ML19323G345

Operational QA Program,Revision 8

ML19323G345
Person / Time
Site:	Three Mile Island
Issue date:	04/18/1980
From:	Herbein J, Kazanas N, Long R METROPOLITAN EDISON CO.
To:
Shared Package
ML19323G337	List: ML19323G336 ML19323G340 ML19323G343 ML19323G345
References
NUDOCS 8006020210
Download: ML19323G345 (115)

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OPERATIONAL t QUALITY ASSURANCE PLAN  !

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- The Metropolitan Edison Company GPU Nuclear Corporation Three Mile Island Nuclear Station REVISION EIGHT April 18, 1980 i

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O . $%po h l Manager' Quality Assurance

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Vice Presioe 7/'- Nuclear V ce7 reticent - TMI Unit 1 Assurance ((/

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. hh l Vice President - Vice Pre doent - Aoministration I

Technical Functions f &

Office of ttYs Presioent - GPUNC i

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( ,) STATEMENT OF POLICY AND AUTHORITY It is the policy of the Metropolitan Edison Company to operate the Three Mile Island Nuclear Station so as to ensure the safety and healtn of the public ana the person-nel on site.

It is also the policy of the Metropolitan Edison Com-pany to comply witn the reouirements of the Code of Feoeral Regulations, the NRC Operating Licenses ano tne applicable codes, guides and stancaros with respect to operation, inservice inspection, refueling, maintenance, procurement, repair and modification of the Station.

The President of Metropolitan Edison has full respon-sibility for TMI Unit 1. He has delegated to GPU Nuclear Corporation (GPUNC) the responsibility for all aspects of operations, design, procurement and modification of TMI Unit 1.

The President-GPU Nuclear Corporation has the respon-sibility and the authority to implement tne Quality Assurance Program.

The Vice President-Nuclear Assurance reports directly

,s l  ; to the President - GPUNC and provides, by way of the J' Quality Assurance Department, the staff necessary to develop and maintain the Quality Assurance Program consis-tent with the applicable Federal and State reauirements and to verify the implementation of the Program.

Tne Manager-Quality Assurance, who reports directly to the vice President-Nuclear Assurance, has the overall authority and organizational freedom to identify auality assurance or management control problems and provide recommended solutions. This authority and responsibility includes stop work authority in activities associated witn operations, maintenance, repair, modification, refueling and manufacturing at or for the Three Mile Islano Nuclear Station. With regard to the stoppage of work, including tne recommendation that an operating nuclear unit be shut down, the Manager-Quality Assurance has direct access to the Vice President-TMI 1 and the Office of the President-GPUNC. The Manager-Quality Assurance shall use this path when dif ferences of opinion regarding auality arise within GPUNC.

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I (l The effectiveness of any Quality Assurance Program is

\/ oepencent upon the incividuals wno implement the program.

- Accoroingly, all personnel of the General Public Utilies System and their contractors must comply with the reouire-ments of this Quality Assurance Program. All members of management must give full support to maintaining an e f fective cuality program as defined in tnis Plan.

Tne Quality Assurance Program, as described in this Plan, is approved for implementation at Three Mile Island Unit 1.

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() TABLE OF CONTENTS Statement of Policy and Authority

$ Introduction 1.0 Organization 2.0 Quality Assurance Program 3.0 Control of Documents and Records 3.1 Instruction, Procedures and Drawings 3.2 Document Control 3.3 Quality Assurance Records 4.0 Design Control 5.0 Procurement and Mattrial Control 5.1 Control of Procurement 5.2 Identification and Control of Materials Parts

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and Components 6.0 Control of Station Activities 6.1 Policy 6.2 Reouirements 6.2.1 Details 6.2.1.1 Control of Inspection 6.2.1.2 Plant QA Monitoring 6.2.1.3 Control of Special Processes 6.2.1.4 Test Control 6.2.1.5 Control of Measuring & Test Eouipment 6.2.1.6 Handling, Storage and Shipping 6.2.1.7 Inspection, Test & Operating Status

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Housekeeping and Cleanliness

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- 6.2.1.9 Eculpment Control 6.2.1.10 Control of Construction, Maintenance (Preventive / Corrective), and Modifications 6.1.1.11 Procedural Recuirements 6.2.1.12 Control of Surveillance Testing and Inspection 6.2.1.13 Radiation Control 6.3 Responsibilities 7.0 Control of Radioactive Wastes 8.0 Control of Corrective Actions and Nonconformances 9.0 Audits Appendices:

Appendix A Comparison Chart of Quality Assur-ance Plan Recuirements with those of

() various parts of the Code of Federal Regulations and Nuclear Industry Standards Appendix B Minimum Document Control Responsi-bility for "Important to Sa fety" Documents Quality Assurance Program Appendix C NRC Regulatory Guide Commitments ano Exceptions Appendix 0 Definitions s- O Rev. 8 j

() OPERATIONAL QA PLAN Introduction Tnis Quality Assurance Plan is formatted in sucn a manner to provide all users with a functionally workable docu-ment. It is structured to cescribe how the Quality Assurance Program is to be functionally implemented with due regard to tne safety and healtn of tne public and tne personnel onsite. The plan contains a description of tne organizations responsible for the implementation of tne Quality Assurance Program (Section 1) The andremaining an overallsec-oes-cription of the Program (Section 2) .

tions are structured in a functional manner.

Therecuirementsforadministrativecontrolsaregekeric and apply to all subseouent sections. Control of docu-ments and records are contained in Section 3.0; control of design is contained in Section 4.0; control of materials and services including procurement is containea in Section 5.0.

Sections 6.0 and 7.0 contain the program recuirements for those direct and supportive activities associated witn :ne operation and safety of the plant; construction and/or modifications associated witn corrective maintenance,

(' ) plant improvement, and/or repair; and the processing and

- transportation of radioactive wastes. Specific reouire-ments such as control of measurement and test eouipment, inspection, special processes, test control, and status of inspections, tests anc operations are included therein.

Sections 8.0 and 9.0 again apply to all functions covered by the scope of this Quality Assurance Program. Section 4

8.0 addresses the identification and disposition of non-conformances associated with all aspects of the program.

In addition, this section contains the management controls provided for evaluating collectively all nonconformances and determining what corrective actions should be taken to preclude their recurrence. Section 9.0 contains tne reouirements and administrative controls applicable to audits. Appendices A, B, and C contain additional Quality Program readirements associated with the functional areas ,

Appendix D contains definitions of discussed in the plan.

terms used throughout the plan.

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/ 1.0 Organization

- 1.1 Policy It is the policy of GPU Nuclear Corporation (GPUNC) to operate Three Mile Islano Unit 1 so as to ensure the safety and health of tne To imple-puolic and the personnel on site.

ment this policy GPUNC will meet tne Quality assurance reouirements of Nuclear Regulatory Commission as presented in 10 CFR 50, Appendix B, and other applicable regulatory guides, codes, and standards pertinent to operation of Tnree Mile Island Unit 1. Therefore GPUNC has authorized the establishment of a formal and comprehensive Quality Assurance Program for TMI Unit 1 operation. Tne Program, which is described in the following sections, shall oe implemented in documented approved policies, procedures and instructions which comply witn this Plan.

1.2 Responsibilities The structure of the organizations responsible for the operation, maintenance, mooification,

(~T repair, inservice inspection and refueling of

\_) the TMI Nuclear Station is illustrateo in is s-Figure 1. The overall organization chart provided to illustrate the interfaces between the various departments anC! to identify those normally located on-site and off-site.

1.2.1 President Met-Ed As the chief operating officer, the Presioent-Met-Ed is ultimately responsible for the safe operation of the plant and for Q A commitments to the Nuclear Regulatory Commission for Unit 1 operation. The responsibility and authority for assuring that the conduct of tnese activi-ties affecting auality are performed in a manner consistent witn this Quality Assurance Program is delegated to tne President-GPUNC.

1.2.2 President - GPUNC The President - GPUNC has the overall respcn-sibility for the establishment, implementation Rev. 8 l Il  ;

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and ef fectiveness of tne TMI Unit 1 Opera-(_) tional Quality Assurance Program. Tnis

- responsibility is adminstereo througn his management staff inclucing:

Executive Vice President - GPUNC Vice President - THI Unit 1 Vice President - Tecnnical Functions Vice President - Nuclear Assurance Vice President - Administration 1.2.3 Executive Vice President - GPUNC The Executive Vice Presfdent-GPUNC reports directly to the President-GPUNC ano shares in the duties and responsibilities of the Office of the President.

1.2.4 Office of the President Tne President and the Executive Vice President constitute the Office of the President. The two officers work in close cooperation and share the executive duties of GPUNC. As used in this Plan, the Office of the President means either the President or the Executive

() Vice President.

1.2.5 Vice President - TMI Unit 1 Tne Vice President - TMI Unit 1 reports directly to the Office of the President. He is responsiole for the overall safety of the Unit; for ensuring that tne applicable proce-dures for the management control and Quality Assurance Program activities are implemented in the conduct of operations, preventative and corrective maintenance, replacement, modifica-tion, refueling, engineering support, in-service inspection, radiation protection and control of radioactive wastes, fire protec-tion, training and plant security; and for ensuring that these activities are performed in accordance with the provisions and limitations set forth in the licenses and permits of the jurisdictional agencies of Federal, State, and local governments. He is also responsible for ensuring that the operations organization is adeauately staffed and that the personnel are adequately

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i trained and Qualified to perform their

(']) assigned tasks. Additionally, tne Vice Presi-cent-TMI Unit 1 is responsible for activities such as support services and logistics and for the planning and scheouling of plant opera-tions such as start-up and test, refueling and planned outages, and productivity of the generating station.

Tne Vice President - TMI Unit 1 gives his fullest support to the Quality assurance recuirements set forth in this Operational Quality Assurance Plan, assuring compliance to the fullest degree by his staff.

1.2.5.1 Manager-Plant Engineering The Manager-Plant Engineering is responsible for maintaining technical liaison and coordi-nation between operating shift personnel and tne technical support engineering staff. This is accomplished by providing on-shift engi-neers to the Operations staff for direct tech-nical coverage of the plant reactor perfor-mance and associated safety systems in order to improve the safety of unit operations and

() maintenance performance. In addition, the Manager-Plant Engineering is responsible for in-plant engineering support in the nuclear, mecnanical, instrumentation and control, and electrical engineering areas. The Manager-Plant Engineering is also responsible for plant chemistry, fire protection and engi-neering input for procurement of items and services important to safety.

1.2.5.2 Manager-THI Unit 1 The Manager - TMI Unit 1 is responsible for the day-to-day operation of Unit 1. He will have a Shift Supervisor directing the opera-tions of each shift through the Control Room Operators and Auxiliary Operators. A mainte-nance force under the direction of a Supervi-sor-Maintenance, covering the areas of elec-trical, mechanical and instrument control maintenance and surveillance, will also report to the Manager. Additionally, the Manager -

TMI Unit 1 has responsibility for the I-3 Rev. 8

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s-coordination of start-up and test evaluations and responsi- ollity for administrative

- control of the training of Unit 1 personnel.

1.2.5.3 Manacer-Radiological Controls The Manager-Radiological Controls is respon-sible for the personnel, procedures and administrative controls of the 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 physics engineering including ALARA programs, and dosimetry control.

The Manager-Radiological Controls is respon-sible for providing and maintaining up-to-date procedures controlling the activities of the department, providing training of Unit person-nel in special topics regarding radiation pro-tection, providing adequate sta f fs of trained personnel to perform the duties of radiation protection, implementing the "as low as rea-sonably achievable" policy and making it a formal part of the Radiation Protection

("% Program.

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l.2.5.4 Manager-Administration and Services The Manager-Administration and Services is responsible for the Station Document Center.

These responsibilities include establishing, supervising and operating the Station Document Center; providing and maintaining up-to-date procedures for controlling the distribution of documents, and the collection, indexing and storage of records; providing and maintaining up-to-date procedures for controlling tne distribution of documents, and the Collection, indexing and storage of records; providing the staff necessary to fulfill these responsioili-ties, and ensuring that staff is adequately trained and qualified to perform tneir assigned tasks. l l

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() 1.2.6 Vice President-Tecnnical Functions The Vice President-Technical Functions reports directly to the Office of the President with responsibility for the detailed development, direction and overall coordination of all engineering, licensing and construction (not 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 resoonsiole to assure compliance and implementation of the Quality Assurance Program requirements applicaole to technical 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 responsiole to develop and control the Quality Classification List (QCL).

Additionally, he is responsible for nuclear fuel management, process computer, control and safety analysis, and plant operational analysis.

([^) The Vice President-Technical Functions and his staf f give full support to the TMI Operational Quality Assurance Program described herein, thereoy assuring that all work performed under 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 providing technical support for the operations of the TMI Nuclear Station. He is responsible to assure compliance with the implementation of the Quality Assurance Program requirements applicaole to' engineering and design activities. He will assure the maintenance of technical capability in the various disciplines, such as mechanical, i civil, electrical and instrumentation, and engineering mechanics. The department will review, and where appropriate, approve the work of Architect / Engineering Organizations, and will perform basic engineering and av O

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() design for modifications. The department has capabilities in the following functional areas:

a. Engineering Mechanics

b. Mechanical Systems

c. Mechanical Components

d. Electrical Power & Instrumentation

e. Design & Drafting Additionally, he is responsible for the iden-tification and classification of materials and activities important to safety, and the development anc 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 safety analysis, and plant operational analy-sis. His department provides capabilities in

() the following functional areas:

a. Nuclear Analysis and Fuels

b. Process Computers

c. Control and Safety Analysis

d. Plant Analysis He is responsible to assure compliance with and implementation of the Quality Assurance Program reouirements applicable to Systems Engineering activities.

1.2.6.3 Project Engineering Manager The Project Engineering Manager is responsible for the coordination, staffing and directing of engineering projects that are assigned by the Vice President-Technical Functions. These activities will vary, depending on the scope and purpose of the assigned project. These responsibilites generally include providing I-6 Rev. 8

p'g the tecnnical support necessary for a study, an evaluation or a modification ano incluoe

, tne coordination of the Departments within Technical Functions with those of TMI-Unit 1.

1.2.6.4 Director-Environment, Health and Safety The Director-Environment, Health and Safety reports directly to the Vice President-Techni-cal Functions and is responsible for the development, direction and overall coordina-tion of the environmental, regulatory, water resources, of fsite radiological health and safety efforts at TMI in compliance with the TMl Quality Assurance Program. His responsi-bilities include:

a. Developing and implementing Environ-ment, Health and Safety procedures covering items such as sa fety evalua-tions, and others necessary to fulfill j the reauirements of this Plan. -

b. Concurring with important to safety Design Criteria Documents from the standpoint of having addressed all r applicable regulatory reauirements and .

licensing ccmmitments. I

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c. Exercising project control of amendment j reauests to the Safety and Environ-mental Technical Specifications and the FSAR in accordance with 10 CFR. l l

d. Developing biological monitoring  !

programs and special studies in the i Environmental Technical Specifications l to auantify the impact of Unit 1 opera-tion on the environment.

e. Performing an environmental evaluation of proposed modifications, including publishing of environmental rt. ports.

f. Maintaining liaison between GPUNC and NRC's Project Management regarding licensing and environmental issues which are applicable to operating facilities.

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() 1.2.7 Vice President-Nuclear Assurance The Vice President-Nuclear Assurance nas the overall authority and direct responsiollity for Quality Assurance, Nuclear Safety Assess-ment, Training and Operational Safety Support activities as defined in this Plan. These activities include, but are not limited to:

a. Development, distribution, and main-tenance of the Quality Assurance Plan, D. Assessing program implementation and evaluating its effectiveness,

c. Identification of Quality problems,

d. Initiation and recommendations of cor-rective actions for Quality related problems.

e. Evaluation of effectiveness of plant radiation control operations.

f. Preparation, review and approval of Emergency Plans.

O' k- g. Recommendation of policy for radio-logical system controls,

h. Technical and administrative direction of training for plant operations.

1. Evaluation of effectiveness of the training programs in meeting course objectives.

Additionally, he is responsible for providing Quality Assurance and Quality Control support services such as laboratory analysis, safety review (Nuclear Safety Assessment), audits ano reliability information systems. The Vice President-Nuclear Assurance utilizes the following management staff memoers in-carrying out his responsibilities:

Director-Training and Operational Safety Support Manager-Quality Assurance l

fg Manager-Nuclear Safety Assessment Manager-Radiological Systems Control I-8 Rev. 8

() 1.2.7.1 Manager-Ouality Assurance (Figure 2)

The Manager-Quality Assurance Department (QAD) has the functional authority, independence and responsibility to verify the effective imple-mentation of the administrative controls ano compliance to the Quality Assurance Program during the operational phase of TMI Nuclear Station. The Manager of QAD reports directly to the Vice President-Nuclear Assurance.

Additionally, he has direct unencumbered ac-cess to the Office of the President, and the Vice President-TMI Unit 1 with regard to cuality activities.

This reporting relationship has been esta-blished to provide the Quality Assurance organization with sufficient independence from the influence of costs ano scheoules to be able to effectively assure conformance of Operational Quality Assurance Program recuire-ments. Figure 2 identifies the Quality Assurance Department organizational elements which function under the Quality Assurance Program. The Manager-QAD nas no duties or responsibilities unrelated to Quality Assurance that would prevent his full atten-(~)

'/ tion to Quality Assurance matters, and he has authority:

a. To evaluate the manner in which all activities, both onsite and offsite are conducted, with respect to cuality, by means of review, survey, audit, sur-veillance, monitoring, and inspection.

b. To perform evaluations on a planned'and periodic basis to verify that the Quality Assurance Program is being e f fectively implemented.

c. To identify cuality problems, and to initiate, recommeno or provide solu-tions through designated channels and to verify implementation of resolutions.

d. To stop work or further processing, delivery, or installation of noncon-forming material, to stop work on non-conforming activities, to initiate unit A

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() snutcown recommendations and to ootain unit shutdown with appropriate upper management concurrence as described in applicable Quality Assurance procedures.

