where national standards do not exist, provisions shall be established to document the basis for the calibration.
l ! 1. ~NDE equipment, such as ultrasonic l equipment, shall oe controlled and calibrated in accordance witn the ASME l code governing its use.
'6.:2.1.6 Handling, Storage and Shlocino Measures shall be estaolisned and documenteo to control handling, storage, and snipping, (v~1 VI-10 Rev. 8
including cleaning,' packaging, and preserva-tion of items important to safety in accor- {}} dance with estaolisned instructions, proce-dures, and drawings to prevent damage, deterioration or loss. Organizations performing special handling, preservation, storage, cleaning, packaging, and shipping activities shall do so in accordance witn predetermined work and inspection procedures or instructions utilizing suitably trained individuals. Procedures shall be established to control the cleaning, handling, storage, packaging, and shipping of materials, components, systems in accordance witn design and procurement re-auirements to preclude damage loss or deterioration by environmental conditions sucn as temperature or humidity. These procedures shall include an assessment of, but not limited to, the following:
- a. ' Packaging and preservation procedures I,
l to provide assurance of adequate pro-tection against corrosion, contamina-tion, physical damage or any ef fect (1 N-wnich would lower the quality o f tne items or cause tnem to deteriorate during shipping, handling or storage. Special protective environments, special coverings, inert gas atmos-phere, allowable moisture content, and temperature level shall be specified as required and their existence verified and documented. D. Cleaning procedures to provide assurance that necessary cleaning operations are carried out prior to packaging, storage or installation. The level of cleanliness required, and verificat' ion and documentation require-ments shall be specified in the proce- , dures.
- c. Detailed handling procedures to be
~
prcvided for all items that require special handling. Special handling tools and eouipment snall oe provided ano controlled to ensure safe and ade-quate handling. These tools ano equia- {; ment shall oe maintained, inspecteo and VI-ll Rev. 8
tested in accordance with written procedures at estaolished intervals to ensure their reliacility and availa-f- bility for use. (S /
'd , Storage procedures to provide for methods of storage and the control of items in storage which will minimize -
the possibility of damage or deteriora-tion during storage. Periodic inspec-tions of storage areas snall oe performed and documented to verify compliance with storage procedures. Release of items for installation shall also be procedurally controlled.
- e. Procedures to be provideo to assure that proper marking and labeling of items and containers is accomplished to provide identification and necessary instructions during packaging, shipment and storage.
- f. Procedures for documenting.and report-ing noncompliance and nonconformance to handling, and shipping requirements,
- g. Provisions for the storage of chemi-cals, reagents, luoricants and other
() consumable materials which will oe useo in conjunction with systems wnich are important to safety.
- h. Provisions for " Limited Life" require-ments (including " Shelf Life" and
" Service Life" for applicaole l materials).
l
- 6. 2.1. ' Insoection. Test, and Goerating Status Measures shall oe estaolished and documented to ensure tnat the required inspections and tests are performed and that the acceptability of items with regard to inspection and tests performed is known throughout manufacturing,
' installation, and operation. Status of items covered by the scope of the TMI Quality Assurance Plan shall be controlled in accor-dance with approved procedures. These proce-dures shall include the use of aopropriate tags, markings, lists, logs, diagrams, or other suitaole means, to assure tnat required O v VI 12 Rev. 3
i l Inspections and tests are satisfactorily completed to prevent inadvertent oypassing of recuired inspections and tests and to prevent r inadverent operation. C] Tne requirements for an acceptable inspection, test and operating status program for struc-tures, systems, and components througnout fabrication, installation and test include:
- a. Design and cuality documents whicn address the requirements for tne iden-tification of inspection, test, and operating status of structures, systems and components.
- b. Procedures which include controls for the application and removal of inspec-tion and welding stamps, and otner status indicators sucn as tags, marxings, labels, and stamps,
- c. Bypassing or altering the sequence of recuired inspections, tests or other critical operations procedurally con-trolled by Engineering procedures with concurrence oy the appropriate cuality organization. Where necessary to preclude inadvertent bypassing of C_s) recuired inspections and tests, the procedures snall provide for the iden-tification of items wnich have passed sucn inspections ano test.
- d. In cases where documentary evidence is not available to confirm that an item has passed required inspections ano tests, that item shall be consicereo nonconforming until such evidence oe-comes available. Affected systems shall also be considered to oe inoperable and reliance shall not be placed on such systems to fulfill their intended safety functions,
- e. Procedures to be provided to require identification of the operating status of systems, components, controls, or support equipment in order to prevent inadvertent or unautnorized operation.
These procecures snall require control l measures sucn as locking or tagging to (~h Nl yI_13 Rev. 8
secure and identify equipment in a controlled status. Independent verifi-T cation snali ce required, wnere appro-priate, to ensure tnat necessary measures, such as tagging eouipment, have been implemented correctly.
- f. Temporary modifications snall oe con-trolled by approved procedures wnien
!nclu da - r=cuirement for indeoendent verification. A log anali ce main-tained o f the current status of such temporary mooification.
- g. Nonconforming services and inoperative or malfunctioning structures, system, components or materials shall oe iden-tified, documented and controlled in
- accordance with the requirements of this Plan.
6.2.1.8 Fire Protection The primary objective of a Fire Protection Program is to minimize oath the procacility and consequences of postulated fires. Fire Protection starts with design and must be carried through all phases of construction and (w) (_ operation. Therefore, Quality Assurance Program requirements in accordance witn Branen Technical Position ASB 9.5-1 and this Plan shall ce estaolished to assure tne reliaoility of the TMI fire protection systems. Quality measures snall oe estaolisned to ensure that the guidelines for design, measurement, installation, testing and administrative con-trols for the fire protection systems are satisfied. 6.2.1.9 Plant Security Procedures shall ce developed utilizing the guidelines of ANSI N18.17-1973 to supplement features and physical carriers designed to control access to the plant and to vital areas witnin the plant. Information concerning specific design features and administrative provisions of the plant security programs shall ce confidential and thus accordeo limited distribution. Quality measures shall be estaolisned to ensure tnat the guioelines for design, measurement, installation, testing ~ O VI-14 Rev. 8 1
and administrative controls for the plant security systems are satisfied. 6.2.1.10 Housekeeping and Cleanliness Housekeeping practices on a regularly sche-duled basis shall oe utilized recognizing tne requirements for the control of radiation zones and the control of work activities, conditions and environments that can affect the Quality of important parts of the nuclear plant. Housekeeping encompasses all activi-tias related to the control of cleanliness of facilities, materials, equipment fire preven-tion and protection including disposal of combustible material and deoris and control of accesses to areas, protection o f equipment, radioactive contamination control and storage Housekeeping of solid radioactive waste. practices shall assure that only proper materials, eculpment processes, and procedures are utilized and that the quality of the item is not degraded as a result of housekeeping practices or techniques. During maintenance activities, certain portions of safety-related systems may be suoject to potential contamina-tion with foreign materials. To prevent sucn contamination, control measures, including es measures for access control, shall be estao-(_) lished. Additionally, immediately prior to closure, an inspection shall oe conducted Specialand documented to ensure cleanliness. housekeeping considerations shall be made for maintenance of raoloactively contaminated systems for components. 6.2.1.11 Eculoment Control Permission to release equipment or systems for maintenance shall oe granted by designateo NRC SR0 licensed operations personnel. Procedures as shall be provided for control of eoulpment, necessary, to maintain personnel and reactor safety, to avoid unauthorized operation of eoulpment, and to assure that operational equipment is a ready status. These procedures shall require:
- a. Control measures such as locking or tagging or secure and identify equip-ment in a controlled status.
