ML20140J159

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Rev 18 to Operating QA Manual, mark-up,identifying Changes Through Use of Strikeover & Inserts
ML20140J159
Person / Time
Site: Callaway Ameren icon.png
Issue date: 11/30/1995
From:
UNION ELECTRIC CO.
To:
Shared Package
ML20140J155 List:
References
NUDOCS 9705130431
Download: ML20140J159 (76)


Text

J - --4 l

! Attachment I to ULNRC-3575 1

i Operating Quality Assurance Manual (OQAM) ,

Revision 18 mark-up changes 4

1 i

9705130431 DR 970509 ADOCK 0500 3 '

i Umon Etscraic a

CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL (0QAM)

Rev.18 File Code A210.0012 l

Afark-up pages I

Union Ets.craic g REVISION: 18 CALLAWAY NUCLEAR PLANT DATE: 11/95 TAHLE OF CONTENTS Section Title Pace Table of Contents i Policy / Introduction iii

1. Organization 1-1
2. Quality Assurance Program 2-1
3. Design Control 3-1
4. Procurement Document Control 4-1
5. Instructions, Procedures, and Drawings 5-1
6. Document Control 6-1
7. Control of Purchased Material, Equipment, and Services 7-1
8. Ideintification and Control of Materials, Parts, and Components 8-1
9. Control of Special Processes 9-1
10. Inspection 10-1
11. Test Control 11-1
12. Control of Measuring and Test Equipment 12-1
13. Ilandling, Storage, and Shipping 13-1
14. Inspection, Test, and Operating Status 14-1
15. Nonconforming Materials, Parts, or Components 15-1
16. Corrective Action 16-1
17. Quality Assurance Records 17-1
18. Audits 18-1 Appendix A OQAM Conformance to Applicable NRC Regulatory Guides A-1 Mtrk-up pages -i-

Union ELECTRTC g REVISION: 18 CALLAWAY NUCLEAR PLANT DATE: 11/95 OOAP POI,ICWINTRODUCTIONS It is the policy of Union Electric Company (UE) to develop, implement, and maintain an Operating Quality Assurance Program (OQAP) for Callaway Plant as required by provisions 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 NRC 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 safety. (CTSN 1825)

UE Company has established an organization to implement the OQAP as documented in policies, 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. i l

(CTSN 1788)

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. (CTSN 1879,1111) l Mark-up pages -ii-l

I I

Union ELE.CTRIC g REVISION: 18 CALLAWAY NUCLEAR PLANT DATE: 11/95 The responsibility for formulating, authorizing, and assuring implementation of the UE Company q) l OQAP rests with the Sede- Vice Presidert Nuclear Vice President and ChiefNuclear Officer. 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 interfaces. (CTSN 1799)

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

D'nald " Sc!'ne!' Date O Ses' " ice P: sidert Muclea-Garry L Randolph Vice President and Chief Nuclear Officer Joseph V. Laux Date Manager, Quality Assurance Afark-up pages .iii.

sea SECTION NO.1 REVISION-* 18 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11/95

1. 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 organization responsible for implementing appropriate portions of the OQAP is shown in Section 13 of the FSAR. The Callaway Plant operating organization is also shown in Section 13 of the FSAR.

The SeWoe%ce Pre.!d ' "":!:ar Vice President and ChiefNuclear Oficer is responsible for initiating the

@ l 1.2 Quality Assurance Program, formulating the policy, and authorizing and assuring Program implementation. lie 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. Ile has corporate responsibility for the operation and physical control of the Callaway Plant. lie reports to the President and Chief Executive Omcer who has ultimate responsibility for the Callaway Plant. (CTSN 371)

@ l 1.3 The Manager, Quality Assurance reports to the F: "!:: N!de > "u !::: Vice President and Chief Nuclear Officer on Quality Assurance Program and administrative matters. QA Program matters are reported to the President and Chief Executive Officer through the Een "k: P' 9': * "u !::: Vice President and Chief

@ Nuc/ car Ogicer. The Manager, Quality Assurance is responsible to the F: ucr "!:: "resid:

  • N :! :: Vice President and ChiefNuclear Oficer for assuring the OQAP is being effectively implemented for operating activities; directing the overall Quality Assurance Program for UE including Program development, maintenance, and verification ofimplementation; and providing a constant independent overview of nuclear plant safety. 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 responsibilities which unduly influence attention to quality matters. A communication path shall exist between the Manager, Quality Assurance and the gl Vice President Nu:!: : Opere . = and ChiefNuc/ car Oficer, as well as the other Nuclear Division management, thus providing a direct path to inform management regarding conditions affecting quality and nuclear plant safety. The qualifications of the Manager, Quality Assurance are at least equivalent to those specified in ANSI /ANS-3.1-1978," Selection and Training of Nuclear Power Plant Personnel," Sections 4.2.4 and 4.4.5. The Manager, Quality Assurance is located at Callaway Plant and provides technical direction and administrative guidance to the ISEG staff, the Quality Assurance staff, and the Quality Control staff.

@ (CTSN M8,1790,1799) 1.4 The Manager, QA directs Supervisors and Supervising Engineers who have primary duties for assuring implementation of the OQAP and who devote full attention to this effort. The Supervising Engineer, Operations Support provides for maintenance of the Operating Quality Assurance Manual (OQAM). The Supervising

@j Engineer, F pp!k:Qu:!ny TechnicalSupport is responsible for audit, surveillance, and evaluation of nuclear supplier quality activities; and for performing those procurement document reviews assigned to him. The Supervisor Quality Control is responsible for work activity inspections, receipt inspection as described in Section 7.0, and nondestructive examinations. The activities of the QA staff assure implementation of the g OQAP. (GTF#MS)

Mark-uppages 1-1

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  • OPERA TING QUALITYASSURANCE MANUAL DATE: 11195 1.5 The Manager and Supervising Engineers in the Quality Assurance Department are authorized by the Semer Vi= S :!d: ' Mx!=- Vice President and ChiefNuclear Officer 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 activities and the authority to recommend to the Manager, 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 denciency and preclude identiGcation and correction, or increase the extent of the deficiency is subject to stop work action by the Quality Assurance Department. The Manager, Quality Assurance has no duties or responsibilities unrelated to QA that would prevent his full attention to QA matters.

1.6 The authorities and duties of persons and organizations performing quality assurance functions shall be clearly established. Such persons have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to evaluate corrective action. Assurance of quality by checking, .

auditing, inacting, or otherwise verifying Program activities shall be by personnel other than the individual or group performing the specinc activity. (CTSN 1790,2255) 1.7 The Manager, QA also directs the Supervising Engineer, ISEG and staff who evaluate Callaway Plant operations from a safety perspective and compare Callaway operating experience with that of plants of similar design. In addition, they assess the conformance of Plant performance to safety requirements. (CTSN 1790) g I.8 The Manager, Nuclear Engineering reports directly to the Sen "i= Presiden* N=!:= Vice President and ChiefNuclear Officer 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; modifidon; configuration control; system and equipment perfonnance; reliability, and testing; technicoi programs administration; and contractor support. Ile controls those activities and implernents the OQAP through the Superintendents, Design Engineering, System 1 Engineering, and Technical Support Engineering. Within the Technical Support Engineering organization, QC Inspectors (ISl/NDE) report to the Supervising Engineer Performance and 151, and perform inspection and j nondestructive examinations. These inspectors do not perform inspections or examinations which provide  ;

quality verincation of Nuclear Engineering work activities. (CTSN 2184)

@ 1.9 The Manager, Licensing and Fuels reports directly to the S=!r *= "e'.id: * 'c'er Vice President an<l ChicfNuclear Oficer 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 provides technical support activities in the area of reactor design and radiological engineering.

(CTSN 2184,2293)  !

I g 1.10 The Manager, Nuclear Services reports directly to the SH 9= Presid: ' N=': - Vice President and Chief Nuclear Officer and is responsible for providing administrative and management support including cost forecasting, status reporting, and budgeting matters. lie is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal llealth Physicist. lie is also responsible for the  ;

administrative contact with the Institute of Nuclear Power Operatiens (INPO). As Principal licalth Physicist, he '

prosides 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.

Afark-up pages 1-2

MUmonELECTRICCALLAWAY NUCLEAR PLANT N

OPERATING QUALITYASSURANCEMANUAL DATE: 11195 The Vice President Fu&r Op=ene, and ChiefNuclear Oficer reports to the Seni= "i= Preid=' N='er g 1.1 i Prcsident and ChiefExecutive Oficer and is responsible for the activities of the Callaway Plant Operations Department and the Operations Support Department. This responsibility includes:

e assuring a high level of quality is achieved in the Plant operations and support activities, e the execution of the administrative controls and quality assurance program, e the safe, legal and efficient operation rnd maintenance of the Plant, e protecting the health and safety of the public and Plant personnel

@ 1,12 The Manager, Callaway Plant reports directly to the Vice President Nu&r Op= t; = and ChiefNuclear Oficer, and is responsible for the safe, legal, and efficient operation and maintenance of the Callaway Plant. lie has overall responsibility for the execution of administrative controls and the quality assurance program to assure safety. lie controls Plant functions and implements the OQAP through the Assistant Manager, Work Control; the Superintendent, llealth Physics; the Superintendent, Chemistry and Radwaste; the Superintendent, Operations; the Superintendent, Maintenance; and the General Supervisor, I&C (see Section 13 of the FSAR).

lie has the primary responsibility for reactor operation and safety. (CTSN 1799) g l 1,13 The Manager, Operations Support reports to the Vice President-Mu&- Opra:h = and ChiefNuclear Officer, I and is responsible for Plant support activities including training, materials management, security, and administration services activities required to support the Callaway Operating License, lie controls Plant support activities and implements the OQAP through the Superintendent, Materials, the Superintendent, Training, the Superintendent, Security, and the Superintendent, Administration. (CTSN 2293) 1.14 General quality assurance indoctrination and training for the Nuclear Division is the responsibility of UE Nuclear Operations (UENO), Training. The Quality Assurance Department is responsible for specific QA

@ training as requested by Nuclear Division organizations. (GTM4498) 1.15 The Manager, Nuclear Information Services (NIS) reports to the Vice President Nu&r Op=asms and Chicf Nuc/ car Oficer. lie is responsible for providing the analysis, programming, operations, hardware support, files, reports, and capabilities necessary to maintain the nuclear infonnation system and network in support of the plant.

1.16 The Manager, Emergency Preparedness and Organizational Support reports directly to the Vice President-

@l Nc'ec Opna6ms and ChiefNuclear Oficer, and is responsible for emergency preparedness, organizational support, personnel development, process re-engineering, personnel, and fitness for duty. (CTSN 43030) 1.17 The Supenisor, EP and staff have overall responsibility for the development and maintenance of the Emergency Preparedness Program. This includes onsite and offsite emergency preparedness, coordination 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.

1.18 The Superintendent, Personnel (Local 148) and the Superintendent, Personnel (Local 1439 and 1455) report directly to the Manager, Emergency Preparedness and Organizational Support and are responsible for assisting in the areas ofindustrial relations and other matters under the guidance of UE policies. In addition, the Superintendent, Personnel (Local 1439 and 1455)is responsible for the Fitness for Duty, Access Authorization and medical physical programs, Mark-up pages 1-3

$$NIONELECTRIC CALLAWAY NUCLEAR PLANT

  • N OPERA TING QUALITYASSURANCE MANUAL DATE: 11/95 1.19 The Manager, Purchasing reports directly to the Vice President-Supply Service who in turn reports to the Senior

@l Vice President-C*hner Ser ::: EnergySupply Services. The Manager, Purchasing is responsible for commercial aspects involved in procurement of materials, 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. (CTSN 43026)

@ l 1.20 The Manager, .d :ica! Eng:ner ng Power Plant Design Engineering reports to the Vice President-Engineering and Construction who in turn reports to the Senior Vice President-Finance and Corporate gl Services. The Manager, Meehan:ca! %gu dng Power Plant Design Engineering provides technical support, as necessary, to the Nuclear Engineering staff. (CTSN 2184) 1.21 ne Manager, Electrical Engineering reports to the Vice President-Engineering and Construction. The Manager, Electrical Engineering provides technical support, as requested, to the Nuclear Engineering staff.

(CTSN 2184) 1.22 The Manager, System Relay Sersices reports to the Vice President-Tran  : and Dis:r!butian Customer Services-Division Support who in turn reports to the Senior Vice President-Customer Services and is responsible for providing qualified engineers, technicians and equipment to maintain Callaway Plant relays. (CTSN 43027) 1.23 The Manager, Distribution Operating Department reports to the Vice President Tran:n 2: nd D bution

@l Customer Services-Division Support and is responsible for providing qualified engineers, technicians and equipment for Callaway Plant battery testing and technical support. (CTSN 43027)

@ 1.24 The Manager, hn . ' , Transmission Planning reports to the Vice President Car;mrc:: P' ng

@ Engineering and Construction and is responsible for directing all activities related to the Planning of transmission facilities. The Vice President-C*pe ate P!anning Engineering and Construction also provides

@ engineering and other support services when requested by the Sen , r Vice Pre:.id: ' Nu:! ear Vice President and ChiefNuclear Oficer (CTSN 43027,43025) 1.25 Other UE divisions may provide safety-related services which augment and support selected Program activities.

These organizations shall be required to implement controls consistent with the OQAP requirements applicable to their scope of activities. He coordination of these activities is the responsibility of the Sr "ce

& Pres! den * %':- Vice President and ChiefNuclear Oficer.

1.26 Safety review committees shall be established to provide an independent review of those items required below.

These committees are the Onsite Review Committee (ORC -- refer to Section 1.26.1) and the Nuclear Safety Review Board (NSRB -- refer to Section 1.26.2) 1.26.1 The ORC shall function to advise the Manager, Callaway Plant on all matters related to nuclear safety. The Manager, Callaway Plant shall be Chairman of the ORC.

1,26.1.1 ORC membership shall include a minimum of six additional members appointed by the Chairman and an additional member appointed by the Manager, Quality Assurance. Selected members shall include, at a minimum, management responsible for the following areas of expertise:

a) Operations b) Maintenance c) Instrumentation and Controls d) Chemistry e) Radwaste 0 llealth Physics Mark-uppages 1-4

ea SECTION NO.1 7

REVISION-* 18 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 11/95 1.26.1.2 All alternate members shall be appointed in writing by the ORC Chairman to serve on a temporary basis.

1.26.1.3 The alternate for Quality Assurance is appointed by the Manager, Quality Assurance.

1.26.l A The ORC shall meet at least once per calendar month and as convened by the ORC Chairman or his designated alternate.

l.26.1.5 The quorum of the ORC necessary for the performance of the ORC responsibility and authority provisions shall consist of the Chairman or his designated alternate and four members of which no more than two shall be alternates.

l.26.1.6 The ORC shall maintain written minutes of each ORC meeting that, at a minimum, document the results of all ORC activities. Copies shall be provided to the S:9 " ice Preside * " dear Vice President and Chief

@ Nuclear Oficer and the NSRB.

1.26.1.7 The ORC shall be responsible for a) Review of all Administrative Procedures; b) Review of safety evaluations for:

e procedures, e change to procedures, equipment, systems or facilities, and e tests or experiments completed under the provision of 10CFR50.59 to verify that such actions did not constitute an unreviewed safety question; c) Review of proposed procedures and changes to procedure, equipment, systems or facilities which may involve an unreviewed safety question as defined in 10CFR50.59 or involves a change in Technical Specifications; l d) Review of proposed test or experiments which may involve an unreviewed safety question as defined j in 10CFR50.59 or requires a change in Technical Specifications; e) Review of proposed changes to Technical Specifications or Operating License; f) Investigation of all violations of the Technical Speci0 cations including the forwarding of reports covering evaluation and recommendations to prevent recurrence to the F: =r "ic Presiden* "Wer Vice President and ChiefNuclear Offcer and to the NSRB; g) Review of report of operating abnormalities, deviations from expected performance of plant equipment and of unanticipated deficiencies in the design or operation of structures, systems or components that affect nuclear safety; h) Review of all REPORTAllLE EVENTS; i) Review of the plant Security Plan and shall submit recommended changes to the NSRB; )

j) Review of the Radiological Emergency Rqc.se Plan and shall submit recommended changes to the NSRB; l k) Review of changes to the PROCESS CONTROL PROGRAM, the OFFSITE DOSE CALCULATION ,

MANUAL, and Radwaste Treatment Systems; l) Review of any accidental, unplanned or uncontrolled radioactive release including the preparation of  !

reports covering evaluation, recommendations, and disposition of the corrective action to prevent recurrence and the forwarding of these reports to the Manager, Callaway Plant and to the NSRB;  ;

m) Review of Unit operations to detect potential hazards to nuclear safety; j n) Investigations or analysis of special subjects as requested by the Chairman of the NSRB; j o) Review of Unit Turbine Overspeed Protection Reliability Program and revisions thereto; p) Review of the Fire Protection Program and submitting recommended changes to the NSRB.

Mark-up pages I-5 l

l SECTION NO. I eei3 5 CALLAWAY b7NIONELECTRICNUCLEAR PLANT nevisiOut is

)

OPERATING QUALITYASSURANCEMANUAL I)ATEt 11/95 i 1.26.1.8 The ORC shalt:

i a) Recommend in writing to the Manager, Callaway Plant approval or disapproval ofitems considered i under Sections 1.26.1.7.a through 1.26.1.7.e,1.26.1.7.i,1.26.1.7.j,1.26.1.7.k,1.26.1.7.1,1.26.1.7.0, and 1.26.1.7.p above.

b) Render determinations in writing with regard to whether or not each itern considered under Sections 1.26.1.7.b through 1.26.l.7.e, and 1.26.1.7.m, above, constitutes an unreviewed safety question; and g c) Provide written notification within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the Senia '":: Pr :!d:n' "u:!::: Vice President and ChiefNuclear Oficer and the NSRB of disagreement between ORC and the Manager, Callaway Plant; however, the Manager Callaway Plant shall have responsibility for resolution of such disagreements.