The specific responsibilities of the Manager-QAD, include the following:

a. Provide for the review and acceptance of the Quality Assurance Program of contractors providing services affect-ing quality and of vendors supplying materials, parts, or components covered by the scope of this Quality Assurance Program.

D. Provide for review and acceptance of procedures prepared by other TMI organizations when these procedures control or exercise an effect upon items and activities important to safety.

c. Provide direction and management of tne Q4D.

d. Provide a working interface and commu-s- nication with the TMI organizations, A/E's agents, contractors, vendors, and others with respect to QA matters.

Additionally, in conjunction with the licensing organization, he shall pro-vide a working interface and communi-cations with the NRC with respect to QA matters.

e. Provide, as applicable, planned and periodic audits, monitoring, surveil-lance, and inspections of organiza-tions, contractors, and vendors per-forming work functions important to safety.

f. Estaolish and assure the continuous implementation of an indoctrination and ,

training program for QA and QC per- l sonnel and assure that a quality assurance indoctrination is provided to appropriate personnel outside the Quality Assurance organization.

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g. Issue periodic reports to the Of fice .of

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N- the Presioent, the Vice President-

" Nuclear Assurance and the Vice Presi-cent-TMI Unit 1 on the status of ouality activities, and bring to their attention immediately any significant cuality-related problem or deficiency.

h. Provide for cuality assurance review and acceptance of aesign and engi-neering documents, as delineated in the detailed procedures.

1. Provide for ovality assurance review and acceptance of procurement documents generated for the accuisition of mate-rials and services within the scope of the program.

J. Provice for and maintain cuality assurance records generated by QAD until such time as they are turned over to document control for storage.

The Manager-Quality Assurance shall have, as a minimum, a baccalaureate degree in Engineering or Science, with at least five years of QA

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_,ss experience in nuclear power plant operations or supporting activities. Additionally, the Manager-Quality Assurance must be knowledge-able in QA regulations, policies and standards.

1.2.7.l(a) Quality Assurance Design and Procurement Manager The Quality Assurance Design and Procurement Manager is responsible for establishing ouality programs and inspection recuirements in support of design and procurement activi-ties in compliance with the TMI Quality Assurance Program. These activities include, but are not limited to:

a. Review and approve contractor and ven-dor cuality programs for those supply-ing services or items important to safety.

b. Reporting ouality trends to his super-visor and to the cognizant purchasing or contract manager.

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c. Review anc accept design control proce-dures prepared by otner TMI organiza-

' tions when these procedures control or exercise an effect upon systems, components, or activities important to safety,

d. Identify ouality problems and initiate, recommend or provide solutions througn designated channels and to verify implementation of resolutions.

1.2.7.l(b) Quality Assurance Manufacturing Assurance Manager Yne QA Manufacturing Assurance Manager is responsible:

1. To perform the necessary post-award ouality related activities, including post-award surveys and source surveillance, in compliance with the TMI Quality Assurance Program,

2. To coordinate with the QA Modifications /

g- Operations Section to assure that documentation of the manufacturing

- discrepancies are available to the receiving inspectors and cognizant purchasing or contract manager,

3. To provide the Design and Procurement Assurance Section with the results of Manufacturing Assurance Activities and recommendations relative to the acceptability of a vendor.

4. To identify ouality proolems and to initiate, recommend or provide solutions through designated channels and to verify implementation of the resolutions.

1.2.7.l(c) Quality Assurance Modifications / Operations Manager ,

The Quality Assurance Modifications / Operations  ;

Manager is responsible l

1. To monitor the implemer.tation and l effectiveness of the Quality Assurance Program on site, I-12 Rev. 8

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2. To establish adeouate site monitoring anc inspection programs necessary to verify conformance to Quality Assurance Program recuirements,

3. To review site procedures from a QA standpoint,

4. To provide nondestructive examination support for TMI,

5. To notify appropriate TMI station management and tne Manager of Quality Assurance immediately of any condition tnat warrants operational snutdown of a nuclear unit as defined in the appropriate QAD procedures.

6. To identify cuality problems and to initiate, recommend or provide solutions througn designated enannels and to verify implementation of tne resolutions.

He reports directly to the Manager of Quality Assurance and ne periodically reports on the 7g implementation and effectiveness of the Opera-() tional Quality Assurance Program to tne Vice President - TMI Unit 1. He has the authority to stop work on all important to safety activities associated with tne on site TMI Tne Nuclear Station Operational QA Program.

Quality Assurance Modifications / Operations Manager is ass!sted in carrying out his responsibilities by an Operations Quality Assurance Supervisor, a Quality Control Manager and their associated staffs located on site.

1.2.7.1(d) Quality Assurance Methods /00erations/ Audits Manaaer The Quality Assurance Metnods ,derations/

Audits Manager is responsiD1e

1. To coordinate activities recuired to main-tain the Quality Assurance Plan and the QAD procedures,

2. To implement QA Training witnin tne department, f

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3. To implement a comprehensive system of planned and occumented audits to verify complisnce witn all aspects of the Quality Assurance Program, 4 To identify cuality problems and to initiate, recommend or provide solutions through designated Channels and to verify implementation of the resolutions.

The Quality Assurance Methods / Operations /

Audits Manager maintains a full-time staf f of Quality assurance engineers and oualified ouality auditors at both the corporate and 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 the audit findings and the effactiveness of the Quality Assurance  :

Program.

1.2.7.1(e) Materials Technolooy Manaaer The Materials Technology Manager is responsible:

() 1. To direct and supervise the off site engineering organizations which have the responsibility for the establishment of recuirements for welding, inservice inspection, materials, and materials evaluations.

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2. To provide NDE and ISI program of flaw analysis and reporting,

3. To provide technical reovirements for repair and repair programs,

4. To identify cuality problems and to initiate, recommend, or provide solutions through designated Channels and to verify implementation of t he resolutions.

5. To provide support related to manufacturing and systems materials technology problems.

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() The specific disciplines included in the Materials Technology section are:

a. Nondestructive Examination

b. Inservice Inspection

c. Materials Engineering

d. Welding Engineering

e. Metallurgical Analysis 1.2.7.1.1 Minimum Qualifications of Quality Assurance Personnel The cualification recuirements and experience levels for key Quality Assurance personnel are such as to assure competence commensurate with the responsibilities of each position.

Quality managers and supervisory personnel are recuired to have a degree in Engineering or Science and experience in a position having responsibility for the performance of ouality activities. The degree recuirement may be waived for personnel with exceptional cualifi-() cations and a minimum of seven (7) years related experience.

1.2.7.2 Director-Training and Operational Safety Support The Director-Training and Operational Safety Support reports directly to the Vice Presi-dent-Nuclear Assurance and has the overall authority and responsibility for technical training, emergency planning and the system laboratory. These activities include but are not limited to:

a. Providing technical and administrative direction of training for plant opera-tions in the areas of:

o operator training o maintenance training a fire protection training (m]

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health physics and chemistry training

() o o plant related technology o cuality assurance training

b. Evaluation of the effectiveness of the training program in meeting established course objectives.

c. Preparation, review and approval of the Emergency Plan. Provide a competent staff to act as plan coordinators ano evaluators.

d. Provide management direction to tne system chemistry laboratory.

1.2.7.2.1 Manacer-System Laboratory The Manager-System Laboratory is responsible for the administration and operation of the Environmental and Operational Chemistry Analyses Section of the System Laboratory in compliance with the TMI Quality Assurance Program. This section provides the central-r 's ized laboratory analyses services for TMI.

V The specific responsibilities of the Manager--

cystem Laboratory include the following:

a. Perform analysis of water and waste-water samples submitted by the generating station,

b. Prepare calibration standards for the labs at the generating stations,

c. Monitor the analysis capabilities of the labs at the generating stations through audits and independent analysis of samples,

d. Assist station personnel in unusual operations such as chemical cleaning,

e. Provide consultation on eauipment startup and performance, as reauested,

f. Perform chemical analysis of fuels, lubricants, insulating fluids and ion exchange resins,

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() g. Ensure that the laboratory is ace-cuately staffed ano that the laooratory personnel are adeouately trained and cualified to perform their assigned tasks,

h. Ensure that the System Laboratory meets the applicable recuirements of the Quality Assurance Program,

1. Develop and implement laboratory proce-dures covering the control of the laboratory activities and the records documenting the results of the analysis.

j. Provide support to Materials Technology regarding material specimen preparation and testing.

1.2.7.3 Hanager-Nuclear Safety Assessment The Manager-Nuclear Safety Assessment is responsible for the development, direction and supervision of the Nuclear Safety Assessment Department. The function of this group is to n review and assess the safety significance of

' ls,) the broad range of activities, practices and conditions which may have an adverse effect on cuality and to make recommendations to the appropriate levels of management for correc-tive action to preclude repetition.

The Nuclear Safety Assessment Department (NSAD) will have access to all documents ano reports identifying conditions adverse to cuality (audit reports, r unconformance reports, surveillance / inspection reports, reportable 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 ombudsman for all members of the Corporation having a concern for nuclear safety. Additionally, the Nuclear Safety Assessment Department, working with Systems Engineering, will evaluate the opera-tional experience of other nuclear power stations to improve plant operational status and derive benefit from other stations experience.

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() 1.2.7.4 Manager - Radiological Systems Control The Manager-Radiological Systems Control reports directly to the Vice PresidentNuclear Assurance. He is responsible for providing policy, guidance and coordination of radio-logical control programs to De 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:

1. Materials management, including pur-chasing, contracts, expediting, receiving and warehousing.

2. Fisca', management including oudget/ cost cont--1/ management information systems

3. Industrial safety

4. Personnel and labor relations.

O 5. Security systems

6. Facilities management

7. Legal services He is assist 3d in the performance of these responsibilities at the site by individuals with assigned responsibility for security, procurement, warehousing, pere.onnel, laoor relations and facilities management. The Vice-President-Administration and his staff give full support to the TMI Operational Quality Assurance Program descrioed herein, thereby assuring that all work performed under their cogrizance will conform to and support the requirements of this plan.

1.2.8.1 Manager - Field Warehousing, TMI The Manager-Field Warehousing, TMI is respon-sible for maintaining an inventory, initiating reouisitions for inventory reorder, receiving both direct turnover and inventory items, maintaining adequate storage space and facili-(~>)

s ties, and issuance of material from storage.

I-18 Rev. 8

O Manager - Field Procurement, TMI

(/ 1.2.8.2 TMI is respon-

' The Manager-Field Procurement, sible for all TMI purchasing and expediting activities including the following:

a. the implementation of an approved procurement control process,

b. the receipt, review, recorcing and tracking of purchase requisitions,

c. the incorporation of engineering recuirements into purenase orders,

d. compliance and implementation of the TMI Quality Assurance Program with regard to his areas of responsiollity.

e. the preparation and document control of all purchase orders including those for contracts.

1.2.8.3 Manager-Contracts, TMI The Manager-Contracts, TMI is responsible for procuring those TMI purchasing recuirements N-

\

that involve custom-engineered owners-fur-nished (powerhouse) equipment, construction work, high tecnnology and high dollar value engineering services and administering the resulting contracts for compliance.

His corporate headquarters counterpart pro-cures and administers the plant's nuclear fuel requirements.

s-O I-19 Rev. 8

-~ - _ _ .

'r O FIGURE 1 O GIU Nue; ear Corporation Project OrFanization Office of the TM1 Un'.<. 1 President President Exective Vice President i

Vice President Vice President Vice President Vice President TMI Unit 1 Administration A i nee Fu i n 1

I I Home Office Director Director Manager Environmental - -

Training & Oper.

l Till Unit 1 l Staff ISafety Support Health and Safety I I I Manager l Manager Manager Manager Field y Plant _

Quality Engineering _

_ l Procurement and Design Engineering Assurance l i I I Manager Manager g g g Manager l Radiologien1 -

Nuclear Safety - Systems - -

Field Warehousing Engineering Controls l Assessment l l Manager i Manager Project Manager -

Engineering Admiaistration l Contracts Radiological  ! and Services Syst:cm Control fianager l i

I i

Located On Site L- - GRC L _ _ _ c mgg )

- Functional Reporting

\

\

O O O Manager FIGURE 2 Quality Assurance QUALITY ASSURANCE DEPARTMENT Materials Methods, Site Technology Operations and Audit Manager Audits Supervisor Manager QA Ifod/ Ops ,

QA QA Design and Manager Manufacturing Procurement Assurance Manager Manager 1

Quality Operations Site Control QA Quality Engineering i

l Located on Site

() 2.0 2.1 Quality Assurance Procram Policy 2.1.1 General The TMI Operational Quality Assurance Program has been established to provide overall cua-lity assurance of activities within the scope of the program. Adherence to the reouirements of the TMI Operational Quality Assurance Program is mandatory for all TMI organizations and for all external organizations providing items or services covered under tne scope.

This Quality Assurance Plan is the highest level document which describes the Quality Assurance Program. The term " Program" as used herein includes suDtier implementing policies, procedures and instructions.

Any conflicts regarding interpretation or implementation of this Plan shall be promptly reported to the Manager-Quality Assurance for resolution.

() 2.1.2 Scope 2.1.2.1 The scope of the TMI Operational Quality Assurance Program includes all items and ac-tivities considered to be "important to safety." This term is intended to De broader than " safety-related" and encompasses struc-tures, systems, and components (including nuclear fuel and radwaste) which have been designated as Safety-Related, Safety Class, IEEE Class IE, Seismic Category 1 or Fire Protection. The scope of the Program will include all items reauired by the following:

a. Title 10, Code of Federal Regulations, Part 50, Appendix A " General Design Criteria for Nuclear Power Plants"

b. Title 10, Code of Federal Regulations, Part 50, Appendix B " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" Il-1 Rev. 8

A c. Title 1G, Code af Federal Regulations,

() Part 71, Appendix E " Quality Assurance for Shipping Packages for Radioactive Material"

d. United States Nuclear Regulatory Com-mission Regulatory Guide 1.143 " Design Guidance for Radioactive Waste Manage-ment Systems, Structures and Components Installed in Light Water Cooled Nuclear Power Plants"

e. Branch 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 the seismic aspects of components whicn have impact on items important to safety,

g. Other items when designateo by Tecnni-cal Functions.

The TMI Operational Quality Assurance Program

(-) applies to all items on the QCL. The QCL will

- be periodically updated to include new plant modifications or construction, or any enanges in classification. The list will be treated as a controlled document.

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 includeo in the next revision to the QCL. Documents which control the installation of modifica-tions which have been classified as 'important to safety" will be clearly identifj c as such.

2.1.2.2 Activities whicn are important to safety shall include, but not be limited to:

a. Those activities covered by Appendix A of Regulatory Guide 1.33 and ANSI N18.7.

b. The reouirements of other Regulatory Guides applicable to operations, maintenance, modification, repair and refueling of a nuclear power plant as identified in Appendix C herein.

}

II-2 Rev. 8

c. Those activities related to Fire

[- Protection as covered by Branen Tecnnical Position ASB 9.5-1.

o. Those activities related to Plant Security as covered by ANSI N18.17-1973.

e. Those activities covered by procedures which have been designated during the review cycle as "important to safety".

2.1.3 Quality Assurance Plan This Quality Assurance Plan is the primary document which provides a description of the Program. The Plan is authorized oy 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 procedures and instructions.

The purpose of this Plan is to establish the principles which, when implemented, will pro-vide that level of ouality assurance which is

-( ) appropriate to each item or activity important to safety. It is recognized that the degree of management control or cuality assurance to be applied varies with different systems and activities, and the degree of applicability of any specific item in this Program will differ from item to item and activity to activity.

The degree to which the reouirements of this Plan and its implementing procedures are applied will be based upon the following:

a. The importance of a malfunction or failure of the item to safety;

? b. The design and fabrication complexity or unioueness of the item;  ;

c. The need for special controls and sur-veillance or monitoring of processes, eouipment and operational activities;

d. The degree to which functional com-pliance can be demonstrated by inspec-tion or test; and C( S II-3 Rev. 8

e. Tne cuality nistory and degree of stan-darization of tne item or activity.

7 V

)

- The cuality recuirements for items important to safety will be estaolisned using approveo procedures based on the " General Logic Consi-derations" listc_ in the Appendix to ANSI-N45.2.13-1976. Quality reouirements will be establisned by the responsible Engineering Department and concurred with oy Quality Assurance Department for those items which are important to safety.

GPUNC is Committed to a comprehensive Quality Assurance Program consisting of a three level approacn to assure satisfactory and complete 1mplementation of the program commensurate witn its recuirements for safety and perfor-mance. The Program's foremost considerations are the protection of tne general public's healtn and safety.

2.1.3.1 Level 1 - activities at tnis level include inoependent inspections, enecks and tests.

This level of activity may be performed by:

1. Operations personnel in activities sucn

/~) as surveillance tests, calloration of

~

(J.

instruments, radiation surveys, analyses of samples, valve line-ups, etc.

2. Tne Quality Control Section by receipt inspection or inspections of modifica-tion or corrective maintenance activities.

