ML20043G936

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Rev 13 to Operating QA Manual
ML20043G936
Person / Time
Site: Callaway Ameren icon.png
Issue date: 06/30/1990
From:
UNION ELECTRIC CO.
To:
Shared Package
ML20043G934 List:
References
NUDOCS 9006210335
Download: ML20043G936 (177)


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i o

OOAP POLICY / INTRODUCTION It 'is the policy of Union Electric Company (UE) to

develop, implement, and maintain an Opnating Quality Assurance Program (OQAP) for-utilization facilities regulated by provisions of a Nuclear Regulatory Commission (NRC) operating license and amendments thereto.

The QA 1

Program shall be applied to those activities affecting 1

quality (safety-related) regarding structures,

systems, i

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 I

off-site exposures comparable to the guideline exposures of NRC Regulations 10 CFR 100.

l

.These activities include operational

testing, operations, maintenance, refueling, and modifications.

Control over these activities as they affect quality shall r

be to the extent consistent with their importance to safety.

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

Specific OOAP 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, r

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.

Clarifi-cations, 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 i

of how' corresponding criteria of 10 CFR 50, Appendix B are i

satisfied.

-111-Rev. 13 6/90

7~

The responsibility for formulating, authorizing, and assuring implementation of the UE Company OOAP rests with the Senior Vice President-Nuclear.

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.

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.

AT an sNw Donaid T. Schnell ~' ~

Date Senior Vice President-Nuclear 4fYko g

VJoseph V. Laux Date Manager, Quality Assurance

-iv-Rev. 13 6/90

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EFFECTIVE PAGE LISTING 4

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Appendix l

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00AM t

l them technical direction and administrative guidance.

He is responsible for establishing and implementing a comprehensive audit program.

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," Section 4.2.4.

The l

Manager, Quality Assurance is located at Callaway Plant and provides technical direction and i

administrative guidance to the Superintendent, Quality Assurance and the Supervising

Engineer, Quality Support, Quality Assurance.

2012 1.5 The Superintendent, OA is located at Callaway Plant.

He directs Supervising Engineers who have primary duties for assuring implementation of the CQAP.

The Supervising Engineer, Quality Support, QA, located l

at callaway Plant, directs a group of engineers who

?

provide additional support activities including maintenance of the Operating Quality Assurance Manual (oOAM).

The activities of the groups report-1 ing to the Superintendent combined with the activ-ities of the group reporting to the Supervising Engineer, Quality Support assure implementation of j

l the OQAP.

The qualifications of the Superintendent are at least equivalent to those specified in ANSI /ANS-3.1-1978,

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

l 16 The Manager, Quality Assurance, the Superintendent, Quality Assurance, and Supervising Engineers in the Quality Assurance Department are authorized by the Senior Vice President-Nuclear to stop work on ongoing quality activities in accordance with approved procedures.

During the operating phase they have the authority-to stop unsatisfactory work during repair, maintenance, and refueling 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 deficiency and preclude identification and cor rection, or increase the extent of the deficiency is subject to stop-work action by the Quality Assuratee Department.

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

1-2 Rev. 13-6/90

i OQAM i

management.

The Manager, Licensing and Fuels is also responsible for coordinating licensing activi-ties for Callaway Plant.

The Licensing and Fuels organization provides technical support activities in the area of reactor design and radiological engineering.

1.12 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is responsible i

for providing administrative and management support I

including cost forecasting, status reporting, and J

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

He is also responsible for the adminis-trative contact with the Institute of Nuclear Power Operations (INPO).

As Principal Health Physicist, he provides a corporate level overview and guidance in 1.he formulation and implementation of applied radiation protection programs and reviews the rad'.ological safety programs for compliance with Federal and State standards and regulations.

l.13 The General Manager, Nuclear Operations reports to

+he Senior Vice President-Nuclear and is responsible for the activities of the Callaway Plant Operations Department and the Operations Support Department.

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

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

1.14 The Manager, Callaway Plant reports directly to the General Manager, Nuclear Operations and is responsi-ble for the safe, legal, and efficient operation and maintenance of the Callaway Plant.

He controls Plant functions and implements the OQAP through the Assistant Manager, Operations and Maintenance, the Assis tar.t

Manager, Technical
Services, and' the r

l Assistant Manager, Work Control (see Figure C of the 00AM).

He has the primary responsibility for reactor operation and safety.

Within his organization, the QC Supervisor reports to the Assistant Manager, Work Control who reports to the Manager, callaway Plant.

The Quality Control Group performs work activity inspections, receipt inspec-tion as described in Section 7,

and nondestructive examinations and is not involved-in those activities performed by others which are considered "inspec-tions" unto themselves, e.g.,

surveillance testing, initial startup testing, and I&C, Radiation Protec-

tion, and Chemistry group activities.

Activities considered to be inspections unto themselves are b

OOAM if covered by QA audits and QA surveillances as dis-cussed under Section 18.

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

1.15 The

Manager, Operations Support reports to the General Manager, Nuclear Operations and is responsi-ble for Plant support activities including training, materials management,
security, and administration services activities required to support the Callaway Operating License.

He controls Plant support activities and implements the OOAP through the Assistant Manager, Materials, the Superintendent,

Training, the Superintendent,
security, and the Superintendent, Administration.

1.16' The

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

He is responsible for providing the

analysis, programming, operations, hardware
support, files, reports, and capabilities necessary to. maintain the nuclear information system and network in support of the plant.

1.17 The Manager, Nuclear Safety and Emergency Prepared-ness (NSEP) reports directly to the General Manager, Nuclear Operations and is responsible for providing a constant independent overview of nuclear Plant safety.

He directs the Supervising

Engineer, Independent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP).

1.18 The Supervising Engineer, ISEC and staff evaluate Callaway Plant operations fror. a safety perspective and compare Callaway operati'4g experie. ice with that of plants of similar design.

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

The Supervisor, EP and staff have overt 11 responsibility for the development and maintenanca of the Emergency Preparedness Program.

This incluces onsite and offsite emergency prepared-ness, coord(nation of the Plant Radiological Emer-gency Response Plan with State and local emergency plans, and tre planning and execution of emergency drills and emargency plan exercises.

A communica-tion path exists between the Manager, NSEP and the Senior Vice President-Nuclear for matters having immediate or significant safety implications, thus providing a

direct path to contact management personnel having corporate responsibility for Callaway Plant.

l l-5 Rev. 13 6/90

i L

i t

00AM l-l 1.19 The Superintendent, Personnel (Local 1439 and 1455) reports directly to the General Manager, Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel l

activities, Fitness-For-Duty, and other matters under the guidance of UE policies, j

l 1.20 The Superintendent, Personnel (Local 148) reports J

directly to the General Manager, Nuclear Operations-j and is responsible for assisting in areas of labor o

relations, organizational and personnel activities, and other matters under the guidance of UE policies.

l 1.21 The Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative 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.

l 1.22 The Manager, Mechanical Engineering reports to the Vice President-Engineering and Construction who in turn reports to the President.

The

Manager, Mechanical Engineering provides technical support, as necessary, to the Nuclear Engineering staff.

The Chief Draftsman, who reports to the

Manager, Mechanical Engineering provides drawing preparation and revision
support, as. requested, for design performed by Nuclear Engineering or other UE organ-izations.

l 1.23 The 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.

l 1.24 Other UE divisions may provide safety-related a

services which augment and support selected Program activities.

These organizations shall be required to implement controls consistent with the 00AP requirements applicable to their scope of activi-ties.

The coordination of these activities is the i

responsibility of the Senior Vice President-Nuclear.

1-6 Rev. 13 6/90 1

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. 1.25' Safety; review ' - committees shall-be. established to' provide ' an independent review of those items re-

[

-quired by the Callaway Plant Technical Specifica--

,tions.

These committees,- the Onsite Review Commit-tee (ORC) and the Nuclear-Safety Review Board (NSRB), are. described-in the Administrative Controls.

1 Section of the callaway Plant Technical ; Specifica-tions.

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i OQAM 12974 2.0 QUALITY ASSURANCE PROGRAM l

i 1799 2.1 UE has established an OQAP '.hich 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 CPR 50, Appendix B

" Quality Assur-ance Criteria for Nuclear Power Plants and Fuel i

Reprocessing Plants" as described herein and with the Regulatory Position of Regu3atory Guide 1.33.

Commitments, clarifications, alternatives, and J

exceptions to the Regulatory Position of Regulatory Guide 1.33 are stated in Appendix A of this 00AM.

In addition, the 00AP has incorporated the commit-monts made in responding to applicable NRC ques-tions.

The text of the NRC questions applicable to the OOAP, along with the responses, are maintained as a OA, Record separate from the OQAM.

The Senior Vice President-Nuclear has initiated the Program and formulated the policy in addition to authorizing Program implementation.

This responsibility has been established by the President who is responsible to the Chief Executive Officer of UE for establish-ing and. implementing the Quality Assurance Program requirements.

2.2 Lines of authority and responsibility have been i

established from the highest management level.

through intermediate levels and to the General t

Manager, Nuclear Operations and the onsite operating organization.

These relationships shall be. docu-mented and updated, as appropriate, in the - form of 1

organization

charts, functional descriptions of departmental responsibilities, and position guides for key personnel having direct operating, support, or audit responsibility.

Where specific responsi-bilities are assigned within the OQAP, the pre-scribed individual shall retain the overall respon-sibility; however, subject to applicable regulatory constraints, authority may be delegated to aubordi '

nates.

Considering these same regulatory con-straints, the authority of a subordinate may always be assumed by a superior.

1104 2.3 Updating and revision of the 00AP as described in 1105 this 00AM.shall be in accordance with the applicable i

requirements of 10 CFR 50.54 (a) and 10 CFR.50.71.

1824 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 2-1 Rev. 13 6/90

1 OQAM i

2.

Operating Quality Assurance Manual-(OQAM)

The OQAM contains a delineation of the Policy statement, quality assurance requirements, assignment of responsibilities, and a defini-

)

tion of organizational interfaces.

The OQAM is the written description of the OQAP.

Approval J

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

3.

Callaway Plant Operating Manual The Callaway Plant Operating Manual consists of a multi-volume set of Plant operating proce-dures prepared or reviewed by the staff with the aid of other SNUPPS utilities, Nuclear Engineering, the Lead A/E, the NSSS Supplier, and Fuel Fabricator.

These procedures are controlled, approved, and issued in accordance with Administrative Procedures contained within the Manual.

This Manual includes. administra-tive controls consistent with those required by Regulatory Guide 1.33.

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

The final approval of Administra-tive Procedures and revisions thereto shall be by the Manager, callaway Plant.

The review and approval of other procedures and revisions thereto shall be in accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications.

I 679 2.7 UE may empicy the safety-related services of 1746 architect engineers, NSSS suppliers, fuel 1787 fabricators, constructors, and others which provide 2293 or augment UE efforts during the operating phase.

1 2460 These organizations shall be required to work.under a

quality assurance program whose controls are consistent with the scope of their effort.

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

The quality assurance program of' outsik organizations shall be subject to review, evaluation and acceptance by the UE Quality Assur-ance Department or Quality Services Department prior to the initiation of safety-related work.

Vendor programs and procedures shall also meet UE's commitment to USNRC Generic Letter 83-28.

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I h

OQAM i

11864

.3.0 DESIGN CONTROL 2183 12974

[

11850 3.1 The design, modification, addition, and replacement 2168 of safety-related structures, systems, and 4

2185 components shall be controlled to assure appropriate 2189 design control measures are implemented.

2222 Procedures shall establish requirements; assign 2187 responsibilities; and provide control of activities r

2193 regarding design in a

planned, controlled, and orderly manner.

'2188 3.2 The Plant design is defined by those UE NSSS, A/E and selected supplier design drawings and specif1-cations which illustrate the general arrangement and details of safety-related structures, systems, and components and define the requirements for assuring their continued capability to perform their intended operational or safety design function.

3.3 As the result of operating experience, or as necess-itated by regulatory requirements, Plant systems and 2664 equipment may have to be changed.

A design change i

is a modification in Plant design or operation and is accomplished in accordance with requirements and limitations of applicable codes, standards, specifi-cations, licenses, and predetermined safety restrie-tions.

An alteration of Plant equipment, structures or systems, which is not by nature operational, 4

maintenance or replacement by like kind, is consid-ered a design change.

?

1850 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 specified in original design bases and requirements, materials a

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.

r 12184 3.5 Design, including related procurement efforts, may 2189 be carried out by Nuclear Engineering, Licensing and 2222 Fuels, or outside organizations.

3-1 Rev. 13 6/90 1

4 OQAM i

12164 3.6 Control of design shall be specified in procedures.

2190 These procedures shall include instructions for 2191 defining typical design requirements; communicating 2192 needed design information across internal and 1

2196 external interfaces; preparing, reviewing, approv-2202 ing, releasing, distributing, revising, and 2221 maintaining design documents; performing design l

12222 reviews and reviews of design; and controlling field 2243 changes.

12164 3.7 Design control shall involve measures which include a

definition of design requirements; a

design process ' which includes design analysis and deline-ation 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 l

become acquainted with design features.

2195 3.8 Design requirements and changes thereto shall be 2207 identified, documented, reviewed and approved to 2222 assure incorporation of appropriate quality stand-2664 ards in design documents and to control departures 1850 from these standards.

Modifications to structures, 2203 systems, and components shall consider, as e mini-2204 mum, the design bases described in the Callaway-SP and the Callaway-SA FSAR and the Technical Specifi-cations.

Design criteria documents which are newly issued or modified in the course of design'or design changes shall be reviewed by a superintendent in the Nuclear Engineering Department for seismic and quality group classification and selection lof quality standards.

Design criteria documents consist of original Plant design criteria, system descriptions and other documents defining design input which change the Plant as described in 2205 the PSAR.

The design input shall be specified on a timely basis and to the 2evel of detail necessary to permit the design activity to be carried out in a correct manner and provide a consistent basis for L

making design decisions, accomplishing design l

verification measures, and evaluating design chang-es.

I 3.9 Design activities shall include the correct transla-l 2207 tion of regulatory requirements and design bases 12209~

into specifications, drawings, written procedures, 2210 and instructions (design outputs) that define the 2212 design.

Design analyses regarding reactor physics, 2974 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, 3-2 Rev. 13 6/90

m OQAM i

'o assumptions, design requirements, references, and units.

When computer codes are

employed, only verified codes shall be used in safety-related design and design changes.

1 l2165 3.10 Procedures shall specify requirements for the review j

2166 and approval of design changes by the organizations i

2168 or individuals that performed the original design or 2169 Nuclear Engineering.

Design control activities, 12243 including design changes, may be delegated to others q

provided they have access to background and techni-cal information. Design control measures for design revisions shall be commensurate with those applied to the original design.

12694 3.11 Design activities shall also include:

1) reviewing the applicability of standards; 2) reviewing commer-cial 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, mainte-nance, and repair; 5) specifying criteria for l1934 inspection and test / retest; and 6) reviewing and approving procedures for special processes.

12164 3.12 The design process shall establish controls for 2168 releasing design documents which are technically 2220 adequate and accurate in a controlled manner with a 2243 timely distribution to responsible individuals and groups.

Documents and revisions shall be controlled through the use of written procedures by the issuer, 2191 distributor, and user to prevent inadvertent use of superseded documents.

Document control procedures shall govern the collection, storage, and mainten-ance 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 flow dia-

grams, piping, and instrument
diagrams, control logic diagrams, electrical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations.

12164 3.13 The design interfaces between UE organizations 2188 performing wark affecting quality of design and 2190 between UE rnd outside organizations shall be 2217 identified And controlled by procedures.

These 2218 procedures shall address control of the interface, 2219 responsibitities, lines of communication, and 2223 documentation of internal and external interface activitien.

3-3 Rev. 13 6/90

OQAM i

12182 3.14 The design process shall ir)clude design verifica-2209 tion.

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 verifi-i cation program.

The program depth shall be commen-

~

surate with the importance of the system or compo-nent 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 identify the responsibilities of the verifier and the documenta-tion required and which, through adherence to the procedures, provide for the identification of the areas, features, and pertinent considerations to be i

verified.

Design verification shall be by either design review, alternate calculation, qualification 11934 testing, or by a combination of these.

Where 2235 alternate calculations are performed to verify the correctness of a calculation, a review shall be performed to address the appropriateness of assump-tions, 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 indepen-dent third-level review must be employed as an additional verification when UE judges that the design involves unique or special design features.

The organization performing design shall have the 2234 responsibility for design control unless specified otherwise.

Design verificacion shall be performed by competent personnel other than those who performed the original design and other than the designer's immediate supervisor.

However, an individual's supervisor may perform design verifica-tion 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 approved in advance by the supervisor's management.

Quality Assurance Department audits shall examine the frequency and the effectiveness of use of supervi-sors as design verifiers to guard against abuse.

l1934 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 organiza-tion for use in other design activities.

In those L

cases where this timing cannot be met, the design verification may be deferred, providing the justifi-cation for this action is documented and the por-L tions of the design output documents based on the I

unverified data are appropriately identified and I

3-4 Rev. 13 6/90 l

l

OOAM controlled.

Without verification, site activities associated with a design or design change must not i

proceed past the point where the installation would l

become irreversible (i.e., require extensive demoli-tion end rework).

The design verification shall be complete prior to relying upon the component, system, or structure to perform its safety-related function.

12200 3.16 Action shall be initiated to correct errors found in I

the design process.

Errors and deficiencies identi-fied in approved design documents shall be document-ed 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.

I 3.17 Requests for design changes affecting safety-related

\\

structures, systems, and components may be originat-ed by the unit staff, Licensing and Fuels or Nuclear Engineering. Design changes shall be processed by Nuclear Engineering. Design changes engineered by Nucicar 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.

I 3.18 Independent of the responsibilities of the design organization, the requirements of the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB) as defined in the Technical Specifications 1137 shall be satisfied.

Design changes require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, Callaway Plant.

In addi-tion, changes in the facility as described in the FSAR which involve a change in the Callaway Plant 15844 Technical Specifications incorporated in the license or an unreviewed safety question require review and approval by the NSRB and the Nuclear Regulatory Commission prior to implementation.

When design is performed by an outside organization, UE shall perform or coordinate a review of the design for operability, maintainability, inspectability, FSAR commitment compatibility, test and inspection acceptance criteria acceptability, and design requirements imposed by Plant generating equipment.

l l

l-3-5 Rev. 13 6/90 1

(

OQAM l5844 3.19 Safety evaluations which consider the effect of the I

design as described in the design documents, shall be performed by the responsible UE engineering organization or outside organization (s).

These evaluations shall include the basis for the determi-nation that the design change does not involve an unreviewed safety question.

As deemed necessary by

{

the evaluating organization, detailed aaalyses shall i

be performed to support the bases of safety evalua-tions.

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 consistent with and do not alter the design criteria specified in existing design documents.

When design documents and safety evaluations are prepared by an outside organi::ation under its OA program, review and approval per ANSI N45.2.11 will be included.

UE will approve all outside organizations' design documents and safety evaluations, and will perform appropriate reviews necessary for final approval.

l1140 3.20 The ORC shall review design change safety evalua-tions to recommend final approval of design changes.

Design changes which involve an unreviewed safety question or a change in the Technical Specifications shall be forwarded to the NSRB for review.

An application for amendment of the license shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90.

j i

3.21 The NSRB shall review safety evaluations to verify that changes did not involve unreviewed safety questions.

11910 3.22 Procedures and instructions related to equipment or systems that are modified shall be reviewed and updated to reflect the modification prior to placing the equipment or systems in operation to perform 2162 safety-related functions.

Plant personnel shall be l

made aware of changes affecting the performance of their duties through procedure revisions, or specif-ic training in the operation of modified equipment or systems, or other appropriate means.

12039 3.23 Records shall be maintained which reflect current 2132 design including safety analyses, safety 2163 evaluations, design change installation procedures, 12173 material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings.

3-6 Rev. 13 l

6/90 l

l

OQAM l

3.24' Drawings.shall be prepared under a drawing control system which provides for checking methods and review and approval requirements.

Drawings shall be subject to reviews by the responsible design organ-ization for correctness, conformance to design criteria, and compliance with applicable codes and standards.

4 3-7 Rev. 13 6/90

OQAM 4.0 PROCUREMENT DOCUMENT CONTROL l 975 4.1 Safety-related procurements shall be documented.

1875 Procurement document control applies to documents 1876 employed to obtain safety-related materials, parts, 1887 components, and services required to support Plant 13541 activities.

Written procedures establish require-3548 ments and assign responsibility for measures to assure applicable regulatory requirements, design

bases, and other requirements necessary to assure l

quality are included in procurement documents.

679 4.2 Written procedures shall include controls, as 3559 applicable, for preparation,

content, review,
approval, and processing of the following related procurement documents:

1.

Purchase Requisitions 2.

Purchase Orders 3.

Letters of Intent 4.

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

Contracts 6.

Specifications 7.

Drawings 3560 Collectively, these procedures shall assure that 3601 technical and quality requirements are correctly

stated, inspectable, and controllable; there are

+

adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with QA Program require-ments.

3572 4.3 Consideration of the verification activities to be 3579 employed for item or service acceptance should begin 4

3580 during the purchase requisition, ESA, or contract 3582 preparation and review stage.

Planning of verifica-3584 tion activities shall include a review of the 3585' established acceptance criteria and identified 3607:

documentation.

Verification methods which may be employed include certifications. (certificates of conformance and material certificates or test re-ports),

source verification,- 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 verification activities is a function of the purchased item's or service's complexity and l

l 4-1 Rev. 13 l

6/90

~

00AM relative safety significance, as well as the suppli-er's past performance.

3572 4.4 Acceptance by source verification should be consid-3580 ered when the item or service is vital to Plant safety; or the quality characteristics are difficult to verify af ter 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.

1875 4.5 Purchase requisitions must be employed to initiate the procurement of safety-related materials, parts, components, and services while ESAs must be used to contract for safety-related engineering, construction, or consultant services.

Contracts, purchase orders generated from purchase requisitions, and ESAs must be employed. o procure certain goods t

and services associated with the nuclear fuel cycle.

Purchase requisitions for safety-related materials,

parts, components, and services and ESAs for professional cervices may be initiated by personnel in the Quality Assurance or Quality Services Depart-ments:

Nuclear Engineering, Nuclear

Services, or Licensing and Fuels Department; or the unit staff.

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

' standards, and technical requirements which are equal i

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 l

properly reviewed and approved revision; packaged and transported in a manner to assure the non-degradation of quality during transit; and. properly documented to R.

show compliance with applicable specifications, codes, and standards.

l s

1876 4.7 Each item or service to be procured is evaluated by the procurement document originator to determine whether it performs a

safety-related function or l

involves activities which affect the function of safety-related materials, parts, or components and to appraise the importance of this function to Plant or

~

i 4-2 Rev. 13 6/90 l

00AM 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 or Materials Engineering and shall classify the safety relationship of the service or questionable component, parts or items of safety-related structures, systems, and components.

Evaluations chall be documented for future reference.

1876 4.8 Commercial grade items shall rely on proven design 3601 and utilize verification methods by the purchaser, to the extent appropriate to item application.

Proce-dures provide for the acceptance of commercial grade items based on one or more of the following:

1.

Special Tests and Inspections 2.

Survey of Supplier (Commercial Grade) 3.

Source Verification 4.

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

a)

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

The manufacturer's measures for the control of g

design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).

4.9 Provisions for the following shall be included in procurement documents as applicable:

1864 1.