i f'J L VI-15 Rev. S
- b. Independent verifications, where appro-priate, to ensure that necessary mea-sures, such as tagging equipment, has
(,), been implemented correctly. Control measures for temporary modifi-
'c .
cations, sucn as temporary oy-pass lines, electrical jumpers, lifted elec-trical leads, and temporary trip point settings. Included shall be a require-ment for independent verification. (A log shall be maintained of the current status of temporary modifications.)
- d. Control of inspection and test status on indiviaual items oy the use of markings such as stamps, tags, laoels, routing cards or other suitable means,
- e. When equipment is ready to be returned to service, operating personnel snall place the equipment in operation and verify and document its functional acceptability.
- f. When traceability is required as deter-mined by Engineering and Quality Assurance, the components / equipment
() shall be identified in such a manner that they can be traced to its asso-ciated occumentation. 6.2.1.12 Control of Construction, Maintenance (Preventive / Corrective) and Mooifications Construction, maintenance or modifications which has the potential to affect the func-tioning of structures, systems or components important to safety shall be performed in a manner to ensure quality at least equivalent to that specified in original design bases and requirements, materials specifications and inspection requirements. A suitable level of confidence in structures, systems or compo-nents on which maintenance or modifications have been performed shall be attained by appropriate inspection and performance test-ing. Construction, maintenance or modifica-tion of equipment shall oe preplanned and performed in accordance with written proce-dures, documented instructions or drawings appropriate to the circumstances which conform ('h
\/ Rev. 8 VI-16 l
to applicaole codes, standards, specifica-tions, and criteria. Skills normally
-~ possessed by qualified maintenance personnel x
may not reouire detailed step-by-step delinea-tions in a written procedure out are suoject to " general adminstrative procedural controls that govern or' define the following areas:
- a. Methods for obtaining permission and clearance for operation personnel to work and for logging such work.
- o. Factors to be taken into account,-
including tne necessity of maintaining occupational radiation exposure as low as is reasonaoly achievsble (ALARA).
- c. Method for identification of what pro-cedural coverage is necessary for the maintenance, construction and modifica-tion activity.
- d. Considerations for system / equipment cleaniness control.
- e. Method for identification of post main-tenance, construction or modification, testing, including system / equipment 7s functional capability to meet opera-T) tional requirements in all respects.
- f. Method for ensuring that maintenance, contruction or modification activities, performed either on-site or off-site, are properly reviewed.
The following type of activities are among those that may not require detailed step-cy-step written procedures:
- a. Gasket replacement
- b. Trouble . shooting electrical circuits
- c. Changing chart or drive speed gears or slide wires on recorder.
Means for assuring ouality o f maintenance, modifications or construction activities (for example, inspections, measurements, tests, welding, neat treatment, cleaning, nondestruc-tive' examination and worker qualifications in N
~
VI-17 Rev. 8 _. . __ - i
accordance with applicable codes and stan-dards) and measures to document the perfor-es mance tnereof snall ce estaolisned. Measures (_) snall be estaolished and documented to identify tne inspection and test status of ite~ms to be used in maintenance modi'fication, and construction activities. Normally, the point of control for sucn items should oe tne plant storage area. A corrective maintenance program shall oe developed to maintain structures, systems and components important to safety at tne cuality required for them to perform their intenced functions. Corrective maintenance shall be performed in a timely manner to insure that important to safety items are adequately main-tained in the original, design, functional status. A preventative maintenance program including proceoures as appropriate for structures, systems, and components important to safety shall be established which prescrioes the frecuency and type of maintenance to be per-formed. In all cases, maintenance shall De scheduled and planned so as not to compromise the safety of the plant. Planning shall con-sider the possiole safety consequences of () concurrent or sequential maintenance, testing or operating activities. Preventive main-tenance shall De performed in a timely manner to insure that important to safety items are adequately maintained in tne original, design, functional status. 6.2.1.13 Procedural Reauirements Measures shall oe established to control and coordinate the approval and issuance of docu-ments, including changes, wnich prescribe all' activities affecting quality. Those documents which are considered important to safety require a documented Quality Assurance Depart-ment review. This review is to provide an ' independent verification that the procedures have been prepared, reviewed and approved in ' accordance with estaolished policy and program controls; they contain tne necessary policy u ' and program requirements including the inspec- , l tion and verification recuirements where l D VI-18 Rev'. 8 ) I
applicable; and tney contain clear descrip-tions related to the extent of documenting r~N results of completed actions when required. kJ These documents include operating and special ord,ers, operating procedures, test procedures, equipment and material control procedures, maintenance or modification procedures, and refueling procedures. Plant procedures shall be reylewed oy an individual knowledgeaole in
- ne area affac:ad y inn procedure no less frequently than every two (2) years to deter-mine if changes are necessary or desiracle.
6.2.1.14 Control of Surveillance Testing and Insoection A surveillance testing and inspection program shall be estaolished to insure tnat important to safety structures, systems, and components will continue to , operate, keeping parameters within normal counds, or will act to put the plant in a safe condition if they exceed normal bounds. Provisions shall be made for performing required surveillance testing and inspections, including inservice inspections. Such provi-sions snall include the establishment of a master surveillance schedule reflecting the status of all planned inplant surveillance
-( ) tests and inspections. Frequency of surveil-lance tests and inspections may oe related to the results of reliacility analyses, tne frecuency and type of service, or age of the item or system, as appropriate.