3. Contractors as part of their scope of work.

In all cases, the activity is performed by individuals knowledgeable of tne activity being performed and cualified to perform the work (refer to Section 6.2.1.1). Cnecklists or data sneets are used for documenting the results of tne activity and for providing a permanent record of the performance of the activity.

In all cases where tne first level activities involve independent inspection for purposes of A- II-4 Rev. 8

acceptance and/or verification of modifica-

[-s) tions to safety systems, tne activity will be performed by tne QA Department or oy organiza-

" tions autnorizec to perform tnose activities by the QA Department.

2.1.3.2 Level II - tne activities at tnis level are primarily tnose of surveillance or monitoring and are performed as deemed necessary by tne QA Modifications / Operations, QA Design and Procurement or QA Manufacturing Assurance Sections. Tne level of surveillance / monitor-ing applied is consistent with tne importance of the item to safety. For activities, where Quality Control is performing first level inspection, no second level activity will be reouired.

At this level procedures and instructions are establisned and surveillance records will be completed and maintained. Suen surveillance /

monitoring normally includes observation of ouality control tests and inspections, obser-vation of significant operations, review of records, verifications of test reports, 00d direct inspection on a spot eneck oasis. The organizations performing this activity have

() the levels of autnority, the lines of internal and external communication for management direction, and the properly trained personnel I for implementation of these activities. l 2.1.3.3 Level III - the purpose of this level of activity is to assure tnrougn a comprenensive program of review and auditing tnat tne first and second levels of the program are properly functioning. Tne purpose of tnis level is also to establish that all other organizations including Operations, Maintenance, Engineer-I ing, Materials Management, etc. are properly satisfying all the reouirements of the Operational Quality Assurance Program.

At this level procedures and instructions are established including the use of comprenensive checklists for documentation of the audit or third level activity in accordance with reouirements of ANSI N45.2.12. Qualifiad audit personnel are included that satisf / the recuirements of ANSI N45.2.23. Additional I

(~'T i

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II-5 Rev. 8 ,

O

'() tecnnical experts from areas with administra-tive reporting outside the function that is being audited will be included as the Audit Team Leader oeems necessary. The organization performing this activity has sufficient autnority and lines of internal and external communications for obtaining tne necessary management direction.

2.1.3.4 Appendix A, herein, is included to provide a comparison of the sections of the Plan with the recuirements of 10CFR50, Appendix B, 10CFR71, Appen- dix E, ANSI N18.7, and ANSI N45.2.

2.1.4 Quality Assurance Program Review The TMI Quality Assurance Program effective-ness and implementation is periodically evaluated by the GRC and the Nuclear Safety Assessment Department. Tney report their findings directly to GPUNC management. Tnese groups provide safety review reports and review operational methods. These groups each have technical expertise necessary to support r~ their areas of concern. In addition, the Quality Assurance Department conducts

" activities which provide canagement with additional information pertaining to effectiveness and implementation.

2.1.5 Training The TM1 Quality Assurance Program includes recuirements for formal training programs for personnel performing or verifying activities important to safety.

2.2 Recuirements 2.2.1 Quality Assurance Plan The Operational Quality Assurance Plan and any significant revisions shall be approved by the following:

Of fice o f the Presiden.m - GPUNC Vice President - TMI Unit 1 Vice President - Nuclear Assurance r~

L )g II-6 Rev. 8

Vice President - Technical Functions Vice President - Administration Manager - Quality Assurance The Plan includes a Statement of Policy wnicn is signed by the Presidents - GPUNC and Metro-politan Edison. The Statement of Policy pro-vides authorization and evidence of nanagement commitment to the Quality Assurance Program.

Revisions to this plan shall be consider.ed significant if they alter the degree of com-pliance with regulatory reouirements committed to in Appenoix C, herein. Changes to the TMI-l organization in assignment of responsibilities to the extent described below the Vice President's level shall not be considered significant except in the area of Quality Assurance. Changes in name or title changes with no basic change in function shall not be considered significant. Editorial and typo's which do not change the intent of the words or scope of the program shall not be considered significant. Significant plan O: revisions shall be submitted to tne Nuclear NRC approval is

Regulatory Commission.

reouired prior to implementation.

Plan revisions not considered by the Manager -

Quality Assurance to be significant can De issued with approval of the Manager - Quality Assurance and the Vice President - Nuclear Assurance. The Manager-Quality Assurance is responsible for notifying the NRC of such changes to the Plan within 30 days of tne change.

Copies of Quality Assurance Plan may be dis-tributed as " Controlled" or " Uncontrolled" copies in accordance with the recuirements established in Section 3.

2.2.2 Classification 2.2.2.1 General The Quality Assurance Department will concur with the procedures used for classification, and audit the process for implementation.

Additionally, engineering classification of

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II-7 Rev. 8

~ _

' items "important te safety" will be suoject to independent design review by Engineering.

2.2.2.2 Parts Classification The Quality Classification List (QCL) will normally list systems and com- ponents, but not parts. For procurement of spare or replacement parts, classification Engineering will will be on a classify case by case basis.

the parts to be ordered. QA concurrence is reouired. The determinations will not necessarily be added to the QCL. An approved engineering evaluation snallNo beevaluation prepared for is the parts being procured.

necessary for cases where the part being replaced was purchased as commercial cuality.

2.2.3 Regulatory Commitments A listing is maintained by Technical Functions of commitments to regulatory reouirements.

Each new or revised USNRC Regulatory Guide will be evaluated by Technical Functions The for applicability and acceptability to TMI. is GPU Nuclear Corporation position on each O' documented stating the method and degree of v

compliance or the justification for lack of compliance.

lists those regulatory Appendix C, herein, guides which are cuality related or affected with stated company position, exceptions and These must be complied or clarifications.

with in conjunction with the QA Plan, 2.2.4 Safety Review Safety review groups have been establisheo These to perform regulatory reouired reviews.

groups provide management witn visability and recommendations for improved plant safety.

Plant Operations Review Committee (PORC):

2.2.4.1 The PORC is an on-site operations review organization functionally reporting to the This group reviews Vice President-TMI Unit 1.

all matters which potentially reouire independent review by GRC.

O v

Rev. 8 II-8

T l O PORC is made up of plant senior tachnical personnel with day-to-day responsibility and account- ability for safe operation. Its memoers 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 that the day-to-day operating activities are conducted safely and in accord-ance with applicable administrative controls.

These continuing monitorin0 activities are considered to be an integral part of the routine supervisory function and are important to the safety of plant operation. The Vice President - TMI Unit 1 in carrying out his responsibility for overall safety of plant operations, shall be responsible for timely referral of appropriate matters to management and the GRC.

2.2.4.2 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-() dent safety review of operations, nuclear engineering, chemistry and radiochemistry, matallurgy, nondestructive examination, instrumentation and control, radiological safety, mechanical and electrical engineering, radwaste, administrative controls, quality assurance and other appropriate fields asso-ciated with the unique characteristics of TMI. The GRC is responsiole for reviewing the following specific subjects:

a. Written safety evaluations of changes in the facility as descrioed in the Safety Analysis Report, changes in procedures as described in the Safety Analysis Report and tests or experi-ments not described in the Safety Analysis Report which are completed without prior NRC approval under the provisions of 10 CFR 50.59(a)(1). This review is to verify that such changes, tests or experiments did not involve a i change in the technical specifications or an unreviewed safety question as

! defined in 10 CFR 50.59 (a)(2).

II-9 Rev. 8 i

f)

N'

b. Any proposed change in procedures or

the facility or proposed tests or experiments which involve a change in the technical specifications or an unreviewed safety auestion as defined in 10 CFR 50.59(c). Matters of this kind shall be referred to the GRC by PORC following its review, or by other functional organizational units witnin the GPU Nuclear Corporation, prior to implementation.

c. Changes in the technical specifications or license amendments relating to nuclear safety prior to submittal to the NRC for approval.

d. Violations, deviations and reportable events which reauire reporting to the NRC in writing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, such as:

1. Violations of applicable codes, regulations, orders, technical specifications, license reauire-ments, internal procedures or instructions having safety signi-() ficance.

2. Significant operating abnormali-ties or deviations from normal or expected performance of plant structures, systems, or compo-nents important to safety.

3. Reportable everts, which require reporting to the NRC in writing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, as defined in the plant technical specifica-tions.

e. Violations, deviations and reportable events as described in 10CFR Part 50, Domestic Licensing of Production and Utilization Facilities. Section 50.72, shall be reported to the NRC by telephone within one hour.

GRC reviews of these items (d and e) .

normally occur af ter the NRC has been l notified. GRC reviews shall include '

l 6

l II-10 Rev. 8 ;

l l

l

/' ' the results of any investigations maoe and the recommendations resulting from such investigations to prevent or reduce the probability of recurrence of the event.

f. Any other matter involving safe opera-tion of the nuclear power plant which an idependent reviewer deems appro-priate for consideration, or which is referred to the independent reviewers by the onsite operating organization or by other functional organizational units within the TMI organization.

2.2.4.3 Puclear Safety Assessment Department (NSAD):

NSAD is an independent organization reporting to the Vice President - Nuclear Assurance. It performs evaluations and investigations as it deems appropriate or as assigned by the 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 software systems which affect the

(~' safe, reliable operation of the plant. They

\ interf ace with the QAD audit section to assure complete coverage ano utilization of the audit program.

2.2.4.4 Quality Assurance Department:

The normal audit program conducted by the Quality Assurance Department and described in Section 9.0 also provides management with assessment of program status and ef fectiveness.

2.2.5 Indoctrination and Training Indoctrination and training programs are established for both on-site and off-si.te personnel performing important to safety activities by the organizational units responsible for the activities. These programs are implemented by appropriate training plans and procedures which assure that:

a. Personnel are instructed as to the purpose, scope, and implementation of manuals, procedures, and instructions; II-11 Rev. 8

() D. Personnel are trained and certified in the principles anc techniques of tne activities oeing performed. Acceptance criteria vill be established consistent witn the importance to safety of the activity requiring qualification;

c. Proficiency is maintained by retrain-ing, re-examining, or recertifying;

d. The scope, method and objective of the training is documented;

e. Records of training sessions are pre-pared and maintained, including identi-fication of the content, the attencees, and the date the training was conducted.

2.2.6 For personnel performing inspection, examina-tion, and special processes, the qualification criteria shall oe delineated to the techniques of inspection or items oeing inspected anc the technical abilities of the person oeing certi-fled will be consistent with the assigned tasks (e.g., electrical inspection, mechanical inspection, etc.).

2.3 Responsibilities l

2.3.1 Office of the President - GPUNC The Office of the President - GPUNC is respon- I sible to regularly assess the scope, status, ,

adequacy and compliance of the Quality l Assurance Program to the requirements of 10 CFR 50, Appendix B. This assessment shall oe the combined result of:

l

a. Contact with Quality Assurance Program status through review of periodic '

status reports on the effectiveness and implementation of the Quality Assurance Program.

b. Performance at least once a year of a l preplanned and documented assessment of the ef fectiveness of the Quality Assurance Program to assure that the program meets regulatory requirements, and the policies and directives of l TMI. This assessment may be performed i

,(

II-12 Rev. 8 l

k utilizing the safety review groups, an independent consultant, or his own staff. Any corrective action which may be deemed necessary as a result of these assessments shall be formally identified and tracked through resolu-tion.

2.3.2 Vice President - Nuclear Assurance The Vice President - Nuclear Assurance has overall responsibility for establishment of the Operational Quality Assurance Program. He also has overall responsibiliity for estab-lishment and management of the Nuclear Safety Assessment Department and the Quality Assurance Department, including Metnods/ Opera-tion / Audit Section. He shall provide periodic status reports to the Office of the President on the Quality Assurance Program.

2.3.3 Manaoer - Quality Assurance The Manager-Quality Assurance, has the direct responsibility for verifying the effective

, T implementation of the Quality Assurance Program. He shall establish and implement a

- formally documented and procedurally con-trolled program to evaluate and report to the Vice President - Nuclear Assurance on the adecuacy and continued effectiveness of the overall TMI Operational Quality Assurance Program. Reports of audits performed by the Quality Assurance Department or their agents, and ouality trend analyses based on nonconfor-mance and deficiency reports will provide the basis for this evaluation. Corrective action shall be implemented by responsible management as deemed appropriate when analyses reveal adverse cuality trends. These actions may involve specific actions to provide compliance with the Quality Assurance Program, and may include follow-up system attribute 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.

Tne Manager-Quality Assurance is responsible for the contents of Quality Assurance Plan and for ensuring that the Quality Assurance Plan

{}

l l II-13 Rev. 8 l

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is modified and updated as standards, regula-tion, reouirements and experience dictate.

Proposed revisions to the Plan may be suggested by GPU Nuclear Corporation personnel by submitting the reouest, in writing, to the Manager-Quality Assurance for review and action. The Manager-Quality Assurance is responsible for the monitoring, surveillance and auditing of Quality Assurance Program implementation.

He is also responsible to provide the reouired training and oualification of Quality Assurance Department personnel.

2.3.4 Manager - Engineering & Design The Manager of Engineering & Design is respon-sible for 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 safety.

2.3.5 GPU Nuclear Corporation - Management

-() Management personnel in each department are responsible for Quality Assurance Program implementation by their department or groups.

They are further responsible for development of procedures, for scope of involvement, for activities important to safety, and for training and indoctrination of 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 Station which are covered under the scope of this Quality Assurance Program shall be subject, when specified in procurement documents, to review and acceptance by the Quality Assurance Department prior to the commencement of any important to safety activity.

2.4 Resolution of Disputes Resolution of disputes involving ouality, arising from a dif ference of opinion between 11-14 Rev. 8

J i

l (j.

'N QA/QC personnel ano other organization (engi-neering, procurement, manuf acturing, construc-tion, operation, maintenance, etc.) personnel shall, if possible, be accomplished at tne level such disputes occur. If this is not possible the difference of opinion snall be escalated through supervisory / management levels until resolution is achieved.

i The Manager - Quality Assurance snall make tne decision on matters concerning inspection and j acceptance to established reouirements. The Vice President - Tecnnical Functions shall make the decision on matters concerning interpretation of technical recuirements or

design changes.

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, - _ . -_ _ -_- - ~- _

() 3.0 Control of Documents and Records 3.1 Instructions, Procedures, Drawings ano Policies 3.1.1 Policy Tne TMI Quality Assuranc6 Program recuires tnat activities important to safety be pre-scribed by documented procedures, instruc-tions, and/or drawings and that these cuality-a f fecting activities be accomplished in accordance with these documents. All user personnel must be indoctrinated to the above prior to implementation.

3.1.2 Recuirements Procedures, instructions drawings, and/or policies which prescribe the performance of activities important to safety shall comply with recuirements of this Plan. To accomplish this these documents shall:

a. Include cuantitative (suen as dimen-sions, tolerances, and operating g-~ limits) and oualitative (such as work-( manship samples) acceptance criteria sufficient for determining that important activities have been satisfactorily accomplished.

b. Recuire approval of responsible personnel prior to the initiation of the cuality-a f fecting activity.

c. Describe the action to be accomplished.

d. De fine the responsibilities and author-ities of personnel performing the activity,

e. Describe interfaces with other company elements or otner organizations,

f. Be distributed in a controlled manner to preclude the use of obsolete docu-ments.

g. Be distributed with sufficient con-trolled copies to assure availability to responsible personnel.

Q III-l Rev. 8 l

l

() Appendix B identifies organiza'.ional respons-ibilities for tne preparation, review, ap-proval, concurronce and issuance of documents important to su ety.

3.1.3 Responsibilities 3.1.3.1 Department Managers The Manager of each department performing activities important to safety is responsible for the preparation, approval and imple-mentation of procedures, instructions anc/or drawings necessary to effectively implement the Quality Assurance Plan. He is responsiole to assure that provisions are mace for inter-face controls for internal and external lines of communications among participating organ-izations and technical disciplines. Adoition-ally, he is responsible to insure that the procedures reference the documents useo in their preparation and the extent to which the procedures meet the reouirements of the re fe rences.

3.1.3.2 Quality Assurance Department The QAD shall review those administrative pol-icies, procecures, instructions and/or draw-ings whien delineate the methods of complying with the recuirements of this Plan.

Selected vendor Quality Assurance Plans /

Manuals, special process procedures, and in-spection and test procedures shall be reviewed and approved by QAD prior to releasing the

. vendor to implement such documents. Selectec contractor Quality Assurance Plans / Manuals, work plans, drawings, instructions and pro-cedures shall be reviewed and approved oy QAD prior to releasing the contractor to start work. Compliance shall be verified by audit, surveillance and inspection programs.

3.1.3.4 External Organizations Those activities important to safety which are performed by contractors, agents, or vendors shall be delineated by documented, approved, and controlled procedures, instructions or drawings.

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III-2 Rev. 8 l

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( 3.2 Document Control 3.2.1 Policy Measures shall be established and documented to control the issuance of documents, sucn as program documents, design documents, instruc-tions, procedures, and drawings, including changes thereto, which prescribe activities as defined in Section 2.0 of this Plan. These measures shall assure tnat cocuments, includ-ing changes, are reviewed for adeouacy and approved for release by authorized personnel and are distributed to, and used at, the 10-cation where tne prescribed activity is per-formed.