1.26.2 The NSRB shall function to provide indepandent review and audit of designated activities in the areas of:

a) Nuclear power plant operations, b) Nuclear engineering, c) Chemistry and radiochemistry, d) Metallurgy, c) Instrumentation and control, f) Radiological safety, g) Mechanical and electrical engineering, and h) Quality assurance practices The NSRB shall report to and advise the S:nb "ke Pre:,ident "u !::: Vice President and ChicfNuclear g 1.26.2.1 Oficer on those areas of responsibility stated in OQAM Sections 1.26.2.10 and 18.8.

1.26.2.2 The NSRB shall be composed of at least the following members:

1 Chairman: Manager Licensing and Fuels l Tiimber: Manager, Nuclear Engineering i Member: ' Manager, Quality Assurance )

& Member: MWetid: ::, Nu !: i op:rauens Manager, Operations Support l g Member: Supervising Engineer, Nu:!:- 9:b Fuct Cycle Management 1.26.2.3 Additional members and Vice Chairman may be appointed by the Chairman.

1.26.2.4 The NSRB members shall hold a Bachelor's degree in an engineering or physical science field, or equivalent experience, and a minimum of 5 years of technical experience of which a minimuni of 3 years shall be in one or more of the disciplines of Section 1.26.2.

1.26.2.5 All alternate members shall be appointed in writing by the NSRB Chairman to serve on a temporary basis; however, no more than two alternates shall participate as voting members in NSRB activities at any one time.

l.26.2.6 - Consultants shall be utilized as determined by the NSRB Chairman to provide expert advice to the NSRB.

1.26.2.7 The NSRB shall meet at least once every 6 months.

MarA-up pages 1-6

SUNIONELECTRIC CALLAWAY NUCLEAR PLANT

{ ,

OPERATING QUALITYASSURANCEMANUAL DATE: 11l95 1.26.2.8 The quorum of the NSRB necessary for the performance of the NSRB review and audit functions herein, shall consist of the Chainnan or his designated alternate and at least two-thirds of the NSRB members, including alternates. No more than a minority of the quorum shall have line responsibility for operation of the unit. Fw thetwpec: cf: queru:n, 'hc= censidered :^ h::: F : := pend!!!:y :" :n:! de :h: V!:: P cid:

  • Nu:!:::

@ Opera:i , : 4per=rn:! pHng th:"!:: Pr=iden* Mu:'::: Opera:ims, 1.26.2.9 Minutes of each NSRB meeting, including reports of reviews encompassed by Section 1.26.2.10, shall be prepared, approved and forwarded to the Rai:: "i:: Preiden' "u:!::: Vice President and ChiefNuclear Of/Iccr within 14 days following each meeting.

1.26.2.10 The NSRB shall be responsible for the review of:

a) The safety evaluations for:

  • changes to procedures, equipment, systems or facilities; and e tests or experiments completed under the provision of Section 50.59,10CFR, to verify that such actions did not constitute and unreviewed safety question; b) Proposed changes to procedures, equipment, systems or facilities which involve an unreviewed safety question as denned in Section 50.59,10CFR:

c) Proposed tests or experiments w hich involve an unreviewed safety question .as defined in Section 50.59, 10CFR; d) Proposed changes to Technical SpeciGcations or the Operating License; e) Violations of Codes, regulations, orders, Technical Specifications, license requirements, or of internal procedures or instructions having nuclear safety significance; f) Significant operating abnormalities or deviations from nonnal and expected performance of unit equipment that affect nuclear safety; g) ALL REPORTABLE EVENTS; h) All recognized indications of an unanticipated deficiency in some aspect of design or operation of structures, systems or components that could affect nuclear safety; and i) Reports and meeting minutes of the ORC.

~

Ifark-up pages 17

EEUNIONEtscraic CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL CC DATE: 11/95

2. QUALITY ASSURANCE PROGRAM 2.1 UE has established an OQAP which controls activities 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 Assurance Criteria for Nt. clear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33. Commitments, clariGcations, 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 commitments made in responding to applicable NRC questions. 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 Senk: "!:: Ni&" Mu:!::: Vice President and ChiefNuclear Officer has Wiiated reviewed the Program and formulated the policy in addition to authorizing Program implementation. This responsibility has been established by the President and Chief Executive Officer of UE for establishing and implementing the Quality Assurance Program requirements. (CTSN 1799,2974) 2.2 Lines of authority and responsibility have been established from the President and ChiefErecutive Officer

@ higher agem e !:ve! thrwgbatermed!:2 !: vee -d to the Vice President Mu !::: Operatic = andChief Nuclear Officer and the onsite operating organization. These relationships shall be documented 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 responsibilities 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.

(CTSN 1788) 2.3 Updating and revision of the OQAP as described in this OQAM shall be in accordance with the applicable requirements of 10 CFR 50.54 (a) and 10 CFR 50.71.

2.4 The pertinent requirements of the OQAP apply to all activities affecting the safety-related functions 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 structures, systems and components identified in Table 3.2-1 of the Callaway-SP Final Safety Analysis 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 importance to safety. Modifications to this list require the approval of the Manager, Quality Assurance 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, tit 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 OQAP. (CTSN 1824,1853,20200) 2.5 The OQAP shall be implemented throughout the operating life of the Callaway Plant. Activities affecting I quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of l appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate i cleanness; and assurance that all prerequisites for the given activity have been satisfied. (CTSN 1879,1947) l l

l l

Mark-up pages 2-1 i

EGrIONELECTRIC CALLAWAY NUCLEAR PLANT It i OPERATING QUALITYASSURANCEMANUAL DATE: 11195 2.6 Consistent with the schedule for accomplishing 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 implement approved procedures. The OQAP shall utilize the following document types to describe Program objectives: (CTSN 1788,1879)

1. Operatine Ouality Assurance Procram Poliev/ Introduction 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 S ~ "i:: P::dh" Nud ar Vice President and ChiefNuclear Oficer.

Q

2. Operatine Ouality Assurance Manual (OOAM)

The OQAM contains a delineation of the Policy statement, quality assurance requirements, assignment of responsibilities, and a definition of organizational interfaces. The OQAM is the written description of the g OQAP. Approval of the OQAM is by the S 9 "!:: P :d* ' Nudear Vice President andChief Nuclear Officer and the Manager, Quality Assurance. (CTSN 1823)

3. Callaway Plant Operatine Manual The Callaway Plant Operating Manual consists of a multi-volume set of Plant operating procedures 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. (CTSN 1947)

Administrative procedures which apply to the entire staf 6 and revisions thereto, shall be reviewed by the .

Callaway Plant Onsite Review Committee (ORC) and the Quality Assurance Department. The final l approval of Administrative Procedures and revisions thereto shall be by the Manager, Callaway Plant. l The review and approval of other procedures and revisions thereto shall be in accordance with approved Administrative Procedures w hich implement the requirements of the Technical Specifications, and this OQAM.

2.7 UE may employ the safety-related services of architect engineers, NSSS suppliers, fuel fabricators, constructors, and others which provide or augment UE efforts during the operating phase. These organizations shall be required to work unde. 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, evaluation and acceptance by the UE Quality Assurance Department prior to the initiation of safety-related work. Vendor programs and procedures shall also meet UE's I commitment to USNRC Generic Letter 83-28. (CTSN 679,1746,1787,2293,2460) I 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 higher level of management for resolution. Disputes w hich cannot be resolved through these levels shall be resolved ultimately by the Chief Executive Officer.

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Afark-up pages 22 l

SECTION NO. 2 REVISION: 18 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL I) ATE: 11195 2.9 Preservice (PSI) and inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspections and other operating phase " code" activities shall comply with the requirements of the applicable 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 Inspector.

2.10 General indoctrination and training programs shall be developed for personnel performing safety-related activities to assure that responsible functions, departments, and individuals are knowledgeable 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 sessions. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equipment 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 Regulatory 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 procedures in the principles and techniques of performing specific activities. Special equipment, environmental conditions, skills, or processes shall be provided as necessary for the effective implementation of the OQAP. (CTSN 1795, 1916,2188) 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 Assurance is responsible for a system of planned audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance and in accordance with the requirements 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 follow-up to assure corrective action. (CTSN 1799)

G) l 2.12 The Een - V!:: P=ide * =!:- Vice President and ChiefNuclear Oficer provides for an independent assessment of the scope, implementation, 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 representatives.

In addition, various reports are issued to the E9 Vice Ptiden' N=!:n Vice President and ChiefNuc/ car Officer on a periodic basis to assist his independent assessment of the OQAP (e.g., semiannual QA trend analysis, and periodic QA audit reports). (CTSN 1799,1800) 2.13 Implementation of OQAP controls over activities affecting quality assures achieving the objective of the UE OQAP to provide management with adequate 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 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.

Mark-up pages 2-3

320xiouELECTRIC CALLAWAY NUCLEAR PLANT h.s OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 J

2.14 UE Management has established standards of performance which exceed those set forth by the Regulatory Agencies. As a management initiative in this area UE has defmed the word "must" to impose management directed performance standards in excess of and in addition to established Regulatory directed performance.

From the viewpoint of UE employees and UE contractors, there is no difference in the degree of complianct 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 Department. Failure to implement a "must" mandated activity requires corrective action in the same way as failure to implement a "shall" mandated activity. Ilowever, from an external viewpoint, internally imposed "must" requirements (i.e., those in excess of Regulatory requirements) are not intended to be subject to enforcement action. "Must"is defined in Appendix A of this OQAM under Regulatory Guide 1,74.

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SECTiON NO. 3 daeiCALLAWAY b7NIONELECTRIC NUCLEAR PLANT atvisiON.

  • is OPERATING QUALITYASSURANCEMANUAL DATE: 11/95
3. DESIGN CONTROL 3.1 The design, modification, addition, and replacement of safety-related structures, systems, and components shall be controlled to assure appropriate design control measures are implemented. Procedures shall establish requirements; assign responsibilities; and provide control of activities regarding design in a planned, controlled, and orderly manner. (CTSN 1850,2070,2072,2096,2168,2185,2187,2188,2222,I864,2183,2974) 3.2 ne Plant design is defined by those UE NSSS, A/E and selected supplier design drawings and specifications which illustrate the general arrangement and details of safety-related structures, systems, and components and i define the requirements for assuring their continued capability to perform their intended operational or safety design function. (CTSN 2188) 3.3 As the result of operating experience, or as necessitated by regulatory requirements, Plant systems and equipment may have to be changed. A design change is a modification in Plant design or operation and is accomplished in accordance with requirements and limitations of applicable codes, standards, specifications, licenses, and predetermined safety restrictions. An alteration of Plant equipment, structures or systems, which is not by nature operational, maintenance or replacement by like kind, is considered a design change.

(CTSN 2664) 3.4 Maintenance or modifications which may affect functioning of safety-related structures, systems, or components shall be performed in a manner to ensure quality at least equivalent to that tpecified in original design bases and requirements, materials specifications and inspection requirements. A suitable level of confidence in structures, systems, or components on which maintenance or modifications have been performed shall be attained by appropriate inspection and performance testing. (CTSN 1850,2100,2101,2105,2111) 3.5 Design, including related procurement efTorts, may be carried out by Nuclear Engineering, Licensing and Fuels, or outside organizations. (CTSN 2184,2188,2222) 3.6 Control of design shall be specified in procedures. nese procedures shall include instructions for defining typical design requirements; communicating needed design information across internal and external interfaces; preparing, reviewing, approving, releasing, distributing, revising, and maintaining design documents; performing design reviews and reviews of design; and controlling field changes. (CTSN 2071,2074,2164, 2188,2221,2222,2223,2225,2243) 3.7 Design control shall involve measures which include a definition of design requirements; a design process w hich includes design analysis and delineation of requirements through the issuance of drawings, specifications, and other design documents (design outputs); and design verification or review of design to verify the adequacy of design or to become acquainted with design features. (CTSN 2164) 3.8 Design requirements and changes thereto shall be identified, documented, reviewed and approved to assure incorporation of appropriate quality standards in design documents and to control departures from these standards. Modifications to structures, systems, and components shall consider, as a minimum, the design bases described in the Callaway-SP and the Callaway-SA FSAR and the Technical Specifications. Design criteria documents which are newly issued or modified in the course of design or design changes shall be reviewed by a g] wpenntemleet Supervising Engineer in the Nuclear Engineering Department for seismic and quality group classification and selection of quality standards. Design criteria documents consist of original Plant design i criteria, system descriptions and other documents defining design input which change the Plant as described in the FSAR. De design input shall be specified on a timely basis and to the level of detail necessary to permit the design activity to be carried out in a correct manner and provide a consistent basis for making design decisions, Mark-up pages 31

see SECTION NO. 3 REVISION-

  • 18 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 accomplishing design verification measures, and evaluating design changes. (CTSN 1850,2188,2203,2204, 2205,2207,2222,2664) 3.9 Design activities shall include the correct translation of regulatory requirements and design bases into specifications, drawings, written procedures, and instructions (design outputs) that define the design. Design analyses regarding reactor physics, stress, thermal, hydraulic, radiation, and accident analyses used to produce design output documents, shall be sufficiently detailed to permit an independent review by a technically qualified person. Analyses shall specify purpose, method, assumptions, design requirements, references, and units. When computer codes are employed, only verified codes shall be used in safety-related design and design changes. (CTSN 2207,2209,2210,2212,2974,2170) 3.10 Procedures shall specify requirements for the review and approval of design changes by the organizations or individuals that performed the original design or Nuclear Engineering. Design control activities, including design changes, may be delegated to others provided they have access to background and technical infonnation.

Design control measures for design revisions shall be commensurate with those applied to the original design.

(CTSN 2165,2166,2168,2169,2243) 3.1 l Design activities shall also include: 1) reviewing the applicability of standards; 2) reviewing commercial or previously approved materials, parts or equipment for suitability of application; 3) reviewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment and components for inservice inspection, maintenance, and repair; 5) specifying criteria for inspection and test / retest; and 6) reviewing and approving procedures for special processes. (CTSN 1934) 3.12 The design process shall establish controls for releasing design documents which are technically adequate and accurate in a controlled manner with a timely distribution to responsible individuals and groups. Documents and revisions shall be controlled through the use of written procedures by the issuer, distributor, and user to prevent inadvertent use of superseded documents. Document control procedures shall govern the collection, storage, and maintenance of design documents, results of design document reviews, and changes thereto. The design documents subject to procedural control include, but are not limited to, specifications, calculations, computer programs, system descriptions, SAR when used as a design document, and drawings including How diagrams, piping, and instrument diagrams, control logic diagrams, electrical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations. (CTSN 2164,2163,2188,2220,2243) 3.13 The design interfaces between UE organizations performing work affecting quality of design and between UE and outside organizations shall be identified and controlled by procedures. These procedures shall address 1 control of the interface, responsibilities, lines of communication, and documentation ofinternal and external  ;

interface activities. (CTSN 2164,2188,2217,2218,2219,2223,2231) 3.14 The design process shall include design verification. Design verification assures that design is adequate and meets specified design inputs. Design control procedures shall specify requirements for the selection and  ;

accomplishment of a design Verification program. The program depth shall be commensurate with the importance of the system or component to safety, complexity of the design, and similarity of the design to previously proven designs. Design verification shall be conducted in accordance with procedures which 1 identify the responsibilities of the verifier and the documentation required and which, through adherence to the j procedures, provide for the identification of the areas, features, and pertinent considerations to be verified. ]

Design verification shall be by either design review, alternate calculation, qualification testing, or by a  !

combination of these. Where alternate calculations are performed to verify the' correctness of a calculation, a review shall be perfonned to address the appropriateness of assumptions, input data, and the code or other )

calculation method used. UE shall perform " reviews of design" of selected documents for subcontracted design to become familiar with design features. An independent third-level review must be employed as an additional Mark uppages 3-2 l

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MUnionELECTRIC CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 verification when UE judges that the design involves unique or special design features. The organization performing design shall have the responsibility for design control unless specified otherwise. Design verification shall be performed by competent personnel other than those who performed the original design and other than the designer's immediate supervisor. Ilowever, an individual's supervisor may perform design verification when he is the only technically qualified individual and in such instances the need for design verification by the designer's immediate supervisor shall be individually documented and ipproved in advance by the supervisor's management. Quality Assurance Department audits shall examine the frequency and the cf fectiveness of use of supervisors as design verifiers to guard against abuse. (CTSN 1934,2182,2209,2234, 2188,2227,2231) 3.15 Design verification, if other than by qualification testing of a prototype or lead production unit, shall be completed prior to release for procurement, manufacturing, construction or to another organization for use in other design activities. In those cases where this timing cannot be met, the design verification may be deferred, providing the jus;ification for this action is documented and the portions of the design output documents based on the unverified data are appropriately identified and controlled. Without verification, site activities associated with a design or design change must not proceed past the point where the installation would become irreversible (i.e., require extensive demolition and rework). The design verification shall be complete prior to relying upon the component, system, or structure to perform its safety-related function. (CTSN 1934,2227) 3.16 Action shall be initiated to correct errors found in the design process. Erors 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.

(CTSN 2188,2172)

Q) 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 N ; clear 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.

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 OQAM Section 1.0 shall be satisfied.

Design changes require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, Callaway Plant. In addition, changes in the facility as described in the FSAR which involve a change in the l Callaway Plant Technical Specifications incorporated in the license or an unreviewed safety question require I review and approval by the NSRB 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 l operability, maintainability, inspectability, FSAR commitment compatibility, test and inspection acceptance 4 criteria acceptability, and design requirements imposed by Plant generating equipment. l 1

3.19 Safety evaluations which consider the effect of the design as described in the design documents, shall be j performed by the responsible UE engineering organization or outside organization (s). These evaluations shall '

include the basis for the determination that the design change does not involve an unreviewed safety question. i As deemed necessary by the evaluating organization, detailed analyses shall be performed to support the bases 1 of safety evaluations. All nuclear safety evaluations are submitted to the ORC. Changes involving the substitution of equivalent hardware require safety evaluations to assure that the design requirement changes are j consistent with and do not alter the design criteria specified in existing design documents. When design I documents and safety evaluations are prepared by an outside organization under its QA program, review and approval per ANSI N45.2.1 I will be included. UE will approve all outside organizations' design documents and safety evaluations, and will perform appropriate reviews necessary for final approval.