The scope of work and basic administrative and 1890 technical requirements including drawings, 2416 specifications, regulations, special instruc-3550 tions, applicable codes and industrial standards 3551 and procedural requirements identified by titles 3552 and revision levels; special process instruc-tions; test and examination requirements with corresponding acceptance criteria; and special requirements for activities such as designing, identifying, fabricating,

cleaning, erecting, packaging, handling, shipping, and storing.

4-3 Rev. 13 6/90

OQAM 1888=

2.

Requirement that the. supplier have an. accept-1890 able Quality Assurance Program which implements 3542 the appropriate sections and elements of ANSI-3553 N45.2-1977 or the ASME code as ' applicable as established for the item or_ service to be sup-plied.

This requirement is not applicable to commercial grade items which utilize a suppli-er's standard or proven design to meet-published' product descriptions.

l1890 3.

Requirements for supplier surveillance, audit, 3542 and inspection including provisions for UE or--

3555 agent access to facilities and records and for 3573 identification of witness and hold points.

3574 1890 4.

Requirements for extending applicable require-3543 ments of UE procurement documents to lower-tier 3555 suppliers and subcontractors.

These require-ments shall include right-of-access to sub-aupplier facilities and records by UE.

3550 5.

Requirements for suppliers to obtain UE 3558 approval of nonconformances to procurement 3576 document requirements disposititned "use-as-is" and " repair" and conditions of their-disposition including identification of those subject to UE approval prior to further processing.

3484 6.

Applicability cf 10 CFR 21 reporting require-ments.

1890 7.

Documentation requirements including-records to 2132.

be prepared, maintained, submitted for approval, 3550 or made available for review, such as,~ drawings,'

3556 specifications, procedures, procurement docu -

ments, inspection and. test records, - personnel and procedural. qualifications, chemical and physical test results, and instructions for the retention, transfer, and disposition of records.

8.

Requirements that the. supplier furnish documen-tation which identifies the purchased item and provides traceability to the procurement-re-quiremente met by the item and documentation identifying any procurement requirements which have not been met.

4-4 Rev. 13 6/90 4

J

w g

OQAM-r 5

51. -

{<'

~h 3559 4;10 The originating organization shall perform a docu-3560-mented independent review of procurement documents to-assure.

requirements-

'are correctly

stated, inspectable, and controllable and that there are adequate acceptance and-rejection criteria.

This o

3562-review shall be performed by personnel who have access to pertinent - information, and who have an adequate understanding of the requirements and intent of the procurement documents.

3567 4.11 Bids or proposals shall-he evaluated by the i'

3568 Purchasing Department, the originating organization, 3569 the Quality Services 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:

1.

Technical considerations 1

2.

Quality Assurance requirements 3.

Research and development effort 4.

Suppliers' personnel qualifications 5.

Suppliers' production capability 6.

Suppliers' past performar.ce 7.

Alternates i

8.

Exceptions q

  • 2560 4.11.'1 The Purchasing Department shall initiate and 3567' coordinate bid evaluation activities for those proposals received in response to requisitions.

The Purchasing Department shall review bids or proposals, except those associated with Engineering service Agreements (ESAs) or nuclear fuel cycle related goods or

services, for alternates or exceptions to procurement document requirements (areas 7

and 8

above) taken by-the Supplier.

These reviews 3563-shall be documented, t

3560 4.11.2 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 replacements or from the original approved supplier.

They shall also review areas 1 through 3 above for l

replacement parts-or equipment ordered from the original supplier as part of procurement document preparation.

3560 4.11.3 The Quality Services Department and the originating-organization review areas 4 through 6 above as part of maintaining a supplier on the qualified supplier i

list as described in the OQAM, Sections 7.0 and 18.0.

(.

4-5 Rev. 13 6/90 1

D OQAM e

'3560 4.11.4 The-Licensing

(, Fuels Department shall evaluate' bids or proposals for fuel cycle goods or services in the above-areas.

I 3560' 4.12 Bids or proposals with altornates or exceptions 3561 identified in Section 4.11 by the-Purchasing Depart-3568-ment shall also be evaluated by the-originating 3570-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.

4.13' Letters of intent may be utiidzed with suppliers o f-materials, parts, components,- and services for the purpose of reserving schedule space prior to: the resolution of the requirements to be included in ' a-purchase o.rder,

contract, or ESA.

If

employed, letters of intent must normally specify. that no.

safety-related activities may begin until an approved purchase order, contract, or ESA is executed..However:

1 in the event a letter of intent is issued for. the purpose of securing an agreement and thereby allow safety-related work to begin prior to the issuance of such documents, it shall specify the applicable

quality 'and technical requirements.

. Letters of j

c intent shall be prepared by the Purchasing = Department-

'{

or the originating organization, _ reviewed by the 1

originating organization, and approved and-issued'by Purchasing.

Letters of intent issued prior to the 1'

= execution of a

contract _for nuclear-fuel cy-cle-related. goods and/or services shall be prepared, reviewed and issued by the Nuclear Fuel Department.

"o Letters of intent issued prior to the' execution of.an-f ESA shall be prepared,, reviewed, and issued by ithe originating organization.

The-above reviews shall'be e

to assure that appropriate requirements have been 1

imposed.

a d

J d

j t

4-6 Rev. 13 6/90

'OQAM' 3563 4.14-

-The Purchasing-Department is responsible for E

reviewing; purchase

orders to verify that the' technicalL -and.

quality requirements have been accurately - transferred -from the requisition to the-purchase. order.-

Approval of the purchase-requisi-tion, letter of intent, Engineering Service Agree-ment, 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 Engineering Service Agreements for

+

professional services shall be executed by the Senior-Vice President-Nuclear or another company of ficer in accordance with Nuclear Division and corporate procedures' related: to _ agreements or contracts for services.

975 4.15 Additions, modifications, exceptions, and other.

3549 changes to procurement: document quality and 3575 technical requirements shall require a review equiva-3576 lent =to.that of.the original document and approval by the originator 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 (OSL) thst apply.to.a vendor may be revised without concurrence from the-originating organization since they are imposed without the knowledge of the origi-

~ nator.

(

r 1

4-7 Rev. 13 6/90

c OQAM i

I i

(2974-5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 1830 5.1

.The activities affecting quality' associated with the 1858 operating phase shall be-accomplished in accordance l1861 with documented instructions, procedures, drawings or checklists which specify the methods for-comoly-ing with 10 CFR 50, Appendix B and the Technical Specifications.

The degree of control imposed shall be consistent with the relative importance of.the activity to safety.

l 1948 5.2 Activities affecting quality shall be controlled-by:

1.

preparing procedures, instructions, specifi-

cations, drawings or checklists. of a

type n

appropriate to the activity and its importance to-safety; 2.

including in these documents quantitative or qualitative acceptance criteria for verifying that an-activity has been satisfactorily 4

accomplished; 3.-

having responsible personnel approve -these documents prior to accomplishing an activity;-

and 1820 4.

using approved drawings, procedures, instruc-3 1916-tions-or checklists to accomplish an activity.

1833 5.3 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 affecting safety-related struc-tures, systems, and ; components.

It 'is recognized that skills normally possessed by qualified person-

-nel may. not-require. detailed step-by-step delinea-tions in written procedures.

,,3 5.4 The Manager, Callaway Plant shall be responsible for providing specific guidance via Administrative-Procedures for the development, review and approval of other Plant -operating procedures to govern activities which affect safety or quality consistent-with the Technical Specifications.

Similar guidance shall-be provided for revisions and' temporary changes to Plant operating procedures.

Plant-operating procedures shall be reviewed no less.

frequently than every two years to determine. if changes are necessary or desirable.

A revision of a procedure constitutes a procedure review.

.q 5-1 Rev. 13 6/90

m

.o OQAM' 6.0 DOCUMENT' CONTROL

-1908-6.1 Documents and their revisions which control all 1916 activities-affecting 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.

1908 6.2 Divisions, departments, and organizations responsi-y 1916 ble for UQAP impicmenting documents shall be re-1917

. quired to provide the necessary. review and approval.

2262 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 OA Depart-ment-shall review Administrative Proceduresi as described in Section 2.6;~ QC personnel shall review-maintenance and modification procedures;*

and QC personnel are responsible for the preparation of~

inspection. procedures and/or checklists to support maintenance and modification activities.

Collec-tively, these reviews by the QA Department and OC personnel determine:

1.

The need for inspection, identification of inspection -personnel, and documentation of q,

inspection results; and 2.

That the necessary inspection requirements,

methods, and acceptance criteria have been identified.

k l

11908 6.3 Changes to documents shall be reviewed and' approved 1

1914 by the same function, department, group, or organ-l2170 ization' that performed the original review and approval; however, UE may assume or delegate this responsibility.

The reviewing organizations shall L

have access to pertinent background information upon which to base their approval and shall have adequate

'*- Work Requests

{WRs) and preventive maintenance requests L

(PMRs) may contain instructions to workers.

However, WRs and PMRs are not considered " maintenance procedures" which require OC L

review.

When required, the assignment of inspection points for work authorizing documents is performed by Planning Department j.

. personnel based on established criteria.

l l-l' 6-1 Rev. 13 6/90 l

1, OQAM

-understanding of requirements and intent of the-original document.

6.4 Documents relating to the UE OQAP shall be con-trolled to an extent which 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 draw-ings shall adhere to the OQAP.

i 11828 6.5 The controls governing the issuance of documents 1833 shall provide for the availability of documents at 1908' the point of use prior to commencing an activity and'-

s 1917 the prompt transmittal of approved ' changes for incorporation into subsequent revisions.

Measures shall be established to prevent the inadvertent use t

of superseded documents.

6.6, Types of. documents which shall be controlled include 7'

the FSAR, specifications, Operating Quality AFlur-

_i ance

Manual, pracurement documents, procedures, design documents (e.g.,

calculations, drawings,-

analyses) including documents related to computer

codes, nonconformance reports, as-built drawings, a

the Callaway ~ Plant Operating Manual, and topical reports.

6. 7 '

The-issuance of controlled documento at the General Office and callaway Plant is coordinated by-the i

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, j

Nuclear Services shall be responsible for assuring a

the issuance of controlled documents at the General

Office, and for transmittal of documents to the Administration organization for entry ~

into the' document control system.

~

6.8 Document control methods shall be defined consistent i

with the importance of the document to safety.-

Selected documents shall receive a control number.

3 A

serialized distribution list shall identify selected document holders by name and control number.

Acknowledgement of receipt of selected documents, incorporation of revisions, and de-stroying or voiding of superseded documents shall be required by the distributor.

In addition the distributing organization for documents controlled by a system of control numbers shall periodically 6-2 Rev. 13 6/90 D

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OOAM i

7.0

. CONTROL' OF PURCHASED

' MATERIAL, EQUIPMENT AND SERVICES 1892 7.1 Materials, equipment,land services shall' conform to 3541 procurement documents as prescribed in Section 4.

Provisions shall be established to control' activi-1 ties affecting quality associated with the. procure-ment of material, equipment and : services including:.-

1.

The ! preparation, review,.and change control of prccurement' documents as described in Section 4 4

2.

Bid evaluation. and award as described in Section 4 l

3.

Procurement source selections 4.

= Verification activities (surveillance, inspec--

t 1 tion, and audit) required by the purchaser.

~

5.

Control =of nonconformances as described in Section.15 6.

~ Corrective action as described'in.Section 16 7.

Material, equipment, and. service acceptance 2416 8.

Control of quality assurance: records 9.

JAudits of the procurement' program as described

~1n Section 18 i 1875. 7.2 UE: shall assure that suppliers providing safety-3541 related materials, equipment, or. services are 3564'

' acceptable procurement sources.- Provisions shall be 3

13879 made for supplier evaluations ' which assess their capabilities prior to award by:

1) source evalua '

tion'; or 2) review for objective evidence of quali-ty; or-3)- a review of supplier' history.

When evaluations are performed, the assessment of a-supplier's. capability shall be specific to the procured item, commodity, or servicetand the suppli-er's _ ability to provide the items or services in accordance with procurement-document requirements.

Suppliers of hardware and services :which are.manu-factured prior to award, -considered a commercial

. grade item, or implemented under-~the UE'OQAP do not require pre-award. source evaluation or post-award audits which attest to their capability as a pro -

curement source.

2337 7.3 During Callaway's operating life,.procurements may l

3564 be made from:

1) suppliers judged capable (prior L

to award) of providing items or services in L,

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o OOAM I

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 manufactured prior to award and whose acceptability can be determined by receiv-ing inspection, an examination of quality verifi-cation documentation, or other suitable means; 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information) ; and 4) outside organizations working under the UE OQAP.

Regardless of the basis for-the acceptability of the procure '

ment source, prior to the issuance of a purchase order or execution of a contract or ESA, a verifi-cation of the supplier /outside organization's 2977 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 Suppli-er's acceptability as a procurement source shall be 4

accomplished _ prior.to= award.

In the case 3874 of. purcl'ase orders,< the supplier shall be verified as an acceptable procurement source for_the item or service being procured.

Purchase, orders may be issued prior to an assessment of suppliers'-capabil-ity provided a prohibition on safety-related work is imposed.

Such suppliers may be released to begin-safety-related work when evaluated.- to be an accept-able procurement source.

l2337 7.4 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 receiv '

.ing or utilizing procured items _ ory services shall establish measures-to maintain and' control procure-ment-documents-until the items or services are received and accepted.

These

_ documents shall include purchase

orders, drawings and specifi-cations, approved changes, and other related docu-ments.-

7.5 Without any further evaluation,the suppliers to UE -

or its-agents during the design and construction phase may be regarded as-qualified procurement sources for replacement parts during the first three years of Callaway's operating phase as the procure-ment source evaluation measures employed previously have identified these suppliers as qualified pro-curement sources.

Callaway's operating phase began on June 11, 1984 with issuance of the operating License.

7-2 Rev. 13 6/90

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i 1894 7.6 Procurement' source' evaluation and selection involves 3565=

the Quality Assurance and Quality Services Depart-ments and the originating organization. _The evalua-tion and _ selection process shall, ' be epecified in

. department procedures and may vary depesoing on the complexity and relative importance.to safety of-the 1

item or service.

Nuclear Engineering, Licensing'and s

Fuels, Nuclear Services, the unit-staff or other organizations may be requested to_ provide. input to the' qualification evaluations of' suppliers.._ Suppli
  • ers of hardware and servic'es which are manufactured-prior to award, considered a commercial grade; item, or implemented under-the- 00AP do. not require -

1 pre-award source evaluation-audits which: attest to a-suppliers capability.as a procurement source-13566 7.7 Procurement ' source selection and evaluations sha'11 consider one or more of the following:

l 13564 1.

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

NRC

, Licensee Contractor and Vendor Inspection Program (LCVIP) reports, ASME. Certificates of l

Authorization (C

of

'A),.

audit' reports, UE 3

. records accumulated in previous procurement

actions, and UE product-op'erating experience may be used in. this evaluation.

Supplier-history shall reflect recent.

capability.

Previous favorable-quality-experience. with suppliers may be an adequate basis for judgements attesting to.their capability.

When

-I an LCVIP' report, an audit report, eor an ASME'C of A is used to establish:a suppller's accept-ability as a

procurement:

source, the-1 document shall be identified.'

2.

An evaluation'of the supplier's current quality records supported by documented qualitative and-quantitative information which can be objec-tively evaluated.

This may' include review and evaluation of the supplier's-QA

Program, Manual, and Procedures, as appropriate; and responses to questionnaires.

l- '

3564 3.

A source evaluation of the supplier's technical l

i 3605 and quality capability as determined by a

l direct evaluation (audit or surveillance) of-i facilities, personnel and -Quality Assurance Program implementation.

L l

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4.-

For commercial grade ' items, the procurement source-selection should consider one-or more of-the followings o

a)

Survey of documented supplier controls-over-critical characteristics -and-:that supplier activities adequately control the items supplied, and verify'the implementa-tion

'of-manufacturer's

-measures for ie control of design, process, and material.

changes.

r b)

Acceptable.

supplier / item performance record utilizing. monitored performance of' the item, inductry product tests, national-codes, and standards (not' specific - to the nuclear industry),

or other industry databases- (UL, INPO

NPRDS, EPRI
EQDB, ANSI,
NEMA, MIL-STDS, NRC-Bulletins /-

Notices, and Licencee Event Reports, etc.)

that is directly related to the item'.s critical characteristics

'and intended application.

7. 8 -

Procurement source avaluations involve a review'of technical and cuality assurance considerations;

' Technical-considerations include the design or manufacturing capability and technical ability of'

p' suppliers to produce or provide the design,, service, item, or component.

Quality - Assurance considera-tions. includte 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 j

source (af ter the ' initial source evaluation)

are, described in Section 18'.

- b l2337; 7.9 Receiving inspection instructions shall be' document-C

'.2416 ed.

These instructions include specifying inspec-tions or tests - of commercial-grade items - procured from suppliers on the basis of product performance.

r 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.

-975 Documentation shall be generated as a result of UE receiving inspection activities.

13571 7.10 organizations participating in the procurement process shall prepare procedures to monitor and eval"ste suppliers' performance to procurement document requirements.

These procedures shall o

include provisions for:

1) controlling documents 7-4 Rev. 13 6/90 a_:

_ x x__ _ - __ _ _ - _ _ _ _ _ - _ _ _ _ _. - - _ _ - _ _ _ _

?

OOAM i

e generated or processed during activities fulfilling procurement requirements; 2). _ identify 4.ng - and pro-cessing. change information; 3) establishing a method of control and documentation of information: exchange with the supplier; and 4). audit or surveillance of supplier activities.

e

.l3571 7.11 Depending on the complexity or' scope of the item or l

4 3572 service, the Purchasing Department and/or the' I

3573 originating organization shall initiate award ~

3580 activities.

Meetings or other forms of communica-3585-tion may be held to establish._the intent of : UE in-monitoring and evaluating-the supplier's perfor-

mance, establish an understanding of procurement t

requirements, and' identify supplier activities-to be utilized in fulfilling requirements.

The depth and r

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.

m 13574 7.12 The originating organization shall establish mea-sures.for monitoring supplier-generated' document i

s submittals against-procurement

-document requirements.

Similarly, measures shall be estab-lished for reviewing and approving supplier generat-a ed documents

~for use.

Changes to procurement documents shall:be in 'accordance with the controls described in Section'4.

13577 7.13 Supplier monitoring activities may be performed by 3578 personnel from-Quality _ Assurance, Quality Services, l

13584.

Nuclear Engineering, Nuclear Services, - Nuclear I

Safety. and Emergency Preparedness, Licensing and Fuels, the ' unit staff, or outside organizations iin

. 1 accordance with plans to perform

' inspections, examinations or tests.

Supplier monitoring activi-

.a ties may include:

=

i l

1.

Audits of supplier quality assurance program implementation 2.

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

3.

Surveillance of manufacturing processes 4.

Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-l-

mances F

7-5 Rev. 13 6/90

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l 975'. 7414'- Acceptance of items and-services shall include one

'1891

.or more of the followings

3601' i

3608-1.

Written certifications l-2.

Source verification' 3.

Receiving inspection 4.

Post-installation test (in addition to_ one of the above) 11891-7.15 Where required by code, regulation or contract 1893 requirement, documentary evidence _that items conform 3601-to procurement documents shall be available,during 3603 receiving inspection or prior to use of such items.

'3605 Where not precluded by other requirements, documen-3607 tary evidence may take the form of written certifi-cates of conformance.

When certificates of confor-mance are employed as a means of - item acceptance, verification of the validity of supplier - certifi-cates and-the effectiveness of the certification systems shall be conducted at intervals' commensurate with the supplier's past quality performance.

Certificates of conformance and compliance shall be required to be signed or accompanied.by a s i g r: e d letter of transmittal.

Where-acceptance is-based I

upon source verification, documented. evidence of these surveillances shall be furnished to the Plant Quality Control organization, by the responsible UE organization or their designated agent prior to acceptance.

11884 7.16 Acceptance-by receiving-inspection shall be utilized 3606 as a prime method of verification and may be uti-5 lized as the sole means of item acceptance when items are relatively simple and standard in design and - manuf acture, such as certain-spare. parts: when items are adaptable to standard or automated inspec-i tions; and when inspections do not ' require opera-tions 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.

13578 7.17 Receiving inspection shall be performed by personnel 1978, (as-clarified in certified to_ ANSI N45.2.6 OQAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization.

Other unit staff personnel qualified to ANS 3.1 1978 may be utilized to perform receipt inspections requiring specialized

skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel.

During outages, extensive modifi-7-6 Rev. 13 6/90

OQAM 1,

cations, or other _ special < circumstances, _ receiving:

inspection may be ~ assigned to an outside. organiza-C tion (s).

[ 975 7.-18 Receiving inspection activities shall~ include:

2337

- 1..-

Verifying that materials, parts',

and compo-

'nents, have been identified by' tagging or other means; or that they are segregated and. con-trolled in areas separate from.the-storage facilities for. accepted items..

2.

Verifying that items - for acceptance have been:

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

2325 3.

Verifying that received items conform to 3577 procurement documents by inspecting or, where 3591 appropriate, testing using_ approved procedures 3592 and calibrated. tools, gages and measuring equipment to verify the acceptability of items, e

including those from - commercial grade suppli-ers.

i 2326 4.

Providing final acceptance after~ determining "gJ

-2329 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 of' items by receiving inspection

~

J 2328-

.shall be procedurally controlled.

2327 5.

Verifying that received items which do not 3576 conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15.

13608 7.19 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 diffi-cult 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.

7-7 Rev. 13 6/90

n OQAM-

g s

E 2337-7.'.'0

. Final acceptance of items shall be by Quality 3601 Control personnel' or designated inspection person--

i nel.

The final acceptance; of. services shall be the' responsibility of

.the originating ' organization.

y.-

Acceptance.shall be documented.

l~

7.21 Code certified material may,be obtained from an ASME g.

accredited Material Manufacturer or Materi,1 Suppli-k;y er for' repair or replacement applications.

However=

1 UE' may also obtain Code certified' materials ~from

'non-ASME accredited Material Manufacturers.

or Q

Material Suppliers if such Manufacturers or Suppli '

f

ers are otherwise qualified - as stipulated in Sec-j m

tions 4 and 7 of the oQAM.. Thesc o provisions are 9

consistent with ASME Code Interpretation XI-1-83-50R l

dated May-14, 1985.

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28.0:. IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS l 975 8.1 The identification and control of materials, parts, 1884-and components shall be accomplished in accordance.

1885 with documented procedures and apply to safety-related materials,. parts, and components during fabrication, storage, installation or use.

Materi-als, parts, and components identified as nonconform-ing shall be controlled as described in Section 15.

1897 8.2 The identification and control requirements-shall L

12090 address traceability to associated documents, as 2337 appropriate; specification of the degree of identi-fication and control necessary;. location and method 2333 of identification to preclude a degradation of the:

item's functional capability or quality; and proper identification of materials, parts, and components-prior.

to release for manufacturing,.

shipping,.

construction, or installation..

Materials,

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

1884 8.3 Documented procedures shall assure that specifica-l2088 tions and other procurement documents. include or reference appropriate requirements for the.identifi-

' cation and control of materials, parts, and compo-nents including partially fabricated--assemblies.

c 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 materi-als,. parts, or components

received, stored, in-7 stalled, modified, or used at the Plant site.

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

1895 8.4 Physical identification shall be employed to the 2337 maximum possible extent for relating an item at any 2346 point in time to applicable design or other perti-3593 nent specifying documents

~ including

drawings, specifications, purchase orders, manufacturing and inspection documents, nonconformance ' reports, and physical and chemical mill test reports.

Physical 1896 identification or marking shall not affect 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 installa-tion.

When unique traceability is impractical, bulk traceability may be employed consistent with the 8-1 Rev. 13 6/90

OQAM-c.

relative importance of the item to safety.