3.2.2 Recuirements Written document control procedures shall be established to provide for control of the fol-lowing documents as a minimum:

j a. As-built Drawings

' b. Quality Assurance Plans / Manuals, and 1

Procedures

c. Operating Procedures & Instructions

d. Maintenance Procedures & Instructions

e. Design Documents (e.g., calculations, drawings, specifications, analyses) including documents related to computer codes.

f. Manufacturing, Construction and Instal-lation Drawings

g. Manufacturing, Construction Modifi- I cation, Installation, Test, and Inspec-tion Procedures and Instructions

h. Procurement Documents

1. FSAR and Related Design Criteria Docu-ments J. Nonconformance Reports f) k. Desi 0 n Change Documents III-3 Rev. 8

4 4

() 1. Test Specifications

m. Operating and Special Orders

n. Eculpment & Material Control Procedures

o. Refueling Procedures

p. QCL

o. Topical Reports All procedures established for document con-trol shall meet the following recuirements:

a. Review, approval and issuance criteria for documents and their revisions shall be specified to assure adeouate tech-nical and ouality recuirements are met prior to issue.

b. The organizations or positions re-sponsible for reviewing, approving and issuing documents and their revision snall be specified.

i

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c. Changes must be documented ano approved prior to being implemented,

d. Revisions shall be reviewed and ap-proved by the same organizations that performed the original review and ap-proval or by organizations designated by the originating organizations.

e. Document distribution must be suf-ficient to assure that the documents are readily available at convenient locations to plant personnel prior to commencement of work.

f. Document transmittal and maintenance measures shall be incorporated in docu-ment control systems to prevent in-advertent use of voided, superseded or ,

obsolete documents. Holders of con- l trolled documents are responsible for l maintaining their asrigned copies 1.9 3 I current status. Documents distrC ofe.*

for information only will not be ene sidered a controlled copy, and, 3, s such, must be clearly marked and will III-4 Rev, 8 j l

_1

I not be used in performing an activity important to safety since they will not ,

be maintained current. Exceptions to {

this recuirement must be approved, in writing, by QAD.

g. Master lists or eaulvalents will be established and maintained to identify the current revision number of instruc-tions, procedures, specifications, l drawings, and procurement documents.

This list will be distributed to pre-oetermined responsible personnel to preclude the use of superceded docu-ments.

3.2.3 Responsibilities 3.2.3.1 Vice President - Administration Responsible via the Manager Management Services to approve the GPU Nuclear Corporation procedures for off-site document control.

Vice President - THI Unit 1

() 3.2.3.2 Responsible via the Manager - Administration and Services for implementation of the occu-ment control system for all instructions, pro-cedures, drawings and otner controlled docu-ments prepared for TMI in administration, operation, testing, maintenance, and modifi-cation of structures, systems and components important to safety.

3.2.3.3 Vice President - Nuclear Assurance Responsible via tne Manager - Quality Assurance for the review and approval of docu-ment control procedures for cuality assurance reouirements and document control measures; to evaluate the document control system ef-fectiveness through review and audit.

3.2.3.4 All Functional Managers Responsible to ensure that documents are available when reouired; to properly review -

and approve documents such as procedures, instructions, specifications, drawings, etc.

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to ensure that changes to documents are reviewed ano approved by the same organization that performed the original review and approval of the document; to ensure that approved changes are promptly transmitted for incorporation into documents; to ensure that obsolete or superseded documents are eliminated from use.

3.2.3.5 External Organizations External organization QA programs shall be reviewed to assure compliance with the re-ouirements of this section.

3.3 Quality Assurance Records 3.3.1 Policy Quality Assurance records for items and ac-

' tivities covered under the scope of the TMI QA Program shall be identified, documented, re-viewed, retained, and retrievable. These reouirements are imposed on all organizations performing activities important to safety.

O Quality Assurance record systems shall be described and controlled by approved written procedures and instructions.

, 3.3.2 Reauirements The procedures established for the generation, collection, storage, maintenance, and re-trieval of TMI Quality Assurance records shall meet the following minimum reouirements:

a. Design specifications, procurement doc-uments, test orocedures, and opera-tional procedures shall specify the records to be generated, supplied and maintained by or for the owner.

Typical records to be specified include inspection and verification procedures (exclude completed checklists when re-sults are documented in a separate report), results of reviews, in.

spections, tests, audits, and material analysis; monitoring of work per-formance; cualification of personnel, -

procedures, and eauipment; and other III-6 Rev. 8

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() documentation such as calculations, design verifications, drawings, speci-fications, procurement documents, cali-bration procedures and reports; non-conformance reports; and corrective action re~ ports.

D. Sufficient records and documentation shall be aintained to provide evidence of the c ality of items or activities important to safety. Inspection and test records shall contain the fol-lowing wnere applicable:

1. A description of the type of observation.

2. The date and results of the inspection or test.

3. Identification of any conditions adverse to cuality.

4. Inspector or data recorder identification.

'() 5. Evidence as to the acceptability of tne results.

6. Action taken to resolve any dis-crepancies noted.

c. Documented and approved measures shall be established for complying with the reauirements of codes, standards, and procurement documents regarding record transmittal, retention, and maintenance subsecuent to completion of work,

d. Record storage facilities snall be established and utilized to prevent destruction of auality records by fire, flooding, theft and deterioration by environmental conditions such as temperature or humidity in compliance with the standards, codes and regu-latory guides endorsed in Appendix C of tnis Plan.

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() 3.3.3 Responsibilities Vice President - Nuclear Assurance 3.3.3.1

a. Responsible via the Manager - Quality Assurance for reviewing proceoures for GPU Nuclear departments who perform activities related to the maintenance of Quality Assurance records; estab-lishing a program for the identi-fication, storage, retrieval, and maintenance of Quality Assurance records generated by QAD, until they are turned over for storage, and performing planned and periodic audits to verify adecuacy and implementation of Quality Assurance records recuire-ments by both internal TMI organ-izations and external organizations.

3.3.3.2 Vice President - TMI Unit 1

a. Responsible via Manager - Adminis-tration and Services for the collec-tion, maintenance, and storage of ,

records at the plant site in accordance

() with approved written procedures which conform to the requirements and policy of this section.

b. Responsible via the Manager -

Administration and Services for provioing proceoures whicn ensure the i maintenance of records sufficient to I furnish objective evidence that activ-ities a f fecting auality are in compli-ance with the standards, codes ano reg-ulatory guides endorsed in Appendix C of the TMI Quality Assurance Plan.

3.3.3.3 Vice President - Administration

a. Responsible via the Manager -

Management Services for the collection, maintenance, a..d storage of records at the home office in accordance with ,

approved written procedures which I conform to the requirements and policy ,

of this section. l 1

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b. Responsible via the Manager -

Management Services for providing pro-cedures which ensure the maintenance of records sufficient to furnish objective evidence that activities affecting ouality are in compliance with the standards, codes and regulatory guides endorsed in Appendix C of the THI Quality Assurance Plan.

3.3.3.4 External Organizations Records generated by contractors shall be controlled according to contractor procecures

• until such time as they are turneo over to the QAD for review, acceptance, and transmittal to the permanent records file. Purchaseo eculp-ment records shall be retained oy the vendor until the eculpment is released for shipment.

When reouired by the procurement documents, contractors and vendors shall establish procedures to control Quelity Assurance records. Implementation of these procedures shall be assured by performance of source surveillance and audits performed by QAD.

Records to be submitted with the shipment or retained by the vendor will be specifically identified in procurement documents. These records will be reviewed as necessary by QAD to provide the reouired degree of confidence in the adecuacy of compliance of the vendor with the recuirements of this section.

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4.0 Design Control 4.1 Policg Measures shall be established and documented to assure that the applicable specified design recuirements, such as design bases, regulatory reouirements, codes and standards are cor-rectly translated into specifications, draw-ings, procedures or instructions. These measures shall include provisions to assure that appropriate cuality standards are speci-fled and inciaded or referenced in design documents for design of systems ano struc-tures; external design of systems ano structures ; ano assessment of damage.

4.2 Reouirements 4.2.1 Design control measures recuire that:

4.2.1.1 The organizational structure be oefined, and authority and responsibility of personnel in-volved in preparing, reviewing, approving and verifying design documents be delineated.

4.2.1.2 The FSAR design bases, FSAR safety analysis,

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design regulations, codes and standards and Plant Technical Specifications be adhered to in design work, except where the necessary operating license amendment is obtained.

4.2.1.3 The materials, parts and processes selected by design are reviewed to assure that they are suitable for the intended application, incluo-ing compatibility of materials, accessibility for inservice inspection, maintenance and re-pair, associated computer programs, and ouali-ty standards. The review will also evaluate suitability with regard to human factors which may effect safe operation.

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4.2.1.4 Internal and external design interface con-trols, procedures, and lines of communication among participating design organizations ano across technical disciplines are established and descrioed for the preparation, review, approval, release, distribution, and revision of documents involving design interf aces.

4.2.1.5 Errors and deficiencies in approved design documents, including design methods (such as computer codes) that could adversely affect items and activities important to safety shall be documented, and action shall be taken to assure that these errors or deficiencies are corrected.

4.2.1.6 Deviations in specified Quality standards shall be identified and procedures shall be established to assure their resolution and control.

4.2.1.7 Review of standard "off the shelf" commercial materials, parts, and equipment for suita-bility of application witn structures, sys-tems, and components important to safety shall oe conducted prior to selection.

Design verification methods (design review, 4.2.1.8 alternate calculations or qualification test-ing) shall be established.

4.2.1.9 Design verification procedures ; hall be estab-lished which assure the following:

a. The verifier is cualified and is not directly responsible for the design.  ;

b. Verification shall be complete prior to f relying upon the component, system, or '

structure to perform its function during plant operations. Turnover of Systems to Operations recuire that applicable design verification be completed.

c. Design documents subject to procedural control include, but are not limited to, specifications, calculations, com-puter programs, system descriptions, and drawings, including flow dizgrams, piping and instrument systems for major facilities, site arrangements, and

,O equipment locations.

IV-2 Rev. 8

d. The responsibilities of tne verifier, the areas and features to be verifiec, the pertinent considerations to be verified, and the extent of documenta-tion shall be identified in procedures.

4.2.1.10 When verifications are to be accomplisheo by test:

a. Prototype, component or feature testing shall be performed as early as possible prior to installation of plant equip-ment', or prior to the point when the installation would Decome irreversible.

b. Verification by test shall De performec under conditions that simulate the most adverse design conditions as determineo by analysis.

4.1.2.11 Procedures shall be establisned to assure tiat computer codes are verified prior to use.

4.1.2.12 Design and specification changes, including field changes, will be subject to design con-l trol measures commensurate with those appliec

- to the most recently verified design. Design changes shall be reviewed and approved by tne organization responsible for the original de-sign or by another organization with compar-able expertise designated to review and ap-prove changes.

4.2.1.13 Measures shall be provided to assure that re-sponsible plant personnel are maoe aware of design chances and/or modifications, whicn may aifsct ine performance of their duties.

4.3 Responsibilities l 4.3.1 Vice President - TMI Unit 1 The Vice President - TMI Unit 1 is responsiDie through the Plant Engineering Department for the development and implementation of design control measures related to routine mainte-nance and minor plant modifications.

4.3.2 Vice President - Technical Functions The Vice President - Technical Functions is j() 4.3.2.1 responsible through the Project Engineering IV-3 Rev. 8

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( Manager for the design control measures re-latea to engineering tasks outside of the nor-mal scope of Plant Engineering activities.

4.3.2.2 The Vice President - Technical Functions is responsible tnrough the Systems Engineering Department for the development ano implementa-tion of aesign control measures related to conceptual and analytical engineering support and nuclear fuel-related engineering activi- .

ties which are important to safety.  !

4.3.2.3 The Vice President - Technical Functions is responsible through the Engineering ano Design  ;

i Deoartment for the classification of items ano activities important to safety and for the preparation and maintenance of the Quality Classification List (QCL). The department is also responsible for implementation of tne design control program for tneir activities j which are important to safety. j 4.3.3 Vice President - Nuclear Assurance The Vice President - Nuclear Assurance is responsible via Manager Quality Assurance for O- providing Quality Assurance review and concur-rence with design and engineering documents i relating to items and activities important to safety to assure that appropriate cuality recuirements have been included. In addition, ,

i Quality Assurance will perform planned and periodic audits of all responsible design or-ganizations to verify implementation of design control measures. <

l 4.3.4 Other Design Organizations All design organizations performing design activities for TMI shall have cuality programs which include design control provisions eoul-valent to tnose provided in the TMI Quality Assurance Program.

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f 5.0 Procurement and Material Control 5.1 Control of Procurement 5.1.1 Policy Procurement of material, eauipment and 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 doc-uments and shall provide measures to comply with applicable regulatory recuirements. Ap-propriate measures shall be establisnea to evaluate procurement sources, monitor the ac-tivities of consultants, venoors and contrac-tors, and confirm that purchased items and services conform to procurement document re-auirements. The programs of all participants shall be in accordance with the reauirements of the TMI Quality Assurance Program.

The general and specific recuirements for the Quality Assurance Program of all vendors and contractors, including their subvendors and O, subcontractors supplying material, eauipment, or services which are considered important to safety, shall be delineated by procurement documents. These cuality program reauirements shall be commensurate with the degree of com-plexity, the uniaueness, and the importance to safety of the items and services being per-formed.

Quality Assurance measures shall apply to the procurement of materials including spare parts, replacement parts, of -the-shelf items and consumables. Procuremen. of spare or re-placement parts for structures, systems, and components shall be subject to current Quality Assurance Program controls and to codes, stan-dards, and technical reauirements ecual to, or better than, original technical recuirements, or in accordance with an approved engineering document.

5.1.2 Recuirements

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1 5.1.2.1 Procurement Documents

) The requirements for tne preparation, review, approval and control of procurement documents shall be delineated in detailed proceoures.  ;

These procedures sna11 delineate reouirements l to asssure that procurement documents:

a. Specify cuality assurance reouirements  ;

commensurate with the recuirements of this QA Plan. l I

b. Recuire applicable cuality program re- l Quirements to be passed on to suo-vendors and suocontractors.

c. Specify or reference design bases teen-nical reouirements, including applic- ,

able reguitory recuirements, material, l and component identification reouire-ments, drawings, specifications, cooes and standards, test and inspection re- i 1

ouirements, and special process in-structions.

Identify the documentation to be pre-4 d.

pared, maintained, and submitted for review, approval and record information l

_ ) as applicable. l I

e. Include an identification of those items and activities important to sa fe ty .

f. Identify those records which vendors or I

contractors shall ratain, maintain, anc control; and those which vendors or contractors snall deliver prior to use or installation of the item.

g. Include right of access to vendors or contractors and their subtier vendor and contractor facilities and recorde for source inspection and/or audit.

h. For spare or replacement parts, contain f technical reouirements at least eoui- l valent to those used for tne original procurement. The original procurement document may be used as the tecnnical l reouirements for purchase of spare or replacement parts.

V-2 Rev. 8 I

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Include the provision that suppliers

( i.

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 snali assure the inclusion of the applicable tech-nical, quality, and administrative require-ments in procurement documents prior to their use.

Review of procurement documents shall De docu-mented to provide objective evidence of tneir approval prior to their release.

5.1.2.2 Qualification and selection of External Organizations Evaluations of prospective suppliers shall be conducted and documented to demonstrate Quali-fications Dased upon one or more of the fol-lowing criteria:

a. Review of performance histories whicn O provide records of suppliers previous capability to provide similar products or services.

b. Review of the external organization's capability to comply with the criteria of 10 CFR 50, Appendix B, applicaole to the items or services to De supplied and other standards,

c. A pre-award survey of external organization's facilities and Quality Assurance program to determine nis capability to supply the items or services that meet the design and Quality requirements of the speci-fication.

Procedures shall be established to accomplish the evaluation and selection of external organizations. Contracts or purchase orders for material, equipment or services covered by the scope of the Quality Assurance Program shall be awarded either to:

1. External organizations wno have been l (-) qualified by the QAD as naving a Qual-l ity Assurance program commensurate witn the equipment or services to De pro-vided, or V-3 Rev. 8

N' 2. The external organization will be re-cuired, by procurement documents, to

, work under the dir..;t control of tne TMI Quality Assurai.ce Program. In these instances, the supplier will not be reouired to have a separate Quality assurance program.

When an external organization cuality program is recuired, it shall be reviewed and approved prior to initiation of the activity af fectea by their program.

5.1.2.3 Control of Manufacturing Process Measures shall be established to provide con-trol of manufacturing activities of vendors.

These methods shall be Thedescribed extent to in detailec which these written procedures.

specific controls will be applied to venoors will be described in individual vendor inspec-tion plans. A vendor inspection plan will be prepared for each major contract within tne scope of the TMI Quality Assurance Program.

The attributes of the manufacturing assurance

() program shall include:

a. Provisions for the review and approval of the vendor's drawings, Quality Assurance manual and selected manufac-turing and ouality procedures prior to fabrication. Vendors may not implement procedures until written notice of approval is received, if applicable,

b. Established vendor inspection plans that delineate, as recuired the hold and/or witness points in the manufac- )

turing process for specified review, inspection, verification and test.

c. Methods for resolution of nonconfor-mance where the vendor's suggested dis-position is "Use-as is" or " Repair".

Such nonconformances require approval O

s.

V-4 Rev. 8

by the responsible engineer and the concurrence of the responsible Quality Assurance organization. QAC will also

(% - provide followup of corrective action implementation.

d. Planned and systematic audit and sur-veillance of vendor cuality activities.

Scope of coverage and freauency snall be determineo by the criticality of tne furnisned items and the evaluated re-sults of vendor cualifications, includ-ing pre-award surveys and auality proc-edure reviews. Revisions to audit and surveillance plans snall be made as warranted by vendor performance,

e. Control of vendor document package in-cluding review for completeness and acceptability. Inadeauate records shall be sufficient cause to reject the items furnished due to their indeter-minate cuality status.

f. Assessments of vendor control of auali-ty snall be made at a freauency and depth commensurate with the importance, complexity and cuantity of the items furnished. Tne.e e assessments shall F}

k- utilize the cualitative and auantita-tive information provided by vendor noncompliance documents; surveillance, inspection and audit reports; and re- 4 ceiving inspection and test records.

g. Receiving inspection procedures assure that:

1. The material, component, or eauipment is clearly identifieo and that the identification and cuantity correspond to tne infor-mation on the snipping documents and ouality records.