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Mark-up pages 3-3

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SECTiON NO. 3 I en3((NIONELECTRIC 5 CALLAWAY NUCLEAR PLANT nevisiONt is OPERATING QUALITYASSURANCE MANUAL i)ATEt it/95 3.20 The ORC and NSRB shall review design changes pursuant to the requirements of OQAM, Section 1.0 3.20.1 Design changes which require an amendment of the license, shall be submitted on an application to the Nuclear Regulatory Commission for approval in accordance with 10CFR50.90.

3.21 Procedures and instructions related to equipment or systems that are modified shall be reviewed and updated in accordance with Appendix A to this OQAM (Regulatory Guide 1.33, Section 5.2.15 of ANSI N18.7), to renect 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 revisions, or specific training in the operation of modined equipment or systems, or other appropriate means.

(CTSN 1911,2164) 3.22 Records shall be maintained which renect current design including safety analyses, safety evaluations, design change installation procedures, material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings. (CTSN 2039,2132, M64,2173) g 3.23 Drawings shall be prepared under a drawing controi system which provides for checking methods and review and approval requirements. Drawings shall be subject to reviews by the responsible design organization for correctness, conformance to design criteria, and compliance with applicable codes and standards.

MarA-up pages 3-4

MUnionELECTRIC CALLAWAY NUCLEAR PLANT N

OPERATING QUALITYASSURANCE MANUAL DATE: 11l95

4. PROCUREMENT DOCUMENT CONTROL 4.1 Safety-related procurements shall be documented. Procurement document control applies to documents employed to obtain safety-related materials, parts, components, and services required to support Plant activities.

Written procedures establish requirements and assign responsibility for measures to assure applicable regulatory requirements, design bases, and other requirements necessary to assure quality are included in procurement documents. (CTSN 679,975,1876,1887, I875,3541,3548) 4.2 Written procedures shall include controls, as applicable, for preparation, content, review, approval, and processing of the following related procurement documents: (CTSN 3559)

1. Purchase Requisitions
2. Purchase Orders
3. Letters ofIntent
4. Engineering Service Agreements (agreements for engineering, construction, or consultant services)

(ESAs)

5. Contracts
6. SpeciGcations
7. Drawings Collectively, these procedures shall assure that 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 requirements.

(CTSN 3560) 4.3 Consideration of the verification activities to be employed for item or service acceptance should begin during the purchase requisition, ESA, or contract preparation and review stage. Planning of verincation activities shall include a review of the established acceptance criteria and identiGed documentation. VeriGcation methods w hich may be employed include certifications (certificates of conformance and material certificates or test reports), source veriGcation, receiving inspection, and post-installation tests established by UE. Selected verification methods may be indicated as inspections, examinations, tests, or documentation reviews. The extent of the acceptance methods and associated veriGcation activities is a function of the purchased item's or service's complexity and relative safety significance, as well as the supplier's past performance. (CTSN 3572, 3580,3582,3584,3607,3874) 4.4 Acceptance by source verification should be considered when the item or service is vital to Plant safety; or the quality chara teristics are difGcult to verify after receipt; or the item or service is complex in design, manufacture, inspection 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 (CTSN I892,3572,3582,3584) 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, construction, 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, component <, and services and ESAs for professional services may be initiated by personnel in the Quality Assurance Depar. ment; Nudear Engineering, Nuclear Services, or Licensing and Fuels Department; or the unit staff. (CTSN 1815)

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EEUnionELECTRIC CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL le [

DATE: 11/95 4.6 The procurement of spare or replacement parts for safety-related structures, systems, and components shall be subject to the QA Program controls in effect at the time the order is issued; and to codes, standards, and technical requirements w hich are equal to or better than the original requirements or as may be required to reduce the probability for repetition of defects. Procurement document control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifications and codes equivalent to those specified originally 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, codes, and standards. (CTSN 975, I876) 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 afTect 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 unclear if an individual piece (part of a safety-related structure, system, component or service) is governed by the OQAP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering and shall classify the safety relationship of the service or questionable component, parts or items of safety-related structures, systems, and components. Evaluations shall be documented for future reference. (CTSN 1876) 4.8 Provisions for the following shall be included in procurement documents as applicable. These provisions may be addressed by invoking a supplier's approved quality program in the procurement document.

1. The scope of work and basic administrative and technical requirements including drawings, specifications, regulations, special instructions, and applicable codes and industrial standards and procedural requirements identified by titles and revision levels. Procurement documents shall also include special process instructions; identification ofinspection, test and acceptance requirements; and any special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, packaging, handling, shipping, and storing. (CTSN 1864,1890,2416,3550,3551,3552)
2. Requirement that the supplier have an acceptable Qua!ity Assurance Program which implements the appropriate sections and elements of ANSI N45.2-1977 or the ASME 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 supplier's standard or proven design to meet published product descriptions.

(CTSN I888, !890,3542,3550,3553,42668)

3. Requirements for supplier surveillance, audit, and inspection including provisions for UE or agent access to facilities and records and for identification of witness and hold points. (CTSN 1890,3550, 3555,3573,35f2,3867,3874)
4. Requirements f , extending applicable requirements of UE procurement documents to lower-tier suppliers and suecontractors. These requirements shall include right-of-access to subsupplier facilities and records by UE. (CTSN 1890,3542,3550,3554,3555)
5. Requirements for suppliers to obtain UE approval of nonconformances to procurement document .

requirements dispositioned "use-as-is" and " repair" and conditions of their disposition including l

identification of those subject to UE approval prior to further processing. (CTSN 3550,3558,3597) l

6. Applicability of 10 CFR 21 reporting requirements. (CTSN 3484) i i

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EEUNIONEtscmc CALLAWAY NUCLEAR PLANT

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  • OPERATING QUALITYASSURANCEMANUAL DATE: 1ll95
7. Documentation requirements including records to be prepared, maintained, submitted for approval, or made available for review, such as, drawings, specifications, procedures, procurement documents, inspection and test records, personnel and procedural qualifications, chemical and physical test results, and instructions for the retention, transfer, and disposition of records. (CTSN 1890,2132,3550,3556, 3574)
8. Requirements that the supplier furnish documentation which identifies the purchased item and provides traceability to the procurement requirements met by the item and documentation identifying any procurement requirements which have not been met.

4.9 The originating organization shall perform a documented independent review of procurement documents 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 procuremeni documents.

(CTSN 3559,3560,3562,3563) 4.10 Bids or proposals shall be evaluated by the Purchasing Department, the originating organization, the Quality Assurance Department, and the Licensing and Fuels Department to assure conformance to procurement document requirements in the following areas as applicable to the type of procurement as described below:

(CTSN 3563,3564,3567,3568,3569)

1. Technical considerations
2. Quality Assurance requirements
3. Research and development effort
4. Suppliers' personnel qualifications
5. Suppliers' production capebility
6. Suppliers' past performance
7. Alternates
8. Exceptions 4.10.1 The Purchasing Department shall initiate and coordinate bid evaluation activities for those proposals received in response to requisitions. The Purchasing Department shall review bids or proposals, except those associated with ESAs or nuclear fuel cycle relatea goods or services, for attemates or exceptions to procurement documeid requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented. (CTSN 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. (CTSN 3560) 4.10.3 The Quality Assurance 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.

(CTSN 3560) 4.10.4 The Licensing & Fuels Depanment shall evaluate bids or proposals for fuel cycle goods or services in the above areas. (CTSN 3560)

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MUwoNELECTRIC CALLAWAY NUCLEAR PLANT o

OPERA TING QUALITYASSURANCE MANUAL DATE: 11l95 4.11 Bids or proposals with alternates or exceptions identified in Section 4.10 by the Purchasing Department shall also be evaluated by the originating organization to provide additional assurance that no unacceptable conditions result from such changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award. (CTSN 3560,3561,3567,3568,3570) 4.12 Letters ofintent may be utilized with suppliers of materials, parts, components, and services 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 ofintent 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, llowever in the event a letter ofintent 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 organization.

4.13 The Purchasing Department is responsible for reviewing purchase orders to verify that the technical and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisition, letter ofintent, ESA, or contract shall be by an individual who has approval authority and signifies that the technical and quality review of the document 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 negotiation by the Licensing and Fuels Department. Nuclear fuel cycle-related contracts and ESAs for professional services shall be executed by the F: ' "i= P=ide" N=!:ac Vice President and Chic /Nuc/ car Officer or another company officer in accordance with Nuclear Division and corporate procedures related to agreements or contracts for services. (CTSN 3563) 4.14 Additions, modifications, exceptions, and other changes to procurement document quality and technical requirements shall require a review equivalent to that of the original document and approval by the origine or the originating department approval authority. Commercial consideration changes shall not require review and concurrence by the originator. Conditions specified on the Qualified Suppliers List (QSL) that apply to a vendor may be revised without concurrence from the originating organization since they are imposed without the knowledge of the originator. (CTSN 975,3543,3548,3563,3575,42587)

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EENIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95

5. INSTRUCTIONS, PROCEDURES AND DRA%INGS 5.1 The activities affecting quality associated whh the onerating phase shall be accomplished and controlled by:

(CTSN 1830,1858,1867,1916,1948,2073,2074,2091,2974)

1. Preparing procedures, instructions, speci0 cations, drawings or checklists of a type appropriate 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. llaving responsible personnel apprce these documents prior to accomplishing an activity; and
4. Using approved drawings, procedures, instructions or checklists to accomplish an activity; The degree of control imposed shall be consistent with the relative importance of the activity to safety.

5.2 The Nuclear Division and other responsible functions and departments shall provide written procedures and drawings as required to support the Callaway Plant operating phase. These procedures shall prescribe those activities afTecting safety-related structures, systems, and components it is recognized that skills normally possessed by qualined personnel may not require detailed step-by-step delineations in written procedures.

(CTSN 1833,1830) 5.3 'he Manager, Callaway Plant shall be responsible for providing speci0c 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 procedures. Procedures which impleraent the Security Plan and Radiological Emergency Response Plan shall be reviewed no less frequently than every twelve months (in accordance with Technical Speci0 cations). A revision of a procedure may constitute a procedure review.

1 5.4 The approval, issue and control ofimplementing procedures, manuals and policy shall be prescribed in j Administrative Procedures consistent with the requirements of Sections 2,5 and 6.

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

l 5.6 Main:cnance and modification procedures shall be reviewed in accordance with Section 6.2. l 5.7 Special process procedures supplied by outside organizations shall be reviewed in accordance with Section 9.6.

1 5.8 in addition to the procedures identified in Table 13.5 t of the Callaway-SA FSAR (CALLAWAY PLANT l

ADMINISTRATIVE PROCEDURES), the OQAP : Gudes procedural coverage in the following areas: design control; design change control; preparation, review, approval, and revision of specincations, drawings, requisitions, Engineering Service Agreements, contracts and procedures (instructions); QA indoctrination and training; auditor training; supplier evaluations; receipt and transfer of records; document control; quality program audits; correctis e 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).

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MUurouELECTiUC CALLAWAY NUCLEAR PLANT

[e ,I OPERA TING QUALITYASSURANCE MANUAL DATE: 11195

6. DOCUMENT CONTROL 6.1 Documents and their revisions which control all activities afTecting safety-related structures, systems, and components shall be prepared, reviewed by knowledgeable individuals, and approved by authorized personnel prior to release or issuance in accordance with written approved procedures. (CTSN 1916,1908) 6.2 Divisions, departments, and organizations responsible for OQAP implementing documents shall be required to provide the necessary review and approval for instructions, procedures, specifications, and drawings. Reviews and approvals shall assure that issued documents are adequate, authorized, include proper quality and technical requirements, and are correct for intended use. Individuals or groups responsible for preparing, reviewing, and approving documents and revisions thereto shall be identified in written procedures. Specifically, the QA Department shall review Administrative Procedures as described in Section 2.6; QC personnel shall review maintenance and modi 0 cation procedures; ' and QC personnel are responsible for the preparation ofinspection procedures and'or checklists to support maintenance and modincation activities. Collectively, these reviews by the QA Department and QC personnel determine:(CTSN 1908,1916,1917,1262,4616)
1. The need for inspection, identification ofinspection personnel, and documentation ofinspection results; and
2. That the necessary inspection requirements, methods, and acceptance criteria have been identined.

6.3 Changes to documents shall be reviewed and approved by the same function, department, group, or organization that performed the original review and approval; however, UE may assume or delegate this responsibility. The reviewing organizations shall bve access to pertinent background information upon w hich to base their approval and shall have adequate understanding of requirements and intent of the original document.

() (CTSN 1908,1914,1915,2170) 6.4 Documents relating to the UE OQAP shall be controlled to an extent w hich considers the document type, its importance to safety, and the intended use of the document. The preparation, review, approval and revision of {

procedures, instructions and drawings shall adhere to the OQAP. l 1

6.5 The controls governing the issuance of documents shall provide for the availability of documents at the point of use prior to commencing an activity and the prompt transmittal of approved changes for incorporation into subsequent revisions. Measures shall be established to prevent the inadvertent use of superseded documents.

(CTSN 1828,1833,1908,1917) 6.6 Types of documents u hich shall be controlled include the FSAR, specincations, Operating Quality Assurance Manual, procurement doeurnents, procedures, design documents (e g., calculations, drawings, analyses) including documents related to computer codes, nonconformance reports, as-built drawings, the Callaway Plant Operating Manual, and topical reports.

' Work Requests (WRs) and preventive maintenance requests (PMRs) may contain instructions to workers. Ilowever, WRs and PMs are not considered " Maintenance procedures" which require QC review. When required, the assignment of inspection points for work authorizing documents is performed by Planning Department personnel based on established 1 criteria. I l

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SECTION NO. 6 7

ses3[JNIONELECTRIC 5 CALLAWAY NUCLEAR PLANT

><svisiOs.* is OPERATING QUALITYASSURANCEMANUAL I) ATE: 11195 6.7 The issuance of controlled documents at the General Office and Callaway Plant is coordinated by the Nuclear Services and the Administration organizations. The Administration organization shall be responsible for assuring the issuance of controlled documents at the Plant Site and to the Nuclear Services Department at the General Office. Nuclear Services shall be responsible for assuring the issuance of controlled documents at the General Office, and for transmittal of documents to the Administration organization for entry into the document l

I control system.

6.8 Document control methods shall be defined consistent with the importance of the document to safety. Selected documents shall receive a control number. A serialized distribution li;t shall identify selected document holders by name and control number. Acknowledgment of receipt of selected documents, incorporation of revisions, and destroying or voiding of superseded documents shah be required by the distributor in addition the distributing organization for documents controlled by a >ystem of control numbers shall periodically compose a master list of the documents showing the effective revision date of each.

6.9 Procedures shall specify the requirements for the processing and maintenance of records. Procedures shall also be established to control instructions, procedures, and drawings governed by the OQAP. These procedural controls shall provide for the prompt transmittal of document revisions to work locations and the removal, destruction, or voiding of obsolete / superseded documents. The unit staff and other UE organizations shall assure that current documents are distributed to and used at the location where the prescribed activity is performed. It is recognized that, in certain instances, activities are controlled via the communication of documented procedural instructions from a remote location,(i.e., separated from the location where the prescribed activity is being performed). Identified, controlled copies of documents shall be used to perform an i activity. Uncontrolled copies shall be identified (CTSN 1872,2132,2136,2164) I I

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ENINIONEtscmc CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11195 7 CONTROL OF PURCll ASED MATERI AL, EQUIPMENT AND SERVICES 7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4.

Provisions shall be established to control activities affecting quality associated with the procurement of material, equipment and r,cniem including:(CTSN I875,3541)

1. The preparation, review, and change control of procurement documents as described in Section 4
2. Lid evaluation and award as described in Section 4
3. Procurement source selections (CTSN 3565)
4. VeriGcation activities (surveillance, inspection, and audit) required by the purchaser
5. Control of nonconformances as described in section 15 (CTSN 3597,3576)
6. Corrective action as described in Section 16
7. Material, equipment, and service acceptance
8. Control of quality assurance records (CTSN 2416)
9. Audits of the procurement program as described in Section 18 7.2 UE shall assure that suppliers providing safety-related materials, equipment, or services are acceptable procurement sources. Provisions shall be made for supplier evaluations uhich assess their capabilities prior to award by: 1) source evaluation; or 2) review for objective evidence of quality ; or 3) a review of supplier history.

When evaluations are performed, the assessment of a supplier's capability shall be speciGc to the procured item, commodity, or service and the supplier's ability to provide the items or services in accordance with procurement document recerements. Suppliers of hardware and services which are manufactured prior to award, considered a commercial grade item, or implemented under the UE OQAP do not require pr:-award source evaluation or post-award audits which attest to their capability as a procurement source. (CTSN 1891,3564,3565,3596, 3874) 7.3 During Callaway's operating life, procurements may be made from: 1) suppliers judged capable (prior to award) of providing items or services in accordance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware l manufactured prior to award and whose acceptability can be determined by receiving inspection, an I examination of quality verification documentation, or other suitable means; 3) suppliers of commercial grade j items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) l' 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 l service being procured. Purchase orders may be issued prior to an assessment of suppliers' capability provided a l

prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work l when evaluated to be an acceptable procurement source. (CTSN 2337,2977,3564,3874) l MarA-np pages 7.l

l 5%NIONEtscnuc CALLAWAY NUCLEAR PLANT C M*

OPERA TING QUALITYASSURANCEMANUAL DATE: 11195 7.4 Code certified material may be obtained from an ASME accredited Material Manufacturer or Material Supplier for repair or replacement applications. Ilowever UE may also obtain Code certified materials from non-ASME accredited Material Manufactur:rs or Material Suppliers if such Manufacturers or Suppliers are otherwise qualified as stipulated in Sections 4 and 7 of the OQAM. These provision are consistent with ASME Code Interpretation XI-1-83-50R dated May 14,1985.

