ML20097D800

Rev 15 to Operating QA Manual

ML20097D800
Person / Time
Site:	Callaway
Issue date:	06/30/1992
From:	UNION ELECTRIC CO.
To:
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ML20097D780	List: ML20097D777 ML20097D800
References
NUDOCS 9206110127
Download: ML20097D800 (187)

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A T T-A C H M E N T 1

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OQAM, REVISION 15 UPDATED PAGES

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OOAP POLICY /INTRODUCTIQH It is the policy of Union Electric Company (UE) to develop, implement, and maintain an Operating Quality Assurance Program (OQAP) for utilization facilities regulated by prov:sions of a

Nuclear Regulatory Commission (NRC) operating license and amendments thereto.

The QA Program shall be applied to those activities affecting quality (safety-related) regarding structures, systems, and components necessary to assure:

1.

The integrity of the reactor coolant pressure boundary, 2.

The capability to shut down the reactor and maintain it in a safe shutdown condition, or 3.

The capability to prevent or mitigate the consequences of accidents which could result in off-site exposures comparable to the guideline exposures of HRC Regulations 10 CFR 100.

These activities include operational testing, operations, maintenance, refueling, and modifications. Control over these activities as they affect quality shall be to the extent consistent with their importance to sufety.

UE Company has established an organization to implement the OQAP as documented in policy, manuals, and procedures.

Specific OQAP requirements and corresponding organizational responsibilities are specified in the Operating Quality Assurance Manual (OQAM).

The OQAP involves the proper functioning of many disciplines and activities.

Functions, departments, groups, committees and other organizational subdivisions shall control activities affecting quality through implementation of appropriate written procedures or instructions. Documentation shall be maintained to provide objective evidence of program implementation and effectiveness.

The OQAP shall comply with 10 CFR 50, Appendix B

" Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and follow the guidance of the Regulatory Position of Regulatory Guide 1.33.

Clarifications, alternatives, and exceptions to this Regulatory Position are described in Appendix A of the OQAM. An eighteen (18) section format is employed with a discussion of how corresponding criteria of 10 CFR 50, Appendix B are satisfied.

-lii-Rev. 13 6/90 s.

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responsibility

.for formulating, authorizing, and assuring:_ implementation of the UE-Company OQAP rests with the-Senior Vice -President-Nuclea1..The Policy and resultant QA Program are mandatory. for Callaway Plant operational _ phase activities.

Accordingly, personnel shall be made cognizant of QA Program requirements and responsibilities applicable to their individual-activities and intetfices.

i By the signatures of the undersigned, this OQAM is approved

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and those UE personnel whose activities are within the purview of the OQAP are responsible for its implementation in accordance with the requirements described herein.

h Donald'F. Schnell

/ Gate Senior Vice President-Nuclear a

/A (S / '7 2_

' Jgeph V. TauX Date nag h, Quality Assurance L-

-iv-Rev. 15 6/92

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-V-Rev. 15 6/92

OQAM ErJECTIVE PAGE LISTING Pace No.

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OQAM EFFECTIVE PAGE LIlIIEg Annendix A Pace No2 Fev.

A-1 15 7-2 15 A-15 A-15 A-b 15 A-6 15 A-7 15 A-8 15 A-9 15 A-10 15 A-11 15 A-12 15 A-13 15 A-14 15 A-15 15 A-16 15 A-17 15 A-18 15 A-19 15 A-20 15 A-21 15 A-22 15 A-23 15 A-24 15 A-25 15 A-26 35 A-27 15 A-28 15 A-29 15 A-30 15 A-31 15 A-32 15 A-33 15 A-34 15 A-35 15 Floures Ep_h Figure A 15 Figure B 15 Figure C 15

-v11-Rev. 15 6/92

OQAM OPERATING. QUALITY 1ssURANCE R$ANUAL_.iDOAM) 1.0 ORGAN 15hTION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for the development, implementation and maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OQAP, although certain Program activities may be delegated to others. The organi-zation responsible for implementing appropriate portions of the OQAP is shown in Figures A and B of the 00AM. The callaway Plant operating organization is shown in Figure C of the cQ4M.

I i

1.2 The Senior Vice President-Nuclear is responsible for initiating the Quality Assurance

Program, formulating the

policy, and authorizing and assuring Program implementation. He is responsible for directing activities within the Nuclear Divi-sion which support the engineering, construction, testing,- and operation of the Callaway Plant and L

coordinating support activities performed by others who are not under his direct administrative control.

He has corporate responsibility for the operation and physical control of the-Callaway Plant.

He reports to the Chairman and Chief Execu-tive officer who has ultimate responsibility for the Callaway Plant.

l 398 1.3

.The Manager, Quality Assurance reports to the 1790 Senior Vice President-Huclear on Quality Assurance 2006 Program and administrative matters. QA Program 2012 matters are reported to the Chairman and Chief Executive Officer through the Senior Vice-Presi-dent-Nuclear.

The Manager, Quality Assurance is responsible to the Senior Vice President-Nuclear for assuring the OQAP is being effectively imple-mented for operating activities; directing-the overall Quality Assurance Program for UE including Program development, maintenance, and verification of' implementation. The Manager, Quality Assurance has sufficient authority, organizational

freedom, and independence to effectively assure compliance with OQAP requirements as they control Callaway Plant and offsite quality activities; and shall bear.no cost, schedule, or production responsibil-ities which unduly influence attention to quality matters. A communication path shall exist between 1-1 Rev. 15 6/92

OQAM the Manager, Quality Assuranco and the Vice Presi-

dont, Nuclear Operations, as well as the other Nuclear Division ninagement, thus providing a

direct path to inform management regarding condi-tions affecting quality. The qualifications of the

Manager, Quality Assurance are at least equivalent to those specified in ANSI /ANS-3.1-1978, "Solection and Training of Nuclear Power Plant Personnol,"

Section 4.2.4.

The Managor, Quality Assurance is located at Callaway Plant and providos technical direction and administrativo guidance to the Super-intendent, Quality Assuranco; the Supervising Engi-

neer, Quality Support, the Supervising

Engineer, Supplier Quality; and the Quality Assuranco staff.

I 398 1.4 The Superintendent, QA is located at Callaway Plant.

He directs Supervising Engineers who have primary duties for assuring implomontation of the OQAP and devotes full attention to this effort. The Supervising Engineer, Quality Support, located at callaway

Plant, directs a group of ongineers who provide additional support activities including maintenance of the operating Quality Assurance Manual (0QAM). The Suparvising Enginner, Supplier Quality is responsible for rudit, survoillance, and evaluation of nuclear supplier quality activities; and for performing those procurement document reviews assigned ho him. The activities of the QA staff assure implementation of the OQAP. The quali-fications of the Superintandant are at least equi-valent to those specified in ANSI /ANS-3.1-1978,

" Selection and Training of Nuclear Power Plant Personnel," Section 4.4.5.

1.5 The Manager, Quality Assurance, the Superintendent, Quality Assurance, and Supervising Engineers in the Quality Assurance Department are authorized by the Senior Vice president-Nuclear to stop work on ongoing quality activities in accordance with approved procedures.

During the operating phase they have the authority to stop unsatisfactory work during

repair, maintenance, and refueling activ-ities and the authority to recommend to the

Mansger, callaway Plant stop work affecting the continuation of Plant operation. Other stop work authority shall be delineated in procedures.

The continuance of an activity which would cover up a

deficiency and preclude identification and correc-

tion, or increase the extent of the deficiency is subject to stop work action by the Quality Assur-ance Department.

The Manager, Quality Assurance, and the Superintendent, Quality Assurance have no duties or responsibilities unrelated to QA that would prevent their full attention to QA matters.

1-2 Rev. 15 6/92

OQAM 1790 1.6 The authorities and duties of persons and organiza-tions performing quality assuranco functions shall be clearly established. Such persons have suffi-cient authority and organizational froodom to iden-tify quality problems; to initiato, recommend, or provide solutions; and to verify corrective action.

Assurance of quality by

chocking, auditing, inspecting, or othorvise verifying Program activ-ities shall bo by personnel other than tha indi-vidual or group performing the specific activity.

I 2184 1.7 The Manager, Nuclear Engineering reports directly to the Senior Vice President-Nuclear and directs a staff of superintendents, supervisors, supervising engineers, and quality control inspectors whose primary function is to provide technical support to the operation of Callaway Plant.

This support includes, but is not necessarily limited to design; modification; configuration control; system and equipment performance; reliability, and testing; technical programs administration; and contractor support.

He controls thoso activities and implo-ments the OQAP through the Superintendents, Design

Control, System Engineering, and Project Engineer-ing. Within the System Engineering organization, QC Inspectors (ISI/HDE) report to the Supervising Engineer Performance and ISI, and perform inspec-tion and nondestructive examinations. Those inspec-tors do not perform inspections or examinations which provide quality verification of Nuclear Engi-neering work activities.

I 2184 1.8 The Manager, Licensing and Fuels reporte directly to the Senior Vice President-Nuclear and has overall responsibility for UE nuclear fuel cycle activities including responsibility for procurement of fuel cycle goods and services, and for incore fuel management. The Manager, Licensing and Fuels is also responsible for coordinating licensing activities for Callaway Plant. The Licensing and Fuels organization providos technical support activition in the area of reactor design and radi-ological engineering.

1.9 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is respon-sible for providing administrative and management support including cost forecasting, status report-

ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal Health Physicist.

He is also responsible for the adminis-trative contact with the Institute of Nuclear Power 1-3 Rev. 15 6/92

OQAM Operations (INPO). As Principal Health Physicist, he provides a corporate level overview and guidance in the formulation and implementation of applied radiation protection programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations.

1.10 The Vice President, Nuclear Operations reports to the Senior Vice President-Nuclear and is respon-sible for the activities of the callaway Plant Operations Department and the Operations support Department.

This responsibility includes the safe, legal and efficient operation and maintenance of the Callaway Plant and protecting the health and safety of the public and Plant personnel.

He assures a high level of quality is achieved f.n the Plant operations and support activities.

l 1798 1.11 The Manager, callaway Plant reports directly to the Vice President, Nuclear Operations and is respon-sible for the safe, legal, and efficient operation and maintenance of the Callaway Plant.

He has overall responsibility for the execution of admin-1strative controls and the quality assurance program to assure safety. He controls Plant func-tions and implements the OQAP through the Assistant i

Manager, Work Control; the Superintendent, Health Physics; the Superintendent, Chemistry and Radwa s'.o ;

the Superintendent, Operations; the Superintendent, Malatenance; and the Supervising

Engineer, I&C

'see Figure C of the OQAM). He has the primary responsibility for reactor operation and safety. Within hJs organization, the QC Super-visor reports to tae Assistant

Manager, Work Control who reports to the Manager, callaway Plant.

The Quality Control Group performs work activity inspections, receipt inspection as described in Section 7, and nondestructive examinations and is not involved in those activities performed by others which are considered

" inspections" unto themselves, e.g.,

surveillance

testing, initial startup testing, and I&C, Radiation Protection, and Chemistry group activities. Activities considered to be inspections unto themselves are covered by QA audits and QA surveillances as discussed under Section 18.

The QC Supervisor has no duties or responsibilities unrelated to quality control that would prevent his full attention to quality control matters.

1-4 Rev. 15 6/92

OQo.M i

2293 1.12 The Manager, Operations support reports to the Vice President, Nuclear Operations and is responsible for Plant support activities including

training, materials management, security, and administration services activities required to support the callaway operating License.

Ho controls Plant support activities and implements the OQAP through the Assistant Manager, Materials, the Superinten-

dent, Training, the Superintendent, Security, and the Superintendent, Administration.

I 398 1.13 General quality assurance indoctrination and training for the Nuclear Division is the responsi-bility of UE Nuclear Operations (UENO),

Training.

The Quality Assurance Department is responsible for specific QA training as requested by Nuclear Divi-sion organizations.

1.14 The

Manager, Nuclear Information Services (NIS) reports to the Vice President, Nuclear Operations.

He is responsible for providing the

analysis, programming, operations, hardware support,

files, reports, and capabilitics necessary to maintain the nuclear information system and network in support of the plant.

1.15 The Manager, Nuclear Safety and Emorgency Prepared-ness (NSEP) reports directly to the Vice President, Nuclear Operations and is responsible for providing a

constant independent overview of nuclear Plant safety.

He directs the Supervising Engineer, Inde-pendent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP). A communi-cation path exists between the Manager, NSEP and the Senior Vice President-Nuclear for matters having immediate or significant safoty implica-

tions, thus providing a direct path to contact management personnel having corporate responsi-

-bility for callaway Plant.

I 1790 1.16 The Supervising Engineer, ISEG and staff evaluate callaway Plant operations from a safety perspectivo and compare Callaway operating experience with that of plants of similar design..In

addition, they assess the conformance of Plant performance to safety requirements.

1.17 The Supervisor, EP and staff have overall responsi-bility for the development and maintenanco of the Emergency Preparedness Program.

This includes onsite and offsito emergency preparedness, coordi-nation.of the Plant Radiological Emergency Response Plan with Stato and local emergency plans, and the planning and execution of emergency drills and 1-5 Rev. 15 6/92

OQAM omorgency plan exercises.

1.16 The Superintendant, Personnel (Local 1439 and 1455) reports directly to the Vice President, Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel activition, Fitness-For-Duty, and other matters under the guidance of UE policios.

1.19 The Superintendent, Personnel (Local 148) reports directly to the Vice President, Nuclear Operations and is responsib10 for assisting in areas of labor relations, organizational and personnel activition, and other matters under the guidanco of UE policios.

1.20 The

Manager, Purchasing reports directly to tho Vice President, Supply Service who in turn reports to the Senior Vice President-Administrativo Serv-icos.

The Manager, Purchasing is responsible for commercial aspects involved in procurement of mate-rials, systems, components, and services (oxcluding engineering services and certain nuclear fuel cyclo-related procuromonto) not delegated to others which are emp.oyed in support of Callaway Plant.

1.21 The Managor, Mechanical Engincoring reports to the Vice President-Engineering and Construction who in turn reports to the Senior Vice-President, Tech-nical Services. The Manager, Mechanical Engineering providos technical support, as noconsary, to the Nuclear Engineering staff.

1.22 The Manager, Electrical Engineering reports to the Vice President-Engineering and Construction.

The

Manager, Electrical Engincoring provides technical

support, as requested, to the Nuclear Engincoring staff.

I 1.23 The Manager, System Relay Services reports to the Senior Vice-President, Technical Services and is responsible for providing qualified engincors, technicians and equipment to maintain Callaway Plant relays.

1.24 The

Manager, Distribution Operating Department reports to the Vice-President Transmission and Distribution and is responsible for providing qual-ified engineers, technicians and equipment for Callaway Plant battery testing and technical support.

1-6 Rev. 15 6/92

OQAM 1.25 Other UE divisions may provido safoty-related services which augment and support selected Program activities.

Those organizations shall be required to implomont controls consistant with tho OQAP requirements applicable to their scope of activ-ition.

The coordination of those activities is the responsibility of tho Senior Vico President-Nuclear.

1.26 Safety review committoon shall bo established to provido an independant review of those items required by the Callaway Plant Technicdi Specifica-tions.

Those committoos, the Onsite Review Committoo (ORC) and the Nuclear Safoty Review Board

(!! SRB),

are described in the Administrative Controls Section of the Callaway Plant Technical Specifications.

1-7 Rev. 15 6/92

OQAM 2794 2.0 QUALITY ASSURANCE PROGRAM 1799 2.1 UE has established an OQAP which controls activ-ities affecting quality. The Program encompasses those quality activities necessary to support the operating phase of the callaway Plant and shall comply with 10 CFR 50, Appendix B

" Quality Assur-ance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33.

Commitments, clarifications, alternatives, and exceptions to the Regulatory Position of Regulatory Guide 1.33 are stated in Appendix A of this OQAM.

In addition, the OQAP has incorporated the commit-ments made in responding to applicable NRC ques-tions.

The text of the NRC questions applicable to the OQAP, along with the responses, are maintained as a QA Record separate from the OQAM. The Senior Vice President-Nuclear has initiated the Program and formulated the policy in addition to author-izing Program implementation. This responsibility has been established by the chairman and Chief Executive Officer of UE for establishing and imple-menting the Quality Assurance Program requirements.

l 1788 2.2 Lines of authority and responsibility have been established from the highest management level through intermediato levels and to the Vice Presi-

dent, Nuclear Operations and the onsite operating organization.

These relationships shall be docu-mented and updated, as appropriate, in the form of organization

charts, functional descriptions of departmental responsibilities, and position guides for key personnel having direct operating, support, or audit responsibility. Where specific responsi-bilities are assigned within the

OQAP, the prescribed individual shall retain the overall responsibility;

however, subject to applicable regulatory constraints, authority may be delegated to subordinates. Considering these same regulatory constraints, the authority of a subordinate may always be assumed by a superior, 1

2.3 Updating and revision of the OQAP as described in this OQAM shall be in accordance with the appli-cable requirements of 10 CFR 50.54 (a) and 10 CFR 50.71.

1824 2.4 The pertinent requirements of the OQAP apply to all i

1853 activities affecting the safety-related functions 20200 of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. The safety-related struc-2-1 Rev. 15 6/92 l

l OQAM and safety of the public. The safety-related struc-

turas, systems and components are identified in Table 3.2-1 of the Callaway-SP Final Safety Anal-ysis Report (FSAR). This list includes structures,

systems, and compenants identified during the design and construction phaso and may be modified as required during operations consistent with their importance to safety. Modifications to this list require the approval of the Manager, Quality Assur-ance and the Manager, Nuclear Engineering and shall be issued and controlled in accordance with Section 6.

The development, control, and use of computer programs to be used in safety-related activities are within the scopo of the OQAP. The degree of controls applicable to each computer program shall be consistent with the program's importance to safety-related activities. Consumables which could affect the form, fit or function of safety-related structures, systems, and components, although not listed in Tabic 3.2-1 of the callaway-SP FSAR, are also under the control of the OQAP.

1826 2.5 The OQAP shall be implemented throughout the oper 1879 ating life of the Callaway Plant. Activitics 1947 affecting quality shall be accomplished under suit-ably controlled conditions. Controlled conditions include the use of appropriate equipment; suitablo environmontal conditions for accomplishing the activity, such as adequato cleanness; and assurance that all preroquisitos for the given activity have been satisfied.

1789 2.6 Consistent with the schedulo for accomplishing 1879 quality activities, the OQAP shall be established and documented by written policy, program

manual, and procedure manuals. Persons conducting safety-related activities shall be responsible to imple-ment approved procedures. The OQAP shall utilize the following document types to describe Program objectives:

1.

Operatina Ouality Assurance Pronram Poliev/

M rgduction Statement The operating Quality Assurance Program Policy statement establishes governing principles in accordance with the requirements of 10 CFR 50, Appendix B.

The Operating Quality Assurance Program Policy statement and any revisions thereto shall be approved by the Senior Vice President-Nuclear.

2-2 Rev. 15 6/92

OQAM l

1823 2.

Operatina Ouality Assurance Manual (OOAM)

The OQAM contains a delineation of the Policy statement, quality assurance requirements, assignment of roeponsibilities, and a defini-tion of organizational interfaces. The OQAM is the written description of the OQAP.

Approval of the OQAM is by the Senior Vice President-Nuclear and the Manager, Quality Assurance, i

1947 3.

Callaway Plant Oooratina Manual The callaway Plant Operating Manual consists of a

multi-volume set of Plant operating proca-dures prepared or reviewed by the staff with the aid of other SNUPPS utilities, Nuclear Engineering, the Lead A/E, the NSSS

Supplier, and Fuel Fabricator.

These procedures are controlled, approved, and issued in accordance with Administrative Procedures contained within the Manual. This Manual includes administrative controls consistent with those required by Regulatory Guide 1.33.

l 1800 Administrative procedures which apply to the entire staff, and revisions thereto, shall be reviewed by the callaway Plant Onsite Review Committee (ORC) and the Quality Assurance Department.

The final approval of Administra-tive Procedures and revisions thereto shall be by the Manager, callaway Plant. The review and approval of other procedures and revisions thereto shall be in accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications.

679 2.7 UE may employ the safety-related services of archi-1746 tect engineers, NSSS suppliers, fuel fabricators, 1787 constructors, and others which provide or augment 2293 UE efforts during the operating phase. These organ-2460 izations shall be required to work under a quality assurance program whose controls are consistent with the scope of their effort.

This does not preclude any organization from working under the UE OQAP.

The quality assurance program of outside organizations shall be subject to review, evalua-tion and acceptance by the UE Quality Assurance l

Department prior to the initiation of safety-re-lated work.

Ve' dor programs and procedures shall also mees J's tammitment to USNRC Generic Letter 83-28.

2.8 Disputes voich may arise Netween QA or QC personnel and persw.. 1 in otbu UE organizations which 2-3 Rev. 15 6/92 i

oQAM cannot be resolved shall be referred to the next higher level of management for resolution. Disputes which cannot be resolved through these levels shall be resolved ultimately by the Chief Executive Officer.

2.9 Preservice (PSI) and inservice (ISI) inspection,

testing, and examination act ivities may be performed by outside organizations. These inspec-tions and other operating phase " code" activities shall comply with the requirements of the appli-cable Coce Edition and Addenda of the ASME Boiler and Pressure Vessel Code. This compliance includes the independent third-party inspection coverage of

" code" items by an Authorized Nuclear Inspector.

l 1795 2.10 General indoctrination and training programs shall 1916 be developed for personnel performing safety-2194 related activities to assure that responsible func-l

tions, departments, and individuals are knowledge-able regarding quality policy and requirements of applicable manuals and procedures. The requirements for training of Callaway Plant personnel are described in Section 13.2 of the Callaway-SA FSAR.

The training of permanent Plant personnel is the responsibility of the Superintendent, Training. UE personnel performing complex, unusual, or hazardous work shall be instructed in special indoctrination or briefing r ssions. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equip-ment and

systems, operating constraints, and control requirements in effect during performance of work.

Training shall be conducted as required to, as a minimum, meet the requirements of UE's commitment to Regulatory Guide 1.8 ( ANSI /ANS 3.1),

Regulat,ry Guide 1.33 (ANSI U18.7), other Regula-tory Guides as endorsed in OQAM Appendix A,

and other regulatory requirements. Records of training shall be maintained as described in Section 17.

Where required by code or standard, personnel are trained or qualified according to written proce-dures in the principles and techniques of performing specific activities. Special equipment, environmental conditions,

skills, or processes shall be provided as necessary for the effective implomontation of the OQAP.

I 1799 2.11 An audit system shall be established to assure management is advised of Program effectiveness. The implementation and effectiveness of the OQAP shall be assessed through an audit program of quality activities which includes

design, procurement, modification, and operation. The Manager, Quality 2-4 Rev. 15 6/92

OQAM Assurance is responsible for a nystem of planned audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance and in accordance with the require-monts of Section 18.

He is responsible for conducting audits of offsite and onsito activities.

Deficiencies identified during the audit process are reported to responsible management of the organization involved in the resolution and follow-up to assure correctivo action.

1799 2.12 The Senior Vice President-Nuclear providos for an 1800 independent assosoment of the scope, impicmenta-

tion, and offectiveness of the OQAP to assuro compliance with

policy, commitments, and the requiromonts of 10 CFR 50, Appendix B as set forth in this OQAM. This assessment shall be conducted biennially with a

scheduling allowance of plus three months for each assessment and a combined timo interval for any throo consecutivo assessment intervals not to exceed 6.25 years. This assessment may be by representativos of other utilition, outsido consultants, or UE management representa-tives.

In addition, various reports are issued to the Senior Vice President-Nuclear on a periodic basis to assist his indopondent assessment of the OQAP (e.g.,

semiannual QA report, and periodic QA audit reports).

2.13 Implomontation of OQAP controls over activities affecting quality assures achieving the objectivo of the UE OQAP to provide management with adequato confidence that activities affecting quality regarding the design, installation, modification, and operation of the callaway plant are performed consistent with policy.

Documentation of the accomplishment of OQAP objectivos is maintained in the form of records of data and other information as necessary to support operation, maintenance,

repair, modification, refueling, and inservice inspection.

2.14 UE Management has established standards of perfor-mance which exceed those set forth by the Regula-tory Agencies. As a management initiative in this

area, UE has defined the word "must" to impose management directed performance standards in excess of and in addition to established Regulatory directed performancc.

From the viewpoint of UE omployees and UE contractors, there is no differ-ence in the degree of compliance mandated by use of the words "shall" or "must."

Compliance with actions initiated by use of either "shall" or "must" is audited and surveilled by the QA Depart-2-5 Rev. 15 I

6/92

l oQAM ment.

Failure to implement a "must" mandated activity requires corrective action in the same way as failure to implement a "shall" mandated activ-ity.

However, from an external viewpoint, -inter-nally imposed "must" requirements (i.e., those in excess of Regulatory requirements) are not intended to be subject to enf orce.nent action.

"Must" is defined in Appendix A of this OQAM under Regulatory Guide 1.74.

2-6 Rev. 15 6/92 1

OQAM 2165 3.10 Proceduros shall specify requirements for the 2166 review and approval of design changes by the organ-2168 izations or individuals that performed the original 2169 design or Nuclear Engincoring. Design cc..rol 2243 activities, including design changes, udy be dele-gated to others provided they have access to back-ground and technical information. Design control measures for design revisions shall be commensuratn with those applied to the original design.

1934 3.11 Design activities shall also includo:

1) reviewing I

the applicability of standards;

2) reviewing commercial or previously approved materials, parts or equipment for suitability of application; 3) re-viewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment and components for inservico inspection, mainto-

nanco, and repair;

5) specifying critoria for inspection and test / retest; and 6) reviewing and approving procedures for special processes.

2164 3.12 The design process shall establish controls for 2168 roloasing design documents which are technically 2191 adoquato and accurato in a controlled manner with a 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled through the use of writton procedures by the

issuor, distributor, and user to provent inad-vertont use of superseded documents.

Document control proceduros shall govern the collection,

storago, and maintenance of design documents, results of design document reviews, and changes thoroto. The design documents subject to procedural control includo, but are not limited tc, specifica-

tions, calculations, computer

progrtms, system descriptions,.SAR when used as a design

document, and drawings including flow diagrams, piping, and instrument diagrams, control logic diagrams, eloc-trical single line diagrams, structural systems for major facilities, sito arrangements, and equipment locations.

2164 3.13 The design interfaces betwoon UE organizations 2188 performing work affecting quality of design and 2190 betwoon UE and outside organizations shall be 2217 identified and controlled by procedures. Those 2218 proceduros shall address control of the interface, 2219 responsibilities, lines of communication, and 2223 documentation of internal and external interface activities.

1934 3.14 The design process shall include design verifica-2182 tion. Design verification assures that design is 2209 adequato and meets specified design inputs. Design 3-3 Rev. 15 6/92 O

MM i

tion would become irreversible (i.e.,

require extensive demolition and rework). The design veri-fication shall be complete prior to relying upon the component, system, or structure to perform its safety-related function.

2200 3.16 Action shall be initiated to correct errors found in the design process. Errors and deficiencies identified in approved design documents shall be documented and the process of their correction (i.e.,

review and approval) shall be controlled.

4 These actions shall assure that changes to design or installed components are controlled.

3.17 Requests for design changes affecting safety-related structures, systems, and components may be originated by the unit staff, Licensing and Fuels or Nuclear Engineering. Design changes shall bo processed by. Nuclear Engineering.-Design changes engineered by Nuclear Enginetting shall be the

. responsibility of the Manager, Nuclear Engineering.

Design changes engineered by Licensing and Fuels shall be the responsibility of Licensing and Fuels.

5844 3.18 Independent of the responsibilities of the design organization, the requirements of the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB) as defined in the Technical Specifications shall be satisfied. Design changes require a safety evaluation which shall be reviewed by the ORC and I

approved by the Manager, Callaway Plant. In addi-

tion, changes in the facility as described in the FSAR which involve a change in the Callaway Plant Technical Specifications incorporated in the license or an unreviewed safety question require review and approval by the NSRB and the Nuclear Regulatory. Commission prior to implementation. When design is-performed by an outside organization, UE shall perrorm-or coordinate a review of the design for operability, maintainability, inspectability, 1

FSAR commitment compatibility, test and inspection acceptance criteria acceptability, and design requirements imposed by Plant generating equipment.

5844 3.19 Safety evaluations which consider the effect of the i

design as described in the design documents, shall be performed by the responsible UE engineering organization or outside organization (s). -These evaluations shall include the basis for the deter-mination that the design change does not involve an unreviewed safety question. As deemed necessary by the evnluating organization, detailed analyses shall be~ performed to support the bases of safety evaluations.

All nuclear safety evaluations are 3-5 Rev. 15 6/92

~

--..n--.-.

OQAM submitted to tho ORC. Changes involving the evbsti-tution of equivalent hardware require safety evaluations to assure that the design requirement changes are consistent with and do not alter the design critoria specified in existing design docu-monts. When design documents and safety evaluations are prepared by an outside organization under its QA program, review and approval por ANSI N45.2.11 will be included.

UE will approvo all outsido organizations' design documents and safety evalua-

tions, and will perform appropriato reviews necos-sary for final approval.

I 3.20 The ORC shall review doelgn change safety evalua-tions to recommand final approval of design changes. Design changos which involvo an unroviewed safety question or a change in the Technical speci-fications shall be forwarded to the NSRB for review. An application for amendment of the licenso shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90.

3.21 The NSRB shall review safoty evaluations to verify that changen did not involvo unroviewod safoty questions.

l 1911 3.22 Proceduros and instructions related to equipment or 2162 systems that are modiflod shall be reviewed and updated to reflect the modification prior to placing the equipment or systems in operation to perform safety-related functions. Plant personnel shall be made aware of changes affecting the performance of their duties through procedure revi-

sions, or specific training in the operation of modified equipment or systems, or other appropriate means.

2039 3.23 Records shall be maintained which reflect current 2132 design including safety analyses, safety ovalua-2163

tions, design change installation proceduros, 2173 material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings.

3.24 Drawings shall bo prepared under a drawing control system which provides for checking methods and review and approval requirements. Drawings shall be subject to reviews by the responsible design organ-ization for correctness, conformance to design

critoria, and compliance with applicaFle codes and standards.

3-6 Rev. 15 6/92

OQAM 1875 4.0 ERD 9HRElif.HT_ DOCUMENT CONTRQL 3541 3548 I

679 4.1 Safety-related procurements shall be doctmented.

975 Procurement document control applies to documents 1876 employed to obtain safety-related materials, parts, 1887 components, and services required to support Plant activities.

Written procedures establish require-ments and assign responsibility for measures to assure applicable regulatory requirements, design

bases, and other requirements necessary to assure quality are included in procurement documents.

3559 4.2 Written procedures shall include

controls, as applicable, for preparation,

content, review,

approval, and processing of the following related procurement documents:

1.

Purchase Requisitions 2.

Purchase orders 3.

Letters of Intent 4.

Engineering Service Agreements (agreements for engineering, construction, or consultant serv-ices) (ESAs) 5.

Contracts 6.

Specifications 7.

Drawings 3560 Collectively, these procedures shall assure that I

technical and quality requirements are correctly

stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with QA Program require-monts.

3572 4.3 Consideration of the verification activities to be 3607 employed for item or service acceptance should 3874 begin during the purchase requisition,

ESA, or w

contract preparation and review stage. Planning of verification activities shall include a review of the established acceptance criteria and identified documentation.

Verification methods which may La employed include certifications (certificates of conformance and waterial certificates or test reports),

source verification, receiving inspec-

tion, and post-installation tests established by UE.

Selected verification methods may be indicated as inspections, examinations, tests, or documenta-tion rsviews. The extent of the acceptance methods and associated verification activities is a func-tion of the purchased item's or service's complexity and relative safety significance, as 4-1 Rev. 15 6/92

g

%.C.,

Ec; 00AM 4

i M

well as the supplier's past performance.

[

C.

l 1892 4.4 Acceptance by source verification should be consid-3572 ored when the item or service is vital to Plant safety; or the quality characteristics are diffi-cult to verify after recolpt; or the item or service is complex in design, manufacturo, inspec-tien or test. Verification in this senso involvts a physical prosence to

monitor, by observation, designated activities for the purpose of ovaluating supplier portormanco and product acceptability.

1875 4.5 Purchase requisitlons must be employed to initiato the procuromont of aafety-related materials, parts, components, and servicus while ESAs must be used to contract for safety-related engincoring, construc-

tion, or consultant services. Contracts, purchase orders generated from purchaso requisitions, and ESAs must be employed to procuro certain goods and nervices associated with the nuclear fuel cycle.

Purchase requisitions for safety-related materials,

parts, components, and services and ESAs for professional services may be initiated by personnel in the Quality Assurance or Quality Services Departments; Nuclear Engineering, Nuclear Services, or Licensing and Fuels Department; or the unit staff.

975 4.6 The procuromont of spare or replacement parts for 1876 safety-related structures, systems, and components 1877 shall be subject to the QA Program controls in 1878 offect at the time the order is issuod; and to 1883

codes, standards, and technical requirements which are equal to or better than the original requiro-ments or as may be required to reduce the proba-bility for repetition of defects, procurement docu-mont control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifica-tions and codes equival3rt to those specified orig-inally or those specified by a properly reviewed and approved revision; packaged and transported in a

manner to assure the non-degradation of quality during transit; and properly documented to show compliance with applicable specifications,

codos, and standards.

1876 4.7 Each item or service to be procured is ovaluated by the procurement document originator to datormine whether it performs a safety-related function or involves activities which affect the function of safety-related materials, parts, or components and to appraise the importance of this function to Plant or public safety. For those cases where it is 4-2 Rev. 15 6/92

OQAM i

unclear it an individual picco (part of a safety-related structure, system, component or servico) is governed by the OQAP, an engincoring evaluation shall be conducted.

The ovaluation shall be conducted by Nuclear Engineering or Hatorials Engi-nooring and shall classify the safety relationship l

l of the service or questionablo component, parts or ltoms of safety-related structures, systems, and components.

Evaluations shall bo documented for futuro reference.

4.8 Provisions for the following shall be included in procutement documents as applicable. Those provi-sions may be addressed by invoking a supplier's approved quality program in the procurement docu-mont.

1864 1.

The scopo of work and basic administrativo and 1890 technical requirements including drawings, 2416 specifications, regulations, special instruc-3550 tions, and applicable codos and industrial 3551 standards and procedural requirements identi-3552 fled by titles and revision lovels. Procurement documents shall also include special process instructions; identification of inspection, test and acceptanco requirements; and any special requirements for activitics such as designing, identifying, fabricating, cleaning,

erecting, packaging, handling, shipping, and storing.

1888 2.

Requiremont that the supplier have an accept-1890 ablo Quality Assuranco Program which implements 3542 the appropriate occtions and elements of ANSI l

3550 N45.2-1977 or the ASME code as applicable as 3553 established for the item or service to be supplied. This requiremont is not applicable to commercial grado items which utilize a suppli-or's standard or proven design to moet published product descriptions.

1890 3.

Requirements for supplier surveillanco, audit, 1

3550 and inspection including provisions for UE or 3555 agent access to facilities and records and for 3573 identification of witness and hold points.

3867 3874 1890 4.

Requirements for extending applicable require-3542 ments of UE procurement documents to lowor-tier 3550 suppliers and subcontractors. Those requiro-

-3554 monts shall include right-of-access to subsup 3555 plier facilities and records by UE.