2. The item's nandling and snipping, reauirements have been met by tne vendor and maintained by tne car-rier.

Rev. 8 v() V-5

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The item's Quality record package

( 3.

or compliance certificate is ccm-plete, and adequate.

4. Items delivered, which are not in compliance with requirements are documented in accordance with t".e nonconformance procedure, *29ged, segregated (if possiole), 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 Responsibilities 5.1.3.1 Vice President - Administration The Vice President - Administration is respon-sible through the Director - Materials Manage-

~

O ment Systems and Purchases ano the Director of Contracts for:

a. the administration and operation of procurement and warehousing activities associated with the operation of the TMI Nuclear Station,

b. the assurance that the technical and quality requirements, as established oy engineering, are incorporated into pro-curement documents without revision.

C. the assurance that the contractural, l

t legal and commercial requirements are incorporated into the procurement docu-ments in a manner which will enforce the technical or Quality requirements.

5.1.3.2 Vice President - Nuclear Assurance The Vice President - Nuclear Assurance is re-sponsible through the Manager - Quality Assur-i ance to:

a. Assure that QAD procedures for the con-l --(]) trol of purcnased equipment, material and services are established, approved, l implemented and effective.

l V-6 Rev. 8

b

( ,/ b. Approve all TMI procedures necessary for the control of purchased eculpment, material, and services within the scope of the TMI Quality Assurance Program,

c. Approve supplier Quality Assurance Programs to the extent reouired in the procurement documents.

d. Review and accept supplier record packages.

e. Establish and implement an adeouate program of source inspection, surveil-lance and receipt inspection to assure supplier compliance with contract re-ouirements.

f. Review and concur with the adecuacy of ouality recuirements to determine that they are correctly stated, inspectable and controllable, that tnere are ade-ouate accpetance/ rejection criteria and that the procurement documents have been processed in accordance with es-tablished reouirements.

5.1.3.3 Project Engineering Manager The Project Engineering Manager shall maintain a status reference of all documents recuiring approval and distribute such information as reouired.

5.2 Indentification and Control of Materials, Parts ano Components 5.2.1 Policy Measures shall be established to provide for the identification and control of materials, parts and components important to safety.

These measures shall assure that incorrect or V-7 Rev. 8  !

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nonconforming items are identified and con-trolled in order to prevent their inadvertant installation or use at TMI units. Wnere re-l

, cuired by design documents, the system establ-ished shall provide traceability of components from the receipt of material through fabrica- [

tion and testing. Verification shall include review of objective evidence of inspections iden-and tests which demonstrate tnat product tification and control is maintained at vari' ous stages of manufacture, installation, or erection. Identification reouirements snall be specified in the applicable design and pro-curement documents.

5.2.2 Recuirements

a. Identification and traceability re-ouirements shall be incluoed in speci-fications and orawings.

b. Material, parts, and components, in-cluding partially fabricated subassem-blies or subdivided materials shall be identified to preclude the use of in-correct or defective items.

O 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. Pnysical and Chemical Test Reports

5. Nonconformance Reports

6. Inspection Reports and Cnecklists

7. Storage Maintenance Instructions

8. NDE Reports i

9. Vendor Certificates of Compliance

( Rev. 8 V-8

d. The location and method of identifica-tion shall be specifiec so as not to affect the form, fit, function or cuality of the item being icentifiec.

e. Correct identification of materials, parts and components shall be verified prior to release for fabrication, snip-ping, installation, and testing,

f. Where physical identification is either impractical or insufficient, physical separation, procedural control, or other approved means may be employed.

g. A receipt inspection at the site ware-house verifies th3t identification for received items is complete and accom-panied by appropriate documentation.

5.2.3 Responsibilities 5.2.3.1 Project Engineering Manager The Project Engineering Manager is responsible for ensuring.that procurement documents O' contain appropriate requirements for the identification and control of meterials, parts, or components.

5.2.3.2 Vice President - Nuclear Assurance The Vice President - Nuclear Assurance is responsible through the Manager - Quality Assurance for:

a. Quality Assurance review and concur-rence of procedures for maintaining identification in accordance with the recuirements of this section.

b. Verification of identification during receipt inspection,

c. Monitoring and conducting inspections, surveillances and audits to verify con-formance to the recuirements of this section.

V-9 Rev. 8

l 6.0 Control of of Station Activities l

' l 6.1 Policy Station activities considered important to safety shall be conducted in accordance with i the requirements of this Plan. These activi-ties include design changes, procurement, fabrication, handling, shipping, storage, cleaning, erecting, installation, inspection, testing, operation, maintainance, repair, i refueling and modification.

6.2 Reouirements The Quality Assurance requirements for station activities are contained in tnis Plan and include compliance with applicaole USNRC Regu-latory Guides and ANSI Standards indicated in Appendix C. These requirements shall De im-plemented in appropriate THI procedures The require-governing station activities.

ments of the Plan apply to all organizations or positions performing functions which af-fect the Quality of structures, systems, com-ponents, or activities important to safety.

- 6.2.1 Details The following subsections discuss typical activities which are representative of the broad scope of administrative controls and ouality assurance requirements that are appli-cable to station activities. The organiza-tional structures and functional responsibi-lities governing station activities shall be structured so that attainment of Quality As-surance Plan objectives is accomplished oy those who have been assigned or delegated responsibility for performing the work; and verification of conformance to established requirements is accomplished by qualified personnel who do not have direct responsi-bility for performing or directly supervising the work. Quality Assurance Department acti-vities such as inspection, monitoring, sur-veillance, reviews and audits are performed to independently verify conformance to this plan, applicable station administration controls, and applicable regulatory and licensing com-mitments. These independent verifications are applied to station activities on a graded

])

VI-1 Rev. 8 i

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() .aporoach and to the extent necessary to pro-vide adequate confidence that structures, systems, components, and personnel perform satisfactorily to maintain the safety of the station. Station work functions such as rou-tine and abnormal operations, maintenance, repair or rework, in-service inspections, technical specification compliance, fuel handling, radwaste handling, radiation protec-tion, chemical analysis, housekeeping 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 controlled to an extent consistent with their importance to safety.

6.2.1.1 Control of Inspection A program for inspection of activities affect-ing ouality shall be estaolished 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 shall include the necessary inspection These requirements include requirements.

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 characteristics and activities to be inspected,

b. Inspection methods,

c. Identification of organization respon-sible for performing the i.ispection.

d. Acceptance and rejection criteria.

e- Identification of applicable revisions of required procedures, drawings and specifications.

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VI-2 Rev. 8

Documentation of inspection results

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f.

incluaing identification of tne in-spector.

g. Listing of necessary measuring ano test ecuipment including tneir accuracy requirements.

Inspectors (including NDE personnel) shall oe cualified in accordance with applicaole coces, standards and TMI training programs ano tneir qualification and certification snall oe kept current and cocumented.

Individuals performing inspections snall be other than those who performeo or airectly supervised the activity oeing inspecteo 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 e~ of the inspection activity. Inspection of

( )s activities as defined in ANSI N45.2.lO may be

- conducted by second line supervisory personnel or by other Qualified personnel not assigned first line supervisory responsibility for the conduct of work. These inspections, i.e.,

those performed by individuais not assigned first line supervisory responsiollity, are not intended to dilute or replace the clear re-sponsibility of first line supervisors for the cuality of work performeo under their super-vision. When inspections associatec with normal operations of the plant (such as rou-tine maintenance, surveillance and tests) are performeo by individuals other than tnose wno performed or directly supervised the work, out are witnin the same group, tne following con-trols shall De met:

a. The Quality o f tne work can ce demon-strated through a functional test wnen the activity involves creacning a pres-sure retaining item.

9 . VI-3 Rev. 8

O. The cualification criteria for inspec-

[o)

' tion personnel are revieweo and founo

,/ acceptacle by the Quality Assurance organization prior to initiating tne

- inspection, wor < authorization documents relating to work considered important to safety snali be reviewed and concurred witn oy Quality As-surance Department personnel to cetermine tne need for: a) inspection, 0) identification of insoection organization, c) ice tificati;n of inspection witness and nolo points, d) docu-menting inspection results.

When hold points have oeen estaclishec, either contractually oy procurement or internally oy 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 oe oy the same method ano to the same criteria as the original inspec-tion or by an approved, documented, engi-neering and QA slternate. Where verification of inspection is being performed on previously

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\_ accepted lots, sampling inspection shall be

- representative and only to the extent neces-sary to assure adequacy of control. The sampling plan shall be determined oy Quality Assurance. Inspection personnel shall be provided with suitaole eculpment and tools, whjch are callorated as necessary, and con-trolled to assure that accuracy reouirements are satisfied and that inspections are complete.

Inspection data and r( sults shall De evaluatec by designated personnel to assure that the inspection oojectives have been met and tnat items requiring action or follow-up are ioen-tified and documented.

Records shall De kept in sufficient detail to provide adeouate confirmation of an inspection program.

6.2.1.2 Plant GA Monitor. 3 A program for QA Monitoring of activities affecting important to safety materials, parts, components or processes shall De estao-A lisned and executed oy Quality Assurance.

Vl-4 Rev. 8

Monitoring is used to establish adeouate confidence levels that important to safety

' activities are being performed in accorcance with Quality Assurance Program recuirements and plant administrative controls. Monitoring will be performed on a graded approach and the degree of monitoring performed shall be 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 they can readily verify compliance o f the activity being performed.

Monitoring reports shall contain as a minimum the following:

a. Identification of activity being moni-tored including specific reference to O the program or procedural reauirements governing the activity.

b. Indication of compliance,

c. Identification of monitor 1 1

d. Appropriate distribution to supervisory i or managerial personnel tnat have l responsibility for the performance of 1 the activity.

e. Identification of each nonconformance document when such nonconformances exist and are identified as a result of the monitoring.

Records shall be kept in sufficient detail to provide adeouate confirmation of a monitoring program.

VI-5 Rev. 8 l

Control of Special Processes

/~) 6.2.1.3

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Measures shall oe estaolisneo ano documenteo to assure tnat special processes are accom-plished under controllea conoitions in accordance with applicaole codes, stancaros, applications criteria, and otner special reauirements including the use of avalifiec personnel anc proceoures. Special processes are tnose that require interim in process controls in addition to final inspection to assure auality including, but not limitea to, suen processes as welding, heat treating, chemical cleaning, and nondestructive examina-tion. Proceoures for special processes snali ce estaolished to meet the recuirements or applicaole codes and stancards, where appli-caole, or to meet the reauirements of special process specifications whien may oe procucea 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 oy qualified personnel. Procedures, equipment, and personnel performing special processes shall be avalified in accordance with appli-(~}

'v /

cable codes, stancards, and specifications.

s Organizational responsibilities snall be delineated for the cualification of special processes, eauipment and personnel. Qualifi-cation records of personnel equipment and procedures associated with special processes shall be estaolished, maintained and kept current. For special processes not covereo oy the existing codes or standaros, or when item auality reauirements exceed the requirements of estaolished codes or standards, the neces-sary aualifications of personnel, procedures and equipment shall oe defined.

6.2.1.4 Test Control A documented test program snall be estaolisnea to assure that all testing reaulred to demon-strate that the structure, system or component considered important to safety will perform satisfactorily in service. The tests shall De performed in accordance witn written, ap-proved, and controlleo test procedures whien incorporate or reference the requirements ano VI-6 Rev. 8 l l l

1

i acceptance standards contained in the appil-() cable oesign documents. The extent of testing shall De cased on the complexity of Testing,the modi-fication, replacement, or repair.

including proof tests prior to installation and preoperational tests, necessary to demon-strate that structures, systems ano components will perform satisfactorily in service, snall oe accomplished in accordance with written approved procedures. These proCeoures shall be based on requirements and acceptance limits contained in applicaole design ano procurement cocuments. These test procecures or instruc-tions shall provide for the following as required:

a. A description of the test oojective.

D. Instructions for performing the test, including caution or safety notes in

, sufficient detail to avoid operator interpretation.

c. Test prerecuisites such as calibrated instrumentation, adequate test equip-ment and instrumentation including accuracy requirements, completeness of

() item to be tested, suitable ano con-trolled environmental conditions, and

, trained oualified and licensed or certified personnel.

d. Provisions for data collection and storage.

e. Acceptance and rejection criteria as i

specified in design and procurement documents,

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 oeen met.

h. Mandatory hold or witness points for inspection'by THI Quality Assurance and/or other designated personnel.

1. Provisiuns for control of jumpers, lifted leads and juriscictional or safety tags.

O[)

VI-7 Rev. 8

J. Provisions for returning a system to normal configuration upon completion of the test, including verification.

Test results shall be documented, evaluated, and their acceptability determined oy a re-sponsible individual or group.

The test program snall cover all reouired 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 reouired rella-bility of systems important to safety O- 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 changes.

Tests performed following plant repairs or replace..ents shall be conducted in accordance with the original design and testing reouire-ments or engineering approved, documented alternatives. Testing shall be sufficient to confirm that the changes reasonably produce expected results and that the change does not reduce safety of operations.

6.2.1.5 Control of Measuring and Test Eculpment Measures shall be established to assure that tools, gauges, instruments, and other measuring and testing devices used in activi-ties af fecting the function or ouality of structures, systems, and components covered under the, scope of the TMI Quality Assurance Program be properly controlled, calibrated, f<-)

l VI-8 Rev. 8

and adjusted at specified periods to maintain s accuracy witnin specified limits. Additional

- measures shall be estaolisned to ensure tne range, type and accuracy of test equipment conforms to tne specified testing reouirements.

Requirements for each control program shall include inspection and verification of accuracy upon receipt of equipment, identifi-cation of all gauges and instruments, calibra-tion ano scheduleo recall for calioration and traceability to an accepted Standard. Tnese activities shall be suoject to QAD monitoring and auditing. Procedures snall be estaolished to implement the following requirements:

a. To estaolish the calibration technicue ano frecuency maintenance, and control of all measuring and test equipment which are used in the measurement, inspection, ano monitoring of compo-nents, systems, ar.d structures coverec under the scope of the TMI Quality Assurance Program (instruments, tools, gauges, fixtures, reference and trans-fer standards, and nondestructive examination eauipment).

(~}

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-- b. The identification of measuring and  !

test equipment traceable to tne cali-bration test data.

c. Installed operations measuring and test i eauipment requiring calibration shall  !

l be laoelled, tagged or otherwise con-trolled in accorcance with written, f approved procedures to assure that i approved callDration intervals are not I

exceeded. Portable measuring and test equipment may be similarly controlled- I I

but shall, as a minimum, De clearly labelled to indicate the date on whien I the current calioration expires. i Portable measuring and test equipment that has exceeded the approveo calibra-tion interval shall not be used for measurements or tests. l

d. Establish Calibration frequency for measuring and test eauipment based on I recuired accuracy, purpose, degree of

, t Rev. 8 VI-9

usage, stooitity characteristics, ano/

f or any other condition wnicn may affect

((py the measurement. A calioration recall system shall be implemented to assure

. recalibration within the recuired period for each ciece of measuring anc

, test couipment covered under the scope of this program.

' e. Methods for determining the validity of previous inspections performec when the measuring and test eculpment is found to oe out of calloration. Inspections or tests are repeated on items oeter-mineo to be suspect. Such determina-tion is to be documented in suitaole form. If any calibration, testing or .

'; measuring device is consistently founo to oe out of calioration, it shall be repaired or replaced.

f. Calibration shall oe against standaros that have an accuracy of at least four

times the recuired accuracy of the ecuipment being calibrated, wnen tnis is not possible, standards shall have t

an accuracy that assures the equipment being calibrated will ce within O-required tolerance and that the basis of acceptance is documented and authorized oy the supervisor of the callorating organization.

g. A status of all measuring and test eculpment under the calloration program is to be maintainea.

n. Utilization of reference and transfer standards traceaole to nationally re-cognized standards. Where national standards do not exist, provisions shall be estaolished to occument the basis for tne calloration.

i. NDE equipment, such as ultrasonic eauipment, snail ce controlled and J calibrated in accordance witn the ASME code governing its use.

6.2.1.6 Handling, Storboe and Shipping Measures shall 'be estaolisned and documented to control handling, storage, and snipping, g'} Rev. 8

# VI-lO f

. , - - , - - , . . - - ,_- -.c s,,---, -

s including cleaning, packaging, and preserva-tion of items important to safety in accor-j',)

( dance witn estao11sned instructions, proce-dures, and drawings to prevent damage, deterioration or loss.

Organizations performing special nanclir 3, preservation, storage, cleaning, packag.ng, and snipping activities shall do so in accordance witn predetermined work anc inspection procedures or instructions utilizing suitaoly 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 ey environmental conditions sucn as temperature or humidity. These procecures shall include an assessment of, but not limited to, the following:

a. Packaging and preservation procedures to provice assurance of adequate pro-tection against corrosion, contsmina-tion, physical camage or any ef fect

( i which would lower the avality of the

\ 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 specifieo 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 verification and documentation require-ments shall be specified in the proce-dures.

c. Detailed handling procedures to be provided for all items that require special handling. Special handling tools and equipment shall oe provided and controlled to en;ure safe and ade-Quate handling. These tools ano equip-ment shall oe maintained, inspecteo and VI-11 Rev. 8

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Gi

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tested in accordance with written procedures at established intervals to ensure their reliability and availa-bility for use.