7.5 Procurement source evaluation and selection involves the Quality Assurance Department and the originating organization. The evaluation and selection process shall be specified in department procedures and may vary depending on the complexity and relative importance to safety of the i em or service. Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organizations may be requested to provide input to the qualification evaluations of suppliers. (CTSN 1891,1894.3564,3565) 7.6 Procurement source selection and evaluations shall consider one or more of the following:(CTSN 3565,3566, 3604)

1. Experience of users ofidentical 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 reficct recent capability. Previous favorable quality experience with suppliers may be an adequate basis forjudgments attesting to their capability. When an LCVIP report, an audit report, or an ASME C of A is used to establish a supplier's acceptability as a procurement source, the document shall be identi6ed. (CTSN 3564)
2. An evaluation of the supplier's current quality records supported by documented qualitative and quantitative information which can be objectively evaluated. This may include review and evaluation of the supplier's QA Program, Manual, and Procedures, as appropriate; and responses to questionnaires.
3. A source evaluation of the supplier's technical and quality capability as determined by a direct evaluation (audit or surveillance) cif facilities, personnel and Quality Assurance Program implementation. (CTSN 3564)
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 codes, and standards (not specinc to the nuclear industry), or other industry databases (UL, INPO NPRDS, EPRI EQDB, ANSI, NEM A, MIL-STDS, NRC Bulletins' Notices, and Licensee Event Reports, etc.) that is directly related to the item's critical characteristics and intended application.

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 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 acceptability as a procurement source (after the initial source evaluation) are described in Section 18.

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ei SECTION NO. 7 REVISION-* 18 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 11/95 7.8 Organizations participating in the procurement process shall prepare procedures to monitor and evaluate suppliers' performance to procurement document requirements. These procedures shall include provisions for:

1) controlling documents generated or processed during activities ful0lling 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. (CTSN 1892,3571) 7.9 Depenaling on the complexity or scope of the item or service, the Purchasing Department and/or the originating organization shall initiate award activities. Meetings or other forms of communication may be held to establish the intent of UE in monitoring and evaluating the supplier's performance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulnlling requirements. The depth and necessity of these activities shall be a function of the relative importance, quantity, uniqueness, complexity, frequency of transactions with the same supplier, and the supplier's past performance. UE hold and witness points shall be documented as early as practicable in the procurement process. (CTSN 3572,3573,3580) 7.10 The originating organization shall establish measures for monitoring supplier-generated document submittals against procurement document requirements. Similarly, measures shall be established for reviewing and approving supplier generated documents for use. Changes to procurement documents shall be in accordance with the controls described in Section 4. (CTSN 3571,3574) 7.11 Supplier monitoring activities may be performed by personnel from Quality Assurance, Nuclear Engineering, Nuclear Services, Emergency Preparedness and Organizational Support, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests. Supplier monitoring activities may include: (CTSN 3565,3584)
1. Audits of supplier quality assurance program implementation
2. Monitoring, witnessing, or observing inspections, examinations, and performance tests
3. Surveillance of manufacturing processes
4. Audits of supplier records to verify certification validity and the resolution of nonconformances 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. Departments 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 specifications, approved changes, and other related documents. (CTSN 2337) 7.13 Receiving inspection instructions shall be documented. These instructions include specifying inspectioris 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, tests, or documentation reviews may be employed to establish the items' acceptability. Documentation shall be generated as a result of UE receiving inspection activities. (CTSN 975,2337,2416) 7.14 Acceptance of items and services shall include one or more of the following: (CTSN 975,1891,1892,3608)
1. Written certifications
2. Sourr e verification *
3. Receiving inspection
4. Post installation test (in addition to one of the above) .

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EUuronELECNC CALLAWAY NUCLEAR PLANT

),"?h OPERA TING QUALITYASSURANCE MANUAL DATE: 11195 7.15 Commercial grade items shall rely on proven design 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:(CTSN 1892,3565,1876)

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 characteristics and the intended safety-related application; and
b. The manufacturer's measures for the control of design, process, and material changes have been adequately implemented as verined by audit (multi-licensee team audits are acceptable).

7.16 Where required by Code, regulation or contract requirement, documentary evidence that items conform to procurement documents shall be available during receiving inspection or prior to use of such items. Where not precluded by other requirements, documentary evidence may take the form of written certincates of conformance. When certi0 cates of conformance are employed as a means ofitem acceptance, verincation of the validity of supplier certiGcates and the effectiveness of the certification systems shall be conducted at intervals commensurate with the supplier's past quality performance. Certi0 cates of conformance and compliance shall be required to be signed or accompanied by a signed letter of transmittal. Where acceptance is based upon source verincation, documented evidence of these surveillances shall be fumished to the plant Quality Control organization by the responsible UE organization or their designated agent prior to acceptance.

(CTSN 1891, I893,3603,3605,3607) 7.17 Acceptance by receiving inspection shall be utilized as a prime method of veri 0 cation and may be utilized as the sole means ofitem 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 w hen inspections do not require operations which could adversely affect the integrity, function, or cleanliness of the item. When other methods are utilized, receiving inspection shall be employed to verify that items have not sustained damage.

(CTSN 1876,3606) 7.18 Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 - 1978,(as clarined in OQAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization. Other unit staff personnel qualiGed to ANS 3.1 - 1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt inspec tion of radioactive material, bulk chemicals and diesel fuel. During outages, extensive modi 0 cations, or other special circumstances, receiving inspection may be assigned to an outside organization (s). (CTSN 2483) 7.19 Final acceptance ofitems shall be by Quality Control personnel or designated inspection personnel. The Gnal acceptance of services shall be the responsibility of the originating organization. Acceptance shall be documented. (CTSN 2337) 7.20 Receiving inspection activities shall include: (CTSN 975,2337)

1. Verifying that materials, parts, and components, have been identined by tagging or other means; or that they are segregated and controlled in areas separate from the storage facilities for accepted items.

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$3NONELECHUC CALLAWAY NUCLEAR PLANT

[) 7 ik OPERATING QUALITYASSURANCEMANUAL 1) ATE: 11/95

2. Verifying that items for acceptance have been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documentation.
3. Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures and calibrated tools, gages and measuring equipment to verify the acceptability ofitems, including those from commercial grade suppliers.
4. Providing final acceptance after determining that required verifications are complete and acceptable.

Items determined to be acceptable for use shall be tagged with an accept tag or other means of identification or segregation, and released for storage or use. Conditional acceptance ofitems by receiving inspection shall be procedurally controlled. (CTSN 2326,2329,2328)

5. Verifying that received iterns which do not conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15. (CTSN 2327) 7.21 Acceptance by post-installation test may be utilized following one of the preceding acceptance methods.

Post installation testing shall be used as the prime means of acceptance verification when it is difficult to verify item quality characteristics; 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 documentation shall be established by UE. (CTSN 3608)

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$NINIONELECTRIC CALLAWAY NUCLEAR PLANT

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OPERATING QUALITYASSURANCEMANUAL DATE: 11/95

8. IDENTIFICATION AND CONTROL OF MATERI ALS, PARTS AND COMPONENTS 8.1 The identification and control of materials, parts, and components shall be accomplished in accordance with documented procedures and apply to safety-related materials, parts, and components during fabrication, storage, installation or use. Materials, parts, and components identiGed as nonconforming shall be controlled as described in Section 15. (CTSN 975) 8.2 The identification and control requirements shall address traceability to associated documents, as appropriate; specification of the degree ofidentification and control necessary; location and method ofidentification to preclude a degradation of the item's functional capability or quality; ed pre L*rtification of materials, parts, and components prior to release for manufacturing, shipping, construction, or installation. Materials, r, arts, and components manufactured or modified by UE shall be controlled and identified during manefact"'*

(CTSN 1897,2089,2090,2093,2333,2337) 8.3 Documented procedures shall assure that specifications and other procurement documents include or reference appropriate requirements for the identification and control of materials, parts, and components including partially fabricated assemblies. 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 asstre that correct identifications are verified and documented prior to release. (CTSN 1876,2088) 8.4 Physical identification shall be employed to the maximum possible extent for relating an item at any poir.t in time to applicable design or other pertinent specifying documents including drawings, specifications, purchase orders, manufacturing and inspection documents, nonconfonnance reports, and physical and chemical mill test reports. Physical identification or marking shall not afTect the form, fit, or function of the item being identified.

Where physical identification is not employed, physical separation, procedural control, tags, or other means shall be utilized. Identification shall be maintained on items, or records traceable to items through fabrication, erection, 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 the items, and displayed in an area that is readily accessible. (CTSN 1895,1896,2318,2331,2333,2337,2346) 8.5 Changing or correcting any marking on a code stamp name plate is prohibited, unless authorized by the manufacturer whose serial number is applied. (CTSN 2336) 8.6 in the event the identincation or tracer cility of an item is lost, it shall be handled as nonconforming in accordance with Section 15, if the di, position is other than to scrap or to retain for non-safety related applications. (CTSN 1895)

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EENIONELECTRIC CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL 1) ATE: 11195

9. CONTROL OF SPECIAL PROCESSES 9.1 Special processes are fabrications, tests, and final preparation pr9 cesses which require in-process 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 committed. Special processes include such activities as welding, heat treating, nondestructive examination, the application of specialized coatings, and chemical cleaning. For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established Codes or standards; the necessary qualifications of personnel, procedures, or equipment shall be defined by Nuclear Engineering. (CTSN 1851,1937,2098) 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. QA audits shall be performed to assure special processes are performed by qualified and certified personnel. Nondestructive examination (NDE) personnel shall be qualified in accordance with procedures established to meet the requirements of the Code Edition and Addenda to which UE is committed at the time the NDE is performed. When non-code NDE is performed, persornel shall be qualified to the version of SNT TC-I A used to meet UE's current commitment to the ASME B&PV Code.

9A 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.

9.5 Planning for maintenance shall include evaluation of the use of special processes, equipment and materials in perfonnance of the task, including assessment of potential hazards to personnel and equipment. (CTSN 1857) 9.6 Qualified outside organizations may be employed to perform special processes onsite and shall be required to conform to the requirements described herein. Special process procedures submitted by these organization (s) in accordance with the procurement document requirements shall receive a technical review by the responsible engineering organization and a quality review by the Quality Assurance Department.

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ae - SECTION NO.10 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 11195

10. INSPECTION 10.1 A program for the inspection of safety-related activities shall be established and executed to verify conformance with appicable dccumented instructions, procedures, drawings, and specifications. Inspections and monitoring of processes which serve an inspection function shall be performed by personnel qualined to perform assigned tasks and who are independent ofindividuals who perform the activity. (CTSN 1851,1926,1927,2094,2095, 2974,42430,42431) 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.

10.3 Inspection of activities at the Callaway Plant 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 subsequent monitoring planning.

(CTSN 1850,1937) 10.4 Nuclear Engineering shall be responsible for assuring the development of preservice and . inservice (PSI /ISI) inspection programs; the reference PSI /ISI examination plans for ASME Code Class I,2, and 3 systems and components including steam generator eddy current examination; the NDE procedures required by ihe reference plans; and the initial updating of the reference plans and procedures 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.

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

In addition Nuclear Engineering shall be responsible for administering 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 PSl/ISI

@) examinations. (CTSN 2049) 10.6 An inspection personnel qualification program shall be established to assure inspection activities are being performed by personnel trained and qualified to a capability necessary for performance of the activity. Plant procedures shall prescribe the qualification requirements ofinspection personnel. The Superintendent, Training shall be responsible for providing related technical and quality training appropriate to the certincation'quali0 cation of UE personnel. (CTSN 2483,2484,2485) 10.7 Quality Control inspection personnel or other unit staff organizations who perform " inspection" activities shall be qualined within their respective areas of responsibility. The qualification of QC inspection personnel shall be defined in three levels of capability as described in ANSI N45.2.6. Other members of the unit staff performing " inspection" activities shall has e appropriate experience, training, and retraining to assure competence in accordance with ANSI /ANS-3.1. Inspection assignments shah be consistent with the quali0 cation 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. (CTSN 1851,2079,2263,2479,2480,2481,2482,2483,2484,2485,2994)

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t MNIONELECTRIC CALLAWAY NUCLEAR PLANT

  • , j CPERATING QUALITY ASSURANCE MANUAL I) ATE: 11/95 10.8 Personnel from outside organizations performing QC inspection activities associated with safety-related items at the Callaway Plant shall be certiGed as required by ANSI N45.2.6. (CTSN 2079,2097,2263,2480,2482, 2483,2484,2485,2994) 10.8.1 Personnel from outside organizations or UE personnel who are not members of the unit staff selected to perform other activities associated with safety-related items at the Callaway Plant shall meet one or more of the following for the activities which they are performing:

e be certified as required by ANSI N45.2.6, e meet the education and experience requirements applicable to the position, a be qualiGed through UEs " systematic approach to training",

e be qualified through a vendor's training and qualification program, which has been approved by UE.

10.9 When contractors or vendors ar : .iained to perform work activities or to provide services associated with safety-related items at the Callaway Plant, the qualification ofinspection personnel and the conduct of inspections associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procurement documents. As an example, if a vendor was contracted to conduct eddy current examinations of the Callaway lantp steam generators, then the persons performing the examination would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurernrnt documents. (CTSN 2482,2484,2485) 10.10 Procedures which specify inspection activities shall provide for the following, as required: 1) the inclusion of independent inspection or monitoring of processes when required; 2) the identi6 cation ofinspection personnel;

3) the documentation ofinspection results; 4) a description of the method ofinspection including any mandatory hold points; 5) the identification of the characteristics and activities to be inspected; 6) the acceptance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from drawings, instructions, speci0 cations, codes, standards, or regulatory requirements. (CTSN I930,1931,1935,2073,2075) 10.11 The inspection function shall be conducted in accordance with written approved procedures w hich specify inspection scope; personnel qualification requirements; and data collection requirements. Inspection or testing.

as appropriate, shall be employed as a means of verifying suitable perfonnance subsequent to a component replacement or repair. (CTSN 1928,1929,1973,2039,2979) 10.12 instructions, procedures, and supporting documentation shall be provided to inspection personnel for use prior to performing irispection activities. Inspection results shall be documented. Procedures shall prescribe the review and approval authority for inspection results. (CTSN 1935,1936) F 10.13 Indirect control by monitoring processing methods, equipment, and personnel shell be utilized as a control if  ;

inspection of processed items is impossible or disadvantageous. Iloth inspection and monitoring of processes shall be provided when control is inadequate without both. (CTSN 1932) 10.14 Inspection data shall be analyzed and evaluated to verify completeness of resuhs, achievement ofinspection objectives, and operational pro 6ciency 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 ofitems performed subsequent to final inspection shall require reinspection or retest to verify acceptability. (CTSN 1934,1973, 2125,2262,42479)

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OPERATING QUALITYASSURANCEMANUAL DATE: 11/95

11. TEST CONTROL 11.1 Testing programs shall be established to demonstrate that safety-related structures, systems, and components will perform satisfactorily in service. Testing programs include such tests as initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those associated with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or components function in accordance with predetermined specifications. (CTSN 1850,1934,2052,3577,2974, 42430,42431) 11.2 Provisions shall be established for the performance of surveillance testing to assure that the necessary quality of systems and components is maintained, 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 Plant Technical Specifications. The provisions for surveillance testing shall include the preparation of a surveillance testing schedule (s) which reflects the status of in-plant surveillance tests. Qualified personnel shall perform surveillance tests. (CTSN 1853,1865)

I 1.3 Appropriate tests shall also be performed subsequent to Plant modifications, maintenance or significant operating procedure changes to confirm expected results. Tests provide a level of confidence in structure, system or component operation or functional acceptability. (CTSN 1851,2053)

I 1.4 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 accordance with Section 7. (CTSN 3577) 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 equipment and similar components shall be reviewed and evaluated to determine whether a like kind replacement component can be expected to perform its function reliably.

I 1.6 Testing shall be performed in accordance with written procedures which incorporate or reference the requirements and acceptance limits contained in applicable Callaway Plant Technical Specifications, drawings, instructions, procurement documents, specifications, codes, standards, and regulatory requirements.

(CTSN 1938. 2055,2056) 11.7 Administrative procedures, test procedures, or checklists shall include: provisions for assuring all prerequisite conditions are met; test equipment calibration requirements; testing method instructions including hold or witness points; limiting conditions and acceptance / rejection criteria; and data collection and test result approval requirements. (CTSN 1930,1938,2075,2132)

I1.8 Test data shall be analyzed and evaluated by qualified individuals or groups to s erify completeness of results, achievement of test objectives, and 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 resuhs 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. (CTSN 1848,1934,1973,2075,2125,42479) 11.9 Review and approval of tes'ts and experirnents not described in the FSAR shall be conducted as specified in the Callaw ay Plant Technical Specifications and 10 CFR 50.59.

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$NINIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 11/95 11.10 A program shall be established to assure testing activities are performed by personnel trained and qualified to a capability necessary for performance of the activity. Plant procedures and procurement documents shall prescribe r:te qualification requirements for testing personnel. Provisions may be made for on-the-job training ofindividuals not qualified to the program provided they are supervised 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. (CTSN 2039,2481,2482,2483,2484,2485) 11.11 Personnel within the various UE organizations may perform testing activities including implementing test procedures and the evaluation and reporting of test results. The assignment of Plant testing personnel shall be

@l under the direction and control of the Vice President-Ne<4wepwanens and ChiefNuclear Officer. The qualification of QC testing personnel shall be defined in three levels of capability as described in ANSI N45.2.6.

Other members of the unit staff performing " testing" activiti'es shall have appropriate experience, training, and retraining to assure competence in accordance with ANSI /ANS-3.I. Testing assignments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC testing 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. (CTSN 2263,2479,2480,2482,2483,2484,2485)

I1.12 Personnel from outside organizations or UE personnel who are not members of the unit staff selected to perform other testing activities associated with safety-related items at the Callaway Plant shall meet one or more of the followmg for the activities which they are performing:(CTSN 2263,2480,2482,2483,2484,2485) e be certified as required by ANSI N45.2.6, e meet the education and experience requirements applicable to the position, e be qualified through UEs " systematic approach to training,"

e be qualified through a vendor's training and qualification program, w hich has been approved by UE.