Additional control procedures shall De insti-tuted, as necessary, to assure timely conduct of surveillance tests and inspections and appropriate documentation, reporting, and evaluation of the results. Following the completion of testing, procedures snail oe established to assure the return of systems to an operable status. These procedures shall include provisions for the documentation of authority, conduct, responsibility, and veri-fication involved in returning the system to an operable status. Sucn provisions shall include the use of procedures, checklists, and independent verification as appropriate, con-sidering the degree that system status was altered during the performance of the test. ('T
'J ~ Rev. 8 l
i VI-15 f
6.2.1.15 Radiation Control Procedures shall oe provided for the implemen-tation of a radiation control program. The (~)3
\-
rad,iation control program involves tne acaul-sition of data and provision of equipment to perform necessary radiation surveys, measure-ments and evaluations for the assessment ano control of radiation hazards associated with TMI. Procedures shall be developed and imple-mented for quality assurance review of records and programs to insure the adequacy of measures taken to control radiation exposure of employees and others. Additionally, cuality measures for radwaste management shall be implemented in accordance with 10 CFR 71, Appendix E. 6.3 Resoonsioilities 6.3.1 Of fice o f the President - GPUNC The Office of tne President - GPUNC has over-all responsiollity for the management, super-vision, and control of all station activities. 6.3.2 GPUNC Hanagement () GPUNC Managers with direct responsiellity for activities described herein are responsiole for the implementation and compliance of the Quality Assurance Plan ano directly respon-sible to insure their respective activities and responsiollities are conducted in accor-dance with applicaole adminsitrative controls, regulatory and licensing requirements. 6.3.3 Delegated Authorities Contractors or otner agents outside GPUNC wno are assigned or delegated responsibilities and/or activities governed by this Plan shall comply with th.e.applicaole requirements of the Plan. I l ' /^T# VI-20 Rev. 8
7.0 Control of Radioactive Waste 3 7.1 Policy kJ Measures shall be established and documented to accure that the upplicacle requirements o f the Code of the Federal Regulations, Title 10, Part 71 and Title 49, Parts 100 through 199 applicable to the packaging and transporting of radioactive wastes are satisfied. Appenoix E to 10 CFR 71 identifies the quality as-surance criteria applicable to the control of radioactive waste. The applicable portions of this Plan that relate to the criteria in Appendix E to 10 CFR 71 describe to a large extent the admini-strative controls and quality requirements to be applied in the control, packaging and transportation of radioactive material. The applicable sections of this Plan will be implemented to satisfy the requirements o f Appendix E to 10CFR 71. Typically, Sections 6.2.1.1 thru 6.2.1.6 and 6.2.1.9 apply to Control of Radioactive Waste. 7.2 Reouirements 7.2.1 Procedures shall be developed and implemented' -* (']) to cover the following:
- a. Processing o f radioactive wastes including the collection, handling and preparation for shipment of radioactive 11gulds and solids. These procedures shall be consistent with the ALARA program and shall clearly identify the administrative controls and organiza-tional responsibilities.
- b. Training and qualification o f personnel operating radioactive waste processing equipment, health physics monitoring, packaging and shipping and other opera-tions deemed appropriate by management.
c. The activities associated with the packaging of radioactive wastes to include the proper selection of the receptacles to be used for containing the waste materials, the selection of the shipping containers (structures O Rev. 8
used to contain and support the receptacle and its contents) Health r') (~ Physics inspections of the packaging prior to release, proper markings on the outside of the package and the preparation of shipping papers and certificates.
"r.* ament 0" :. disc;;;/a materials alth-in and outside the protected area to assure personnel protection at all times.
- e. The shipment of radioactive material from the Station to be in accordance with the regulations of the U.S.
Department of Transportation for the transportation of hazardous. materials (49 CFR) and of the NRC (10 CFR 71).
- f. The packaging used for transporting o f radioactive wastes, whether purchased from an outside supplier or designed by GPUNC, shall meet the applicable re-quirements o f 10 CFR 71 and 49 CFR.
7.2.2 Ine carriers to be used for trar. sporting o f radioactive wastas shall be selected on the ()' basis of their experience, knowledge of 00T regulations, control and maintenance of their equipment and the selection and control of their drivers. The carrier is required to have or shall be supplied documented proce-dures covering acceptance of materials from a shipper, certification requirements, placard-ing, stowage control, reporting of incidents and security. 7.2.3 Radwaste operations shall be controlled to minimize personnal exposures or environmental contamination' consistent with ALARA. 7.2.4 Operations procedures shall be reviewed by QA0 to establish any necessary witness or hold points or activities to be monitored. 7.3 Resconsibilities 7.3.1 The Manager - THI Unit I and Manager - Radio-logical Controls shall develop and implement procedures for processing activities and move-ment of radioactive materials. ('\ ^~ VII-2 Rev. 8
~T 7.3.2 Tha Operations Department shall be responsible (d
' for the processing and packaging of liquid wastas and for the packaging of solid wastas 1.n preparation for shipment. Additionally, the Operations Department is responsible for the collection and identification o f radio-active solids, such as rags, papers, boots, gloves, etc., and having them moved to the
.ic e .s a a cc facilacy for pac < aging.
7.3.3 The Radiological Controls Department is responsible for monitoring all activities associated with the processing and handling of radioactive wastes and for providing advice on radiological matters relating to processing, packaging and shipping. 7.3.A The Operations Depa.rtment is responsible for the selection of the specific S e e ? '- proper packaging for the t- . - i ;. c i. : , mi% ac consideratioq the radiation levels, contamina-tion limits and shipping requirements. Health Physics inspects the packaging for radiation level and, if acceptable, the Operations Department marks the outside of the package g~ with the appropriate markings, completes the \_) shipping papers and certificates, attaches the .- security seal and advises the carrier that the s shipment is ready. 7.3.5 Plant Engineering is responsible for reviewing and accepting the designs o f packaging pur-chased from an outside supplier. If packaging is to be designed by GPUSC, the design, faori-cation and licensing of the packaging shall be the responsibility o f the Director - Technical Functions. 7.3.6 Each manager for this functional area related to the control of radioactive wastes shall establish the requirements for person,nel qualification and institute training and in-doctrination to satisfy these requirements. Training requirements shall be consistent with the importance and complexity o f the activity performed. 7.3.7 Quality Assurance Modifications / Operations Manager is responsible for review and con-currence with procedures describing control of radioactive waste. He is also responsiole to (3 \ J VII-3 Rev. 8
.. .-- _ ----..- - _- . _ . . - . .=. . _ - . = - . - . . . - _ . . . -
4 4 monitor and/or.insp'ect radioactive waste pro-pg . cessing operations to the extent to verify , U they are preformed in accordance with esta-blished procedures, applicable administrative { controis and regulatory requirements. The Operations Department shall review and j accept carriers' documented procedures as specified by procurement documents covering { acceptance of radioactive waste materiais for j shipment. I i t i - i. 1 i 3 i i 1 I
- O -
2. f 4 1 i 1 4 ,; O
- i. .