4-3 Rev. 15 6/92

i 00AM i

3550 5.

Requirements for suppliers to obtain UE 3558 approval of nonconformances to procurement i

3597 document requirements dispositioned "use-as-is" and

" repair" and conditions of their disposi-tion including identification of those subject to UE approval prior to further processing.

3484 6.

Applicability of 10 CFR 21 reporting require-ments.

1890 7.

Documentation requirements including records 2132 to be prepared, maintained, submitted for 3550 approval, or made available for review, such 3556 as, drawings, specifications, procedures, l

3574 procurement documents, inspection and test

records, personnel and procedural qualifica-

tions, chemical and physical test results, and

-instructions for the retention, transfer, and disposition of records.

8.

Requirements that the supplier furnish

-documentation which identifies the purchased item and provides traceability to the procure-ment. requirements met by.the item and documen-tation identifying any procurement requiremento which have not-been met.

3559 4.9 The originating organization shall perform a docu-3560 mented. independent _ review of procurement documents 3562 to assure requirements are correctly

stated,

-inspectable, and controllable and_that there are adequata acceptance and rejection criteria.

This review shall be performed by personnei who have access.to; pertinent information, and who have an adequate understanding-of. the requirements and intent"of_the procurement documents.

3564 4.10'

_ Bids or proposals shall be evaluated by the 3567 Purchasing-Department,othe originating-organiza-

<3568 tion, the-Quality' Assurance Department, and the

3569_

Licensing-and Fuels Department to assure confor-mance fto procurement document requirements in the following areas as applicable-to the type of procurement'as described below:

1.

Technical considerations 2.

Quality Assuranceirequirements 3.

Research and development effort 4..

Suppliers'" personnel qualifications 5.

Suppliers' production capability 6.

Suppliers' past' performance 7.

Alternates 8.

Exceptions-4-4 Rev. 15 6/92

oQAM 3560 4.10.1 The Purchasing Department shall initiate and coor-3563 dinate bid evaluation activities for those propos-I als received in response to requisitions.

The Purchasing Department shall review bids or propos-

ala, except those associated with ESAs or nuclear fuel cycle related goods or services, for alter-natos or exceptions to procurement document requirements (areas 7 and 8 above) taken by the supplier. These reviews shall be documented.

3560 4.10.2 The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier.

They shall also review areas 1 through 3 above for replacement parts or equipment ordered from the original supplier as part of procurement document preparation.

I 3560 4.10.3 The Quality Assurance Department and the origin-ating organization review areas 4 through 6 above as part of maintaining a supplier on the Qualified Supplier List as described in the OQAM, Sections 7.0 and 18.0.

3560 d.10.4 The Licensing

& Fuels Department shall evaluate bids or proposals for fuel cycle goods or services in the above areas.

3560 4.11 Bids or proposals with alternates or exceptions 3561 identified in Section 4.10 by the Purchasing i

3567 Department shall also be evaluated by the origi-3568 nating organization to provide additional assurance 3570 that no unacceptable conditions result from such changes.

Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award.

4.12 Letters of intent may be utilized with suppliers of materials, parts, components, and servives for the purpose of reserving schedule space prior to the resolution of the commercial requirements to be included in a purchase order, contract, or ESA. If

employed, letters of intent must normally specify that no safety-related activities may begin until an approved purchase order, contract, or ESA is executed.

Letters of intent shall be

prepared, approved and issued by Purchasing for those suppliers to be covered by purchase order, by the originating organization for ESA's, or by the Nuclear Fuel Department for contracts for nuclear fuel cycle-related goods and/or services.

However in the event a letter of intent is issued for the purpose of securing an agreement and thereby allow 4-5 Rev. 15 6/92 1

OQAM safety-related work to begin prior to the issuance of such documents, it shall include the applicablo quality and technical requirements, as specified by the originating organization.

3563 4.13 The Purchasing Department is responsible for reviewing purchase orders to verify that the tech-nical and quality requiroments have boon accurately transferred from the requisition to the purchase ordor. Approval of the purchase requisition, letter of

intent, ESA, or contract shall be by an indi-vidual who has approval authority and signifies that the technical and quality review of the docu-mont has boon completed. Contracts initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility of the

Manager, Licensing and Fuels with preparation and negotia-tion by the Licensing and Fuels Department. Nuclear fuel cyclo-related contracts and E5 us for profes-sional services shall be executed le the Senior Vice President-Nuclear or another ccapany officer in accordanco with Nuclear Division and corporato proceduros related to agrooments or contracts for services.

975 4.14 Additions, modifications, exceptions, and other 3543 changes to procurement document quality and toch-3549 nical requirements shall require a review equiv-alent to that of the original document and approval 3555 1

3563 by the originator or the originating department 3575 approval authority. Commercial consideration l

42567 changes shall not require review and concurrence by the originator. Conditions specified on the Qual-ified Suppliers List (QSL) that apply to a vendor be revised without concurrence from the origi-may nating organization since they are imposed without the knowledge of the originator, r

4-G Rev. 15 6/92

OQAM 2974 5.0 JMETRUCTIONS, PROCEDURES AND DRM0Mg{

1830 5.1 The activities affecting quality associated with 1858 the operating phase shall be accomplishod and 1867 controlled by:

1916 l

1948 1.

Preparing procedures, instructions, specifica-

-tions, drawings or checklists of a type appro-priate to the activity and its importance to safety which specify the methods for complying with 10 CFR 50, Appendix B and the Technical Specifications; 2.

Including in these documents quantitative or qualitative acceptance criteria for-verifying that an activity -has been satisfactorily accomplished; 3.

Having responsible personnel approve these documents prior to accomplishing an activity; and 4.

Using approved drawings, procedures, instruc-tions or checklists to accomplish an activity; The ' degree of control imposed shall be consistent with. the' relative importance of the activity to safety.

1833 5.2 The. Nuclear Division and other responsible 'func-tions-and departments.shall provide written proce-dures and drawings as required 'to support the callaway. Plant operating phase. These procedures b

shall' prescribe those activities affecting safety-related structures, systems, and components. It is recognized that skills normally possessed by qual-ified personnel may not require detailed step-by-step' delineations in written procedures.

5.3 The Manager,--Callaway Plant.shall be. responsible for-providing specific guidance via Administrative Procedures'for_the-development, review and approval of other Plant = operating procedures to govern activities which affect.

safety or quality consistent with the-Technical Specifications.

'~

'Similar guidance shall be provided for. revisions and -temporary changes to Plant operating proce-dures. Procedures which: implement the Security Plan

- and. Radiological Emergency Response Plan shall-be reviewed no _less frequently--than every-twelve months -(in accordance with Technical Specifica-tions).

A revision of a procedure may constitute a procedure review.

5-1 Rev. 15 6/92

OQAM 5.4' The

approval, issue and control of implementing procedures, manuals and policy shall be prescribed in Administrative Procedures consistent with the i

requirements of Sections 2, 5 and 6.

5.5 Administrative Procedures shall be reviewed by the Quality Assurance Department as described in Section 2.6, item 3.

5.6 Maintenance and modification procedures shall be reviewed in accordance with Section 6.2.

5.7 Special process procedures supplied by outside organizations shall be reviewed in accordance with Section 9.4.

addition to the procedures identified in Table 5.8 In 13.5-1 of the Callaway-SA FSAR (CALLAWAY PLANT ADMINISTRATIVE PROCEDURES),

the OQAP includes

procedural coverage in the following areas: design control; design change _ control; preparation,

review, approval, and revision of specifications,

drawings, requisitions, Engineering-Service _ Agree-

ments, contracts and procedures (instructions); QA indoctrination and-training; auditor trainina-supplier--

evaluations; receipt and transfer e

records; document control; quality program audits; corrective action;_ inspection; inspection, test and operating status; and special processes.

5.9' Applicable procedures shall be reviewed and revised as necessary as described in Appendix A.

Regulatory Guide'1.33'(ANSI N18.7-1976, Section-5.2.15).

5-2 Rev. 14 8/91

OQAM 187E 7.0

. CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND 3541 DERVICES 1-7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4.

Provisions shall be established to control activ-ities affecting quality associated with the procurement of material, equipment and services including:

1.

The preparation, review, and change control of procurement documents as described in Section 4 2.

Bid eJ'luation and award as described in i

Sectior 4 3565 3.

Procurement source selections 4.

Verification activities (surveillance. Inspec-tion, and audit) required by the purchaser l

3597 5.

Control of nonconformances as described in Section 15 6.

Corrective action as described in Section 16 7.

Material, equipment, and service acceptance 2416 8.

Control of quality assurance records 9.

Audits of the procurement program as dnscribed in Section 15 l

1891 7.2 UE shall assure that suppliers providing safety-3564 related materials, equipment, or services are 3565 acceptable procurement sources. Provisions shall 3874 be made for supplier evaluations which assess their capabilities prior to <>.srd by: 1) source evalua-tion; or 2) review for objective evidence of qual-ity; or 3) a review of supplier history.

When evaluations are performed, the assessment of a

supplier's capability shall 'bo specific to the procured

item, commodity, or service and the supplier's ability to provide the items or services in accordance with procurement document require-monts. Suppliers of hardware and services which are manufactured prior to award, considered a commer-cial grade item, or implemented under the UE OQAP do not require pre-award source evaluation or post-award audits which attest to their capability as a procurement source.

7-1 Rev. 15 6/92

ochx 1

2337 7.3 During Callaway's operating life, procurements may 3564 be made.from:

1) suppliers judged capable (prior 3874 to award) of providing items or services in accor-dance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and whose acceptability can be determined by receiving inspection, an examination of quality verification documentation, or other suitable means;

3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAP.

Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a purchase order or execution of a contract or ESA, a verification of the supplier /outside organization's acceptability shall be documented.

Except in y

unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition),

an evaluation of a

supplier's acceptability as a procurement source shall be accomplished prior to award. In the case of purchase orders, the supplier shall be verified as an acceptable procurement source for the item or service being procured.

Purchase orders may be issued prior to an assessment of suppliers' capa-bility provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source.

7.4 Coda certified material may be obtained from an ASME accredited Material Manufacturer or Material Supplier for repair or replacement applications.

However UE may also obtain Code certified materials from non-ASME accredited Material Manufacturers or Material Suppliers if such Manufacturers or Suppliers are otherwise qualified as stipulated in Sections 4 and 7 of tho'OQAM. These provisions are consistent-with ASME Code Interpretation XI-1-83-50R dated May 14, 1985.

1891 7.5 Procurement source evaluation and selection 1894 involves the Quality Assurance Department and the 3564 originating organization. The evaluation and selec I

3565 tion process shall be-specified in department proc-edures and may vary depending on the complexity and relative importance to safety of the item or service.

Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organiza-tions may be requested to provide input to the qualification evaluations of suppliers.

Suppliers 7-2 Rev. 15 6/92

oQAM

of, hardware - and services.which are manufactured prior:to award, considered a commercial grade item, or: -implemented under the OQAP do not require pre-1 award source. evaluation audits which-attest to a

l suppliers capability _as a procurement source.

l=

35651 7.6

.Procuroment source selection and evaluations shall

-3566 consider'one or more of'the following:

3564-1.

Experience of users of identical or similar products of-the prospective supplier.

NRC Licensee Contractor and Vendor Inspection Program (LCVIP) reports,_ASME Certificates of Authorization,(C of A),

audit reports, _

UE records _ accumulated in previous procurement-

actions, and UE product-operating experience may. be used in this evaluation. ' Supplier history shall reflect recent capability.

Previous

_ favorable : quality. experience, with suppliers _maylbe an adequate basis for judge-ments attesting to their capability. When an.

LCVIP report, an audit report, or an ASME C of A

is used to establish a supplier's accepta-bility as a procurement source, the document

.shall-b'e identified, b

2.

- An evaluationlof the supplier's current quality

. records supported by documented qualitative and quantitative information which can be objec-

-tively evaluated. This mayfinclude review and evaluation of the -supplier's-QA

Program,

Manual, and Procedures, as appropriate;-

and responses to questionnaires.

3564-3.

A source evaluation of the supplier's

- l technical and quality capability as determined by a_ direct evaluation (audit or surveillance).

of1 facilities, personnel and Quality-Assurance

' Program implementation.

4.

.For commercial grade-items, the procurement source selection should consider one or more of the following:

a.

Survey of documented supplier controls over

-critical characteristics and that supplier activities adequately -control the items-

supplied, and verify the implementation:of manufacturer's measures for control of design,_ process, and material changes, b.

Acceptable supplier / item performance record utilizing monitored performance of the

item, industry product

tests, national 7-3 Rev. 15 6/92

OQAM

codes, and standards (not specific to the nuclear industry), or other industry data-bases (UL, INPO NPRDS, EPRI

EQDB, ANSI,

NEMA, MIL-STDS, NRC Bulletins /Noticen, and Licencee Event

Reports, etc.)

that is directly related to the item's critical characteristice and intended application.

7.7 Procurement source evaluations involve a review of a

technical and quality assurance considerations.

Technical considerations include the design or manufacturing capability and technical ability of suppliers to produce or provide the

design, service,

item, or component.

Quality assurance considerations include one of the previously defined methods of supplier evaluation and a

consideration of changes in a supplier's Quality Assurance Program or capabilities.

The measures employed to evaluate a supplier's continued accept-ability as a procurement source (after the initial source evaluation) are described in Section 18.

I 1892 7.8 Organizations participating in the procurement process shall prepare procedures to monitor and evaluate suppliers' performance to procurement document requirements.

These procedures snall include provisions for: 1) controlling documenta generated or processed during activities fulfilling procurement requirementa; 2) identifying and processing change information; 3) establishing a

method of control and documentation of information exchanga with the supplier; and 4) audit or surveillance of supplier activities.

1 3572 7.9 Depending on the complexity or scope of the item or 3573

service, the Purchasing Department and/or the originating organization shall initiate award activities.

Meetings or other forms of communica-tion may be held to establish the intent of UE in monitoring and evaluating the supplier's perfor-

mance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulfilling requirements. The depth and necessity of these activities shall be a func-tion of tne relative importance, quantity, unique-

ness, complexity, frequency of transactions with the same supplier, and the supplier's past perfor-mance.

UE hold and witness points shall be docu-mented as early as practicable in the procurement process.

3574 7.10 The originating organization shall establish meas-ures for monitoring supplier-generated document submittals against procurement document require-7-4 Rev. 15 6/92

oQAM ments. Similarly, measures shall be established for reviewing and-approving supplier generated docu-monts for use. Changes to procurement documents shall be in accordance with the controls described in Section 4.

3565 7.11 Supplier monitoring activities may be performed by personnel.from Quality Assurance, Nuclear Engineer-ing, Nuclear Services, Nuclear Safety and Emergency Preparedness, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests.

Supplier monitoring activities may include:

1.

Audits of supplier quality assurance program implementation 2.

Monitoring, witnessing, or observing inspec-tions, examinations, and performance tests 3.

Surveillance of manufacturing processes 4.

Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-mances 2337 7.12 To support the control of purchased

material, copies of purchase orders and other appropriate procurement documents shall'be forwarded to the applicable receiving or acceptance point.

Depart-ments receiving or utilizing procured items or services shall establish measures to maintain and control procurement documents until the items or services are received and accepted. These documents shall include purchase orders, drawings and speci-fications, approved

changes, and other related documents.

975 7.13 Receiving inspection instructions shall be 2337 documented. These. instructions include specifying

-2416 inspections or tests of commercial grade items procured from suppliers on the basis of product performance.

Should it become necessary to upgrade

-stocked non-safety related items to specific requirements, inspections, testo, or documentation reviews may be employed to establish the items' acceptability.

Documentation shall be generated as a result of UE receiving-inspection activities, i

7-5 Rev. 15 6/92

OQAM i

975 7.14 Acceptance of items and services shall include one 1891 or more of the following:

3608 1.

Written certifications 2.

Source verification 3.

Receiving inspection 4.

Post-installation test (in addition to one of the above) 1876 7.15 Commercial grade items sh711 rely on pr een design 1

3565 and utilize verification methods by the pu: chaser, to the extent appropriate to item application.

Procedures provide for the acceptance of commercial grade items on one or more of the following:

1.

Special Tests and Inspections 2.

Survey of Supplier (Commercial Grade) 3.

Source Verification 4.

Acceptable Supplier / Item Performance Record Method 4 should not be used alone unless:

a)

The established historical record is based on industry wide performance data that is directly applicable to the item's critical characteris-tics and the intended safety related applica-tion; and b)

The manufacturer's measures for the control of design, process, and material changes have bean adequately implemented ae verified by audit (multi-licensee team audits are acc9ptable).

I 1891 7.16 Where required by code, regulation or contract 1893 requirement, documentary evidence that items 3603 conform to procurement documents shall be available 3605 during receiving inspection or prior to use of such 3607 items.

Where not precluded by other requirements, documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item accep-

tance, verification of the validity of supplier certificates and the effectiveness of the certifi-cation systems shall be conducted at intervals commensurate with the supplier's past quality performance.

Certificates of conformance and compliance shall be required to be signed or_accom-panied by a signed letter of trancmittal.

Where acceptance is based upon source verification, docu-mented evidence of these surveillances shall be furnished to the Plant Quality Control organization by the responsible UE organization or their desig-nated agent prior to acceptance.

7-6 Rev. 15 6/92

OQAM 1884-7.17 Acceptance by receiving inspection shall be 3606 utilized as a prime method of verification and may be utilized as the sole means of item acceptance when items are relatively simple and standard in L

design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspections; and when inspections do not require operations which could adversely affect the integrity,

function, or cleanliness of the item.

When other methods are utilized, receiving inspec-tion shall be employed to verify that items have not sustained damage.

l 2483 7.18 Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 -

1978, (as clarified in OQAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organi-e zation. Other unit staff personnel qualified to ANS 1978 may be utilized to perform receipt 3.1 inspections requiring specialized skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, exten-sive modifications, or other special circumstances, receiving inspection may be assigned to an outside organization (s).

I 2337 7.19 Final acceptance of items shall be by Quality control personnel or designated inspection person-nel.

The final acceptance of services shall be the e

responsibility of the originating organization.

Acceptance shall be documented.

975 7.20 Receiving inspection activities shall include:

2337 1.

Verifying that materials, parts, and compo-nents, have been identified by tagging or other m

means; or that.they are segregated and controlled in areas separate from the storage facilities for accepted items.

2.

Verifying that items for acceptance have been i

examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documenta-tion.

I 3.

Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures and calibrated

tools, gages and measuri.ng equipment to verify the acceptability of iteins, including those from commercial grade suppli-ers.

7-7 Rev. 15 6/92

.0QAM

~ 2326 4.

Providing final' acceptance.after determining 12329~

'that required verifications are-complate'and 2328-acceptable.

Items determined to be acceptable for-use-shall be tagged-with an accept tag 1'or other.means of identification or; segregation, and released for storage or use.

Conditional acceptance-of. items by ' receiving inspection shall be procedurally controlled, g:

2327' 5.

. Verifying that received items which-do not 1 conform-to procurement documents are segregated (if -practicable) and processed in accordance

-with Section 15.

36087.21 Acceptance by post-installation-test may be-util-<

ized' following one of-the preceding-acceptance methods. Post-installation' testing shell be used as the prime means of acceptance verification-when it is difficult to verify. item-quality' characteris-tics; the; item requires-an-integrated system-checkout or test; or=the item cannot demonstrate its ability to perform when not in use.

Post--

installation. test requirements and acceptance docu-mentation shall be established by UE.

4 o

l 1

.j 7-8 Rev. 15 6/92

OQAM 8.0 IDENTIFICATION AND CONTROL OF MATERIALD, PARTS AND COMPONENTS 975 8.1 The identification and control of materials, parts, 1384 and components shall be accomplir ?d in accordance 1885 with documented procedures and apply to safety-related materials,

parts, and components during fabrication, storage, installation or use.

Materials,

parts, and components identified as nonconforming shall be controlled as described in Section 15, 1897 8.2 The identification and control requirements shall 2090 address traceability to associated documents, as 2333 appropriate; specification of the degree of identi-2337 fication and control necessalf; location and method of identification to preclude a degradation of the item's functional capability or quality; and proper identification of materials, parts, and components prior to release for manufacturing,

shipping, construction, or installation. Materials,

parts, and components manufactured or modified by UE shall be controlled and identified during manufacture.

1884 8.3 Documented procedures shall assure that specifica-2088 tions and other procurement documents include or reference appropriate requirements for the identi-fication and control of materials,

parts, and components including partially fabricated assem-blies.

Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items from storage while maintaining item identity; controlling the return to storage of issued materials, parts, or components

received, stored, installed, modified, or used at the Plant site.

These procedures shall assure that correct identifications are verified and documented prior to release.

1895 8.4 Physical identification shall be employed to the 1896 maximum possible extent for relating an item at any 2318 point in time to applicable design or other perti-2331 nent specifying documents including drawings, 2333 specifications, purchase orders, manufacturing and 2337 inspection documents, nonconformance reports, and 2346 physical and chemical mill test reports.

Physical identification or marking shall not affect the

form, fit, or function of the item being iden-tified.

Where physical identification is not

employed, physical separation, procedural control, tags, or other means shall be utilized. Identifica-tion shall be maintained on

items, or records traceable to items through fabrication,

erection, 8-1 Rev. 15 6/92

oQAM.

and installation.

When unique traceability is impractical, bulk traceability may be-employed-consistent with the-relative importance of the item to safety. When tags are used, the stock shall-be.

made -from material which will not deteriorate during. storage. Tags shall be securely affixed to i

the items, and displayed in an area-that is readily accessible.

2336: 8.5

-Changing -cur correcting any-marking on a code stamp plate is prohibited,-unless-authorized by the

-name-manufacturer whose serial number is applied.

1895 8.6 In the event the identification or traceability of an- -item is lost, it shall be handled as noncon-forming in accordance with Section 15, if the disposition is other than-to scrap or to retain for non-safety related applications.

L-8-2 Rev.114 6/91

OQAM 3.0 CONTROL OF SPECIAL PROCESSEE 1851 9.1 Special processes are fabrications, tests, and 1937 final preparation processes which require in-pro-cess controls in addition to final inspections to ansure quality. Special processes also require the qualification of procedures, techniques, and personnel in accordance with the requirements of applicable

codes, standards, specifications, or other special requirements to which UE is commit-ted.

Special processes include such activities as welding, heat treating, nondestructive examination, the application of specialized coatings, and chem-ical cleaning. For special processes not covered by existing codes or standards, the necessary qualifi-cations of personnel, procedures, or equipment shall be defined by Nuclear Engineering.

9.2 procedures for special processes shall be qualified as part of their approval process, and shall also provide for recording evidence of acceptable accomplishment of the special processes, personnel qualifications shall be certified and equipment shall be qualified prior to use.

9.3 The responsible Plant Department Head shall assure that personnel performing special processes are qualified and are employing approved procedures.

Quality Control personnel shall be responsible for assuring that personnel performing nondestructive examinations are qualified and are employing approved procedures.

Nondestructive examination (NDE) personnel shall be qualified in accordance

.with procedures established to meet the require-ments of the Code Edition and Addenda to which UE l

is committed at the time the NDE is performed. When non-code NDE is performed, personnel shall be qual-ified to the version of SNT-TC-1A used to meet UE's current commitment to the ASME B&pV Code.

9.4 Special process equipment that may require periodic adjustment and whose performance cannot be verified through direct monitoring of appropriate parameters shall be subject to the controls described in Section 12.

1857 9.5 planning for maintenance shall include avaluation of the use of special processes, equipment and materials in performance of the

task, including assessment of potential hazards to personnel and equipment, i

9-1 Rev. 15 6/92

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L LOQAM l;'

9. 6 ;-

Qualified.Loutside: organizations may;be employed to perform special:, processes: onsite and shall be-required-to-conform to the requirements ' described

' Special process procedures submitted-by--

H herein.

these-organization (s) in accordance.with

.the-procurement document--requirements shall-. receive a

o technical-review by-the: responsible.. engineering-organization-and.a quality review bylthe Quality Assurance Department.-

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OQAM 2974 10.0 INSPECTION 1851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to 1927 verify conformance with applicable documented instructions, procedures, drawings, and specifica-tions.

Inspcctions and monitoring of processes which serve an inspection-function shall be performed by personnel qualified to perform assigned tasks and who are independent of individ-uals who perform the activity.

10.2 Required inservice inspection of structures, systems or components shall be planned and executed.

Inspection methods shall be-established and executed to verify that the characteristics of an item remain within specified limits.

1850 10.3 Inspection of activities at the Callaway Plant 1937 shall be at intervals based on the status and importance of the activities. Guidelines shall be established to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subse-quent monitoring planning.

I 10.4 Nuclear Engineering shall be responsible for assuring the development of preservice and inservice (PSI /ISI) inspection programs; the refer-ence PSI /ISI examination plans for ASME Code Class 1,

2, and 3 systems and components including steam generator eddy current examination; the NDE proce-dures required by the reference plans; and the initial updating of the reference plans and proce-dures to reflect "as-built" conditions and the technical requirements of the applicable Code Edition and Addenda prior to the issuance of the inservice inspection plans and procedures, i

10.5 Nuclear Engineering shall be responsible for assuring the development of the inservice testing program plan for pumps and valves, the test proce-dures required by this plan, and the securing of consulting services in this area.

In addition Nuclear Engineering shall be responsible for admin-istering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division.

They are also responsible for updating the reference plans and-NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations.

10-1 Rev. 15 6/92

OQAM 2483 10.6 An inspection personnel qualification program shall 2484 be established to assure inspection activities are i

2485 being performed by personnel trained and qualified to a

capability necessary for performance of the activity.

Plant procedures shall prescribe the qualification requirements of inspection personnel.

The Superintendent, T.;aining shall be responsible for providing related technical and quality training appropriate to the certification /qualifi-cation of UE personnel.

1851 10.7 Quality Control inspection personnel or other unit 2263 staff organizations who perform " inspection" 2479 activities shall be qualified within their respec-1 2480 tive areas of responsibility. The qualification of 2481 QC inspection pirsonnel shall be defined in three 2482 levels of capability as described in ANSI N45.2.6.

2483Property "ANSI code" (as page type) with input value "ANSI N45.2.6.</br></br>2483" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. Other members of the unit staff performing "inspec-2484 tion" activities shall have appropriate experience, 2485 training, and retraining to assure competence in 2994 accordance with ANSI /ANS-3.1. Inspection assign-ments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC inspection personne?.

who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent competence.

1 2263 10.8 Personnel from outside organizations performing QC 2480 inspection activities associated with safety-2482 related items at the Callaway Plant shall be certi-1 2483 fled as required by ANSI N45.2.6. Personnel from 2484 outside organizations or UE personnel who are not 2485 members of the unit staff who perform other.activ 2994 ities associated with safety-related items at the Callaway Plant shall either be certified as required by ANSI M45.2.6 or they shall mest the education and experience requirements applicable to the equivalent position on the unit staff for the activities which they are performing.

2484 10.9 When contractors or vendors are retained to perform 2485 work activities or to provide services associated I

with safety-related items at the Callaway

Plant, the qualification of inspection personnel and the conduct of inspections associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procure-ment documents.

As an examplc, if a vendor was contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing the examination would be qual-5 10-2 Rev. 15 6/92

oQAM ified as required by the vendor's quality assurance program unless otherwise specified in the appli-cable procurement documents.

1930 10.10 Procedures which specify inspection activities l

1931 shall provide for the following, as required:

2124

1) the inclusion of independent inspection or moni-toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta-tion of inspection results; 4) a description of the method. of inspection including any mandatory hold points;

5) the identification of the characteris-tics and activities to be inspected; 6) the accep-tance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from

drawings, instructions, specifications, codes, standards, or regulatory requirements.

1928 10.11 The inspection function shall be conducted in 1929 accordance with written approved procedures which 1

1973 specify inspection scope; personnel qualification 2039 requirements; and data collection requirements.

2124 Inspection or testing, as appropriate, shall be employed as a means of verifying suitable perfor-mance subsequent to a component replacement or repair.

1935 10.12 Instructions, procedures, and supporting documenta-1936 tion shall be provided to inspection personnel for i

use prior to performing inspection activities.

Inspection results shall be documented. Procedures shall prescribe the review and approval authority for inspection results.

1932 10.13 Indirect control by monitoring processing methods, 1933 equipment, and personnel shall be utilized as a

control if inspection of processed items is impos-sible or disadvantageous. Both inspection and moni-toring of processes shall be provided when control is inadequate without both.

-1934 10.14 Inspection data shall be analyzed and evaluated to 1973 verify completeness of results, achievement of 2124 inspection objectives, and operational proficiency 2125 of equipment and systems; to identify additional i

2262 inspection requirements; and to identify necessary changes to the installation inspection procedures.

The acceptance of an item shall be documented by authorized personnel.

Modification, repair or replacement of items performed subsequent to final inspection shall require reinspection or retest to verify acceptability.

10-3 Rev. 15 6/92

OQAM 2974 11.0 TEST C0fffROL 1850 11.1 Testing programs shall be established to demon-1934 strate that safety-related structures, systems, and 2052 components will perform satisfactorily in service.

13577 Testing programs include such tests as initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those asso-ciated with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications.

1853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-sary quality of systems and components is main-

tained, that facility operations are within the safety

limits, and that limiting conditions foc operation can be met. The testing frequency shall be as prescribed in the Callaway Plant Technical Specifications.

The provisions for surveillance testing shall include the preparation of a survell-lance testing schedule (s) which reflects the status of in-plant surveillance tests. Qualified personnel shall perform surveillance tests, t1851 11.3 Appropriate tests shall also be performed subse 2053 quent to Plant modifications, maintenance or significant operating procedure changes to confirm expected-results. Tests provide a level of confi-dence in structure, system or component operation or functional acceptability.

I 3577 11.4 When required by procurement documents, testing shall be employed as a means of purchased material and equipment acceptance. Acceptance testing of this nature shall be performed during receiving inspection or subsequent to installation in accor-dance with Section 7.

11.5 Equipment failure or malfunction analysis testing may also be performed. The causes of malfunctions shall be investigated, evaluated, and recorded.

Experience with malfunctioning equipoent and similar components shall be reviewed and evaluated to determine whether a like kind replacement compo-nent can be expected to perform its function relia-bly.

I 1938 11.6 Testing shall be performed in accordance with 2055 written procedures which incorporate or reference.

2056 the requirem sts and acceptance limits contained in applicable Callaway Plant Technical Specifications, 11-1 Rev. 15

)

6/92 l

i l

OQAM

drawings, instructions, procurement documents, specifications,

codes, standards, and regulatory requirements.

6 l-1930 11.7 Administrative procedures, test procedures, or 1938 checklists shall include: provisions for assuring 2132 all prerequisite conditions are met; test equipment calibration requirements; testing method instruc-tions including hold or witness points; limiting conditions and acceptance / rejection criteria; and data collection and test result approval require-ments.

1848 11.8 Test data shall be analyzed and evaluated by quali-1934 fled individuals or groups to verify completeness i

1973 of results, achievement of test objectives, ano 2124 operational proficiency of equipment and syste73; 2125 to identify additional test requirements; at to identify necessary changes to the installatior test procedures.

Equipment found to be deficient shall be identified in accordance with Section 14.

Surveillance test procedure results which fail to meet the requirements and acceptance criteria of Callaway Plant Technical Specifications shall be documented and reviewed in accordance with Section 15.

Deficiencies identified as nonconforming shall be processed in accordance with Section 15.

approvaloftests<((:orperMaents 11.9 Review and not described in the FSAR shall be conducted os speci-fled in the Callaway Plant Technical Specifications and 10 CFR 50.59.

I 2039 11.10

.A program shall be established to~ assure testing 2481 activities are performed by personnel trained and 1

2482 qualified to a capability necessary for per:formance 2483 of the activity. Plant procedures MQi! procurement 2484 documents shall prescribe the qualification 4 2485 requirements for testing personnel. Provist< r.s may l

be made for on-the-job training of indi"iduals not qualified to the program provided they 3r9 super-vised or overseen by qualified indirLilais for the activities being performed.

The superintendent, Training shall be responsible for providing related technical and quality training for UE' personnel who perform testing.

22G3 11.11-Personnel within the various UE organizations may 2479 perform testing activities including implementing i

2480 test procedures and the evaluation and reporting of 2483 test results. The assignment of Plant testing 2484 personnel shall be under the directioacand control i

2485 of the Vice President, Nuclear Operations.

The qualification of QC testing personnel shall be 11-2 Rev. 15 6/92

OQAM 12.0

, CONTROL OF NEA80 RING AND TEST EQUIPMENT 1919 12.1 Measuring and test equipment utilized in activities 1920 affecting quality shall be controlled in accordance 1969 with written procedures or instructions. The 2042 procedures for calibration and control shall 2264 address the identification of test equipment, cali-I bration techniques, calibration frequencies, main-tenance

control, and storage requirements.

The equipment subject to these controls includes (1)

M&TE (portable measuring instruments, test equip-ment, tools, gages, and non-destructive test equip-ment used in measuring and inspecting safety-related structures, systems, and components);

(2) reference standards (primary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).

1920 12.2 Tools, instruments, testing equipment ar.d measuring 1851 devices used for mcscurements, tests, and calibra-2295 tion shall be of the proper range and type; and 2044 shall be controlled, calibrated, adjusted and main-2060 tained at specified intervals or prior to use to I

assure the necessary accuracy of calibrated devices.

M&TE and reference standards shall be tagged or labeled indicating the date of calibra-tion and the due date for recalibration.

12.3 Permanently installed process instrumentation shall be afforded the control measures described hereAn consistent with the surveillance testing program and preventive maintenance program.

12.4 The calibration and control program established at the Callaway Plant shall assure that M&TE, refer-ence standards, and PI maintain their required l

accuracy.

The Manager, Callaway Plant is respon-sible for assuring the program establishment.

Program implementaticn is the responsibility of the appropriate Department Heads.

1920 12.5 METE, reference standards, and PI shall be utilized by various organizations as required to perform tests or other special operations. Each crganiza-tion shall be responsible for assuring that the M&TE or reference standards it uses have been cali-brated.

Outside organizations using M&TE or refer-ence standards at the Callaway Plant in activities affecting quality shall be required to implement calibration and control measures consistent with the applicable requirements of this section.

Vendors activities performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 12-1 Rev. 15 6/92

OQAM 9 of OQAM Section 12.6 unless specified in procure-mont documents.

Vendor-provided calibration services for Callaway Plant M&TE or PI are required to be consistent with the requirements of iten 8

and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using M&TE or referance standards at the callaway Plant in activ-itica affecting quality shall be required to imple-ment a calibration and control program consistent with the requirements described herein, or control their activitics relating to M&TE or reference standards via the Callaway Plant calibration and control program.

12.6 The calibration and control program shall provide for:

1923 1.

The assignment of specific calibration inter-

vals, calibration procedures which specify calibration

methods, and instrument accuracy requirements.

Interval selection shall be a

function of the equipment

type, inherent stability and reliability, intended

use, required accuracy, and other conditions which may affect calibration. Records shall be main-tained to permit a determination of calibration intervals.

A calibration shall be performed when the accuracy is suspect.

2.

The unique identification of items.

3.

The traceability to calibration test data.

l 4.

The traceability of reference standards and thereby M&TE and PI, to nationally recognized standards and the periodic revalidation of reference standards.

I 5.