Il.13 When contractors or vendors are retained to perform work activities or to provide services associated with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct of tests associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway Plant, then the persons perfbrming the testing / valve settings would be qualified as required by the vendor's quality assurance program unless otherw ise specified in the applicable procurement documents. (CTSN 2483,2484,2485)

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ei SECTION NO.12 REVISION *- 18 '

CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11195 l 12, CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 Measuring and test equipment utilized in activities affecting quality shall be controlled in accordance with  ;

written procedures or instructions. The procedures for calibration and control shall address the identification of j test equipment, calibration techniques, calibration frequencies, maintenance control, and storage requirements, i l

The equipment subject to these controls includes: (1) M&TE (portable measuring instruments, test equipmenti I

tools, gages, and non-destructive test equipment 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). (CTSN 1919,1920,1969,2042,2081,2083,2264) 12.2 Tools, instruments, testing equipment and mesuring devices used for measurements, tests, and calibration shall be of the proper range and type; and shall be controlled, calibrated, adjusted and maintained at specified intervals or prior to use to assure the necessary accuracy of calibrated devices. M&TE and reference standards shall be tagged or labeled indicating the date of calibration and the due date for recalibration. (CTSN 1920, I851, 2295,20w34,2060,2080) 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, reference standards, and P1 maintain their required accuracy. The Manager, Callaway Plant is responsible for assuring the program establishment. Program implementation is the responsibility of the appropriate Department Heads.

12.5 M&TE, reference standards, and PI shall be utilized by various organizations as required to perform tests or other special operations. Each organization shall be responsible for assuring that the M&TE or reference standards it uses have been calibrated. Outside organizations using M&TE or reference 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 ofitem 8 and 9 of OQAM Section 12.6 unless specified in procurement documents. Vendor-provided calibration services for Callaway Plant M&TE or Pi are required to be consistent with the requirements ofitem 8 and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using MATE or reference standards at the Callaway Plant in activities affecting quality shall be required to implement 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. (CTSN 1920,2084) 12.6 The calibration and control program shall provide for: (CTSN 2082)

1. The assignment of specific calibration intervals, calibration procedures w hich 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 w hich may affect calibration. Records shall be maintained to permit a determination of calibration intervals. A calibration shall be performed w hen the accuracy is suspect. (CTSN 1923)
2. The unique identification ofitems.
3. The traceability to calibration test data.
4. The traceability of reference standards and thereby M&TE and PI, to nationally recognized standards and the periodic res alidation of reference standards.

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,,,2UurouELECTRIC s itsvisiONt is CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL pg3g: 11795

5. The maintenance of records which indicate the status of each item, maintenance history, calibration 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 ofitems not in 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.
8. M&TE shall be calibrated from reference standards with an accuracy ratio of at least four-to-one (Reference standard to M&TE). Calibration accuracy ratios of less than 4.0 but equal to or better than 1.0 (Reference standard to M&TE) shall be acceptable w hen equipment to meet specided 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 maintained to achieve its specined 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 ofless than 2.0 but equal to or better than 1.0 shall be acceptable when equipment t a meet specified requirements is not commercially available. The basis of acceptance in these cases shall be documented.

12.7 Calibration shall be performed against certiDed equipment or reference standards having known relationships 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.

12.8 M&TE and reference standards found to be out of calibration shall require an investigation to evaluate the validity of previous measuring, test, inspection, and calibration results and the acceptability ofimpacted 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. (CTSN 2044)

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l eei SECTION NO.13  !

REVISION-* 18 CALLAWAY NUCLEAR PLANT l OPERA TING QUALITYASSURANCEMANUAL DATE: 11195

13. IIANDLING, STORAGE, AND SillPPING 13.1 Safety-related items including safety-related parts of structures, systems, and components and related consumables shall be handled, stored, shipped, cleaned, and preserved in accordance with procedures, instructions or drawings, to assure that the quality ofitems is preserved from fabrication until incorporation in the Callaway Plant. The procedures shall also establish responsibilities for determining applicable requirements for packaging, shipping, receiving, storage, and handling activities. (CTSN 975,2093,2293,2417) 13.2 Generic procedures or instructions shall be prepared for application to these activities; however, detailed procedures or instructions shall be prepared for the handling, cleaning, storing, maintaining while stored, or shipping of certain items and types of equipment or material. (CTSN 2293,2349,2416,41668) 13.3 Applicable manufacturer instructions and recommendations, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review. Deviations which relax manufacturer's recommendations shall involve an engineermg evaluation. This may be appropriate when unrealistic requirements are recommended and such recommendations are not reasonably necessary to preclude equipment degradation. (CTSN 2354,2l05) 13.4 The requirements for activities described in this Section shall be divided into levels with respect to protective measures to prevent damage, deterioration, or contamination ofitems. 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 specinc environmental, special measures or other conditions applicable to each level shall be described in implementing procedures. (CTSN 2416) ,

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. Routine inspections shall determine the acceptability of equipment and rigging. Routine inspections shall be 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 quali6ed.

13.6 Procedures shall be prepared for items that require special handling and shall be available prior to the time items are to be handled. Items not specifically 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 alterations. 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. (CTSN 2325,2356,2416,2984) 13.7 Procurement documents or procedures shall address packaging requirements which afford protection from the possible degradation of quality during shipping, handling, or storing. The packaging protection speciGed may vary in degree consistent with the item's protection classification. Similarly, the mode of transportation employed shall be consistent with the protection classification ofitems. (CTSN 2416,2304) 13.8 Measures shall also be established to control the shipping oflicensed radioactis e materials in accordance with 10 CFR 71. l l

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SECTION NO.13

,,,E.INIONELECTRIC 5 CALLAWAY NUCLEAR PLANT 11cyisios, ,,

OPERA TING QUALITYASSURANCE MANUAL I) ATE: 11/95 13.9 Procedures shall provide instructions for the storage of materials and equipment to minimize the 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 ofitems. The various levels of storage shall correspond to prescribed environmental conditions which are procedurally defined. (CTSN 234),2981,2984)

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SECTION NO.14

$EINIONEtscrarc CALLAWAY NUCLEAR PLANT

,Ev, ,eN, ,,

OPERA TING QUALITYASSURANCEMANUAL DATE: 11195

14. INSPECTION, TEST AND OPERATING STATUS I 4.1 Safety-related items that are received, stored or installed at the Callaway Plant shall be identified and controlled in accordance with documented procedures.

14.2 Items received at or installed in the Plant shall be identified in accordance with procedures as to their status regarding required inspections and tests before the items are stored, issued or operated. Prior to storage or installation, items shall be identified by means of stamps, tags, labels, routing cards, segregation, or other means traceable to manufacturers' and receiving inspection documentation. In the event traceability is not available, the item (s) shall be considered nonconforming and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications. (CTSN 1847,2116,2331) 14.3 Plant procedures shall provide instructions relating to the manner ofindicating the operational status of safety-related structures, systems, and components, including temporary modifications, and shall require independent verifications, where appropriate, to assure necessary measures, such as tagging equipment, have been implemented 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 unauthorized operation of equipment. Equipment and systems in a controlled status to prevent unauthorized operation, shall be identified. (CTSN 1841,1842,1844) 14.4 Plant procedures shall establish controls to identify the status ofinspection and test activities associated with maintence, repair, modification, refueling, inservice inspection, and instrumentation and control system calibrai.; nd 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 modifications. (CTSN 972,1844,1846,1847,1851) 14.5 Required safety-related inspections, tests, and operations and their sequencing are performed in accordance whh Plant operating procedures which are reviewed and approved in accordance with the 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) w hich are allowed by the Technical Specifications and w hich are administratively controlled, any deviations from procedural requirements shall be subject to the original or equivalent review and approval controls. (CTSN 1848) l 1

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SECTION NO' 15 P3UuronELECTRIC CALLAWAY NUCLEAR PLANT imy,siONt is OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 l l

15. NONCONFORMING MATERI AL, PARTS, OR COMPONENTS 15.1 Material nonconformances include material denciencies (including inoperative and malfunctioning structures, systems, and components). Material nonconformances identified under the UE OQAP shall be controlled to prevent the inadvenent use of material, parts, or components which are defective or ofindeterminate quality and <

to identify documentation inadequacies. Measures shall be established regarding identification, documentation, I

@l status control, disposition, and notification of affected organizations. (CTSN 1848,1861,1862,1870,1907, 2045,2112) 1 15.2 Under the UE OQAP, Nonconforming Material Reports (NMRs), nonconformance logs, or other administrative controls shall be employed to identify and control nonconformances. Nonconformance logs may be employed to control deficiencies of a minor nature or to control documentation denciencies 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 ofidentifying corrective action to be taken for a nonconforming item or series of nonconforming items. Until suitable 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. (CTSN 1848,1876,1903,1907,2328,2334,3600) 15.3 Plant and other UE organization's procedures shall prescribe measures for the control and disposition of UE purchased items and services identified by outside organizations as nonconforming. Procurement documents shall specify those nonconformances to be submitted to UE for approval of the recommended disposition. As speci0ed in procurement documents, actions taken in response to these nonconformances shall be documented and forwarded to UE along with the hardware and accompanying quality veriGcation documentation. Nuclear Engineering shall be responsible for assuring the processing of supplier- recommended dispositions for Plant-initiated procurements. Similarly, other UE or outside organizations shall approve or be requested to provide a technical evaluation regarding supplier-recommended dispositions of nonconformances regarding procurements they initiate. (CTSN 1906,3558,3598,3599,3600) 15.4 Material nonconformances shall be processed in accordance with documented procedures and shall identify the specincs 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 individuals or groups assigned the responsibility and authority to approve and verify the implementation of the disposition of material nonconformance. (CTSN 1904,1905,1907) 15.5 Material nonconformar.ce disposition categories shall include: (CTSN 1907,2334)

1. "Use-as-is" or " acceptable"(including conditional releases)
2. " Reject" or "no: scceptable, scrap, or return to sendor"
3. " Rework"in accordance with approved procedures
4. " Repair"in accordance with approved procedures Material nonconformances shall be reviewed and eccepted, rejected, repaired, reworked, or conditionally released in accordance with documented procedures. An approved disposition of a nonconformance which allows a reduction in the requirements of a safety-related structure, system, or component, shall be treated as a design change subject to the controls prescribed in Section 3.

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..i SECTION NO.15 l REVISION: 18  !

CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 15.6 Nuclear Engineering shall be responsible for approving material nonconformance dispositions of"use-as-is" and

" repair". Licensing and Fuels shall be responsible for approving material nonconformance dispositions of "use-as-is" and " repair" on nuclear fuel which are generated prior to the arrival of such fuel at 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-oft. (CTSN 1848,1905, 1907,2335) 15.7 Nonconformance documents which record defects in basic components shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Significant nonconforming conditions involving a defect or material noncompliance in a receipt accepted component or a service which has commenced which could create a substantial safety hazard shall be reported to the Nuclear Regulatory g Commission pursuant to the requirements of 10CFR21. (CTSN 1862) 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. (CTSN 1906) 15.9 Repaired and reworked items shall be reinspected or tested. Measures may be established to conditionally release nonconforming items whose disposition is pending, provided that an evaluation indicates that further work or activity will not contribute adversely to the material ronconformance or preclude identification and correction. (CTSN 1848,1904,1906,2053,2328,2332) 15.10 Material nonconformance summaries shall be prepared and analyzed for potential adverse quality trends Q) l semiannually in accordmcc with Section 16. -by t!': " acer, Nu:!:r Eng:re ng. '"': Oua!!!) ?' :: ase Dgwtn . : sh '! pehen ndepenJ:nwe . ef!he: na!) e::nd repM !he:: u!::: neg at j thr ugh 1 'neaud:" .' :.ur e:"~n: - l l

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esi SECTION NO.16 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL I) ATE: 11/95 1

16. CORRECTIVE ACTION l 16.1 Measures shall be established to assure that conditions adverse to quality are promptly identified, reported, and corrected. Such measures shall be established in a program or programs which are proceduralized. These

@ procedures, as a minimum, shall: (CTSN 1870,1871,1903,2970, 2973, 2978,3599,3600, 42214)

1. Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.
2. Define responsibility for verifying that remedial action was taken for conditions adverse to quality.
3. Define responsibilities for determination of conditions adverse to quality which are significant.

Significant conditions adverse to quality will require both remedial action and action to prevent recurrence.

4 Define responsibility for performing root cause evaluation, determining necessary actions to prevent recurrence, implementing those actions and verifying completion of those actions for significant conditions adverse to quality.

5. Provide a method for documenting the identification of conditions adverse to quality. This documentation shall also include the root cause or causes and the action implemented to prevent recurrence for significant conditions adverse to quality.
6. Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct address, distribution of copies, electronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.
7. Provide methods for submitting reports required by external agencies concerning conditions adverse to quality.
8. Provide for developing and analyzing trends on at least a semiannual basis. Trending of conditions adverse to quality identified at suppliers' facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12. (CTSN 1800) 16.2 Conditions adverse to quality w hich are classified as nonconformances shall be controlled in accordance with the additional requirernents described in OQAM, Section 15.

16.3 Conditions adverse to quality w hich impede the implementation or reduce the efTectiveness of the Operating QA Program shall be considered significant conditions adverse to quality. Significant conditions adverse to quality may include, but are not limited to, noncompliance with procedural requirements which impact nuclear or personnel safety; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies identified in the OQAP; recurring conditions for which past corrective action has been ineffective; and managerial controls which could result in the failure of a plant system to perform it's intended function.

Examples of such conditions include those which match the descriptions in Sections 1.26.1.7.f, g, h, I, m (potential hazards to nuclear safety) of this OQAM and National Pollutant Discharge Elimination System (NPDES) violations.

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OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 16.4 Conditions adverse to quality which involve defects in basic components shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Reportable conditions adverse to quality are classified as signi6 cant.

16.5 The nature of the condition adverse to quality may be such that remedial actions must be taken immediately, whereas development and implementation of corrective action to preclude recurrence may take substantially longer, 16.6 Nuclear Engineering personnel shall review conditions adverse to quality which involve design deficiencies or which involve recommending design changes as corrective action. Licensing and Fuels should review conditions adverse to quality for fuel-related issues. The ORC shall review significant conditions adverse to g quality. (CTSN 1871, 217/, 2171) 16.7 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action.

The closure of corrective action documents shall be accomplished as promptly as practicable after the corrective action taken has been verined. Verification may be accomplished through direct observations, written (3) communications, re-audit, surveillances, or other appropriate means. (CTSN 3870) 16.8 Copies of completed corrective action documents shall be available for management review (hard copy or electronic media). The Quality Assurance Department shall periodically review corrective action documents and identify significant conditions. Summaries of signi6 cant conditions adverse to quality shall be submitted to the NSRIl and appropriate levels of management. (CTSN 1871) 16.9 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.

The results of these assessments shall be reported to management. (CTSN 1800) s MarA uppages 16 2

MUnionELECTRIC CALLAWAY NUCLEAR PLANT N

OPERATING QUALITYASSURANCEMANUAL DATE: 11/95

17. QUALITY ASSURANCE RECORDS 17.1 Quality assurance record systems goveming the collection, storage, and maintenance of records shall be established by UE. They shall apply to records associated with startup testing, operation, maintenance, repair, refueling, and modi 0 cation of safety-related structures, systems, and components at the Callaway Plant.

@ (CTSN 1851. 2126,2127,2130,2173, 3002) 17.2 During the operating phase, quality assurance records shall be maintained to furnish documentary evidence of the quality ofitems and activities affecting quality. Applicable design specifications, procurement documents, test procedures, operational procedures or other documents shall specify the quality assurance records to be generated by, supplied to, or held by UE. Documents 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 that a lifetime or Onite retention period shall be speciiled. Records shall provide sufucient information to permit identification to the item or activity to which it applies, and be retrievable.

(CTSN 1851,2128,2132,2133,2137,2138,2173) 17.3 Quality assurance records include, but are not limited to, operating logs; maintenance and modification procedures and inspection results; reportable occurrences; results of reviews; ORC meeting minutes; inspections, tests, audits and material analyses; qualification of personnel, procedures, and equipment; and other documentation including drawings, specifications, procurement documents, nonconformance documentation, corrective action documents, calibration procedures and results, and the results of monitoring work performance

@ (e.g., surveillance). (CTSN 2140, 2258, 2259, 2337,2364,3002, 40635) 17.4 Inspection and test records shall contain the following as a minimum:(CTSN 1936)

1. A description of the type of observation i
2. The date and results of the inspection or test

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3. Identification of the inspector or data recorder
4. Evaluation of the acceptability of the results
5. Action taken in connection with any deficiencies noted 17.5 Quality assurance records generated by others are transferred or made accessible to UE as systems and

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equipment or services are transferred or delivered from A/E's, NSSS suppliers, fuel fabricators, constructors, or others. Records maintained by an outside organization prior to and subsequent to final transfer are required to l be accessible to UE. Records generated internally shall be processed in a timely manner in accordance with l documented procedures.