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 shall be performed and documented to verify compliance with storage procedures.

Release of items for installati.9 shall also be procedurally controlled.

e. Procedures to be provided to assure that proper marking and labeling of items and containers is accomplisned to provide identification and necessary instructions during packaging, shipment and storage.

f. Procedures for documenting aad report-ing nonconformance to handling, and shipping reouirements. _ _ , .

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Provisions for the storage of chemi-cals, reagents, lubricants and other consumable materials which will be used in conjunction with systems which are important to safety.

h. Provisions for " Limited Life" reouire-ments (including " Shelf Life" and

" Service Life" for applicable materials).

6.2.1.7 Inspection, Test, and Operating Status Measures shall be established and documented to ensure that the reouired inspections and tests are per formed- 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 approveo procedures. These proce-dures shall include the use of appropriate tags, markings, lists, logs, diagrams, or other suitable means, to assure that required 7-}

V VI-12 Rev. 8

/

inspections and tests are satisfactorily completed to prevent inaovertent oypassing of Y/

recuired inspections and tests and to prevent inadverent operation.

The requirements for an acceptable inspection, test and operating status program for struc-tures, systems, and components througnout faorication, installation, test and operation include:

a. Design and Quality documents which address the requirements for the iden-tification of inspection, test, and operating status of structures, systems and components.

D. Procedures which include controls for the application and removal of inspec-tion and welding stamps, and other

~

status indicators such as tags, markings, labels, and stamps.

c. Bypassing or altering the seauence of required inspections, tests or other critical operations procedurally con-()

trolled by Engineering procedures witn concurrence by the appropriate Quality Where necessary to organization.

I preclude inadvertent bypassing of reauired inspections and tests, the I procedures shall provide for the iden-f tification of items which have passed such inspections and test.

d. In cases where documentary evidence is not availaole to confirm that an item has passed required inspections and tests, that item shall oe considered nonconforming until such evidence oe-comes availaole. Affected systems shall also oe considered to De inoperaole and reliance snall not ce placed on such systems to fulfill their intended safety functions.

c. Procedures to oe provided to require 1 identification of the operating status of systems, components, controls, or support equipment in order to prevent inadvertent or unautnorized operation.

These procedures snall require control es  ;

[)

measures such as locking or tagging to s-VI-13 Rev. 8 l

l 1

secure ano identify eouipment in a

(^l controlled status. Incependent verifi-cation shall be reouired,necessary where appro-N' priate, to ensure that measures, sucn as tagging equipment, have been implemented correctly,

f. Temporary modifications shall be con-trolled by approved procedures which include a reouirement for inoependent verification. A log shall be main-tained of the current status of such temporary modification.

g. Nonconforming services ano inoperative or malfunctioning structures, system, components or materials shall be loen-tified, documented and controlled in accordance with tne recuirements of this Plan.

6.2.1.8 Housekeecino and Cleanliness Housekeeping practices on a regularly sche-duled basis shall ce utilizea recognizing tne reouirements for the control of radiation

(; zones and the control of work activities, conditions ano environments that can affect

\_/ the cuality of important parts of tne nuclear plant. Housekeeping encompasses all activi-ties related to the control of cleanliness of facilities, materials, equipment fire preven-tion and protection including disposal of combustible material ano debris and control of accesses to areas, protection of equipment, radioactive contamination control and storage Housekeeping of solid radioactive waste.

practices shall assure that only proper materials, equipment processes, and procedures are utilized and that the cuality of the item is not degraded as a result o f nousekeeping practices or techniques. During maintenance activities, certain portions of safety-related systems may be subject to potential contamina-tion with foreign materials. To prevent sucn contamination, control measures, including measures for access control, shall be estab-lished. Additionally, immediately prior to closure, an inspection shall be conducted Specialand documented to ensure cleanliness.

Rev. 8 VI-14

nousekeeping considerations snall be mace for O'i maintenance of radioactively contaminated

,- systems for components.

6.2.1.9 Eaulpment Control Permission to release installed equipment or systems for maintenance snall be granteo by designated NRC SRO licensed operations personnel. Procedures snall be provided for control of eouipment, as necessary, to maintain personnel and reactor safety, to avoid unautnorized operation of equipment, and to assure that operational eculpment is a ready status. Tnese procedures shall recuire:

a. Control measures such as locking or tagging or secure and identify eculp-ment in a controlled status,

b. Independent verifications, wnere appro-priate, to ensure that necessary mea-sures, such as tagging eculpment, has been implemented correctly.

c. Control measures for tenporary modifi-cations, such as temporary by-pass C) lines, electrical jumpers, lifted elec-

' trical leads, and temporary trip point settings. Included shall be a reouire-ment for independent verification. (A log shall be maintained of tne current status of temporary modifications.)

d. Control of inspection and test status on individual items by the use of mark'ings such as stamps, tags, laoels, routing cards or other suitable means.

e. When eouipment is ready to be returneo to service, operating personnel shall place the ecuipment in operation and verify and document its functional acceptability.

f. When traceability is reouired as deter- l mined by Engineering and Quality t Assurance, the components /eoulpment shall be ide:'.tified in such a manner that they can be traced to its asso-ciated documentation.

D VI-15 Rev. 8 l

l l

6.2.1.10 Control of Construction, Maintenance (Preventive / Corrective) ano Mooifications g'^

L Construction, maintenance or modifications

' which has tne potential to affect the func-tioning of structures, systems or cc noonents important to safety shall be perfo ed in a manner to ensure cuality at least .c_ivalent to that specified in original design bases and requirements, materials specifications and inspection reouirements. 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 eculpment shall be preplanned and written proce-performed in accordance with dures, documented instructions or drawings appropriate to the circumstances which conform to applicable codes, standards, specifica-Skills normally tions, and criteria.

possessed by cualified maintenance personnel may not recuire detailed step-by-step delinea-tions in a written procedure but are subject to general adminstrative procedural controls that govern or define the following areas:

Methods for obtaining permissio'n and

()

a.

clearance for operation personnel to work and for logging such work.

l

b. Factors to be taken into account, including tne necessity of maintaining I occupational radiation exposure as low as is reasonably achievable (ALARA).

c. Method for identification of what pro-cedural coverage is necessary for the maintenance, construction and mcdifica-tion activity.

d. Considerations for system /eoulpment cleaniness control.

e. Method for identification of post main-tenance, construction or modification, testing, including system /eoulpment functional capability to meet opera-tional reouirements in all respects, Rev. 8 l'D A_,/

VI-16 l

l 1

l i

() f. Method for ensuring that maintenance, contruction or modification activities, j performed either on-site or off-site, are properly reviewed.

l The following type of activities are among j those that may not reouire detailed step-by-step written procedures: I

a. Gaskti :stlacement

b. Trouble shooting electrical circuits

c. Changing chart or drive speed gears or slide wires on recorder.

Means for assuring ouality of maintenance, modifications or construction activities (for example, inspections, measurements, tests, welding, heat treatment, cleaning, nondestruc- i tive examination and worker cualifications in accordance with applicable codes and etan-dards) and measures to document the perfor-mance thereof shall be established. Measures shall be established and documented to identify the inspection and test status of Ox items to be used in maintenance modification, and construction activities.

A corrective maintenance program shall be developed to mainta.'.n structures, systems and components important to safety at the cuality reouired for them to perform their intended functions. Corrective maintenance shall be performed in a timely manner to insure that important to safety items are adeouately main-tained in the original, design, functional status.

A preventative maintenance program including l procedures as appropriate for structures, '

systems, and components important to safety shall be established which prescribes the l frecuency and type of maintenance to be per- l formed. In all cases, maintenance shall be scheduled and planned so as not to compromise  ;

the safety of the plant. Planning shall con-sider the possible safety consecuences of ,

concurrent or secuential maintenance, testing l

(

i VI-17 Rev. 8 l l

l

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() or operating activities. Preventive main-tenance shall be performed in a timely manner to insure that important to safety items are adeouately maintained in the original, design, functional status.

6.2.1.11 Procedural Recuirements Measures shall be established to control and coordinate the approval and issuance of docu-ments, including changes, wnich prescribe all activities affecting ouality. 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 established policy and program controls; they contain the necessary policy ,

I and program recuirements inc.'uding the inspec-tion and verification reouirements where l applicable; and they contain clear descrip- l tions related to the extent of documenting i results of completed actions when reouired. l These documents include operating and special orders, operating procedures, test procecures,

'O eculpment and material control procedures, maintenance or modification procedures, ano refueling procedures. Plant procedures snall be reviewed by an individual knowledgeable in the area affected by the procedure no less frecuently than every two (2) years to deter-mine if changes are necessary or desirable.

6.2.1.12 Control of Surveillance Testing and Inspection A surveillance testing and inspection program )

shall be established to insure that important to safety structures, systems, and components will continue to operate, keeping parameters within normal bounds, or will act to put the plant in a safe condition if they exceed normal bounds.

Provisions shall be made for performing reouired surveillance testing and inspections, including inservice inspections. Such provi-sions shall include the establishment of a master surveillance senedule reflecting the status of all planned inplant surveillance tests and inspections. Frecuency of surveil-O lance tests and inspections may be related to VI-18 Rev. 8

tne results of reliability analyses, tne j

,s frecuency and type of service, or age of the item or system, as appropriate.

Additional control procedures shall be 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 shall be established to assure the return of systems to an operable status. Tnese procedures shall include provisions for the documentation of authority, conduct, responsibility, and veri-fication involved in returning the system to an operable status. Such provisions shall include the use of procedures, checklists, and independent verificat'.on as appropriate, con-sidering the degree toat system status was altered during the performance of the test.

6.2.1.13 Radiation Control Procedures shall be provided for the implemen-tation of a radiation control program. The radiation control program involves the acoul-sition of data and provision of eouipment to perform necessary radiation surveys, measure-O ments and evaluations for the assessment and control of radiation hazards associated with THI. Procedures shall be developed and imple-mented for cuality assurance review of records and programs to insure the adecuacy of measures taken to control radiation exposure of employees and others. Additionally, cuality measures for rodwaste management shall be implemented in accordance with 10 CFR 71, Appendix E.

6.3 Responsibilities 6.3.1 GPUNC Management GPUNC Managers with direct responsibility for activities described nerein are responsible for the implementation and compliance of the Quality Assurance Plan ano directly respon-sible to insure their respective activities and responsibilities are conducted in accor-d?lce with applicable adminsitrative controls, reealatory and licensing reouirements.

' ' ' VI-19 Rev. 8

i 1

l 6.3.2 Delegated Autnorities Contractors or other agents outside GPUNC wn3 l are assigned or celegated responsibilities ,

l' and/or activities governed by this Plan snail comply with tne applicable recairements of tne Plan.

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i VI-20 Rev. 8 I

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( ,/ 7.0 Control of Radioactive waste 7.1 Policy Measures shall be establisned ano occumentec to assure that the applicable recuireme'.cs ;f the Code of the Federal Regulations, Title AG, Part 71 and Title 49, Parts 100 tnrougn 199 appl 1' cable to the packaging and transporting of radioactive wastes are satisfied. Appencix E to 10 CFR 71 identifies tne cuality as-surance criteria applicable to tne control cf radioactive waste.

'he applicable portions of this Plan :nat relate to the criteria in Appendix E to 10 C#R 71 describe to a large < tent the aomini-strative controls and ..ality reouirements tc be applied in the con' al, packaging ano transportation of rad.aactive material. The applicable sections of this Plan will be implemented to satisfy the reouiremer.;s of Appendix E to 10CFR 71. Typically, 5sctions 6.2.1.1 thru 6.2.1. 6 and 6.2.1.13 ap; 1y to Control of Radioactive Waste.

r~s 7.2 Reouirements U 7.2.1 Procedures shall be developed and im;lementeo to cover .ae following:

a. Processing of radioactive wastes including the collection, hanoling ano preparation for shipment of radioactive liouids and solids. These prccecures shall be consistent with tne ALARA program and shal) clearly identify tne administrative controls and organiza-tional responsibilities.

b. Training and oualification of personnel operating radioactive waste processing eouipment, health physics monitoring, packaging and shipping and otner opera-tions deemed appropriate by management.

c. The activities associated witn the packaging of radioactive wastes to include the proper selection af the receptacles to be used for containing the waste materials, the selection of the shipping containers (structures 8

VII-1 Rev. 8

used to contain and support tne receptacle and its contents) Healtn Physics inspections of tne packaging prior to release, proper markings on the outside of the package ano the preparation of shipping papers and certificates.

d. Movement of radioactive materials witn-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 accoroance with the regulations of the U.S.

Department of Transportation 'or the transportation of nazardous materials (49 CFR) and of the NRC (10 CFR 71).

f. The packaging used for transporting of radioactive wastes, wnether purchasec from an outside supplier or OE31gneo ey GPUNC, shall meet the applicable re-ouirements of 10 CFR 71 and 49 CFR.

7.2.2 The carriers to be used for transporting of radioactive wastes shall be selected on the basis of their experience, knowledge of DOT regulations, contrcl and maintenance of tneir eculpment and the selection and control tf their drivers. The carrier is recuired to have or shall be supplied documented proce-dures covering acceptance of materials from a shipper, certification recuirements, alacara-ing, stowage control, reporting of incioents and security.

7.2.3 Radwaste operations shall be control.eo to minimize personnal exposures or environmental contamination consistent with ALARA.

7.2.4 Operations procedures shall be revieweo Dy QAD to establish any necessary witness or hold points or activities to be monitored.

7.3 Responsibilities 7.3.1 The Manager - TMI Unit 1 through the Manager -

Radiological Controls, shall develop and implement procedures for processing activities

[,-) and movement of radirective materials.

A./

VII-2 Rev. 8

O 7.3.2 The Manager-THI Unit 1 shall be responsicle for the processing and packaging of licula wastes and for the packaging of solic wastes in preparation for shipment. Accitionally, the Operations Department is responsible for the collection and identification of radio-active solids, such as rags, papers, ooots, gloves, etc., and having them moved to the Radwaste facility for packaging.

7.3.3 The Manager-Radiological Controls is respon-sible for monitoring all activities associated with the processing and hancling of radio-active wastes and for proviaing advice on radiological matters relating to processing, packaging and shipping.

7.3.4 The Manager-TMI Unit 1 is responsible for tne selection of the proper packaging for tne specific contents to be shipped, taking into consideration the radiation levels, c antamina-tion limits and shipping recuirements. Healtn Physics inspects the packaging for radiaticr level and, if acceptable, the Operatians Department marks the outside of the package with the appropriate markings, completes tne Os shipping papers and certificates, attaches tne

" security seal and advises the carrier that tne shipment is ready.

7.3.5 The Manager-Plant Engineering is respJnsible for reviewing and accepting the designs of packaging purchased from an outside SJpplier.

7.3.6 Each manager for this functional ares related to the control of radioactive wastes, shall establish the recuirements for personnel cualification and institute training anc in-doctrination to satisfy these recuirements.

Training recuirements shall be consistent witn ,

the importance and complexity of tne activity l J

performed.

7.3.7 Quality Assurance Modifications /Operetions Manager is responsible for review ano con-currence witn crocedures describing control of radioactive waste. He is also responsible to .

monitor and/or inspect radioactive waste pro-  !

cessing operations to verify they are l preformed in accordance with establisheo  !

procedures, applicable administrative controls  !

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and regulatory reouirements.

v,/

VII-3 Rev. 8

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Tne Operations Department shall review and i l

1 accept carriers' documented procedures as  !

J' specified by procurement documents covering ,

acceptance of radioactive waste materials for  !

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(_- 8.0 Control of Corrective Actions anc NonConformances 8.1 Policy Nonconforming materials, parts, components, services or activities within tne scope of tne QA Plan shall be controlled to prevent tneir inadvertent utilization. Measures snall ce established which ensure that conoitions adverse to cuality, such as failures. malfunc-tions, deficiencies, deviations, defe:tive material and equipment, and nonconformances ce promptly identified and corrected. Tne cause of the condition adverse to cuality small De determined and appropriate action taken t0 preclude repetition. The identificatf.on, cause, and actions taken to correct conoitions adverse to cuality shall be documented anc reported to the appropriate levels of management.

Significan, conditions within the intent of 10CFR 50.55(e) or 10 CFR 21 shall be eported to appropriate management levels witrin the

(~* affected organization for review and evalua-a b tion.

8.2 Retuirements Procedures shall be establisned whicr cetail and implement the following corrective action system measures:

a. Conditions adverse to cuality shall ce evaluated to determine tne need for corrective action.

b. Corrective action documentation snall include identification, cause, and actions taken to correct and to pre-clude the similar recurrence for conoi-tions adverse to Quality. Cotrective action documentation recuires con-currence by QAD.

c. Follow-up activities shall be conductea to verify implementation of corrective actions and to close out corrective action in a timely manner.

d. Significant deficiencies, noncon-formances and defects, potentially VIII-1 Rev. 8

,9 reportaole under 10 CFR 50.55(e) or 10 k/ CFR 21 shall De reported to appropriate

, management levels for evaluation anc possible reporting to the Nuclear Regulatory Commission,

e. Procedures shall be estaolisheo for control of nonconforming materiais, parts, components, services, or activ-ities. These procedures shall address 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 nonconformances shall be made by the organization that estaolished the governing reauirements or by otner autnor-ized individuals. QA0 concur-rence is recuired if tne or disposition is "use-as-isa 7 " repair."

lw)* Nonconformar.ce reports snail De 3.

used to identify materials, parts, components, and activities which are not in compliance witn the requirements of specifica-tions, codes, drawings, and de-tailed installation or manufac-turing program recuirements.