VII-A Rev. 8 i. 4
~ =. -. - . . . ~ -
8.0 Control of Corrective Actions and (]l) Nonconformances 8.1 Policy Nonconforming materials, parts, components, services or activities witnin the scope of the QA Plan shall be controlled to prevent their inadvertent utilization. As a result, mea-sures shall oe established which ensure tnat conditions adverse to quality, sucn as fail-ures, malfunctions, deficiencies, deviations, defective material and equipment, ano noncon-formances ce promptly identified and correct-ed. The cause of the condition adverse to quality shall be determined and appropriate action taken to preclude repetition. The identification, cause, and actions taken to correct conditions adverse to quality shall be documented and reported to the appropriate levels o f management. Significant conditions within the. intent of 10CFR 50.55(e) or 10 CFR 21 shall be reported to appropriate management levels within tne af fected organization for review and evalua-O 't "- 8.2 Recuirements Procedures shall be estaolished which detail and implement .no following corrective action system measures:
- a. . Conditions adverse to quality shall ce evaluated to determine the need for corrective action.
b. Corrective action documentation shall include identification, cause, and actions taken to correct and to pre-clude the similar recurrence for condi-tions adverse to quality. Corrective action documentation requires con-currence by QAD. c. Follow-uo activities shall be conducted to verify implementation of corrective actions and to close out corrective action in a timely manner. s (d i
- d. Significant deficiencies, noncon-formances and defects, reportable under 10 CFR 50.55(e) or 10 CFR 21 shall De Rev. 8
reported to appropriate management levels for evaluation and possible (~' reporting to tne Nuclear Regulatory Commission.
'e . Control of nonconforming materials, parts, components, services, or activ-ities. These procedures shall adoress and detail measures to implement tne
' following requirements:
- 1. Measures for the identification, documentation, segregation, and dispositions of nonconforming materials, parts or components.
- 2. Disposition of nonconformanccc shall oe made by the organization that estaolished_the governing requirements or by other autnor-ized individuals or committees.
QAD concurrence is required if the disposition is "use-as-is" or
" repair."
- 3. Nonconformance reports shall oe '
used to identify materials,- 1 r- - parts, components, and activities ~ i
' which are not in compliance with the requirements of specifica-tions, codes, drawings, and de-tailed installation or manufac-turing program requirements.
> This shall include use of noncon-formance reports on items whose status is indeterminate due to J the lack of documentation. Non-conformance reports on items shall contains the following
! minimum information:
-(a) Identification of the non-
, conforming item and date of inspection.
(b) Identification of the initi-ator of the nonconformance report. (c) Description of the noncon-formance. O VIII-2 Rev. 8 4
.~ -- -n> w - -- ,p-e, . - - n - n
(d) Disposition of the noncon-formance (repair, rework, (]' ' use as is, or scrap).
. (e) Iripection reautrements.
(f) Required approval signatures of the disposition and the verification. (g) Evidence of review for re-oorting 'er 10 CFR 50.55(e) or 10 CFR 21.
- 4. Reworked, repaired, and replace-ment items shall oe reinspected and tested in accordance with the original inspection and test recuirements or acceptaole alter-natives as determined by Engi-neering and Quality Assurance.
All inspection, testing, rework, and repairs shall ce by approved procedures and the results docu-mented.
- 5. Identification of nonconforming O, -
items be appropriate means (tags, labels, ste.) and segregation, if practica., until disposition of the nonconforming item has oeen determined.
- 6. Prior to the initiation of a preocerational test on a safety-.
related item all nonconformances shall be evaluated for signifi-cance or impact on further test-Jng or operation.
- 7. Nonconformance reports shall be periodically analyzed to show quality trends. Such analysis will be based upon severity, numoer, frequency of noncon-formances, the causes of the nonconformances, and the timeli-ness and adequacy of the report-ing and resolution of nonconfor-mances. Significant results shall ce reported to management for review and assessment.
VIII-3 Rev. 8
8.3 Responsibilities o l-) 8.3.1 The Manager - Quality Assurance is responsloie for the review and concurrence of all proce-durss for reporting and controlling of noncon-formances for compliance with the requirements of tne Operational Quality Assurance Plan. 3.3.2 Operations Management is responsible for en-suring that nonconformances are reported and corrected for plant personnel activities in-volving operation, maintenance, repair, re-placement, addition, modification, health physics, environmental monitoring, fuel han-dling, and inservice inspection. Plant items such as failures, malfunctions, deficiencies, deviations and defective materials, parts or components are handled in a manner consistent
- with their importance to safety and reviewed in accordance with appropriate procedures anc the applicaole Technical Specifications.
8.3.3 Each Manager is responsible for the disposi-tion and corrective action of nonconformances identified as within the scope of his respon-sibilities. In the specific case of mate-rials, parts, components, or systems which (~) have not been installed or accepted as opera-(J tional at the Station, the responsible Manager approves and the Quality Assurance Department concurs witn the resolution of nonconformances. l l I ') i \_/ ! VIII-A Rev. 8 l
9.0 Audits ()- 9.1 Policy A comprehensive system of planneo and docu-mented audits shall be estaolished and exe-
- cuted
- a. To ensure that Quality Assurance re-quirements are adequate, ef fective and implemented.
- b. To ensure that nonconformance and Quality Assurance deficiencies are identified and corrected.
- c. To verify compliance with the TMI Quality Assurance Program.
In addition, this audit program shall provide data for a continuing evaluation o f the ef fec-tiveness of the TMI Quality Assurance Program. 9.2 Recuirements A comprehensive system of audits shall oe () established for both internal and external functions which af fect structures, systems, components, operations and activities covered by the scope of the TMI Quality Assurance Program. Planneo and scheduled audits shall verify compliance with the following:
- a. TMI Quality Assurance Program
- b. 10 CFR 50, Appendix B
- c. Regulatory Guides, ANSI, and other codes and standards as endorsed in the TMI Quality Assurance Program.
- d. Operating procedures
- e. 91c it hechnical specificat ions
- f. sa...nistrative procedures n
Rev. 8
- g. Other procedures and instructions af-fecting quality
- h. Procurement documents 9.2.1 Audit Program Audits shall be performed in accordance with pre-established written procedures and eneck-lists, and shall be conducted oy trained and qualified personnel having no direct responsi-bilities in the areas being audited. The '
audit program shall include
- a. Audit schedules
- b. Procedures for preparation, performance and reporting of audits
- c. Analysis of audit data and reporting results to appropriate levels of management
- d. Follow-up action to be taken based upon individual anc collective audit reports
)
- e. Qualification of auditors
/
- f. Delineation of the authority, responsi-bility, and organizational independence of those responsiole for the audit program.
Audits shall be regularly scheduled based upon tne status ano safety importance of activities being performed and shall oe initiated in a timely manner to assure the ef fectiveness during design, procurement, manufacturing, construction, installation, inspection, test-ing and as required by the tecnnical specifi-cations for TMI. In addition, audits may be scheduled and performed as required by manage-ment or the safety review groups for special evaluations. Implementation of corrective action snall be verified in a timely manner. Unscheduled audits may be conducted at any time on any aspect of this Quality Assurance Plan. Both GPUNC and organizations providing goods and/or services are subject to the audit requirements of this Program. 7- \-)! IX-2 Rev. 8
Audits will be performed by the Quality As-surance Methods /0perations/ Audit group. (^}
%s Each audit team shall be leo .?y a.aualified Aud,it Team Leader. Audit team memoers shall be utilized as reouired and will oe classified as either auditors or tecnnical specialists, deoending on.their function on the audit team.