17.6 Record systems shall be established by the Administration organization for the Nuclear Division and shall be controlled in accordance with wrmo, nrocedures. The implementing procedures shall address records '

administration; reecipt of records; storag. geservation and safekeeping of records; record retrieval; and the disposition of records. The Nuclear Services organization is responsible for assuring the handling and maintenance of quality assurance records ger,erated, 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. (CTSN 2129,2130,2136,2145) ,

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17.7 The requirements regarding hard-copy records administration shall require that quality assurance records be  !

listed in an index. The index shall be established prior to the receipt of records and shall indicate the location of I

@l records. Microfilm or opticaldnk 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

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supplementing of quality assurance records, and specifying the retention period of record types shall be delineated in written procedures. The retention period of records generated prior to commercial operation shall begin on ' December 19,1984; the date of commercial operation. (CTSN 2135,2149,2150) 17.8 'Ihe requirements regarding receipt of records shall define the requirements for the receipt of documentation generated by others during the operation of the Callaway Plant. These requirements shall assure that records are submitted and that designated authorities are responsible for organizing and implementing a system of records receipt control. The records' receipt control shall permit an assessment of the status of records during the receiving process. (CTSN 2145,2148) 17.9 The requirements regarding storage, preservation, and safekeeping of records shall establish storage requirements for the maintenance, preservation, and protection of quality assurance records. These requirements shall include methods for maintaining control of, access to, and accountability for records; storing records in a manner to preclude deterioration; and providing record storage facilities which protect contents from possible destruction by causes such as fire. An alternative to the establishment of a single record storage facility shall be the maintenance of a duplicate copy of records in a remote location. Where duplicate storage is employed, the storage environment need not be uniquely controlled in each storage area, but may be the prevailing building temperatore and humidity. (CTSN 2150,2151,2153,2155) 17.10 Record storage systems shall provide for an accurate retrieval ofinformation without undue delay. Those records maintained by an outside organization shall be required to be accessible to the buyer or UE; in the case of lifetime records for the life of the items involved, or for designated retention times for nonpermanent records.

(CTSN 2157) 17.11 Record disposition practices shall establish requirements for the transfer of records from others to UE. Upon final transfer, records shall be inventoried against any transmittal forms and processed in accordance with written procedures. Nonpermanent records shall be retained for the specified retention period; after the specified retention period they are no longer required to be maintained as records. (CTSN 2160)

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

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l. l SECTION NO.18 I seiENIONEucmc 5 CALLAWAY NUCLEAR PLANT

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1 OPERA TING QUALITYASSURANCEMANUAL 1) ATE: 11/95 l l

18, AUDITS 18.1 A comprehensive audit program shall be established and implemented by UE to verify internal and extemal l quality activities' compliance with the OQAP. The audit program shall assure that all applicable elements of the I

Program have been developed, documented, and are being effectively implemented and shall provide for the reporting and review of audit results by management. The audit system is described in manuals and procedures.

Nonconformances and program deficiencies shall be identified and corrective action shall be initiated and

@l verified. See Section 3.14 for a specific audit topic. (CTSN 2037,2186,2188,2978,2988,3865,3867,3883, 2180,3869,41639) 18.2 The UE audit system shall include the performance of audits and surveillances by the Quality Assurance (QA)

Department. Audits determine, through investigation, the adequacy of and adherence to established procedures, instructions, specifications, codes, and other applicable contractual and licensing requirements and the effectiveness ofimplementation. Surveillances involve the periodic or continuous moni:oring of the operation or performance of a supplier, item, component, or systern. 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 met (surveillance tests). QA 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 quali0 cations 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.

(CTSN I800,2037,2245) 18.3 The Manager, Quality Assurance shall establish a program which provides for the quali0 cation and training of QA Department audit and surveillance personnel. Audits shall be directed by an Audit Team Leader (ATL) who is a certined Lead Auditor. A Lead Auditor is an individual certified as qualified to direct an audit, perform an audit, report audit findings, and to evaluate 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 activities 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 scope, complexity, or special nature of the activities to be reviewed or investigated and shall have no direct responsibility for the area being evaluated. The QA personnel training program shall provide general orientation and specific training which develop competence for performing audits or surveillances. Training records shall provide a history of QA personnel training, g evaluations, qualification, certifications, and retraining. (CTSN 1818,2037, 2244,2245, 2247, 2248, 2250, 2252,2253, 2254, 2255,2257, 2968, 3001, 3866,3877,3892, 40635) 18.4 QA Department personnel w ho perform audit and surveillance activities shall be qualified in accordance with the requirements prescribed in QA Department procedures. Lead Auditor qualification 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 denned by procedure. The qualification certification of Lead Auditors shall be based on an evaluation of these factors by the Manager, Quality Assurance. The maintenance of proficiency by Lead Auditors 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 determine proficiency. As long as a Lead Auditor is performing satisfactorily and is maintaining proficiency, there is no limit on the period of certification. Ilowever if at anytime the Lead Auditor's performance is evaluated as being unacceptable, Lead Auditor certification shall be rescinded. In addition the failure to Mark-up pages 18 1

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SUNIONELECTRIC CALLAWAY NUCLEAR PLANT

$$ l OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 1

l maintain proGciency for a period of two years or more shall be basis for Lead Auditor certincation revocation.

If certification is rescinded or revoked, requalification shall be required prior to recertification. (CTSN 2244, q 2245,2246, 2247, 2248, 2249, 2250, 2251, 2252, 2253, 2254, 2257, 2259,2969, 3866, 40862) l 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 sufficient authority and organizational freedom to schedule and perform both internal and external audits. He has the organizational responsibility to measure and assure the overall efrectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality. The Manager, Quality Assurance has Q) direct access to the W : V!=44edde" N=1= Vice President andChiefNuclear Officer. (CTSN 3865,

/790) 18.6 The audit system shall include internal and external audits. The system shall be planned, documented, and conducted to assure coverage of the applicable elements of the OQAP, and overall coordination and scheduling of audit activities. Audit results shall be periodically reviewed by the QA Department for quality trends and rr sults reported to the appropriate management. The Manager, Quality 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 audit program as developed by the QA Department, to assure that audits are being performed in accordance with the OQAP. Appropriate levels of management shall be provided copies ofinternal and external audit reports. (CTSN 1790,1799,1800,3871) 18.7 Internal audits shall be conducted by the QA Department and shall be performed with a frequency commensurate with their safety signincance. An audit of safety-related functions shall be 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. (CTSN 1792,1816, 2188,3873) 18.8 Supplementary to the biennial requirements to audit safety-related functions, audits of Unit activities (listed below) SilALL be: (CTSN 2666,2681,2847,3873,41777) e performed under the cognizance of the NSRB, and e conducted on a performance based frequency by the QA Department, not to exceed 24 months a) The conformance of Unit operation to provisions contained within the Technical Speci0 cations and applicable !icense conditions; b) The performance, training and qualifications of the entire Unit staff; c) The results of actions taken to correct deficiencies occurring in Unit equipment, structures, systems or method of operation that affect nuclear safety; d) The performance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B,10CFR Part 50; e) The Fire Protection equipment, programmatic controls, and implementing procedures utilizing either a qualiGed offsite licensee Fire Protection Engineer or an outside independent Fire Protection Consultant (non-Union Electric). However, an outside independent Fire Protection Consultant (non Union Electric)

SilALL be used at least every third year.

f) The Radiological Environmental Monitoring Program and the results thereof; Mark-up pages 18-2

aea < SECTION NO.18 REVISION *- 18 CALLAWAY NUCLEAR PLANT OPERATING QUALiTYASSURANCE MANUAL DATE: 11/95 g) The OFFSITE DOSE CALCULATION MANUAL and implementing procedures; h) The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wastes; i) The performance of activities required by the Quality Assurance Program for ef6uent and environmental monitoring; and j) Any other area of Unit operation considered appropriate by the NSRB or the Ec=r " ice Prc:i&"

Q %4m Vice President and ChiefNuclear Oficer.

18.8.1 In addition to audits conducted under the cognizance of the NSRB, the following areas shall be reviewed or audited per the frequency specified in applicable regulations:

o Special Nuclear Material Accountability program o Radiological Protection program o Security program o Fitness-For-Duty program o Radiological Emergency Response Plan

~

18.9 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that (3) Quality Assurance Program requirements are properly implemented. (CTSN /799,1800,3873) 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 documents. 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 audit specinc items furnished to UE. These audits and surveillances shall utilize personnel quali6ed in accordance with this OQAM and shall be conducted 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 design and manufacture may not require supplier qualification or post-award audits to assure their quality. (CTSN 3577,3584,3596) 18.11 Applicable elements of suppliers' quality assurance programs shall be audited (post-award) on a triennial basis.

Audits generally should be 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 w hich significantly enlarge the scope of activities by the same supplier shall be considered in establishing audit requirements. In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the QA Department that the results of mini-audits performed during source verification and source surveillance activities confinn the adequacy and implementation of the supplier's QA Program. (CTSN 1780, 3565,3596,3878,3872) 18.12 Supplementary to audits, annual evaluations of suppliers shall be performed w hich take into account, as applicable: 1) the review of supplier furnished documents such as certificates of conformance, nonconformance notices, and corrective actions; 2) results of previous source verifications, audits, and receiving mspections; 3) operating experience ofidentical or similar products furnished by the same supplier; and 4) results of audits from other sources. (CTSN 3565,3566,3596)

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m SECTION NO.18 REVISION: 18 l CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 18.13 Audits shall also be conducted when: 1) significant changes are made in functional areas of the Quality Assurance Program such as significant reorganization or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assurance Program; or 3) when a systematic, independent assessment of Program effectiveneas is considered necessary; or 4) when it is necessary to verify implementation of required corrective action. (CTSN 3565,3872,3874,3883) 18.14 Audits shall be conducted using written plans in accordance with QA Department procedures. The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records f:,r quality-related practices, procedures, and instructions to determine the effectiveness of the implementation of the OQAP and compliance with 10 CFR 50, Appendix B. The audit plan shall identify the audit scope, the cirements, the activities to be audited, organizations to be notified, the applicable documents, the schedule, 9 the written procedures or checklists as appropriate. The audit plan and any necessary reference documents

@ shall be available to the audit team members. (CTSN 3876,3878,3881,3889) 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 performance, post-audit conference, reporting, records, and l'ollow-up activity to

@l assere corrective action. (CTSN 3877,3889)

The audited organization should be informed of adverse findings. Agreement or disagreement with a finding may be expressed in the response from the audited organization. (refer to Appendix A, Subsection 4.3.2.5 of '

4NSI N45.2.12) l Any adverse findings shall be reported in a post-audit conference with team members and the audited j organization, unless the post-audit conference is waived by the management of the audited organization. (refer l to Appendix A. Section 4.3.3 of ANSI N45.2.12) l 18.15.1 Formal audit reports shall be prepared and submitted within 30 days after the post audit conference (nr last day of the audit, w hichever is latei) to:

@

  • the audited organization for internal audits conducted in accordance with See ! S."', r the Sections described herein, and e specifically, the ?e : : Predde:%-Nuetear Vice President and ChiefNuclear Oficer for audits conducted under the cognizance of the NSRB in accordance with Section 18.8.

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1 m F APPENDIX A l

i 320NIONELECTRIC CALLAWAY NUCLEAR PLANT yyy,siost ,,

OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 l .

OOAM CONFORMANCE TO APPLICAHLE NRC REGULATORY GUIDES I

This Appendix brie 0y discusses the extent to which Union Electric's Operating Quality Assurance Program (OQAP) j conforms to NRC published Regulatory Guides for the Callaway Plant. All statements within the Regulatory Position l Section (C) of the Regulatory Guides are considered requirements unless a specific exception or clarification has been l proposed by Union Electric 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 Regulatory Guide, ANSI /ANS Standards "shall" statements denote requirements while "should" statements denote recommendations.

Clarifications, alternatives, and exceptions to these Regulatory Guides are identified herein. Union Electric's position on other Regulatory Guides is given in Appendix 3A of the Callaway-SA and Callaway-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 identilied 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 referenced within a standard, it is understood that UE shall comply with the referenced section as clarified.


1 ri REGULATORY

- - - - - - - - - - GUIDE

- - - - - 1.8

- - - - - - - - - - - - - - - - -REVISION

- - - - - - - - - - - - - - - - - - - - D A T E D 4 /8 7 i L_______-._________________________________________________________J 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 (Section 4.4.4) only, and ANSl/ANS 18.l-1971 for all other positions).

1 DISCUSSION:

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

{

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

The experience, training, and education requirements for the positions of Shift Supervisor, Operating Supervisor, and l Reactor Operator, and personnel fulfilling the duties of Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANSI /ANS 3.1-1981 as endorsed by the Reg latory Guide 1.8.

For all other positions, qualification and training shall comply with ANSI /ANS 3.1 1978 as clarified below:

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 met the qualifications of the Regulatory Guide, but were not required to be certified, i

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EUurouELECTRIC CALLAWAY NUCLEAR PLANT

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OPERA TING QUALITYASSURANCEMANUAL DATE: 11I95 UE may use additional Union Electric employees or contract personnel to augment the unit staff. These groups include, but are not limited to, UE personnel from outside the Nuclear Division as well as supplemental lip and I&C technicians t 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 specified education and experience requirements for non-equivalent positions. As an alternative, these personnel can be qualified for assigned tasks either by UE through its systematic approach to training or by Vendors with UE approved training and qualification programs. Inspection, examination and testing personnel shall meet the requirements for certification as inspection, examination or testing personnel as set forth in UEs commitment to ANSI N45.2.6-1978 given elsewhere in this Appendix.

With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Documentation: UE shall maintain records in accordance with and to meet the requirements of OQAM Section 17 and ANSI N45.2.9 as specified herein.

r-----------------------------------------------------------------1 i REGULATORY GUIDE 1.28 REVISION 2 DATED 2/79 i L_________________________________________________________________J Quality Assurance Program Requirements (Design and Construction)(Endorses ANSI N45.2-1977)

DISCUSSION:

This Regulatory Guide is not applicable to the operating phase. Ilowever, 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).

r---------------------------------------------------------------- i i REGULATORY GUIDE I.30 INITI AL ISSUE DATED 8/72 i L_________________________________________________________________J Quality Assurance Requirements for the Installation, inspection, and Testing ofInstrumentation 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 maintenance 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 requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects. j 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 - Plannine requirements, as determined by engineering, shall be incorporated into modification procedures.

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 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.

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5UNIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 Section 2.3 - Procedures and instructions shall be implemented as set forth in OQAM Sections 2,3,5,10 and i 1 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 requirements of the Quality Assurance program standards.

Section 2.4 - Results shall be implemented as set forth in OQAM Sections 10,11 and 17 and by compliance with ANSI N18.7 as set forth in this Appendix in lieu of the requirements set forth here. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.

Section 2.5.2 - Calibration and Control covers three classes ofinstrumentation used by UE:

(1) M&TE (portable measuring instruments, test equipment, tools, gages, and non-destructive test equipment 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).

With respect to the first sentence, M&TE and reference standards snall 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 use: 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 instrumentation. This identification provides traceability to calibration data. These actions are UE's alternative to the tagging or labeling ofitems to indicate the calibration date and the identity of the person who performed the calibration.

Permanently installed process instrumentation shall comply with sentences I,2, and 5.

Section 3 - Preconstruction Verification shall be implemented as follows:

(l) 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 review ed and approved, per se, by UE; (3) no special checks shall be required to be made by the person withdrawing 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 technicians as part of the modification process. 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 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.

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i APPENDIX A see3UIONELECTRIC 5 CALLAWAY NUCLEAR PLANT 1mvis,oyt is OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 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 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.

Section 5.1 -Jnspections. 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 incorporate, 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 shall 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 i1. In some cases Surveillance testing may be used to meet the appropriate requirements of this Section.

Section 6 post-Convruction Verification is not generally considered applicable at operating facilities because of the scope of the work and the relatively short interval between installation and operation. Where considered necessary by engineering or QC, the elements described in this Section shall be used in the development and implementation ofinspection and testing programs as described in OQAM Sections 3,10 and 11.

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

Section 8 - Records shall be implemented by conformance with OQAM Section 17 and Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix.

r----------------------------------------------------------------1 i REGULATORY GUIDE I.33 REVISION 2 DATED 2/78  :

L---------------------------------------------------------------- J 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 l required by OG.4Af Section 13 shopplisab!e C !!:way P!;.t T=Hica' S; =meni ; which defines 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.

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DATE: 11/95 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 these 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 inspection activities assure QA/QC involvement.

Paragraph C.5.c 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).

Paragraph C.5.f of Regulatory Guide 1.33 (and Section 5.2.19(2) of ANSI N18.7 w hich it references) shall be implemented with the substitution of the word " practicable" 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.

Paragraph C.5.g of Regulatory Guide 1.33 (and Section 5.2.19.1 on ANSI N18.7 w hich it references) shall be implemented with the addition of the modifier "normally" after each of the verbs (should) which the Regulatory Guide converts to "shall." It is UE's intent to fully comply with the requirements of this paragraph, and any conditions which do not fully comply shall be 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.

With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Reauirements for thc Onsite Operatine Oreanization:

Some of UE's technical support organizations are physically located at the Callaway site. Therefore the second sentence of this Section shall be implemented as follows:

" Initial incumbents or replacements for members of the onsite or offsite technical support organizations shall have appropriate experience, training and retraining to assure that necessary competence is maintained in accordance with the provisions of ANSl/ANS 3.1 - 1978 as committed 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.

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,

@ andOQAM Section 18ra*Mh+Cahway P4am Tedden' Sped &a&=.

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APPENDIX A REVISION: 18 CALLAWAY NUCLEAR PLANT 1 OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 With regard to Section 4.2 of ANSI N18.7 - 1976 titled Procram

Description:

Two aspects are addressed in this Section:

audits and independent reviews. The independent review program shall be implemented as required by the Technical 1 Specifications. The UE audit program shall be described in accordance with and to meet the requirements of Regulatory I b l Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix,'h C !!: y P!an T=hn!=! Sp=$=::en:, and OQAM Section 18.

With regard to Section 4.3 of ANSI N18.7 - 1976 titled independent Pgjew Process: The requirements of this Section, including ofits subparts, shall be met by compliance with the Technical Specification requirements and the OQAM.

With regard to Section 4.5 of ANSI N18.7 - 1976 titled Audit Pronram: 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, g Ae and OQAM Section 18 r-end N C !!^ 'ay P! n* *=Hi=! Spni5:2.ms.

With regard to Section 5.1 of ANSI N18.7 - 1976 titled Procram

Description:

The fourth sentence in this Section requires a " summary document." UE's OQAM is organized in accordance with the 18 criteria of 10 CFR 50, Appendix B. UE interprets this OQAM and applicable Regulatory Guides as endorsed in this Appendix to fulfill the requirements for a

" summary document."