The maintenance of records which indicate the status of each item, maintenance history, cali-bration results, anomalies, and most recent and next scheduled calibration dates. A recall system shall be established to assure that calibration intervals are not exceeded.

6.

The maintenance and control of items not ir use.

7.

Provisions to control the purchase requirements and acceptance tests for items sent out for calibration and for new or replacement items including the requirements for

accuracy, stability, and repeatability.

12-2 Rev. 15 6/92

oQAM 9.

M&TE shal) be calibrated from reference stan-dards with an accuracy ratio of at least four-to-one (Re.srence standard to M&TE).

Calibra-tion accuracy ratios ef-less than 4.0 but equal to or better than 1.0 (Reference standard to M&TE) shall be acceptable when equipment to meet specified requirements is not commercially available.

The basis of acceptance in these cases shall be documented.

9.

M&TE used for calibrating Plant PI shall have calibration ranges, precisions, and accuracies such that the PI can be calibrated and main-tained to achieve its specified accuracy.

PI shall be calibrated from M&TE with an accuracy ratio of at least two-to-one (M&TE to PI).

Calibration accuracy ratios of less that 2.0 but equal to or better than 1.0 shall be acceptable when equipment to meet specified requirements is not commercially available. The basis of acceptance in these cases shall be documented.

I 12.7 Calibration shall be performed against certified equipment or reference standards having known rela-tionships to nationally recognized standards. Where no national standard exists, provisions shall be established to document the basis for calibration.

Calibration and control measures shall not apply to

rulers, tape measures, levels, and other devices when normal commercial practice affords adequate accuracy.

2044 12.8 M&TE and reference standards found to be out of I

calibration shall require an investigation to eval-uate the validity of previous measuring,

test, inspection, and calibration results and the acceptability of impacted items.

Investigations shall evaluate the necessity of repeating original measurements, inspections, tests, or calibrations to establish the acceptability of such items. When the calibration history of an item shows it to be consistently out of calibration, the item shall be

repaired, replaced, or the' calibration interval modified.

12-3 Rev. 15 6/92

OQAM 13.0 liAHQLING, STORAGE, AND SHIPPING 975 13.1 Safety-related items including safety-related parts 2293 of structures, systems, and components and related 2417 consumables shall be

handled, stored,

shipped, cleaned, and preserved in accordance with proce-dures, instructions or drawings, to assure that the quality of items is preserved from fabrication unt31 incorporation in the Callaway Plant.

The procedures shall also establish responsibilities for determining applicable requirements for packag-

ing, shipping, receiving, storage, and handling activities.

I 2293 13.2 Generic procedures or instructions shall be 2349 prepared for application to these activities; I

2354 however, detailed procedures or instructions shall 2416 be prepared for the handling, cleaning, storing, 41668 maintaining while stored, or shipping of certain items and types of equipment or material.

Appli-cable manufacturer instructions and recommenda-

tions, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review.

1 2354 13.3 Deviations from manufacturer's recommendations may impose more stringent requirements or may relax the requirements.

The relaxation of manufacturer's requirements shall involve an engineering evalua-tion and is appropriate when unrealistic require-ments are recommended and such recommendations are not reasonably necessary to preclude equipment degradation.

i 2416 13.4 The requirements for activities described in this i

Section shall be divided into levels with respect to protective measures to prevent damage, deterio-ration, or contamination of items. These levels are based upon the important physical characteristics ar.d not the important functional characteristica of the item with respect to safety, reliability, and operation.

The specific environmental, special measures or other conditions applicable to each level shall be described in implementing procedures.

I 13.5 The Superintendent, Maintenance shall establish an inspection program for Plant material handling equipment that provides for routine maintenance and inspection in accordance with documented procedures which specify acceptance criteria. Rottine inspec-tions shall determine the acceptability of equip-ment and rigging.

Routine inspections shall be 13-1 Rev. 15 6/92

[

l OQAM supplemented by nondestructive examinations and proof tests as delineated in procedures for items requiring special handling. Personnel performing nondestructive examination and proof testing shall be qualified.

2325 13.6 Procedures shall be prepared for items that require 2356 special handling and shall be available prior to 2416 the time items are to be handled. Items not speci-2984 fically addressed by procedures shall be handled in accordance with sound material handling practice.

Fuel assemblies, which require unique equipment and handling, shall be handled under the direction of a Licensed Senior Reactor Operator during core alter-ations.

Other material handling activities may involve personnel from various Plant organizations.

Operators of special handling and lifting equipment shall be experienced or trained in the use of equipment.

241C 13.7 Procureme.it documents or procedures shall address packaging requicements which afford protection from the possible degradation of quality during ship-ping.

handling, or storing. The packaging protec-tion specified may vary in degree consistent with the item's protection classification.

Similarly, the mode of transportation employed shall be consistent with the protection classification of items.

13.8 Measures shall also be established to control the shipping of licensed radioactive materials in accordance with 10 CFR 71.

2341 13.9 Procedures shall provide instructions for the 2981 storage of materials and equipment to minimize the 2984 possibility of damage from the time an item is stored following receiving inspection, until the time the item is removed from storage and placed in its final location. Periodic inspections shall be performed to assure that storage areas are being properly maintained. Material and equipment shall be placed in a storage level commensurate with the protection level of items. The various levels of storage shall correspond to prescribed environ-mental conditions which are procedurally defined.

i l

13-2 Rev. 14 6/91

OQAM 24.0 INSPECTION, TEST 3_AND OPERATING STATUS 14.1 Safety-related items that are received, stored or installed at the Callaway Plant shall be identified and controlled in accordance with documented procedures.

1847 14.2 Items received at or installed in the Plant shall 2116 be identified in accordance with procedures as to 12331 their status regarding required inspections and tests before the items are stored, issued or oper-ated. Prior to storage or installation, items shall be identified by means of stamps,

tags, labels, routing cards, segregation, or other means trace-able to manufacturers' and receiving inspection documentation.

In the event traceability is not available, the item (s) shall be considered noncon-forming and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications.

1841 14.3 Plant procedures shall provide instructions 1842 relating to the manner of indicating the opera-1844 tional status of safety-related structures, and components, including temporary modi-

syscems, fications, and shall require independent verifica-tions, where appropriate, to assure necessary meas-

ures, such as tagging equipment, have been imple-mented correctly.

These procedures shall address for the release and control of equipment measures during periods of maintenance; thereby maintaining personnel and reactor safety and avoiding the unau-thorized operation of equipment.

Equipment and systems in a controlled status to prevent unau-thorized operation, shall be identified.

972 14.4 Plant procedures shall establish controls to 1844 identify the status of inspection and test activ-1846 ities associated with maintenance, repair, modifi-1847 cation, refueling, inservice inspection, and 1851 instrumentation and control system calibration and testing. The Technical Specifications establish the status required for safe Plant operation, including provisions for periodic and non-periodic tests and inspections of various structures,

systems, and components. Periodic tests may be operational tests tests following maintenance while non-periodic or be made following repairs or modifica-tests may tions.

1848 14.5 Required safety-related inspections,

tests, and operations and their sequencing are performed in accordance with Plant operating procedures which are reviewed and approved in accordance with the 14-1 Rev. 15 6/92

oQAM requirements of the Technical Specifications.

In cases where required documentary evidence is not available with respect to whether an item has satisfactorily passed required inspections and

tests, the associated equipment or materials must be-considered nonconforming in accordance with Section 15. Except in the case of temporary changes (non-intent changes) which are allowed by the Tech-nical Specifications and which are administratively controlled, any deviations from procedural require-ments shall be subject to the original or equiv-alent review and approval controls.

l l

14-2 Rev. 14 6/91 d

OQAM i

1875 15.0 NONCONFORMING MATERIbL, PARTS, OR COMPONENTS 2337 1848 15.1 Material nonconformances include material deficien-1870 cies (including inoperative and aalfunctioning 1907 structures, systems, and components). Material 2045 nonconformances identified under the UE OQAP shall 2112 be controlled to prevent the inadvertent use of

material, parts, or components which are defective or of indeterminato quality and to identify docu-mentation inadequacies.

Measures shall be estab-lished regarding identification, documentation, status

control, disposition, and notification of affected organizations.

1848 15.2 Under the UE OQAP, Nonconforming Material Reports 1885 (NMRs), nonconformance logs, or other administra-1903 tive controls shall be employed to identify and 1907 control nonconformances. Nonconformance logs may be i

2328 employed to control deficiencies of a minor nature 2334 or to control documentation deficiencies both of which can be corrected by bringing the deficiency into compliance with the original requirements.

Material nonconformances shall be controlled, as appropriate, by documentation, tagging,

marking, logging, or physical segregation.

The programs describing the administrative nonconformance controls shall delineate the methods of identifying-corrective action to be taken for a nonconforming item or series of nonconforming items. Until suit-able documentary evidence is available to show the equipment or material is in conformance, affected systems shall be considered inoperable and reliance shall not be placed on such systems to fulfill their intended safety function.

i 1906 15.3 Plant and other UE organization's procedures shall 3558 prescribe measures for the control and disposition 3598 of UE purchased items and services identified by 3599 outside organizations as nonconforming. Procurement 3600 documents shall specify those nonconformances to be submitted to UE for approval of the recommended disposition. As specified in procurement documents, actions taken in response to these nonconformances shall be dccumented and forwarded to UE along with the hardware and accompanying quality verification documentation. Nuclear Engineering shall be respon-sible for assuring the processing of supplier-recommended dispositions for Plant-initiated procurements. Similarly, other UE or outside organ-izations shall approve or be requested to provide a technical evaluation regarding supplier-recommended dispositions of nonconformances regarding procure-ments they initiate.

15-1 Rev. 15 6/92

1 OQAM i

1 1904" 15.4

Materialinonconformances shall be processed in

- 1905 accordance with documented procedures and shall 1907_

identify the specifics of the nonconformance stating the-particular drawing, specification or other requirement; shall record the disposition; and' -shall register'the' signature of.an approval authority.

Procedures shall. prescribe the individ-uals or - groups assigned'the responsibility and authority _ to approve and verify the implementation of the disposition of material nonconformance.

' 1907 115.5-Material nonconformance disposition categories 2334 shall includet 1.

"Use-as-is" or " acceptable" (including condi-tional releases) 2.

" Reject" or "not acceptable, scrap, or return

-to vendor"

'3.-

" Rework" in accordance with approved procedures 4.

" Repair" in accordance with approved procedures Material nonconformances shall be reviewed and

accepted, rejected, repaired,. reworked, or condi-tionally-released-in accordance with documented procedures. An approved disposition of a nonconfor-mance ~ which allows a reduction in the requirements of_-a safety-related structure, system, or compo-nent,- shall be treated as a design change subject to the controls prescribed in Section 3.

1848 15.6

-Nuclear Engineering shall be responsible for

~

. 1905' approving material nonconformance dispositions of 1907-

"use-as-is" and " repair". Licensing and-Fuels

- 2335 lshall be responsible for approving material noncon-formance dispositions of'"use-as-is" and

" repair" cn1 -nuclear fuel which are' generated prior to the arrival of: such fuel nat the. Callaway Plant.

Regarding' : material-nonconformances.

identified on-site, QC personnel shall be-responsible for verification that approved dispositions have been implemented'and for the final sign-off.

15.7 Nonconformance documents which record defects-in basic components-or deviations-'from technical requirements in-procurement-documents -shall be 4

reviewed -for reporting applicability under 10CFR21 and. other Federal reporting-requirements. Signifi-

' cant nonconforming-conditions involving a defect or material-noncompliance in a delivered component or

service which could create a.

substantial safety hazard shall be reported to the Nuclear Regulatory Commission pursuant to the requirements of 10CFR21.

15-2 Rev. 14 6/91

OQAM i

1906 15.8 Material nonconformances which would impact the conduct of a test shall be corrected or resolved prior to initiation of the test on the item.

The decision to proceed with the testing of a system or subsystem with outstanding material nonconformances shall consider the nature of the nonconformance, its effect on test results, and the need for supplemental tests or inspections after correction of the nonconformance. The evaluations shall be documented.

1848 15.9 Repaired End reworked items shall be reinspected or 1904 tested. Measures may be established to condition-1906 ally release nonconforming items whose disposition 2053 is pending, provided that an evaluation indicates 1

2328 that further work or activity will not contribute 2332 adversely to the material nonconformance or preclude identification and correction.

15.10 Material nonconformance summarios shall be prepared and analyzed for potential adverse quality _ trends semiannually.

For nonconformances discovered upon receipt inspection of new purchases or discovered after an item has been accepted by receipt inspec-tion but before issue from the warehouse, the

Manager, operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered installed, the

Manager, Nuclear Engineering shall have the trend analysis prepared. These analyses shall be sent to the Quality Assurance Department for an independent review. The result of this review shall be reported to management.

i l

l 15-3 Rev. 15 l

l 6/92

OQht i

1875 16.0 QQRRECTIZE ACTION l

1800 16.1 Measures shall be established to assure that condi-1870 tions adverse to quality are promptly identified, 1903 reported, and corrected. Nonconformancea shall be 2973 controlled in accordance with the requirements i

3598 described in Section 15. Each of the Nuclear Divi-sion Managers 10 responsible for developing and implementing a program for identifying and control-ling adverse conditions. This responsibility may be satisfied by one or more programs.

As a minimum each program shall provide for developing and anal-yzing trends on a semiannual basis.

Trending of conditions adverse to quality identified at suppli-er's facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12. Proce-dures shall provide instructions for identifying, reporting, and initiating corrective action to preclude recurrence of adverse conditions. It is understood that the term

" corrective action" includes rcmedial action necessary to correct the deficiency, as well as corrective action necessary to preclude recurrence.

16.2 Conditions adverse to quality which impede the implementation or reduce the effectiveness of the Operating QA Program shall be controlled by the measures described herein. Adverse conditions may include, but are not limited to, noncompliance with procedural requirements; reportable occurrences required by regulations; adverse nonconformance trends;. deficiencies identified in the OQAP; recur-ring conditions for which past corrective action has been ineffective; or breakdowns in administra-tive and managerial control-systems which could result in a system designed to prevent or mitigate serious events not being able to perform its intended function.

16.3 Corrective action documents which record defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements.

3599 16.4 Corrective action documents shall be transmitted 3600 to the responsible organization. The responsible organization shall investigate the findings and identify the cause(s) of the deficiency, and specify and initiate the action (s) necessary to correct the conditions and prevent recurrence.

1 16-1 Rev. 15 6/92 1

o 00AM 16.5 Huclear Engineering shall review documented condi-i tions adverse to quality which involve design deft-c!ancies or design changes which are recommended as corrective action.

Licensing and Fuels should review documented cor.ditions adverse to quality for fuel-related issues. The orc shall reitiew signifi-cant adverse conditions. Examples of such condi-tions include those identified by callaway Plant Technical Specifications 6.5.1.6(f),

6.5.1.6(g),

6.5.1.6(h),

6. 5.1. 6 (1), and 6. 5.1. 6 (m) ; and NPDES violations.

16.6 corrective action documents shall be closed by

'(

verifying the implementation and adequacy of corrective action. The Quality Assurance Department shall-close QA-originated corrective action docu-ments by verifying the implementation and adequacy of corrective acticn. copies of completed correc-tive action documents shall be available for management review (hardcopy or electronic' media) to

('

keep them apprised of conditions adverse to qual-ity..The-Quality Assurance Department shall period-ically prepare summaries of significant corrective action documents and submit them to the HSRB and appropriate levels of management.

16.7 The closure of corrective action documents shall be accomplished as promptly as practicable but dell occur only after the corrective action taken Las been verified.

Verification may be accomplished through direct observations, written communica-

tions, re-audit, 'surveillances, or other appro-priate meane. The nature of the deficiency may be suct that rismedial actions need to be taken imme-diaialy whAreas development and implementation of-corrective action to preclude recurrence may take substantially longer, i

'l 1800 8

Summaries of corrective action documents shall be reviewed for the effectiveness of the corrective actions taken-and analyzed for potential adverse quality trends.

Quality Assurance-shall evaluate the analyses, the identification of adverse trends,

'and the acceptability of actions taken on these trends through-routine audit and surveillance activities; and shall report-the results of these

. assessments to management.

?

16-2 Rev. 15 6/92

DQAM 17.0 QUM.ITY ASSURANCE RECORDS 1851 17.1 Quality assurance recc'd systems governing the 2130 collection, storage, and maintenance of records 2173 shall be established by UE. They shall apply to records associated with startup testing, operation, maintenance-repair, refueling, and modification of safety-related structures, systems, and components at the Callawry Plant.

I 1851 17,2 During the operating phase, quality assurance 2128 records shall be maintained to furnish documenta;y 21;2 evidence of the quality of items and activities 2133 affecting quality. Applicable design specifica-2137 tions, procurement documents, test procedures, 21?H operational ptocedures or other documents shall 2173 specify the quality assurance records to be gener-ated by, supplied to, or held by UE.

Documents shall be consider ed quality assurance records when completed.

Records may be maintained for varying periods and shall be identified as lifetime or nonpermanent records in that a lifetime or finite retention period shall be specified. Records shall provide sufficient information to permit identifi-cation to the item or activity to which it applies, and be retrievable, a

2337 17.3 Quality assurance records include, but are not 2364 limited to, operating logs; maintenance and modifi-cation procedures and inspection results; report-able oc<urrences; results of ccviews; inspections,

tetts, audits and material analyssa; qualification of personnel, procedures, and equipment; and other documentation including drawings, specifications, procureront documents, nonconformance documenta-

tion, corrective action documents, calibration procedures and results, and the results of moni-toring work performance (e.g., surveillance).

1936 17.4 Inspection and test records shall contain the following as a minimum:

1.

A description of the type of observation 2.

The date and results of the inspection or test 3.

Identification of the inspector or data recorder 4.

Evaluation of the acceptability of the results 5.

Action taken in connection with any deficien-cies noted 17-1 Rev. 15 6/92

)

1

GQAM 17.5 Quality assurance recorda generated by others are transferred or made accessible to UE as systems and equipment or services are transferred or delivered from A/E's, NSSS suppliera, fuel fabricators, constructors, or others. Records maintained by an outside organization prior to and subsequent to final transfer are required to be accessible to UE.

Records gonorated internally shall be processed in a

timely manner in accordance with documented procedures.

2129 17.6 Record systems shall be established by the Adminis-2131 tration organization for the Nuclear Division and 2136 shall be controlled in accordance with written 2147 procedures.

The implementing proceduros shall address records administration; receipt of records;

storage, preservation and safekooping of records; h

record retrieval; and the disposition of records.

The Nuclear Sorvices organization is responsible (N

for assuring the handling and maintenance of quality assurance records generated, received, and temporarily stored at the General Offices.

The Administration organization shall provide for the administration of the quality assurance record system at the Callaway plant.

2135 17.7 The requirements regarding hard-copy records 2149 administration shall require that quality assurance 2150 records be listed in an index. The index shall be established prior to the receipt of records and shall indicate the location of records.

Microform records shall be controlled as indicated in UE's commitment to ANSI N45.2.9 as stated in Appendix A.

The distributing and handling of

records, the correcting or supplomonting of quality assurance

records, and specifying the retention period of record types shall be dolineated in written proco~

dures.

The rotontion period of records generated prior to commercial operation shall begin on December 19, 1984; the dato of commercial opera-tion.

2145 17.8 The requirements regarding receipt of records shall 2146 define the requirements for the receipt of 2148 documentation generated by others during the opera-tion' of the callaway Plant.

Thcso requirements shall assure that records are submitted and that designated authoritios are responsible for organ-

• Callaway was declared available for unrestricted loading by the UE Load Dispatchr2r on December 19, 1984. The PSC Commercial Operation date is April 9, 1985. The PM and EQ programs use the PSC dato. Refer to UO 86-107.

17-2 Rev. 14 6/91

oQAM izing and implomonting a system of records receipt control.

The records' recolpt control shall permit an assessment of the status of records during the receiving process.

2150 17.9 The requirements regarding storage, preservation, 2151 and safokooping of records shall ostablish storage 2152 requirements for tho maintenance, preservation, and 2153 protection of quality assuranco records. Those 2155 requirements shall include methods for maintaining control of, access to, and accountability for records; storing records in a manner to precludo datorioration; and providing record storage facil-itios which protect contents from possible destruc-tion by causes such as fire. An alternative to the establishment of a single record storage facility shall be the maintenanco of a duplicato copy of records in a

remoto location.

Where duplicato storage is employed, the storage environment need not be uniquely controlled in each storage

area, but may be the prevailing building tempora *.ure and humidity.

2157 17.10 Record storago systems shall provido for an 2159 accurato retrieval of information without undue delay.

Thos?

records maintained by an o",tsido organization shall be required to be acconsible to the buyer or UE; in the caso of lifetimo records for the life of the items involved, or for desig-nated rotontion times for nonpormanent records.

2160 17.11 Record disposition practicos shall establish 2161 requirements for the transfer of records from othora to UE. Upon final transfer, records shall be inventoried against any transmittal forms and processed in accordance with written proceduros.

Nonpormancnt records shall be retained for the specified rotontion period; after the specified retention period they are no longer required to be maintained as records.

l l

l 17-3 Rev. 14 6/91

OQAM l

1875 18.0 AUDIIS 2180 3869 l

41639 2186 18.1 A comprehensive audit program shall be established 2199 and implomonted by UE to verify internal and 2978 external quality activitics' compliance with the 2988 OQAP. The audit program shall assure that all appli 3586 cable elements of the Program have boon developed, 3865 documented, and are being offectively implemented 3867 and shall provide for the reporting and review of 3883 audit results by management. The audit system is i

4140 described in manuals and procedures.

Nonconfor-mances and program deficiencies shall be identified and corrective action shall be initiated and verified.

See section 3.14 for a specific audit topic.

l 1800 18.2 The UE audit system shall include the performanco 2245 of audits and surveillancos by the Quality i

3586 Assuranco-(QA)

Department.

Audits determino, through investigation, the adequacy of and adhor-once to establiched proceduros, instructions, spec-ifications, codes, and other applicable contractual and licJn3}fg requiromonts and the offectivanoss of implementation.

Surveillances involvo the periodic or continuous monitoring of the operation or performance of a

supplier, item, component, or system. Surveillance in this audit sense should not be confused with inspections for the purpose of process control or product acceptance or with requirements relating to

test, calibration or inspection to assure that the necessary quality of systems and components is maintained, that facility operations are within the safety limits, and that limiting conditions of operations are being mot I

(survoillance testo).

QA personnel performing surveillances should be familiar with the area to be surveilled and the applicable implementing proc-edure(s) governing surveillances. Surveillances may alsc be performed by personnel from other organiza-tions, but those require no unique personnel quali-fications or certifications (except when performed for product acceptance). See Sections 10.6, 10.7, 10.8, 11.10, 11.11, 11.12, and 18.4.

1818 18.3 The Manager, Quality Assurance shall establish a 2244 program which provides for the qualification and 1

2250 training of QA Department audit and surveillance 2255 personnel. Audits shall be directed by an Audit 2963 Team Leader ( ATL) who is a certified Lend Auditor.

3866 A Lead Auditor is an individual certified Ms qual-3877 ified to direct an audit, perform an audit, report 18-1 Rev. 15 6/92

00AM 3892 audit findings, and to ovaluate corrective action.

Other personnel may assist Lead Auditors in the conduct of audits; namely, technical specialists, management representatives, auditors and other Lead Auditors.

The persons having direct responsibility for performance of the activitios being audited shall not be involved in the selection of the audit team.

Personnel selected for QA auditing or surveillance assignments shall have training or experience commensurate with the scopo, complexity, or special nature of the activities to be reviewed or investigated and shall have no direct responsi-bility for the area being evaluated.

The QA personnel training program shall provido general orientation and specific training which develop competence for performing audits or surveillances.

Training records shall provide a history of QA personnel

training, evaluations, qualification, certifications, and retraining.

l 2244 18.4 QA Department personnel who perform audit and 2245 surveillance activities shall bo qualified in 2259 accordance with the requirements proscribed in 1

3866 QA Department procedures. Lead Auditor qualifica-tion requirements shall include education or professional

status, previous work experience or

training, training received through UE, on-the-job performance and participation in surveillances or audits as an auditor, a qualification examination, and other factors applicable to auditing not defined by procedure. The qualification certifica-tion of Lead Auditors shall be based on an ovalua-tion of those factors by the Manager, Quality Assu-rance. The maintenance of proficiency by Lead Audi-tors shall be accomplished by active participation in the audit process; a review of program,

codes, standards, procedures and other document revisions related to the OQAP; or participation in training programs.

The

Manager, Quality Assurance shall provide for annual assessments of each Lead Auditor to determino proficiency. As long as a Lead Auditor is performing satisfactorily and is maintaining proficiency, there is no limit on the period of certification. However if at anytime the Lead Audi-tor's performance is evaluated as being unaccept-

able, Lead Auditor cortification shall be rescinded.

In addition the failure to maintain proficiency for a period of two years or more shall be basis for Lead Auditor certification revocation.

If certification is rescinded or revoked, roquali-fication shall be required prior to recortifica-tion.

18-2 Rev. 15 6/92

l OQAM 3865 18.5 The Manager, Quality Assurance shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Quality Assurance has suffi-cient authority and organizational freedom to schedule and perform both internal and external audits. He has the organizational responsibility to measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality.

The Manager, Quality Assurance has direct access to the Senior Vice President-Nuclear.

I 1800 18.6 The audit system shall include internal and 3871 external audits. The system shall be plenned, uocu-

mented, and conducted to assure coverage of the applicable elements of the OQAP, and overall coor-dination and scheduling of audit activities. Audit I

results shall be periodically reviewed by the QA Department for quality trends and results reported to the appropriate management. The Manager, Qual.ity Assurance shall monitor the OQAP audit program to assure audits are being accomplished in accordance with the requirements described herein and for overall Program effectiveness.

The NSRB shall selectively review audit reports of onsite audits.

The NSRB shall also periodically review the onsite I

audit program as developed by the QA Department, to assure that audits are being performed in accor-dance with Callaway Plant Technical Specification requirements and the OQAP. Appropriate levels of management shall be provided copies of internal and external audit reports. The audits described in the Callaway Plant Technical Specifications which are performed under the cognizance of the NSRB shall be I

conducted by the QA Department.

I 1792 18.7 Internal audits shall be conducted by the QA 1816 Department and shall be performed with a frequency 3873 commensurate with their safety significance.

An audit of safety-related functions shall Le completed in accordance with formal audit schedules within a period of two (2) years. Each element of the

OQAP, such as design control and document control, and each area of Plant operations shall be audited.

2666 18.8 Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be 2847 audited under the cognizance of the NSRB at the 3873 frequencies indicated in Section 6.5.2.9 of the 41777 Technical Specifications and the Radiological Emer-gency

Response

Program.

In addition to audits conducted under the cognizance of the

NSRB, the 18-3 Rev. 15 6/92 l

1

oQAM following areas shall be audited at least once por 12 months o

Special Nuclear Material Accountability program o

Radiological Protection program o

Security program o

Fitness-For-Duty program i

1800 18.9 During Plant modifications or other major unique 3873 activities, audits shall be scheduled as required to assure that Quality Assurance Program require-monts are properly implemented.

I 3577 18.10 External audits shall be conducted by or for the QA Department as a

method for the evaluation of procurement sources and as a post-award source verification of conformance to procurement docu-monts.

Audits conducted by other organizations (with similar orders with the same supplier),

including other utilities or A/E's, may be employed as a

means of post-award source verification in lieu of UE performed audits and may not necessarily l

audit specific items furnished to UE. These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted I

in accordance with this OQAM and QA Department procedures.

commercial grade items do not require pre-or post-award audits. Similarly, items which are relatively simple and standard in desian and manufacture may not require supplier qualification or post-award audits to assure their quality.

1780 18.11 Applicable elements of suppliers' quality assurance I

3565 programs shall be audited (post-award) on a 3878 triennial basis. Audits generally should be 3872 initiated when sufficient work is in progress to determine whether the organization is complying with the established quality assurance provisions.

Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same supplier shall be considered in estab-lishing audit requirements. In addition, the need for a triennial audit may be precluded upon evalua-l tion and documentation by the QA Department that the results of mini-audits performed during source inspection and-source surveillance activities confirm the adequacy and implementation of the supplier's QA Program.

18-4 Rev. 15 6/92 4

00AM 3565 18.12 Supplementary to audits, annual evaluations of 3566 suppliers shall be performed which take into

account, as applicable: 1) the review of supplier furnished documents such as certificates of confor-

mance, nonconformance

notices, and corrective actions; 2) results of previous source verifica-

tions, audits, and receiving inspections; 3) oper-ating experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources.

I 3565 18.13 Audits shall also be conducted when

1) significant 3872 changes are made in functional areas of the Quality 3875 Assurance Ecogram such as significant reorganiza-1 3883 tion or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assur-ance Program; or 3) when a systematic, independent assessmert of Program effectiveness is considered necessary; or

4) when it is necessary to verify implementation of required corrective action.

3876 18.14 Audits shall be conducted using written plans in i

3878 accordance with QA Department procedures. The 3881 procedures require evaluation of work areas, activ-

ities, processes, goods, services, and the review of documents and records for quality-related prac-

tices, procedures, and instructions to determine the effectiveness of the implementation of the OQAP and compliance with 10 CFR 50, Appendix B and the Callaway Plant Technical Specifications. The audit plan shall identify the audit scope, the require-ments,.the activities to be audited, organizations to be

notified, the applicable documents, the

schedule, and the written procedures or checklists as appropriate.

The audit plan and any necessary reference documents shall be available to the audit team members.

3877 18.15 An audit team consists of one or more auditors.

A Lead Auditor shall be appointed Audit Team Leader.

The Audit Team Leader shall be responsible for the written plans, checklists, team orientation, audit notification, pre-audit conference, audit perfor-

mance, post-audit conference, reporting,

records, and follow-up activity to assure corrective action.

Any adverse findings shall be reported in a post-audit conference with team members and the audited organization subject to the clarification of Section 4.3.3 of ANSI N45.2.12 in Appendix A. When a

post-audit conference is held it shall be, to discuss items and arrive at a general agreement on the identification of the findings.. Formal audit reports shall be prepared and submittod to the audited organization within thirty days after the post-audit conference or last day of the

audit, whichever is later.

18-5 Rev. 15 6/92

QPIRATING OUALITY ASJ_URARCZJANUAL (00hKL AEEENDIX A QQAK_qQEIQEM&RQE TO APPLICABLE NRC REGULATORY GUIDER This Appendix briefly discusses the extent to which Union Elec-tric's Operating Quality Assurance Program (OQAP) conforms to NRC published Regulatory Guidos for the Callaway Plant. All state-ments within the Regulatory Position Section (C) of the Regula-tory Guides are considered requirements unless a specific excep-tion or clarification has been proposed by Union Elsctric and accepted by the NRC. This is true regardless of the qualifier (i.e.,

"shall" or "should") which prefaces the statement. Unless further qualified by a statement within the corresponding Regula-tory Guide, ANSI /ANS Standards "shall" statements denote require-ments while "should" statements denote recommendations. Clarifi-

cations, alternatives, and exceptions to these Regulatory Guides

)

are identified herein. Union Electric's position on other Regula-1 tory Guides is given in Appendix 3A of the callaway-SA and calla-way-SP Final Safety Analysis Reports (?SARs).

In each of the ANSI standards referenced by one of the listed Regulatory Guides, other documents (i.e. other standards, codes, regulations or appendicos) required to be included as a part of the standard are either identified at the point of reference or are described in a special section of the standard. The specific applicability or acceptability of these listed standards, codes regulations or appendices is either covered in other specific areas in the PSAR or this Operating QA Manual (OQAM),

including

tables, or such documents are not considered as requirements, although they may be used as guidance. When sections are refer-onced within a standard, it is understood that UE shall comply with the referenced section as clarified.

REGULATORY GUIDE 1. 8 REVISION 2 DATED 4/87 Qualification and Training of personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor (Section 4.3.1.1),

Senior Operator (Section 4.3.1.2), Licensed Operators (Section 4.5.1.2), Shift Technical Advisor (Section 4.4.8),

and Radiation Protection (Manager) (Section 4.4.4) only, and ANSI /ANS 18.1-1971 for all other positions).

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications and exceptions:

Revision 1,

dated 9/75, applies to the position of Radiation Protection Manager only, in-accordance with the Callaway Plant Technical Specifications.

A-1 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.8 (cont.)

The experience,

training, and education requirements for the positions of Shift Supervisor, Operating Supervisor, Reactor

Operator, and Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANSI /ANS 3.1-1981 as endorsed by the Regulatory Guide 1.8.

For all other positions, qualification and training shall comply with ANSI /ANS 3.1-1978 as clarified belows Refer to callaway-SA FSAR Section 13.1 for a discussion of the qualifications of personnel responsible for plant operation and support.

Personnel responsible for directing or supervising the conduct of safety-related preoperational and startup tests and for review and approval of safety-related preoperational and startup test procedures or results not the qualifications of the Regulatory Guide, but were not required to be certified.

With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Q2pumen-tation:

UE shall maintain records in accordance with and to meet the requirements of OQAM Section 17 and ANSI N45.2.9 as specified nerein.

UE may use additional non-Callaway employees or contract personnel to augment the unit staff. These persons may or may not report to the Manager-Callaway Plant. These groups include, but are not limited to, UE personnel fron 'ther plants as well as supplemental HP and I&C technicians and QC inspectors. When used to perform safety-related activities, these personnel shall meet the education and experience requirements of ANSI /ANS 3.1 - 1978 for equivalent positions or else they shall meet the requirements for certification as inspection,-examination or testing personnel as-set forth in UE's commitment to ANSI N45.2.6-1978 given else-where in this Appendix.

REGULATORY GUIDE 1.28 REVISION 2 DATED 2/79 Quality Assurance Program Requirements (Design and Construction)

(Endorses ANSI N45.2-1977)

DISCUSSION:

This Regulatory Guide is not applicable to the operating phase.

However, ANSI N45.2-1977 will be applied to suppliers of safety related

items, components or

services, as appropriate, as described under Regulatory Guide 1.123 (ANSI N45.2.13-1976).

A-2 Rev. 15 6/92

r OQAM APPENDIX A REGULATORY CUIDE 1.30 INITIAL ISSUE QhIED 8/72 Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electronic Equipment (Safety Guide 30) (Endorses ANSI N45.2.4-1972/IEEE 336-1971)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

For maintenance and modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these main-tenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be equal to or better than the original requirements (e.g., code require-

ments, material properties, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

Specific clarifications for ANSI N45.2.4 - 1972 are indicated below by sections.

Section 1.4 - Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.

Section 2.1 - Planning requirements, as determined by engineer-

ing, shall be incorporated into modification procedures.

Engi-neering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are sub audit. Procedures for these activities receive a crossject to QA disci-plinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committeo). For other activ-

itles, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

Section 2.3 Procedures and Instructions shall be implemented as set forth in OQAM Sections 2, 3,

5, 10 and 11 and by compliance with the Callaway Plant Technical Specifications and Regulatory Guide 1.33 (ANSI N18.7) as set forth in this Appendix in lieu of the requirements set forth here. When compliance with an NRC accepted program (e.g., Callaway Plant Technical Specifications) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requir-oments of the Quality _ Assurance program standards.

A-3 Rev. 15 6/92 l

OQAM APPENDIX A l

REGULATORY GUIDE 1.30 (cont.)

Section 2.4 - Results shall be implemented as set forth in OQAM Sections 10, 11 and 17 and by compliance with ANSI N18.7 an set forth in this Appendix in lieu of the requirements set forth here.