When 2333.-

tags are'used, the stock'shall beimade from-. material.

which will not-deteriorate during storage.

Tags shall. be securely affixed _to the items, ' and dis-played in an area that is readily accessible.

2336

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.

11895

'8.6 In the event the identification or traceability of 6,

-an item is lost, it shall'be handled as nonconform-ing in accordance with Section-15, if the disposi-tion is.other than to scrap or to retain for non-safety related applications.

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12974 10.0 INSPECTION r

11851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to 11927 verify conformance with applicable-documented-instructions, procedures, drawings, -and specifica-tions.

Inspections and monitoring' of processes which serve an inspection function shall be per-g formed by personnel qualified to perform assigned

. tasks and who are independent of individuals who perform the activity.

11928 10.2 The inspection function shall be conducted in l

l1930 -

accordance with written approved procedures whick 1925 L

specify inspection scope; personnel qualificet.1on 1

requirements; inspection method descriptic:4, includ-

l1931 ing any mandatory hold points; acceptance criteria; I

2039 data collection requirements; and documentation 1

approval requirements.

Inspection-requirements may be obtained from drawings, instructions, specifi-

cations, codes, standards, or. regulatory require-4 iments.

j m

11932 10.3 Indirect control by monitoring processing methods,-'

i 1933 equipment, and personnel shall be utilized as a '

control if inspection of processed-items is impossi-ble or disadvantageous.

Both inspection - and moni-i toring of processes shall-be provided when control

-is' inadequate without both.

O, 10.4 Inspection of activities at the Callaway Plant shall be at intervals based on the status and importance 1

1850-of the activities. -Guidelines shall be established 1937

- to indicate the ' minimum frequency for inspecting

'i maintenance, modification, and special processes' activities to provide a basis for subsequent moni-toring planning.

-t 12125 10.5 The acceptance of an item shall be ' documented by authorized personnel.

Modification, repair or i

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

10.6 Required inservice inspection of structures, systems o

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.

11851 10.7 Quality Control inspection personnel or other unit 2263 staff organizations who perform " inspection" activi-2479 ties shall be qualified within their respective 12481 areas of responsibility.

The qualification of QC 10-1 Rev. 13 6/90

,4 I

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+

2482 inspection personnel shall be defined in three 12483 levels of capability as described in ANSILN45.2.6.

j 2494 Other members of the unit staff performing "inspec-t' R

2498 tion" activities shall_have appropriate. experience,.

2994

training, and retraining-to assure ' competence in accordance-with. ANSI /ANS-3.1.

Inspection. assign-

'ments shall be consistent with the qualification of an? individual.

In instances where the education and experience recommendations are not met'by QC inspec-i tion 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 R

or equivalent competence.

-2480- '10.8 Personnel from outside organizations' performing-QC 2482-

-inspection activities associated with safety-related 2484-items at the Callaway Plant shall be certified as j

l2485 required by ANSI N45.2.6.

Personnel from outside

.)

2994-organizations or UE personnel who are not members of the unit staff who perform other activities associ-ated with safety-related items at the Callaway Plant-1 shall either be certified as required by ANSI l

N45.2.6 or they shall meet the education _and experi-ence requirements applicable to the equivalent-position on the unit staff for the activities'which they are performing.

3 i

'2484 10.9' When contractors or vendors are retained to perform 2485 work activities or to providelservices associated "3577 with safety-related items at the'Callaway Plant,;the qualification of inspection personnel and the conduct of inspections associated with that - con.

tracted work activity or service-shall meet the

'j requirements -stipulated in the : applicable procure--

ment - documents.

As an example, if a vendor was contracted 'to conduct eddy current examinations of tha' Callaway Plant steam generators, then the persons performing the examination would be-quali-fied as required by the vendor's quality assurance-a program unless otherwise specified in the applicable W

procurement documents.

12483 10.10 An inspection personnel qualification program shall 2484 be established to assure inspection activities are 2488 being performed bv.ersonnel trained and qualified l

to a capability

essary for performance of the l

activity.

Plant procedures shall' prescribe the qualification requirements of in pection personnel.

The Superintendent, Training shall be responsible l-for providing related technical and quality training L

appropriate to the certification / qualification of UE personnel.

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, i' l1930 '10.11 Procedures which-specify inspection activities shall r

' provide for the following, as required

-1) the i

,K

-inclusion of independent inspection or monitoring of F

processes when required; 2) the identification of inspection personnel; 3) the documentationL ~ of inspection results; 4 )' a description'of the method of inspection; 5) the identification of the-charac--

i teristics and activities to. be inspected; 6) the acceptance and rejection criteria; and'7) specifying m

the necessary measuring and test equipment.

Inspec-p6-tion or testing, as appropriate, shall be-employed-as a means of verifying suitable performance subse-ry '

quent to a component replacement or repair.

W 10.12 Instructions, procedures, and= supporting documenta-e3' tion shall be provided to inspection personnel for:

]'L use-prior to performing inspection activities.

M 1935 Inspection results shall be documented.

Procedures t

1936 shall prescribe the review and approval authority-2262 for inspection results.

+^

1 2694 10.1'3 Nuclear Engineering shall be responsible for assur-7:-

I ing the-development of preservice and inservice-i (PSI /ISI) inspection-programs; the reference PSI /ISI examination plans for ASME Code Class 1,

2,

'and 3 systems and components including steam generator-i eddy current examination; the NDE _ procedures re-

[

quired by the 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 j

Addenda-prior to the issuance o f.

the inservice inspection plans and procedures.

2694 10.14 Nuclear Engineering shall be responsible for assur-i l

ing the development of the inservice'. testing program plan for pumps and valves,' the-test procedures required'by this plan, and the securing of consult-'

r ing 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 1

the Nuclear Division.

They'are also. responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspec-tion plans and procedures.

The services of an outside organization may be secured to conduct the PSI /ISI examinations.

10-3 Rev. 13 6/90 1

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12974 11~. 0 L TEST CONTROL I

'1850 11.1 Testing shall be performed to demonstrate that l'1934' safety-related structures, systems, and components r

2052 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 Plant maintenance, modification, procedure n'

changes,- failure analysis, and the acceptance of purchased material.

A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications.

1938 11.2 Testing programs shall be established to demonstrate 2039 item or system performance.

Testing shall be 2055 performed in.accordance with written procedures 2056 which incorporate or reference the requirements and-acceptance limits contained in applicable Callaway Plant Technical Specifications, drawings, instruc-tions, procurement documents, specifications, codes, standards, and regulatory requirements.

t 1938 11.3 Administrative' procedures, test procedures, or 2132 checklists shall include:- provisions for assuring all prerequisite conditions are met; test equipment ca]ibration requirements; testing method instruc-tions; limiting conditions and acceptance / rejection criteria; and data-collection and test result approval requirements.

i

'2263 11.4 Personnel within the various UE organizations may 2479 perform testing activities including implementing 2482 test procedures and the evaluation and reporting of 2483.

test results.

The. assignment of Plant testing.

12484 personnel shall-be under the direction and control 2494-of the General Manager, Nuclear Operations.

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" activities shall have appropri-ate experience, training, and retraining to assure competence in accordance with ANSI /ANS-3.1.

Testing assignments shall be consistent with the qualifica-tion 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 4

11-1 Rev. 13 6/90

t OOAM

-1137 11.9-Review;and approval of' tests and experiments not l1140 described in the FSAR shall be conducted as speci-fied' in the Callaway Plant. Technical Specifications _

and 10 CPR 50.59.

11853 11.10 Provisions sh'all be established for-the performance

.i of. surveillance testing.to assure that=-the necessary'

-quality of systems and components is maintained, that facility operations-are within the'.. s a f e ty limits, and that limiting conditions for operation

  • ?

can be met.

The' testing frequency shall be. as prescribed in the Callaway Plant Technical Specifi-ca tion s '.

The provisions for surveillance testing of a surveillance shall include the preparation ~

testing schedule (s) which reflects the status of in-plant surveillance tests.

Qualified personnel shall perform surveillance tests.

2053 11.11 Appropriate-tests shall.also be performed subsequent J

to Plant-modifications, maintenance or significant operating. procedure changes: to confirm expected.

l s.

results.

Tests provide.a level of confidence in

~

structure, system or component operation or func-tional-acceptability..

.t 1

11.12 When required by procurement documents, testing shall-be employed as a means of purchased material.

1 and equipment acceptance.

Acceptance. testing of this nature shall be. performed during-receiving-.

E inspection or subsequent to installation inLaccor-t dance with Section 7.

malfunction ' anal'ysis testing 11.13 Equipment failure or4 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.

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12.0 CONTROL OF MEASUh1NG AND TEST EQUIPMENT

]

'1919' 12.1 Measuring and test equipment utilized in' activities 1920 affecting quality shall be controlled in accordance 1969 with written procedures or instructions.

The 2042 procedures for calibration and control shall-address 2264-the identification of test equipment, calibration:

3591-techniques, calibration' frequencies, maintenance 3592

control, and ' storage requirements.

The equipment i

subject to these controls. includes (1) ' M&TE ' (port-able measuring instruments, test equipment, tools,.

gages, and non-destructive test equipment used in l

measuring-and inspecting safety-related structures, o
systems, and components) ;' (2) reference standards (primary,-secondary, transfer, and working); and'(3) permanently installed process instrumentation (PI).

i 1920

-12.2

. Tools, instruments, testing equipment and measuring 2295 devices used for measurements, tests, and calibra-2043-tion shall be of the proper range and type; and

[

12044 shall be controlled, calibrated,' adjusted and main-2060 tained at specified intervals or prior to use to 3591-assure the necessary accuracy of calibrated devices.

M&TE. and reference standards shall be tagged 'or labeled indicating the date o.f calibration and the duendate for recalibration.

2043 12.3-Permanently installed process instrumentation shall I

be afforded the control measures. described herein consistent with the surveillance. testing. program and-preventive maintenance program, s

12.4 The calibration.and control program-established.at the Callaway Plant shall assure-that M&TE, reference standards, and'PI maintain.their required accuracy.

[

The Assistant Manager,; Operations and Maintenance is responsible for assuring the program establishment.

Program implementation'is the responsibility of the appropriate Department Heads.-

p 1920 12.5 M&TE, reference standards, and PI shall be utilized by various organizations as required to perform L

tests or other special operations.

Each organiza-l' tion shall be responsible for assuring that the M&TE or reference standards it uses have been calibrated.

Outside organizations using M&TE or reference stan-l dards at the Callaway Plant in activities affectinq quality shall be required-to implement calibration 1.

and control measures consistent:with the applicable

)

requirements of this section.

Vendors activities i

performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 9 of OQAM Section r

l -

12.6 unless specified in procurement documents.

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14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 Safety-related _ items that are received, stored or installed at the callaway Plant.shall be identified and controlled in accordance with documented proce-dures.

11847 14.2: Items recaived at or installed in the Plant shall be 2116 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 i

identified by means of stamps, tags,. labels, routing-t

cards, segregation, or other means traceable to manufacturers' and receiving inspection documen-l tation.-

In.the event traceability is not available, the item (s) shall be considered nonconforming and' I

handled in. accordance with Section 15, if the disposition is other than to scrap or retain for

-non-safety related applications.

1 i

in 1841 14.3 Plant procedures shall_ provide instructions relating 1842 to the manner of indicating the operational status 1844

~of safety.-related structures, systems, and compo =

nents, including temporary modifications, and shall require independent verifications, where appropri-ate, to _ assure necessary measures, such as tagging equipment, have been implemented correctly.

These' procedures shall address measures for the release r -

and control 'of equipment during periods of mainte-m nance; thereby maintaining personnel and reactor safety and avoiding; the unauthorized operation of equipment.-. Equipment- 'and systemE 'in a controlled ststus to prevent: unauthorized operation, shall be b

identified.

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L I 972 14.4 Plant procedures shall establish controls to identi-1844 fy the-status of inspection and test activities l

1846 associated with' maintenance, repair, modification, L

1847 refueling, inservice inspection, and instrumentation 11851 and control system calibration and testing.

The 3

Technical Specifications establish the status required. for safe Plant operation, including provi-sions for periodic and

.non-periodic tests and inspections of various structures,

systems, and L

components.

Periodic tests may be operational tests L

or tests ' following maintenance while non-periodic l

tests may be made following repairs or modifica-tions.

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l 14-1 Rev. 13 6/90

OOAM p

2337: 15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 1848 15.1 Material nonconformances include material deficien-1870-cies (including inoperative and malfunctioning L

1907-structures, systems, and components). - Material 12045 nonconformances identified under the UE OOAP shall 2112' be controlled to prevent the inadvertent use of material, parts, or components which are defective g

or of indeterminate quality and to identify documen-Q tation inadequacies.

Measures shall be established 23 "

regarding identification, documentation, status y'

control, disposition, and notification.of affected organizations.

1848 15.2 Under the UE OQAP, Nonconforming. Material Reports 1903:

(NMRs), nonconformance logs, or other administrative 1907 controls shall be esployed to identify and control 2334 nonconformances.

Nonconformance logs may be em-ployed to control deficiencies of a minor nature or to control documentation deficiencies both of which can be corrected by bringing. the ' deficiency into compliance with the original requirements.

Material 4

1885-nonconformances shall be controlled, as appropriate, by documentation,

tagging, marking,
logging, or

' physical segregation.

The programs describing.the administrative nonconformance controls shall delin-9 eate the methods of identifying corrective action to be taken for a nonconforming item or series of nonconforming items.

Until suitable. documentary 6

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.

11906 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.

Procuremenc 3558 documents shall specify those nonconformances to be 3576

-submitted to UE for aporoval of the recommended 3598 disposition.

As specified in procurement documents,

-3599 actions'taken in response to these nonconformances 3600 shall be documented and forwarded to UE along with the hardware and accompanying quality verification documentation.

Nuclear Engineering shall be respon-s!ble for assuring the processing of supplier-recom-e nded dispositions for Plant-initiated procure-monts.

Similarly, other UE or outside organizations shall approve or be requested to provide a technical evaluation regarding. supplier-recommended disposi-tions of nonconformances regarding procurements they initiate.

15-1 Rev. 13

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t 1904' 15.4-Material.nonconformances.shall be processed in m'

1905-accordance with documented procedures _and shall 1907 identify the specifics of the nonconformance stating 1

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-c material nonconformance.

1 1907 15.5 Material nonconformance disposition categories shall 12334 include:

' 1.

"Use-as-is" or a c ceptabl e "

(including condi-G..

tional releases)

O 2.

" Reject" or "not acceptable, scrap, or return to vendor" 3.

Rework" in accordance with approved procedures

~4.

" Repair" in accordance with approved procedures Material nonconformances shall be reviewed and accepted, rejected, repaired, reworked, or condi-tionally released in accordance with documented procedures.

An approved disposition of-a 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.

1848-15.6 Nuclear Engineering shall be responsible for approv-1905 ing material nonconformance dispositions of 1907 "use-as-is" and " repair".

Licensing and Fuels shall v

2335 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.

Regard;.3 material nonconformances identified on-site, QC personnel shall be responsible for verification that approved dispositions have been implemented and for the final j

sign-off.

,1 L

15.7 Nonconformance documents which record defects in l

basic components or deviations from technical l

requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 L

and.other Federal reporting requirements.

Signifi-L cant nonconforming conditions involving a defect _or l'

material noncompliance in a delivered component or L

service which could create a

substantial safety hazard shall be reported to the Nuclear Regulatory l

Commission pursuant to the requirements of 10CFR21.

t 15-2 Rev. 13 6/90 w

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F 11906

-15.8.-

Material nonconformances which would impact the

. conduct of a test 'shall be corrected or -resolved 1992-

- prior to initiation 'of the test on the item.

The t

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 i supplemental tests or, inspections after correction of the nonconformance.

The evaluations shall be i

documented.

1848 15.9 Repaired and reworked item, hall be_ reinspected or

'l

.1904' tested.

Measures may be_ established to condition-1906-ally release nonconforming items'whose disposition

- 2053-

is pending, provided that an evaluation indicates

-2332; that further work or activity will not contribute adversely to the material nonconformance or preclude l

identification and correction, j

15.10 The Manager, Operations Support'shall have material nonconformance summaries prepared semiannually and

- analyzed for. potential adverse quality trends.

These summaries shall'be sent to the Quality Assur-ance Department for an independent review.

The result of this review shall' be reported to manage-ment.

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16.0- CORRECTIVE-ACTION l

l'324 - 16.1 -- Measures.shall be established to assure:that condi-1870

-tions adverse to quality are promptly identified,

'1903 reported, and corrected.

Nonconformances shall be 1935

, controlled in accordance with the_ requirements (29783 described in Section 15.

Each of the Nuclear Division Managers is responsible for developing and.

,i implementing a program for identifying and control-ling adverse conditions.

This.-responsibility'may be satisfied by one or. more programs.

As a minimum; each program shall provide for developing and analyzing trends on a semiannual basis.

Procedures

-t shall provide instructions for identifying, reporting, and initiating corrective action-to.

preclude recurrence of adverse conditions.

It is-understood that the term

" corrective action" includes remedial action necessary to correct the.

H deficiency, as well as corrective action. necessary a

to-preclude recurrence.'

1 16.2 Conditions adverse to ' quality which impede the li implementation or. reduce the effectiveness of -' the J

Operating QA Program shall be controlled by the measures described herein.

Adverse conditions t may E

include, but are not limited to,-noncompliance with

-l procedural requirements;-

reportable occurrences'-

required. by regulations;-

adverse nonconformance'-

trends; deficiencies identified in the OQAP; recurring conditions for which past ' corrective H

I action has been ineffective;.or breakdowns ~ Lin administrative and. managerial control-systems'which-could result in a system designed ~ to L prevent ~ or 1

mitigate-. serious events not being able to perform i

its intended function.

1 I

16.3 Corrective action documents which record. defects'in

-(

basic.

compenents or deviations from technicall requirements in procurement documents shall' be-reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements.

l 16.4 Corrective action documents 1shall be. transmitted.to the responsible organization.

The responsible.

3599 organization shall investigate the' findings and 3600 identify the cause (s) of the deficiency, and specify 1

'I f

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47

)

00AM and initiate the action (s) necessary to correct the conditions and prevent recurrence.

16.5 Nuclear Engineering shall review documented condi-tions adverse tc quality which involve design deficiencies or design changes which are recommended as correctivo action.

The ORC shall review i

significant adverse conditions identified on corrective action documents such as those identified by callaway Plant Technical Specifications j

6. 5.1. 6 ( f), 6.5.1.6(g), 6.5.1.6(h), and 6. 5.1. 6 (1) ;

and NPDES violations.

Licensing and Fuels should review documented conditions adverse to quality for fuel-related issues.

16.6 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action.

The Quality Assurance Department shall close OA-originated corrective action documents by verifying the implementation and adequacy of corrective action.

Copies of completed corrective action documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to quality.

The Quality Assurance Department shall periodically prepare summaries of significant corrective action documents and submit them to the NSRB and apprentiate levels of management.

l16.7 The closure of correctiva action documents shall ha accomplished as promptly as practicable but shall occur only after the corrective action taken has been verified.

Verification may be accomplished through direct observations, written communications, re-audit, surveillances, or other appropriate means.

The nature of the deficiency may be such that remedial actions need to be taken immediately whereas development and implementation of corrective action to preclude recurrence may take substantially longer.

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

Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trends through routine audit and surveillance activities; and shall report the results of these assessments to management.

16-2 Rev. 13 6/90

OCAM 17.0 QUALITY ASSURANCE RECORDS l1851 17.1 Quality assurance record systems governing the 2130 collection, storage, and maintenance of. records 12173 shall be established by UE.

They shall apply to i

records associated with startup testing, operation, maintenance, repair, refueling, and modification of safety-related structures, systems, and components at the Callaway Plant.

11140 17.2 During the operating phase, quality assurance 1150 records shall be maintained to furnish documentary

'l1851 evidence of the quality of items and activities 2128 affecting quality.

Applicable design specifica-2132 tions, procurement documents, test procedures, 2138 operational procedures or other documents shall 12173 specify the quality assurance records to be gener-ated by, supplied to, or held by UE.

Documents shall be considered quality assurance records when completed.

Records may be maintained for varying peric4 and shall be identified as lifetime or nonpermanent records in that a lifetims or finite 2133 retention period shall be specified.

Records shall 2137 provide sufficient information to permit identifica-tion to the item or activity to which it applies, and be retrievable.

'1139 17.3 Quality assurance records include, but are not 1140 limited to, operating logs; maintenance and modifi-2337 cation procedures and inspection results; reportable l

2364 occurrences; results of reviews; inspections, teets, 2666 audits and material analyses; qualification of 2681 personnel, procedures, and equipment; and other documentation including

drawings, specifications, procurement documents, nonconformance documentation, s

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

4 1935 17.4 Inspectibn and test records shall contain the 1936 following as a minimum 1.

A description of the type of observation 2.

The date and results of the inspection or test 3.

Identification of the inspector or data record-eT 4.

Evnluation of the acceptability of the results 5.

Action tnken in connection with any deficien-cies noted 17.5 Quality assurance records generated by others are transferred or made accessible to UE as systems and equipment or services are transferred or delivered from A/fj's, NSSS suppliers, fuel fabricatcts, 17-1 Rev.-13 6/90

OQAM constructors, or others.

Records maintained by an i

outside organization prior to and subsequent to final transfer are required to be accessible to UE.

Records generated internally shall be processed in a timely manner in accordance with documented proce-i dures.

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

The implementing procedures shall address records administration; receipt of records; storage, preservation 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 generated,

received, and tempo-l rarily stored at the General Offices.

Tne I

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

2135 17.7 The requirements regarding hard-copy records admin-2169 istration shall require that quality assurance 2150-records be listed in an index.

The index shall be established prior to the receipt of records and shall indicate the location of records.

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

The distributing and handling of

records, the correcting or supplementing of quality assurance
records, and specifying the retention period of record types shall be delineated in written proce-dures.

The retention period of records generated prior to commercial operation shall begin on December 19, 1984; the date of commercial operation.

2145 17.8 The requirements regarding receipt of records shall-2146 define the requirements for the receipt of documen-tation 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.

2148 The records' receipt control shall permit an assess-ment of the status of records during the receiving process.

  • 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 EO programs use the PSC date.

Refer to UO 86-107.

17-2 Rev. 13 6/90

OQAM i

2150 17.9 The requirements regarding storage, preservation, 2151 and safekeeping of records shall establish storage 12152 requirements for-the maintenance, preservation, and j

2153 protectior, of quality assurance records.

These 2155 requirements shall include methods for maintaining j

control of, access to, and accountability for i

records; storing records in a manner to preclude deterioration; and providing record storage heili-ties which protect _ contents from possible destruc-tion by causes such as fire.

An alternative to the establishment of. a single record storage facility i

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 temperature and r

humidity.

2157 17.10 Record storage systems shall provide for an accurate 2159 retrieval of information 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 '.ifetime records for the life of the items involved or for designated retention times for nonpermanent records.

2160 17.11 Record disposition practices shall establish re-2161 quirements for the transfer of records from c,aers

~

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.

J t

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00AM 1

3869 18.0 AUDITS i

2186 18.1 A comprehensivo audit program shall be established 2199 and implemented by UE to verify internal and exter-2978 nal quality activitics' compliance with the 00AP.

2988 The audit program shall assure that all applicable 3586 elements of the Program have been developed, docu-3865 mented, and are being effectively implemented and 3867 shall provide for the reporting and review of audit 3883 results by management.

The audit system is de-141949 scribed in manuals and procedures.

Nonconformances i

and program deficiencies shall be identified and corrective action shall be initiated and verified.

See Section 3.13 for a specific audit topic.