With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Procedure 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 requirements 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 Fauinment Control: UE 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.

l 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 ofinspections and tests."

The first sentence in the seventh paragraph shall be met after clarifying " operating personnel" to mean trained employees 1 assigned to, or under the control of, Plant management at Callaway.

With regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Maintenance 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 w hich are similar in nature to original construction activities. In dev: loping means to assure the quality of maintenance or modification activity, inspection requirements from associated construction activities shall be considered.

Operational inspection requirements shall assure quality at least equivalent to the original quality.

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

"Except in emergency or abnormal operating conditions w here immediate actions are required to protect the health and safety of the public, to protect equipment or personnel, or to prevent the deterioration of j Plant conditions to a possibly unsafe or unstable level, maintenance or modification of equipment shall j be preplanned and performed in accordance with written procedures. Where written procedures would l be required and are not used, the activities that wcre accomplished shall be documented after-the-fact and receive the same degree of review as if they had been preplanned."

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EUNIONELECTRIC CALLAWAY NUCLEAR PLANT yi ) isios, is OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 With regard to Section 5.2.7.1 of ANSI N18.7 1976 titled Maintenance Procrams: UE shall comply with the requirements of the first sentence of the 6fth paragraph, where practical. This clari6 cation 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 both audits and surveillances, and QC is involved in inspection of maintenance inspection activities.

With regard to Section 5.2.8 of ANSI N18.7 1976 titled Surveillance Testine and Inspection Schedule: In lieu of a

" master surveillance schedule," the following requirement shall be met: " Schedules shall be established reflecting the status ofin-plant surveillance tests and scheduled inspections."

With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled plant Security and Visitor Control: The requirements 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 the general requirements of the Quality Assurance program standards.

With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled flousekeepine and Cleanliness Control: The requirements of this Section, beginning with the last sentence of the Grst paragraph and continuing through the end of the Section, shall be implemented as described in UE's commitments to Regulatory Guide 1.39 (ANSI N45.2.3) and Regulatory Guide 1.37 (ANSI N45.2.1) as set forth in this Appendix. In every case either identical or equivalent controls are provided in the Sections of the reference standards or documents.

With regard to Section 5.2.13.1 of ANSI N18.7 - 1976 titled 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 N18.71976 titled Review. Arnroval and Control of Procedures; in lieu of the l uording starting with the second sentence in the third paragraph of this section beginning with "The frequency of.. ."

through the end of the fourth paragraph, w hich ends " . a procedure review.", UE provides the following alternative guidance: l i

l

" Procedures shall be revised as necessary. These revisions will generally be initiated through reviews

)

conducted by knowledgeable personnel during routine performance of activities. Examples of such l reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identined de6ciencies or events, evaluation of events occurring at other plants, evaluation of procedure changes necessary to implement modifications, evaluation of procedure changes necessary to implement License, Technical Speci0 cation, FSAR or OQAM revisions as well as evaluations of changes necessary to resolve Regulatory issues. Such changes shall be implemented as necessary. In some situations such implementation will be completed prior to completion of the in-process activity. Guidance on the need to revise procedures shall be provided in plant administrative controls." i 1

With regard to Section 5.2.17 of ANSI N18.7 - 1976 titled inspection: The third paragraph is replaced with the following: I Inspections for modi 6 cations and nonroutine maintenance shall be conducted as indicated in our reference to Section 5.2.7 of this standard.

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1 sei APPENDIX A j E%7NIONELECTRIC CALLAWAY NUCLEAR PLANT

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OPERA TING QUALITYASSURANCEMANUAL DATE: 11l95 The following is a clarification to the sixth paragraph:

Inspections may not require generation of a separate inspection report. Inspection requirements may be integrated into appropriate procedures or other documents with the procedure or document serving as tia record. Ilowever, records of inspections shall be identiGable and retrievable.

With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control of Special 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, equipmeat and procedure quali0 cation shall be defined by engineering.

With regard to Section 5.3.5(4) of ANSI N18.7 - 1976 titled Sunnortine Maintenance Documents: UE may choose to include material from vendor manials 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 specinc section; the manual may then be used in conjunction with the procedure for performing the activity.

(3) The material, either as originally written or as modined by the procedure's author, may be reproduced within the body of the procedure.

In cptions (l) and (2) above, the material shall be considered as having received "the same level of review and approval as operating procedures" by virtue of the review and approval of the maintenance procedure. In option (2), the manual shall be available when the procedure is being considered for approval. In option (3), this material receives the same review and approval as the procedure since it is part of the procedure. In any of the options, Union Electric is NOT reviewing and accepting the entire manual. UE reviews and accepts that portion of each vendor manual that is used by UE.

With regard to Section 5.3.9 of ANSI N18.7 - 1976 titled Emercency Procedures: UE's Emergency Procedures are in the format speciGed 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 Emereency: The licensing FSAR identiGed natural occurrences which affect the Callaway Plant. Therefore, UE shall interpret item (1 l) to mean the natural occurrences which were evaluated in the licensing FSAR.

With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Procedures for Imniementina Emercency Plan: UE's NRC accepted Emergency Plan shall be implemented in lieu of the requirements in this Section. When compliance with an NRC accepted program (e.g., Callaway Plant Radiological Emergency Response Plan) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance Program standards.

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APPENDIX A i see3NIONELECTRIC 5 CALLAWAY NUCLEAR PLANT neyisiost is l j

OPERATING QUALITYASSURANCEMANUAL DATE: 1ll95 r----------- ---------------------------------------------------- i l l REGULATORY GUIDE I.37 INITIAL ISSUE DATED 3/73 i I t_________________________________________________________________j l Quality Assurance Requirements for Cleaning of Fluid 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 clari0 cations:

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 clari0 cations below) shall apply to these maintenance and modi 0 cation activities even though such requirements may not have been in efTect originally. Technical requirements associated with maintenance and modi 0 cations 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.

Specinc clarincarions 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 Gnal Hushing of Guid systems and associated components shall be at least equivalent to the quality of the operating 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 Dush water.

With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as ink's and related products; temperature indicating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT penetrant materials and couplants, desiccants, 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 shdi be allowed w here such elements are leachable or where they could be released by breakdown of the compounds un&< expected environmental conditions, except as provided for in approved design documents. No more than 10M ppm sulfur shall be allowed where such elements are teachable or w here they could be released by breakdown of the compounds under expected environmental conditions, except as provided for in approved design documents.

With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installation Cleaninc: 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 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 by the Onsite Review Committee (QA is a permanent member of this committee). For other actisities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

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$NINIONELECTRIC CALLAWAY NUCLEAR PLANT

$$s OPERATING QUALITYASSURANCEMANUAL DATE: 1Il95 r---------------------------------------------------------------- i i REGULATORY GUIDE I.38 REVISION 2 DATED 5/77 i t__________________________________________________-______________;

Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling ofitems for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.2-1972)

DISCUSSION:

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 DeHnitions: 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 clariGed in UE's commitment to Regulatory Guide 1.74.

With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Plannine:(First sentence) The specine items to be governed by the Standard shall be identined 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 Section 2.3 of ANSI N45.2.2 1972 titled Results: The specific methods for performing and documenting tests and inspections are given in OQAM Sections 10 and 11. The requirements 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 referenced Standards or do uments.

With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Personnel Oualifications: Specinc requirements for personnel qualifications are set forth in the OQ AM description and in the commitments in this Appendix. These requirements shall be implemented in lieu of the general requirements stated in this Section. In every case either identical or equivalent controls are provided in the sections o'the referenced Standards or document.

With regard to Section 2.7 of ANSI N45.2.2 - 1972 titled Classineation ofitems: UE may choose not to explicitly use the four level classincation system. Ilowever, the specine 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.

Engineeri g 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 by the Onsite Review Committee (QA is a pennanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

l l

With regard to Section 3.2.1 of ANSI N45.2.2 - 1972 titled 1 evel A Items: As an alternate to the requirements for packaging and containerizing items in storage to control contaminants (ltems (4) and (5)), UE may choose a storage atmosphere which is fiee of harmful contaminants in concentrations that could produce damage to stored items, as 1 determined by engineering. Similarly (for item (7)) UE may obviate the need for caps and plugs, as determined by l engineering, with an appropriate storage atmosphere, and may choose to protect weld-end preparations and threads by controlling the manner in w hich the items are stored. These clarincations apply whenever items (4), (5) or (7) are subsequently referenced and to Section 3.5.1 titled Cans and Plues 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 f

are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite  !

Resiew Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

4 l

l Mark-up pages A.lo j l

EEUnionELECTRIC CALLAWAY NUCLEAR PLANT s .

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OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 With regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Cleanine: (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.

With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Methods of Preservation: (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 adversely affects form, fit, or function.

With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrier and Wran Material and Desiccants: This Section requires the use of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the UE position.

With regard to Section 3.7.1 of ANSI N45.2.2 - 1972 titled Containers: Cleated, sheathed boxes may be used up to 1000 lbs. rather than 500 lbs. as specified in 3.7.l(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 and Skids: 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 sufficient floor clearance for forklift tines (as nominally provided by 4 inch lumber).

With regard to Section 4.2.2 of ANSI N45.2.2 - 1972 titled Closed Carriers: The use of fully enclosed fumiture vans, as recommended 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 Section 5.2.1 of ANSI N45.2.2 - 1972 titled Shinnine Damage Inspection Stores personnel shall normally visually scrutinize incoming 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 aller unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping 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 Regulatory Guide 1.74; therefore, while he shall be trained to 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 inspection: 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 ofitems in Section 5.2.2. Engineerir.g 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 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.

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MUniouELECMC CALLAWAY NUCLEAR PLANT i ") ^w OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled I evels of Storagr Subpart (2)is replaced with the following:

(2) Level B items shall be stored within a Orc resistant, weathertight, and well ventilated building or equivalent enclosure in which measures have been taken against vandalism. 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 p411ets or shoring or shelves to permit air circulation. The building shall be provided with heating and temperature control or its equivalent to reduce condensation and corrosion. Minimum temperature shall be 40 F and maximum temperature shall be 140' F or less if so stipulated by a manufacturer.

With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to Storace Areas: Items which fall within the Level D classincation 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 engineering'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 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 ANS. N45.2.2 - 1972 titled Storace of Food and Associated items: The sentence is replaced with the following:

"The use or storage of food, drinks, and salt tablet dispensers in any 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."

l Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and i 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.

i With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled Measures to Prevent Entrance of Animals: The sentence is replaced with the following:

" Exterminators or other appropriate measures shall be used to control animals to minimize possible l contamination and mechanical damage to stored material." j With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Storace ofliazardous Materials: The sentence is replaced with the following:

"llazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers w hich 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-related systems, not particular components.

With regatd to Section 6.4.2 of ANSI N45.2.2 - 1972 titled Care 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."

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MUnionELECTRIC CALLAWAY NUCLEAR PLANT

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OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 (6) "Large (greater than or equal to 50 IIP) 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 5011P or when designed to be used with a prime mover of greater than or equal to 50 llP) horizontal rotating equipment shall be evaluated by engineering to determine if shan rotation in storage is required: the results of the evaluation shall be documented. if rotation is required, it shall be perfonned at specified intervals, be documented, and be conducted so that parts receive a coating oflubrication where applicable and so that the shaft does not come to rest in the same position occupied prior to rotation. For long shafts or heavy equipment subject to undesirable bowing, shaft orientation after rotation shall be specified and obtained."

(8) Maintenance 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 ofitems 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. He first sentence of the Section is replaced with:

"UE shall develop, issue, and implement a procedure (s) which cover (s) the removal ofitems from storage. The procedure (s) shall assure that the status of material issued is known, controlled, and appropriately dispositioned."

With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.21972 titled insnection of Eauipment and Riccine Stated for information only, it is UE's position that this relates to the operability of the hoisting equipment and does not preclude re-rating as allowed by Section 7.3.

p_________________________________________________________________3 i REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 i L______________________________..__________________________________J llousekeeping Requirements for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.31975)

DISCUSSION:

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

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 maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance or modification 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.

Specific clarifications for ANSI N45.2.3 1973 are indicated below by Sections.

Section 1.4 - Definitions: 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 commitment to Regulatory Guide 1.74.

Section 2.1 Planninc: 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.

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ENhTIONELECTRIC CALLAWAY NUCLEAR PLANT

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OPERATING QUALITYASSURANCEMANUAL DATE: 11/95 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, documented cleanliness inspections which shall be performed prior to system closure. As necessary,(e.g. the opening is larger than the tools teing 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 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, documented 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.

Section 4 - Records: The requirements of OQAM Section 17 and 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 documents.

r---------------------------------------------------------------- 1 i REGULATORY GUIDE I.58 REVISION I DATED 9/80 i L_________________________________________________________________J 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 w ork 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 experience, training, and retraining to assure competence in accordance with Regulatory Guide 1.8 (ANSI /ANS 3.1 1978). This position is consistent with Regulatory Guide 1.33 (ANSI N18.7-1976/ANS-3.2 Section 3.4.2). (CTSN 3739,42434)

In instances where the education and experience recommendations of ANSI N45.2.6-1978 are not met by QC personnel, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that these individuals possess comparable or equivalent competence. Persons performing Nondestructive Examinations (NDE) as may be required by Section ill or XI of the ASME B&PV Code shall be qualified and certified as required by the Edition and Addenda of the Code to w hich UE is committed at the time the NDE is performed.110 wever, when qualifying personnel to perform visual examinations VT 2, VT-3, and VT-4 in accordance with IWA-2300 of Section XI, Division I, 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.

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... APPENDIX A i 5ENIONELECTRIC CALLAWAY NUCLEAR PLANT aEvisioxt is i OPERA TING QUALITYASSURANCEMANUAL DATE: 11/95 1

With regard to Section 1.2 of ANSI N45.2.6 -1978 titled Annlicability: The third paragraph requires that the Standard be l used in conjunction with ANSI N45.2; UE no longer specifically commits to ANSI N45.2 in the Operating QA Manual.

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 De6nitions: Dennitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; dennitions 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 N45.2.6 - 1978 titled Physical: UE shall implement the requirements of this Section with the stipulation that, where no special physical characteristics are required, none shall be specided. The converse is also true: if no special physical requirements are stipulated by UE, none shall be considered necessary.

r---------------------------------------------------------------- 1 1 REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 L_________________________________________________________________J Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.Il-1974)

D15' USSION:

UI. a mMies with the recommendations of this Regulatory Guide with the following clarifications:

Wh'n uniqueness or special design considerations warrant or are judged to be appropriate, an independent third-level o ew may be employed.

With regard to Paragraph C.2(l) of Regulatory Guide 1.64: If the designer's immediate Supervisor is the only technically qualified individual available, this review may be conducted by the Supervisor, provided that:

(a) the other provisions of the Regulatory Guide are satis 0ed, and (b) the justincation is individually documented and approved in advance by the Supervisor's management, and (c) quality assurance audits cover frequency and effectiveness of use of the Supervisors as design veriGers to guard against abuse.

With regard to Section 1.4 of ANSI N45.2.11 - 1974 titled Dennitions: Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; dennitions which are included in ANSI N45.2.10 shall be used as clarined in this Appendix.

With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12, under Procram Reauirements, and Section iI (including subsections 11.1 through 11.7) of ANSI N45.2.11 - 1974, titled Audits: UE's 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

@) l this Appendix,andOQAM Sections 16 and 18ran44hueq= . " cf hCaHawrP4arn-Tech"ca! SpeciF:: tim in every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.

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ess 7 APPENDIX A REVISION: 18 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL UATE: 11/95 c-____________--__--______________________________________________,

i REGULATORY GUIDE 1.74 INITIAL ISSUE DATED 2/74 u-----_----______________-------_--_-----_-_-----__--_______-----_s Quality Assurance Tenns 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 denne additional words or phrases which are not included in this Standard. Such additional dennitions shall be documented in appropriate procedures or in Sections of the Operating QA Manual.

In addition to the Standard's de6nition of" Inspection," UE shall use the following: "Ir,spection (when used to refer to activities that are NOT performed by QA or QC personnel)- Examining, viewing closely, scrutinizing, looking over or otherwise checking activities. Personnel performing these functions are not necessarily certined to Regulatory Guide 1.58 (ANSI N45.2.6)." These activities are controlled by the Callaway Plant Operating 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 references are NOT made, inspections are to be considered under the additional definition given above, in addition to the Standard's de6nition of" procurement documents," UE shall utilize the definition given in ANSI N45.2.13. The compound dennition is given as follows: Procurement documents - 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 documents which authorize the seller to perform services or supply equipment, material or facilities on behalf of the purchaser (e g. Engineering Service Agreement agreements for engineering, construction, or consulting services), contracts, letters ofintent, purchase requisitions, purchase orders, or proposals and their acceptance, drawings, specifications, or instruction w hich define requirements for purchase.

" Bids"- Supplier quotation submitted in response to specified 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 N45.2.12))- Failure to develop, document or implement effectively any applicable element of the Operating QA Program.

" Quality Assurance Program Requirements"(Not denned in ANSI N45.2.10 but used and denned differently in ANSI N45.2.13)- Those individual requirements of the Operating QA Program u hich, w hen 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.

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ENINIONELECTRIC CALLAWAY NUCLEAR PLANT s$. \

  • OPERA TING QUALITYASSURANCE MANUAL g> ATE: 11/95

" Independent Verification"- Verification by an individual other than the person who perfonned the operation or activity being verified that required actions have been completed. Such verification need not require confirmation of the identical action when other indications provide assurance or indication that the prescribed activity is m 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 (made 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 positioned by observing the starting or stopping of flow on meter indications 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 (Regulatory Guide 1.146) as opposed to the definition given in ANSI N45.2.10 1973)- A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of ebjective evidence where available,(subjective 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 accordance with specified requirements. An audit should not be confused with surveillance or inspection for the sole purpose of process control or product acceptance.