This shall include use of noncon-formance reports on items nose status is indeterminate due to the lack of documentation. Non-conformance reports on items shall contains tne following minimum information:

(a) Identification of tne non-conforming item or activity and date of inspection.

(o) Identification of the initi-ator of the nonconformance l report.

Rev. 8 VIII-2

\

(c) Description of the noncon-formance.

(d) Disposition of the noncon-formance (repair, rework, use as is, or scrap).

(e) Inspection recuirements.

(f) Recuired approval signatures of the disposition and the verification.

(g) Evidence of review for re-porting per 10 CFR 50.55(e) or 10 CFR 21.

4. Reworked, repaired, and replace-ment items shall be reinspecteo and tested in accordance with the original inspection and test recuirements or acceptable alter-natives as determined by Engi-neering and Quality Assurance.

All inspection, testing, rework,

/"

and repairs shall be by approved kT/ procedures and the results docu-mented.

5. Identification of nonconforming items by appropriate means (tags, labels, etc.) and segregation, if practical, until disposition of the nonconforming item has been determined.

6. Prior to the initiation of a preoperational test on a safety-related item all nonconformances shall be ev31uated for signifi-cance or impact on further test-ing or operation.

7. Nonconformance reports shall be periodically analyzed to snow ouality trends. Sucn analysis will be based upon severity, number, frecuency of nonconfor-mances, the causes of the noncon-formances, and the timeliness and adecuacy of the reporting and 3

CL VIII-3 Rev. 8

() resolution of nonconformances.

Significant results shall be reported to management for review and assessment.

8.3 Responsibilities 8.3.1 The Vice President - Nuclear Assurance through the Manaaer - Quality Assurance is responsible for tne review ano concurrence of all proce-dures for reporting and controlling of noncon-formances for compliance with the recuirements of the Operational Quality Assurance Plan.

8.3.2 Tne Vice President-THI Unit 1 is responsible for ensuring that nonconformances are reported and corrected for plant personnel activities involving 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 and

() the applicable' 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-tional at the Station, the responsible Manager approves and the Quality Assurance Department concurs with the resolution of nonconformances.

-J VIII-4 Rev. 8

(

V) 9.0 Audits 9.1 Policy A comprehensive system of planned and docu-mented audits shall be established and exe-cuted:

a. To ensure that Quality Assurance re-ouirements are adeouate, effective 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 of the effec-tiveness of the TMI Quality Assurance Program.

9.2 Reouirements A comprehensive system of audits shall be h3'j establisned for both internal and external

- functions which affect structures, systems, components, operations and activities covered by the scope of the TMI Quality Assurance Program.

Planned 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. Plant technical specifications

f. Administrative procedures IX-1 Rev. 8

g. Other procudures and instructions af-

, -- 3 fecting cuality

(_,/

h. Procurement documents 9.2.1 Audit Prooram Audits shall be performed in accordance with pre-estaolisned written procedures and eneck- ano lists, anc snall oe conducted oy trained responsi-cualified personnel naving no oirect The oilities in the areas oeing audited.

audit program shall include

a. Audit schedules

b. Procedures for preparation, performance anc reporting of audits

c. Analysis of audit data and reporting results to appropriate levels of management

d. Follow-up action to De taken caseo upon individual ano collective aucit reports cs

e. Qualification of auditors

f. Delineation of the authority, responsi-bility, and organizational indepencence of those responsiole for the audit program.

Audits shall be regularly scheduled based upon the status ano safety import 3nCS of CCtivities being performed and shall oe initiated in a timely manner to assure the effectiveness during design, procurement, manufacturing, construction, installction, inspection, test-ing and as reouired In by the tecnnical addition, audits specifi-may be cations for TMI.

scheouled and performed as recuired by manage-ment or the safety review groups for special evaluations. Implementation of corrective action snali be verified in a timely manner.

Unscheduleo 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 reouirements of this Program.

IX-2 Rev. 8

Audits will be performed by the Quality As-surance Methods / Operations / Audit group.

((/)

' Each audit team shall be led by a cualified Audit Team Leader. Audit team memoers shall be as utilized as reouired eitner auditors and will specialists,.

or tecnnical oc classified depending on their function on the audit team.

Procurement documents shall include audit access requirements in insure vendor com-Audited organi-program.

pliance to the audit zations shall cooperate with the auditing organization, providing whatever assistance is necessar/ in the performance of the audit.

Tne audi*.ed organization shall take corrective action for findings and resolve coservations in a timely manner.

9.2.2 Audit Frecuency Audit frequencies shall be based upon tne status and safety importance of activities, Jegree of previous experience, consistency of overall coverage, unicue testing / operating activities, and follow-up on previous audit findings.

9.2.3 Documentation j- in a written Audit results shall be documented report to the audited organization. The Quality Assurance organization conducting the audit is resconsible for conducting follow-up j actions including re-audit o f deficient areas, as required, to assure correction of the defi-ciencies.

9.2.4 Training l

Audits shall be performed by personnel who are trair.ed and Qualified to theThese recuirements recuirements defined in ANSI.N45.2.23 provide the means to assure that audits are performed in a thorougn ano professional man-ner. Documented training programs shall oe organized to provide auditors with the neces-sary training and knowledge of regulatory requirements, codes, standards, procedures, etc. applicaole to the activities being audited.

IX-3 Rev. S

\' 9.3 Responsibilities 9.3.1 Office of tne President - GPUNC Responsible for the performance of an indepen-dent review of the TMI Quality Assurance Pro-gram and related activities.

9.3.2 Vice President - Nuclear Assurance The Vice President - Nuclear Assurance is responsible through the Manager - Quality Assurance to:

a. Establish and implement the overall Quality Assurance audit program. He assures that all applicable areas are audited and that the auditing organiza-tion meets tne reauirements of tnis Plan. He evaluates the effectiveness of tne overall audit program, analyzes tne reports ano related information for cuality trends ano appraises Vice President - TMI Unit 1 and.tne Vice President - Nuclear Assurance of signi-ficant findings of the program. Tne

(~']

(/ Manager-Quality Assurance further en-

~ sures that an overall Quality Assurance Audit Program Senedule is established and implemented.

b. Schedule and perform audits and to identify auality or management control problems and provide recommended solu-tions.

I l

1 s dll 1 i

l IX-4 Rev. 8

,a

(/ APPENDICES APPENDIX A Comparison Chart of Quality Assurance Plan Reouirements with those of various parts of tne Code of Federal Regulations and Nuclear Industry Standards APPENDIX B Minimum Document Control Responsibility for "Important to Safety" Documents Quality Assurance Program 73 APPENDIX C NRC Regulatory Guide Commitments ano e i

\' > Exceptions APPENDIX D Definitions

Cot-tPAHISO!3 Cil AftT OF' QUAI 1T' 'SUllAIICE PIAft DD{UlillfIEllTS v WITil '1110SE OF VA X; I AfrrS OF Tile y/

CODE OF FEDEllAL RM;UI,ATIOils AllD fiUClJ:AR IlllA33TilY GTAilDAftDG 10 C Q So, App. ti A;isi 1315.2 4 10 CFR 71, App. E ~ A!pl__llIT.7 l - 12j6 QA Plan criterion QA Plan Paragra g QA PJan l'ararrag li ';/. P l . a n Criigrion QA Plan Paragraph 1 1.0 2.0 2.0 1 1.0 3.1 1.0 S.2.11 8.0 11 2.0 3.0 1.0 2 2.0 1.2 1.0 5 2.12 3.i III 14 . 0 h.0 h.0 3 h.0 3.3 1.0 5 2.13 5.0 JV 51 50 5.1 h 51 3.h 1.0 5.2.jh 8.0 V 31 6.0 3.1 5 3.1 3.5 2.0 5.2.15 3.0 VI 3.2 7.0 3.2 6 3.2 is .1 2.0/9.0 5 2.16 6.2.1.5 VII 51 8.0 51 7 51 h.2 2.0/9 0 5.2.17 6.2.1.1 VIII 52 90 52 8 5.2 h.3 2.0 5 2.18 6.2.1 3 IX 6.2.1.3 10.0 6.2.1.3 9 6.2.1.3 Is .h 2.0 5.2.19 6.2.1.h X 6.2.1.1 11.0 6.2.1.1 7.0 h.5 9.0 5.3 6.2.1.11 XI 6.2.1.h 12.0 6 . 2 . 1 . 14 10 6.2.1.14 5.1 2.0 XII 6.2.1.5 13 0 6.2.1.5 T.0 5.2.1 2.0 XIII 6.2.1.6 13 . 0 8 6.2.1.6 11 6. 2.1.1 5 2.2 3.1 XIV 6.2.1 7 15.0 6.2.1.7 T.0 5.2.3 3.1 XV 8.0 16.0 8.0 12 6.2.1.5 5.2.h 3.1 XVI 8.0 17.0 8.0 T.0 5 2.5 3.1

. XVII 33 18.0 3.3 13 6.2.1.6 5.2.6 6. 2.1.9 XVIII 90 19 0 90 T.0 527 6.2.1.10 lb 6.2.1.7 5 2.8 6.2.1.12 T.0 5.2 9 6.2.1.2.0 15 8.0 5.2.10 6.2.1.8 16 8.0 IT 3.3 18 90 i

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s b AFFE:fDIX R ISSUED PY 1. . 3 F3EPARED BY ' AFTPOVfD BY/CONCtmRrf3CE DOCU'4E'37

' Unit itsnyer THI Station C.3 Pfl Station TG Station Administre len Crgsnt:ations QA Modification / Operations Mansger Afminletrative Orgsnization flas1 Af f act e! (Station)

Proce lares

'TtG Station Section Msnager/ Supervisor Ut! Station C.ls rtl Station TG Station Alministrstinn Sectiens Unit Itansgar Cection Procedures TMI Statinn uate 7 t!I Station

'TLf! Station Section ffansger/Superwisor C.5 tti Statien Organizat ion Hemd Affected (Statien) Administration raction Instructions Sect!cns nff Stati,n tiote 7 O Statien 't' nit itsnver C.6 'I'41 Speelal PCRC Administrstion Orgri zations Test Pracedures GBC (per 10 CFR 53.59) 14ot e 7 Pa11ation 'Fadiation Protection Manigar/Supervisar Tit! Station C.T TM1 Badiation Ra.ilation Trotection Engineer Admi nist r stion Protectton Procedures Protection Originating Delsrtment Site Crgsnizations ' Construction or Maintenance er C.8 En Vork Start Up snd Test Authori:stion Doc.r ents QA Modifications / Operations Project ingin.erirg 0.r Site ' Project Engineering 11anager D.1 Pro?urement fian a e,* r Organiza*lons QA Destr.c/ Procurement Manager Fequisition Manager-Materials Managem*nt Originatin6 Site Organizations ' Manager-Plant Engineering D.2 Pr wurement Orgentrations QA Design / Procurement Suparvisor Fequisitton Manncer ttrit erials Management Cittric inr im erinc  !! .t . .

GT9t!C tratineering ' Project Enr,ineering !bny,cr 8. . . ' .

E.1 Enrineering charge tocuments na f e i ./rror..ren.ia M.n.re.

'es e 1 l t if t Mart sp,er Appl 1."r De l. *-e

,e-m-.w ..-=w-.-m... -e=+e.e-.a==+*e*

t-

t APPENI cs who NOTE: 1) kesponsible organizations or positions may have documented, designated alternt*

are authorized to perform the function.

) may be authorized 2)' Designated support organization (within GPUNC or outside contractors and designated to perfom certain of the functions.

3) This Appendix is a supplement of Section 3.0 of the QA Plan.

b) Drawings need not be reviewed by QA unless used in lieu of specifications.

5)

GPUNC Engineering is defined as those sections within the Technical Functions Division.

6) Engineering Change documents are defined as any formalized documents providing description I

and approval of changes prepared for incorporation at TffI.

7)

In these cases QA review may be conducted after the document is issued.

t B-3

APPENDIX C

' OUALITY ASSURANCE PROGRAM NRC REGULATORY Cw nE COMMITMENTS AND EXCEPTIONS i Engineering, in establisning specific reouirements for design will use regulatory guide positions controlled by Tecnnical Functions in a project criteria cocument.

Examples of positions taken relative to regulatory guides are listed. Those identified by an asterisk cover regulatory guides wnich are specifically ouality related or impacted and are therefore controlled by tnis manual.

Tne TMI Quality Assurance Program complies withExceptions Section C of the NRC Regulatory Guides indicated Delow.

to NRC Regulatory Guide position are detaileo in Part 2 of tnis Appendix.

This Appendix addresses additional Reg. GJioes not listed in Re.'. 7 of the Operational Quality Assurance Plan.

Compi .?nce with tnese added Reg. OJides will apply to modi-fications, additions and activities performeo after issue of Rev. 8 and does not imply backfitting and/or retroactive s;- compliance. It is also to be recognized tnat existing plant conditions, may prevent or preclude tne satisfaction of all reouirements of a specific design relatea regulatory -

guide. The deviation will be documented and, along witn the justification, will be approved by the Manager - ,

Engineering and Design.

r

(

\_ /

C-1 Rev. 8 i

t i

t

(

J Q)

APPENDIK C, PART I n n .. ;oCa COMMITMENT TO QUALITY ASSUPANCE REGUALTORY CUIDES FOR THRE_E MILE ISMTQ DEGR2E OF ANSI STD. COMPLIA1CE RD4 ARKS REG. CLIIDE Pull Comply with " Reg 4stery Pesitio .",

N18.1 1971 Persennel Selection and Training G l.B 5/7T, Rev. 1-R Full Comply with "Regfato y Pesitic ".

Nh5 2 1977 Quality Assurance Progran Pequirements

'1.26 2/79,Bev. 2 (Design and Construction)

Pull

.Cerply with "Re M aten Positief .

Nb5 2.h 1972 QA Requirements for the Installation, Inspection 1.30 8/11/72 and Testing of Instrumentation and Electrical Equipment N18.7 1976 Modified See alternate rethei sttached.

Quality Ass rance Program Requirements

1. 1.33 2/7S, Rev. 2 (Operation) 1973 Modified See alternate meth:1 attached.

Nh5 2.1 QA Requirements for Cleaning of riuid Systers 1.3T 3'16/T3 an1 Asscelsted Components of Vater Coole!

Nuclesr Power Plants See alternate methed attachea.

Nh5 2.2 1972 Modified QA seguirements for Packaging. Shipping, 1.36 5/7T, Bev. 2 Receiving, Storage ara *Ian111ng of Items for Water Cooled Nuclear Power Plants Co:trply with " Regulatory Position".

Nk5 2.3 1973 Full Housekeeping Requirements for Vater Cooled 1.39 9/77. Rev. 2 Nuclear Power Plants Modified Ee? alternate methed attache 4.

101.h 1972 CA Pequirements for Protective Coatings 1 5h 6/T3 Applied to Water Cooled Nuclear Power Plants Modified See alternate method attnebed.

Uh5 2.6 1978 Quellfications of Nuclear Power Plant Inspection, 01 53 T/79 Examination and Testing Personnel Proposed Rev. 1 Modified See alternate ciethed attache 1.

Nh5.2.11 197h Quality Assurance Requirements for the Design 1.6% 6/76 Rev. 2 of Euclear Power Plants Comply with "Pegf atcry Positica" Pull Nh5 2.10 19T3 quality Assurance Terms and Definitions

1. 1.Th 2/Th C-2

(['i L)

' ( ,.s

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i APPENDIX C, PART I APRIL , 19PO ANSI STD_. Co m IARCZ RDf.Oq REO. OUIDP. Modified Se? alternate reth>d attached.

Collection 3torage and Maintenance of Nk5 2 9 197h cl.88 10/76, Pev. 2 Uuclear Power Plant Quality Assurance Pecords Nb5 2 5 197k M>dified See alternate method attache 1.

1. 9's h/76, Rev. 1 QA Requirerents for Installation, Inspection and Testing of Structural Concrete & Steel daring Nuclear Power Plant Construction Ms5.7.8 1975 Modified . Eca alternata method attached.

1.116 5/TT, Rev. 0-R QA Requirements f ar Inste.11rtion Inspection and Testir.g of Mechenical Equipaent and Systems Full Comply with " Regulatory Position" QA Requirements for Centrol of Procurement of 3h5 2.131976 81.123 7/77. Rev.1 Itecs and Services for Nuclear Power Plants Nh5.f.12 1977 Modified Ce- cornents attached.

Pequire:ents for Auutting of Qus11ty Assurance

1. 1.1Lk 1/79 Prc6ra s for Nuclesr Power Plants Modifiel See 11 ternate method attached.

1.26 2/76, Rev. 3 CA Cisssirleations and Standards for water Stream and Stdioactive Waste Containing Ccrpenents of Naclear Power Plants Tull 01.31 h/78, Rev. 3 Control of Ferrite Content in Stainless Steel Veld Metal I.ECE-317 1975 Modified See clarification attached.

1.63 8/T8, Rev. 2 Electric Penetration Assemblies in Containnent Structure for Light Water Cooled Nuclear Power Plants Modified Sane comment as for Reg. Guide 1.26.

Jetsmie Design Classification 1.29 9/78 Rev. 3 0-3 ,

A APPENDIX C, PART 2 v

NRC Regulatory Guide 1.30, August 1972 Quality Assurance Raouirements for the Installation, Insoection anc Testing of Instrumentation ano Electric Ecuipment TMI shall comply with the Regulatory Position estab-lished in this Regulatory Guide in tnat QA program-matic/ administrative reouirements included therein snall apoly to maintenance and modification activities even tnougn such reouirements were not in effect originally.