Procurement documents shall include audit access requirements in insure vendor com-pliance to the audit program. Audited organi-zations shall cooperate with the auditing organization, providing whatever assistance is necessary in the performance of the audit. The audited organization shall take corrective action for findings and resolve observations in a timely manner. 9.2.1 Audit Frecuency Audit frequencies shall be based upon the status and safety importance of activities, degree of previous experience, consistency of overall coverage, unique testing / operating activities, and follow-up on previous audit findings.
)
Documentation 9.2.3 Audit results shall be documented in a written report to the audited organization. The Quality Assurance organization conducting the audit is responsible for conducting follow-up actions including re-audit o f de ficient areas, as required, to assure ' correction of the de fi-ciencies. 9.2.4 Training Audits shall be performed by personnel who are trained and qualified to the requirements defined in ANSI.N45.2.23. These requirements provide the means to assure that audits are performed in a thorough ano professional man-ner. Documented training programs shall be organized to provide auditors with the neces-sary training and knowledge o f regulatati
. requirements, codes, stancards, procedures, etc. applicaole to the activities being audited.
/^
i 1._)T . IX-3 Rev. S 1 I t
9.3 Resoonsibilities O 9.3.1 Office of the President - GPUNC Responsible for the performance of an indepen-dent review of the TMI Quality Assurance Pro-gram cnd related activities. Manaaer >- Quality Assurance 9.3.2
- a. The Manager-Quality Assurance is re-sponsible for establisning and imple-menting the overall Quality Assurance audit program. He assures that all applicable areas are audited and that the auditing organization meets He tne evalu-requirements of this Plan.
ates the effectiveness of the overall audit program, analyzes the reports and related information for quality trends and appraises the Vice President - TMI Unit i and the Vice President - Nuclear Assurance of significant findings of tne program. The Manager-Quality As-surance further ensures that an overall Quality Assurance Audit Program Sche-
~
dule is established and implemented.
.({} O. The Manager-Quality Assurance has tne authority and organizational freedom to schedule and perform audits and to identify quality or management control proolems and provide recommended solu-tions.
l l l l l l ( Rev. 8 IX-4
4 i-APPENDICES i I . . - APPENDIX A Comparison Chart o f Quality Assursoce Plan Recuirements with those. of various parts of
- . - tne Coce of Federal Regulations and Nuclear Industry Standards APPENDIX S Minimum Document Control Responsibility.for "Important to Safety" Documents Quality Assurance-Program APPENDIX ~C NRC Regulatory Guide Commitments and n^' Exceptions y,
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fg3 APPENDIX B MINIt DOCU!MIT CONTROI,RESEONSIBILITY ltR "IMPCirtANT TO SAFETY" DOCUt&NTS l.%tes) Reviewed By aApproved By/ Concurrence . Issur.d 37 (1,2,3) 4 D*unent Prepared By Office of the President QA Department A.1 QA Plun QA Department Managar - QA (Significant Organization Heads Affected aPresident , Changes) aExecutive Vice President ,
"Vice Pres.-Huclear Assurance
-
- Manager - QA Manager - QA ' Manager - QA - QA Department A.2 QA Plan QA Department Organization Head Affected - Applicable Unit V.P. '
(Insignificas.t Vice Pres.-Ituelear Assurance Cbz.nces )
- Manager - QA QA Department B.1 QA Departa.ent QA Department QA Department Procedures
" hsignated site WA Mgr. QA Department B.2 QA QA Department QA Section Projtet Procedures QA Section Manager QA Department B.35A QA Section QA Section
#QA Subsection Manager / Supervisor
- Ssction Procedures
*0utce og rres.
C.1 C1+J Nuclear GPU !!uclear CPUNC Nainistr. t ion Division Heads Affected. V.P. - Nuclear Assurance Pqlicy hirective6 Administration. r CPtJhc GFU Nuclear GPU Huclear Division / *Div. V.P. ' Dept. Mgr. C.2 Citi nuclear Group Administ estion Division /Degt. Division / Dept. Dept. Procedures k nager - QA Affected TMI Station ManagemenE *att Manager TMI utation C.3114L Stution THI Station Administauti, Organizations V Mod / Ops Manager Administrative . Procedures TMI Station Section Manager / , *Tt41 Station Section Manager / Supvr. Tr(I Station C.3. THI StatLon THI Station Unit Mana6er Auministratian. Section Sections sum rvisor Procedures QA Hud/ Ops Hans6er
m
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(4b v' L h . o o h' G Al'it!! DIX B (Il tes) Ibceent Prepared by Reviewed Inf
- Approved By/ Concurrence Issued 11y ,
('If.3F
*1111 Station Section Itanager/ Supervisor .'114I Station C.5 Titt Station T!!! Station THI Station Sections Administration Stction Sections QA Nd/ Ops Manager '
Instructions C.6 TM1 Special TI-II Station FORC ' Unit Manager. . T!4I Station ffRC Alministr.ation Test Prscedures Organizations CBC (per 10 CITt 50.59) Unit Manager QA Nd/ Ops Hgr. QA Nd/ Ops !!anager Radiation Radiation Protection *Badiation Protection Manager / THI Station C.7 '1111 BaJiatto.. Protection Protection Engineeri..g Supervisor Ada.inistration Procedures QA Mod /01 a llanager C.8 TM1 llork Authoriza- Site Organizations TItI Stat on Sections Construction or Maintenance or Originating Start Up and Test Department tion locuanents QA Modifications / Operations l J D.1 Procuremen. Off Site Applicatic Section Managers
- Project Engineering Manager Project Engineering Organizations QA Desig:/l'rocurer.ent Manager QA Design / Procurement Manager Msnager itequisition Applicable Section Managers
- Manager - Plant Engineering Originating D.2 Procuremont Site Organizations QA Design / Procurement Supvr. Organizatic.ns Ite<nuisi tion E.1 Engineering Applicat,)e Section Managers
- Project Engineering Manager (tfotes)
CtJange Documents CPUNC. QA Design /Frocurement N nsect CPUt!C (f,$,6) Engineering Applicable Section k nager Engineering E.2 Engineering THI Plant Eng. Applical,'ae Department Managers Applicable Department Managers TMI Plant Eng. (Mtes) QA Mod /W a E nager *'1111 Plant Engineering ( ie ,', ,6) C4.us.gv Docu= nta QA Design / Procurement Supvr. B-2
s I Al>PLilDIX B 110T1): 1) Responsible individuals or organizations muy have documented, designated alternates who q are authorized to perform the function. 2)~ Dcuignated support organin tions (within CPilNC i.r outside contractors) may be authorized and designated to perform cert ain of the runctions. i
- 3) This Appendix is a suppleracut of Section 3.0 of the QA Plan
- 1. ) Drawinds will not-be reviewed by QA unless used in lieu of specifications.
- 5) GPUitC Engineering is define.1 as those sections within the Technical Functions-Division.
- 6) Engineering Change documenta for design are defined as formalized documents providing description and approval of. changes prepared for incoproration at TMI.