"Must"-(Not defined in any ANSI Standard)- An internally 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 enforceable. (See additional discussion under Section 2.14 of the OQAM.)

l " Unit stafl'-(Not defined in any ANSI standard)- Means those personnel who report to the Afanager, Callaway Plant g VE: 'ee %w4pemens. This tenn shall also be synonymous with the "onsite operating organization" described (but not defined)in ANSI N18.71976, Section 3.4.2; the " unit staff" as used in the OQAM and in Callaway Plant Technical Specifications Section M 6.2 and its subparts; nd F &n 6.5,2? h, the including " unit organization" as

@ described in the Callaway Plant Technical Specifications Section 6.2.2; andpersonnelhaving "line responsibilityfor operation ofthe unit" as used in the ogA Aiand Callaway Plant TechnicalSpecifications Section 6.1.1.

"1.ike kind replecements"-(Not defined in any ANSI standard) Like kind replacements include both exact item replacements and other item replacements which are not " exact" but meet the original design requirements.

r-------------------------'---------------------'------------------t i REGULATORY GUIDE 1.88 REVIMON 2 DATED 10/73 i L..________________________________________________________________J Collection, 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 Generation 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 information, not the form, that is the record. Thus the infonnation, 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 documents or indices which, when taken together, supply the information attributed to "an index" in the Standard.

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MUnionELECTRIC CALLAWAY NUCLEAR PLANT fe 8 OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 The specific location of a record "within a storage area" may not be delineated. (e.g. The specifk :ation within a computer record file may not be constant. Further, UE may utilize a computer assisted 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 Timeliness: UE's contractual agreement with its contractors and suppliers shall constitute fulfillment of the requirements of this Seuion.

With regard to Section 5.3.3 of ANSI N45.2.9-1974: Tl'e phrase 'A method for verifying that the records received are in agreement with the transmittal document . . , is clarifed to n'.:an that internal Callaway Plant generated records received are in agreement with procedural guidelines contained in Callaway Plant Administrative procedures. If a transmittal does exist (e.g. on supplier-generated documents, etc.), the records received will be verified against the transmittal document.

The following clari0 cation 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 Safekeepina: 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 Facility: This Section provides no distinction between temporary and permanent facilities. To cover temporary storage, the following clarification is added: " Active records (those complGed 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 after completion without

@ l being duplicated (for dual storage)-*w-being placed on microfilm or optica/ disk. 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 cumulatise in nature (e.g. nonconforming item logs and control room tog books)-- are not considered as QA records since they are not

" complete." These types of documents shall become QA records w hen 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 he transferred to document control as a " record" (e g. training and qualification records).

Paragraph 4, subsection 3 is clarified to require a two-hour minimum fire rating to be consistent with the 1979 version of the Standard and FRC Criteria for Records Storace Facilities (Guidance-ANSI N45.2.9. Section 5.6) issued 7/1/80.

Paragraph 4, subsection 9 is clarified to read:

"No pipes or pc .etrations except those providing fire protection, lighting. temperature / humidity control, or communicr4 ions are to be located within the facility and they shall comply with a minimum two-hour fire pratection rating " l Where duplicate storage is employed, no special precautions or provisions (including vault storage, special humidity and temperature recorders and similar items) are required.

Paragraph 5 is clarified to read the same as our commitment to subsection 5.4.3. Both pangraphs address the same requirement and therefore the commitment must be the same.

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l

MUTIONELECTRICCALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 1II95 With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits: These speciDe activities in sub-sections I,2 and 3 are accomplished through the establishment of administrative controls by the responsible management.

Audits of these administrative controls are performed in accordance with this OQAM, Section 18 and commitments to Reg.

Guide 1.144 in this Appendix, r---------------------------------------------------------------- 1 i REGULATORY GUIDE I.94 REVISION I DA i L_________________________________________________________TED4/76 ________J Quality Assurance Requirements for Installation, inspection and Testing of Structural Coacrete 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 clarincations:

For 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 modi 0 cation activities even though such requirements may not have been in effect originally. Technical requirements associated with modi 0 cations 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. 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 Calibration and Control: The last sentence is clari6ed as follows:

"UE's inspection or test results conducted with M&TE found to be discrepant are to be evaluated as described in the OQAM, Section 12.8."

With regard to Section 5.4 of ANSI N45.2.5-1974 titled Ilich Strencth floltine:in lieu of the Grst two sentences in the Orst paragraph, UE will comply with the following:

"flolts 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 Ilolts, approved May 8,1974."

In lieu of(l) 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 tl:at the point of the bolt shall be Bush with or outside of the face of the nut when completely installed."

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APPENDIX A asi 7 REVISION: 18 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 ir REGULATORY

- - - - - - - - - - GUIDE

- - - - -1.116

- - - - - - - - - - - - - - - - REVISION

- - - - - - R

- - - - - - - - - - - - - - - - D A T E D 5n 7 i L_________________________________________________________________J

- 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 modi 0 cation activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modi 0 cations 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.

With regard to Section 2.7 ofANSI N15.2.8 - l975 titled Personnel Qualifications: Personnelperforming inspection and

@ testing activities, shall be quahfiedconsistent with the quahfication requirements ofOQAMSection 10 and, as endorsedin this Appendix, Regulatory Guide 1.58 [ ANSI N45.2. 6-1978] and Regulatory Guide 1.8 (ANSUANS 3.1-1978).

__________3 p _ _ _ _ _ _ _ _ _ _GUIDE i REGULATORY _ _ _ _ _1.123

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _REVISION

_ _ _ _ _ _1_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D A T E D 7/7 7 L_________________________________________________________________J Quality Assurance Requirements for Control of Procurement ofitems 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 Dennitions: 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 commitment to Regulatory Guide 1.74. The two exceptions are defined in this Appendix under Regulatory Guide 1.74.

With regard to Section 1.2.2 of ANSI N45.2.13 - 1976 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 Vil as implemented by OQAM Sections 4 and 7 may also be used.

With regard to Sec6n 3.1 of ANSI N45.2.13 - 1976 titled Procurement Document Preparation. Review and C hance Control: ne phra e "the same degree of control" is stipulated to mean " equivalent level of review and approval." The changed document nay not always be re-reviewed by the originator; however, at least an equivalent level of supervision shall review and approve any changes.

With regard to Section 3.4 of ANSI N45.2.13 1976 titled 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 documents. .

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SUIONELECTRIC CALLAWAY NUCLEAR PLANT N$s .

OPERA TING QUALITYASSURANCEMANUAL I) ATE: 11/95 With regard to Section 5.3 of ANSI N45.2.13 - 1976 titled Preaward Evaluation: UE shall comply with an alternate paragraph which reads:

"Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition at Callaway), an evaluation of the supplier's acceptability as a procurement source shall be performed as required by the Operating QA Manual."

While it is not the intent to make "unusuai drcumstances" determinations without Engineering or QA involvement, Callaway Operations Support is ultimately respnsible for the decision. QA audit and surveillance activities assure against abuse.

With regard to Section 6.4 of ANSI N45.2.13 - 197t' titled Control of Channes in items of Services: The phrase "the Operating QA Program" is inserted in lieu of" ANSI N45.2, Section 7."

With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source Veri 0 cation Activities and Section 12 of ANSI N45.2.13 - 1976 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 Appendix, and OQAM

@ Sections 16 and 18, " the reysc et cPh: Callauay P'

  • TeF: ! Spec!Ecanm With regard to Section 7.5 of ANSI N45.2.13 - 1976 titled Personnel Ouali0 cations: The phrase: " Personnel responsible for performing verincation activities shall be qualined in accordance with ANSI N45.2.6 as applicable", is subject to the following clarification: Quali0 cation of personnel performing verincation activities for the Callaway Plant shall be in accordance with Union Electric's position on Regulatory Guide 1.58.

With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disposition: The third sentence ofitem b is revised to read:  ;

Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist l of one or more of the following shall be submitted to the Purchaser for approval of the recommended disposition prior to shipment w hen 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; j
3) Nonconformance cannot 'cw arrected 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 I such that the capability of the item to function is unimpaired.

, ' A module is an assembled device, instruir ent, or piece of equipment identi6ed by seriat number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A l

shippable component is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an l individual item and w hich has been evaluated by inspection and/or test for conformance to procurement requirements regarding end use, 1

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EEUniouELECTRIC CALLAWAY NUCLEAR PLANT

[,I((*.,3 OPERATING QUALITYASSURANCE MANUAL DATE: 11/95 r---------------------------------------------------------------- i i REGULATORY GUIDE I.144 REVISION I DATED 9/80 i t_________________________________________________________________j Auditing of Quality Assurance Programs for Nuclear Power Plants (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 Definitions: With one exception (Program Deficiencies) the definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; dennitions 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 clarified 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 Personnel Oualification: The qualification of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory 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 Trainine: The training of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.

With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Maintenance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory Guide 1.146 (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 Essential Elements of the Audit System: UE shall comply with subsection 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 responsible management." For the auditing

@ l organization (UE), effectiveness shall be reported as required by OGAAf Section 18 tlM:ahway P!:n' T=h= !

Sp=!E=' m Other than audit reports, UE may not directly report on the effectiveness of the quahty assurance programs to the audited organization when such organizations are outside of UE.

Subsection 3.3.6 requirements are considered to be fulfilled by compliance with the organization and reporting measures

@ l outlined in this OGAAf Operatin;; Q.^ Mam:a! and the C !!= y P!=* T=h+! Sp=iEcatiens. In every case either identical or equivalent controls are provided in the sections of the referenced documents.

Subsection 3.3.7 requires verification of efTective corrective action on a timely basis.

Verification of the implementation of corrective action is performed as indicated in Section 16 of this OQAM. Corrective action program efTectiveness is determined through audit or surveillance as described in Section 18 of this OQAM, using previously issued conective action documents as input to the scope of audits and surveillances. Additionally, trending of corrective action documents will be used to reveal potentially inefTective corrective actions and the effectiveness of the corrective action program.

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APPENDIX A I ses REVISION: 18 CALLAWAY NUCLEAR PLANT OPERA TING QUAIJTYASSURANCEMANUAL DATE: 11/95 With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planninc: Identical or equivalent controls are provided in this OQAM, Section 18.

With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Scheduline: 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 quatincation of a contractor's or supplier'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 N45.2.12 - 1977 titled pre-Audit Conference: UE shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the Srst sentence. This clari0 cation is required because, in the case of certain unannounced audits or audits of a particular operation or work activity, a pre-audit conference might interfere 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 availability should not be an impediment to beginning an audit. Even in the above examples, which are not intended to be all inclusive, the material set forth in Section 4.3.1 shall normally be covered during the course of the audit.

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 elements, no objective evidence may be available. UE shall comply with an alternate sentence which reads: "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 deficiency is identiGed as a result of an audit, unless the apparent cause, extent, and corrective action are readily evident, further investigation shall be condveted 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 clarified with the deOnition 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 or disagreement with a Onding 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 w hich are so severe that any delay would be undesirable) shall be reported immediately to the audited organization and as soon as practical to the management thereof" With regard to Section 4.3.3 of ANSI N45.2.12 - 1977 titled Post-Audit Conference: UE shall substitute and comply with the following paragraph:

"For external audits, a post-audit conference shall be held with management of the audited organization to present audit findings and clarify misunderstandings; where no adverse 6ndings exist, this conference may be waived by management of the audited organization: such waiver shall be documented in the audit report. Unless unusual operating or maintenance conditions preclude ,

attendance by appropriate managers / supervisors, a post-audit conference shall be held with managers / supervisors 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."

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MUnionELECTRIC CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 11195 With regard to Section 4.4 of ANSI N45.2.12 - 1977 titled Reportine:

(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 supervisor 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 level personnel with whom significant discussions were held during the course of pre-audit (where conducted) audit, and post-audit (where conducted) activities."

(c) Audit reports may not necessarily contain an evaluation statement regarding the effectiveness of the Quality Assurance 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 Ornanization: UE shall comply with the following clarification 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 remedial action. The audited organization shall assure documentation of remedial action taken is provided. Adverse audit findings shall be evaluated to determine the need for action to prevent recurrence. If such action is deemed necessary, the results of the investigation (root cause analysis), the corrective action taken or planned to prevent recurrence, and a schedule for implementation shall be provided by the audited organization. Such evaluations and implementation of actions shall be scheduled and performed consistent with the safety significance of the item. The audited organization shall take appropriate action to assure corrective action is accomplished as scheduled. In the event the action or schedule of implementation must be changed, the audited organization shall provide a revised response on or before the originally scheduled completion date which statuses the corrective action and states its completion date. Evaluation progress and corrective action implementation will be performed and tracked in accordance with provisions of Section 16 of the Union Electric Operating Quality Assurance Manual.

With regard to Section 4.5.2 of ANSI N45.2.12-1977 titled BY Auditine Orcanization: UE shall comply with the following clarification of the section: For intemal audits, performed by or for the Quality Assurance Department, follow-up actions will be taken by the audited organization as described in Section 16 of this OQAM. The internal audit program implemented in Section 18 of this OQAM provides assurance that the corrective action program requirements are properly implemented. By sampling responses to conditions adverse to quality, the adequacy of root cause analysis, implementation of remedial action, and action to prevent recurrence are verified to assure effective corrective action program implementation. Therefore, the auditing organization will not necessarily evaluate the adequacy and assure action is identified and accomplished for each adverse finding. External audits shall comply with section 4.5.2 of ANSI N45.2.12-1977.

1 1

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32UNIONELECTRIC CALLAWAY NUCLEAR PLANT

. ,3 OPERA TING QUALITYASSURANCEMANUAL l DATEt Ill95 r----------------------------------------------------------------,

a REGULATORY GUIDE 1.146 INITIAL ISSUE DATED 8/80  :

L_________________________________________________________________J Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants (Endorses ANSI N45.2.23-1978)

(CTSN 2247, 2248, 2249, 2250, 2251, 2232, 2234, 2257, 2258, 2259, 2968, 2969, 2986, 3739)

DISCUSSION:

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

With respect to Section 1.4 of ANSI N45.2.3 1978 titled Definitions: 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 Appundix under Regulatory Guide 1.74.

With respect to Section 2.2 of ANSI N45.233 1978 titled Ouatincation of Auditors: Subsection 2.2.1 references an ANSI 1.154.2 (presumed to be standa:d N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 w hich reads:

g (CTSN 2246)

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 procedures for implementing audits and reporting results.

With respect to Section 3.2 of ANSI N45.2.23 - 1978 titled Maintenance 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 certiGcation (not the calendar year) as the starting date for determining when such annual assessment is due. The combined time interval for any three consecutive assessment intervals shall not exceed 3.25 years.

@ (CTSN 2233)

With respect to Section 4.1 of ANSI N45.2.23 1978 titled Oreanizational 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; Supervising Engineer, QA; or Lead Auditor shall, prior to commencing the audit, assign personnel who collectively have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.

With respect to Section 5.3 of ANSI N45.2.23 - 1978 titled Undatine of Lead Auditor's Records: UE shall substitute the

@ following sentence for this Section: (CTSN 3001)

Records for each Lead Auditor shall be maintained and updated during the period of the annual management assessment as denned in Section 3.2 (as clariGed).

With respect to Section 5.4 of ANSI N45.2.23 - 1978 titled Records Retention: UE shall substitute the following sentence g for this Section: (CTSN 3002)

Quali0 cation 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 clariGed in this Appendix .

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

Mark.uppages . A-25

Attachment 2 to ULNRC4575 Operating Quality Assurance Manual

, (OQAM)

Description andJustificationfor Proposed Changes I

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Aitachment 2 to ULNRC-3575 Page 1 of 2 Operating Quality Assurance Manual Description and Justification for Proposed Changes The descriptions and justifications listed below, refer to several OQAM section changes as indicated by the marked-up pages. The changes do not represent a reduction in the Operating Quality Assurance Program, as previously accepted by the NRC. The OQAM continues to meet the requirements of10CFR50, Appendix B.

Ref. # Description of Changes

@ Changes made to reflect organizational changes in support of an executive title change and a retirement. The title of Senior Vice-Presidert Nuclear is replaced by the title, Vice President and Chief Nuclear OfHcer. Other than title designation, the responsibilities for implementing the Operating Quality Assurance Program continues to reside with the chief nuclear officer of the Company, who reports to the President and Chief Executive Officer. The responsibilities assumed and the title change, does not represent a reduction in the OQAM.

@ Changes made to reflect internal organization / responsibility adjustments.

@ Changes made to internal tracking numbers; no impact on stated text.

@ ' Editorial change.

@ Changes [nade to delete reference to Technical Specification audits, since all audit requirements are now delineated in OQAM, Section 18. This was previously approved by the NRC in Revision 18 to the OQAM.

@ Changes made to clarify Regulatory Guide 1.116, ANSI N45.2.8 - 1975, Section 2.7, consistent with other OQAM statements regarding qualifications ofinspection personnel. This clarification has been approved by the NRC in previous revisions to the OQAM (refer to Appendix A position for Regulatory Guides 1.8 and 1.58) and does not represent a reduction in the OQAM.

@ Changes made to add " optical disk" technology based on 1 IRC Generic Letter 88-18, dated October 20,1988. Union Electric's position on the Generic Letter was submitted to the NRC Document Control Desk via Union Electric Letter No. ULNRC-3156, dated March 7,1995. This position is implemented through plant procedures and does not represent a reduction in the OQAM.

l . Attachment 2 to l . ULNRC-3575 Page 2 of 2 Ref. # l Description of Changes

@ Editorial deletion; redundant with previous sections of the OQAM. Section 1 (specifically Sections 1.1 and 1.11) clearly describe the organizational elements which function under the QA Program, and the lines of responsibility of these organizational elements. In addition, details ofline responsibility for the operation of the Plant are stated and implemented by administrative procedures and organizational charts.

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@ Changes made to clarify the definition of" unit staff" due 10 the changes described in

@ above. This clarification is consistent with Plant Technical Specifications Section 6.1.1, which states in part that the Manager, Callaway Plant, shall be responsible for overall unit operation. This change does not represent a reduction in the OQAM.

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