I 324-18.2 The UE audit system shall include the performance of audits and surveillances by the Quality Assurance and Quality Services Departments.

Audits determine, through investigation, the adequacy of and adherence to established procedures, instructions, specifica-tions, codes, and other applicable contractual and licensing requirements and the effectiveness of implementation.

Surve111ances involve the periodic or continuous monitoring of the operation or perfor-mance of a supplier,

item, component, or system.

Surveillance in this audit sense should not be i

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).

0A and OS personnel performing surveil-lances should be familiar with the area to be surveilled and the applicable implementing proce-dure (s) governing surveillances.

Surveillances may i

also be performed by' personnel from other organiza-tions, but these require no unique personnel quali-fications or certifications (except when performed for product acceptance).

Soo Sections 10.7, 10.8, 11.4, 11.6, and 18.4.

2244 18.3 The Manager, Quality Assurance shall establish-a 2250 program which provides for the qualification and 2255 training of QA and OS Department audit and surveil-2963 lance personnel.

Audits shall be directed by an 3866 Audit Team Leader (ATL) who is a certified Lead 3877 Auditor.

A Lead Auditor is an individual certified as qualified to direct an audit, perform an audit, report audit findings, and to evaluate corrective l

action.

Other personnel may assist Lead Auditors in the conduct of audits; namely, technical special-ists, management representatives, auditors and other 18-1 Rev. 13 L

L 6/90

i 00AM 1818 Lead _ Auditors.

The persons having direct responsi-bility for performance of the activities being audited shall not be involved in the selection of I

the' audit team.

Personnel selected for QA cuditing 3892 or surveillance assignments shall have training or i

experience commensurate with the scope, complexity, or special nature of the activities to be reviewed or investigated and shall have no direct responsi-bility for the area being evaluated.

The QA person-nel training program shall provide general orienta-tion and specific training which develop competence for -performing audits or surveillances.

Training records shall provide a history of OA personnel

training, evaluations, qualification, certifica-3 tions, and retraining.

1 12245 18.4 Quality Assurance and Quality Services personnel who 2246 perform audit and surveillance activities shall be 12:47 qualified in accordance with the requirements pre-2259 scribed in Quality Assurance Department procedures.

f 3866 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 qualifi-cation examination, and other factors rpplicable to auditing not defined by procedure.

The qualifica-3 2244 tion certification of Lead Auditors shall be based r

on (a evaluation of these factors by the Manager, Quality Assurance.

The maintenance of proficiency 2253 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 00AP; or partic-ipation in training programs.

The Manager, Quality 2249 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 cortification.

However if at anytime the Lead Auditor's performance is evaluated as being unacceptable, Lead Audi,0r certification shall be a

2254 rescinded.

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

If certification is rescinded or revoked, requalifi-cation shall be required prior to recertification, a

3865 18.5 The Manager, Quality Assurance shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OOAP.

The

Manager, Quality Assurance has sufficient authority and organizational freedom to schedule and perform both internal and external l

l 18-2 Rev. 13 1

6/90 1

00AM audits.

He has the organizational res ponsibility to measure and assure the overall effect:.veness of the 00AP and is independent of the economic pressures of production when opposed to safety or quality.

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

The Senior Vice President-Nuclea'r has direct access to the President, l

l 18.6 The Manager, Quality Assurance is responsible to the-Senior Vice President-Nuclear for assuring the OOAP-is being effectively implemented for operating activities and supervises Superintendents, Quality k

Assurance who direct full attention to this effort.

The Manager, Quality Assurance shall be knowledge-

<.m able and experienced in nuclear power plant activi-ties and shall bear no cost, schedule, or production responsibilities.

He reports _on.the Program effec-tiveness directly to the Senior Vice President-Nuclear.

A communication path shall exist between the Manager, Quality Assurance and General Manager,

~~

Nuclear Operations, the Manager, callaway Plant and the Manager, Operations Support as well as the other Department Heads in the Nuclear Division thus providing a direct path to inform management regard-ing conditions affecting quality.

3871 18.7 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 00AP,- and overall coordination. and 7

scheduling of audit activities.

The

Manager, Quality Assurance shall review the 00AP audit program annually to assure audits are being accom-plished in accordance with the requirements de-scribed herein, j

1792 16.8 Internal audits shall be conducted by the Quality 7

3816 Assurance Department and shall be performed with a 3873 frequency commensurate with their safety signifi-cance.

An audit of safety-related functions shall be completed in accordance with formal audit sched-ulos within a period of two (2) years.

Each element of the 00AP, such as design control and document control, and each area of Plant operations shall be o

audited.

2666 18.9. Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be 2847 audited at the frequencies indicated in Section 3873 6.5.2.9 of the Technical Specifications and under i

141777 the cognizance of the NSRB.

In addition to audits conducted under the cognizance of the NSRB, the following areas shall be audited at least once per 12 months.

18-3 Rev. 13 6/90

i 00AM Special Nuclear Material Accountability program Radiological Protection program Radiological Emergency Response program Security program

-Fitness-For-Duty program l

i 3873 18.10 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements are properly implemented.

3577 18.11 External audits shall be conducted by or for the Quality Assurance 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 verifi-cation in lieu of UE performed audits and may not necessarily audit specific items furnished to UE.

Audits and surveillances may also be performed for the Quality Assurance Department by the Quality Services Department.

These audits and surveillances shall utilize personnel qualified in accordance with this 00AM and shall be conducted in accordance with this 00AM and Quality Assurance Department proce-dures.

Commercial grade items do not require l

pro-or post-award audits.

Similarly, items which are relatively simple and standard in design and 3

manufacture may not require supplier qualification or post-award audits to assure their quality.

1780 18.12 Applicable elements of suppliers' quality assurance 3578 programs shall be audited (post-award) on a trienni-3872 al 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 which significantly enlarge the scope of activities by the same supplier shall be considered in establishing audit require-ments.

In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the OA - or OS Department that the results of mini-audits performed during source inspection and source surveillance activities confirm the adequacy and implementation of the supplier's OA Program.

18 4 Rev. 13 6/90 U

OOAM 18.13 Supplementary to

audits, annual evaluations of suppliers shall be performed which take into ac-count, as applicable:

1) the review of supplier furnished documents such as certificates of confor-

mance, nonconformance
notices, and corrective actions; 2) results of previous source verifica-tions, audits, and receiving inspections; 3) operat-ing experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources.

3872 18.14 Audits shall also be conducted when:

1) significant 3875 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)

I g

when a. systematic, independent assessment of Program effectiveness is considered necessary; or 4) when it is necessary to verify implementation of required corrective action.

The NSRB shall selectively review audit reports _ of onsite audits.

The NSRB shall also periodically _ review the onsite audit program as developed by the Quality Assurance Department, to assure that audits are being per-formed in accordance with Callaway Plant Technical Specification requirements and the 00AP.

Appro-priate levels of management shall be provided copies of internal and external audit reports.

The audits described in the Callaway Plant Technical Specifica-tions which are performed under the cognizance of the NSRB shall be conducted by the Quality Assurance Department.

3876 18.15 Audits shall be conducted using written plans in 3878 accordance with Quality Assurance Department proce-3881 dures.

The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for quality-related practices, procedures, and instructions to determine the effectiveness of the implementation of the 00AP and compliance with 10 CFR 50, Appendix B and the Callaway Plant Technical Specifications.

o The audit plan shall identify the audit scope, the l'

requirements, the activities to be audited, organ-izations to be notified, the applicable documents, the schedule, and the written procedures or check-L lists as appropriate.

The audit plan and any necessary reference documents shall be available to 1:

the audit team members.

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3877 18.16 An audit team consists of one or more auditors.

A Lead Auditor shall be appointed Audit Team Leader.

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

~

mance, post-audit conference, reporting,
records, and follow-up activity to assure corrective action.

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

When a

post-audit conference is held it shall be, to l

t discuss items and arrive at a general agreement on-the identification of the findings.

Formal audit reports shall be prepared and submitted to the audited organization within thirty days after the post-audit conference or last day of the audit, whichever is later.

18.17 Audit results shall be periodically reviewed by the Quality Assurance Department for quality trends and overall Program effectiveness.

Results of these reviews shall be reported to appropriate management in periodic summary reports of audit activities.

A 18-6 Rev. 13 6/90

r OPERATING QUALITY ASSURANCE MANUAL (OOAM)

APPENDIX A OOAM CONFORMANCE TO APPLICABLE NRC REGULATORY GUIDES i

This Appendix briefly discusses the extent to which Union Electric's Operating Quality Assurance Program (OOAP) conforms to NRC publ3 Sned Regulatory Guides for the Callaway Plant.

Clarifications, alterna-

tives, 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 Analy-sis Paports (FSARs).

In each of the ANSI standards referenced by one of the listed Regula-tory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either identified at the point of reference or are described in a special section of the standard.

The specific applicability or acceptability of these listed standards, codes regulations or appendi-ces is either covered in other specific areas in the FSAR or this Operating QA Manual (OOAM), 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.

REGULATORY GUIDE 1.8

  • PROPOSED REVISION 2
  • DATED 2/79
  • Revision 1

dated 9/75 for the position of Radiation Protection Manager only, in accordance with the Callaway Plant Technical Specifi-cations.

Personnel Selection and Training (Endorses ANSI /ANS 3.1-1978)

DISCUSSION:

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

Refer to Callaway-SA FSAR Section 13.1 for a discussion of the quali-fications 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..

A-1 Rev. 13 6/90

OQAM APPENDIX A-REGULATORY GUIDE 1.8 (cont.)

With regard to section 5.2 titled Training of Candidates to be Licensed by the NRC and section 5.5, Operator Retraining and Replacement Training of ANSI /ANS 3.1-1978:

In lieu of the training and retraining requirements for licensed reactor operators and senior reactor operators outlined in these sections, UE shall follow training and qualification in accordance with INPO accredited programs 1

referenced in Chapter 13.1 of the FSAR.

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

UE may use additional non-Callaway employees or contract personnel to augment the unit staff.

These persons may or may not report to the Manager-Callaway Plant.

These groups include, but are not limited to, UE personnel from other plants as well as supplemental HP cnd ItC technicians and QC inspectors.

When used to perform safety-related activities, these personnel shall meet the education and experience requirements of ANSI /ANS 3.1 1978 for equivalent positions or else they shall meet the requirements for certification as inspection, examAnation or testing personnel as set forth in UE's commitment to ANSI N45.2.6-1978 given elsewhere in this Appendix.

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

(Endorses ANSI N4 5. 2-197 7)

DISCUSSION:

This Regulatory Guide is not applicable to the operating phase.

However, ANSI N45. 2-1977.will be applied to suppliers of safety related items, components or services, as appropriate, as described under Regulatory Guide 1.123 (ANSI N45.2.13-1976).

REGULATORY GUIDE 1.30 INITIAL ISSUE DATED 8/72 Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electronic Equipment (Safety Guide 30)

(Endorses ANSI N45.2.4-1974/IEEE 336-1971)

DISCUSSION:

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

A-2 Rev. 13 6/90

OQAM APPENDIX A REGULATORY GUIDE 1.30 (cont.)

For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) chall apply to these maintenance and modifi-cation activities even though such requirements may not have been in effect originally.

Technical requirements associated with the mainte-nance 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.

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 l

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.

1 Section 2.1 Planning 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 CA/QC involvement and are subject to QA audit.

Proce-dures 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, OA audits and surveillances, and OC. inspection activities assure QA/QC involvement.

Section 2.3 - Procedures and Instructions shall be implemented as set forth in 00AM Sections 2,

3, 5,

10 and 11 and by compliance with the Callaway Plant Technical Specifications and Regulatory Guide 1.33 (ANSI N18.7) as set forth in this Appendix in lieu of the requirements set forth here.

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

callaway Plant Technical Specifications) is referenced, UE has substi-tuted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards.

Results shall be implemented as set forth in OQAM

'Section 2.4 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 overy case either identical or equivalent controls are provided in the sections c f the referenced Standards or documents.

Section 2.5.2 Calibration and Control covers three classes of instrumentation used by UE: (1) M&TE (portable measuring instruments, test equipment, tools, gages, and non-destructive test equipment used an measaring and inspecting safety-related structures, systems, and componr.n ts) ;

(2) reference standards (primary, secondary,

transfer, tand working); and (3) permanently installed process instrur.entation (PI).

A-3 Rev. 13 6/90 l

F i

OOAM APPENDIX A REGULATORY GUIDE 1.30 (cont.)

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

With respect to the last sentence, personnel shall be trained and proce-dures shall require that the calibration label or tag shall be re-viewed 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 of items to indicate the calibration date and the identity of the person who performed the calibration.

Permanently installed process instrumenta-tion shall comply with sentences 1, 2, and 5.

Section 3

Preconstruction Verification shall be implemented as follows:

(1) shall be required only for modifications (2) shall be impicmented with the clarification that " approved instruction manuals" shall be interpreted to mean the manuals provided by the supplier as required by the procurement order - these manuals are not necessarily reviewed and approved, pe r se, by UE: (3) no special checks shall be required to be made by the person withdrawing a replacement part from equivalent controls are assured by compliance with the warehouse 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.

Engineer-ing actions performed in accordance with this Section of the Standard 1

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, OA audits and surveillances, and QC inspection activities assure OA/QC involvement.

Installation shall be implemented as stated and as fol-Section 4 lows:

Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to OA 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, OA audits and-surveillances, and QC inspection activities assure OA/0C involvement.

A-4 Rev. 13 6/90 l

APPENDIX A p

REGULATORY GUIDE 1.30 (cont.)

l Section 5.1 Inspections, including subsections 5.1.1, 5.1.2, and the first sentence in 5.1.3, shall be implemented as set forth in OQAM c

section 10.

The inspection program shall incorporate, as determined by engineering and OC, 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 requirement.s 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 11.

In some cases Surveillance testing may be used to meet the appropriate requirements of this Section.

i Section 6 - Post-Construction 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 de-scribed in this Section shall be used in the development and implemen-tation 'of inspection and testing programs as described in OOAM Sec-tions 3, 10 and 11.

Section 7-Data Analysis and Evaluation shall be implemented as' stated herein after adding the clarifying phrase "Where used" at the i

beginning of the paragraph.

This clarification accounts for the fact that some usting will not generate " Data" as such.

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

REGULATORY GUIDE 1.33 REVISION 2 DATED 2/78 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."

A-5 Rev. 13 6/90

OOAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

Paragraph C.4.a of Regulatory Guide 1.33 (and Section 4.5 of ANSI N18.7 which it references) shall be implemented as required by the applicable Callaway Plant Technical Specifications which define the

" audit program" to be conducted.

The audit program is further defined and shall be implemented as required by the commitment to Regulatory Guide 1.144 (ANSI N45.2.12) as stated in this Appendix.

Paragraph C.5.d of Regulatory Guide 1.33 (and Section 5.2.7.1 of ANSI I

N18.7 which it references) shall be implemented by adding the clarify-ing 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/0C involvement and are subject to CA 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 sur-veillances, and OC inspection activities assure QA/QC involvement.

Paragraph C.5.e of Regulatory Guide 1.33 and section 5.2.13.4 of ANSI N18.7 which i' references shall be implemented subject to the same clarificationr 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 which it references) shall be implemented with the substi-tution 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 Organi::ation, and includes OA/0C involvement.

QA is involved through audit and surveillance activi-ties.

QC is involved in maintenance inspection activities.

l Paragraph C.5 9 of Regulatory Guide 1.33 (and Section 5.2.19.1 on ANSI l

N18.7 which 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 manage-ment personnel.

Management personnel includes QA through cross-disciplinary reviews and through QA permanent membership cn the-Callaway Onsite Review Committee.

0A has and shall conduct audita or surveillances of preoperational testing.

In cases where conditions do l

not fully comply, the reason for the exception shall also be documen'.-

ed.

The documentation shall be retained as lifetime records.

1 l

l A-6 Rev. 13 6/90

OOAM APPENDIX A j

REGULATORY GUIDE 1.33 (cont.)

With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Requirements i

for the Onsite operating Organization:

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 i

forth in 00AM Section 2,

in the callaway Plant Technical Specifica-tions, and in other licensing commitments.

Some of UE's technical support organizations sre physically located at the Callaway site.

Therefore the second sentence of this Section shall be implemented as follows: " Initial incumbena 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 provi-sions of ANSI /ANS 3.1 - 1973 as committed to in the 00AM."

In the third sentence, UE interprets "0A" to be "0C",

consistent with the intent of Regulatory Guide 1.58 (ANSI N45.2.6-1978) and the 00AM.

1 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 Regulatoq Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, 00AM Section 18, and the Callaway Plant Technical Specifications.

With regard to Section 4.2 of ANSI N18.7 1976 titled Program De-scription:

Two aspects are addressed in this Section:

audits and independent reviews.

The independent review program shall be imple-mented as required by the Technical Specifications.

The UE audit program shall be described in accordance with and to meet the require-ments of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this

Appendix, the Callaway Plant Technical Specifications, and OOAM Section 18.

1976 titled Independest With regard to Section 4.3 of ANSI N18.7 Review Process:

The requirements of this Section, including of iIii subparts, shall be met by compliance with the Technical Specification requirements and the 00AM.

With regard ta E :Livu 4.5 of ANSI N18.7 - 1976 titled Audit Program:

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, the 00AM, and the Callaway Plant Technical Specifications.

1976 titled Program De-With regard to Section 5.1 of ANSI N18.7 scription:

The fourth sentence in this Section requires a " summary document."

UE's OOAM is organized in accordance with the 18 criteria of 10 CFR 50, Appendix B.

UE interprets this OOAM and applicable Regulatory Guides as endorsed in this Appendix to fulfill the require-ments for a " summary document."

A-7 Rev. 13 6/90

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

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 Equipment Controls UE shall comply with the " independent verification" require-ments based on the definition of this phrase as given under our commitment to Regulatory Guide 1.74 in this Appendix.

Since UE sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with:

" Suitable means include identification numbers or other descriptions which are trace-able to records of the status of inspections and tests."

The first sentence in the seventh paragraph shall be met after clari-fying " operating personnel" to mean trained employees 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 only required for modifications and maintenance that are similar in nature and extent to original construction activities.

This makes this Section consistent with Section 5.2.17 of the Standard, opera-tional inspection requirements shall be in accordance with UE's commitment to Section 5.2.17 of the Standard and, in conjunction with the use of qualified maintenance personnel and approved procedures, shall assure quality at least as good as 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 senten::e in the second paragraph which reads:

"Except in emergency or abnormal operating conditions where immediate actions are required to protect the health and safety of the public, to protect equipment or personnel, or to prevent the deterioration of Plant conditions to. a possibly unsafe or unstable level, maintenance or modification of equipment shall be preplanned and performed in accor-dance with written procedures.

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

A-8 Rev. 13 6/90

OQAM APPENDIX A REGUI.ATORY GUIDE 1.33 (cont.)

With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 titled Maintenance Programs:

UE shall comply with the requirements of the first sentence of the fifth paragraph, where practical.

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

UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical.

QA is involved via both audits and surveillances, and OC is involved in inspection of maintenance inspection activities.

Witt regard to Section 5.2.8 of ANSI N18.7 - 1976 titled Surveillance i

Testing and Inspection Schedules In lieu of a " master surveillance sch9dule," the following requirement shall be met: " Schedules shall be established reflecting the status of in-plant surveillance tests and schaduled inspections."

With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled Plant Securi-ty 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 refer-

enced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards.

1976 titled Housekeep-With regard to Section 5.2.10 of ANSI N18.7 ing and cleanliness control:

The requirements of this

section, beginning with the last sentence of the first 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 Regulato-ry 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 Procure-ment 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 q

review and approval by the originating organization and QA review.

With regard to Section 5.2.17 of ANSI N18.7 - 1976 titled Inspection:

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 the record.

However, records of inspections shall be identifiable and retrievable.

3 A-9 Rev. 13 6/90

f l

OOAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)_

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, equipment and procedure qualification shall be defined by engineering.

With regard to Section 5.3.5 (4) of ANSI N18.7 - 1976 titled Support-ing Maintenance Documents:

UE may choose to include material from vendor manuals in any of three ways.

(1) The applicable section of a manual may be duplicated, referenced in, and attached to the proce-dure.

(2)

The procedure may reference the technical manual or a specific section; the manual may then be used in conjunction with the procedure for - performing the activity.

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

In options (1) and (2) above, the material shall be considered as having received "the same j

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.

1976 titled Emergency With regard to Section 5.3.9 of ANSI N18.7 Procedures:

UE's Emergency Procedures are in the format specified by the NRC in the Callaway Safety Evaluation Report, as required for issuance of the operating License, in lieu of the recuirements given here.

)

With regard to Section 5.3.9.2 of ANSI N18.7 - 1976 titled Events of Potential Emergency:

The licensing FSAR identified natural occurrenc-es which affect the Callaway Plant.

Therefore,. UE shall interpret item (11) to mean the natural occurrences which were evaluated in the licensing FSAR.

I i

With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Procedures

.for Implementing Emergency 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 Radiation Emergency Response Plan) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in i

lieu of the general requirements of the Quality Assurance Program standards.

J A-10 Rev. 13 6/90

x 00AM i

APPENDIX A o

~

INITIAL ISSUE DATED 3/73 REGULATORY GUIDE 1.37

' Quality Assurance Requirements for C1 caning 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 clarifications:

For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that-QA programmatic / administrative requirements included therein (subject to i'

the clarifications below) shall apply to these maintenance and modifi-cation activities even though such requirements may not have been in effect originally.

Technical requirements associated with maintenance and modifications shall be equal.to or better than the original requirements (e.g.,

code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.

Specific clarifications for this Regulatory Guide and ANSI N45.2.1 -

1973Property "ANSI code" (as page type) with input value "ANSI N45.2.1 -</br></br>1973" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. are indicated belcw by Sections.

With regard to Paragraph C.3 of Regulatory Guide 1.37:

The water quality for final flushing of fluid 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 flush water.

With re' "d to Paragraph C.4 of Regulatory Guide 1.37:

Expendable materialt

.ch as inks and related products; temperature indicating sticks; tay < :

gummed labels; wrapping materials (other than polyeth-ylene); wate. soluble dam materials; lubricants; NDT penetrant materi-als and couplants, dessicants, which contact stainless steel or nickel alloy surfaces shall not contain lead, zinc, copper, mercury, cadmium and other low melting points metals, their alloys or compounds as basic and essential chemical constituents.

No more. than 0.1 percent (1,000 ppm) halogens shall be allowed where such elements are leachable or where they'could be released by breakdown of the com-pounds under expected environmental conditions.

j.-

A-11 Rev. 13 6/90

00AM APPENDIX A REGULATORY GUIDE 1.37 (cont.)

With regard to Section 5 of ANSI N45.2.1 1973 titled Installation Cleaning:

The recommendation that local rusting on corrosion resis-tant alloys'be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but tSe 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 OA/0C 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 (OA is a permanent member of this committee).

For other activities, OA audits and surveillances, and OC inspection activities assure OA/0C involvement.

REGULATORY GUIDE 1.38 REVISION 2 DATED 5/77 Quality Assurance Requirements for Packaging,

Shipping, Receiving, Storage, and Handling of Items 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 Definitions:

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

With regard to Section 2.1 of ANSI N45.2.2 1972 titled Planning:

(First sentence) The specific items to be governed by the standard shall be identified in Callaway-SP FSAR Table 3.2-1, which lists those structures, systems and components to which the UE OA 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 documents.

With regard to Section 2.4 of ANSI N45.2.2 1972 titled Personnel Qualifications:

Specific requirements for personnel qualifications are set forth in the 00AM 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 of the referenced Standards or document.