They will include: a) Cover Sheet b) 'lluelea$ Safety Environmental Impact Eval uation , c) Safety Evaluation d) Fire Hazards Analysis e) lluelear Safety Related Design VerificatJons f) Index of Interim Drawings and Related Purchase Orders {
- 7) Reviewed By: Requires a documented review but need r.ot be performed in line prior to !
implementation. !
-)
Approved By/ Concurrence: In line review prior to implementation. ' f 1 l u .l
73 APPENDIX C ( ) OUALITY ASSURANCE PROGRAM NRC HEGULATORY GUIDE COMMITMENTS AND EXCEPTIONS Engineering, in establishing specific requirements for design will use regulatory guide positions controlled oy Engineering in a project criteria document. Examples of positions taken relative to regulatory guides are listed. Those identified by an asterisk cover regulatory guides which are specifically quality related or impacted and are therefore controlled by this manual. The TMI Quality Assurance Program complies with Section C of the NRC Regulatory Guides indicated below. Exceptions to NRC Regulatory Guide position are detailed in Part 2 of this Appendix. This Appendix addresses additional Reg. Guides not listed in Rev. 7 of the Operat'ional Quality Assurance Plan. Comoliance with these added Reg. Guides will apply to modi-
*i :". ice.r,.3dditi ns and activitias performed after issue
(]) o f Rev. 8 and does not imply backfitting and/or retroactive compliance. It is also to be recognized that existing plant conditions, may prevent or preclude the satisfaction of all requirements of a specific design related regulatory guide. Tne deviation will be documented and, along with the justification, will be approved by the Manager - Engineering and Design. l l L [~) v C-1 Rev. 8
e
,m L
s#o 2: h' s o s' ' f . APPi;!! DIX C, l'AHT I JLUUAh!, 1980 Ct*N!1HENT TO QUAL.ITY ASSURAllCE REGUAT/!'OHY CHIDFS POH TifREE t!!!E IGt..*1y DEGHLE 06 hi d. CUII;L ANSI STD. COMPLTA&M RDtAliKJ Personnel Selection and Training N18.1 1971 Nodified Comply with "Raya.htccy Posit ten"
- 1. 6 5/77, Rev. ;-H 1345 2 197T Pull Comply wit's "Regulatcey Po:.ition".
S l.Tr0 2/ D, Bev. 2 Quality Assurance Program Requiretaents (Des 16r. and Construction) H45.2.4 1972 Full Comply with "Hegulator y Position". 1.30 0/11/72 QA Hequiremer.ta for the Installation Inspectior. ar.J Testi6 g of Instrumentation and Electrical , Equircent Quality Assurence Progr.un Requirements N18.7 1976 tiodified See alternate method attacLe.i. 9 1.33 2/76, hev. 2 (Operation) QA seguirements for Cleaning or Fluid Systems Uh5.2.1 1973 ttodified See alternate met:iod attuclea. 1.3T d/16/73 ar.d Associated Components of Water Couled
!!uclear Power Plants QA Requirements for Packaging, Shipping, Nh5.2.2 1972 ltodified See alternate method attached.
1.3b 5/77, hev. 2 Heceiving Stcrage and Handling of Items for Water Cooled Huclear Power flants If5usekeeping Hequireaents for Water Cooled Nk5.2.3 1973 Full Comply with "Reguiu ory Position" 1.3) 9/7T , sha. 2 llaclear Power Plants QA Requirements for Protective Ccutings 101.4 197'2 tlodified See alternute melhed attuehed. 1 . 51 6/73 A1, plied to Water Cooled Nuclear Power Flants Qualifiention:. of Hueleur Power Plant Inspection, 111 6 5 . 2 . 1978 (LJified See alternate sethod uttacheJ. St.58 7/1-) Examination and Testing Personnel P opo vd Rev. 1 Q.astity Assurance Bequirements for the Dealgn Nk5.2.11 1.fl. Ibdi fi ed See alternate methv2 attached.
- 01. tA 6/76 hev. .?
of Huclear Power Plt.nts Nk5.2.lO 1973 Full Comply with "Regalutcry Position'
#1 186 2/71 Quality Assurance Terma and Definitio;.s
. _ . . _ _ _ _ _ _ . . . _ _ _ . _ _ _ ~ . , . _ _ .
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)
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- A?i3I ph @!!PI.T U;'y EE2 TAPES ,
h45.2.9 1974 Hadiflo. See alters. ate mett:a c.ttactwa. . el.b4 10/76, Twv.' ? Collection Storage and :taintenance of Iluelear Power Plant Quality Assurar.ce Records 1.% 4/l6, Hev. 1 QA Beguirements for Installation, Inspection N45.2.5 1974 HoJiri A See alternate mettad attact.-M. and Testibd of Structural Concrete & Steel durind fluelear Power Plant Cor.struction (A Requirements for Installation, Inspection 1845.2.8 1975 ILaiffua See alternate s.ett.od attact. d. 1.216 5/77. Hev. 0-It ard Testing of Hechanical Equirment an.1 Systems el.123 T/TT, Euv. 1 CA hoquiremen'ts for Contrcl or Procurement of ul 5.2.13 1976 Ettl . Comply with "aeguie tory Pasition". 4 Ittss'ar.d Services for Huclear Power Plants Requirements for Ausitir.g of Quality Assurance 'M45.2.12 197T tbd i fi<.- See comments attached, el.1kh 1/19 i :... ~
- for Fluclear Power Plants 1.?6. 2/76, Rev. 3 QA Casaf fications and Standards for Vater Modifica See alternate met- . t ac t.ed .
Mre:um ana hadioactive Maste Containind crionents of helcar Power Plants Cor. trol of Ferrite Contcut in Stainless Ndifica 1.31 L/78. Rev. 3 Steel Weld Metal l.63 6/Td, hev. 2 Electric Fenetration Assea.blies in Containnent 1.EEE-31T 1976 M-A t fic.: See clarification attached. Structure for Light Water Cooled flucicar Power Plants Seismic Design Classifiestion Modiftwa Same cor.A. t as for. Heg. Gu1Je 1.26. l 1.3 9/T8, bcv. 3 i e e
APPENDIX C, PART 2 g I 'NRC Reoulatory Guide 1.30, August 1972 Quality ~ Assurance Reouirements for the Installation. Inscection ano Testino or' Instrumentation anc Electric Eculoment TMI shall comply witn tne Regulatory Position estao- ' 11shed in tnis Regulatory Guide in that QA program-matic/ administrative requirements included therein shall apply to maintenance and modification activities even though such requirements were not in ef fect originally. Technical requirements associated with maintenance ano modifications shall oe the original recuirements or cetter (e.g., code requirements, material properties, design mar-gins, manufacturing processes, and inspection requirements). NCR Regulatory Guide 1.33, Rev. 2. February 1978 Quality Assurance Program Recuirements (Oceration) The TMI QA Program complies with the regulatory position of this guide with the following clarifications:
- 1. Paragraph C.4.3 is interpreted to mean ucits sill
("N be made once each 6 months to verify tne nonconfor-
\> mances and corrective action program is properly implemented and documented, particularly as related to actions-taken to correct deficiencies that af fect items important to safety.