In every casa either identical or equivalent controls are provided in the sections of the referenced Standards or docu-ments.

Section 2.5.2 - Calibration and Control covers three classes of instrumentation used by UEt (1) M&TE (portable measuring instru-

ments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related struc-

tures, systems, and components); (2) reference standards (pri-

mary, secondary,

transfer, and working); and (3) permanently installed process instrumentation (PI).

With respect to the first sentence, M&TE and reference standards shall be included in a calibration program and shall either be calibrated at prescribed intervals or shall be calibrated prior to use.

With respect to the last sentence, personnel shall be trained and procedures shall require that the calibration label or tag shall be reviewed to determine calibration status prior to uset This label or tag shall be considered to clearly identify equipment which is out of calibration. Lack of a label or tag shall require the organization responsible for calibrating the M&TE to review records and affix a new label or tag based on calibration data. M&TE and reference standards shall comply with sentences 2, 3 and 4.

With respect to the 3rd sentence, UE uniquely identifies each safety-related item of permanently installed process instrumenta-tion.

This identification provides traceability to calibration data.

These actions are UE's alternative to the tagging or labeling of items to indicate the calibration date and the iden-tity of the person who performed the calibration.

Permanently installed process instramentation shall comply with sentences 1, 2,

and 5.

Section 3 - PIeconstruction verification shall be implemented as follows:

(1) shall be required only for modifications (2) shall be implemented with the clarification that " approved instruction manuals" shall be interpreted to mean the manuals provided by the supplier as required by the procurement order - these manuals are not necessarily reviewed. and approved, per se, by UE:

(3) no special checks shall be required to be made by the person with-drawing a

replacement part from the warehouse -

equivalent controls are assured by compliance with Regulatory Guide 1,38 (ANSI N45.2.2) as set forth_in this Appendix; and, (4) shall be complied with as determined by engineering or by individual tech-nicians as part of the modification process. Enginecring actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

A-4 Rev. 15 6/92 l

L

- - ~

-.. _. - _ ~ _ _. _ _. _. _.. < _ - _ _. - _ _ _.. _

OQAM APPENDIX A i

REGULATORY GUIDE 1.30 (cont.)

Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and.surveillances, and QC inspection activities assure QA/QC involvement.:

l Section 4

- Installation shall be implemented as stated and as follows:

Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and

.are subject to QA audit. Procedures for these activities receive I

a cross-disciplinary-review as well as review by the Onsite Review Committee (QA is a permanent member of this committee).

For other activities, QA audits and surveillances, and QC inspec-tion activities assure QA/QC involvement.

Section 5.1

- Insocctions, including subsections 5.1.1, 5.1.2, and the first sentence in 5.1.3, shall be implemented as set forth in OQAM Section 10. The inspection program shall incorpo-

rate, as determined by engineering and QC, those items listed in these subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in UE's commitment to Regulatory Guide 1.33 (ANSI N18.7),

Section 5.2.6; the requirements as set forth in that commitment 9 hall be implemented _in lieu of the requirements stated here.

In every case either identical or equivalent controls are-provided in the Sections of the referenced Standards or documents.

Section 5.2

. Tests, including subsections 5.2.1 through 5.2.3, shall be implemented as set-forth in OQAM Sections 3 and 11.

In some - cases Surveillance testing may be used to meet the approp-riate requirements of this section.

Post-Construction Verification is not-generally Section 6

1 considered applicable at operating facilitien because of the scope of the work and the relatively short interval between installation and operation. Where_ considered necessary by engi-neering or QC, the elements described in this Section shall be used _in the-development and implementation of inspection and testing programs.as described in OQAM dections 3, 10 and 11.

Shotion 7 - Data Analysis and Evaluation shall be implemented as stated herein after adding the clarifying phrase "Where used" at the beginning of the paragraph. This clarification accounts for the fact that some testing will not generato " Data" as such.

Section 8 - Records shall be implemented by conformance'with OQAM i

Section 17 and Regulatory Guide 1.88 (ANSI-N45.2.9) as-set forth in this Appendix.

A-5 Rev. 15 6/92

OQAM APPENDIX A

_ATED 2/78 REGULATORY GUIDE 1.33 REVISION 2 D

Quality Assurance Program Requirements (Operation) (Endorses ANSI N18.7-1976/ANS 3.2)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

Paragraph C.3 of Regulatory Guide 1.33 (and Section 4.3.4 of ANSI N18.7 which it references) shall be implemented as required by the applicable callaway Plant Technical Specifications which define " Subjects Requiring Independent Review."

Paragraph C.4.a of Regulatory Guide 1.33 (and Section 4.5 of ANSI N18.7 which it references) shall be implemented as required by the applicable callaway Plant Technical Specifications which define the " audit program" to be conducted. The audit program is further defined and shall be implemented as required by the commitment to Regulatory Guide 1.144 (ANSI N45.2.12) as stated in this Appendix.

Paragraph C.5.d of Regulatory Guide 1.33 (and Section 5.2.7.1 of ANSI N18.7 which it references) shall be implemented by adding the clarifying phrase "When determined by engineering" in front of the fourth sentence of the fifth paragraph. It is not always practicable to test parts prior to use. For modifications where those requirements are not considered practicable, a review in accordance with the provisions of 10 CFR 50.59 shall be conducted and documented. Engineering actions performed in accordance with this Section of the Regulatory Guide are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities -receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of ORC).

For other activities, QA audits and surveillances, and QC inspec-tion activities assure QA/QC involvement.

Paragraph C.S.e of Regulatory Guide 1.33 and Section 5.2.13.4 of ANSI N18.7 which it references shall be implemented subject to the same clarifications made for Regulatory Guide 1.38 (ANSI N45.2.2).

l Paragraph C.S.f of Regulatory Guide 1.33 (and Section 5.2.19(2) l of ANSI N18.7 which it references) shall be implemented with the substitution of the word "practicasle" for the word "possible" in the last sentence. The action referenced in this Section is the responsibility of the Callaway Plant Operating Organization, and includes QA/QC involvement.

QA is involved through audit and surveillance activities. QC is involved in maintenance inspection activities.

l l

A-6 Rev. 15 6/92

l 00AM APPENDIX A REGULATORY GUIDE 1.33 (cont 1 Paragraph C.S.g of Regulatory Guido 1.33 (and Section 5.2.19.1 on ANS1 N18.7 which it references) shall bo implemented with the addition of the modifier "normally" after each of the verbs (should) which the Regulatory Guido converts to "shall." It is UE's intent to fully comply with the requirements of this para-

graph, and any conditions which do not fully comply shall be documented and approved by management personnel.

Managomont personnel includes QA through cross-disciplinary reviews and through QA permanent membership on the callaway Onsite Review Committee.

QA has and shall conduct audits or surveillances of preoperational testing.

In cases where conditions do not fully

comply, the reason for the exception shall also be documented.

The documentation shall be retained as lifetimo records.

With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Eqquirg-ments for the onsite operatina Oraanization:

Some of UE's technical support organizations are physically located at the callaway site. Therefore the second sentence of this section shall be implomonted as follows: " Initial incumbents or replacements for members of the onsite or offsito technical support organizations shall have appropriato experience, training and retraining to assure that necessary competence is maintained in accordance with the provisions of ANSI /ANS 3.1 -

1978 as committed to in the OQAM."

In the third sentonce, UE interprets "QA" to be "QC",

consistent with the intent of Regulatory Guide 1.58 (ANSI N45.2.6-1978) and the OQAM.

Training standards referenced in this Section are implemented as described in this Appendix's commitments to Regulatory Guide 1.8 (ANSI /ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2.6-1978) or as otherwise included as part of the callaway operating license.

UE's methods of documenting and otherwise meeting the remainder of the requirements of this section are set forth in OQAM Section 2,

in the callaway Plant Technical Specifications, and in other licensing commitments.

With regard to Section 4.1 of ANSI N18.7 - 1976 titled General:

The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, OQAM Section 18, and the Callaway Plant Technical Specifications.

A-7 Rev. 15 6/92 1

l um inum ar-i..

meni

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

With regard to Section 4.2 of ANSI N18.7 - 1976 titled Proaran Qgpeription:

Two aspects are addressed in this section; audits and independent reviews. The independent review program shall be implemented ac r Suired by the Technical Specifications. The UE audit program shall be described in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, the callaway Plant Technical Specifi-cations, and OQAM Section 18.

With regard to Section 4.3 of ANSI N18.7 - 1976 tit ' ed Indosend-ent Review Process! The requirements of this Sect 13.,

includiny i

of its subparts, shall be met by compliance with the Technics 1 Specification requirements and the OQAM.

With regard to Section 4.5 of ANSI N18.7 - 1976 titled

&Rdl%

Proaramt The UE audit program shall be implemented in accordante with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12)

.as endorsed in this Appendix, the

OQAM, and the callaway--Plant Technical Specifications.

With regard _ to Section 5.1 of ANSI N18.7 - 1976 titled Prouran Descrintion: The fourth sentence in this Section requires a " sum-mary document." UE's OQAM is organized in accordance with the 18 critoria of 10 CFR 50, Appendix B. UE interprets this OQAM and applicable Regulatory Guides as endorsed in this Appendix to fulfill tha iquirements for a " summary document."

With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Proced-ure Adherence: The temporary change requirements of this Section are delineated in the Technical Specifications for activities occurring after the Operating License (OL) is issued; the requir-ements of the callaway Plant Technical Specifications shall be used to control temporary changes.

With respect to Section 5.2.6 of ANSI N18.7 - 1976 titled Equin-ment control US shall comply with the " independent verification" requirements based on the definition of this phrase as given under our commitment to Regulatory Guide 1.74 in this Appendix.

Since UE sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with: " Suitable means include identification numbers or other descriptions which are traceable to records of the status of inspections and tests."

The first sentence in the seventh paragraph shall be met after clarifying

" operating personnel" to mean trained employees assigned to, or under the control of, Plant management at calla-way.

A-8 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

With regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Mainte-nDnce and Modification UE shall interpret the word " original" in the first sentence of this Section to modify ONLY the words

" design bases."

This interpretation is to assure that original inspection requirements are not imposed, without appropriate

review, on modifications or maintenance activities which are similar in nature to original construction activities. In devel-oping means to assure the quality of maintenance or modification

activity, inspection requirements from associa

,d construction activities shall be considered. Operational inspection require-monts shall assure quality at least equivalent to the original quality.

Since some emergency situations could arise which might preclude preplanning of all activities, UE nhall conply with an alternate to the first sentence in the second paragraph which reads:

"Except in emergency or abnormal operating conditions whern imme-diate actions are required to protect the health and cafety of the public, to-protect equipment or personnel, or to prevent the deterioration of plant conditions to a possibly unaafe or unstable level, maintenance cr. modification of equipment shall be preplanned and performed in accordance with written procedures.

Where written procedures would be required and are not used, the activities that were accomplished shall be documented after-the-fact and receive the same degree of review as if they had been proplanned."

With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 titled Main-tenance Pronramot UE shall comply with the requiren.ents of the first sentence of the fifth paragraph, where practical.

This clarification is needed since it is not always possible to promptly determine the cause of the malfunction.

UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. QA is involved via loth audits and surveillances, and QC is involved in inspec&ior.

of maintenance inspection activities.

With regard to Section 5.2.8 of ANSI N10.7 - 1976 titled Surveil-lance Testina and__Jnsoection Schedule: In lieu of a

" master surveillance schedule," the following requirement shall be met:

" Schedules shall be established reflecting the status of in-plant surveillance tests and scheduled inspections."

With regard to Section 5.2.9 of ANSI N18.7 1976 titled ElA7%

Security and Visitor Controlt The requiremer.cs of the Security Plan shall be implemented in lieu of these general requirements.

When compliance with an NRC accepted program (e.g.,

Callaway security Plan) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of thu general requirements of the Quality Assurance program stendards.

A-9 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled Egggg-i keepina and Cleanliness ContI21a The requirements of this

Section, beginning with the last sentence of the first paragraph and continuing through the end of the Section, shall be imple-mented as described in UE's commitments to Regulatory Guide 1.39 (ANSI H45.2.3) and Regulatory Guide 1.37 (ANSI N45.2.1) as set forth in this Appendix. In every case either identical or equi-valent controls are provided in the Sections of thL reference standards or documunts.

1976 titled With regard to Section 5.2.13.1 of ANSI N18.7 Procurement - Document control UE shall comply with the following sentence in lieu of the last sentence of the referenced Section.

Where changes are made to the technical or quality requirements on procurement documents, they shall be subject to an equivalent level of review and approval as the original document by the originating organization.

With regard to Section 5.2.15 of ANSI N18.7-1976 titled

Review, dooroval and Control of Procedurgg; in lieu of the wording starting with the second sentence in the third paragraph of this through the end of section beginning with "The frequency of the fourth paragraph, which ends "... a procedure review.",

UE provides the following alternative guidance: "Prscedures shall be revise 6 as necessary. These revisions will generally be initiated through reviews conducted by knowledgeable personnel during routine performance of activities. Examples of such reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identified deficiencies or events, evaluation of events occurring at other

plants, evaluation of procedure changes necessary to implement modifications, evaluation of procedure 9hangos necessary to implement

License, Technical Specification, FSAR or OQAM revi-sions as-well as evaluations of changes necessary to resclve Regulatory Issues.

Such changes shall be implemented as neces-sary.

In some situations such implementation will be ccupleted prior to conpletion of the in-process activity. Guidance on the need to reviso procedures shall be provided in plant administra-tive controls."

With regard to Section 5.2.17 of ANSI N18.7 - 1976 titled Inspec-tion: The third paragraph is replaced with the following:

Inspections for modifications and nonroutine maintenance shall be conducted as' indicated in our reference to Section 5.2.7 of this stancard.

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I OQAM APPENDIX A i

REGULATORY GUIDE 1.33 (cont.)

The following is a clarification to the sixth paragraph:

Inspections may not require genoration of a separate inspection rnport.

Inupection requirements may be integratUd into approp-riate procedures or other documents with the procedure or docu-ment serving as the record. However, recorda of inspections shall be identifiable and retrievable.

With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control of Soecial Processes: UE shall comply with the following sentence in lieu of the last sentence of the referenced Section.

For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established codes or standards, personnel, equipment and procedure qualification shall be defined by engineering.

With regard to Section 5.3.5(4) of ANSI N18.7 -

1976Property "ANSI code" (as page type) with input value "ANSI N18.7 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Sunnortinn Maintenance Documents: UE may choose to include mate-rial from vendor manuals in any of three ways. (1) The applicable section of a _ manual may be duplicated, referenced in, and attached to the procedure. (2) The procedure may reference the technical manual or a specific section; the manual may then be used in conjunction with the procedure for performing the activ-ity.

(3)

The

material, either as-originally written or as modified by the procedu::e's author, may be reproduced within the body of the procedure.

I, options (1) and (2) above, che material shall be considered as.taving received "the same level

,f review and approval as operating procedures" by virtue of the review and approval of the naintenance procedu*e. In option (2), the manual shall be availab.te whtn the procedure is being considered for approval.

In optio1 (3), this material receives the same review and approval as the procedure since it is part of the procedure.

l In any of the optioris, Union Electric is NOT reviewing and accepting the entire.anual. UE reviews and accepts that portion of each vendor manual that is used by UE.

Witt. regard to Section 5.3.9 of ANSI N18.7 - 1976 titled Emercen-cv Procedures UE's Emergency Procedures are in the format spec-ified by the NRC in the Callaway Safety Evaluation

Report, as required for issuance of the Operating License, in lieu of the requirements given here.

With regard to Section 5 3.9.2 of ANSI N18.7 - 1976 titled Events of Potential Emeraency: The licensing FSAR identified natural occurrences which affect the Callaway Plant. Therefore, UE shall interpret item (11) to mean the natural occurrences which were evaluated in the licensing FSAR.

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OQAM APPENDIX A REGULATORY GUIDE 1. 33 (cont.)

With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Erag-edures for Imolementina Emeraency Plan: UE's NRC accepted Emer-gency Plan shall be implemented in lieu of the requirements in this Section. When compliance with t.. NRC accepted prujran (e.g.,

callaway Plant Radiation Emergency Response Plan) is referenced, UE has substituted the NRC accepted program for applicable regu-latory requirements in lieu of the general requirements of t;.e Quality Assurance Program standards.

REGULATORY GUIDE 1.37 INITIAL ISSUE DATED 3/73 Quality Assurance Requirements for Cleaning of l'.uid Systems and Associated Components of Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.1-1973)

DISCUSSION:

UE_ complies with the recommendations of this Regulatory Guide with the following clarifications:

For maintenance and modification activities UE snall comply with the Reaulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these main-tenance and modification activities even though such requirement 3 may not have been in effect originally. Technical requirements associated with maintenance and modifications shall be equal to or better than the original requirements (e.g.,

code require-

ments, material proportiss, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

Specific clarifications for this Regulatory Guide and ANSI N45.2.1 - 1973 are indicated below by Sections.

With regard to Paragraph C.3 of Regulatory Guide 1.37: The water quality for final flushing of fluid systems and associated compo-nents shall be at least equivalent to the quality of the oper-ating system water except for the oxygen and nitrogen content; but this does not infer that chromates or other additives, normally in the system water, are added to che flush water.

With regard to Paragraph C.4 of Teoulatory Guide 1.37: Expendable

- maturials, such as inks and related products; temperature indic-ating ct.icks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT penetrant asterials and couplants, dessicants, which contact stainless steel or nickel alloy surfaces shall not contain lead,

zinc, copper,

mercury, cadmium and other low molting points metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall A-12 Rev. 15 6/92

.,e n

, ~~

r-

,,--n,...

e r,--.,,.. -,.,

OQAM APPENDIX A REGULATORY GUIDE 1.37 (cont.)

be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ-mental conditions, except as provided for in approved design documents.

No more than 1500 ppm suli'ur shall be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environmental condi-tions, except as provided for in approved design documents.

With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion Cleaninct The recommendation that loca) rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precluded, as determined by engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted with QA/QC involvenent and are subject to QA audit. Procedures for these

-activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee).

For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

REGULATORY GUIDE 1.38 REVISION 2 DATED 5/71 Quality Assurance Requirements for Packaging, Shipping, Receiv-

ing, Storage, and Handling of Items for Water-Cooled Nuclear Power Plants (F.ndorses ANSI N45.2.2-1972)

DISCUSSIO":

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Defini-tions:

Definitions in this Standard which are not included in ANSI N45.2.10 ~ shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.

With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Plann-1Dg:

(First sentence) The specific items to be governed by the Standard shall be identified in Callaway-SP FSAR Table 3.2-1, which lists those structures, systems and components to which the UE QA Program is applied.

With regard to Sectaon 2.3 of ANSI N45.2.2 - 1972 titled Results:

The specific methods for performing and documenting tests and inspections are givan in OQAM Sections 10 and 11. The require-ments in these Sections shall be implemented in lieu of the general requirements here.

In every case either identical or equivalent controls are provided in the sections of the refer-enced Standards or documents.

A-13 Rev. 15 6/92

OQAM APPENDIX A d

RPGULATORY__ GUIDE 1.38 (cont i t

With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Person-nel cualifications: Specific requirements for personnel qualifi-cations are set forth in the OQAM description and in the commit-ments in this Appendix. These requirements shall ba implemented in lieu of the general requirements stated in this Section.

In every case either identical or equivalent controls are provided in the sections of the referenced Standards or document.

With regard to Section 2.7 of ANSI N45.2.2 - 1972 titled Classi-fication of items: UE may choose not to explicitly use the four level classificaticq system. Howevor, the specific requirements of the Standard that are appropriate to each class are generally applied to the items suggested in each classification and to similar items, as determined by engineering. Engineering actions performed in accordance with chis section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

Procedures for these activities receive a cross-disciplinary review as well as review by chc Onsite Review Committee (QA is a permanent member of *his ccmmitteo). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

With regard to Section 3.2.1 of ANSI N45.2.2 -

1972Property "ANSI code" (as page type) with input value "ANSI N45.2.2 -</br></br>1972" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Level A Items: As-an_ alternate to the requirements for packaging and containerizing items in storage to control contaminants (Items (4) and (5)), UE may choose a storage atmosphere which is free of harmful contaminants in concentrations that could produce damage to stored items, as determined by ongineering.

Similarly (for Item (7)) UE may obviate the need for-caps and

plugs, as determined by engineering,'with an appropria.a storage atmos-

phere, and may choose to protect vold-end preparations and threads by controlling the manner in-which the items are stored.

These clarifications apply whenever items (4), (5) or

(?)

are subsequently referenced and to Section 3.5.1 titled Cans and plugs and Section 3.4 titled Methods of Prevention.

Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

Procedures for these activities vr'eive a cross-disciplinary review as well as review by the Ons,t ' Review Committoo (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

With _ regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Clean-ings- (Third sentence) UE interprets " documented cleaning methods" to allow generic cleaning procedures to be written which shall be implemented, as necessary, by trained personnel. Each particular cleaning operation shall be either governed by an individual cleaning procedure or by a generic procedure either of which shall specify method (s) of cleaning or type (s) of solvent (s) that may be used in a particular application.

A-14 Rev. 15 6/92 i

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Msiheda of Preyervation:

(First sentence) UE shall comply with these requirements subject to the clarifications of Section 3.2.1 (4) and (5)

above, and the definition of the phrase

" deleterious corrosion" to mean that corrosion which cannot be subsequently removed and which advercely affects form, fit, or function.

With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrigt and Wran Material and Dessicanta: This Section requires the use of nonhalogenated materials in contact with austenitic stainless stool. Refer to Regulatory Guide 1.37 for the UE position.

1972 titled With regard to Section 3.7.1 of ANS1 N45.2.2 ContalDRI2:

C1cated, sheathed bones may be used up to 1000 lbs.

rather than 500 lbs. as specified in 3.7.1(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs. Other national standards allow this (see Federal Specification PPP-B-601).

Special qualification testing shall be required for loads above 1000 lbs.

With regard to Section 3.7.2 of ANSI 45.2.2 - 1972 titled Crates pnd Ekids: Crates shall be used for equipment in excess of 1000 lb.

in weight. Skids or runners shall be used on boxes with a

gross weight of approximately 100 lb. or more, allowing suffi-cient floor clearance for forklift tines (as nominally provided by 4 inch lumber).

With regard to Sectjon 4.2.2 of ANSI N45.2.2 - 1972 titled Closed f.gr_r i e rg :

The use of fully enclosed furniture vans, as recom-mended in (2) of this Section, is not considered a requirement.

Stated for information only, UE shall assure adequate protection from weather or other environmental conditions by a combination of vehicle enclosure and item packaging.

With regard to Sections.

4.3, 4.4 and 4.5 of ANSI N45.2.2 - 1972

titled, respectively, Precautions Durina Loadina and Transit.

Identification and Markjna, and Shinment from Countries Outside the United Staten: UE shall comply with the requirements of these Sections qubject to the clarifications taken to other Sections which are referenced therein.

With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Ehip-nina Damaae Ineryction: Stores personnel shall normally visually scrutinize inJoatng shipments for damage of the types listed in this Section; this activity is not necessarily performed prior to unloading.

Since required items receive the Item Inspection of Section 5.2.2, separate documentation of the Shipping Damage Inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping A-15 Rev. 15 6/9?

OQAM APPENDfX A REqptATORY GUIDE 1.38 (cont d Damage Inspection. Any nonconformance noted shall be documented and dispositioned as required by OQAM Section 15.

The person performing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regula-tory Guide 1.74; therefore, while he shall be trained La perform this function, he may not necessarily be certified to Regulatory Guide 1.58 (ANSI N45.2.6) as an Inspector.

With regard to Section 5.2.2 of ANSI N45.2.2 - 1972 titled Item InspectiQD:

The second division of this subsection requires six additional inspection activities if an item was not inspected or examined at the source. Engineering shall determine and document the extent of receipt inspection based on consideration of items in Section 5.2.2.

Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC i

involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the onsite Review Committee (QA is a permanent member of this columittee).

For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of Storace: Subpart (2) is replaced with the followings (2)

Level B

items shall be stored within a fire resistant, weathertight, and well ventilated building or equivalent enclosure in which measures have been taken against vandal-ism.

This building shall be situated and constructed so that it is not normally be subject to flooding; the floor shall be paved or equal, and well drained. If any outside waters should come in contact with stored equipment, such equipment shall be labeled or tagged nonconforming, and then the nonconformance document shall be processed and evaluated in accordance with OQAM Section 15. Items shall be placed on pallets or shoring or shelves to permit air circulation.

The building shall be provided with heating and temperature control or its equivalent to reduce condon-sation and corrosion. Minimum temperature shall be 40' F

and maximum temperature shall be 140' F or less if so stip-ulated by a manufacturer.

With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to storace Arean: Items which fall within the Level D classifica-tion. of the standard shall be stored in an area which may be posted to. limit access, but other positive controls such as fencing-or guards shall not normally be provided, with engineer-ing's concurrence.

Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review A-16 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.38 fcont.)

by the Onsite Review Committee (QA is a permanent member of this committee).

For other activities, QA audits and surveillances, and QC inspection activities assure QA/Qc involvement.

With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Stor-Ano of Food and Associated Items: The sentence is replaced with the following:

"The use or storage of food, drinks, and salt tablet dispensers in ar.y storage area shall be controlled and shall be limited to designated areas where such use or storage is not deleterious to stored items, with engineering's concurrence."

Engineering actions perforned in accordance with this section of the Standard are conducted with QA/QC involvement and are subiect to QA audit. Procedures for these activities receive a cross-dis-ciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). Far other activ-

ities, QA audits and surveillances, and QC insp. clon activities assure QA/QC involvement.

With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled Meas-ures to Provent Entrance of Animals: The sentonce is replaced with the following: " Exterminators or other appropriate measures shall be used to control animals to minimies poasible contamina-tion and mechanical damage to stored material."

With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Stor-ace of. Hazardous Materials: The sentence is replaced with the following:

" Hazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed safety-related systems."

The placement of hazardous material storage lockers in the Plant is based upon installed safety-re-lated systems, not particular components.

With regard to Section 6.4.2 of ANSI N45.2.2 - 1972 titled Cara Of Items: The following alternates are provided for the indicated subparts:

(5)

" Space heaters in electrical equipment shall be energized unless a documented engineering evaluation determines that such space heaters are not required."

(6)

"Large (greater than or equal to 50 HP) rotating electrical equipment shall be given insulation resistance tests on a

scheduled basis unless a documented engineering evaluation determines that such tests are not required."

(7)

" Prior to being placed in storage, large (greater than or equal to 50 HP or when designed to be used with a prime mover of greater than or equal to 50 HP) horizontal rotating equipment shall be evaluated by engineering to determine if shaft rotation in storage is required: the A-17 Rev. 15 6/92

= - -. _ - _. _.

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

results of the evaluation shall be documented. If rotation is required, it shall be performed at specified intervals, be documented, ar.d be conducted so that parts receive a

coating of lubrication where applicable and so that the shaft does not come to rest in the same posi'.lon occupied prior to rotation.

For long shafts or heuvy equipment rubject to undesirable bowing, shaft orientation after rotation shall be specified and obtained."

'8)

"aintenance requirements specified by the manufacturer's instructions are addressed in this OQAM, Section 13.3.

With regard to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal of Items from Storace: UE does not consider the last sentence of this Section to be applicable to the Operating Phase due to the relatively short period of time between installation and use. The first sentence of the Section is replaced with:

"UE shall

develop, issue, and implement a procedure (s) which cover (s) the removal of items from storage. The procedure (s) shall assure that the status of material issued is known, controlled, and approp-riately dispositioned."

With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Inspection of EquiDment and Rigdina:

Stated for information only, it is UE's position that this relates to the operability of the hoisting equipment ano does not preclude rerating as allowed by Section 7.3.

REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 Housekeeping Requirements for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.3-1975)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

For maintenance and modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA programmatic /adminictrative requirements included therein (subject to the clarifications below) shall apply to these main-tenance and modification activities even though such requirements may-not have been in effect originally.-Technical requirements associtted with the maintenance or modification shall be equal to or retter than the-original requirements (e.g.,

code require-

ments, material properties, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

A-18 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.39 (cont.)

Specific clarifications for ANSI N45.2.3 - 1973 are indicated below by Sections.

Section 1.4 - Enfinitionn: Definitions in this Standard which are not included in Regulatory Juide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.

Section 2.1

- Planning: UE may choose not to utilize the five-level zone designation system, but shall utilize standard jani-torial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeep-4 Plant and personnel safety, and fire protection.

creanliness shall be maintained, consistent with the work being peFformed, so as to prevent the entry of foreign material into safety-related systems. This shall include, as a minimum, docu-mented cleanliness inspections which shall be performed prior to system closure.

As necessary, (e.g. the opening is larger than the-tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, refueling, modification or repair.

Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.

Section 2.2 - Procedures and Instruction 1: Appropriate procedures shall be written and implemented.

Section 3.2 - Control of Facilities: UE may choose not to utilize the five-level zone designation

system, but shall utilize standard janitorial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeeping, Plant and personnel safety, and. fire protection.

Cleanliness shall be maintained -consistent with the work being performed, so as to prevent the entry of foreign material into safety-related. systems. This shall include, as a minimum, docu-mented cleanliness inspections which shall be performed prior to system closure.

As necessary, (e.g. the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, modification, refueling or repair.

Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.

A-19 Rev. 15 6/92

OQAM APPENDIX A REGULATOBY_ GUIDE 1.39 (cont.)

Records: The requirements of OQAM Section 17 and Section. 4 Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this

~

Appendix shall be implemented in lieu of the requirements of the Section.

In every case either identical or equivalent controls are provided in the sections of the referenced Standards or docu-ments.

REGULATORY GUIDE 1.58 REVISION 1 DATED 9/80 Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

The. qualification of UE QC or contracted QC personnel performing work at the Plant shall be in accordance with Regulatory Guide 1.58 (ANSI N45.2.6-1978). Other personnel performing inspection, examination, and testing activities shall have appropriate expe-

rience, training, and retraining to assure competence in accor-dance with Regulatory Guide 1.8 (ANSI /ANS 3.1-1978). This posi-tion is consistent with Regulatory Guida 1.33 (ANSI N18.7-1976/-

ANS-3.2, Section 3.4.2).

In instances where the education and experience recommendations of ANSI N45.2.6-1978 are not met by QC personnel, UE shall demon-strate by documented results of written examinations and evalua-tions of actual work proficiency that these individuals possess comparable or equivalent competence. Persons performing Nondes-tructive Examinations (NDE) as may be required by Section III or XI of the ASME B&PV Coda shall be qualified and certified as required' by the Edition and Addenda of the Code to which UE is ennmitted at the time the NDE is performed. However, when qual-ifying personnel to perform visual examinations VT-2, VT-3, and VT-4 in accordance with IWA-2300 of Section XI, Division 1,

ANSI /ASME N45.2.6-1978 may be used instead of ANSI N45.2.6-1973 (Code Case N-424). Persons certified to perform NDE for Code work shall also be considered as qualified to perform non-code NDE (e.g.

crane hook inspection) unless more rigorous qualification or certification requirements are imposed by UE's commitments or government regulations.

A-20 Rev. 15 6/92

OQAM APPENDIX A RESEATORY GUIDE 1. 58 (cghd

uid, regard to Section 1.2 of ANSI N45.2.6 -1978 titled Apolica-tdlity: The third paragraph requires that the Standard be used in conjunction with ANSI N45.2; UE no longer specifically commits to ANSI N45.2 in the Operating QA Megual.

The fourth paragraph requires that the Standard be imposed on personnel other than UE employees; the applicability of the Standard to suppliers shall be documented and applied, as appropriate, in the procurement documents for such suppliers.

With regard to Section 1.4 of ANSI N45.2.6 - 1978 titled Q9fini-tions:

Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANbI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in

~

UE's commitment to Regulatory Guide 1.74.

With regard to Section 2.5 of ANSI N4f..

- 1978 titled Physi-gal: UE shall implement the t "".emento af this Section with the stipulation that, where no special physical characteristics are

required, none shall be specified. The converse is also true: if no special physical requirements are stipulated by UE, none shall be considered necessary.

REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.11-1974)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

When uniqueness or special design considerations warrant or are judged to be appropriate, an independent third-level review may be employed.

With regard to Paragraph C.2(1) of Regulatory Guide 1.64: If the designer's immediate Supervisor is the only technically qualified individual available, this review may be conducted by th

uper-

visor, provided that: (a) the other provisions of thc Regalatory Guide are satisfied and (b) the justification is individually documented and approved in advance by the Supervisor's manage-ment, and (c) quality assurance audits cover frequency and effec-tiveness of use of the Supervisors as design verifiers to guard against abuse.

With regard to Section 1.4 of ANSI N45.2.11 - 1974 titled Defini-tions:

Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in this Appendix.

A-21 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.64 (cont.)

With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12,_

under Procram Reauirements, and Section 11 (including subsections 11.1 through 11.7) of ANSI N45.2.11 - 1974, titled Audits:

UE's audit program shall ba implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, OQAM Sections 16 and 18, and the requirements of the Callaway Plant Technical Specifica-l tions.

In every case either identical or equivalent controls are provided in the sections of the referenced Standards or docu-ments.

REGULATORY GUIDE 1.74 INITIAL ISSUE DATED 2/7s Quality Assurance Terms and Definitions (Endorses ANSI N45.2.10-1973)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications.

UE reserves the right to define additional words or phrases which are not included in this Standard. Such additional definitions shall be documented in appropriate procedures or in Sections of the Operating QA Manual.

In addition to the Standard's definition of

" Inspection,"

UE shall use the following: " Inspection (when used to refer to activities that are NOT performed by QA or QC personnel) - Exam-

ining, viewing closely, scrutinizing, looking over or otherwise checking activities. Personnel performing these functions are not necessarily certified to Regulatory Guide 1.58 (ANSI N45.2.6)."

These activities are controlled by the Callaway Plant Operating b

Manual.

When UE intends for Inspection to be performed in accordance with the Operating QA Program by personnel certified as required by that Program and for activities defined by " Inspection" in ANSI N45.2.10, appropriate references to QC group or the procedures to be used for performing the activity shall be made. If such refer-ences are NOT made, inspections are to be considered under the additional definition given above.

In addition to the Standard's definition of " procurement docu-ments,"

UE shall utilize the definition given in ANSI N45.2.13.

The compound definition is given as follows: Procurement docu-ments

- Contractually binding documents that identify and define the requirements which items or services must meet in order to be considered acceptable by the purchaser. They may include docu-ments which authorize the seller to perform services or supply equipment, material or facilities on behalf of the purchaser A-22 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)

(e.g.

Engineering Service Agreement agreements for engineering, construction, or consulting services), contracts, letters of

intent, purchase requisitions, purchase orders, or proposals and their acceptance, drawings, specifications, or instruction which define requirements for purchase.

Supplier quotation submitted in response to specified

" Bids" technical and quality requirements for which price and delivery are primary considerations.

" Proposals"

- Supplier offerings that define the scope of supply as well as specific technical and quality requirements for a

product or service. Such offerings usually require negotiation prior to acceptance as either a purchase order,

contract, or Engineering Service Agreement.

" Program Deficiencies" (Not defined in ANSI N45.2.10, but used and defined differently in Regulatory Guide 1.144 (ANSI Failure to develop, document or implement effec-N45.2.12))

tively any applicable element of the Operating QA Program.