A-12 Rev. 13 6/90

l OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

With regard to Section 2.7 of ANSI N45.5.2.2 - 1972 titled Classifica-tion of Items:

UE may choose not to explicitly use the four level classification system.

However, the specific requirements of the Standard that are appropriate to each class are generally applied to the items suggested in each classification and to similar items, as determined by engineering.

Engineering actions performed in accor-dance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

Procedures for these activi-ties receive a cross-disciplinary review as well as review by the Onsite Review Committee (OA is a permanent member of this committee).

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

1972 titled Level A With regard to Section 3.2.1 of ANSI N45.2.2 Items:

As an alternate to the requirements for packaging and contain-crizing items in storage to control contaminants (Items (4) and (5)),

UE may choose a storage atmosphere which is free of harmful contami-nants in concentrations that could produce damage to stored items, as determined by engineering.

Similarly (for Item (7)) UE may obviate the need for caps and plugs, as determined by engineering, with an appropriate storage atmosphere, and may choose to protect weld-end preparations and threads by controlling the manner in which the items are stored.

These c?rrifications apply whenever items (4), (5) or (7) are subsequently referenced and to Section 3.5.1 titled Caps and Plugs and. Section 3.4 titled Methods of Prevention.

Engineering actions performed in accordance with this section of the Standard are conduct-ed 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.

1972 titled Cleaning With regard to Section 3.3 of ANSI N45.2.2 (Third sentence) UE interprets " documented cleaning methods" to allow generic cleaning procedures to be written which shall be imalemented, as necessary, by trained personnel.

Each particular cleanang opera-tion 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.

1972 titled Methods of With regard to Section 3.4 of ANSI N45.2.2 Preservation:

(Pirst senten @) UE shall co.nply with these require-ments 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.

A-13 Rev. 13 6/90

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrier and Wrap Material and Dessicants:

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, cheathed boxes may be used up to 1000 lbs.

rather than 500 lbs.

as specified in 3.7.1(1).

This type of box is safe for, and has been tested for, loads up to 1000 lbs.

Other national standards allow this (see Federal Specification PPP-0-601).

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 Carriors:

The use of fully enclosed furniture 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 1

other environmental conditions by a combination of vehicle enclosure and item packaging.

With regard to Sections.

4.3, 4.4 and 4.5 of ANSI N45.2.2 1972 titled, respectively, Precautions During Loading and Transit,. Identi-fication and Marking, and Shipment from Countries outside the Unit-ed States UE shall comply with the requirements of these Sections subject to the clarifications taken to other Sections which are referenced therein, i

I With regard to Section 5.2.1 of ANSI N45.2.2 1972 titled Shipping Damage Inspection:

Stores personnel shall normally visually scruti-nize incoming shipments for damage of the types listed in this Sec-tion; this activity is not necessarily performed prior to unloading.

Since required items receive the Item Inspection of Section 5.2.2, separate documenterion of the Shipping Damage Inspection is not necessary.

Releas of the transport agent after unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the. Shipping Damage Inspection.

Any nonconformance noted shall be documented and dispositioned as required by 00AM 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 A-14 Rev. 13 6/90

OOAM i

APPENDIX A 1

4 REGULATORY GUIDE 1.38 (cont.)

i

~ additional inspection activities if an item was not inspected or i

examined at the source.

Engineering shall determine and document the

, extent of receipt inspection based on consideration of items in Section 5.2.2.

Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

Procedures for these activities receive a l

t 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.

j With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of Storage:

Subpart (2) is replaced with the following:

(2)

Level B

items shall be stored within a-fire resistant, weathertight, and well ventilated building or equivalent enclo-sure 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-l contact with stored equipment,such equipment shall be labeled or tagged nonconforming, and then the nonconformance document shall be processed and evaluated in accordance with OQAM Section 15.

Items shall be placed on pallets or shoring or shelves to permit i

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 manu-facturer.

s

'With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to Storage Areas:

Items which fall within the Level D classification 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.

Proce-dures 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 ANSI N45.2.2 - 1972 titled Storage of FoodLand Associated Items:

The sentence is replaced with the follow-ing:

"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."

Engineering actions performed in accordance with this section of the Standard are conduct-

-ed with QA/QC involvement and are subject to QA audit.

Procedures for these activities receive a cross-disciplinary review as well as review A-15 Rev. 13 6/90

p.

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

by the Onsite Review Committee (OA is a permanent member of this committee).

For other activities, OA audits and surveillances, and QC inspection activities assure OA/QC involvement.

1972 titled Measured With regard to Section 6.2.5 of ANSI N45.2.2

_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 contamination and mechanical damage to stored material."

With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Storage of Hazardous Materials:

The sentence is replaced with the following:

" Hazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed safety-related systems."

The placement of hazardous material storage lockers in the Plant is based upon installed safety-related systems, not particular components.

1972 titled Care of With regard to Section 6.4.2 of ANSI N45.2.2 I_tems:

The following alternates are provided for the indicated subparts:

(5)

"Srace heaters in electrical equipment shall be energized unless a documented engineering evaluation determines that such space heaters are not required."

(6)

"Large (greater than or equal to 50 HP) rotating electrical equipment shall be given insulation resistance tests on a sched-uled basis unless a documented engineering evaluation determines that such tests are not required."

(7)

" Prior to being placed in storage, large (greater than or equal to 50 HP or when designed to be used with a prime mover of greater than or equal to 50 HP) horizontal rotating equipment shall be evaluated by engineering to determine if shaft rotation in storage is required: the results of the evaluation shall be documented.

If rotation is required, it chall be performed at specified intervals, be documented, and be conducted so that parts receive a coating of lubrication where applicable and so that the shaft does not come to rest in the same position occu-pied 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 OOAM, Section 13.3.

1972 titled Removal of With regard to Section 6.5 of ANSI N45.2.2 Items from Storage:

UE does not consider the last sentence of this Section to be applicable to the Operating Phase due to the relatively short period of time between installation and use.

The first sentence A-16 Rev. 13 6/90

1 c

p OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

of the Section is replaced with: "UE shall develop, issue, and imple-ment a procedure (s) which cover (s) the removal of items from storage.

The procedure (s) shall assure that the status of material issued is known, controlled, and appropriately dispositioned."

1972 titled Storage l.

With regard to Section 6.6 of ANSI N45.2.2 Records:

UE shall comply with the requirements of this Section with the clarification that, for record purposes, only the access of non-UE

)

employees or contractors into indoor storage areas shall be recorded.

Unloading or pick-up of material shall not be considered " access," nor shall inspection by NRC or other regulatory agents, nor shall tours by non-UE employees who are accompanied by UE employees.

With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Inspection of Equipment and Rigging:

Stated for information only, it is UE's position that this relates to the opera-3 bility of the hoisting equipment and does not preclude rerating as allowed by Section 7.3.

REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 Housekeeping Requirements for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.3-lh75)

DISCUSSION:

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

For maintenance and modification activities UE shall comply with the Regulatory Positior stablished in this Regulatory Guide in that GA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modifi-cation activities even though such requirements may not have been in effect originally.

Technical requirements associated with the mainte-nance 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 - PlanninJ:

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 l

A-17 Rev. 13 6/90 o

1

OOAM APPENDIX A JtEGULATORY GUIDE 1. 39 (cont.)

Program requirements in the areas of housekeeping, Plant and parsonnel safety, and fire protection.

Cleanliness shall be maintained, consistcnt with the work being per-formed, so as to prevent the entry of foreign material into safe-ty-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 eatablished 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.

_ Procedures and Instructions:

Appropriate procedures Section 2.2 shall be written and implemented.

Section 3.2 - Control of Facilities:

UE may choore not to utilize the five-level zone designation system, but shall utilize standard janito-rial and work practices to maintain a level of cleanliness commensu-rate with Program requirements in the areas of housekeeping, Plant and personnel safety, and fire protection.

Cleanliness shall be maintained, consistent with the work being per-formed, so as to prevent the entry of foreign material into safe-ty-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, t

Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.

Section 4 - Records:

The requirements of OOAM Section 17 and Regula-tory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix chall 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.

Y A-18 Rev. 13 6/90

OOAM APPENDIX A REGULATORY GUIDE 1.58 REVISION 1 DATED 9/80 Qualification of Nuclear Power Plant Inspection,. Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)

DISCUSSION:

DE complies with the recommendations of this Regulatory Guide with the following. clarifications:

The qualification of UE QC or contracted QC personnel performing work at the Plant shall be in accordance with Regulatory Guide 1.58 (ANSI i.)'

N45.2.0-1978).

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).

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 exc.minations and evaluations of actual work proficiency that these individuals possess comparable or equiva-lent competence.

Persons performing Nondestructive Examinations (NDE)

Las may be required by1 Section III or XI.of the ASME B&PV Code shall be qualified.and certified as required by the Edition and Addenda of the Code to~ which UE is committed at the time the NDE is performed.

However, when qualifying personnel to perform visual examinations VT-2, VT-3, an'd VT-4 in accordance with IWA-2300 of Section XI, Division 1,

ANSI /ASME N45.2.6-1978 may be used inst'ead 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.

LWith regard to Section 1.2 of ANSI N45.2.6 -1978 titled Applicability:

.The third paragraph requires that the Standard be~used in conjunction with ANSI ~ N4 5,2 ; 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 applica-bility 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 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 commit-ment to Regulatory Guide 1.74.

A-19 Rev. 13 6/90

C' V

m OOAM APPENDIX A REGULATORY GUIDE 1.58 (cont.)

e 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 1

shall be.specified.

-The converse is also true:

if no special physi-cal requirements are stipulated by : UE, none shall be considered r.ecessary.

J REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 i

. Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.11-1974)

DISCUSSION:

UE complies with the recommendations of this Regulatory Guide.with the f611owing clarifications:

When uniqueness or special design considerations warrant or are judged to be appropriate, an independent third-level review may be employed.

j i

With regard to Paragraph C. 2 (1) of Regulatory Guide 1.64:

If - the l

designer's immediate Supervisor i ci the only technically qualified individual available, this review mat be conducted by the Supervisor, s

provided that:

(a) the other provisions of the Regulatory Guide are

'i satisfied and (b) the. justification 10 individually documented and y

l approved in ' advance by the Supervisor's management, and (c) quality assurance audits cover frequency and effectiveness of use of the Supervisors as design verifiers to guard against abuse.

With regard'to Section-1.4 of ANSI N45.'2.11 - 1974 titled 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 iniANSI N45.2.10 shall be used as-clarified in this Appendix.

With regard to the 4th paragraph of subsection 2.1 and subsection i

2.2.12, under Program Requirements, and Section 11 (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 this Appendix, OOAM Sections 16 and 18, and the requirements of the callaway Plant Technical Specifications.

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

A-20 Rev. 13 6/90 i

m

OOAM APPENDIX A I

REGULATORY GUIDE l'.74' INITIAL ISSUE DATED 2/74 Quality Assurance-Terms and Definitions (Endorses ANSI N45.2.10-1973)'

DISCUSSION:

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

- UE reserves the right to define additional words or phrases.which are not included in this Standard.

Such additional definitions shall be documented'in appropriate procedures or in Sections of the Operating.

QA Manual.

- In addition to the Standard's definition of " Inspection," UE shall use the following:

" Inspection (when used to refer to activities that.are Examining, viewing closely, NOT performed by QA or QC personnel) scrutinizing, looking over or otherwise checking activities.. Person--

nel performing-these functions are not necessarily certified to Regulatory Guide 1,58 (ANSI N45.2.6)."

These activities are con-trolled by the Calleway 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 definition of " procurement documents,"

UE shall utilize the definition given in ANSI N45.2.13.

The compound definition is.given as follows:

Procurement documents - Con crnutually binding documents that identify and define the requiremanho which items or services ^must meet in order to be considered acceptable by-the purchaser.

They may include documents which authorizc the seller-to~ perform services or supply equipment, material or facilities on-behalf of the purchaser (e.g.

Engineering Service Agreement agree-

=ments-for engineering, construction, or consulting services),

con-tracts,' letters of intent, purchase requisitions, purchase orders, or proposals and their acceptance, drawings, specifications, or instruc-

' tion which define requirements for purchase.

" Bids" et S u p p l i e r 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.

A-21 Rev. 13 6/90 Ir--

l OQAM APPENDIX A

_ REGULATORY GUIDE 1.74 (cont.)'

" 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 defined in ANSI N45.2.10-but used and defined dif ferently in ANSI.N45.2.13). - Those individual requirements of the Operating QA Program which, when invaked in total or in part, establish the requirements of the quality. assurance program for the-activity being-controlled.

Although not spacAfically used in the Operating QA Program, ANSI N45.2 may be imposed upon UE's suppliers.

I

" Independent Verification" - Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed.

Such verification need not require confirmation of the identical action when other-indications provide assurance or indication that the prescribed activity is in fact complete.

Examples include, but are not limited tot 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.been1 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 ' N4 5. 2.12 1977 (Regulatory Guide 1.144) and Section

1. 4. 3 o f ANSI N4 5. 2. 2 3 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 objective 1

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 effec-tively- ~ 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.

(Not defined in any ANSI Standard) - An internally auditable "Must" requirement imposed by UE management upon its employees, contractors, above and in excess of the legally binding requirements and agents of the appropriate regulatory body.

Such items are internally re-quired but not externally enforceable.

(See additional discussion under Section 2.'15 of the OOAM.).

l l

l 1'

A-22 Rev. 13 6/90 n.

e be

! i OOAM-APPENDIX A E

_-_ REGULATORY GUIDE 1.74'(cont.)

(Not defined in any ANSI standard)

Means.=those

" Unit staff" personnel who report to the General Manager, Nuclear. Operations. 1This term shall also-be synonymous with the "onsite operating-organization"

~ described (but not defined) in ANSI N18.7-1976, Section= 3. 4. 2; the

" unit staff" as' used in the OQAM and in Callaway Plant, Technical Specifications Section 6.3 and its subparts and Section 6.5.2.9;b; the

" unit organization" described in the Callaway Plant Technical Specifi-i cations Section 6.2.2.

"Like kind replacements" (Not defined in any ANSI standard)

,Like kind replacements include both exact item replacements and other item c

replacements which are not

" exact" but meet the original--design requirements.

y REGULATORY GUIDE 1.88 REVISION 2 DATED 10/76 r

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 Quality Assurance Records:

The phrase " completely filled out" is clarified to mean that sufficient information is recorded to fulfill the1 intended : purpose of the record.

It is the information, not the form, that is the record.

Thus the information, not the form, needs to be complete to furnish documented " evidence of activities affecting quality".

With regard to Section 3.2.2-of ANSI N45.2.9 - 1974 titled Index:

The phrase "an index" is clarified to mean a collection of documents or indices wnich, when taken together, supply the information attributed to "an index" in the Standard.

The specific location of a record "within a storage area" may no_t be delineated.

(e.g. The specific location 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 7

time, the specific. location of a record within that file may not M

,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 Section.

L A-23 Rev. 13 L

6/90 h

OOAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

The following clarification is substituted for the current subsection 5.4.3:

" Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microfilm and magnetic media)

.to prevent damage from excessive

light, stacking, electromagnetic fields, temperature and humidity as appropriate to the records type."

Consideration shall be given to manufacturer's recommendation.

With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safekeepin_g:

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.

1974 titled Facility:

With regard to Section 5.6 of ANSI N45.2.9 This Section provides no distinction between temporary and permanent facilities.

To cover temporary storage, the following clarification-is added:- " Active records (those completed but not yet duplicated or placed on microform) may be temporarily stored in one-hour fire' rated j

file cabinets.

In general, records shall not be maintained in such temporary storage for more than three months after completion without being duplicated (for dual storage) or being placed on microform.

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, audit or master surveillance schedules)"quipment histor e and those which are cumulative in nature (e.g. nonconforming item logs and control room log ~ books)--

are_not considered as QA records since they are not " complete." The'se types of documents shall become QA records when they are issued as-a specific - revision (e.g. -the master audit schedule); when they - are 1

filled-up or discontinued (e.g. log books or equipment history cards);

-on a-predefined periodic basis when the completed portion of the on-going _ document shall be transferred to document control as a -

re co rd " (e.g. training.and qualification records).

With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits:

These specific-activities in sub-sections 1,

2 and 3

are accomplished through the establishment of administrative

' controls by the t

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.

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 NRC Criteria for Records Storage Facilities (Guidance-ANSI N45.2.9, Section 5.6) issued 7/1/80.

A-24 Rev. 13 6/90 n

g, Li" OQAM APPENDIX A y

f REGULATORY GUIDE 1.88 (cont.)

i U

Paragraph 4, subsection 9 is clarified to read: "No pipes or penetra-tions except those providing fire protection, lighting, temperature /

humidity ~ control, or communications are to be located within the

. facility and they shall' comply with a minimum two-hour fire protection rating."

Where duplicato storage is employed, no special precautions or provi-sions (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 subsec-tion 5.4.3.

Both paragraphs addreas the same requirement and there-i

-fore the commitment must be the san.e.

REGULATORY GUIDE 1.94 REVISION 1 DATED 4/76 Quality? Assurance Requirements for Installation, Inspection and Testing of Structural Concrete and Structural Steel During the Con-

. struction Phase of Nuclear Power Plants.

(Endorses ANSI N45.2.5-1974)

- DISCUSSION:'

UE complies with-the recommendations of this Regulatory Guide with the 1following clarifications:

4 For-_ modification activities UE shall comply with the Regulatory Position-established in this Regulatory Guide in that QA

. programmatic /cdministrative requirements included therein - (subject to_

the clarifications below) shall apply to these modification activities even though such requirements may not have been in effect originally.

-Technical requirements associated with. modifications shall be. equal to 1

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 ot defects.

,The recommendations for structural concrete, structural steel, and other Plant components shall be met as indicated by the applicable-1 design documents with the fol' lowing exceptions:

-a.-

Bolts for friction type con ictions may be tightened using direct tension indicators an accordance with the AISC Specification for Structural Joints - Using ASTM A 235 or A 490' bolts, approved May 8, 1974.

j b.

Section 5. 4 (1) of ANSI N45.2.5 does not apply.

The require-ment for the acceptance of tightened bolt assemblies is:

"The length of the bolts shall be such that the point of the bolt shall be flush with or outside of the face of the nut when completely installed."

A-25 Rev. 13 6/90

OQAM APPENDIX A r;

REGULATORY ~ GUIDE 1.116 REVISION 0-R DATED 5/77

-Quality ; Assurance Requirements for Installation, Inspection, and Testing

_of Mechanical Equipment and Systems (Endorses ANSI l

'N45.2.8-1975)

' DISCUSSION -

UE complies ~with the recommendations of this Regulatory Guide with the j

following clarifications:

q

-For maintenance and modification activities UE shall comply with-the Regulatory Position established in this Regulatory Guide in that QA programmatic /adminTstrative requirements included ~therein shall apply i

to these maintenance and modification _ activities even though such f

requirements may not have been in effect originally.

Technical requirements associated with maintenance and. modificationo shall be equal to or better.than the original requirements (e.g., code require-monts, material properties, design margins, manufacturing processes, and irispection requirements), -or as required to preclude repetition of l

defects.

1 REGULATORY GUIDE 1.123 REVISION 1 DATED 7/77 1

Quality Assurance Requirements'for Control of Procurement of Items and Services for Nuclear Power Plants (Endorses ANSI N45.2.13-1976)

DISCUSSION:

UE. complies with the recommendations of this~ Regulatory Guide with the

'following clarifications:

1 With regard'to Section 1.3 of ANSI N45.2.13 - 1976-' titled Definitions:

}

With. two exceptions (Procurement Document and Quality Assurance Program - c 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.

4 With regard to.Section 1.2.2 of ANSI N45.2.13 -1976 titled Purchaser's 1

Responsibilities:

Item C is one of the options which may be used by J

UE to assure quality; however, any of the. options given in 10 CFR 50, Appendix B, Criterion VII as implemented by OQAM Sections 4 and 7 may also befused.

' With regard to'Section 3.1 of ANSI N45.2.13 - 1976 titled Procurement fdjacument Preparation, Review and Change Control:

The phrase "the same J

degree:of; control" is stipulated to mean " equivalent level of review and approval." The changed document may not always be re-reviewed by the originator; however, at least an equivalent level of supervision J

shall review and approve any changes.

A-26 Rev. 13 6/90

a

~

$hi?

OQAM-APPENDIX A REGULATORY GUIDE-1.123 (cont.)

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 re.ferenced documents.

With regard to Section 5.3 of ANSI N45.2.13 1976 titled Preaward Evaluation:

GE shall comply with an alternate paragraph which reads:

"Except in ur. usual circumstances (e.g. replacement parts are needed to preclude M.e - development of some - unsafe or undesirable condition at callaway), an evaluation of the supplier's acceptability as a procure-ment souece shall be performed as required by the Operating QA Manual."

While it is not the intent to make " unusual circumstances" 0

determjnations without Engineering or QA involvement, Callaway Opera-tions jupport is ultimately responsible for the decision.

QA audit and surveillance activities assure against abuse.

With regard to Section 6.4 Jof ANSI N45.2'.13 - 1976 titled Control of; Changes in Items of Services:

The phrase "the Operating QA Program"

'Is inserted in lieu of " ANSI N45.2, Section 7."

With regard to Section 8.2 of ANSI N45.2.13 - 1976' titled Disposition:

The third sentence of item b is revised to read:

3 Nonconformances to the contractual procurement requirements or Purchaser approved documents and_which consist of one or more of-the following shall be submitted to-the Purchaser for-approval of the recommended disposition prior to uhipment when the nonconfor-mance could adversely affect the end use of-a module

  • or shippa-ble component relative to safety, interchangeability,- operabili-ty, reliability, integrity, or maintainability:

1)

Technical or material requirement'is violated; o

2)

Requirement in Supplier documents, which have been approved by the Purchaser, is violated; i

3)

Nonconformance cannot be corrected by co'.. tinuation of the

['

original manufacturing process or by rework; and/or 4)

The item does not conform to the original requirement even though the item can be restored to a condition such that the

/

capability of the item to function is unimpaired.

l

  • A module is an assembled device, instrument, or piece of equip-is ment identified by serial number or other identification code, having been evaluated by inspection and/or test for conformance E

to procurement requirements regarding end use.

A shippable component is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an individual item and I

which has been evaluated by inspection and/or test for confor-l-

mance to procurement requirements regarding end use.

l A-27 Rev. 13 L

6/90

[.

I]

r OQAM APPENDIX A i

~

REGULATORY GUIDE 1.123 (cont.)

i With regard _ to Section 7.3.1 of ANSI N45.2.13-1976 titled Source

' Verification Activities and Section 12 of ANSI N45.2.13 - 1976 titled 1

Audit of Procurement Program:

The UE audit program shall-be F

implemented in accordance with and -to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed ~in this Appendix, OQAM Sections 16 and 18, and the requirements of the Callaway Plant Technical ~ Specifications..

REGULATORY GUIDE 1.144 REVISION 1 DATED 9/80 Auditing of Quality Assurance Programs for Nuclear Power Plants 4

(Endorses ANSI N45.2.12-1974)

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; definitions-which are included 'in ANSI

- N45.2.10 shall.be used as clarified in UE's commitment to Regulatory Guide 1.74.

The one excepted definition and a clarified definition (of audit) relevant to this Standard are defined in this Appendix under Regulatery Guide 1.74.

With rege:

to Section 2.1 of ANSI. = N45. 2.12-1977 titled General:

Identical r equivalent controls are provided in this ~ OQAM, Section 18.3 regarding the second. paragraph discussing audit team selection.

o With regard to Section 2. 2 o f.. ANSI N45.2.12 1977 titled = Personnel Qualification:

The qualification of UE audit personnel shall be accomplished as described to meet'the requirements of Regulatory Guide 1978) as endorsed in this Appendix and.OQAM 1.146 (ANSI N45.2.23 Section 18.