- 2. Paragraph 5.2.8 of ANSI N18.7 - 1976 titled "Sur-veillance Testing and Inspection" In lieu of a " master surveillance" schedule, a surveillance testing schedule shall be estaolished reflecting the status of all inplant surveillance tests and inspections.
- 3. Paragraph 5.2.15 of ANSI N18.7 - 1976 titled
" Review, Approval and Control o f Procedures" The third sentence of the third paragraph is inter-preted to mean applicable procedures shall oe reviewed following a reporta01e incident sucn as an l accident, an unexpected transient, significant l operator error, or equipment malfunction.
- 4. 'Parac,raph 5.2.17 o f ANSI N18. 7 - 1976 titled
" Inspections" I ()
l-C-2 Rev. 8
APPENDIX C, PART 2 g
- (__) Not all inspections will require a separate inspec-tion report. Inspection requirements may oe inte-grateo into appropriate procedures or other documents with the procedures or documents with the procedure or document serving as the record; how-ever, records of inspections will be identified and retrievable.
NRC Regulatory-Guide 1.3.7, March 16, 1973 Quality Assurance Reouirements for Cleaning Fluids Systems ano Associated Components of water Cooled Nuclear Power Plants The TMI Quality Assurance Program complies with the regula-tory position of this guide with tne following clarifi-cations:
- 1. The second sentence o f paragraph C.3 should be amenced to read:
"The water quality for final flushes of fluid sys-tems and associated components shall be at least acui'islent to the operating syctsms e.ter, except
~) for tne oxygen nitrogen content and this does not s_,
infer that chromates or other additives normally in the system water will oe added to the flush water."
- 2. ParagraphuC.4 should be amended to add:
Expendable material such as inks, temperature indi-cating crayons, laoels, wrapping materials (other than polyethylene), water soluola dam materials, lubricants, NOT penetrant materials and couplants, whicn contact stainless steel or nickle alloy material surfaces snall not contain lead, zinc, copper, mercury or other low melting alloys or compounds as basic essential chemical consti-tuents. Prescribed maximum levels of water leach-aole chloride ions, total halogens and sulfur com-pounds shall be impos'ea on expendaole products. i C-3 Rev. 8 I
APPENDIX C, PART 2
/~T NRC Regulatory Guide 1.38, Rev. 2, May 1977 \)
Quality Assurance Reouirements for Packaging, Shioping, Receivino, Storage and Handling of Items for Water Cooled Nuclear Power Plants The'TMI Quality Assurance Program complies with the regula-tory position of this guide with the following modifica-tions:
- 1. Section 3.6 of ANSI N45.2.2 - 1972 concerns preven-tion of halogenated materials from contacting stainless steel or nickel alloy materials. The position stated _in Reg. Guide ' l.37 also applies to this guide.
- 2. Section 3.7.1 of ANSI N45.2.2 - 1972 Cleated, sheathed boxes will be used uo to 1000 los, ratner than 500 lbs. as specified. This type of box is safe for, and has oeen tested for, loads up to 1000 lbs. Other material standaros (i.e.,
FED Spec. PPP-8-601) allow this. Special qualifi-cation testing shall be required for loads in excess of 1000 lbs. r~s (s) 3. Section 6/2/1 of ANSI N45.2.2 - 1972 For storage of level D items access will be con-trolled and limited by posting. Other positive controls such as fencing or posting of guards will be provided for higher storage levels.
- 4. Section A.3.4.1 Appendix to ANSI 45.2.2 - 1972 The last sentence of A.3.4.l(4) and (5) should ce corrected as follows:
(4) "However, preservatives for inaccessible inside surfaces of pumps, valves and pipe systems contal'ning, reactor coolant water shall be the~ water flushable type." (5) "The name of the preservative used shall oe indicated to facilitate touch up."
- 5. With regard to Section A.3.5.2 of tne Appendix to ANSI N45.2.2 - 1972 entitieo "Taoes and Adhesives":
Tapes will meet a sulphur limit of 0.30% oy weignt
- (T
%)
insteao o f 0.10% as specifieo in A.3.5.2(1)(a) . C-4 Rev. 8
APPENDIX C, PART 2 (")
' This limit is reasonaole cased upon the chemical content o f commercially available tapes will ce o f a contrasting color ratner than "Brigntly Colored" as required oy A.3.5.l(3).
- 6. With regard to Section A.3.7.1 of the Appendix to ANSI N45.2.2 - 1972 entitled " Fiberboard Boxes":
In lieu of A.3.7.1(3) and (4), che following will be imposed: Fiberocard boxes shall be securely closed either with a water resistant adhesive applied to the entire area of contact oetween the flaps, or all seams and joints snall be sealed with not less than 2-inch wide, water resistant tape. NRC Reoulatory Guide 1.39. Rev. 2, Sectemoer 1977 Housekeecino Reouirements for Water Cooled Nuclear Power Plants Encorses ANSI N45.2.3 - 1973 The Operational Quality Assurance Program complies with this guide with the following clarification:
- 1. With regard to Sections 2.1 and 3.2 of ANSI N45.2.3
- 1973 entitled " Planning and Control o f
() Facilities", respectively: The TMI Nuclear Station will not utilize the five level zone designation system, but will utilize standard Janitorial and work practices to maintain a level of cleanliness commensurate with company policy in the areas o f housekeeping, plant and personnel safety, and fire protection. Cleanliness will be maintained, consistent with the work ceing performed, so as to prevent the entry o f foreign material into safety related systems. This will include as a minimum documented cleanliness inspections which will be performed immediately prior to system closure. Control of cersonnel, tools, equipment, and supplies will oe estaolisneo wnen major portions of the reactor system are opened for inspection, maintenance of repair. Additional housekeeping reouirements will be imple-mented as required for control or radioactive contamination. l f]
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l APPENDIX C, PART 2 ( }} NRC Reculatory Guide 1.54, June 1973 Quality Assurance Reauirements for Protective Coatings ADD 11ec to dater Cooleo Nuclear Power Plants Endorses ANSI N101.4 - 1972 The Operational Quality Assurance Program complies with this guide with the following clarification:
- 1. TMI shall comply with the Regulatory Position established in this Regulatory Guide in tnat QA programmatic / administrative requirements included therein snall apply to maintenance and modification activities even though such requirements were not in-effect originally. Technical reauirements associated with maintenance and modifications shall ce tne original recuirements or better (e.g., code reauirements, material properties, design margins, manufacturing processes, and inspection reauire-ments).
- 2. The guidance or Regulatory Guide 1.54 shall be followed for organic protective coatings selected
/'h and evaluated in accordance with pertinent sections \# of ANSI N101.2 when applied to interior surfaces of the containment. The supplier's cuality assurance program snall o~e approved prior to implementation.