" Quality Assurance Program Requirements" (Not defined in ANSI N45.2.10 but used and deflusd differently in ANSI N45.2.10)

Those _ individual requirements of the Operating QA Program 'hich, when invoked in total or in part, establish the requirements of the quality assurance program for the activity being controlled.

Although not specifically used in the Operating QA Program, ANSI N45.2 may be imposed upon UE's suppliers.

" Independent Verification" - Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed. Such verifi-cation-need not require confirmation of the identical action when other indications provide assurance or indication that the pres-cribed activity is it. fact complete. Examples include, but are not limited to: verification of a breaker opening by observed remote breaker indication lights; verification of a set point (mLde with a voltmeter or ammeter for example) by observing the actuation of status or indicating lights at the required Panel-meter indicated value; verification that a valve has been positi-oned by observing the starting or stopping of flow on meter indi-cations or by remote value positions indicating lights.

" Audit" (This is a modification of the word's definition -

to allow the use of~ subjective evidence if no evidence is available as defined in Section 1.4 of ANSI N45.2.12 - 1977 (Regulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23 - 1978 (Regula-tory Guide 1.146) as opposed to the definition given in ANSI N45.2.10

- 1973Property "ANSI code" (as page type) with input value "ANSI N45.2.10</br></br>- 1973" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.) - A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of objective evidence where available, (subjective A-23 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)

evidence may be used when objective evidence is not available),

that applicable elements of the Quality Assurance Program have been developed, documented and effectively implemented in accor-dance with specified requirements.

An audit should not be confused with surveillance or inspection for the sole purpose of process control or product acceptance.

An internally (Not defined in any ANSI Standard)

"Must" auditable requirement imposed by UE management upon its employees, contractors, and agents - above and in excess of the legally binding requirements of the appropriate regulatory body.

Such items are internally required but not externally enforce-l able. (See additional discussion under Section 2.14 of the OQAM.)

" Unit staff" - (Not defined in any ANSI standard) - Means those personnel who report to the Vice President, Nuclear Operations.

This term shall also be synonymous with the "onsite operating organization" described (but not defined) in ANSI N18.7-1976, Section 3.4.2; the

" unit staff" as used in the OQAM and in Callaway Plant Technical Specifications section 6.3 and its subparts and Section 6.5.2.9.b; the " unit organization" described in the Callaway Plant Technical Specifications Section 6.2.2.

"Like kind replacements" - (Net defined in any ANSI standard)

Like kind replacements include both exact item replacements and other item replacements which are not " exact" but meet the orig-inal design requirements.

REGULATORY GUIDE 1.88 REVISION 2 DATED 10/76 Collectior,

Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (Endorses ANSI N45.2.9-1974)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled Gener-ation of Ouality Assurance Records: The phrase " completely filled out" is clarified to mean that sufficient information is recorded to fulfill the intended purpose of the record. It is the informa-tion, not the form, that is the record. Thus the information, not the form, needs to be complete to furnish documented " evidence of activities affecting quality".

With regard to Section 3.2.2 of ANSI N45.2.9 - 1974 titled Index:

The phrase "an index" is clarified to mean a collection of docu-ments or indices which, when taken together, supply the informa-tion attributed to "an index" in :.he Standard.

A-24 Rev. 15 6/92 l

OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

The specific location of a record "within a storage area" may not be delineated.

(e.g.

The specific location within a computer record file may not be constant. Further, UE may utilize a

computer ancisted random access filing system where such location could not be readily " documented," or would such a location be

" relevant.")

The storage location shall be delineated, but where file locations change with time, the specific location of a

record within that file may not always be documented.

With regard to Section 4.2 of ANSI N45.2.9 - 1974 titled Timeli-ness:

UE's contractual agreement with its contractors and supp-liers shall constitute fulfillment of the requirements of this Section.

The following clarification is substituted for the current subsection 5.4.3: " Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microfilm and magnetic media) to prevent damage from excessive

light, stacking,-

electromagnetic fields, temperature and humidity as appropriate to the records type." Consideration shall be given to manufacturer's recommendation.

With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safe-keenino:

Routine General Offices and Plant site security systems and access controls shall be provided:

no special security systems-are required to be established for record storage areas.

With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Facil-ity:

This Section provides no distinction between temporary and permanent facilities. To cover temporary storage, the following clarification is added: " Active records (those completed but not yet duplicated or placed on microfilm) may be temporarily stored in one-hour fire rated file cabinets. In general, records shall not be maintained in such temporary storage for more than three months arter completion without being duplicated (for dual stor-age) or being placed on microfilm. Open-ended documents

--those revised or updated on a more-or-less continuing basis over an extended period of time (e.g.

personnel qualification and training documents, equipment history cards, master audit or master surveillance schedules) and those which are cumulative in nature (e.g.

nonconforming item logs and control room log books)--

are not considered as QA records since they are not

" complete." These types of documents shall become QA records when they are issued as a specific revision (e.g.,

the master audit schedule);

when they are filled-up or discontinued (e.g.

log books or equipment history cards); on a predefined periodic basis when the completed portion of the on-going document shall be transferred to document control as a " record" (e.g. training and qualification records).

i A-25 Rev. 15 6/92

~

~

OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits:

These specific activities a sub-sections 1, 2 and 3 are accomp-lished thrcugh the establishment of administrative controls by the responsible management.

Audits of these administrative controls are performed in accor-dance with this OQAM, Section 18 and commitments to Reg.

Guide 1.144 in this Appendix.

Paragraph 4,

subsection 3 is clarified to require a two-hour minimum fire rating to be consistent with the 1979 version of the h

Standard and NRC Criteria for Records Storaae Facilities (Gui-dance-ANSI N45.2.9, Section 5.6) issued 7/1/80.

Paragraph 4,

subsection 9 is clarified to read: "No pipes or penetrations except those providing fire protection,

lighting, temperature /

humidity

control, or communications are to be located within the facility and they shall comply with a minimum two-hour fire protection rating."

Where duplicate storage is employed, no special precautions or provisions (including vault storage, special humidity and tempe-rature recorders and similar items) are required.

Paragraph 5

is clarified to read the same as our commitment to subsection 5.4.3.

Boti, paragraphs address the same requirement and therefore the commitment must be the same.

REGULATORY GUIDE 1.94 REVISION 1 DATED 4/76 Quality Assurance Requirements for Installation, Inspection and Testing of Structural Concrete and structural Steel During the Construction Phase of Nuclear Power Plants.

(Endorses ANSI N45.2.5-1974)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

For modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA program-matic/ administrative requirements included therein (subject to the clarifications below) shall apply to these modification activities even though such requirements may not have been in effect originally. Technical requirements associated with modifi-cations shall be equal to or better than the original require-ments (e.g.,

code requirements, material properties, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

A-26 Rev. 15 6/92

1 OQAM APPENDIX A l

REGULATORY GUIDE 1.94 (cont.)

The recommendations for structural concrete, structural

steel, and other Plant components shall be met as indicated by the applicable design documents with the following exceptions:

With regard-to Section 2.4 of ANSI N45.2.5-1974 titled Personnel Oualification:

Union Electric will comply with Regulatory Guide 1.58 as endorsed in this OQAM in lieu of the requirements of this standard.

In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled Calibra-tion and-Control:- The last sentence is clarified as follows:

"UE's inspection or test results conducted with M&TE found to be discrepant are to be evaluated as dercribed in the

C7AM, Section 12.8."

With regard to Section 5.4 of ANSI N45.2.5-1974 titled Hich Etr;nath Boltina: In lieu of the first two sentences in the first paragraph, UE will comply with the following: " Bolts for friction type connections may be tightened using direct tension indicators in accordance with the AISC Specification for Structural Joints Using ASTM A325 or A490 Bolts, approved May 8, 1974."

In lieu of (1) in the second paragraph, UE will comply with the following:

- The requirement for the acceptance of tightened bolt assemblies is, the length of the bolts shall be such that the l

point of the bolt shall be-flush with or outside of the face of t

the nut when completely installed."

REGULATORY GUIDE 1.116 REVISION 0-R DATED 5/77 Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems (Endorses ANSI N45.2.8-1975)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

For maintenance and modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA programmatic / administrative. requirements included therein shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally.

Technical requirements associated with maintenance and modifica-tions.shall be equal to or better than the original requirements (e.g.,

code requirements, material properties, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

A-27 Rev. 15 6/92

OQAM' APPENDIX A-REGULATORY GUIDE 1.123 REVISION 1 DATED 7/77 Quality Assurance Requiremento for Control of Procurement of

-Items and Services _for Nuclear Power Plants (Endorses ANSI N45.2.13-1976)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

With regard to Section 1.3 of ANSI N45.2.13 - 1976 titled Defini-tions:

With two exceptions (Procurement Document and Quality

-Assurance, Program Requirements) definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's comnitment to Regulatory Guide 1.74.-The two exceptions are defined in this Appendix under Regu-latory Guide 1.74.

With rogard to Section 1.2.2 of ANSI N45.2.13 -

1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Purchaser's Responsibilities: Item-C is one of the options which may.be used by UE to assure quality; however, any of the options given in 10 CFR 50, Appendix B, Criterion VII as implemented by ROQAM Sections-4 and 7 may also be used.

.With regard to. Section 3.1-of ' ANSI N45.2.13 1976 titled Procurement Document Preparation. Review and Chance Control: The phrase "the same degree of control" is stipulated to mean " equi-valent level of review and approval." The changed document may not always be re-reviewed by the originator; however, at least an equivalent level lof supervision shall review and approve any changes.

With regard?-to.Section 3.4 of ANSI N45.2.13 -

1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled t

Procurement Document control

UE shall meet the requirements of OQAM Sections

'4 and 7 in lieu of the requirements specified in this Section.- In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments.

With regard to Section 5.3 of-ANSI N45.2.13 - 1976 titled Prea-

' ward Evaluation:

UE shall comply with an alternate paragraph

-which reads: "Except in unusual circunstances (e.g..

replacement parts are needed to preclude the-development of some unsafe or undesirable condition.at callaway), an evaluation of the suppli-er's acceptability as a procurement source shall be performed as required-by the Operating-QA-Manual." While it is not the intent to make- " unusual circumstances"-determinations without Engi-neering-or QA involvement, Callaway Operations Support is ulti-mately responsible for the-decision. QA audit and surveillance

.activitiestassure against abuse.

A-28 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.123 (cont.)

With regard _to Section 6.4-of ANSI N45.2.13 - 1976 titled Control gf Chances in Items of Services: The phrase "the Operating QA Program" is inserted in lieu of " ANSI N45.2, Section 7."

With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disoo-sition: The third sentence of item b is revised to read:

Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist of one or more of the following shall be submitted to the Purchaser for approval of the recommended disposition prior to ship-ment when the nonconformance could adversely affect the end use ~ of a module

• or shippable component relative to safety, interchangeability, operability, reliability, integrity, or maintainability:

1)

Technical or material requirement is violated; 2)

Requirement in Supplier documents, which have been approved by the Purchaser, is violated; 3)

Ncnconformance cannot be corrected by continuation of the original manufacturing process or by rework; and/or 4)

The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

• A module is an assembled device, instrument, or piece of equip-ment identified by serial number or other identification

code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable compo-nent' is a part of sub-assembly of a device, instrument, or piece of equipment _which is shipped as an individual _ item and which has been evaluated by inspection and/or test for conformance to procurement requirements regarding end use.

With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source Verification Activities and Section 12 of ANSI N45.2.13 -

1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Audit of Procurement Procram: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appen-

dix, OQAM Sections. 16 and 18,.and the requirements of the Callaway Plant Technical Specifications.

A-29 Rev. 15 6/92

~_.

~

OQAM APPENDIX A REGULATORY GUIDE 1.144<

REVISION-1 DATED 9/80 Auditing Lof Quality Assurance Programs for Nuclear Power Plants I

(Endorses ANSI N45.2.12-1977)

DISCUSSION:'

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

With regard to-Section-1.4 of ANSI N45.2.12 - 1977-titled Defini-tions:. With.one exception (Program Deficiencies) the definitions in this: Standard which are not included in Regulatory Guide 1.74 (ANSI HN45.2.10) shall be used; definitions which are included in-ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74. The one excepted definition and a clar-ified definition (of audit) relevant to this Standard are= defined in this-Appendix under Regulatory Guide 1.74.

.With' -regard to Section 2.1 of ANSI N45.2.12-1977 titled General:

-Identical or-equivalent controls are provided in this

OQAM, Section 18.~3 regarding the second paragraph discussing audit team selection.

=

With regard to-Section 2.2 of ANSI N45.2.12 - 1977 titled Person-

-nel cualification:.The qualification of UE audit personnel shall be -accomplished as described to meet the requirements of Regula-tory _l Guide 1.146 :(ANSI N45.2.23 --1978) as endorsed in this

-Appendix and OQAM.Section 18.

With-regard to Section 2.3 (and subsections 2.3.1-through 2.3.3) of ANSI N45.2.12 - 1977 titled Trainina: The training of UE audit personnel shall be' accomplished as described to meet the require-ments_ of Regulatory Guide -1.146 (ANSI N45.2.23 -

1978Property "ANSI code" (as page type) with input value "ANSI N45.2.23 -</br></br>1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.) as endorsed in this Appendix and OQAM Section 18.

~

With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Mainte-nance of Proficiencv: _The maintenance of-proficiency of UE audit

-personnel shall be accomplished as described to meet the require-ments of-Regulatory -Guide 1.146L (ANSI N45.2.23 - _1978) as endorsed;in this Appendix and OQAM Section 18.

With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essen-

'tial Elements of the Audit System: UE shall comply.with subsec-tion 3.3.5.as it was originally written (subsection 3.2.5).

in

-ANSI N45.2.12, Draft 3, Revision 4: " Provisions for reporting on the effectiveness of the Quality Assurance Program to the respon-sible1 management."- For the auditing organization (UE), effective--

ness _-shall-be reported as required by the Callaway Plant Tech-nical : Specifications.~ other than audit reports, UE may not directly report on the effectiveness of the quality assurance programs 'to the audited organization when such organizations are outside of-UE.

l A-30 Rev. 15 6/92 l

l OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

Subsection 3.3.6 requirements are considered to be fulfilled by compliance with the organization and reporting measures outlined in this operating QA Manual and the Callaway Plant Technical Specifications.

In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments.

Subsection 3.3.7 requires verification of effective corrective action on a timely basis. Timely basis is interpreted to mean within the framework or period of time for completion of correc-tive action that is accepted by the Quality Assurance Department.

Each finding requires a response and a corrective action comple-tion date; these dates are subject to revision (with the approval i

of the Quality Assurance Department) and must be escalated to higher authority when there is a disagreement between the audited and the auditing organizations on what constitutes

" timely corrective action."

With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planning:

Identical or equivalent controls are provided in this OQAM, Section 18.

With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Sched-ulina:

Identical or equivalent controls are provided in this

OQAM, Section 18 for the requirements of Subsections 3.5.1 and 3.5.2.

Subsection 3.5.3.1 is interpreted to mean that UE may procedurally control qualification of a contractor's or suppli-er's quality assurance program prior to awarding a contract or purchase order by means other than audit. The measures outlined in Sections 4

and 7 of this OQAM address the requirements of Subsection 3.5.3.1, With regard to Section 4.3.1 of ANSI N54.2.12 - 1977 titled Pre-Audit Conference:

UE shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the first sentence.

This clarification is required because, in the case of certain unannounced audits or audits of a particular operation or work activity, a pre-audit conference might inter-fere with the spontaneity of the operation or activity being audited.

In other cases, persons who should be present at a pre-audit conference may not always be available: such lack of avai-lability should not be an impediment to beginning an audit. Even in the above examples, which are not intended to be all inclu-

sive, the material set forth in Section 4.3.1 shall normally be covered during the course of the audit.

A-31 Rev. 15 6/92 1

l

OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

With regard to Section 4.3.2 of ANSI N45.2.12 - 1977 titled Audit Process:

(a)

Subsection 4.3.2.2 could be interpreted to limit auditors to the review of only objective evidence; sometimes and for some Program clements, no objective evidence may be availa-ble. UE shall comply with an alternate sentence which roads:

"When available, objective evidence shall be examined for compliance with Quality Assurance Program requirements.

If subjective evidence is used (e.g.

personal interviews, direct observations by the auditor), then the audit report must indicate how the evidence was obtained."

(b)

Subsection 4.3.2.4 is modified as follows to take into account the fact that some nonconformances are virtually

" obvious" with respect to the needed corrective action:

"When a

nonconformance or Quality Assurance Program defi-ciency is identified as a result of an audit, unless the apparent

cause, extent, and corrective action are readily

evident, further investigation shall be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required."

(c)

Subsection 4.3.2.5 contains a recommendation which is clar-ified with the definition of " acknowledged by a member of the audited organization" to mean that "a member of the audited organization has been informed of the findings."

. Agreement er disagreement with a finding may be expressed in the response from the audited organization.

(d)

Subsection 4.3.2.6 is modified as follows to account for the fact that immediate notification is not always possible:

" Conditions requiring immediate corrective action (i.e.

those which are so severe that any delay would be undesira-ble) shall'be reported immediately to the audited organiza-tion and as soon as practical to the management thereof."

With regard to Section 4.3.3 of ANSI N45.2.12 -

1977Property "ANSI code" (as page type) with input value "ANSI N45.2.12 -</br></br>1977" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Post-Audit Conference:

UE shall substitute and comply with the following paragraph: "For external audits, a post-audit confer-ence shall be held with management of the audited organization to present audit findings and clarify misunderstandings; where no adverse findings exist, this conference may be waived by manage-ment of the audited organization: such waiver shall be documented in the audit report. Unless unusual operating or maintenance conditions preclude attendance by appropriate managers /supervi-

sors, a post-audit conference shall be held with managers / super-visors for internal audits for the same reasons as above. Again, if there are no adverse findings, management of the internal audited organization may waive the post-audit conference:

such waiver shall be documented in the audit report."

A-32 Rev. 15 6/92

~.

OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

With regard to Section 4.4 or ANSI N45.2.12 - 1977 titled Report-1D9:

(a)

This Section requires that the audit report shall be signed by the Audit Team Leader (ATL); this is not always the most expeditious route to take to assure that the audit report is issued as soon as practical. UE shall comply with Section 4.4 as clarified in the following opening: "An audit report, which-shall be signed by the Audit Team Leader (ATL), or the ATL's supervicor in the ATL's absence, shall provide:

In cases where the audit report is not signed by the ATL due to absence, one record copy of the report must be signed by the ATL upon return. The report shall not require the ATL's review / concurrence / signature if the ATL is no longer employed by UE at the time the audit report is issued.

(b)

UE shall comply with subsection 4.4.3 clarified to read:

" Supervisory leve' personnel with whom significant discus-sions were held uring the course of pre-audit (where conducted)

audit, and post-audit (where conducted) activ-itles."

(c). Audit reports may not necessarily contain an evaluation statement regarding the effectiveness of the Quality Assu-rance Program elements which were audited, as required by subsection 4.4.4, but they shall provide a summary of the audited areas and the results which identify the importance of any adverse findings.

With regard to Section 4.5.1 of ANSI N45.2.12 - 1977 titled By Audited Oraanization: UE shall comply with the following clarifi-cation of the Section: Management of the audited organization or activity shall review and investigate adverse audit findings, as necessary, (e.g., where the cause is not already known,-

another organization has not already investigated and found the

cause, etc.)

to determine and schedule appropriate corrective action including action to prevent recurrence. They shall clearly state the corrective action taken or planned to prevent recurrence and the results of the investigation, if conducted. In the event that corrective action is not completed within thirty

days, the audited organization's response shall include a scheduled date for completion of planned corrective action. The audited organi-zation shall take appropriate action to assure that corrective action is accomplished as scheduled. Since the auditing organiza-tion tracks scheduled corrective action completion dates and I

verifies corrective action completion, a follow-up response by l

the audited organization stating the corrective action taken and l

the date that the action was completed is not necessary, provided corrective actions are completed as specified.

If corrective actions are not completed as specified, the audited organization shall provide a revised response stating the corrective action that has been taken, the corrective action yet to be completed, and the date that all corrective action will be completed.

A-33 Rev. 15 l

6/92

OQAM

' APPENDIX A REGULATORY GUIDE 1.146

! INITIAL ISSUE DATED'8/80 Qualification of Quality Assurance Program Audit Personnel-for Nuclear Power Plants-(Endorses ANSI N45.2.23-1978)

DISCUSSION:

UE complies with the recommendations of this. Regulatory Guide with the following clarifications:

With respect to Section 1.4 of ANSI N45.2.23-1978 titled Defini-tions:. Definitions in this~ Standard which are not included in ANSI N45.2.10 shall be used: _" Audit" which is included in this

. Standard _and ANSI-N45.2.10 shall.be used as clarified in this Appendix under Regulatory Guide 1.74.

With respect to Section 2.2 of ANSI N45.2.23 - 1978 titled-Quali-fication of Auditors: Subsection 2.2.1 references an-ANSI B54.2 (presumed to be standard N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 which reads:

Orientation _to provide a working knowledge and understanding

.of the Operating.QA Manual, including the-ANSI standards and Regulatory-Guides included in this Appendix and UE's proced-

-ures for-implementing audits and reporting results.

With : respect.to Section 3.2-of ANSI N45.2.23 - 1978 titled Main-tenance of Proficiency: UE shall comply with the requirements of this Section by defining " annual assessment" as one which' takes places every-12 + or -:3 months and which uses the initial date

-of certification-(not the calendar year) as the starting date for determining when such annual-assessment is due. The combined time Lintervalifor any three consecutive assessment intervals shall not exceed 3.25. years.

With: respect to Section 4.1 of ANSI N45.2.23 - 1978 titled Oraan-cizational-Resnonsibility: UE shall comply with this Section with the-substitution of the following sentence:in place of the last sentence in the Section:

~

The

Manager, Quality Assurance; a Superintendent, Quality Assurance; Supervising Engineer, QA; or Lead Auditor shall, prior -to commencing the audit, assign personnel'who'collec-tively have experience or' training commensurate with the L

scope, complexity, or specialinature of the activities to be h

. audited..

L' With respect to Section 5.3 of ANSI N45.2.23 - 1978 titled Uodat-ina of' Lead Auditor's Records: UE shall substitute the following

. sentence for this Section:

A-34 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.146 (cont.)

Records 'for-each Lead Auditor shall be-maintained and updated during the-period of the annual management-assess-ment as defined in.Section 3.2_(as clarified).

With respect-to Section 5.4 of ANSI N'.5.2.23 -

1978-titled Records Retentiont UE shall substitute the following sentence for this Section:

Qualification records shall be generated and maintained as required by OQAM Section 17 and by commitment to Regulatory Guide 1.88 (ANSI N45.2.9) as clarified in this Appendix.

~

In every case either identical or equivalent controls are provided in the sections of the referenced Standards and docu-ments.

s d

1 A-35 Rev. 15 6/92 l

7..

)

CHAIRMAN L CHIEF SENIOR V.P.

SENIOR V.P.

SEr,IOR V.P ADMIN CUST.

SERVICES SERVICES NUCLCAR I

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ATTACHMENT 2

////////////////////////////////////////////////////////////////////////////////////////////////////////////

OQAM, REVISION 15 IDENTIFICATION OF CHANGES e

/////////////////////////////////////////////////////////.//////////////////////////////////////////////////

_.....,,..-=,----.-------.-;---------...;..---

OQAM EFFECTIVE PAGE LIS 'ItK3 Page No.

Rev.

i 12 il 13 111 B o*T iv 44-/f v

14 t r vi N 'T vil 14if Page No.

Rev.

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4-6 14I 5-1 14 ' I S-2 14 6-1 14 6-2 14 6-3 14

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-v-Rev. 14 6/91 1.

T OOAM EFFECTIVE PAGE LISTING Page No.

Rev.

J 7-1

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-vi-1 Rev. 14 6/91 l

1 i

OQAM EFFECTIVE PAGE LISTING Appendix A Page No.

Rev.

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4-D

i Figures Rev.

Figure A E4-'T Figure B 1-4 r Figure C M

s' c

iJ

-vii-Rev. 14 6/91>

OQAM OPERATING OUALITY ASSURANCE MANUAL (OOAM) 1.0 ORGANIZATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority fw.

the development, implementation and maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OQAP, although certain Program

-activities may be delegated to others. The organi-zation responsible for implementing appropriate portions of the OQAP is shown in Figures A and B of the OQAM. The Callaway Plant operating organization is shown in Figure C of the OQAM.

I 1.2 The Senior Vice President-Nuclear is responsible for initiating the Quality Assurance

Program, formulating the

policy, and authorizing and assuring Progu : implementation. He is responsible for directing activities within the Nuclear Divi-sion which support the engineering, construction,

testing, and operation of the Callaway-Plant and coordinating support activities performed by others who are not under his direct administrative control.

He has corporate responsibility for the operation and physical control of the Callaway Plant.

He reports to the frf414e-e-f Chief Executive cs hw w % whtch has ultimate responsibility for the Callaway Plant.

(% n~m ad M. v.~~/

}

398_

1.3 The Manager, Quality Assurance re~ ports to the 1790 Senior Vice President-Nuclear on' Quality Assurance 2006 Program and administrative matters. QA Program i

2012 matters are reported to the Off-icc of--the Chief Executiygs through the Senior Vice President-Nu-r O EN DesirT The-Manager, Quality Assurance is respon-sible to the-Senior Vice President-Nuclear for assuring the OQAP is being effectively implemented I

for operating activities; directing the overall Quality Assurance Program for UE-including ?rogram development,.

maintenance, and verification of implementation.

The Manager, Quality Assurance has sufficient authority, organizational freedom, and independence to effectively assure conpliance with OQAP requirements as they control Callaway Plant and offsite quality activities; and shall bear no

cost, schedule, or production responsibilities which unduly influence attention to quality matters.

A communication path shall exist between l

1-1 Rev. 15 6/92

(

1 OQAM OPERATING QUALITY ASSURANCE MANUAL (OQAM) 1.0 ORGANIZATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for the development, implementation and. maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OQAP, although certain Program activities may be delegated to others. The organi-zation responsible for implementing appropriate portions of the OQAP is shown in Figures A and B of the OQAM. The Callaway Plant operating organization is shown in Figure C of the OQAM.

o

/

~~

1.2 The President it responsible to the Chief Executive A'=

Officer of UE for the establishment and implementa-tion of the Quality Assurance Program requirements.

)

He has ultimate responsibility for quality assurance, engineering, construction, and operation of the Callaway Plant.

1.3 Under

.ne

?;es-i-dent, ethe Senior Vice President-

/g 1 Nuclear is responsible for initiating the Quality f

Assurance

Program, formulating the

policy, and

-s

/]

authorizing and assuring Program implementation. He

'-y is responsible for directing activities within the Nuclear Division which support the engineering, construction,

testing, and operation of the Callaway Plant and coordinating support activities performed by others who are not under his direct administrative control. He has corocrate resconsi-bility for the ope: 3 tion and phys'ical control of the.Callawa Plant, m; r-r8 6.h - ~w A e h

0 % w & > % y % J E m w.s.l.rj

} L k. ~ y

@.,. i f

al fe y

1790 1.4 The Manager, Quality Assurance reports to che 2006 3

Senior Vice President-Nuclear on Quality Assurance j6 Program and administrative matters _Q\\

Procram N w bu t a /

matters are reported to the P+esident througn the ~ C'"

/;s Senior Vice President-Nuclear. The Manager, Quality

""*^

Assurance is responsible to the Senior Vice Presi-

/ \\

dent-Nuclear for assuring the OQAP is being effec-JN tively implemented for operating activities; The Il '.

Manace-r,

Ouality asarx.ca C cespons4b1h 5or directing the overall Quality Assurance Program for UE including Program development, maintenance; and verification of implementation.

The

Manager, Quality Assurance has sufficient authority, organi-zational freedem, and independence to effectively I

assure compliance with OQAP requirements as they control Callaway Plant and offsite quality activ-i 1-1 Rev. 14 l

6/91 1

w... - -..

.-.. - _ - - _ _ = _

OQAM ities; and shall bear no cost, schedule, or produc-tion responsibilities which unduly influence atten-tien to quality matters. A communication path shall exist between the Manager, Quality Assurance and so Vice President, Nuclear Operations, the--Manager, callaway_ Plant--anti the_ Manage r, npexat-ions-Support s

N""fg o,.,,a '

n as well. as the other Department--Heads in the i

• • ""ic,,,P Tuclear Division, thus providing a direct path to inform management regarding conditions affecting quality. The qualifications of the Managor, Quality l

Assurance are at least equivalent to those spec-ified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Section 4.2.4.

The

Managor, Quality Assurance is located at callaway Plant and provides technical direction and administrative guidance to the Superintendent, Quality Assurance; the Supervising

Engineer, Quality Support,^ Quality-Assurance; and the Quality as Le g T

, S F 4-G Assurance staff.

y

\\(;

1.

Th6 Superintendent, QA is located at Callaway

/

Plant.

Ha directs Supervising Engineers who have primary duties for assuring implen': cation of the x

! '\\

OQAP and devotes full attention :a tr.is effort. The Supervising Engincor, Quality Support,4Nn located

/)\\

at callaway Plant, directs a group of engineers who provide additional support activities including maintenance of the Operating Quality Assurance

[W" Manual (0.2AM).;t The activities of the grmos e ", c, N

py Yporun7 engarintendant. etnM nad wi*h_ r.j.e

• n

• Ma a t-ivit4es---of---.the-gr. cup &pj:;rting

• m the Sq er-vising-E ng i nee rr-Qu a-Hty-sup port assure implomonta-tion of tha OQAP. The qualifications of the Super-intendent are at least equivalent to those spec-ified in ANSI /ANS-3.1-1978, " Selection and Training ef Nuclear Power Plant Personnel," Section 4.4.5.

/(\\

1.k The Manager, Quality Assuranco, the Superintendent, Quality Assurance. and Supervising Engficers in the Quality Assurance Department are authori:cd by the Senior Vice President-Nuclear to stop work on ongoing quality activities in accordance with approved procedures.

During the opercting phase they have the authority to stop unsatisfactory work during

repair, maintenance, and refueling activ-ities and the authority to recommend to the

Manager, Callaway Plant s:cp work affecting the ceStinuation of Plant operation. Other step work autaority shall be delineated in procedures.

The continuance of an activity which would cover up a

deficiency and preclude identification and correc-

tion, or increase the extant.of the deficiency is subject to stop work action by the Quality Assur-ance Cepartment.

The Manager, Quality Assurance, c

1-2 Rev.,14 6/9Y L

OQAM and the Superintendent, Quality Assurance have no duties or responsibilities unrelated to QA that would prevent their full attention to QA matters.

)

l (\\

1790 17 The authorities and duties of persons and organiza-1 j

(

tions performing quality assurance functions shall be clearly established. Such persons have suffi-cient authority and organizational freedom to iden-tify quality problems; to initiate, recommend, or provide solutions; and to verify corrective action.

Ascurance of quality by

checking, auditing, irspecting, or otherwise verifying Program activ-l ities shall be by personnel other then the indi-vidual or group prorforming the specific activity.

l 1184 1.6 The Manager, Nuclear Engineering reports directly 4

7 to the Senior Vice President-Nuclear and directs a staff of superintendents, supervisors, supervising 7

engineers, and quality control inspectors whose primary function is to provide technical support to the operatio'.

Of callaway Plant.

This support includes, but is not necessarily limited to design; modification; configuration control; system and equipment performance; reliability, and testing; technical programs administration; and contracter support.

He controls those activities and impic-l ments the OQAP throunk the Superintendents, Design

control, System Engi: uaring, and Project Engineer-ing. Within the System Enginuering orgeai:ation, QC Inspectors (ISl/NDE) report to the Supervising Engineer Performance and ISI, and pertirm inspec-tien and nondestructive examinations. These inspec-tors do not perform inspections or examinations which provide quality verification of Nuclear Engi-neering work activities.

I l.9 The Manager, Licensing and Fuels reports directly L3q(('h to the Senior Vice President-Nuclear and has fl overall responsibility for UE nuclear fuel cycle

/'\\

activities including responsibility fer procurement of fuel cycle goods and services, and for incere fuel management. The Manager, Licending and Fuels is also responsible for coordinating licensing activities for callaway Plann. The Licensing and Fuels organi:ation provides technical support activities in the area of reactor design and radi-ological engineering.

I

/\\

1. la The Manager, Nuclear Services reports directly to 4

/'

i the Senior Vice President-Nuclear and is respon-sible for providing administrative and management support including cost forecasting, status report-

ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices s

of 1-3 Rev 14 6/91 2

OQAM clerical activities, and serves as Principal Health Physicist.

He is also responsible for the adminis-trative contact with the Institute of Nuclear Power Operations (INPO). As Principal Health Physicict, N he provides a corporate level overview and guidance in the formulation and implementation of applied radiation proteccion programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations.

80 l

g 1.11 The Vice President, Nuclear Operations teports to the Senior Vice Ptesident-Nuclear and is respon-sible for the activities of the Callaway Plant Operations Department and the Operations Support Department.

This responsibility includes the safe, legal and efficient operation and maintenance of the Callaway Plant and protecting the health aN safety of the public and Plant personnel.

He a.;sures a high level of quality is achieved in the Plant operations and support activities.

j{ ff h%&J,<;, p u s.lify % h 4 5 4 el~j

Q pqo l (?qg' /%

The Manager, callaway Plant reports 'direEtTy Ed the m/

A 1.12 f

d Vice President, Nuclear Cperations an$ is respon-g-

sible for the safe, legal, and officiant cperation and maintenance of the callaway Plant #He controls

/;

Plant functions and impicments the OQAP through the assistan4-Managar r-Operations-and-Maintenancef-tue s7\\

{.

Assistant

Manager, Work Contro11 the Superinten-p.l*h, " h a s dent, Health Physics; and the Superintendent, Chem-G istry and Radwaste,(see Figure C of the OQAM).

He zg3 9 ;4@##

the prix.ary responsibility for reactor opera-4 J

A tion and safety. Within his organization, the QC Oh,,(/

,n g'(,

Supervisor reports to the Assistant Manager, Work control who reports to the Manager, Callaway Plant.

'[g, The Quality Control Group performs work activity inspections, receipt inspection as described in

,h Section 7, and nondestructive examinations and is not involved in those activities performed by others which are considered

" inspections" unto themselves, e.g.,

surveillance

testing, initial startup testing, and I&C, Radiation Protection, and Chemistry group activities. Activities considered to be inspections unto themselves are covered by QA audits and QA surveillances as discussed under Section 18.

The QC Supervisor has no duties or responsibilities unrelated to quality control that would prevent his full attention to quality control

matters, ly 4 1.a3 The Manager, Cperat!cns Support reports to the Vice 1

President, Nuclear Operations and is responsible c,-.

/\\

for Plant support activities including

training, 7

materials management, security, and administration services activities required to support the A

1-4 Rev. M 6/91 a

~

r oQAM Callaway operating License.

He controls Plant support acti'ities and implements the oQAP through the Assistant Manager, Materials, the Superinton-

dent, Training, the Superintendent, Security, and the superintendent, Administration.

(3 1 3vf A 1.14 cenoral quality assurance indoctrination and

/4\\

training for the !Amlear Division is the responsi-bility of UE Nucleer operations (UENo),

Training.

The Quality Assurance Department is responsible for specific QA training as requested by Nuclear Divi-sion organizations.