With regard to Section 2.3 (and subsections 2.2.1 through 2.3.3) of

'1977 titled Training:

The training of UE audit ANSI' N45.2.12

- 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 oersonnel shall.be accomplished as described to meet the requirements of Regula-tory Guide 1.146 (ANSI N45.2.23 1978) as endorsed in this Appendix and OOAM Section 18.

A-28 Rev. 13 6/90

t OOAM APPENDIX A.

REGULATORY GUIDE l'.144 (cont.)

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 Lthe auditing organization (UE), effectiveness shall be reported as required by the Callaway Plant = Technical Specifications.

Other than audit. reports, UE may not directly report on the effectiveness of the

{

quality. assurance programs to the audited organization when such organizations are outside of UE.

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

this operating QA Manual and the Callaway Plant Technical Specifi-cations.

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

. Subsection 3.3.7 requires verification.of effective corrective action on'a " timely basis. " Timely basis' is interpreted to mean within the framework or period of time for completion.of corrective action. that t

is accepted. by the Quality Assurance Department or-Quality Services'

'I Department.

Each finding requires a response and a corrective action

, completion date; these dates are subject to revision,(with the approval' of the Quality Assurance Department or Quality Services

. Department) and must be escalated to higher authority when there is a disagreement between the audited and the auditing organizations on

-what constitutes " timely corrective action.'"

.With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit

' Planning:

Identical or equivalent controls are provided in this OQAM, Section:18.

'With: regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Scheduling:

s Identical or equivalent controls are provided in this 00AM,-Section 18 for <the requirements of Subsections 3.5.1 and 3.5.2.

Subsection

'3. 5. 3.1 is interpreted to mean that UE may procedurally control

(

. qualification of a

contractor's or 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 00AM address--the-requirements of Subsection 3.5.3.1.

With regard to Section 4. 3.1 of ANSI N54.2.12 - 1977 titled Pre-Audit Conference:

UE shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the first sentence.

U

'This clarification is' required because, in the case of certain unan-nounced audits or audits of a particular operation or work activity, a pre-audit conference might interfere with the spontaneity of the 1

operation or activity being audited.

In other cases, persons who

~

.should be present at a pre-audit conference may not always be avail-able: such lack of availability should not be an impediment to begin-

.ning an audit.

Even in the above examples, which are not intended to i

a be. ' all inclusive, the materici set forth in Section 4.3.1 shall'

~

l m normally be covered during the course of the audit.

A-29 Rev. 13 c

p 6/90

?

+g 3

i OQAM APPENDIX A.

REGULATORY-GUIDE 1.144 (cont.)

!With regard to Section 4.3.2 of ANSI N45.2.12 1977 titled Audit Process

_ a). Subsection 4.3.2.2 could be interpreted to limit auditors to the

(

review of'only objective evidence; sometimes and for some Program-

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 = requirementet.

If subjective evidence is used (e.g. personal interviews, direct observations by the auditor),

then the audit report must indicate how the evidence was ob-i tained."

(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 identified as a result of an audit, unless.the apparent.cause, extent, and corrective action are--readily-evident, further investigation shall be i

conducted by the audited organization. in an effort to identify the cause and effect and to determine the extent of the correc-tive action required."

(c)

Subsection 4.3.2.5 contains a recommendation which is clarified with the definition of " acknowledged by a member of the audited organization" to mean that "a member of the. audited organization has been informed of the findings."

Agreement _or disagreement with a finding may be expressed in-the' response from the audited organization.

(d)

Subsection 4.3.2.6 is modified'as follows to account for the fact that immediate notification is not'always possible:

" Conditions requiring immediate ' corrective action ' (i.e.

those which are so severe that any delay. would be undesirable) 'shall be reported immediately to the audited organization and as soon as practical-i to the management thereof."

1977 titled Post-With regard to' Section

4. 3. 3 of ANSI N45.2.12 Audit Conference:

UE ' shall' substitute and comply with the following

-paragraph:'

"For external audits, a. post-audit conference shall be.

4 held. with management of the audited organization to present audit findings and clarify misunderstandings; where no adverse findings

exist, this conference - may be waived by 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 confer-ence: such waiver shall be documented in the audit report."

l A-30 Rev. 13 q

6/90

m OQAM APPENDIX A LREGULATORY GUIDE 1.144 (cont.)

n WithlregardLto Section 4.4 of ANSI N45.2.12 - 1977 titled Reporting:

'(a)

Thi's Section requires that the audit report shall be signed-by the Audit Team Leader (ATL); this is not always the most expedi-tious route to take to assure that the audit report is issued as soon as practical.

UE shall comply with Section 4.4 as clarified i

in uthe following opening:

"An audit report, which shall be signed by the AuditsTeam 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 sha]l 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:

" Super-visory level personnel with whom significant discussions were held during the course of pre-audit (where conducted) audit, and s

post-audit (where conducted) activities."

i

+

(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 4

they shall provide.a summary of the: audited areas and the results which identify the importance of any adverse findings, s

II.-

With regard to Section 4.5.1 of ANSI N45.2.12 - 1977_ titled By Audited.

Organization: -UE shall comply with the following clarification of the e

Section:

Management of the audited organization or activity shall

-review and investigate adverse audit findings, as necessary, (e.g.

p where the cause.is not already known, another organization has not already investigated and found - the cause, etc.)

to - determine and schedule appropriate corrective action-including action to prevent recurrence.

They shall clearly state the correctivo action takenfor-

, planned to prevent recurrence and the results of the investigation,Eif conducted.

In.the event that ' corrective action is not completed within thirty days, the audited organization's response shall include 3

a scheduled date for completion of planned corrective action.

The audited organization-shall take appropriate action to assure that corrective action is accomplished as -scheduled.

~Since the auditing organization tracks scheduled corrective action completion dates and verifies corrective action completion, a follow-up response by the.

=I audited organization stating the corrective action taken and the date that s the action was completed is not necessary, provided corrective actions _ are completed 'as specified.

If corrective actions are not completed.as specified, the audited organization shall-provide a

(

l revised response stating the corrective action that has hen taken, the _ corrective action yet to be completed, and the date that all corrective action will be completed.

i A-31 Rev. 13 6/90 a

(.

s!

OQAM.

APPENDIX A REG 4LATORY GUIDE ~1.146 INITIAL ISSUE DATED 8/80 3

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

DISCUSSION:

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

With respect to Section 1.4 of ANSI.N45.2.23-1978 titled 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 Appendix under Regulatory Guide.1~.74.

q 9

With. respect to Section 2.2 of ANSI N45.2.23 - 1978 titled Qualifica-F tion of~ Auditors:

Subsection 2.2.,1 references an ANSI B54.2 (presumed 1

-to be standard N45.2); therefore, UE shall comply with an alternate p

subsection 2.2.-1 which reads:

~

Orientation to - provide a. Working knowledge and understanding of the Operating QA Manual, including the ANSI standards and Regula-tory Guides included' in this Appendix and UE's procedures for L

implementing audits and reporting results, l

With respect to Section

3. 2 of ANSI N45.2.23 1978-titled Mainte-nance 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 certifica-tion (not the calendar year) as the. starting date for determining when such annual assessment is1 due.

The combined time interval for any y

three consecutive assessment intervals shall not exceed 3.25 years.

4

\\

With respect.-to-Section 4.1 of ANSI N45.2.23 1978 titled'Organiza-tional Responsibility:

UE shall comply with this Section with the substitution of the fol' lowing sentence in place of the last sentence in the section.

The Manager, Quality Assurance; a Superintendent, Quality-Assur-ance; Supervising Engineer, QA; or Lead Auditor

t. hall, prior-to commencing the audit, assign personnel who collt.ctively have experience,or training commensurate with the scope, complexity, or special nature of the activities to be audited.

1 A-32 Rev. 13 6/90 o

j 1

N

OOAM

,i APPENDIX A REGULATORY GUIDE 1.146 (cont.)

With respect to Section 5.3 of ANSI N45.2.23 - 1978 titled Updating i

of Lead Auditor's Records:

UE shall substitute the following sentence L

for this section 1

-Records for each Lead Auditor shall be maintained r.n(t updated during the period of the annual management assessment as defined in Section 3.2 (as clarified).

i 1978 titled Records

.With respect to Section 5.4 of ANSI N45.2.23 Retention:

UE shall substitute the following sentence for. this.

Section.

'j Qualification records shall be generated and maintainea as-required by OOAM-Section 17 and by commitment to Regulatory Guide 1.88 (ANSI N45.2.9)-as clarified in this Appendix.

I In every case either identical or equivalent controls are provided in' I

the sections of the referenced Standards and documents.

l i

j i

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OOAM o;

them technical direction and administrative guidance.

He is responsible for establishing. and implementing a

comprehensive audit progran.

.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," Section 4.2.4 The

- - [QE'.t3-

Manager, Quality. Assurance is located at

.ehe-Callaway-Plant and provides technical direction and

' administrative guidance to the SuperintendentX, Quality Assurance and the Supervising

Engineer, Quality support, Quality Assurance, 2012 1.5 The Superintendent, ^perrten: Supperti QA r.f th: is.

s

. g pg Superi-terfert, T:25nical Suppert, 07 =: It,ccted at-

.Wo.

Callaway Plant.

Th;;;

C.p;; int;nf nt;

h Nt.directJSupervising Engineers who have primary duties for' assuring implementation of the OQAP.

The Super-vising Engineer, Quality Support,.QA, located at the-

-Callaway Plant, directs a group of ' engineers who provide additional support activities including

-maintenance of-the operating Quclity-Assurance Manual (OQAM).

The activities of the groups report-ing to the SuperintendentK combined: with the activ -

ities of the group reporting to the - Supervising Engineer, Quality Support assure implenntation of the. OOAP.

The qualifications of be4,h". Superinten-dent)( are at least equivalent to those specified in ANSI / Alls-3.1-19 7 8,

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

[q 1.6 The Manager, Quality Assurance, the Superintenient)(,

Quality Assurance, and Supervising Engineers in tne-Quality Assurance Deptrtment are authorized by the to step work on President-Nuclear $.n

. Senior Vice activities accor:.ance with ongoing quality 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 deficiency and preclude identification and correction, er increase the extent-of the deficiency is subject to stop-work action by the Quality Assurance Department.

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

6 1-2 Fev. JE E / 6,9e

h

.L

.oggg?

. M A 4/dbn t

's

~ management.-

The ' Manager, Licensing and Fuel:

is also responsible: for 1 coordinating licensing activi--

- ties for Callavay Plant.

The ' Licensing and Fuels organi:ation provides technical support activities r

in the area' of reactor design and. rad:.ological engineering.

1.12 The. ' Manager, Nuclear Services reports directly to

l.

the--Senior Vice President-Nuclear and'is responsible r

for providing administrative and' management support j

includingi cost forecasting, status reporting, and i

budgeting matters. He is responsible for direction

.of the Nuclear Division General Offices clerical activities,.

and serves as Principal Health Physicist.

.He is also responsible for the adminis-trative contact with the Institute of Nuclear Power

. Operations ( INPO ) -. -

As. Principal Health Physicist, r

-ne novides: a corporate level overview and guidance in the formulation and implementation of applied

=:

. radiation protection, programs and reviews.

the' l

radiological safety programs for compliance with:

j Federal and State standards and regulations..

}

l.13 The General Manager, Nuclear Operations reports to I

the Senior Vice President-Nuclear and'is responsible 4

for the activities of the Callaway Plant Operations Department and the Operations Support Department.

This responsibility includes the

safe, legal and i

efficient _ operation and maintenance of the Callaway y

Plant and protecting, the health and safety of the j

public and Plant personnel.

He assures a high level of quality is1 achieved in'the 5; ant operations and i

l support activities.

1.14 The. Manager,-Callaway Plant recorts directiv to the General. Manager, Nuclear Operations and is responsi-i ble'for theHsafe, legal, and efficient operat:.on and.

i

~

maintenance of thel.Callaway Plant.

He controls-M Plant functions and' implements the OQAP through the 3

Assistant ' Manager, Operations and Maintenance, the U

Assistant

Manager, Technical
Services, and the C

{l]

Assistant Manager, Work Control'(see Figure g.of the OQAM).

He has the primary responsibility for reactor operation

.and safety.

Within-his organi::ation,

the QC Supervisor reports to the

?'

Assistant Manager, Work. Control who reports to the Manager, Callaway. Plant.

The Quality Control Group.

j performs work activity inspections, receipt inspec-S tion as described in'Section 7,

and nondestructive.

examinations and.is not' involved in those activities I

performed by others which are considered "inspec-tions" unto themselves, e.g.,

surveillance testing, initial startup testing, and I&C, Radiation Protec-

tion, and Chemistry group activities.

Activities considered to be inspections unto themselves are i

O l-4 Rev. M

]

h 6/p9 r

'IC 1;

-)

f' OQAM pt

+

4.

I 3 -h

.,3 covered ; by QA audits and QA surveillances as dis-

? p 7...

cussed under Section 18.-

The QC Supervisor has no i ff. :

duties-or responsibilities unrelated to quality t

control that would prevent his full. attention to

(

' quality control matters.

}

l'.15 The

Manager, Operations Support. reports-to the General Manager, Nuclear Operations'and is responsi-ble for Plant support activities including training, materials management, security, and administration servicer activities required to support the Callaway Operating License.

He controls Plant support

.].

activities and implements the OQAP through the E

3 1-

. Assistant Manager, Materials, the Superintendent, Training, the Superintendent, security,. W e"

r-in-N W ert, M-ini tre*i-- Perer', and the Superinten-dent, Administration Seea4eee.

1.16. The

Manager, Nuclear Information Services (NIS)

L reports to the General Manager, Nuclear Operations.

He is responsible for providing the

analysis, programming, operations, hardware support,
files,
reports, and capabilities necessary to maintain the uclear information system and network in support of l

the plant, r

1.17 The_ Manager, Nuclear Safety and Emergency Prepared-

,C l

. ness:(NSEP) reports directly to the General Manager,

~ Nuclear. Operations and is responsible for providing l

a' constant independent overview of nuclear. Plant t

safety.

He directs the Supervising

Engineer, i:

Independent Safety Engineering Group (ISEG) and the

/

Supervisor, Emergency Preparedness-(EP).

1.12-The Supervising Engineer, ISEG and staff evaluate

'Callaway Plant operations from a safety perspective b

and compare Callaway_ operating experience with;that of. plants of similar design.

In addition, they L

y assess the conformance _of Plant performance to b

safety requirements.

The Supervisor, EP and staff have-overall-responsibility for..the. development and I

maintenance of the Emergency Preparedness Program.

This includes onsite and offsite emergency prepared-

-ness, coordination of the. Plant Radiological Emer-L

-gency Response Plan with State and local emergency plans, and the planning and execution of emorgency

-drills and emergency. plan exercises.

A communica-tien path exists between the Manager, NSEP and the

l Senior Vice President-Nuclear for matters having immediate or significant safety implications, thus providing a

direct path to contact management personnel having corporate responsibility for Callaway Plant.

1-5 Rev. R 6 / P,9

~@

,3 w,

q-lf?

f* _

kg ooAM (p f(41 e

$f _.

m t o ra3

( L&AM6=0 **N Q

Superintendent j Personnel A rc;1;;

.t 49 ' /) :

1.19. The directl reports mW and.1e' y to the General Manager,- Nuclear Operations -

relations, ponsible - for assisting in : areas o res labor l-organizational and personnel t, M8* A

  • a d other matters under the guidance of UE policies.

@] > Se*

  • N t-6e, 1 74 The Manager, Purchasing reports directly to the Vice

~l M Jtl President, Supply Service who in turn reports to the-Senior Vice President-Administrative Services.

The Manager, Purchasing is responsible-for commercial I

aspects involved in procurement of materials, y

y

systems, components, and services (excluding l

3.%.

engineering-services and certain nuclear fuel-l cycle-related procurements) not delegated to others which are employed in support of Callaway Plant.

M

[43 1.)4.

The Manager, Mechanical Engineering reports to the

~

22 Vice President-Engineering and Construction who in turn reports to the President.

The

Manager, Mechanical En provides technical support, as necessary, gineering i

to the Nuclear Engineering staff.-. The Chief Draftsman,

. ho reports to the

Manager, w

Mechanical Engineering provides-drawing preparation and revision

support, as requested, for design performed by $1uclear Engineering or other-UE organ-
izations, y.

'l

. l EQ 1.y!

The Manager, Electrical Engineering reports to the g

jy Vice President-Engineering and Construction.

The Manager, Electrical Engineering provides technical support, as requested, to the staff.

Nuclear Engineering 4

c j4

- l [6 1.M Other UE divisions may provide safety-related q

.24 services which augment _and support selected Program activities.

These organications shall be required to implement controls consistent with the OQAP 4

requirements - applicable to their scope of activi-ties.

I The coordination of these activities is the responsibility of the Senior Vice President-Nuclear.

s

{41 1.M Safety review committees shall be - established to

~

S-(

provide an independent review of. those items re-quired by the Callaway Plant Technical Specifica-tions.

These committees, the Onsite = Review Commit-tee (ORC) and the Nuclear. Safety Review Board (NSRS ), are described in the Administrative Centrols Section cf the Callaway Plant Technical Specifica-tions.

4 q

1-6 Rev. &2 c ' *A f, of n

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.:v:

y x

,i. t

?

/i?

.'! (

r J $' $..I OQAM CN 89-07 4

b.)is Page of;

/i l

-INSERT i

s

.The Super nten ent, Personnel (Local 148) reports directly

p
[21 1.20 i

d l

to the General Manager,. Nuclear. Operations and is responsible for assisting in areas of labor relations,-

organizational and personnel activities, and other matters l

under the guidance of UE policies.

4 j

1 i

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<4 in s

si.

o t

j'i

- t i

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OQAM

'[(fipp

_n7

'il I M] 2974 2.0 QUALITY ASSURANCE PROGRAM

{" -

"R,

}-1799 2.1 UE has established an OQAP which controls act3'rities ol L

af fecting-quality.

The Program encompasses those quality activities necessary to support the operating _ phase of the Callaway Plant:.and shall:

._,6, corraly with 10 CFR 50, Appendix B - " Quality.Assur--

~ance Criteria

  • for Nuclear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide.1.33.

Commitments, clarifications, alternatives, and exceptions to the Regulatory PositionLof-Regulatory i

Guide 1.33 are stated in Appendix A of L this OQAM.

In addition, the OQAP has incorporated' the commit-

',L ments made in responding to : applicable NRC ques-i tions.

The text of the NRC questions = applicable to 7

'N the OQAP, along with the responses, are maintained

~I as a QA Record separate from the OQAM.

The Senior Vice President-Nuclear has initiated the Program and

,N formulated the policy in addition to authorizing Program implementation.

This responsibility 'has been established by the President who is' responsible y

f l

to the Chiof Executive Officer of UE'for establish-1 M

ing and implementing the Quality Assurance Program requirements.

2.2 Lines of authority and responsibility have been established from the highest management. level through intermediate levels and to the Generel Manager, Nuclear Operations and the onsite operating nt unization.

These relationships shall be docu-

..d and updated, as appropriate, 'in -the form of 4

organization

charts, functional-descriptions of departmental responsibilities,. and position guides p~,:

for key personnel having direct operating, support, or audit responsibility.- Where specific responsi-bilities are assigned within the OQAP, the pre-scribed individual shall retain the overall respon-sibility; however, subject to applicable regulatory constraints, authority may be delegated to subordi-nates.

Considering these same regulatory con-straints, the authority of a subordinate may always

,y be assumed by a superior.

3 !y -

'y J?

1104 2.3 Updating and revision of the OQAP as' described in 1105 this OQAM shall be in accordance with the applicable y' ',,

. Ddl +M6 requirements of 10 CFR 50.54 (a) and 10 CFR 50.71.

,+

1824 2.4 The pertinent requirements of the OQAP apply to all 3

T '

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 O

2-1 Rev. It 6/B9 q,

g W

mA-

OQAM 1

c j ' Il y

Y 2.

Operating Quality Assurance Manual (oOAM)

The OQAM contains a delineation of the Folicy statement, quality assurance requirements, assignment of responsibilities, and a defini-tion of organizational interfaces.

The OQAM is the written description of the OQAP.

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

3.

Callaway Plant Operating Manual The Callaway Plant Operating Manual consists of l

a multi-volume set of Plant operating proce-dures prepared or reviewed by the staff with the aid of other SNUPPS utilities, Nuclear L

Engineering, the Lead A/E, the NSSS Supplier, and ruel Fabricator.

These procedures are controlled, approved, and issued in accordance with Administrative Procedures contained within the Manual.

This Manual includes administra-tive controls consistent with those required by Regulatory Guide 1.33.

Administrative procedures which apply to the l

entire staff, and revisions thereto,-shall be reviewed by the Callaway Plant Onsite ~ Review Committee (dRC) and the Quality Assurance g

Department.

The final approvcl of Administra-tive Procedures and revisions thereto shall be by the Manager, Callaway Plant.

The review and l

approval of other procedures and revisions thereto shall be 1 14 accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications.

DOl 679 U(

l 1746 2.7 UE taay employ the safety-related services of 1787 architect engineers, NSSS suppliers, fuel 2293 fabricators, constructors, and others which provide 2460 or augment UE efforts during the operating phase.

These organizations shall be required to work under a

quality assurance program whose controls are.

consistent with the scope of their effort.

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

The quality assurance program of

,~

outside organizations shall be subject to review, evaluation and acceptance by the UE Quality Assur-ance Department or Quality Services Department prior I

to the initiation of safety-related work.

Vendor programs and procedures shall also meet UE's commitment to USNBC Generic Letter 83-28.

11) 2-3 Rev. 44 6/Q9 l

A

0$/M CN b'el oom 1

1elp 3.0 DESIGN CONTROL igg > 2163 n61 I

241 j pgf 2168 3.1 The design, modification, addition, and replacement 2222 of safety-related structures, systems, and 7491[y components shall be controlled to assure apprcpriate tvl decign cortrol measures are iraplamented.

2137 Precedures shall establish requirements; assign 2393 responsibilities; and provide control of activities r+garding design in a

planned, controlled, and crderly manner.

(,o] FFFF 3.2 0:.e Plant design is defined by those UE NSSS, A/E 2168

nd selected supplier design drawings and specifi-r.tions which illustrate the general arrargement and details of safety-related structures, systems, and
omponents and define the requireme:.ts for assuring their continued capability to perform their intended operational or safety design function.

3.3 At the result of operating experience, or as necess-itcted by regulatory requirements, Plant systems and 2664 equipment may have to be changed.

A design change is a modification in Plant design or operation and is accer.plithed in accordance with requirements and l

limitations of applicable codes, standarde, specifi-c.

cations, licenses, and predetermined safety restrie-tionc.

An alteration of Flant equipment, structures or systems, which is not by nature operational, mtintenance er replacement by like kind, is censid-Eq myrf,4 ered a desigt. c:.ange.

rca.a /#

46

.bIh 3.L Design, inclu0ing related procuremcat efforts, may c4]

2222 J

be carried out by Euclear Engineering, Licensing and 1

fie3 '1 Fuels, or outsids organizations.

i g4) 21f4 37 Centrol of design shall be specified in pr::edures.

2190 6

These procedures ehell inrluie instructions for 2191 defining typical design requirements; communicating 2192 needed design infct:.ation across internal and 2196 external interfacert preparing, reviewing, approv-2002 ing, releasing, distributing, revising, and p.3 222}jypt maintaining design documents: performing design 2243 revieus and reviews of design; and controlling field changes.