Quality Assurance documentation may not be similar to records and documents listed in Sections 7.4 through 7.8 of ANSI N101.4 but will oe evaluated to assure tnat they provide at least the same degree of documentation as required oy this standard. NRC Regulatory Guide 1.58, August 1973 Qualifications o f Nuclear Power Plant Insoection, Examination, anc Testing Personnel Endorses ANSI N45.2.6 - 1978 The Operational Quality Asssurance Program complies with this. guide with the following clarification:
- 1. The guidance of Regulatory Guide 1.58 shall ce followeo as it pertains to the cualifications of personnel who verify conformance of work activities to cuality requirements. The qualifications of plant operating personnel concerned with day-to-day i
(~h
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l APPENDIX C, PART 2 (]) operation, maintenance, and certain technical ser-vices shall conform to Regulatory Guide 1.8.
- 2. Not all personnel who approve inspection ano test procedures will be certified as meeting the Level III capaoility requirements of ANSI N45.2.6 - 1978, but personnel who approve inspection and test pro-cedures will be determined oy management, through evaluation of their education, training and ex-perience, to be fully qualified and competent to approve such procedures. The basis for the deter-mination will be documented.
NRC Reculatory Guide 1.64,- R e v .- 2, June 1976 Ouality-Assurance Recuirements for the Desian of Nuclear Power Plants Endorses ANSI N45.2.ll - 1974 TMI shall comply with the Regulatory Position estao-lished in this Regulatory Guide in tnat QA program-matic/ administrative requirements included therin shall apply to maintenance and modification activities even thougn such requirements were not in effect originally.
/')
\- Technical recuirements associated with maintenance and modifications shall be the original requirements or cetter (e.g., code recuirements, material properties, design mar-gins, manufacturing processes, and inspection requirements).
The Operational Quality Assurance Program complies with this guide with the following clarification to paragrapn C.2(1) o f Regulatory Guide 1.64: If in an exceptional circumstance the designer's immediate Supervisor is the only technically qualified individual available, this review can be conducted by the Supervisor, providing that: (a) the other provisions of the Reculatory Guide are satisfied, and (b) One justifica:1cn is inalvidually documented and approved in advance by the Supervisor's management, and (c) quality assurance audits cover frecuency and ef fectiveness of use of Supervisors as design verifi.ers to guard against aouse. l NRC Reoulatory Guide 1.94, Rev. 1, Aoril {976 l Quality Assurance Reouirements for Installation, Insoection l ano Testino or Structural Concrete anc Structurai Steel i curing tne construction Pnase or Nuclear Power Plants l , . \ J C-7 Rev. 8
APPENDIX C, PART 2 Endorses ANSI N45.2.5 - 1974 (-) t_ The Operational quality Assurance Program complies with this guide witn the following clarification: TMI snall comply with the Regulatory Position estao-lished in this Regulatory Cuice in that QA progr3m-matic/aoministrative requirements included therin snall apply to maintenance-and modification activities even tnough such requirements were not in effect origin-ally. Technical requirements associated with main-tenance and modifications shall be the original requirements or cetter (e.g. , code requirements, material properties, design margins, manufacturing processes, and insoection requirements). NRC Regulatory Guide 1.116, Rev. 0-R, May 1977 Quality Assurance Requirements for Installation. Insoection ano Testinn of -Mecnanical Eculoment anc Systems Endorses ANSI N45.2.8 The Operational Quality Assurance Program complies with this guide witn the following clarification: ([) TMI shall comply with the Regulatory Position estab-lished in this Regulatory Guice in tnat QA program-matic/ administrative requirements included therein shall apply to maintenance and modification activities even though such requirements were not in e f fect originally. Technical requirements associated with maintenance and modifications, snall be tne original reouirements or better (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements). NRC Regulatory Guide 1.26, Rev. 3, February 1976 Guality Grouc Classifications and Standard for Water, Steam l ano Raoicactive Waste Containing Components of Nuclear Power ot:nts Since tne original design and construction of the Thiee
- Mile Island Plants was to dif ferent classification criteria than contained in this guide; TMI will comply with the regulatory position of this guide with the following clari-fications:
O C-8 Rev. 8
l APPENDIX C, PART 2 l {] 1. For modifications to existing plant systems and for new construction, items will oe classified l according to tnis guide providing sucn action will I improve the safety of the system being modified or make a significant improvement in overall plant sa fety. Otherwise the items will be classified the . same as the original oesign and construction.
- 2. Tle-in's to existing plant systems will be mace to the same or more recent applicable code, standard and
~
technical requifements which were applicable to the system
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to which the tisa n i~s~to be made, NRC Regulatory Guide 1.63, Rev. 2, July 1978 Electric Penetration Assemblies in Containment Structures for Lignt Water Coolea Nuclear Power Plants TMI will comoly with the regulatory positico of tnis guica with the following clarification: l For modifications to existing structures and to new constructions, this guide will ce utilized providing t ' its use will improve the safety of the structure oeing modified or make a. significant improvement in overall
's plant safety. Otherwise, the code,; standard and tecn-k' /
nical requirements applicable to the original oesign and construction will be utilized. NRC Regulatory Guide 1.144, January 1979 Auditino of Quality Assurance Programs for Nuclear Power Plants TMI is in basic agreement with the position set forth in the Reg. Guide suoject to the following comments:
- 1. Section C.3.a(2)
! The proposed scheduling requirement for internal audits appears to change the oasis for naving a l rational, programmati. apprcach tc auciting. In 1ts place, the new regulatory guide requires manda-tory auditing of all program elements on a yearly basis. The latter would require that all elements l obtain the same attention regaroless of importance, past performance, or to what extent other aspects o f quality assurance measuring and evaluating tecn-l niques are used; as an example, the extent to which n U C-9 Rev. 8
APPENDIX C, PART 2 surveillance and process monitoring is used. O Acccrdingly, minimum seneaule frequency will ce as defineo in R.G. 1.33.
- 2. Section C.3.b(1)
Source insoection provides a controlled oasis for reclacing the need for external audits. The use of quality assurance program surveillance will also oe useo as another alternative.
- 3. Section C.3.b(2) '
While the licenses is responsible for procurement control, this can ce exercised through an annual evaluation of the contractor's performance using pertinent results from manufacturing surveillance, source inspection, receiving inspection, and other apolicaole factors. The evaluation would include a recommendation as to the neeo for a seneauled program or proolem area audit. Hence, auditing, like surveillance and inspection, will oe treated as a quality assurance tool used for evaluation. Furthermore, the recommencation to audit will incluce provisions for reviewing the importance ano impact of.the particular contractor's scope and status. NRC Reculatory Guide 1.88, Rev. 2. Octooer, 1976 i Collection. Storace, and Maintenance of Nuclear Power Plant Availaoility Assurance Recoros TMI will comply compliance with with the intent of -this regulatory guide by Supplement 175-1the andrequirements of ANSI /ASME NQA-1-1979, Appendix 17A-1. 1 b" C-10 Rev. 8
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