H A 1.1S The

Manager, Nuclear Information Services (NIS)

/M \\

reports to the Vice President, Nuclear operations.

He is responsible for providing the

analysis, programming, operations, hardware support,

files, reports, and capabilities necessary to maintain the nuclear information system and network in support of the plant.

W jp 1.14 The Manager, Nuclear Safety and Emergency Prepared-i ness (NSEP) reports directly to the Vice President, m __.

Nuclear operations and is responsible for providing a

constant independent overview of nuclear Plant safety.

He directs the Supervising Engineer, Inde-pendent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP). A communi-4 cation path exists between the Manager, NSEP and the Senior Vice President-Nuclear for matters having immediate or significant safety implica-

tions,

.hus providing a direct path to contact management personnel having corporate responsi-bility for Callawsy Plant.

/b D10

,}*

1.-14 The Supervising Engineer, ISEG and staff evaluate 7

Callaway Plhnt operations from a safety perspective jh\\

and compare Callaway operating experience with that of plants of similar design. In

addition, they assess the conformance of Plant performance to safety requirements.

67

/h(

1. 11 The Supervisor, EP and staff have overall responsi-i bility for the development and maintenance of the 1

Emergency Preparedness Program.

This includes ensite and offsite emergency preparedness, coordi-nation of the Plant Radiological Emergency Response Plan with State and local emergency plans, and the planning and execution of emergency drills and emergency plan exercises.

]

j/jg' reports directly to the Vice President, Nuclear 1.

The Superintendent, Personnel (Local 1439 and 1455) operations and is responsible for assisting in G

1-5 Rev. 14 6/91*

- ~. ~ - - - - - -

ogAM areas of labor relations, organizational and personnel activities, Fitness-For-Duty, and other matters under the guidance of UE policies.

g,y l

1. O The Superintendent, Personnel (Local 148) reports

/

s directly to the Vice President, Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel activities, and other matters under the. guidance of UE policies.

So The

Manager, Purchasing reports directly to the

/k 1.11 Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative Serv-ices.

The Manager, Purchasing is responsible for commercial aspects involved in procurement of mate-rials, systems, components, and services (excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others which are employed in support of Callaway Plant.

%:a va- (m.J~ r, b.h A S" M

/hg 1.12 The Manager, Mechanical / Engineering reports to the Vice President-Engineering and Conctruction who in

/$\\'

turn reports to the President. The Manager, Mechan-ical Engineering provides technical support, _as

/

nec.essary,__to _the Nuclear Engineering.staj D Ths *

~ ho reports to the

Manager,

_ w

' Chief Draftsman, Mechanical Engineering provides drawing preparation and revision

support, as requested, for design performed by Nuclear Engineering or other UE organ,)'

1:ations.

>L 1.23 The Manager, Electrical Engineering reports to the

.A\\

vice President-Engineering and Construction.

The

Manager, Electrical Engineering provides technical

support, as requested, to the Nuclear Engineering O

staff.

g, g,,

g4 l

/b 1.24 The--Ma nager, O u a 1-14ybr v i c c c --- r-spor-ts-4ir-ec t 1 y to T~

the--Sanier " ice President-Technical Serviccc - TT.c

/d\\

Senior ViOO Precidend-Technic 21 Ser" ice? cepert to g

trhe--Grasident.

The Manage, Cu211tv-Services is W la I,

responsible f or supper-c4my audit. curveillance, and evaluatien of nuclear supplier quality activities; and for performing

' chose procurement document I

reviews sssigned to ggelit; Ocrvi:cs.

um.

A

1. 36 The Manager,-Sys*.em Relay Services reports to the f

/~ i 23 Senior Vice-President, Technical Services and is responsible for providing qualified engineers, tachnicians and equipment te maintain Callaway Plant relays.

l l

o 45 1-6 Rev. be 6/91 i

1

OQAM jf

. 2*#

1 The

Manager, Distribution Operating Department si reports to the Vice-President Transmission and Distribution and is responsible for providing qual-ified engineers, technicians and equipment for Callaway Plant battery testing and technical support.

l 1.2 Other UE divisions may provide safety-related A

/a\\

pg services which augment and support selected Program activities.

These organizations shall be required to implement controls consistent with the 00AP requirements applicable to their scope of activ-ities.

The coordination of these activities is the responsibility of the Senior Vice President-Nuclear.

l A

1.2$

Safety review committees shall be established to dl A6 provide an independent review of those items required by the Callaway Plant Technical Specifica-tions.

These committees, the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB),

are described in the Administrati'/e Controls Section of the Callaway Plant Technical Specifications.

d d

1-7 Rev. 44 6/91 L

OOAM 2794 2.0 QUALITY ASSURANCE PROGRAM 17[9 2.1 UE has established an OQAP which controls activ-itles affecting quality. The Program encompasses those quality activities necessary to support the operating phase of the Callaway Plant and shall comply with 10 CFR 50, Appendix B

" Quality Assur-ance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33.

Commitments, clarifications, al srnatives, and exceptions to the Regulatory Position of Regulatory Guide 1.33 are stated in Appendix A of this OQAM.

In addition, the OOAP has incorporated the commit-monts made in responding to applicable NRC ques-tions.

The text of the NRC questions applicable to the OOAP, along with the responsen, are maintained as a QA Record separate from the OQAM. The Senior Vice President-Nuclear has initiated the Program and formulated the policy in addition to author-

[M izing Program implementation. This responsibility 4

has been established by the Presiden t--who-i s c L,, _ _,,f responsibic to the Chief Executive Officer of UE for establishing and implementing the Quality Assurance Program requirements.

m~

, d$$ ;

2.2 Lines of authority and responsibility have been

[7 '

established from the highest management level through intermediate levels and to the Vice Presi-

dent, Nuclear Operations and the onsite operating organi:ation.

These relationships shall be docu-mented and updated, as appropriate, in the form of organization

charts, functional descriptions of departmental responsibilities, and position guides for key personnel having direct operating, support, or audit responsibility. Where specific responsi-bilities are assigned within the

OQAP, the prescribed individual shall retain the overall responsibility;

novever, subject to applicable regulatory constraints, authority may be delegated to subordinates. Considering these same regulatory constraints, the authority of a subordinate may g

always be assumed by a superior, tt01 I 2.3 Up' dating and revision of the OQAP as described in S

M is this OQAM shall be in accordance with the appli-(-s~f[lh cable requirements of 10 CFR 50.54 (a) and 10 CFP 50.71.

~

182U 2.4 The pertinent requirements of the OQAP apply to all

' g pg '3 20200

.s activities affecting the safety-related functions

./?\\

of those structures, systems, and ccmponants that

~ ' ~

prevent or mitigare the consequences of 7sstulated accidents that could cause undue risk to the health C

2-1 Rev, b4 t'91 L

OQAM and safety of the public. The safety-related struc-

tures, systems and components are identified in Table 3.2-1 of the Callaway-SP Final Safety Anal-1 ysis Report (FSAR). This list includes structures,

systems, and components identified during the design and construction phase and may be modified as required during operations consistent with their impo r tance' to sarety. Modifications to this list require the approval of the Manager, Quality Assur-ance and the Manager, Nuclear Engineering and shall be issued and controlled in accordance with Section 6.

The development, control, and use of computer programs to be used in safety-related activities are within the scope of the OQAP. The degree of controls applicable to each computer program shall be consistent with the program's importance to safety-related activities. Consumables which could affect the form, fit or function of safety-related structures, systems, and components, although not listed in Table 3.2-1 of the Callaway-SP FSAR, are also under the control of the OOAP.

lY16 1879 2.5 The OQAP shall be implemented throughout the oper-en '/ /

ating life of the callaway Plant.

Activities

/\\

affecting quality shall be accomplished under suit-7 ably controlled conditions. Controlled conditions include the use of appropyiate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied.

1789 2.6 Consistent with the schedule for accomplishing 1879 quality activities, the OOAP shall be established and documented by written policy, program

manual, and procedure manuals. Persons conducting safety-related activities shall be responsible to imple-ment approved procedures. The OQAP shall utill:e the following document types to describe Program cbjectives:

1.

Operating Quality Assurance

?rogram Policyf Introcuction Statement The Operating Quality Assurance Program Policy statement establishes governing principles in accordance with the requirements of 10 CFR 50, Appendix Br The Operating Quality Assurance Program Policy statement

?ad any revisions thereto shall be approved t ae Senior Vice President-Nuclear.

/

2-2 Rev. li 6/91 r,

OOAM 13db A 2.

Operating Quality Assurance Manual (OQAM)

{\\

The OQAM containc a delineation of the Policy statement, quality assurance requirements, assignment of responsibilities, and a defini-tion of organizational interfaces. The OQAM is the written description of the OQAP.

Approval ot the OQAM is by the Senior Vice President-Nucle.

and the Manager, Quality Assurance.

3.

Callaway Plant Operating Manual zdbs g49 The Callaway Plant Operating Manual consists of a

multi - volume set of Plant operating proce-dures prepared or reviewed by the staff with i

the aid of other SNUPPS utilities, Nuclear Engineering, the Lead A/E, the NSSS

Supplier, and Fuel Fabricator.

These procedures ate controlled, approved, and issued in accordance with Administrative Procedures contained within the Manual. This Manual includes administrative controls consistent with those requit.d by Regulatory Guide 1.33.

(94 /hs Administrative procedures which apply to the entire staff, and revisions thereto, shall be reviewed by the Callaway Plant Onsite Review Committee (ORC)

. ui the Quality Assurance Department.

The !

al approval of Administra-tive Procedures and revisions thereto shall be by the Manager, Callaway Plant. The review and approval of ouner procedures and revisions thereto shall be in accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications.

679 2.7 UE may employ the safety-related services of archi-1746 tect engineers, NSSS suppliers, fuel fabricators, 1787/bg constructors, and others which provide or augment 2293 UE efforts during the operating phase. These organ-2460 12ations shall be required to work under a quality assurance program vnose controls are consistent with the scope of their effort.

This does not preclude any organization from working under the UE OQAP.

The quality assurance program of outside organizations shall be subject to review, evalua-tion and acceptance by the UE Quality Assurance Department o r ;ac l i t y Sc r+4ces Depa r tme n t p r io r t o the initiation of safety-related work.

Vendor programs and peccedures shall alao meet UE's i

commitment to USNRC Generic Letter 87 78.

/

'S 2-3 Rev. la 6/91 2.

OQAM 2.8 Disputes which may arise between QA or QC personnel and personnel in other UE organizations which cannot be resolved shall be referred to the next g,/

higher level of management for resolution. Disputes which cannot be resolved through these levels shall be resolved ultimate.ly by the Chief Executive Officer.

2.9 Preservice (PSI) and inservice (ISI) inspection,

testing, and examination activities may be performed by outside organizations. These inspec-tionn and other operating phase " code" activities shall comply with the requirements of the appli-cable Code Edition and Addenda of the ASME Boiler and Pressure Vessel Code. This compliance includes the independent third-party inspection coverage of

" code" items by an Authorized Nuclear Inspactor.

1. 7 tf 1916 2.10 General indoctrination and training programs shall 12937 p\\

be developed for personnel performing safety-2194/ i related activities to assure that responsible func-

tions, departments, and individuals are knowledge-able regarding quality policy and requirements of applicable manuals and procedures. The requirements for training of Callaway Plant personnel are described in Section 13.2 of the Callaway-SA FSAR.

The training of permanent Plant personnel is the responsibility of the Superintendent, Training. OE personnel performing complex, unusual, or hazardous work shall be instructed in special indoctrination or briefing sessiods. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equip-ment and

systems, operating constraints, and control requirements in effect during performance of work.

Training shall be conducted as required to, as a minimum. meet the requirements of UE's commitment to Regulatory Guide 1.8 (ANSI /ANS 3.1),

Regulatory Guide 1.33 (ANSI N18.7), other Regula-tory Guides as endorsed in OQAM Appendix A,

and other regulatory requirements. Records of training shall be maintained as described in Section 17.

Whern required by code or standard, personnel are trained or qualified according to written proce-dures in the principles and techniques of performing specific activities. Special equipment, environmental conditions,

skills, or processes chalm be

?covided as necessary for the effective ital ~.entarten of tne OQAP.

l idd 2.11 An audit system shall be established to assure i

management is advised of Program effectivenecs. The gp Li_

implementation and effectiveness of the OQAP shall be assessed through an audit program cf quality sf 2-4 Rev. t1 l

S/91 L

l 1

- _ _. -. ~.

OOAM activities which includes

design, procurement, modification, and operation. The Manager, Quality Assurance is responsible for a system of planned audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance cnd in accordance with the require-ments of Section 18.

He is responsible for conducting audits of offsite and onsite activities.

Deficiencies identified during the. audit process are reported to responsible management of the organization involved in the resolution and follou-up to assure corrective action.

l74i 2.12 The Senior Vice President-Nuclear provides for an is independent assessment of the scope, implementa-(qg /l \\

tion, and effectiveness of the OQAP to assure compliance with

policy, commitments, and the requirements of 10 CFR 50, Appendix B as set forth in this OQAM. This assessment shall be conducted biennially with a

scheduling allowance of plus three months for each assessment and a combined time interval for any three consecutive assessment intervals not to exceed 6.25 years. This assessment may be by representatives of other utilities, outside consultants, or UE management representa-tives.

In addition, various reports are issued to the Senior Vice President-Nuclear on a periodic basis to assist his independent assessment of the OQAP (e.g.,

semiannual QA report, and periodic > QA audit reports).

2.13 Imolementation of OQAP controls over activities aftecting quality assures achieving the objective of the UE OQAP to provide management with adequate confidence that activities affecting quality regarding the oesign, installation, modification, and operation of the Callaway Plant are performed consistent with policy.

Documentation of the accom711shment of OQAP objectives is maintained in the form of records of data and other information as necessary to support operation, maintenance,

repair, modification, refueling, and inservice inspection.

2.14 UE Management has established standards of perfor-mance which exceed those set forth by the Regula-tory Agencies. As a management initiative in this

area, UE-has defined the word "must" to impose management directed performance standards in. =ess l

of and in addition to established Regulatory directed pe:formance.

From the viewpoint of UE employees and UE contractors, there is no differ-ence in the degree of compliance mandated by use of the words "shall" or "must."

Compliance with

< T~

2-5 Rev 44 5 /9-1 4

OQAM 2165 3.10 Procedures shall specify requirements for the 2166 review and approval of design changes by the organ-

)

2168 izations or individuals that performed the original 2169 design or Nuclear Engineering. Design control 2243 activities, including design changes, may be dele-gated to others provided they have access to back-ground and technical information. Design control measures for design revisions shall be commensurate with those applied to the original design.

1934 3.11 Design activities shall also include:

1) reviewing the applicability of standards;

2) reviewing 269+ h\\

j commercial or previously approved materials, parts or equipment for suitability of application; 3) re-viewing the compatibility of materials used in the j

design; 4) reviewing the accessibility of equipment and components for inservice inspection, mainte-

nance, and repair;

5) specifying criteria for inspection and test / retest; and 6) reviewing and approving procedures for special processes.

2164 3.12 The design process shall establish controls for 2168 releasing design documents which are technically 2191 adequate and accurate in a controlled manner with a 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled through the -use of written procedures by the

issuer, distributor, and user to prevent inad-vertent use of superseded dccuments.

Document control procedures shall govern the collection,

storage, and maintenance of design dccuments, results of design document reviews, and changes thereto. The design documents subject to procedural control include, but are not limited to, specifica-

tions, calculations, ccmputer

programs, system descriptions, SAR when used as a design

document, and drawings including flow diagrams, piping, and instrument diagrams, control logic diagrams, elec-trical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations.

2164 3.13 The design interf;;es between UE organizations 2188 performing work affecting quality of design and 2190 between UE and outside organizations shall be 2217 identified-and controlled by procedures. These 2218 procedures shall address control of the interface, 2219 responsibilities, lines of communication, and l

2223 documentation of internal and external interface activities.

j 1934 3,14 The design process shall include design verifica-2182 tion. Design verification assures that design is 2209 adequate and meets specified design inputs. Design I

3-3 Rev. 44 6/9r A

-c,--

~. _..

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

00AM tion would become irreversible (i.e.,

require extensive demolition and rework). The design veri-fication shall be complete prior to relying upon the component, system, or structure to perform its safety-related function.

2200 3.16 Action shall be initiated to correct errors found in the design process. Errors and deficiencies identified in approved design documents shall be documented and the process of their correction (i.e.,

review and approval) shall be controlled.

These actions shall assure that changes to design or installed components are controlled.

3.17 Requests for design changes affecting safety-related structures, systems, and components may be originated by the unit staff, Licensing and Fuels or Nuclear Engineering. Design changes shall be processed by Nuclear Engineering. Design changes engineered by Nuclear Engineering shall be the responsibility of the Manager, Nuclear Engineering.

Design changes engineered by Licensing and Fuels shall be the responsibility of Licensing and Fuels.

FFS9-3.18 Independent of the responsibilities of the design 5844 organization, the requirements of the Onnite Review Committee (ORC) and the

. clear Safety Review Board (NSRB) as defined in tac Technical Specifications shall be satisfied. Design enanges require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, Callaway Plant. In addi-

tion, changes in the facility as described in the FSAR which involve a change in the Callaway Plant Technical Specifications incorporated in the license or an unreviewel safety question require review and approval by the NSRS and the Nuclear Regulatory Commission prior to implementation. When design is performed by an outside organization, UE shall perform or coordinate a review of the design for operability, maintainability, inspectability, FSAR commitment compatibility, test and inspection acceptance criteria acceptaollity, and design requirements imposed by Plant generating equipment.

5844 3.19 Safety evaluations which consider the effect of the design as described in the design' documents, shall be performed by the responsil.le UE engineering organization or outside orgrnization(s).

These

• evaluations shall include the iasis for the deter-mination that the design change does not involve an unreviewed safety question. As deemed necessary by the evaluating organization, detailed analyses shall_ be performed to support 'he bases of safety evaluations.

All nuclear safe y evaluations are 3-5 Rev. 14 6/91

OOAM submitted to the ORC. Changes invo ving the substi-tution of equivalent hardware require safety J

evaluations to assure that the de ign requirement changes are consistent with and.io not alter the g,s/

design criteria specified in exis;ing design docu-ments. When design documents and safety evaluations are prepared by an outside organization under its

.l QA program, review and approval por ANSI N45.2.11 will be included.

UE will approve all outside organizations' design documents and. safety evalua-

tions, and will perform appropriate reviews neces-sary for final approval.

FF+0 3.20 The ORC shall review design change safety evalua-A tions to recommend final approval of design M\\

changes. Design changes which involve an unreviewed safety question or a change in the Technical Speci-fications shall be forwarded to the NSRB for review. An application for amendment of the license shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90.

3.21 The NSRB shall review safety evaluations to verify that changes did not involve unreviewed safety questions.

I 1910 3.22 Procedures and instructions related to equipment or A

systems that-are modified shall be reviewed and 2162

/7\\

updated to reflect the modification prior to placing the equipment or systems in operation to perform safety-related functions. Plant personnel shall be made aware of changes affecting the performance of their duties through peccedure revi-

sions, or specific training in the operation of modified equipment or systems, or other appropriate means.

2039 3.23 Records shall-be maintained which reflect current 2132 design including safety analyses, safety evalua-2163

tions, design change installation procedures, 2173 material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings.

3.24 Drawings shall be prepared under a drawing control system which provides for checking methods and review and approval requirements. Drawings shall be suoject to reviews by the responsible design organ-1:ation for correctness, conformance to design

criteria, and compliance with applicable codes and standards.

3-6 Rev. 14 6/91

00AM Nd 4.O PROCUREMElfL DOCUMENT CONTROL 61 9 975 4.1 Safety-related procurements shall be documented.

1679 Procurement document control applies to documents 1876 7 employed to obtain safety-related materials, parts, 1887 components, and services required to support Plant 3541 activities. Written procedures establish require-

-3548 ments and assign responsibility for measures to assure applicable regulatory requirements, design i

bases, and other requirements necessary to assure quality are included in procurement documents.

479 4.2 Written procedurea shall include controls, as 3559 applicable, for preparation,

content, review,

approval, and processing of the following related procurement documents:

1.

Purchane Requisitionc 2.

Purchase Orders 3.

Letters of Intent 4.

Engineering Service Agreements (agreements for engineering, construction, or consultant serv-ices) (ESAs) 5.

Contracts 6.

Specifications 7.

Drawings 3560 Collectively, :hese crocedures shall assure that GdBT'/h\\

technical an' qual'ity requirements are correctly

stated, insp< : table, and controllable; there are adequate acc.ptance and rejection criteria; and procurement documents have been prepared, reviewed, 4

and approved in accordance with CA Program require-ments.

3572 4.3 Consideration of the verification activities to be 3579 employed for item or service acceptance should 4580/h\\

begin during the purchase requisition, ESA, or

}5 &S contract preparation and review stage. Planning of 3984 verification activities shall include a review of 3505 the established acceptance criteria and identified 3607 documentation.

Verification methcds whien may be H74 employed include certificationn (certificates of conformance and material certificates or test reports), -source verification, receiving inspec-

tion, and post-installation tests established by UE.

Selected verification methcds may be indicat?d as inspecticns, examinaticns, tes:3, or d:cumer tion review:. The extent of th

' m"

-t r a ' #' ic and associated verifica tion ac :v.t:.es s a rune-tion of the purchased item's or service's complexity and relative safety at;ni;icance, as well as the supplier's past performance.

4-1 Rev. l4 6/91L

OOAM IML 3572 4.4 Acceptance by source verification should be consid-3580 A ered when the item or service is vital to Plant Q7 safety; or the quality characteristics are diffi-s,/

cult to verify after receipt; or the item or service is complex in design, manufacture, inspec-tion or test. Verification in this sense involves a physical presence to

monitor, by observation, designated activities for the purpose of evaluating supplier performance and product acceptability.

1875 4.5 Purchase requisitions must be employed to initiate the procurement of safety-related materials, parts, components, and services while ESAs must be used to contract for safety-related engineering, construc-

tion, or consultant services. Contracts, purchase orders generated from purchase requisitions, and ESAs must be employed to procure certain goods and services associated with the nuclear fuel cycle.

Purchase requisitions for safety-related materials,

parts, components, and serviceu and ESAs for professional services may be initiated by personnel in the Quality Assurance or Quality Services Departments; Nuclear Engineering, Nuclear Services, or Licensing and Puels Department; or the unit staff.

975 4.6 The procurement of space or replacement parts for 1876 safety-related structures, s/ stems, and ccmponenta 1877 shall be subject to the CA Program controls in 1878 effect at the time the order is issued; and to 1883

codes, standards, and technical requirements which are equal to or better than the original require-ments or as may be required to reduce the proba-kility for repetition of defects. Procurement docu-ent control preparation measures shall further

. assure that safety-related components, piece parts, materials, and services are purchased to specifica-tions and codes equivalent to those specified orig-inally or those specified by a properly reviewed and approved revision; packaged and transported in a

manner to assure the non-degradar!on of quality during transit; and properly documented to shcw compliance with applicable specifications,

codes, and standards.

1876 4.7 Each item or service to be procured is evaluated by the procurement document originator to determine whether it performs a safety-related function or involves activities which affect the function of safety-related materials, parts, or ccmponents and to appra.,e the importance of this function to Plant or puolic safety. For those cases where it is unclear if an individual piece (part of a safety-related structure, system, component or service) is t

4-2 Rev. 14 6/91 2.-

+

OQAN

[(N# "l W-e-f" "L,. t :E w =8

~'

g g,./ governed by the OQAP, an engineering evaluation

.hr/**' f1 shall be conducted.

The evaluation shall be sd'r conducted by Nuclear Engineering or Materials Engi-

}x/,o4pp K^8 A SW[

neering and shall classify the safety relationship

.oppn M P c**"]** items of the service or questionable component, parts or of safety-related structures, systems, and a p

,pe-p components.

Evaluations shall be documented for future reference.

1 4.8 Provisions for the following shall be included in jk procurement documents as applicables T49errem>

1864

' 1.

The scope of work and basic administrative and specifigations, regulations, special instruc pfj technical requirements including drawings, 1890 2416 3550 tions,"*dpplicable codes and industrial stan-gyr%g titles and revisiop levelse(cpecial process $*

dards and procedural requirements identifinds 3551 fa 3552 by

'7ub-cor+espondtg,2B4-examinat4onfreguire ntn>and g instructionsh test g[d P 6 l'#">

acceptarice EdFITe

\\

special requirements for activities such as h_1 designing, identifying, fabricating, cleaning, e r e;c ting,

packaging, handling, shipping, and storing.

1888g^x 2.

Requirecant that the supplier have an accept-1890 able Qu4.ity Assurance Program which implements 4 5ya the appeg riate sections and elements of ANSI 3542 3

3553 N45.2-1977 or the AaME code as applicable as established for the item or service to be supplied. This requirement is not applicable to commercial grade items which utilize a suppli-er's standard or proven design to meet published product descriptiens.

1890 3.

Requirements for supplier surveillance, audit,

-36424 )~d and inspection including provisions for UE or j/\\

agent access to facilities and records and for 355S 7

3573 identification of witness and hold points.

354 3 d0 m+

1890 A

4.

Requirements for extending applicable require-454f,3fe2$ /7\\

ments of UE procurement documents te lower-tier 3555 suppliers and subcontractors. These require-ments shall include right-of-access to subsup-plier facilities and records by UE.

,g Requirenients for suppliers to obtain UE 3550 5.

approval of nonconformances to procurement 3558 1526-document requirements dispositioned "use-as-is" 15'C/

and

" repair" and conditiens of their disposi-

. ion including identification of those subject l

to UE approval prior to further processing.

l

{

4-3 Rev. 14 6/91 L

m

00AM 3484 6.

Applicability of 10 CFR 21 reporting require-monts.

1890 /g 7.

Documentation requirements including records 2132 /7\\

to be prepared, maintained, submitted for 3550 approval, or made available for review, such 3556 as,

drawings, specliAcations, procedures, 7

>S 4 procurement documents, inspection and test

records, personnel and procedural qualifica-

tions, chemical and physical test results, and instructions for the retention, transfer, and disposition of records.

8.

Requirements that the supplier furnish documentation which identifies the purchased item and provides traceability to the procure-ment requirements met by the item and documen-tation identifying any procurement requirements which have not been met.

13559 4.9 The originating organization shall perform a docu-3560 mented independent review of procurement documents 3562 to assure requirements are correctly

stated, inspectable, and controllable and that there are adequate acceptance and rejection criteria.

This review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement. documents.

• gg (3564

.10 Bids or proposals shall be evaluated by the 3568

.x Purchasing Department the criginating organica-

/

3569 A

tion, the Quality ib597Y5esDepartment, and the

/7\\

Licensing and Fuels Department to assure confor-mance to procurement document requirements in the following areas as applicab e to the type of procurement as described below:

1 Technical considerations 2.

Quality Assurance requirements 3.

Research and development effort 4.

Suppliers' personnel qualifications 5.

Suppliers' production capability 6.

Suppliers' past performance 7.

Alternates 8._

Exceptions 13560 4.10.1 The Purchasing Department shall initiate and coor-3540 /s dinate bid evaluation activities for those propos-3563/7' als received in response to requisitions.

The Purchasing Department shall review bids or propes-

als, except those associated with ESAs or nuclear fuel cycle related goods or services, for alter-nates or exceptions to procurement document

?

4-4 Rev. 18 6/91L

OQAM requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented.

l 3560 4.10.2 The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier.

They shall also review areas 1 through 3 above for replacement parts or equipment ordered from the original supplier ac part of procurement document preparation.

h.srece-1 3560 4.10.3 The Quality Gervlees Department and the originating organization review areas 4 through 6 above as part of maintaining a supplier on the Qualified Supplier List as described in the OQAM, Sections 7.0 and 18.0.

I 3560 4.10.4 The Licensing

& Fuels Department shall evaluate bids or proposals for fuel cycle goods or servi'ces in the above areas.

I 3560 4.11 Bids or proposals with alternates or exceptions 3561,97 identified in Section 4.10 by the purchasing 3568'hg' nating organization to provide additional assurance Department shall also be evaluated by the origi-3570/

that no unacceptable conditions result from such changes.

Unacceptable conditiens identified in bid or proposal evaluations snall be resolved prior to purchase award.

1 4.12 Letters of intent may be utilized with suppliers of materials, parts, conponents, and services for the purpose of reserving schedule space prior to the i

resolution of the commercial requirements to be included in a purchase order, contract, or ESA. If

employed, letters of intent must normally specify that no safety-reJated activities may begin until an approved purchase order, contract, or ESA is executed.

Letters of intent shall bo

prepared, approved and issued by purchasing for those suppliers to be covered by purchase order, by the originating organi:stion for ESA's, or by the Nuclear Fuel Department for contracts for nuclear fuel cycle-related goods and/or service-However in the event a-letter of intent is issued for the purpose of securing an agreement and thereby allow safety-related work to begin prior to the issuance of such documents, it shall include the applicable quality and technical requirements, as specified by the originating organi:ation.

(

4-5 Rev. If 6/91 1

OQAM l

3563 4.13 The Purchasing Department is responsible for reviewing purchase orders to verify that the tech-nical and quality requirements have been accurately transferred from the requisition to the purchase *=>

order. Approval of the purchase requisition, letter of

intent, ESA, or contract shall be by an indi-vidual who has approval authority and signifies that the technical and quality review of the docu-ment has been completed. Contracts initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility of the

Manager, Licensing and Fuels with preparation and negotia-tion by the Licensing and Fuels Department. Nuclear fuel cycle-related contracts and ESAs for prof 6s-sional services shall be executed by the Senior Vice President-Nuclear or another company officer in accordance with Nuclear Division and corporate procedures related to agreements or contracts for services.

I 975 4.14 Additions, modifications, exceptions, and other 3543 changes to procurement document quality and tech-3549 nical requirements shall require a review equiv-

3555, alent to that of the original document and approval 3575'3933 by the originator or the originating department Ireb/h\\

approval authority.

Commercial considerati:n q 1967 changen shall not require review and concurrence by the originator. Conditions specified on the Qut -

ified. Suppliers List (QSL) that apply to a veni;r may be revised without concurrence from the ori;;-

nating organization since they are imposed withe :

the knowledge of the originator.

4-6 Rev. 1) 6/91 1

-~--

,,n-s-.

-s.

m n

r-,c--,---

-.ver

.n.,r-.,,----

OQAM 2974 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 1830 5.1 The activities affecting quality asscciated with 1855 the operating phase shall be accomplished and 186%

controlled by:

1916 1948 1.

Preparing procedurec, instructions, specifica-

tions, drawings or checklists of a type appro-priate to the activity and its importance to safety which specify the methods for complying with 10 CFP 50, Appendix B and the Technical specificatious; 2.

Including in these documents quantitative or qualitative acceptance criteria for verifying that an activity has been satisfactorily accomplished; 3.

Having responsible personnel approve these documents prior to accomplishing an activity; and 4.

Using approved drawings, procedures, instruc-tions or checklists to accomplish an activity; The-degree of control imposed shall be consistent with the relative importance of the activity to-

safety, i

1833 5.2 The Nuclear Division and other responsible func-tions and departments shall provide written proce-dures and drawings as required to support the Ca!,laway plant operating phase. These procedures shall prescribe those activities affecting safety-related structures, systems, and components. It is recognized that skills normally possessed by qual-ified personnel may not require detailed step-by-step delineations in written procedures.

1 5.3 The

Manager, callaway Plant shall be responsible for providing specific guidance via Administrative Procedures for the development, review and approval of other Plant operating procedures to govern activities which affect safety or quality consistent

. ith the Technical Specifications.

w Similar guidance shall be provided for revisions and temporary changes to Plant operating proce-dures. Procedures which implement the Security Plan and Radiological Emergency Response Plan shall be reviewed less frequently than every twelve months (in accordance with Technical Specifica-tions).

A revision of a procedure may constitute a precedure review, f

5-1 Rev. 14' 6/91;

_ _ ~

OQAM

\\t16 7.0 CONTROL OF PURCHASED MATIIRIAL, EQUIPMENT AND SERVICES F872' 7.1 Materials, equipment, and services shall conform to 3541 procurement documents as prescribed in Section 4.

/h\\

Provisions shall be established to control activ-ities affecting quality associated with the procurement of material, equipment and services including:

1.

The preparation, review, and change control of procurement documents as described in Section 4 2.

Did evaluation and award as described in Section 4

)fb[

3.

Procurement source selections 4.

Verification activities (surve',llance, inspec-tion, and audit) required by the purchaser 1747 5.

Control of nonconformances as described in Section 15 6.

Corrective action as described in Section 16 7.

Material, equipment, and service acceptance 2416 8.

Control of quality assurance records 9.

Audits of the procurement program as described in Section 18 6941 r$79 7.2 UE shall assure that suppliers providing safety-1644 related materials, equipment, or services are 3564;ggf acceptable procurement sources. Provisions shall 4

3879 be made for supplier evaluations which assess their dh\\

capabilities prior to award by: 1) source evalua-j tion; or 2) review for objective evidence of qual-ity; or 3) a review of supplier history.

When evaluations are performed, the assessment of a

supplier's capability shall be specific to the procured

item, commodity, or service and the supplier's ability to provide the items or serv!ces in accordance with procurement document require-ments. Suppliers of hardware and services which are manufactured prior to award, considered a commer-l cial grade item, or implemented under the UE OQAP i

do not require pre-award source evaluation or post-award audits which attes: to their capability as a procurement source.

2337 7.3 During Callaway's operating life, procurements may l

2942/ys be made from:

1) suppliers judged capable (prior 7-1 Rev. Ik 6/91 2.

~.-

OQAM i3564 to award) of providing items or services in 3874 accordance with procurement document requirements and a quality assurance program appropriate for the g,/

item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and whose acceptability can be determined by receiving inspection, an examination of quality verification documentation, or other suitable means;

3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAp.

Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a purchase order or execution of a contract or ESA, a verification of the supplier /outside organization's acceptability shall be documented.

Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition),

an evaluation of a

supplier's acceptability as a procurement source shall be accomplished prior to award. In the case of purchase orders, the supplier shall be verified as an acceptable procurement source for the item or service being procured.

Purchase orders may be issued prior to an assessment of suppliers' capa-bility provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source.

~

I 7.4 code certified material may be obtained from an ASME accredited Material Manufacturer or Material Supplier for repair or replacement applications.

However UE may also obtain Code certified materials from non-ASME accredited Material Manufacturers or Material Suppliers if such Manufacturers or Suppliers are otherwise qualified as stipulated in Sections 4 and 7 of the CQAM. These provisions are consistent with ASME Code Interpretation XI-1-83-50R dated May 14, 1985.

Ig4I rM(A 1894 7.5 procurement source eval /uation and selection 3564j\\

involves the Quality St w.es Department and the

$ref/ \\

originating organization. The evaluation and selec-7

/

tion process shall be specified in department proc-edures and may vary depending on the complexity and relative importance to safety of the item or service.

Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organiza-tions may be requested to provide input to the qualification evaluations of suppliers.

Suppliers of hardware and services which are manufactured prior to award, considered a commercial grade item, 7-2 Rev. 14 6/9I

ogAM implemented under the oQAP do not require or pre-award source evaluation audits which attest to a

suppliers capability as a procurement source.

l 3566) 7.6

-Procurement source selection and evaluations shall

$ 5G9 consider one or more of the following:

3564 1.

Experience of users of identical or similar products of the prospective supplier.