[q3 2164 3.f Design centrol shall involve measures which include 7

a definition of design requirements; a

design process which includes design anal"ris and deline-etion of

-equirener:s through tr.e issuance of

:awir.g e,

e:ifica ns, and other design cocuments sdes:gn cu: pets) ; ar.d design ve.-ification or review of design :: ver.fy the adequ6ry of design or to becers acquainted with design featurer.

Ps 3-1 Rev. &

6 e LP(b L

i

~

{

Lo-

s'.

OQAM CN 90-01

~.

)

INSERT:

Maintenance or modifications which may affect functioning of 862 5.4 safety-related structures, systems, or components shall be CS3 performed in a manner to ensure quality at least equivalent

- [to3 to that specified 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.

t t

s 1

Page 3-la

(

~

$$hm cN 9't.cl 1

00AM

.ptf(

a nc7 3nt6643./

Design requirements and changes thereto shall be

/')-

y p'

identified, documented, reviewed and approved to incorporation of apprcpriate quality stand-1 assure gv]

ards in design documents and to control departures from these standards.

Modifications to structures, 1850 2203 systems, and components, shall consider, as a mini-J the design bases described in the Callaway-SP

mum, 2204 and the Callaway-SA TSAR and the Technical Specifi-i cations.

Design criteria documents which t.re newly issued or modified in the course of derign or design changes shall be reviewed by a superintendent i.n the 1

Nuclear 2ngineering Department for seismic and

']J quality group classification and selecticn of J

quality standards.

Design criteria cocuments consist of original Plant design criteria, system descriptions and other documents defining design input which change the Plant as described in y

2205 the FSAR.

The design input shall be specified on.a timely basis and to the level cf detail necessary to permit the design activity to be carried out in a correct manner and provide a consistene basis for making design decisions, accomplishing design verification measures, and evaluating design chang-es.

Nb.J Design activities shall include the correct transla-

~

  • ')

2207 1

tion of regulatory requirements and design.>ases Noc/

into specifications, drawings, written procedures, 2210 and instructions (design outputs) that def.'ne the 2212 des 3gn.

Design analyses regarding reactor pnysics, t

2974 stress, thermal, hydrauf.ic, radiation, and accident analyses used to produce design output dccuments, shall.

be sufficiently detailed to permit an independent review by a

technically qualified person.

Analyses shall specify pu. pose,

method, assumptions, design requirements, reterences, end

't units.

When computer codes are

employed, only i

verified codes shall be used in safety related design and design changes.

2165 3.P M eedures shall specify requirements for the review S

and approval of design changes by the crganizations 2166 10 2168 or individuals that performed the criginal design or 2169 Nuclear Engineering.

Design control activities, including design changes, may be delegated to others 5

9 4'>

provided they have access to background and techni-L cal information. Design centrol neasures for design t

revisions shall be commensurate with those applied o

to the original design.

p 3-2 Rev. M E '!9VO

I i

khM cN +c4/

b 00AM I

2JH 39 Design activities shall also include:

1) reviewing li the applicability of standards; 2) reviewing commer-

[43 teo)

CiAl or previously approved materials, parts or equipment for suitab:,11ty of application 3) reviewing the compatibility of materials used in the i

design; 4) reviewing the accessibility of equipment and components for inservice inspection uninte-j

nance, and repair; 5) specifying crite:ia for l'l34 inspection and test / retest; and 6) reviewing and j

approving procedures for special processes.

Slbf i

'g 2168 3.k1 The design process shall establish controls :er

)

2220 C-releasing design documents which are technically 2243 adequate and accurate in a controlled man.cr with-a (43Lill timely distribution to responsible individuals and groups.

Documents and revisions shall be controlled through the use of written procedures by the issuer, 2191 distributor, and user to prevent inadvertent use of superseded documents.

Document control procedures shall govern the collection, storage, and mainten-ance of design documents, results of d2 sign dccument reviews, and changes thereto.

The design docunents subject to procedural control include, but are not limited to, specifications, calculations, computer programs, system descriptions, SAR when ustd as a design document, and drawings including flow fLa-

,)

grams, piping, and instrument
diagrams, cen rol logic diagrams, electrical single line
diagrams, structural systets for. major facilitie.3, site f4 b 3 arrangements, and equipment locations.

7tb4 2188 3.H The design interfaces between UE organizations 2190 6

performing work affecting quality of design and 2217 between UE and outside organizations shall be 2218 identified and controlled by procedu-as.

These All procedures shall address control of thw in erface, 711 responsibilities, lines of communication, and documentation of internal and external interface activitt s.

2182

3. b5 The design process shall include design verifica-K tion.

Design verification assures that design is adequate and meets specified design inputs.

Design control procedures shall specify requireuents for the selection and accomplishment of a design verifi-L cation program.

The program depth shall be commen-I surate with the importance of the system or compc-nent 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 identify the responsibilities of the verifier and the documenta-tion required and which, through adherence to the procedures, provide for the identification of the l

13 l

3-3 Rev. Jet l

6lEfqg 1

n I

U ##~N 00AM L

A..

~

features, and pertinent considerations to be r.reas, verified.

Der ign verification shall be by cither design review, alternate calculation, qualifir ation j

Where testing, or by a combination of these.

calculations are performed to verify the 2235 alternate correctness of a calculation, a review shall be performed to address the appropriateness of assump-tions, input data, and the code or other calculation i

UE shall perform " reviews of design" method used.

of selected documents for subcont.racted design to t

An indepen-become familiar with design features.

'g dent third-level review must be-employed as an verification when UE judges that the

)

additional design involves unique or special design featuree.

The organization performing design shall have the 2234 responsibility for design control unless specified otherwise.

Design verification shall be performed by competent personnel other than those who' l

performed the original design and other than the i

immediate supervisor.

However, an designer's l

individual's supervisor may perform design verifica-tion when he is the only technically qualified individual and in such instances the need for design verification by the designer's immediate supervisor shril be individually documented and_ approved in advance by the superviser's management.

Quality Assurance Department audits shall examine the

)

frequency and the effectiveness of use of supervi-

.t I

sors as design verifiers to guard against abuse.

if other than by qualification Mi

3. y Design verification, 6

testing of a prototype or lead production-unit, f

M,g3 shall be er.mpleted prior to release for procurement, construction or to another organi:a-manufacturing.in other design activities. 'In those tion for use cases where this timing cannot be met, the design verification may be deferred, providing.the justifi-cation for this action is documented and the por-tions of the design output documents based on the unverified data are appropriately identified and controlled.

Without verification, site activities not associated with a design or design change must proceed past the point where the installation would become irreversible (i.e., require extensive demo 11-tion and rework).

The design verification shall be' complete prior to relying upon the component, system, or structure to perform its safety-related function.

P

{

Re v. O-2 3-4 6Ospo

o,

l

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00AM 5

Action shall be initiated to correct errors found in 3.}4 2200 the design process.

Errors and deficiencies identi-

  • g3 fied in approved design documents shall be document-ed and the process of their correction (i.e., review and approval) shall be controlled.

These actions shall assure that changes to design er installed components are :entro11ed.

ry

3. M nequests for derign changes affecting safety-related 87 structures, systems, and components may be originat-L ed by the unit staf f, Licensing and Fuels or Nuclear Engineering. Design changes shall be processed by l'

Nuclear Engineering. Design changes engineered by Nuclear Engineering shall be the responsibility of the Manager,. Nuclear Engineering.

Design changes engineered by Licensing and Fuels shall ne the y

responsibility of Licensing and Fuels.

93 3.M Independent of the responsibilities of the design rg),

16 organization, the requitements of the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB) as defined in the Technical Specifications 1137 shall be satisfied.

Design changes require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, callaway Plant.

In addi-tion, chances in the f acility as described in the FSAR which involve a change in the Calleway Plant l

V Technical Specifications incorporated in the license i

6V44 or an unreviewed safety question require review and pf/

approval by the NSR3 and the Nuclear Regulatory Commission prior to implementation.

Khen design is performed by an outside organization, UE shall perfcrm er coordinate a review of the design for operebility, maintr. inability, inspectability, FSAR commiument compatibility, test and inspection accep ance criteria acceptability, and design requirements imposed by Plant generating equipment.

5844 3.M Safety evaluations which consider the effect of the i

ll design as described in the design do-uments, shall y

[G

~

be performed by the responsible t:E engineering

[4')

organization er outside organization (s).

These evaluatiens shall include the basis for the determi-natien that the design change does not involve an unreviewed safety question.

As deemed necessary by the evaluating organization, detailed analyses shall be performed to support the bases of safety evalua-

"*m>-4-

pa e--

a 9;

y=_n-gll p c/ur lwaUm5 -

engin;; ring Mecncing_ :.nd Feehwer_.. rtH :

"ni:n tions. 4 5

  1. =+y 3

4 pa Y

E: _:i: c gnintir e are submitted to the ORC.

i

Changes invclving the substitution Of ecuivalent hardware require safety evaluations to a s s'u r e that the design requ rement changes are consistent with and do n:t alter the design criteria s?e:ified in 6

3-5 Rev. +2 6/S9 o 9

rI-I OQAM r-l The-en9 r.cering-approvM i

1

' {,3 existing design documents.

j ef design documents and safety-evaluatiene-prepared i

by sutside or9etrientiene--eha-1-1-bc by t-he-ou tside 0 ;2.".1:S t i O"..

87 1140 3.

The ORC shall review design change safety evalua-tions to recommend final approval of design changes.

Design changes which involve an unreviewed sa.ety 1

question or a change in the Technical Specifications shall be forwarded to the NSRB for review.

An application for amendment of the license shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90.

%I

[43 $ 3.J4 The NSRB shall review safety evaluations to verify that changes did not involve unreviewed safety questions.

M

[43 1910 3.X Procedures and instructions related to equipment or systems that are modified shall be' reviewed and updated to reflect the modification prior to placing the equipment or systems in operation to perform 2162 safety-related functions.

Plant personnel shall be made aware of changes affecting the performance of their duties through procedure revisions, or specif-ic training in the operation of modified equipment -

or systems, or ocher appropriate means.

bl iMO 3.

Records shall be maintained which reflect current

[/o] 2039 design including safety analyses, safety 2132 evaluations, design change installation procedures, 2163 material identification documents, procurement h?)

documents, special process documents, equipment and installation specifications, and as-built drawings.

93

3. N Drawings shall be prepared under a drawing control system which provides for checking methods and i

review and approval requirements.

Drawings shall be subject to reviews by the responsible design organ-ization for correctness, co.iformance to design criteria, and compliance with applicable codes and stcndards.

When design documents and safety evaluations are prepared by an outside organization under its OA' program, review and approval per ANSI N45.2.ll will be included.

UE will approve all outside organizations' design documents and safety evaluations, and will perform appropriate reviews necessary for final approval.

~

3-6 Rev. 12 6/89

-y

a OQAM 4.0 PROCUREMENT DOCUMENT CONTROL i
  • 17C

[C 1875 4.1 Procurement document control applies to documents employed to obtain safety-related materials, parts, po3 - 1876 g

1887 g

components, and services required to support Plant activities.

UE. hell contee4-procurement-deeuments 3541 ' hem procedures whtch establish requirements

$[

by ' written 3548 and assign responsibility for measures to assure 4,4 that applicable regulatory requirements, design bases, and other requirements necessary to assure SpAlity are included 19 ocuments, =T ^yed fwAbe d

1 (procureiiien76f 5aIety-re1ated---ma teria1e ---Par-t s,

r compommta and aervices r

4.2 Written procedures shall include

controls, as applicable, for preparation,
content, review, approval, and processing of the following related i

procurement documents:

1.

Purchase Requisitions 2.

Purchase Orders 3.

Letters of Intent 4.

Engineering Service Agreements (agreements for C +~J engineering, construction, or consultant u s'.

b services) 43 d,[

is$s*4 5.

Contracts aw 6.

Specifications

' % h,7-5) p1 (<,c,P 7.

Drawings p ut9 &

14M 4.,3" Provisions for the following shall be included in

[4] Dol procurement documents as applicable:

1888,

1A.

Requirement that the supplier have an accept-3542 93[J) able Quality Assurance Program which implements 3553 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 sup-plied.

This requirement is not applicable to commercial grade items which utilize a

supplier's standard or proven design to meet published product descriptions, und ch;;;-

e ee i epte b

e ei n;

a164 i99o i g g *JA*.

2'.U ) technical requirements including drawings, cope of work and basic administrative and I2416 3550 h*3 specifications, regulations, special instruc-3551 3552

tions, applicable codes and industrial standards and procedural requirements - identi-fled by titles and revision levels; special process instructions; test and examination re-quirements with corresponding acceptance criteria; and special requirements far activi-0 4-1 Rev. }2 6/S9 10

4.

OQAM ties such as designing, identifying, fabricat-

)

ing, cleaning, erecting, packaging, handling, shipping, and storing.

i f to po]

3542 3.

Requirements for supplier surveillance, audit, 3555-and inspection including provisions for UE or 3573 agent access to facilities and records and for 3574 identification of witness and hold points.

3bh0' LO Documentation requirements including records to be

prepared, maintained, submitted for 3556 gg) approval, or made available for review, such as,
drawings, specifications, procedures, procurcaent documents, inspection and test I
records, personnel and procedural qualifica-tions, chemical and physical test-results, and instructions for the retention, transfer, and disposition of records.

1940 4

3543

[() 5.

Requirements for extending applicable require-3555 gg) ments of UE procurement documents to lower-tier suppliers and subcontractors.

These require-ments shall include right-of-access to sub-supplier facilities and records by UE.

3550

[43 Requirements for' suppliers to obtain UE 3558 approval of nonconformances to procurement 3576 document requirements dispositioned "use-as-is" and " repair" and conditions of their disposi-tion including identification of those subject to UE approval prior to further processing.

3484 DO Applicability of 10 CFR 21 reporting require-ments.

8.

Requirements that the supplier furnish documen-tation which identifies the purchased item and provides traceability to the procurement L

requirements met by the item and documentation identifying any procurement requirements which n

L p]

have not been met.

{ ISafety-related mss A7(O *r0 Sta 41 procurements shall be documented.I 1875 -4.4

{G DQ gPurchase requisitions must be employed to initiate the procurement of safety-related materials, parts, hw* h components, and services while Engineering S:rvice A*4" Agreemente

'ESAst must be used to contract. for safety-related engineering, construction, or consul-tant services.

Contracts, purchase orders generated from purchase requisitions, and ESAs must be em-ployed to procure certain goods and services associ-N8' I

ated with the nuclear fuel cycle. < /ug<7 {@[ FR8* N87T G

4-2 Rev. }d 6/99 40

<fl' r

OQAM (8M gm P.

ESAs 1978 4.5 / Purchase requisitions for safety-related materials,

parts, components, and services and
ngin: ring 4ewic:..greement: for professional services may be initiated by personnel in the Quality Assurance or I

Quality Services Departments; Nuclear Engineering, Nuclear Services, or Licensing and Fuels Department; or the unit staff.

[<O 4.f Durch::: :: qui:iti:n:,

"S.'.e r-1 : t t : : Of int;nt :nd c^-tracte f^r refety-related esterisle, p: rte, gg /0 g) cc ;-

nte, er ::rci:::

h:11 he ::/i:r:d b; the int:rnal "" crigin: ting ::;;.ni ;ti:n and t'.,-

l. y I

  • :;r:n:: :: Outlit; S r fi :: D:::rtrent: ir ::::r--

dirr fith

-f ri t t e r ;rcr:f trer./ Collectively, these freuerc5 Pettewe shall assure that; quality requirements are fcorrectlystated, inspectable, and controllable; h

there are adequate acceptance and rejection crite-3601 ria; and procurement documents have been prepared, D'] g N

reviewed, and approved in accordance with QA Procram s

g/g requirements. A he originating organization shall 0

f.43 perform a documented independent review of procure-Mio ment documents to assure requirements are correctly C33 i

SS?!

stated, inspectable, and controllable. and that thereAirss4T 3g M M.

are adequate acceptance and rejection criteria.* hej A

I Cuality ^- ur-

- er Outlity Serfire: Department: M h

r


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. a m,.. - a 2 m3, s_

[d ESEEEe[t7 ~ ~tA a :EEE TEE 5' the lu:Et;

[.E5uh5EE: Q S i-Se.;

Progra requircrente (2 defined ir S::ti:r 2.2.2 Of

?.?:S: ::C. :.12 Y f l

rr;;tly :t:t:i :ni th:t the precur:::nt decurent:

hr >e heer prep red, j

revi;u:d, and :;;r:::2 tr ::::ri:n::.:L ? C? Tre = ~~

requircrrntr'./ Approval of the purchase requisition, p5f4T 3 letter of intent, Engineering Service Agreement, or p wT 4.W, contract shall be by an individual who has approval

.g cQ authority and signifies that the technical and quality review of the document has been completed.

T1f

(

1876 4.J > Procurement document control preparation measures l

1877

[43 shall further assure that purchased safety-related 1878

( 40 3 components, piece parts, materials, and services are 1883 purchased to specifications and codes equivalent to those specified originally or those specified by a pq

'3 rem properly reviewed and approved ' revision; packaged current and transported in a. manner to assure the GedA.ll non-degradation of quality during transit; and properly documented to show compliance with applica-ble specifications, codes, and standards.

'7 1876 4.)

Each item or service to be procured is evaluated by the procurement document originator to determine gg whether it performs a safety-related function or involves activities which affect the function of safety-related materials, parts, or components and to appraise the importance of this function to Plant G

4-3 Rev. 14 6/89 90

OQAM or public safety.

For those cases where it is unclear if an individual piece (part of a safe-ty-related structure, system, component or service) is governed by the OQAP, an engineering evaluation shall be conducted.

The evaluation shall be con-ducted by Nuclear Engineering or Materials Engineer-ing 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.

Evaluations of this nature ch:11 y

b revi.:d by th: Outlity *::ur::::

Ouality I

Service Department:

tr accure that

ppr:prict:

quality Curan : ::quirem:nt hav: b n ;;tisfied.

S 4#

Letters of intent may be utilized with suppliers of g

materials, parts, components, and services for the g

purpose of reserving schedule space prior to the resolution of the requirements to be included in a purchase

order, contract, or ESA.

If employed, letters of intent must s pec.1 y that no safe-ty-related activities may begin until an approved purchase

order, contract, or ESA.is executed.

!!owever in the event a letter of intent is issued for the purpose of securing an agreement and thereby allow safety-related work to begin prior to the issuance of such documents, it shall specify the applicable quality and technical requirements, Letters of intent shall be prepared by the Purchas-i N.

ing Department "and the originating organization, y*M 4 p _ reviewed by thej u lity A: ur:nce er Ou:lity Servi:-

l ee Departrm::, and approved and issued by Purchas-g u.8**

I ing.

Letters of intent issued prior to the execu-l tion of a contract for nuclear fuel cycle-related services shall be prepared and issued I

goods and/or g

by the Nuclear Fuel Department.4ed TeNb by the l-i Outlity Accurene: er Outlity Servi :: 0:p rtm:nts.

t Letters of intent issued prior to the execution of l

an ESA shall b" 'reparedyand issued by the originat-g ing organizaf ' ;n,4nd (reviewed) by th: Ouclity Accur i-an : cr Ouality Servi :: Departments.

The emes review shall be to assure that appropriate qu:lity b

4ss u nse requirements have been imposed.

4. bg W

x b8 Additions, modifications, exceptions, and other D'd 4A 3549 changes to procurement document quality and

@4M.

i 3575 g

technical requirements shall require a

review 357f M

ih equivalent to that of the original document and approval by the originator or the originating department approval authority.

Commercial consider-ation changes shall not require review and concur-rence by the originator.

Conditions specified on the Qualified Suppliers List (QSL) that apply to a vendor may be revised without concurrence from the 3

4-4 Rev. 12 6/89 1

2 4

m

=

w

=

1 N

l OQAM v

originating organization since they are imposed without the knowledge of the originator.

(O[O 1876 -brM [The procurement of spare or replacement parts for

@ To%

safety-related tuM structures, systems, and components shall be subject'to the QA Program controls in

(

4 and to codes, wr46s effect at the time the order is issed;ts standards, and technical requiremen which-are

[

1 equal to or better than the original requirements or

!c as may be required to reduce the probability for repetition of defects.

1076 4 12 Commercial grade items shall rely on proven design 3001 3

and utilize verification methods, to the extent (d3 appropriatetoitemapplication,.hythepurchseerin

[63 lieu cf e;pplier centrele, lu54t f# pyc 7-r,& sw cr o

['m f.,y A -Sc.

1 Inseri@

frer Section i.IO f

N iman e?H 1 m wsar c r,r Fy j

i

.mp f+ n.<446 3 D 3 [(3 4-5 Rev.

6 /3^)

  1. 0.

c-L I

i OOAM CN#89-06 INSERT A TO NEW SECT 104 4.10 3562 DJ This review shall be performed by personnel o have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents.

INSERT B :$4-p j,j g,g 4 3 y,,, 7,et,7,,,,d7.fi) 4.11 Chrn;r t^

tr f ril rt:: :

---A M00 3567

[G

  1. 'Dids or proposals shall be evaluated by e Purchasing i

3568

-Department, the originati organization,2 uality 3569 Services Department, anda censing and Fuels Department to assure conformance to procurement document requirements in the following areas as applicable to the type of procurement as described below:

1.

Technical considerations 2.

Quality Assurance requirements 3.

Research and development effort 4.

Suppliers' personnel qualifications 5.

Suppliers' production capability C5 D3 6.

Suppliers' past performance G

7.

Alternates j["[p+)

8.

Exceptions 3560 4.11.1 The Purchasing Department shall review bids or proposals, except those associated with Engineering Service Agreements-(ESAs) or nuclear fuel cycle related F

goods or services, for alternates or exceptions to procurement document requirements (areas 7 and 8 above) 3563 taken by the Supplier.

These reviews shall be documented.

3560 4.11.2 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.

3560 4.11.3 The Quality Services 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 00AM, Sections 7.0 and 18.0.

3560 4.11.4 The Licensing & Fuels Department shall evaluate bids or proposals for fuel cycle goods or services to assure confornance in the above areas."

(

4-a e '

V, 5>

\\

~

00AM CN#89-06 1

INSERT B (conit) 3560 4.21.5 I'repeccic cre re>!cuc? by eithe: the Ouality '.

uren:0 3MS-D]

-cr Ouality Serficcc Departmente-for cc.-fermence te quality accurance -rcquircrentc. "

it 4..&

Ch n;1 tu rc:? cc fellcao.

[63M 3560 gg

  1. ' Bids or proposals with alternates or exceptions identi-3561 fled in Section 4.7diby the Purchasing Department shall 3568 also be evaluated by the originating organization to 3570 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.""

INSERT C To NEW SECT 20N 4 l4, 3563[3d purchave orders to verify that the technical and gyality The Purchesing Department is responsible for reviewing requirements have been accurately transferred from the requisition to the purchase order.

1 i

4-bb l

1-i 00AM CN 89-06 INSERT To Sfd 4Sf one or more of the following:

1.

Special Tests and Inspections 2.

. Survey of Supplier (Commercial Grade) 3.

Source Verification 4.

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

a)

The established historical record is based on industry wide performance data that is directly applicable to the item's critical 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 verified by audit (multi-licensee team audits are acceptable).

I 1'

4-to W

gw.s i

1

OQAM

-[#63.M7j 5.0 INSTRUCTIONS,-PROCEDURES AND DRAWINGS 1830 5.1 The activities affecting quality associated with the 1858 operating phase shall be accomplished in accordance with documented instructions, procedures, drawings C O l861 or checklists which specify the methods for comply-ing with 10 CFR 50, Appendix B and the Technical Specifications.* The degree of control imposed shall be consistent with the relative importance of the activity to safety.