Technical reouirements associated witn maintenance and modifications shall be the tecnnical reouirements or better (e.g., code reouirements, material properties, design mar-gins, manufacturing processes, and inspection reouirements).

NCR Regulatory Guide 1.33, Rev. 2, Feoruary 1978 Quality Assurance Procram Recuirements (Oceration)

The TMI QA Program complies with the regulatory position of tnis guide witn tne following clarifications:

1. Paragraph C.A.a is interpreted to mean audits will a be made once eacn 6 months to verify tne nonconfor-mances and corrective action program is properly implemented and cocumented, particularly as related to actions taken to correct deficiencies that affect items important to safety.

2. Paragraph 5.2.8 of ANSI N18.7 - 1976 titled "Sur-veillance Testing and Inspection"

'n lieu of a " master surveillance" schedule, a tachnical specification surveillance testing schedule snall be established 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 of Procedures" The third sentence of the third paragraph is inter-preted to mean applicable procedures shall be reviewed following a reportable incident such as an accident, an unexpected transient, significant operator error, or eouipment malfunction.

4. Paragrapn 5.2.17 of ANSI N18.7 - 1976 titled

" Inspections" v

C4 Rev. 8

()

N)PENDIX C, PART 2 Not all inspections will recuire a separate inspec-tion report. Inspection reouirements may oe inte-grated into appropriate procedures or other documents with the procecures or documents with the procedure or document serving as the record; how-ever, recoros of inspections will be ioentified anc retrievable.

NRC Regulatory Guide 1.37, March 16,1973 Duality Assurance Reouirements for Cleaning Fluids Systems ano Associateo Comoonents of water Cooleo huclear Power Plants The TMI Quality Assurance Program complies witn the regula-tory position of this guide witn the following clarifi-cations:

1. The second sentence of paragraph C.3 snould be amended to read:

"The water cuality for final flushes of fluid sys-tems and associated components shall De at least rg eouivalent to the cuality reouired for normal oper-(_j ation. This reouirement cses not apply to disolved s_

oxygen or nitrogen limits nor does it infer that chromates or other additives normally in the system water will be added to the flush water."

2. Paragraph C.4 should be amended to add:

Material such as inks, temperature indicating cray-ons, labels, wrapping materials (other than poly-ethylene), water soluble dam materials, lubricants, NOT penetrant materials and couplants, which con-tact stainless steel or nickle alloy material sur-faces shall contain no more than trace elements of lead, zinc, copper, mercury or otner low melting alloys or compounds. Maximum levels of water leachable enloride ions, total halogens and sulfur compounds shall be imposed on the aforementioned materials.

)

f l

f' V) Rev. 8 C-5 l

g)

(

APPENDIX C, PART 2 i NRC Regulatory Guide 1.38, Rev. 2, May 1977 Quality Assurance Recairements for Packaging, Shipoing, Receiving, Storage ano Handling of Items f or Water Cooled NJclear Power Plants The TMI Quality Assurance Program complies with tne regulatory position of this guice witn 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. Tne position stated in Reg. Guice 1.37 alse applies to this guide.

2. Section 3.7.1 of ANSI N45.2.2 - 1972 Cleated, sheathed boxes will be used up to 1000 lbs. rather than 500 lbs. as specified. This type of box is safe for, and has been tested for, loads up to 1000 lbs. Other material standards (i.e.,

FED Spec. PPP-B-601) allow this. Special cualifi-e3 cation testing snall be recuired for loads in

(_j excess of 1000 lbs.

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. Otner 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 I

The last sentence of A.3.4.l(4) and (5) should be corrected as follows:

(4) "However, preservatives for inaccessible inside surfaces of pumps, valves and pipe systems containing, reactor coolant water shall be the water flushable type."

(5) "The name of the preservative used shall be indicated to facilitate touch up."

, S. With regard to Section A.3.5.2 of the Appendix to ANSI N45.2.2 - 1972 entitled " Tapes and Adhesives":

/' Tapes will meet a sulpnur limit of 0.30% by weight

(_j] instead of 0.10% as specified in A.3.5.2(1)(a).

C-6 Rev. 8 i

O L.)

APPENDIX C, PART 2 This limit is reasonable based upon the chemical content of commercially available tapes. Tapes will be of a contrasting color ratner than

" Brightly Colored" as reouired by A.3.5.1(3).

6. Witn 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.l(3) and (4), the following will be imposed: Fiberboard boxes shall be securely closed either with a water resistant acnesive applied to tne entire area of contact between tne flaps, or all seams and joints shall be sealeo witn not less than 2-inen wide, water resistant tape.

NRC Regulatory Guide 1.39, Rev. 2, September 1977 Housekeeoing Reouirements for Water Cooled MJClear Power Plants Endorses ANSI N45.2.3 - 1973 The Operational Quality Assurance Program complies with this guide with the following clarification:

O 1. Witn regard to Sections 2.1 and 3.2 of ANSI N45.2.3

• - 1973 entitled " Planning and Control of Facilities", respectively.

The TMI Nuclear Station will not utilize the five level zone designation system referenced in ANSI NAS.2.3, but will utilize standaro janitorial and work practices to maintain a level of cleanliness commensurate witn company policy in tne areas of housekeeping, plant and personnel safety, and fire i protection.

I Cleanliness will be maintained, consistent witn tne work being performed, so as to prevent the entry of .

foreign material into systems considered important I to safety. This will include as a minimum docu-mented cleanliness inspections which will be per-formed immediately prior to system closure. Con-trol of personnel, tools, eouipment, and supplics will be estaolished wnen major portions of the re-actor system are opened for inspection, maintenance  ;

of repair. l Additional housekeeping reouirements will be imple-mented as reouired for control or radioactive con-OU tamination.

C-7 Rev. 8 I

,-m APPENDIX C, PART 2 (v)

+ tRC Regulatory Guide 1.54, 3;ne 1973 OJality Assurance Recuirements for Protective Coatings Applied to Water Coclea Nuclear Power Plants Endorses ANSI N101.4 - 1972 The Operational Quality Assurance Program complies with this guioe with the following Clarification:

1. TMI shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic /acministrative reouirements included therein shall apply to maintenance and modification activities even thougn sucn reauirements were not in effect originally. Technical reauirements associated with maintenance aqd modifications (e.g., code reouirements, material properties, design margins, manufacturing processes, and inspection reauirements) snall be the original reouirements or better.

2. The guidance of Regulatory Guide 1.54 shall be followed for organic protective coatings selected p) t 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 shall be approved prior to implementation.

OJality Assurance documentation may not be similar to records and documents listed in Sections 7.4 througn 7.8 of ANSI N101.4 but will be evaluated to assure that they provice at least the same degree of documentation as recuired by this standard.

NRC Regulatory Guide 1.58, August 1973 Qualifications of t4; clear Power Plant Inspection, Examination, and Testing Personnel Endorses ANSI N45.2.6 - 1978 The Operational Quality Asssurance Program complies with this guice witn the following clarification:

1. The guidance of Regulatory Guide 1.58 shall be followed as it pertains to the avalifications of personnel who verify conformance of work activities to cuality recuirements. The cualifications of plant operating personnel concerned with day-to-day 4 C-8 Rev. 8

APPENDIX C, PART 2 operation, maintenance, and certain technical ser-m vices shall conform to Regulatory Guide 1.8.

2. Not all personnel who approve inspection and test procedures will be certified as meeting the Level III capability reouirements of ANSI N45.2.6 - 1978, but personnel who approve inspection and test pro-cedures will be aetermined by management, througn evaluation of their education, training and ex-perience, to be fully cualified and competent to approve such procecures. The basis for the deter-mination will be documented.

NRC Regulatory Guice 1.64, Rev. 2, June 1976 Quality Assurance Recuirements for the Design of toclear Power Plants Endorses ANSI N45.2.ll - 1974 TMI shall comply with the Regulatory Position established in this Regulatory Guide in tnat QA programmatic /adminis-trative reouirements included therin snall apply to main-tenance and modification activities even though such n reouirements were not in effect originally. Technical V reouirements (e.g., code reouirements, material properties,

• design margins, manufacturing processes, and inspection reouirements) associated with maintenance and modifications snall be the original reouirements or better.

The Operational Quality Assurance Program complies with this guide with the following clarification to paragraph C.2(1) of Regulatory Guide 1.64: If in an exceptional circumstance the designer's immediate Supervisor is tne only technically cualified individual available, this review can be conducted by the Supervisor, providing that:

(a) the other provisions of the Regulatory Guide are satisfied, and (b) the justification is individually documented and approved in advance by the Supervisor's management, and (c) cuality assurance audits cover frecuency and effectiveness of use of Supervisors as design verifiers to guard against abuse.

NRC Regulatory Guide 1.94, Rev. 1, April 1976 Quality Assurance Recuirements for Installation, Inspection ano Testing of Structural Concrete anc Structural Steel curing the Construction Phase of foclear Power Plants b '

Rev. 8 C-9 1

APPENDIX C, PART 2 V,r3 1974 fp orses ANSI N45.2.5 The Operational cuality Assurance Program complies witn this guioe with the following clarification:

TMI snall comply with the Regulatory Position estab-lisned in tnis Regulatory Guice in that QA program-matic/ administrative recuirements incluceo tnerin shall apply to maintenance and mooification activities even thougn such recuirements were not in effect origin-ally. Technical reouirements associated with main-tenance and modifications shall be tne original recuirements or better (e.g., code recuirements, material properties, design margins, manufacturing processes, and inspection requirements).

NRC Regulatory Guide 1.116, Rev. 0-R, May 1977 Quality Assurance Recuirements for Installation, Inspection ano Testing of Mecnanical Eouipment anc Systems Endorses ANSI N45.2.8 The Operational Quality Assurance Program complies with

1. }

(V this guide with the following clarification:

v TMI shall comply with the Regulatory Position estab-lished in this Regulatory Guice in tnat QA program-matic/ administrative recuirements incluoed therein snall apply to maintenance and modification activities even though such reouirements were not in effect Technical recuirements associated with originally. maintenance and modifications, shall be the original requirements or better (e.g., code reouirements, material properties, design margins, manufacturing processes, and inspection recuirements).

tRC Regulatory Guide 1.26, Rev. 3, February 1976 Quality Group Classifications and Standard for water, Steam ano Radioactive Waste Containing Components of NJClear Power Plants Since tne original design and construction of the Thr than contained in this guide; TMI will comply with the regulatory position of this guide witn the following clari-fications:

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O aree"otx c. eaa' 2

• 1. For modifications to existing plant systems and for new construction, items will be classified by Technical Functions according to tnis guide providing such action will improve tne safety of the system being modified or make a significant improvement in overall plant safety. Otherwise the items will be classified the same as the original design and construction.

2. Tie-in's to existing plant systems will be made to the same or more recent applicable code, standard and tecnnical reouirements which were applicable to the system to whicn the tie-in is to be made.

NRC Reculatory Guide 1.63, Rev. 2, July 1978 Electric Penetration Assemblies in Containment Structures for Lignt water Cooleo Nuclear Power Plants TMI will comply with the regulatory position of this guide with the following clarification:

For modifications to existing structures and to new constructions, this guide will be utilized providing Ov its use will improve the safety of the structure being modified or make a significant improvement in overall l

plant safety. Otherwise, the same or more recent applicable code, standard and technical recuirements applicable to the original design and construction will be utilized.

MlC Regulatory Guide 1.144, January 1979 l Auditing of QJality Assurance Programs for Maclear Power 1

Plants J

TMI is in basic agreement with the position set forth in the Reg. Guide subject to the following comments:

1. Section C.3.a(2)

The proposed scheduling reouirement for internal audits appears to enange the basis for having a rational, programmatic approach to auditing. In its place, the new regulatory guide reouires manda-tory auditing of all program elements on a yearly basis. The latter would reouire that all elements obtain the same attention regardless of importance, past performance, or to what extent otner aspects of ouality assurance measuring and evaluating teen-h nioues are used; as an example, tne extent to which C-ll Rev. 8 I

l 1

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APPENDIX C, PART 2 surveillance and process monitoring is used.

Accordingly, minimum schedule frecuency will be as

• defined in R.G. 1.33.

2. Section C.3.b(1)

Source inspection provices a controlled easis for replacing the need for external audits. The use of ouality assurance program surveillance will also be used as anotner alternative.

3. Section C.3.b(2)

While the licensee is responsible for procurement control, this can be exercised through an annual evaluation of the contractor's performance using pertinent results from manufacturing surveillance, source inspection, receiving inspection, and other applicable factors. The evaluation would include a ter'..nmendation as to the need for a scheduled program or problem area audit. Hence, auditing, like surveillance and inspection, will be treated as a cuality assurance tool used for evaluation.

Furtnermore, the recommendation to audit will include provisions for reviewing the importance and impact of the particular contractor's scope and O

v status.

NRC Regulatory Guide 1.88, Rev. 2, October, 1976 Collection, Storage, and Maintenance of Nuclear Power Plant Availaoility Assurance Recoros TMI will comply with the intent of tnis regulatory guide by compliance with the recuirements of ANSI /ASME NQA-1-1979, Supplement 175-1 and Appendix 17A-1.

l Rev. 8 l Ov C-12

iN APPENDIX D sd

Definitions Words and phrases used in this Plan shall be as defined" inQualityANSI N45.2.10, 1973, as endorsed by Regulatory Guide 1.74, Items Assurance Terms and Definitions," and as listed below.

shown below with an asterisk (*) have been modified from the ANSI definitions.

1. Acceptance Criteria: Specified limits placed on charac-teristics of an item, process, or service defined in codes, standards, or other documents.

2. (Acronym for As Low As Reasonability Achievable)

- a method of analysis of the performance of activities Alara:

in radiological areas to determine specific methods for reducing man-rem exposure.

Architect / Engineer (A/E): A firm under contract to pro-3.

vide engineering or design services.

4. Agent: A person or firm empowered to provide a service on behalf of GPUNC and under the GPUNC QA Program.

5. Approval:* An act of endorsing and adding positive autn-(^T

\~/

orization (signature) to a document by the person (s) res-s- ponsible for the document.

6. As-Built Data: Documented data that describes the condi-tion actually achieved in a product.

7. Concurrence: Agreement with the content of a document indicated by signature on the document prior to issuance.

8. Condition Adverse to Quality: An all inclusive term used failures, malfunc-in reference to any ofdefective the following:

items, and nonconfor-tions, deficiencies, mances. A significant condition adverse to cuality is one whicn, if uncorrected, could have a serious effect on safety or operability.

9. Contractor:* A person or firm under contract to provide an on-site service and working under the reouirements Firms engaged in of their own Quality Assurance Program.

construction management are considered contractors.

Measures taken by the responsible

10. Corrective Action: j Manager to initiate action to correct the observed l deficiency and others like it in the system, and will modify operating practices so as to prevent future l recurrence.

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m 1

)

)

() 11. Engineering (Engineer): This term refers to the tecn-s, nical responsibilities of Technical Functions, Plant Engineering or A/E's.

12. External Organizations: Any organization participating in the project which is not a part of General Public Utilities. This term includes vendors, A/E's and con-tractors.

13. Important to Safety: As used in the Introouction to Appendix A to 10CFR50, this term refers to, " structures, systems, and components that provide reasonable assurance that the facility can be operated without undue risk to the health and safety of the public." The GPUNC inter-pretation is:

Items or activities having direct or indirect affect on the physical, functional or human ability to operate the facility, to protect the integrity of the core, and to do sc without undue risk to the health and safety of the public.

14. Independent Review Groups: Committees or organizations with responsibilities for the deliberately criticalThey evaluation of methods, procedures or conditions.

gg hcve no direct responsibility for the documents, methods

() or activities being evaluated.

An act of assuring compliance of activities

15. Monitoring:

to program recuirements by direct observation.

16. Qualification (Personnel): The characteristics or abili-ties gained through education, training or experience, as measured against establisheo reouirements, such as stan-dards, or tests, that cualify an individual to perform a reouired function.

17. QA Plan (Plan): The basic document which describes the method and extent of compliance of the QA Program to the applicable regulatory reouirements.

18. QA Program (Program): The planned ar.d systematic actions which constitute compliance with regulatory cuality assurance recuirements and the controlled documents whicn describe and prescribe those actions.

19. QA Records: Those documents reouired to be maintained in accordance with Regulatory Guide 1.88, and ANSI N45.2.9 as referenctd in Appendix C.

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()

20. Quality Classification List (QCL): The controlled occu-ment used to record the results of Quality classification )

evaluations.

21. Safety Review Groups: Committees or organizations with responsibilities for evaluation of methods, procecures or

' conditions affecting plant safety during the operational phase.

22. Special Process: A process, the results of wnich are highly dependent on tne control of the process or the skill of the operators, or both, and in whicn the speci-fled Quality cannot be readily determined by inspection or test of the product.

23. Surveillance: An act of assuring compliance of a manu-facturing process or activity to specified recuirements.

24. Traceability: The ability to trace the history, applica-tion, or location of an item and like items or activities by means of recorded information.

25. Trend Analysis: A Quantitative method of collecting ano analysing nonconformance/ deviations events with the goal of systematically determining programmatic / procedural weaknesses.

w- 26. Vendor: A firm which manufactures items at an off-site facility and operates under the recuirements of their own cuality assurance program.

27. Verification:* An act of confirming, substantiating and assuring that an activity or condition is suitable, proper and has been implemented in conformance with the specified requirements.

5(~T U

D-3 Rev. 8  ;