NRC Licensee Contractor and Vendor Inspection Program (LCVIp) reports, ASME Certificates of Authorization (C

of A),

audit

reports, UE records accumulated in previous procurement actP as, and UE product-operating experience may be used in this evaluation.

Supplier history shall reflect recent capability.

previous favorable quality experience with suppliers may be an adequate basis for judge-ments attesting to their capability. When an LCVIP report, an audit report, or an ASME C of A

is used to establish a supplier's accepta-bility as a procurement source, the document shall be identified.

2.

An evaluation of the suppitar's current quality records supported by documented qualitative and-quantitative information which can be objec-tively evaluated. This may include review and evaluati.on of the supplier's QA

Program, Manual, and' Procedures, as appropriate; and responses to questionnaires.

3564 A 3.'

A source evaluation of the supplier's rGm M\\

technical and quality capability as determined r

by a direct evaluation (audit or surveillance) of facilitier., personnel and Quality Assurance Program implementation.

4.

For commercial grade items, the procurement source selection should consider one or mors of the following:

a.

Survey of documented supplier controls over critical characteristics and that supplier activitien adequately control the items

supplied, and verify the implementation _of manufacturer's measures for control of design, procesc, and material changes, b.

Acceptable supplier / item performance record utilizing monitored performance of the

item, industry product

tests, national

codes, and standards (not specific to the nuclear industry), or other ir.oustry data-(

7-3 Rev. 14 6/91' 2

00AM bases (UL, INPO NpRDS, EPRI

EQDB, ANSI,

NEMA, MIL-STDS, NRC Bulletins / Notices, and Licensee Event

Reports, etc.)

that is directly related to the item's critical

,j characteristics and intended application.

1 l

7.7 Procurement source evaluations involve a review of technical and quality assurance considerations.

Technical considerations include the design or manufacturing capability and technical ability of

'i suppliers to produce or provide the

design, service,

item, or component.

Quality assurance considerations include one of the previously defined methods of supplier evaluation and a

consideration of changes in a supplier's Quality Assurance Program or capabilities.

The measures employed to evaluate a supplier's continued accept-ability as a procurement source (after the initial source evaluation) are described in Section 18.

I p2.

l 19%1 7.8 Organizations participating in the procurement A\\

process shall prepare procedures to monitor and evaluate suppliers' performance to precurement document requirements.

These procedures shall include prsvisions for: 1) controlling documents generated or processed during activities fulfilling procurement requirements; 2) identifying and processing change information; 3) establishing a

method of control and documentation of information exchange with the supplier; and 4) audit or surveillance of supplier activities.

l 2?ti 7.9 Depending on the complexity or scope of the item or 3572 A service, the Purchasing Department and/or the 3573 /7\\

originating organization shall initiate award

}sse

. activities. Meetings or other forms of communica-3545 tion may be held to establish the intent of UE in monitoring and evaluating the supplier's perfor-

mance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulfilling requirements. The depth and necessity of these activities shall be a func-tion of the relative importance, quantity, unique-

ness, complexity, frequency of transactions with the same supplier, and the sui. flier's past perfor-mance.

UE' hoid and witness po AH shall be docu-mented as early as practicable (3 :he procurement process.

l 3574 7.10 The originating organization shall establish osas-ures for monitoring supplier-generated document submittals against procurement document require-Similarly, measures shall be established for ments.

reviewing and reproving supplier generated docu-C 7-4 Rev. 14 6/91

_ =. _ _ -

1 OQAM I

i ments for use. Changes to procurement documents shall be in accordance with the controls described i

in Section 4.

I bhh4 7.11 Supplier monitoring activities ma personnel from Quality Assurance,y be performed by 24,74 qua h ty Services 7 154 4 Nuclear Engineering, Nuclear

Services, Nuclear pyyp jQg Safety and Emergency preparedness, Licensing and

Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, exam-inations or tests. Se,oplier monitoring activities may include:

1.

Audits of supplier quality assurance implementation program 2.

Monitoring, witnessing, or observing inspec-tions, examinations, and performance tests 3.

Surveillance of manufacturing processes 4.

Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-mances l

2337 7.12 To support the control of purchased

material, copies of purchase orders and,other appropriate procurement documents shall be forwarded to the applicable receiving or acceptance point.

Depart-monts receiving or utilizing procured items or services shall establish measures to maintain and control procurement documents until the. items or services are received and accepted. These documents shall include purchase orders, drawings and speci-fications, approved

changes, and other related documents.

l' 975 7.13 Receiving inspection instructions shall be 2337

. documented. These instructions include specifying 2416 inspections or tests of commercial grade items procured from suppliers on the basis of-product performance.

Should it become ecessary to upgrade stocked non-safety related ens to specific requirements, inspections, tests, or documentation reviews may be employed to establish the items' acceptability.

Documentation shall be generated as a result of UE receiving inspection activities.

7-5 Rev. 14 6/91 2-

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

.=

OQAM 975 7.14 Acce.tance of items and services shall include one 1891 o r m > 32 of the following:

3W U

3608 1.

Written certifications 2.

Source verification 3.

Receiving inspection 4.

Post-installation test (in addition to one of the above)

S Y#( #

1876 7.15 Commercial grade items shall rely on proven design 1604 and utilize verification methods by the purchaser, to the extent appropriate to item application.

Procedures provide for the acceptance of commercial grade items on one or more of the following:

1.

Special Tests and Inspections 2.

Survey of Supplier (Commercial Grade) 3.

Source Verification 4.

Acceptable Supplier / Item Performance Record Method 4 should not be used alone unless:

a)

The established historical record is based on industry wide performance data that is directly applicable to the item's critical characteris-tics and the intended safety related applica-tion; and b)

The manufacturer's measu: ; for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).

l 1891 7.16 Where Jequired by code, regulation or contract 1893 /.

requirement, documentary evidence that items IE&t L7]i conform to procurement documents shall be available 3603 during receiving inspection or prior to use of such 3605 items. Where not precluded by other requirements, 3607 documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item accep-

tance, verification of the validity of supplier certificates and the effectiveness of the certifi-cation systems shall be conducted at intervals commensurate with the supplier's past quality performance.

Certificates of conformance and compliance shall be required to be signed or accom-panied by a signed letter of transmittal.

Where acceptance is based upon source verification, docu-mented evidence of these surveillances shall be furnished to the Plant Quality Control organization by the responsible US organization or their desig-nated agent prior to acceptance.

/

7-6 Rev. 13 6/91 L.

OQAM t

11884 7.17 Acceptance by receiving inspection shall be 3606 utilized as a prime method of verification and may be utilized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspections; and when inspections do not require operations which could adversely affect the integrity,

function, or cleanliness of the item.

When other methods are utilized, receiving inspec-tion shall be employed to verify that items have not sustained damage.

l3972 7.18 Receiving inspection shall be performed by AiSS personnel certified to ANSI N45.2.6 -

1978, (as clarified in 00AM Appendix A Regulatory Guide 1.58)

I under the direction of the Quality Control organi-zation. Other unit _ staff personnel qualified to ANS 3.1 1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, exten-sive modifications, or other special circumstances, receiving inspection may be assigned to an outside organization (s).

12337 7.19 Final acceptance of items shall be by Cuality 3641/'\\

Control personnel or designated inspection person-

/

nel.

The final acceptance of, services shall be the responsibility of the originating organization.

Acceptance shall be documented.

! 975 7.20 Receiving inspection activities shall include:

2337 1.

Verifying that materials, parts, and ccmpo-nents, have been identified by tagging or other means; or that they are segregated and controlled in areas separate from the storage facilities for accepted items.

L;;_

2.

Verifying that items for acceptance have been

(;ZA.

e::amined for physical damage, correctness of

~'

identification and quality documentation, and ccmpleteness of specified quality documenta-tion.

Mt 3.

Verifyi:q " hat reaived i: ems conform to

,M7-7 /*

pr r c.m: P n:s by :-:;oct ' 1 or, where

-MM -

appropria:e, ect;ng using apprt"+3 procedures 3641 and calibrated

tools, gages and measuring equipnent to verify the acceptability of items, including those from commercial grade suppli-erS.

7-7 Rev. 14 6/91l

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

OQAM 2326 4.

Providing final acceptance after dete.rmining 2329 that required verifications are complete and 2328 acceptable.

Items determined to be acceptable for use shall be tagged with an accept tag

,j other or means of identification or segregation, and released for storage or use.

Conditional acceptance of items by receiving inspection shall be procedurally controlled.

2327 5.

Verifying that received items which do not 09x :>i conform to procurement documents are segregaten (if practic.able) cnd processed in recordance with Section 15.

,0.

Acceptance by post-installation test may be util-ized following one of the preceding acco

Tee methods. Post-installation testing shall be us.

the prime means of acceptance verification when it

s. as is difficult to verify item quality characteris-i tics; the item requires an integrated system checkout or test; or the item cannot demonstrate its _ ability to perform when not in use.

Post-installation test requirements e.nd acceptanca docu-mentation shall ca established by UE.

a h

7-8 3

i n I.

14 6/91 2-

~

OOAM i

i 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 975 8.1 The identification and control ot materials, parts, 1884 and components shall be acomplished in accordance 1885 with documented proc tures and apply to safety-related materials,

parts, and components during fabrication, storage, installation or use.

Materials,

parts, and components identified as nonconforming shall by controlled as described in Section 15.

1097 8.2 The identification and control requirements shall 2010 address. traceability to associated documents, as 2233 appropriate; specification of the degree of identi-2a37 fication and control necessary; location and method of identification to preclude a degradation of the item's functional capability or quality; and proper identification of materials, pcrts, and components prior

• to release for manufacturing,

shipping, construction, or installation. Materials,

parts, and components manufactured or modified by UE shall be controlled and identified during manufacture.

1884 8.3 Documented procedures shall assure that specifica-2088 tions and other procurement documents include or reference appropriate requirements for tne identi-fication and control of materials,

parts, and components including partial-y, fabricated assem-blies.

Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items from storage while maintaining item identity; controlling the return to storage of issued materials, parts, or components

received, stored, installed, modified, or used at the Plant site.

These procedures shall assure that correct identifications are verified and documented prior tw release.

-1895 8.4 Physical identification shall be employed to the 33fg 3 4

maximum possible extent for relating an item at any 1896 2333 /< \\

point in time to applicable design or other perti-

333, 2337 nent specifying documents irgluding drawincs, 2346 specifications, purchase orders, manufactut ing and inspection documents, nonconformance reports, and physical and chemical mill test reports.

Physical identificatio-or marking shall not affect the

form, fit, or function of the item being iden-tified.

Where physical identification is not

employed, physical separation, precedural control, tags, or other means shall be utilized. Identifica-tion shall be maintained on

items, or records traceable to items through fabrication,

erection, 8-1 Rev. 15 6/91'

~ ~.

3

OQAM 9.0 CONTROL OF SPECIAL PROCESSES gy3g7 9.1 pecial processes are fabrications,

tests, an,d 4

t'nal preparation processes which require the qual-i ' cation of procedere, technique, and personnel and which are performed in accordance with appli-cabl codes and standards.

Special processes requir in-process controls in addition to final inspect n to assure quality.

p

/

11851 9.2 Special pr esses include such activit,l'es as L&&E welding, hea treating, nondestructive examination, 1937 the applicatio of specializ;d coatings, nd 4264 chemical clean g; and shall be accompli, td under controlled condi ions by qualified personnel in accordance with the technical requirements of app:icable

codes, tandards,,' specifications, or other special requi ements to which UE is commit-ted.

Qualified persdnnel and approved procedures shall be employed. Pr dedar's for special processes e

shall be qualified as\\/part of their approval process; personnel qualifications shall be certified; and equipment shall be qualified prior to use. The responsible Plant Department Head shall assure that personnel performing special processas are qualified and'are employing approved proce-dures.

Procedures shall also be established for recording evidence of acceptable' accomplishment of special processes using qualified procedures, equipment, and personnel. Quality Control personnel shall be cdsponsible for assuring that personnel performingf/ nondestructive examinations are qual-ified apd are employing approved procedures.

Nondestrdctive examination (NDE) personnel shall be qualifidd in ac"ordance with procedures established to m,eet the requirements of the Code Edition and Adde da to which CE is committed at the time \\ the NDE is performed. When non-code NDE is performed, personnel shall be qualified to the version

'of SUr-TC-1A used to meet UE's current commitment to phe ASME B&P,V Code.

97 Special process equipment that may require periodic i

adjustment and whose performance cannot be verified thrcugh direct monitoring of appropriate Larameters shall be subject to the controls described in Section 12.

/\\

9.

Qualified outside organizations may be erplayed to perform special processes onsite and shall be required to conform to the requirements described herein.

Special process precedures subr:it ted by j

these organization (s) in accordance with procure-ment document requirements shall receiv a

tech-f 9-1 Rev. 1/

6/9Zt

7_

INSERT A

-1851 9.1 Special processes are fabrications, tests, and i

1937 final preparation processes which require in-pro-7\\

cess controls in addition to final inspections to assure quality. Special processes also require the qualification of procedures, techniques, and personnel in accordance with the requirements of applicable

codes, standards, specifications, or other special requirements to which UE is commit-ted.

Special processes include such activities welding, heat treating, nondestructive examination, as the application of specialized coatings, and chem-ical cleaning.

existing codes or standards,For special processes not covered by the necessary qualifi-cations of personnel, procedures, or equipment shall be defined by Nuclear Engineering.

9.2 Procedures for special processes shall be qualified

(

as part of their approval process, and shall also provide for recording evidence of acceptable accomplishment of the special processes. Personnel qualifications shall be certified and equipment shall be qualified prior to use.

Ai_

9.3 The responsible Plant Department Head shall assure that personnel performing special processes are qualified and are employing approved procedures.

Quality Control personnel shall be responsible for assurin7 that personnel performing nondestructive examinationc-are qualified and are employing appr.ved procedures.. Nondestructive examination (NDE) perconnel shall be qualified in accordance with procedures established to meet the require-ments of the Code Edition and Addenda to which UE is committed at the time the NDE is performed.

When ncn-code NDE-is performed, personnel shall be qual-ified to the version of SNT-TC-1A used to meet UE's current commitment to the ASME B&PV Code.

9-la

OQAM nical review by the responsible engineering organi-zation and a quality review by the Quality Assur-ance Department.

q,/

1857 9.5 Planning for maintenance shall include evaluation of the use of special processes, equipment and materials in performance of the

task, including assessment of potential hazards to personnel and equipment.

1 I

1-9-2 Rev. 14 5/91 1

M 2974 10.0 INSPECTION 1851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to 1927 verify conformance with applicable documented instructions, procedures, drawings, and specifica-tions.

Inspections and monitoring of processes which serve' an inspection function shall be performed by personnel qualified to perform aasigned tasks and who are independent of individ-uals who perform the activity.

I 10.2 Required inservice inspection of structures, systems or components shall be planned

,and executed.

Inspection methods shall be established and executed to verify that the characteristics of an item remain within specified limits.

i 11850 10.3 Inspection of activities at the Callaway Plant l

1937 shall be at intervals based on the status and importance of the activities. Guidelines shall be established to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subse-quent monitoring planning.

I E694 10.4 Nuclear Engineering s hal'1 be responsible for gg assuring the development of preservice and

/.1 inservice (PSI /ISI) inspection programs; the refer-ence PSI /ISI examination plans for ASME Code Class 1,

2, and 3 systems and components including steam generctor eddy current examination; the NDE proce-dures required by the reference plans; and the initial updating of the reference plans and proce-dures to reflect "as-built" conditions and the technical requirements of the applicable Code Edition and Addenda prior to the issuance of the inservice inspection plans and procedures.

I 3644 10.5 Nuclear Engineering shall be responsible for assuring the development of the inservice testing L--

program plan for pumps and valves, the test prece-dures required by this plan, and the securing of consulting services in this area.

In addition Nuclear Engineering shall be responsible for admin-istering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division.

They are also responsible for updating the reference plans and. NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations.

(

10-1 Rev. 13 6/91' i

o

OQAM 10.k Quality Control inspection personnel or other unit 11851 2263 A

staff organizations who perform " inspection" 2479ggp /' \\ activities shall be qualified within their respec-

• j 2481 tive areas of responsibility. The qualification of 2482 QC inspection personnel shall be defined in three 2483gx4gg levels of capability as described in ANSI N45.2.6.

24GA 34%'

Other members of the unit staff perfotming "inspec-2498 tion" activities shall have apprcpriate experience, 2994

training, and retraining to assure. competence in accordance with ANSI /ANS-3.1. Inspection assign-ments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC inspection personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent competence.

4 12483 10.7 An inspection personnel qualification program shall 2484;4y be established to assure inspection activities are

?t&&

being performed by personnel trained and qualified j/y to a

capability necessary for performance of the activity.

Plant procedures shall prescribe the qualification requirements of inspection personnel.

The Superintendent, Training shall be respons.ble for providing related technical and quality training appropriate to the certification /qualifi-cation of UE personnel.

%Cd 2480 10.8 Personnel from outside organizations performing CC 2482 inspection activities associated with safety-g 49;'

2484,N related items at the Callaway Plant shall be certi-2485 /7\\

fied as required by ANSI 144 5. 2. 6.

Personnel from 2994 outside organizations or UE personnel who are not members of the unit staff who perform other activ-ities associated with safety-related items at the Callaway Plant shall either be certified as required by ANSI N45.2.6 or they shall meet the education and experience requirements applicable to the equivalent position on the unit staff for the activities which they are performing.

L 2484 10.9 When contractors or vendors are retained to perform 1

2485 ^

work activities or to provide services associated 3597 / i\\

with safety-related items at the Callaway

Plant, the qualification of inspection personnel and the conduct of inspections associated with that contracted work activity or service shall meet the l

requirements stipulated in the applicable procure-ment documents.

As an example, if a vendor was

~

contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing the examination would ce qual-

\\

10-2 Rev. 22 6/911

00AM ified as required by the vendor's quality assurance program unless otherwise specified in the appli-cable procurement documents.

1930 10.10 Procedures which specify inspection activities l 2124 shall provide for the following, as required:

igg

1) the inclusion of independent inspection or moni-toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta-tion of inspection results; 4) a description of the method of inspection including any mandatory hold points;

5) the identification of the characteris-tics and activities to be inspected; 6) the accep-tance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from

drawings, instructions, specifications, codes, standards, or regulatory requirements.

1928 10.11 The inspection function shall be conducted in 1929 accordance with written approved procedures which E937 ' '

specify inspection scope; personnel qualification b4 Eel 473 requirements; and data collection requirements.

2039 Inspection or testing, as appropriate, shall be 2124 employed as a means of verifying suitable perfor-mance subsequent to a component replacecent or

repair, 1935 10.12 Instructions, procedures, and support'ing documenta-1936 A tion shall be provided to insoection oersonnel for elGa/'\\

use prior to performing i.hspectic'n activities.

Inspection results shall be documented. Procedures shall prescribe the review and approval authority for inspection results.

[1932 10.13 Indirect control by monitoring processing methods, 1933 equipment, and personnel shall be utilized as a

contrcl if inspection of processed items is impos-sible or disadvantageous. Both inspection and moni-toring of processes shall be provided when control is inadequate without both, i1Hf 2124 10.14 Inspection data shall be analyzed and evaluated to 2125 21,L -,K'1 verify completeness of

results, achievement of inspection objectives, and operational proficiency of equipment and_ systems; to identify additional inspection requirements; and to identify necessary changes to the installation inspection procedures.

The acceptance of an item shall be documented by authorized personnel.

Modification, repair or replacement of items performed subsequent to final inspection shall require reinspection or retest to verify acceptability.

10-3 Rev. 1) 6/91 L

i OQAM i

1 2974 11.0 TEST CONTROL 1850 11.1 Testing programs shall be established to demon-1934 A strate that safety-related structures, systems, and 2052/7\\

components will perform satisfactorily in service.

35r?

Testing programs include such tests as initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those asso-ciated.with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications.

11853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-sary quality of systems and components, is main-

tained, that facility operations are within the safety.

limits, and that limiting conditions for operation can be met. The testing frequency shall be as prescribed in the Callaway Plcnt Technical Specifications.

The provisions for surveillance testing shall include the preparation of a surveil-lance testing schedule (s) which reflects the status of in plant surveillance tests. Qualified personnel shall perform surveillance tests.

. (B5t

.l 2053 11.3 Appropriate tests shall also be performed subse-A quent to Plant modifications, maintenance or

/ 7\\

significant operating procedure changes to confirm expected results. Tests provide a level of confi-dence in structure, system or component operation or functional acceptability.

h r7 11.4 When required by procurement documents, testing 35 A

shall be employed as a means of purchased material C1 and equipment acceptance. Acceptance testing of this nature shall be performed during receiving inspection or subsequent to installation in accor-dance with Section 7.

l l

I 11.5 Equipment failure or malfunction analysis testing l

may also be performed. The causes of malfunctions shall be investigated, evaluated, and recorded.

Experience with malfunctioning equipment and similar components nall be reviewed and evaluated to determine whether a like kind replacement compo-nent can be expected to perform its function relia-E bly.

I 1938 11.6 Testing shall be cerformed in accordance with written procedures which incorporate or reference' l

2014 s 2055 7\\

the requirements and acceptance limits contained in l

2056 applicable Callaway Plant Technical Specifications, g-11-1 Rev. 1.4 l

6/91L

/

OOAM

drawings, instructions, procurement documents, specifications,

codes, standards, and regulatory requirements.

3,/

1930 l 1938 11,7 Administrative procedures, test procedures, or 2132 A checklists shall include: provisions for assuring

/I\\

all prerequisite conditions are met; test equipment calibration-requirements; testing method instruc-tions including hold or witness points; limiting conditions and acceptance / rejection criteria; and data collection and test result approval require-ments.

1848 11.8 Test data shall be analyzed and evaluated by quali-1934 gg fled individuals or groups to verify completeness 4

212J g of results, achievement of test objectives, and 2125 /I\\

operational proficiency of equipment and systems; to identify additional test requirements; and to identify necessary changes to the installation test procedures.

Equipment found to be deficient shall be identified in accordance with Section 14.

Surveillance test procedure results which fail to meet the requirements and acceptance criteria of Callaway Plant Technical Specifications shall be documented and reviewed in accordance with Section 15.

Deficiencies identified as nonconforming shall be processed in accordance with Section 15.

4437 11.9 Review and approval of tests and experiments not k&40/h' described in the FSAR shall be conducted as speci-fled in the Callaway Plant Technical Specifications and 10 CFR 50.59.

bu l 248L 11.10 A program shall be established to assure testing 2483'"8' activities are performed by personnel trained and c4 g'.

. qualified to a capability necessary for performance 2484 2488 of the activity. Plant procedures and procurement 2490 documents shall prescribe the qualificatica requirements for testing personnel. Provisions may be made for on-the-job training of individuals not qualified to the program provided they are super-vised or overseen by qualified individuals for the activities being performed.

The Superintendent, Training shall be responsible for providing related technical and quality training for UE personnel who perform testing.

l 2263 11.11 Personnel via..n the various OE organizations may 2479;M B A perform teat: g activities includinc imolementing

'24 &2 O

test procect es and the evaluation and ' reporting of 2483 test results. The assignment of Plant testing 2484 ay personnel shall be under the direction and control c

l 2+94 of the Vice President, Nuclear Coerations.

The qualification of CC testing perso'nel s all be n

c' 11-2 Rev. 14 6/91 2-

OQAM 12.0 COvrROL OP MEASURING AND TEST EQUIPMENT 1919 12.1 Measuring and test equipment utilized in activities 1920-affecting quality shall be controlled in accordance 1969 7 with written procedures or instructions. The 2042 procedures for calibration and control shall 2264 address the identification of test equipment, cali-

1994, bration techniques, calibration frequencies, main-

}&92 tenance

control, and storage requirements.

The equipment subject to these controls includes:

(1)

M&TE (portable measuring instruments, test equip-ment, tools, gagest and non-destructive test equip-ment used in measuring and inspecting safety-related structures, systems, and components);

(2) reference standards (primary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).

1920 12.2 Tools, instruments, testing equipment and measuring 11851 devices used for measurements, tests, and calibra-2295 tion shall be of the proper range and type; and 2044 shall be controlled, calibrated, adjusted and main-2060 tained at specified intervals or prior to use to 1501 assure the necessary accuracy of calibrated devices.

M&TE and reference standards shall be taggnd or labeled indicating the date of calibra-tion and the due date for recalibration.

I 12.3 Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program.

12.4 The calibration and control program established at the Callaway Plant shall assure that M&TE, refer-j(g-accuracy.

The Acc4ce,e.'t Manage r,

Operationc cad ence standards, and PI maintain their required Gl% (Km/"

1. M etenance is responsible for assuring the program i

J establishment.

Program implementation is the responsibility of the approprb.te Department Heads.

~

1920 12.5 M&TE, reference standards, and PI shall be utilized by various organizations as required to perform tests or other special operations. Each organiza-tion shall be responsible for assuring that the M&TE or reference standards it uses have been cali-brated.

Outside organizations using H&TE or refer-ence standards at the Callaway Plant in activities affecting quality shall be required to implement calibration and control measures consistent with j

the applicable requirements of this section.

[

Vendors activities performed offsite, other than calibration services for Callaway Plant M&TE or P1, do not need to meet the requirements of item 8 and

/

5 12-1 Rev. 14 6/91'-

OQAM 9 of OQAM Section 12.6 unless specified in procure-ment documents.

Vendor-provided calibration services for Callaway Plant M&TE or PI are required y,/

to be coasistent with the requirements of item 8

and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using M&TE or reference standards at the Callaway Plant in activ-ities affecting quality shall be required to imple-ment a calibration and control program consistent with the requirements described herein, or control their activities relating to M&TE or reference standards via the Callaway Plant calibration and control program.

12.6 The calibration and control program shall provide for:

1923 1.

Tha assignment of speciale calibration inter-

vals, calibration procedures which apecify calibration

methods, and instrument accuracy requirements.

Interval selection shall be a

function of the equipment

type, inherent stability and reliability, intended

use, required accuracy, and other conditions which may affect calibration. Records shall be main-tained to permit a determination of calibration intervals.

A calibration shall be performed when the accuracy is suspect.

2.

.che unique identification of items.

3.

The traceability to calibration test data.

4.

The traceability of reference standards and 3541 7\\

thereby M&TE and PI, to nationally recognized standards and the periodic revalidation of reference standards.

lit 3 jh\\

5.

The maintenance of records which indicate the status of each item, maintenance history, cali-bration results, anomalies, and most recent and next scheduled calibration dates. A recall system shall be established to assure that calibration intervals are not exceeded.

6.

The maintenance and control of items not la use.

7.

Provisions to control the purchase requirements an'd acceotance tests for items sent out for calibration and for new or replacement items including the requirements" for

accuracy, stability, and repeatability, f

12-2 Rev. 14 6/91P

OQAM' 8.

M&TE shall be calibrated from reference stan-dards~ with an accuracy ratio of at least four-to-one (Reference standard to M&TE).

Calibra-tion accuracy ratios of less than 4.0 but equal to or better than 1.0 (Reference standard to M&TE) shall be acceptable when equipment to meet specified requicements is not commercially available.

The b:4 sis of acceptance in these cases shall be documented.

9.

M&TE used for calibrating Plant PI shall have calibration ranges, precisions, and accuracies such that the PI can be calibrated and main-tained to achieve its specified accuracy.

PI shall be calibrated from A&TE with an accuracy ratio of at least two-to-one (M&TE to PI).

Calibration ac~: racy ratios of less that 2.0 but equal to or better than 1.0 shall be acceptable when equipment to meet specified requirements is not commercially available. The basis of acceptance in these cases shall be documented.

399-2 12.7

' Calibration shall be performed against certified equipment or reference standards having known rela-

/7\\

tionships to nationally recognized standards. Where s

no national standard exists, provisions shall be established to document the basis for calibration.

Calibration and control measuret shall not apply to

rulers, tape measures, levels, and other devices when normal commercial practice affords adequate accuracy.

2044 12.8 M&TE and reference standards found to be out of

}59d calibration shall require an investigation to 1544 --

evalui:e the validity of previous measuring, test, inspection, and calibration results and the acceptability of impacted iteas.

Investigations shall evaluate the necessity of repeating original measurements, inspections, tests, or calibrations to establish the acceptability of such items. When the calibration history of an item shows it to be consistently out cf calibration, the item shall be

repaired, replaced, or the calibration interval modified.

i 12-3 Rev. 14 6/9I1

OQAM 13.0 HANDLING, STORAGE, AND SHIPPING 1975 13.1 Safety-related items including safety-related parts 2293

- of structures, systems, and components and related 2417 consumables shall be

handled, stored,

shipped, cleaned, and preserved in accordance with proce-dures, instructions or drawings, to assure that the quality of items is preserved from fabrication until incorporation in the Callaway Plant.

The procedures shall also establish responsibilities for determining applicable requirements for packag-

ing, shipping, receiving, storage, and handling activities.

2293 13.2

. Generic procedures or instructions shall be 23 49pg, prepared for application to these activities; 2416 however, detailed procedures or instructions shall h

12+B7/\\

be prepared for the handling, cleaning, storing, 41668 maintaining while stored, or shipping of certain' items and types of equipment or material.

Appli-cable manufacturer instructions and recommenda-

tions, or procurement requiremente shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review.

2497 13.3 Deviations from manufacturer's recommendations may 139 $

impose more stringent requirements or may relax the requirements.

The relaxation of manufacturer's requirements shall involve an engineering evalua-tion and is appropriate when unrealistic require-ments are reccmmended and such reccmmendations are not reasonably necessary to preclude equipment degradation.

2343 13.4 The requirements for activities described in this 2416g Section shall be divided into levels with respect to protective measures to prevent damage, deterio-ration, or contamination of items. These levels are based upon the important physical characteristics and not the important functional characteristics of the item with respect to safety, reliability, and operation.

The specific environmental, special measures or other conditions applicaole to each level shall be described in implementing i

procedures, t+FF 13.5 The Superintendent, Maintenance shall establish an

^jg' inspection program for Plant material handling i

equipment that provides for routine maintenance and inspection in accordanca with documented procedures which specify acceptance criteria. Routine inspec-4 tions shall determine the acceptability of equip-ment and rigging.

Routine inspections shall be

'4 13-1 Rev.

6/911

\\

OQAM 14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 Safety-related items that are received, stored or

_ installed at the Callaway Plant shall be identified and controlled in accordance with documented procedures.

1847 14.2 Items received at or installed in the Plant shall 2116 be identified in accordance with procedures as to ADI /h\\

their status regarding required inspections and tests before the. items are stored, issued or oper-ated. Prior to storage or installation, items shall be identified..by means of stamps,

tags, labels, reuting cards, segregation, or other means trace-able to manufacturers' and receiving inspection documentation.

In the event traceability is not available, the item (s) shall be considered noncon-forming.and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications.

1841 14.3 Plant procedures shall provide instructions 1842 relating to the manner of indicating the opera-1844 tional status of safety-related structures,

systems, and components, including temporare modi -

fications, and shall require independent verifica-tions, where appropriate, to assure necessary meas-

ures, such as tagging' equipment, have been imple-mented-correctly.

These procedures shall address measures for the release and control of equipment during~ periods of maintenance; thereby maintaining personnel and reactor safety and avoiding the unau-thorized operation of equipment.

Equipment and systems in a controlled status to prevent unau-thorized operation, shall be identified.

972 14.4 Plant procedures shall establish controls to 1844 identify the status of inspection and test activ-1846 ities associated with maintenance, repair, modifi-1847 cation, refueling, inservice inspection, and 1851 instrumentation and control system calibration and testing. The Technical Specifications establish the status required for safe Plant operation, including

" provisions for periodic and non-periodic tests and inspections of various structures,

systems, and components. Periodic tests may be operational tests or tests following maintenance while non-periodic tests may be made following repairs or modifica-tions.

Ic i8 14.5 Required safety-related inspections,

tests, and operations and their sequencing are performed in accordance with Plant operating prccedures which are reviewed and approved in accordance <ith the f

14-3 Rev. II4 6/91 1

l OQAM 197 I k2337 15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 1848 15.1 Material nonconformances include material deficien-1870

- cies (including inoperative and malfunctioning 1907 structures, systems, and components). Material 2045 nonconformances identified under the UE OQAP shall 2112 be controlled to prevent the inadvertent use of

material, parts, or components which are defective or of indeterminate quality and to identify docu-mentation inadequacies.

Measures shall be estab-lished regarding identification, documentation, status

control, disposition, and notification of affected organizations.

1848 15.2 Under the UE OQAP, Nonconforming Material Reports 1885 A (NMRs), nonconformance logs, or other administra-1903 /7 \\

tive controls shall be employed to identify and 1907-control nonconformances. Nonconformance logs may be 10gg y 2334 employed to control deficiencies of a minor nature or to control documentation deficiencies both of which can be corrected by bringing the deficiency into compliance with the original requirements.

Material nonconformances shall be controlled, as appropriate, by documentation, tagging,

marking, logging, or physical segregation.

The programs describing the administrative nonconfGrmance controls shall delineate the methods of identifying corrective action to be taken for a nonconforming item or series of nonconforming items. Until suit-able documentary evidence is available to show the equipment or material is in conformance, affected systems shall be considered inoperable and reliance shall not be placed on such systems to fulfill their intended safety function.

1906 15.3 Plant and other UE organization's procedures shall 3558 prescribe measures for the control and disposition 39?6.

of UE purchased items and services identified by 3598 outside orga.izations as nonconforming. Procurement 3599 documents shall specify those nonconformances to be 3600 submitted to UE for approval of the recommended disposition. As specified in procurement documents, actions taken in response to these ncncenformances shall be documented and forwarded to UE along with the hardware and accompanying quality verification documentation. Nuclear Engineering shall be respon-sible for asquring the processing of supplier-re-commended dis ositions for Plant-initiated procure-monts. Simila ly, other UE or outside organizations snall approv2 or be requested to provide a tech-nical evaluition regarding supplier-recommended dispositions of nonconformances regarding procure-ments they in tiate.

f

\\

15-1 Rev. 13 l

6/901

OQAM 1906 15.8 Material noncon?ormances which would impact the F992 conduct of a :est shall be corrected or resolved 7

prior to initiation of the test on the item.

The decision to pro:eed with the testing of a system or subsystem with outstanding material nonconformances shall consider thr natur3 of the nonconformance, its effect on test results, and the need for supplemental tests or inspections after correction of the nonconfor=ance. The evaluations shall be documented.

1848 15.9 Repaired and reworked items chall be reinspected or 1904 tested. Measures may be established to condition-1906 ally release nonconforming items whose disposition pp4 is pending, provio-J that m evaluation indicates 2053 2332 that further work or act. ity will not contribute adversely to the material nonconformance or preclude identification and correction.

15.10 Material nonconformance summaries shall be prepared and analyzed for potential adverse quality trends semiannually.

For nonconformances discovered up7n receipt inspection of new purchases or disen ered after an item has been accepted by receipt inspec-tion-but before issue from the warehouse, the

Manager, Operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered instc' led, the

Manager, Nuclear Engineering shall nave le trend analysis _ prepared. These analyses shall oe sent to the Quality Assurance Department for an independent review. The result of this review shall be reported to management.

L l

l l

,?

L 15-3 Rev. 1 o/91L w

OQAM

/

if75 16.0

, CORRECTIVE ACTION A

att 16.1 Measures shall be established to assure that condi-gpo 1870 tions adverse to quality are promptly identified, 1903 reported, and corrected. Nonconformances shall be 2978 controlled in accordance with the requirements 3gif described in Section 15. Each of the Nuclear Divi-sion Managers is responsible for developing and implementing a program for identifying and control-ling adverse conditions. This res onsibility may be t

satisfied by one or more programs.

As a minimum each program shall provide for developing and anal yzing trends on a semiannual basis.

Trending of conditions adverse to quality identified at suppli-er's facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12. Proce-dures shall provide instructions for identifying, reporting, and initiating corrective action to preclude recurrence of adverse conditions. It is understood that the term

" corrective action" includes remedial action necessary to correct the deficiency, as sell as corrective action necessary to preclude recurrcnce.

16.2 Conditions adverse to quality which impede the implementation or reduce the effectiveness of the Operating QA

.rogram shall be controlled by the measures described herein. Adverse conditions may include, but are not limited to, noncompliance *ith procedural requirements; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies ident fled in the OOAP; recur-ring conditions for whit ' past corrective action has been ineffective; or breakdowns in administra-tive and managerial control systems which could result in a system designed to prevent or mitigate serious events not being able to perform its intended function.

16.3 Corrective action documents which record defects in basic components or deviations from technical l

requirements in procurement documents snall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements.

3599 16.4 Corrective action documents shall be transmitted 3600 to the responsible organization. The responsible organization shall investigate the findings and identify the cause(s) of the deficiency, and specify and initiate tne actien(s) necessary to correct the conditions and prevent recurrence.

l 16-1 Rev. 14 l

l 6/91

OQAM 16.5 Nuclear Engineering shall review documented condi-tions adverse to quality which involve design defi-ciencies or design changes which are. recommended as g,j/

corrective action.

Licensing and Fuels should review documented conditions adverse to quality for fuel-related issues. The ORC shall review signifi-cant adverse conditions. Examples of such condi-tions include those identified by Callaway Plant Technical Specifications 6.5.1.6(f),

6.5.1.6(g),

6.5.1.6(h) 6.5.1.6(1), and 6.5.1.6(m); and NPDES violations, 16.6 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action. The Quality Assurance Department shall close QA-originated corrective action docu-ments by verifying the implementation and adequacy of corrective action. Copies of completed correc-tive action documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to-qual-ity. The Quality Assurance Department shall period-ically prepare summaries of significant corrective action documents and submit them to the NSRB and appropriate levels of management.

16.7 The closure of corrective action documents shall be accomplished as promptly as practicable but shall occur only after the corrective action taken has been verified.

Verification may be accomplished through direct observations, written communica-

tions, re-audit, surveillances, or other appro-priate means. The nature of the deficiency may be such that remedial actions need to be taken imme-diately whereas development and implementation of corrective action to preclude recurrence may take substantially longer.

fa -rkd 16.8 Summaries of corrective action documents shall be

<tlus reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends.

Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on theae trends through routine audit and surveillance activities; and sh,all report the results of these assessments to management.

16-2 Rev. 14 6/91

OQAM 17.0 QC LLITY ASSURANCE RECORDS 1851 17.1 Quality assurance record s'rstems governing the 2130 collection, storage,.and maintenance of records 2173 shall be established by UE. They shall apply to records associated with startup testing, operation, maintenance, repair, refueling, and modification of safety-related structures, systems, and components at the Callaway Plant.

4444 17.2 During the operating phase, quality assurance 1450 A records shall be maintained to furnish documentary 1851 /7\\

evidence of the quality of items and activities 2128 affecting quality. Applicable design specifica-2132-tions, procurement documents, test procedures, 2133 operational procedures or other documents shall 2137 specify the quality assurance records to be gener-2138 ated by, supplied to, or held by UE. Documents 2173 shall be considered quality assurance records when' completed.

Records may be maintained for varying periods and shall be identified as lifetime or nonpermanent records in thau a lifetime or finite retentior.

period shall be specified. Records shall provide sufficient information to permit identifi-cation to the item or activity to which it applies, and be retrievable, bis 9 17.3

' Quality assurance records ir-lude, but are not FF+&

limited to, oper-ting legs; aintenance and modifi-2337.

cation procedures and inspe.; ion results; report-2364 able occurrences; cesults of teviews; inspections, 2644 tests,. audits and raaterial analysos; qualifiestion

}G&P of personnel, procedures, and equipment; and other documantation includjng drawings, specifications, procurement documents, nonconformance documenta-tion corrective action documents, -calibration e

procedures and results, and the results of moni-toring work performance (e.g., surveillance).

11936 17.4 Inspection and test records shall contain the following as a minimum:

1.

A description of the type of observation 2.

The date and results of the inspection or test 3.

Identification of the inspector or data recorder 4.

Evaluation of the acceptability of the results 5.

Action taken in connection with any deficien-cies noted C

17-1 Rev. 14 6/91 2.-

09AM i

/

LB15 2180. 18.0 AUDITS 3869 416 bi 2186 18.1 A comprehensive audit program shall be established 2199 and implemented by UE to verify internal and 2978 7g external quality activities' compliance with the 2988 OQAP. The audit program shall assure that all appli 3586 cable elenents of the Program have been developed, 3865 documented, and are being effectively jmplemented 3867 and shall provide for the reporting and review of 3883 audit results by management. The audit system is 41(49 described in manuals and procedures.

Nonconfor-mances and program deficiencies shall be identified and corrective action shall be initiated and j

verified.

See Section 3.14 for a specific audit topic.

d$b4r 18.2 The UE audit system shall include the performance l

2245 A of audits and surveillances by the Quality 3 V86 / ' \\

AssuranceD)and-Qua14tr-ser-vices Departmenth. Audits determine, through investigation, the adequacy of ta and adherence to established procedures, instruc-QN

tions, specifications, codes, and other applicable

/

contractual and licensing requirements and the effectiveness of implementation.

Surveillances involve the periodic or continuous monitoring of the operation or performance of a supplier,

item, component, or system. Surveillance in this audit should not be confused with inspections for sense the purpose of process control or product accep-tance oc with requirements relating to test, cali-bration or inspection to assure that the necessary quality of systems and components is maintained, that facility operations are within the safety

limits, and that limiting conditions of operations are being met (surveillance tests).

QA and 03 personnel performing surveillances should be familiar with the area to be surveilled and the applicable implementing procedure (s) governing surveillances.

Surveillances may also be performed by personnel from other organizations, but these require no unique personnel qualifications certifications (except when performed for product or acceptance).

See Sections 10.7, 10.8, 11 3, 11.6, 4: 1 and 12.4.

4

!0 ft 30, 1818 13.3 The Managur, Quality Assurance shall establish a 2 2 4 4 f-program which previces for the qualification and 2250/;'

training Of CA a.d-Ga Department audit and 2255 Sur"3illar:2 72- :rnel. i.udits ahn11 be directed 2963 by an Aud1: Talm Leader (ATL) who is a certified 3866 Lead Auditor. A Lead Auditor is an individual 3377 certified as qualified to direct an audit, perfcrm 3892 an

audit, report audit findings, and to evaluate 13-1 Rev. 14 5/91 2_

OOAM corrective action. Other personnel may assist Lead Auditors in specialists,the conduct of audits; namely, nical tech-management auditors and other Lead Auditors.

The persons representatives, having direct y,j-being audited shall not be involvedresponsib activities the selection of the audit team. Personnel selecte in for QA auditing or surveillance assignments have training or experience commensurate with shall

scope, ities to be reviewed or investigated and shall hav the direct responsibility for the area being evalu-no ated.

The QA personnel training program shall provide which general orientation and specific surveillances. develop competence for performing auditstraining Training records shall provide a

or history of QA personnel qualification,

training, evaluations, Ghp rLwn4--

certifications, and retraining.

Qua-he 2244 18.4 who perform audit and surveillance activitiesAsmIra 2245 A 324E/1\\

shall be qualified in accordance with the require-N2259[]2-_

ments prescribed in QuT1WAssucarace Department procedures. Lead Auditor qualification requirements 3866

\\

shall include education or professional

status,

{

previous work experience or

training, training received through UE, on-the-job performance and participation in surveillances or audits as an

auditor, a

factors qualification examination, a

and' other procedure.pplicable to auditing not defined The qualification certification of Leadby Auditors shall be based on an evaluation of factors by the these maintenance Manager, Quality Assurance.

The of proficiency by Lead Auditors be accomplished shall by active partici audit process; a review of Jrogram,pation in the

ards, codes, stand-procedures and other document revisions related to the OQAP: or participation in training programs.

The

Manager, Quality Assurance shall provide for annual assessments of each Lead Auditor to determine proficiency. As long as a Lead Auditor is performing satisfactorily and is L

proficiency, there is no limit maintaining certification. However on the period of performance is evaluated as beingif at anytime the Lea tor's l

able, Lead Auditor certification shall be unaccept-rescinded.

In addition the failure to maintain be basis for Lead Auditor certification revocation l

If certification is rescinded or fication shall revoked, requali-tion.

be required prior to recertifica-18-2 i

Rev. 14 6/91 2-

~

OQAM 3865 18.5 The Manager, Quality Assurance shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Quality Assurance has suffi-cient authority and organizational freedom to schedule and perform both internal and external audits. He has the organizational responsibility to measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality.

The Manager, Quality Assurance has direct access to o

Ai A1 the Senior Vice President-Nuclear J he SEhlor Vice f reil' dent-Nuclear has oirect access to the Presi-P hile (dent.

I tid l3871 18.6 The audit system shall include internal and A8 external audits. The system shall be planned, docu-

mented, and conducted to assure coverage of the

/,(

applicable elements of the OQAP, and overall coor-dination and scheduling of audit activities. Audit resgits shall be periodically reviewed by the Qua44ey, Asserance Depa r tment for quality trends and results reported to the appropriate management. The

Manager, Quality Assurance shall monitor the CQAP audit program to assure audits are being acccmp-lished in accordance with the requirements described herein and for overall Program effective-ness.

The NSRB shall sele.ctively review audit reports of onsite audits. The NSRB shall also peri-odically review the onsite audit

~orogram as devel-oped by the Q fa4Te? Assurance Department, to assure that audits are being performed'in accordance with Callaway Plant Technical Specification requirements and the OOAP.

Appropriate levels of management shall be provided copies of internal and external audit reports. The audits described in the Callaway Plant Technical Specifications which are performed j

under the qqcnizance of the NSRB shall be conducted by the Qua-1-i-t-y Assur-ance Depa r tment.

11792 18.7 Internal audits shall be conducted by the Q aL4&y 1816 3873 /'\\

assusance Department and shall be performed with a f

frequency ccamensurate swith their saf ety signifi-

\\

l cance.

An audit of safety-related functions shall be ccmpleted in accordance with formal audit sened-ules within a period of two (2) years. Each element I-of the OCAP, such as design control and document control, and each area of Plant operations snall be audited.

l 2666 18.8 Supplementary to the biennial requirement to audit i

2681 ?

safety-related functions, other activities shall be 2847 /l\\

audited at the frequencies indicated in Secti_on 4

3873 6.5.2.9/of the Technical Specifications and/under

\\

'7 l

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~

g h R do h (ad j 18-3 s., - b M e Rev. 14 I

J

/

6/91 s x en W t

OQAM

~

41777 the

~

cognizanceoftheNSRh.Inauditionto audits

' conBUcted under the cognizance of the

NSRB, the following areas shall be sadited at least once per 12 months:

y Special Nuclear Material Accountability program o

Radiological Protection program o

o-

-Radiologivsl--Emor4*nci nesponsa--progr-am-A o

Sacurity program Fitness-For-Duty program o

IWO 13873 18.9 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program require-ments are properly implemented.

13$77 18.10 External audits shall be conducted by or for the QuM-ity'Asseance-Department as a method for the t

evaluation of procurement sources and as a post-award source verification of conformance to

./1 procurement documents.

Audits conducted by ather

. organizations (with similar orders with the same supplier),

including other utilities or A/E's, may be employed as a means of post-award source verifi-cation in lieu of UE performed audits and may not necessarily audit specific items furnished to UE.

-Audhs---and-cu rvcillances-eay also be per f acmed fvr 1

64e Quality

'asur2nce Depaemen t by the QuaItty Services Ospartssnt, These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall_ @he conducted in acc with this OQAM and Qua-l Assu+ance, Department procedures.

Commercial grade items do not require pre-or post-award audits. Similarl'y, items which are relatively simple and standard in design and manufacture may not require supplier qualification or post-award audits to assure their quality.

s/ 11780 18.11 Applicable elements of suppliers' quality assurance

\\'*'3578<\\

programs shall be audited (post-award) on a 3872/f-triennial basis.

Audits generally should be

/

initiated when sufficient work is in progress to determine whether the organizatica i:

complying with the established quality assurance provisions.

Subsequent contracts or contract m difications which significantly enlarge the scope o activities by the same supplier shall be considered in estab-lishing audit requirements. In additior, the need for a triennial audit may be precluded pon evalua-tion and documentation by the QA or-OS Department

(

18-4 Rev. 14 6/91 L

(

OQAM i

that the results of mini-audits perfor ned during source inspection and source surveillance activ-ities confirm the adequacy and implemt ntation of the supplier's QA Program.

3 51I lM56 18.12 Supplementary to

audits, annual evaluations of suppliers shall be performed which take into

/7\\

account, as applicable: 1) the review of supplier furnished documents such as certificates of confor-

mance, nonconformance

notices, and corrective actions; 2) results of previous source verifica-

tions, audits, and receiving inspections; 3) oper-ating experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources.

$$d' 13872 18.13 Audits shall also be conducted when: 1) significant 3875 A changes are made in functional areas of the Quality 3983/7\\

Assurance Program such as significant reorganiza' tion or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assur-ance Program; or 3) when a systematic, independent assessment of Program effectiveness is considered necessary; or

4) when it is necessary to verify implementation of required corrective action.

13876 18.14 Audits shall be conducted using written plans in 3878 accordance with Qii3M-ty Assuctnee Department 3881/ybs procedures.

The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for qual-ity-related practices, procedures, and instructions to determine the effectiveness of the imolementa-tion of the OQAP and compliance with 10 'CFR 50, Appendix B and the Callaway Plant Technical Speci-fications.

The audit plan shall identify the audit

scope, the requirements, the activities to be

audited, organizations to be notified, the appli-cable documents, the schedule, and the aritten procedures or checklists as appropriate. The audit plan and any necessary reference documents shall be available to the audit team members.

l3877 18.15 An audit team consists of one or more auditors.

A Lead Auditor shall be appointed Audit Team Leader.

The Audit Team Leader snall be responsible for the written plans, checklists, team orientation, audit notification, pre-audit conference, audit perfor-

mance, pcst-audit conference, reporting,

records, and follow-up activity to assure corrective action.

Any adverse finoings shall be reported in a post-audit conference with team members and the audited organization subject to the clarification of 18-5, Rev. 1 6/91L

u.

OQAM reports shall-be prepared and. submitted

'co the-audited organization within thirty days after. the post.-audit conference -or=last day of the

audit, whichever is later.

M 4

e 41 1

. Jh, t

13-6

[-

Rev._15$si' l

6/92 4 f.1'

OPERATING QUALITY ASSURANCE MANUAL (OQAM)

APPENDIX A r us e< r A OQAM CONPORMANCE 'IO APPLICABLE NRC REGULATORY GUIDES pg,m fs 9 A43 This Appendix briefly discusses the extent to which Union Elec-tric's Operating Quality Assurance Program (OQAP) conforms to NRC

/k\\ published Regulatory GuidesfortheCallawayPlant.(Clarifica-

tions, alternatives, and exceptions to these Regulatory Guides are identified herein. Union Electric's position on other Regula-tory Guides is given in Appendix 3A of the Callaway-SA and Calla-way-SP Final Safety Analysis Reports (FSARs).

In each of the ANSI standards referenced by one of the listed Regulatory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either identified at the point of reference or are described in a special section of the standard. The specific applicability or acceptability of these listed standards, codes regulations or appendices is either covered in other specific areas in the FSAR or this Operating QA Manual (OQAM),

including

tables, or such documents are not considered as requirements, although they may be used as guidance. When sections are refer-enced within a standard, it is understood that UE shall comply with the referenced section as clarified.

REGULATORY GUIDE 1.8 REVISION 2 DATED 4/87 Qualification and Training of personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor (Section 4.3.1.1),

Senior Operator-(Section 4.3.1.2), Licensed Operators (Section 4.5.1.2), Shift Technical Advisor (Section 4.4.8),

and

, Radiation Protection (Manager) (Section 4.4.4) only, and ANSI /ANS

,18.1-1971 for all other positions).

DISCUSSION:

!: UE complies with the recommendations of this Regulatory Guide j with the.following clarifications and exceptions:

} Revision 1,

dated 9/75, applies to the position of Radiation l Protection Manager only, in accordance with the Callaway Plant

[TechnicalSpecifications.

,The experience,

training, and education requirements for the i positions of Shift Supervisor, Operating Supervisor, Reactor

• Operator, and Shift Technical Advisor shall meet or exceed the I requirements _and recommendations of ANSI /ANS-3.1-1981 as endorsed i by the Regulatory Guide 1.8.

(

A-1 Rev. 14 6/91 2

Insert All statements within the. Regulatory Position-Section.C of-the' Regulatory Guides are-considered requirements unless a specific-exception or-clarification'has been proposed-by Union-Electric and. accepted by the NRC. Thisjis true regardless of.the. qualifier--

(i.e.,

"shall".or "should"):which prefaces <the statement. Unless further qualified by a statementLwithin the corresponding ~

Regulatory Guide, ANSI /ANS standards "shall" statements denote requirements while "should" statements denote-recommendations.

(

i Page A-la-

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

documented and approved by management personnel.

Management personnel includes QA through cross-disciplinary reviews and

-through QA permanent membership on the Callaway Onsite Review Committee.

QA has and shall conduct audits or surveillances of preoperational testing.

In cases where conditions do not fully

comply, the reason for the exception shall also be documented.

The documentation shall be retained as lifetime records.

A With regard to Section 3.4.2 of ANSI N18.7_- 1976 titled Require-t h ments for the Onsite Operating OrganizationlqJTy'aining standards ireferenced in this Section are implemented]aA' described in this Appendix's commitments to Regulatory Guide 1.8 (ANSI /ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2,6-1978) or as otherwise included as part of the Callaway operating license. UE's methods of documenting and otherwise meeting the remainder of the requir-j ements of this Section are set forth in OQAM Section 2, in the Callaway Plant Technical Specifications, and in other licensing fcommitments.

i flScme of UE's technical support organizations are physically-I) located at the Callaway site. Therefore the second sentence of this Section shall be implemented as follows: " Initial incumbents 4 or replacements for members of the unsite or oftsite ~ technical

) support organizations shall have appropriate experience, training and retraining to assure that necessary competence is maintained in accordance with the provisions of ANSI /ANS 3.1 -

1978 as ccmmitted to in the OQAM."

In the third sentence, UE interprets "QA" to be "QC",

consistent with the intent of Regulatory Guide 1.58 (ANSI N45.2.6-1978) and (the OQAM.

With regard to Section 4.1 of ANSI N18.7 - 1976 titled General:

The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANS1 N45.2.12) as endorsed in this Appendix, OQAM Section 18, and the callaway Plant Technical Specifications.

With regard to Section 4.2 of ANSI N18.7 - 1976 titled Program

==

Description:==

Two aspects are addressed in this Section:

audits and independent reviews. The independent review program shall be implemented as required by the Technical Specifications. The UE audit program shall be described in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, the Callaway Plant Technical Specif1-cations, and OQAM Section 18.

With regard to Section 4.3 of ANSI N18.7 - 1976 titled Indeoend-ent Review Process: The requirements of this Section, including

/**

of its suoparts, shall be met by compliance with the Technical Specification requirements and the OQAM.

A-7 Rev. 14 6/93

~

1

OOAM APPENDIX A REGULATORY GUIDE 1.37 (cont.)

~

For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these main-tenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modifications shall be equal to or better than the original requirements (e.g.,

code require-

ments, material properties, design

margins, manufacturing processes, and inspection requirements),

or as required to preclude repetition of defects.

Specific clarifications for this Regulatory Guide and ANSI N45.2.1 - 1973 are indicated below by Sections.

With regard to Paragraph C.3 of Regulatory Guide 1.37: The water quality for final flushing of fluid systems and associated compo-nents shall be at least equivalent to the quality of the oper-ating system water except for the oxygen and nitrogen content; but this does not infer that chromates or other additives, normally in the system water, are added to the flush water.

With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indic-ating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT penetrant materials and couplants, dessicants, which contact stainless steel or nickel alloy surfaces shall not contain lead,

zinc, copper,

mercury, cadmium and other low melting points metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ-kmentalconditions. 4-,%u.7Aram A c. s. q With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion Cleaning: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precluded, as determined by engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted'with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee).

For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

f A-12 Rev. 13 6/91 1.

l OQAM, Rav. 15 Insert 2

... except as provided for in approved design documents. No more then 0.1 percent (1500 ppm) sulphur content shall be allowed where it could be released by breakdown of the compounds under expected environmental conditions except as provided for in approved design documents.

9 O

r l

I O

90 A-12a

OQAM j

APPENDIX A i-i

[

REGULATORY GUIDE 1.74 (cont.)

l

" Quality Assurance Program Requirements" (Not defined-in-ANSIE i

N45.2.10 but used and defined differently in ANSI-N45.2.13)-

l Those individual requirements of:the Operating QA Program which, U

when invoked in total or in part, establish the requirements 'of the quality assurance program for the activity-being controlled.

i Although.not specifically-used in the Operating QA: Program,JWSI N45.2 may be imposed upon DE's suppliers.

+

" Independent Verification" - Verification by an individual _other-j than the person who performed the operation _or-activity =-being verified that required actions have been completed. Such,verifi-

{

cation need not require confirmation of the identical action'when i

other indications provide assurance or indication that the pres-cribed activity is in fact complete. Examples-include, but Dare-i not limited tot verification of a breaker opening by observed..

L remote breaker indication lights; verification of a set rpoint j

(made with a voltmeter or ammeter for example) by oh{arving the i.

actuation of status or indicating lights. at the reqtured Panel-j meter indicated value; verification-that a valve has been positi-j oned by observing the starting or stopping of flow on1meterLindi-

[

cations or by remote value positions indicating' lights.

i

" Audit" (This is a modification of the word's definv. an -

to allow the use of subjective-evidence if no. evidence.is available-as defined in Section 1.4 of ANSI N45.2.12 - 1977: :(Regulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23,- 1978 (Regula--

tory Guide 1.146) as opposed'to the definition given in ANSI l

N45.2.10

-_1973) - A documented' activity performedfin accordance with written procedures or checklists to verify, by examinationL and evaluation of objective evidence where available -(subjective r

i evidence may be used when objective evidence-is not Lavailable),

[

that applicable-elements of the Quality-Assurance Program have-been developed, documented and effectively implement'ed inJaccor--

l dance with specified requirements._ An audit 'should; not.--be-confused with surveillance or< inspection for-the sole purpose'of:

process control or product acceptance.

l "Must" (Not-defined in any ANSI Standard)

Arr ' internally auditable requirement imposed - by UE management:?upon-

)

employees, contractors, and agents - above and in. excess of_

its-the--

i legally binding requirements 1of'the appropriate regulatory body.

Such-items are internally' required but not extepaally1 enforcea-p ble.-(See additional discussion'under Section/2T M Mf the OQAM.)

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i A-23 Rev. II4 6/91 i

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' APPENDIX'A REGULATORY' GUIDE 1.88 (cont.)-

l M

Paragraph 4,

subsection 9: is clarified to read: "No pipes or penetrations except those providing fire protection,

lighting, temperature /

humidity

control, or communications are to be l-located within the facility and they shall comply with a minimum j

two-hour fire protection rating."

Where duplicate _ storage is employed, no special precautions or provisions (including vault storage, special humidity and tempe-rature recorders and similar items) are required-.

I Paragraph 5

is clarified to read the same as our commitment to subsection 5.4.3.

Both paragraphs address the same requirement j

and therefore the commitment must be the same._

REGULATORY GUIDE 1.94 REVISION _1 DATED 4/76 1

l Quality Assurance Requirements for Installation,-Inspection and i

Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plants.

(Endorses ANSI i

N45.2.5-1974)

DISCUSSION:

l UE complies with the recommendations of-this Regulatory. Guide

{

with the following clarifications:

[

Por modification activities UE shall comply with the Reculatory

{

Position established in this Regulatory Guide in that QA program-i matic/ administrative requirements included therein (subject to i

the clarifications below) shall apply to these modification j

activities even though'such requirements may not.have been in effect originally. Technical requirements associated'with modifi-cations shall be equal to or better than the original'_ require-ments (e.g.,

code requirements, material-properties, -design

[

margins, manufacturing' processes, and-inspection requirements),

or as required to preclude repetition of defects, p

The recommendations for structural concrete, structural _ cteel, and other olant components shall'be met as Lindicated by the' applicable C_:ign-documents with the following_ exceptions:

a h olt.

for friction type connections may be tigtft ed

' $ j t>

usingN-recj; tension-indicators -.in accogdanc~ii with the II AISC. Specificltio qfor Structural, Joints Using: ASTM A

235 or A 490 bolts, Tpp m ed May'B, 1974.

/

b.

Section 5.4(1).' o f ANSI N45.2.5 o s qot apply. 'The requirement for the', acceptance of tightenedsbolt assem-blies is: ",The' length of - the bolts shall-be 'shc(that the point-of the bolt shall be -flush'with or outsicesof the face' of. the nut when completely installed."

k A 26-Rev. 14

. /91.

6

OQAM CN 91-04 1

i With regard to Section 2.4 of ANSI N40.2.5-1974 titled Personnni 4

oualification: Union Electric will comply with Regulatory Guide 1.58 as endorsed in this OQAM in lie' of the requirements of this standard.

In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled:

Calibration and Control: The last sentence l' clarified as follows: "UE's inspection or test results cc. ducted w3th M&TE found to be discrepant are to be evaluated a described in the OQAM, Section 12.8."

A With regard to Section 5.4 of ANSI N45.2.5-1974 titled high

/'\\ Strenoth Boltina: In lieu of the first two scntonces in the first paragraph, UE will comply with the following: " Bolts for friction type connections may be tightened using direct tension indicators in accordance with the AISC' Specification for Structural Joints Using ASTM A325 or A490 bolts, approved May 8, 1974".

In lieu of (1) in the second paragraph, UE will comply with the following: "The requirement for the acceptance of tightened bolt assemblies is, the length of the bolts shall-be such that the point of the bolt shall be flush with or outside of the face of the nut when completely installed."

e A-26a

OQAM 1

APPENDIX A REGULATORY GUIDE 1.123 (cont.)

1 4)

The item does not conform to the original requirement 4

even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

• A module is an assembled device, instrument,.or piece of equip-ment identified by serial number or other identification

code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable compo-nent is a part of sub-assembly of a device, instrument, or piece

)

~

of equipment which is shipped as an individual item and shich has been evaluated by inspection and/or test for conformance to l

procurement requirements regarding end ase.

With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source l

Verification Activities and Section 12 of ANSI N45.2.13 --

1973 titled Audit of Procurement Program: The UE audit prograr shull be implemented in accordance with and to meet the requirenents of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appen-

dix, OQAM Sections 16 and 18, and the requirementr, of the Callaway Plant Technical Specificacions.

REGULATORY GUIDE 1.144 REVISION 1 DATED 9/80 A Auditing of Quality Assurance Programs for Nuclear Power Plants

/O' ' Endorses ANSI N45.2.12-197.4) 5 j

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide with the following clarifications:

i l

With regard to Section 1.4 of ANSI N45.2.12 - 1977 titled Defini-tions:

With one exception (Program Deficiencies) the definitions i

in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definiticas which are included in J

ANS_

N45.2.10 shall be used as clarified in 0E's commitment to Regulatory Guide 1.74. The one excepted definition and a clar-ified definition (of audit) relevant to this Standard are defined in this Appendix under Regulatory Guide 1.74.

Wi t..

regard to Section 2.1 of ANSI N45.2.12-1977 titled General:

Identical or equivalent controls are provided in this

OQAM, 3ection 18.3 regarding the second paragraph discussing audit team selection.

With regard to Section 2.2 of ANSI N45.2.12 - 1977 titled Person-nel Qualification: The qualification of UE audit personnel shall be accomplisned as described to meet the requirements of Regula-tory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.

A-29 Rev. 14 4

6/91

OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

%,g/

With regard to Sectio'n 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titled Training: The training of UE audit personnel shall be accomplished as described to meet the require-ments of Regulatory Guide 1.146 (ANSI N45.2.23 -

1978Property "ANSI code" (as page type) with input value "ANSI N45.2.23 -</br></br>1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.) as endorsed in this Appendix and OQAM Section 18.

With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Mainte-nance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the require-ments of Regulatory Guide 1.146 (ANSI N45.2.23 -

1978Property "ANSI code" (as page type) with input value "ANSI N45.2.23 -</br></br>1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.) as endorsed in this Appendix and OQAM Section 18.

With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essen-tiai Elements of the Audit System: UE shall comply with subsec-tion 3.3.5 as it was originally written (subsection 3.2.5) in ANSI N45.2.12, Draft 3, Revision 4: " Provisions for reporting on the effectiveness of the Quality Assurance Program to the respon-sible management." For the auditing organization (UE), effective-ness shall be reported as required by the Callaway Plant Tech-nical Specifications.

Other than audit reports, UE may not directly report on the effectiveness of the quality assurance programs to the audited organization when such organizations are outside of UE.

Subsection 3.3.5 requirements are considered to be fulfilled by compliance with the organization and reporting measuras outlined in this Operating QA Manual and the Callaway Plant Technical Specifications.

In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments.

/k(Subsection 3,3.7 requires / verification of effective corrective action on a (" timely basis.6 Timely basis is interpreted to mean within the framework or period of time for completion of correc-tive action that is accepted by the Quality Assurance Department or Quali ty ca ru 4 cas-Depar-twent. Each finding requires a response and a corrective action completion date; these dates are subject to revision (with the approval of the Quality Assurance Depart-ment or Qur.lity Serd ca:

n partment) and must be escalated to e

nigher authority when there is a disagreement between the audited and the auditing organizations on what constitutes

" timely corrective action."

With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planning:

Identical or equivalent controls are provided in this OQAM, Section 18.

A-30 Rev. 14 6/91

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.4 ATTACHMENT 3

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3 OQAM, REVISION 15 EXPLANATIONS OF AND JUSTIFICATIO:.,

FOR PROPOSEi) CHANGES TO THE OQAM l

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Attachmsnt 3 to ULNRC-Page 2 of 3

-i DESCRIPTION OF AND JUSTIFICATIONS FOR PROPOSED CRANGE8 1

TO THE OPERATING QUALITY ASSURANCE NANUAL (OQAN)

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The bracketed numbers [ ] in this attachment may apply to-several l

changes. The affected OQAM sections.are referenced following each justification. It should be noted some sections: eppear under more than one justification. Based on Union Electric's evaluations,.

the proposed changes do not represent a reduction in the Operating Quality Assurance Program (OQAP) as previously accepted by the NRC. The OQAM continues to meet the requirements of i

10CFR50, Appendix B.

[1]

Editorial changes to remove redundancy, clarify meaning, reformat in a more logical sequence, and-clarify references.'

(Sections 1.3, 1.4, 9.1-9.3, 18.2, 18.4, 18.6-10.8, 18.10, 18.14; Appendix A, Reg. Guide 1.33, 1.74,-1.94, 1.144)'

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(2)

Organization changes made to improve interdapartment coordination and efficiency.-(Sections 1.2-1.4, 1.11, 1.21, 2.1, 2.7, 4.10, 4.10.3, 7.5, 7.11,-12.4, 18.2-1(

1, 18.10, 18.11; Appendix A, Reg. Guide 1.144; Figures A, B, and C)

(3)

Added sections or changed text based on the. review of Union Electric commitments to various documents.-'(Sections 1.11, 2.5, 4.8.1, 9.1, 18.8, Reg. Guide ~1.37)

[4]

RLnumbering of Sections. The section. number'shown is the new number. (Sections 1.2 through 1.26, 9.4, 9.6, 10.6, 10.7)

[5]

Changes to corrective action program, OQAM CN 90-10, have not been approved at this time. When comments.are resolved, the revised text will be-inserted:via CN.

[6]

Clarify endorsement of-ANSI N45.2.5-19745to[be consistent-with Reg. Guide 1,58 (Appendix A,' Reg. Guide 1.94)

The change clarifies Union Electric's position'on this-Eagulatory. Guide to be consistent with RegulatoryEGuide 1.58. The change is due to an apparent oversight:in previous OQAM revisions. Per the endorsementLof Regulatory Guide 1.58, personnel other than QC personnel performing

-inspection, examination, and testing activities shall-have appropriate experience, training, and retraining to' assure-competence in accordance with Regulatory Guide 1.8-(ANSI /ANS~ 3.1-1978).

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Attechmsnt 3 to-ULNRC-Page 3 of 3 While the change could be construed to-be a lessening of commitment, and Union Electric has not previously taken exception to the requirements of ANSI N45.2.5-1974, Section 2.4; the position taken to Regulatory Guide 1.58 has not changed. Union Electric has persons charged with engineering managerial responsiblity -of the inspection and testing organization who are qualified per ANSI /ANS 3.1-1978. Within the Quality Control organization, a revel III in the civil discipline oversees Level II Inspectors / Testers who are-certified per ANSI N45.2.6-1978 Also, change to ANSI N45.2.5-1974, Section 2.5.2 clarifies UE actions when discrepancies with M&TE or references are found.

[7]

Changes to Commitment Tracking System numbers. These numbers appear in left margin. They are an internal tracking system for UE commitments and have no impact on the stated text.

(Sections 1.3, 1.4, 1.7, 1.8, 1.11-1.13, 1.16, 2.2-2.6, 2.10-2.12, 3.11, 3.18, 3.20, 3.22, 4,

4.1-4.4, 4.8.2-4.8.5, 4.8.7, 4.10, 4.10.1, 4.11, 4.14, 5.1, 7,

7.1-7.3, 7.5, 7.6, 7,8, 7.9, 7.11, 7.14-7.16, 7.18-7.20, 8.4, 10.4-10.12, 2

10.14, 11.1, 11.3, 11.4, 11.6-11.11, 12.1, 12.2, 12.6, 12.7, 12.8, 13.2-13.5, 14.2, 15, 15.2, 15.3, 15.8, 15.9, 16.1, 16.8, 17.2, 17.3, 18, 18.1, 18.2,-18.4, 18.6, 18.9, i

18.10-18.13)

(8)

Added a clarifying note to prevent confusion when purchase documents reference or invoke an approved Supplier Quality Program (Section 4.8)

[9]

The QA Department has maintained that a Reg. Guide is followed as a "si.all" requirement unless otherwise interpreted in either the OQAM, App. A or-FSAR Appendix 3A.

This policy had been previously delineated in an administrative procedure-(APA-ZZ-00100), which is considered a subtier to the OQAM. However, since the OQAM and the FSAR interpret Regulatory Guides it appears more appropriate for this guidance to be in the upper tier documents. Due to this revision, APA-ZZ-00100 would become the implementing procedure to the OQAM/FSAR committent. This is not a change in-commitment, only a relocation of existing guidance. The-FSAR will also bc updated in a aimilar manner. (Appendix A) 3 l

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