1948 5.2 Activities affecting quality shall be controlled by:

1.

preparing procedures, instructions, specifi-

cations, drawings or checklists of a

type appropriate to the activity and its importance to safety; 2.

including in these documents quantitative or qualitative acceptance criteria for verifying that an activity has been satisfactorily acccmplished; 3.

having responsible personnel approve these documents prior to accomplishing an activity; and 1830 4.

using approved drawings, procedures, instruc-1916 tions or checklists to accomplish an activity.

11833 5.3 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 affecting safety-related struc-tures, systems, and components.

It is recognized that skills normally possessed by qualified person-nel may not require detailed step by-step delinea-tions in written procedures.

5.4

'The Manager, Callaway Plant shall be responsible for providing specific guidance via Administrative Procedures for the development, review and approval of other Plant operating procedures to govern activities which affect safety or quality consistent with the Technical Specifications.

Similar guidance shall be provided for revisions and temporary changes to Plant operating procedures.

Plant operating procedures shall be reviewed no less frequently than every two years to determine if changes are necessary or desirable.

A revision of a procedure constitutes a procedure review.

L 6

l-5-1 Rev. 14 6/.9 8

.r L

OQAM 6.0 DOCUMENT CONTROL 1908 6.1 Documents and their revisions which control all 1916 activities affecting 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.

1908 6.2 Divisions, departments, and organizations responsi-603 ll 4/6 ble for OQAP implementing documents shall be re-

  1. g quired to provide the necessary review and approval for instructions, procedures, specifications, and FM 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 Depart-ment shall review Administrative Procedures as described in Section 2.6; QC personnel shall review maintenance and modification procedures;*

and QC personnel are responsible for the preparation of inspection procedures and/or checklists to support maintenance and modification activities.

Collec-I tively, these reviews by the QA Department and QC personnel determine:

1.

The need for inspection, identification of inspection personnel, and documentation of inspection results; and 2.

That the necessary inspection requirements,

methods, and acceptance criteria have been identified.

Mofl (U 1914 6.3 Changes to documents shall be reviewed and approved y 70 by the same function, department, group, or organ-ization that performed the original review and approval; however, UE may assume or delegate-this responsibility.

The reviewing organizations shall' have, access to pertinent background information upon which to base their approval and shall have adequate 4

Work Requests (WRs) and preventive maintenance requests (PMRs) may contain instructions to workers.

However, WRs and PMRs are not considered " maintenance procedures" which require QC i

review.

When required, the assignment of inspection points for work authorizing documents is performed by Planning Department personnel based on established criteria, i

6-1 Rev.

6/ Sg I

CGhm ooAn w tY-u?

understanding of requirements and intent of the original document.

6.4 Documents relating to the UE OQAP shall be con-trolled to an extent which 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 draw-ings shall adhere to the OQAP.

IN l

fe]1833 6.5 The controls governing the issuance of documents j

1908 shall provide for the availability of documents a+

-)

the point of use prior to commencing an activity and 1917 the prompt transmittal of approved changes for incorporation into subsequent revisions.

Measures shall be established to prevent the inadvertent use of superseded documents.

6.6 Types of documents which shall be controlled include the FSAR, specifications, operating Quality Assur-ance

Manual, procurement documents, procedures, design documents (e.g.,

calculations,

drawings, analyses) including documents related to computer
codes, nonconformance reports, as-built drawings, i

the callaway Plant Operating Manual, and topical reports.

1 ssuance of controlled documents at the General 6.7 d

y Office d Callaway Plant is the responsibility of I b#

the Admini

  • 1on-Records (AR) organization.

AR 4

e shall be respons. '

for assuring the issuance cf l

g/AM

' controlled documents erated or received ensite p.g,+ b and for which Plant perso.

1 have the preparation g f-h and final approval or e

rnal interfacing g

responsibility.

AR shall also be -esponsible for I

assuring the issuance of contro1A documents Cg generated or received at the General 0.

dces for l'

which General Offices' personnel have prep -ation

[.

and final approval or external interfacing respo'.. i-a bility.

In addition, AR shall be responsible fe.

l the issuance of the FSAR and revisions theretc.

1 L

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 list shall identify selected document holders by name and control number.

Acknowledgement of receipt of selected documents, incorporation of revisions, and de-stroying or voiding of superseded documents shall be required by the distributor.

In addition the distributing organization for documents controlled by a system of control numbers shall periodically 0

6-2 Rev. 42 6 / ys;p

i t

I OQAM CN 89-07 h'

Page of 93,p6 INSERT 6.7 The issuance of controlled documents at the General Office -

andCallawayPlantiscoordinatedby}'heNuclearServicesAdministrationvym *l*'

and the Administration organizations.7 shall be responsible for assuring the issuance of

'I 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 Administration for entry into t

y the document control system. lhe

,,y,j,,

8 N

w b*

6-2a 4

v-w

EN 4' C/V 08AM V9-8

~

7.0 CONTROL OF PURCHASED

MATERIAL, EQUIPMENT AND SERVICES 1892 7.1 Materials, equipment, and services shall conform to 3541 procurement documents as prescribed in Section 4.

Provisions shall be established to control activi-ties affecting quality associated with the procure-ment of material, equipment and services including:

review, and change control of The preparation, 1.

procurement documents as described in Section 4 Col 3/.

Procurement source selections Bid evaluation and award n<I5cn b b M >*4 J/.

4.

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

5.

Control of nonconformances as described in Section 15 Corrective action as described in Section 16 6.

7.

Material, equipment, and service acceptance 2416 8.

Control of quality assurance records 9.

Audits of the procurement program as described L

in Section 18 I

UE shall assure that suppliers providing 1875 7.2 or services are GMb safety-related materials, equipment,

)

Provisions shall be acceptable procurement sources.-

60 3541 made for supplier evaluations which assess their 3564 source evalua-1).

capabilities prior to award by: review for objective evidence of qua l

387/((

tions or 2) ty; or 3) a review of supplier history.

When evaluations are performed, the assessment of a

l supplier's capability shall be specific 'to the procured item, commodity, or service and the suppli-er's ability to provide the items or services in accordance with procurement document requirements.

Suppliers of hardware and services which are manu-factu ed prior to award, considered a commercial grade item, or implemented under the UE OQAP do not require ore-award source evaluation or post-award K

audits which attest to their capability as a pro-curement source.

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

1) suppliers judged capable (prior to award) of providing items or services in accor-dance with procurement document requirements and a B

1 Rev. 1-2 4

7-1 6/&9g

00AM quality assurance program appropriate for the item or service procured:

2) suppliers and others in i

possession of hardware manuf actured prior to award and whose acceptability can be determined by receiv-ing inspection, an examination of quality verifi-cation documentation, or other suitable means: 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OOAP.

Regardless of the basis for the acceptability of the procure-ment source, prior to the issuance of a purchase order or execution of a contract or ESA, a verifi-cation of the supplier /outside organization's 2977 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 Suppli-er's acceptability as a procurement source shall be accomplished prior to award.

In the case 3874 of purchase orders, the supplier chall be verified as.an acceptable procurement source for the item or-service being procured.

Purchase orders may be issued prior to an assessment of supplists' capabil-ity provided a prohibition on safety-related work is imposed.

Such suppliers may be released to begin safety-related work when evaluated to be an accept-able procurement source.

'). D 7 7.4 To support the control of purchased material, copies g

of purchase orders and other appropritte procurement documents shall be forwarded to the applicable receiving or acceptance point.

Departments receiv-ing or utilizing procured items or services shall establish measures to maintain and contul procure-ment documents until the items or, services are received and accepted.

These documents shall include purchase

orders, drawings and specifi-cations, approved changes, and other related-docu-ments.

7.5 Without any further evaluation,the suppliers to UE or its agents during the design and construction phase may be regarded as qualified procurement sources for replacement parts during the first three years of Callaway's operating phase as the procure-ment source evaluation measures employed previously have identified these suppliers as qualified pro-curement sources.

Callaway's operating phase began on June 11, 1984 with issuance of the operating License.

th 2

Rev. cid 6/83 g

d i

. 01w L

1 I

P 2e94

  • (

Procurement seurce evaluatien and selection involves t

'35(5 the Quality Assurance and W:::y Serv,ces Depart-l ments and the.or:,g:,nating cyear?sation.

The evalua-tion t.n d selection procesa shall be specified in I

department procedures and may vary depending en tne complexity and relative importance to safety of the item or service.

Nuclear Engineering, 1,1 censing and

)

Tuels, Nuclear Services, the unit staff or other i

organizations may be requested to provide input to the qualification evaluations of suppliers.

Suppliers of hardware and services which are manufactured prior to award, considered a commercial grade item, or implemented under the CCAP do net j

require pre-award source evaluation audits wh,ch i

i attest to a suppliers capability as a procurement l

1 source.

y4/o d J

[f33566 7.7 Procurement source, evaluations shall consider one or more of the following:

(C*A')

hN 1.

Experience of sers of identical or similar

[,,1 products of pne prospective suppiler.

t:RO Licensee Contrae:c and Vendor Inspection Program (1,0Vp) reperts, ASME Certificates cf X Authori:atieny C::rd;-..ing i;:

f
:
p;1irr
.. _ :..... i.e.10 r;;ir --

11::_..,., UE records MMIT ME%.

accumulated in previous procurement actions, and UE product-operating experience may be used in this evaluation.

Supplier history shall reflect recent capability.

Previous favorable quality experience with suppliers may be an adecuate basis fer mudeementr attesting o

neir capa::..;;y.

Wnen an LOV;PT 1 r --

cf g-f'

~ 'ir:2:ir- ::...; CA;;...::::..;.:

. s A pg7* g g,7 used to establish a suppiter's acceptabil:, v assha *,1 pr M t

M%df, GT M MC a procurement source, the documenteocen ggf.,

idr if.

.r.; "ir n:r" 1.

An evaluation cf the supplier's current quality recerds supported by documented qualitat:,ve and quantitative information which can be objec-tively evaluated.

This may include review and evaluatien cf the supplier's CA

Program, Manual, and Procedures, as appropriate and responses to questionnaires.

3564 1.

A source evaluation of the supplier's technica; 3605 and quality capability as determined by a

direct evaluat:,cn (audit er surveillance) ef l

f acil:, ties,

personnel and Quality Assurance I'

Program implemen:ation.

mwcr

~

P4 e f*60 l

?. A 0

2

-3 Rev. >.:

GHO

i OQAM CN #89-06 I

((t) INSERT TO SECTION 7.7 4.

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

i a)

Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementa-tion 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 specific to li the nuclear industry), or other industry databases (UL, INPO NPRDS, EPRI EQDB, ANSI, NEMA, MIL-STDS, NRC Bulletins / Notices, and Licensee Event Reports, etc.)

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

t r

t l

l l^

7-3a l

Rev. 13 06/90

OQAM i

7.8 Procurement source evaluations involve a review of technical and quality assurance considerations.

Technical considerations include the design or l

manufacturing capability and technical ability of suppliers to produce or provide the design, service, item, or component.

Quality Assurance considera-4 tions include one of the previously defined methods of supplier evaluation and a

consideration of i

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

The measures employed to evaluate a i

supplier's continued acceptability ss a procurement j@

source (after the initial soupe t:Jsluation) are V 4 +0gescribed in Section 18.

A, t i.

3560 +r9 Nue4+w Engineering, Quality Assurence, Quality

""d

ruele, uuci,3r geryiees, 3567 [g Services.

Licensing C4 NUCl;;r E2f*t? and " I7?"CY "f"P"f9dN955-t%

Cd ent-t etaff p rform bid evaluations in accordenr:

with 2 :um:=ted prcc:!ur::.

Th:::

y::i::ti:n
  • U# pg,,.a1 shall initiate and coordinate bid evaluation activi-Ng,,,nd. ties for those proposals received in response to t

4 documente initiated b/ them,fcontractd N 4 M.*precurement 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.

i Nuclear fuel cycle-related contracts and Engineering i

  • y Service Agreements for professional services shall I

g-Q be executed by the Senior Vice President-Nuclear or another company officer in accordance with Nuclear i

Division and corporate procedures related to agree-ments or contracts for services.

b h.n wh> w orpr, n Sun.oj

$ 4.ud,Hed ven.q r(EIDMII'bb~eVsItisted by the h N r or pr6p1 3560 7'.

O e

3567 fs) originating organization for conformance to l

3568 g p

curement document requirements.

The Quality l

3569 Assu ce or Quality Services Departments shall i

review posals for conformance to quality assur-ance requi ents.

Bid evaluations of selected bidders shall

.a documented and shall be made by individuals or or izations designated to evaluate the following subje where appropriate to the type of procurement:

1.

Technical considerations 1

2.

Quality assurance requirement L

3.

Suppliers' personnel qualificati l-4.

Suppliers' production capability 5.

Suppliers' past performance 6.

Alternates 7.

Exceptions O

7-4 Rev. 34 6/S9 40

7 1

1

)

00AM

& MM M \\

l w w w Mn4.123 u-3570 7.11 Exce io s t

pr urem t

docu nt requi ment

] h ah

{fgj re es d

b bid ers all be evaluate by e

g i) r sp sib 1 org izat'on(s).

naccept e

co.di-RWA 4.g W 4 2..

io s id-tifi in id eva~ ations all b re-I s.ved p ior pur ase av d.

3579 Consideration of the verification activities to be 3580 N f63 employed for item or service acceptance should begin 3582 during the purchase requisition, ESA, or contract 3585 preparation and review stage.

Planning of verifi-3607 cation activities shall include a review of the established acceptance criteria and identified g 4p2.

t rei documentation.

Verification methods which may be employed include certifications (certificates of conformance and material certificates or test reports) p.ppli:: -"-

! mer, receiving inspec-g

  • 4 J K tion, and post-installation tests established by UE.

Selected verification methods may be indicated as inspections, examinations, tests, or documentation reviews.

The extent of the acceptanc,e methods and associated verification activities is a function of the purchased item's or service's complexity and i

relative safety significance, as well as the suppli-er's pas't performance.

T-hc ^urlity

  • cur;nce er (9)

Quality Service: D:p::tment: 25:11 revier precure-

-..; document and evaluct: the Orig!"eting

^rge"-

1 sticr':

determinatier cf need fer pert-art:d epplier

~^"i t a r d "m 4 =

e^"rc=

3 " e r=* i^"

er curveill:nce.f Procedures provide for the acceptance of commercial grade items based exclusively on gn to Sg receiving inepectier "i t S' nc cupplier generated seality

/cr i Mear-ier decumentatier re':uire--"ts.

~

Documentation shall be generated as a result of UE receiving inspection activities.

O by Suppa, anLk kuq r ruaillance should be 3584 7 F3 Acceptance p3 g considered when the item or service is vital to 302 Plant safety; or the quality characteristics are difficult to verify after receipt; or the item or service is complex in design, manufacture, inspec-

}

c"~~411*" % in this sense involves a DO'"f* ~ tion or test physical presence to

monitor, by observation, designated activities for the purpose of evaluating supplier performance and product acceptability.

2337 9

2416 7.}4 Receiving inspection instructions shall be document-These instructions include specifying inspec-g gg ed.

tions 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 W

employed to establish the items' acceptability. v (3

7-5 Rev. J4 6/p4 1-y.

l) t OQAM l

i to 3571 7.15 Organizations participating in the procurement

[

l g

process shall prepart 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 fulfilling procurement requirements:

2) identifying. and pro-cessing change information: 3) establishing a method of control and documentation of information exchange with the suppliers and 4) audit or surveillance of supplier activities, il 3571 7 14 Depending on the complexity or scope of the item or 3572 service, the Purchasing Department and/or the N

originating organization shall initiate award 3573 3580 activities.

Meetings or other forms of communica-3585 tion may be held to establish the intent of UE in monitoring and evaluating the supplier's perfor-

mance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulfilling requirements.

The depth and necessity of these activities shall be a 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.

Il 3574 7.}7 The originating organization shall establish mea-g sures for monitoring supplier-generated document submittals against procurenent document require-ments.

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..

I'!.

3577 7.}8 Supplier monitoring activities may be performed by l 3578 personnel from Quality Assurance, Quality Services, 34el Nuclear Engineering, Nuclear

Services, Nuclear M

Safety and Emergency Preparedness, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests. ' Supplier monitoring activi-ties may include:

1.

Audits of supplier quality assurance program implementation 2.

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

Surveillance of manufacturing processes 13 7-6 Rev. if 6/$99

t

3, 3 :

OQAM 4.

Audits of supplier records to verify certifica-tion va.1'dity and the resolution of nonconfor-

.l mances j

9?l H

1891 7.29 Acceptance of items and services shall include one f

3601 p g,g3 or more of the following:

3608 1.

Written certifications 2.

Supplier curveill*aee j

{f]

2J.

Source inept:ticr. Ven&Nd 3/.

Recetving inspection Q.

Post-installation test (in addition to one of the above) og' t

1891 7.20 Where required by code, regulation or contract 1893

[g requirement, documentary evidence that items conform 3601 to procurement documents shall be available during 3603 receiving inspection or prior to use of such items.

3605 Where not precluded by other requirements, documen-3607 tary evidence may take the form of written certifi-cates of conformance.

When certificates of confor-mance are employed as a means of item acceptance, verification of the validity of supplier certifi-cates and the effectiveness of the certification i

systems shall be conducted at intervals commensurate with the supplier's past quality performance.

Certificates of conformance and compliance shall be required to be signed or. accompanied-by a signed letter of transmittal.

Whcre acceptance is based u ay uppli- -ur"ei11

, documented evidence of (6)y,er.he.* Lese surveillances shall be furnished to the Plant Quality control organization by the responsible UE organization or their designated agent prior to acceptance.

16 1884 7.24 Acceptance by receiving inspection shall be utilized 3606 y

as a prime method of verification and may be uti-lized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automhted inspec-tions; and-when inspections do not require opera-tions 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, n

3578 7.22-Receiving inspection shall be performed by personnel 1978, (as clarified in certified to ANSI N45.2.6 g

00AM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization.

Other unit staff persennel qualified to ANS 3.1 13 7-7 Rev. 12 6/gSg

(

3 iOQAM._

y j

4.

1978 may b utilized to. perform receipt inspections-q

. requiring specialized

_ skills, such as receipt inspection of radioactive.~ material, bulk ' chemicals l

and diesel fuel.

During outages, extensive modifi-cations,- or other special circumstances, receiving-l inspection may be assigned to an outside organiza-t tion (s),

-97S

.17 2337 7.JB Receiving inspection activities shall include:

l.'

Verifying that materials,

parts, and compo-nents, have been identified by tagging or other 1

.means; or that they are segregated and con-h trolled _in areas separate from the storage.

l facilities for accepted items.-

l 2.

Verifying ~ that items for acceptance -have. been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documenta-tion.

l
2325 3.

Verifying that-received items conform to

- 3577 procurement documents by inspecting or, where 3591 appropriate, testing using approved procedurcs

'3592 and' calibrated

tools, gages ~ and measuring.

equipment to verify the acceptability of items,-

' including those from commercial grade suppli-ers.-

l 2326 4.

Providing final acceptance after; determining 2329 that required verifications are -complete and j

acceptable.

Items. determined-to be acceptable i

for use shall be tagged with an acceptctagLor-

-i other. means of ident.i fication or segregation,

. [

and released, fora storage or use.

Conditional acceptance of items by receiv'ing inspection 3

2328 shall be procedurally controlled.

+

2327 5.

Verifying that received. items which do not 3576-conform to' procurement documents are segregated j

(if _ practicable) and processed in. accordance with Section 15.

A g

.3608-7.)4 Acceptance by post-installation test may be. utilized-following one of the preceding teceptance methods..

j g

Post-installation-testing shall be used as the prime means of acceptance verification when it is diffi-1 cult ' 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.

i f3 7-8 hev. J-2 6/.89h

T

\\

OQAM,

_& ~ <...

m lLo -

m.,

'.2397' - 7.36 ' _ rinal-acceptance of' items. shall be by Quality 3 6(>I b37) Control personnel or designated _ inspection ' person-nel.

The - final acceptance of services shall: be the.

responsibility.-of. the _ originating organization.

Acceptance shall.be. documented.

?!

7.J6 -Code certified material may be obtained from an ASME accredited Material Manufacturer'or Material Suppli-g er for repair'or replacement applications.

However UE _may also obtain Code certified materials from-

-t non-ASME accredited-Matetial Manufacturers or Material Suppliers if such Manufacturers or Suppli-ers are otherwise qualified as -stipulated - in Sec-;

i, -

tions 4' and 7 of the OQAM.

These provisions _-are '

consistent with ASME Code Interpretation XI-1-83-50R 1

dated May 14,,1985.

L

-i i

I i

i

)

'l x

i i

5-

, i '.

7-9 Rev. 12 6/89 4

y 1-

L OQAM 1

1

'8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND j

COMPONENTS r

pf D01884 8.1 The-identification and control of materials, parts,

.1885 and components shall be accomplished lu.accordance i

with documented procedures and-apply to. safety-related materials,

parts, and components during h

fabrication, storage, installation or use.

Materi-Lls, parts, and components identified as nonconform-ing shall be controlled as described in Section 15.,

o 8.2 The identification and control requirements shall M } >1897 2337 address traceability to associated documents, as

[

appropriate; specification of the degree of lienti-i fication and control necessary; location and mathod

't 23 3 of identification to preclude a degradation of the item's functional capability or quality; and prcpr identification of materials, parts,. ' and components prior to release for manufacturing,

shipping, construction, or installation.

Materials,. parts,

.and components manufactured or modified by UE shall' be controlled and identified d'tring manufacture.

A f,i] 1884 8.3 Documented procedures shall assure that specifica-g.

tions and other procurement documents include or reference appropriate requirements for the identifi-cation and control of materials, parts, and compo-nents including partially fabricated assemblies, i

Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items f rom-. storage while maintaining item identity; cont rolling. - the return to storage of issued materi-

als, parts, or components
received, stored, in-stalled, modified, or used at the Plant site.

These proce'ures shall assure that-correct identifications d

are verified and documented' prior to release.

1895 2.4 Physical identification shall be employed to the 2337 maximum'possible extent for relating an-item at any 2346 point ~in time to applicable design or other perti-3593 nent specifying documents including

drawings, specifications, purchase orders, manufacturing and inspection documents, nonconformance' reports, and

+

physical and chemical mill test reports.

Physical 1S96 identification or marking shall not affect 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 installa-tion.

When unique traceability is impractical, bulk

-traceability may be employed consistent with the 8-1 Rev. 12 6/&9g

=

1 3

OQAM i

1

' relative'importance of the item to safety.

When 2333 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 dis-played in an area that is-readily accessible.

2336 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, gq(

8.6 In the event the identification or traceability of an item is_ lost, it shall be handled as nonconform-

~ ['*1 ing in accordance with Section-15, if the disposi-tion is other than to scrap or to retain for non-safety related applications.

b l'

.'d.,

l.

4 f

i--

t I

h) 8-2 Rev. &2 6/8/

1 5

F

+

OQAM i

ht3.1TN 10.0- INSPECTION l.

p,f'1852 10.1 A program for the inspection of safety-related b

1926 activities-shall be established and executed = to 142.7

' verify conformance with applicable

' documented-instructions, ecocedures, drawings, and specifica-tions.

Inspections and monitoring of processes which serve an inspection function shall.be per-l formed by personnel qualified to - perform assigned tasks-and who are - independent of individuals who perform the activity.

s 19291 l

b83.1929 10.2 The inspection-function shall-be conducted in 1930 accordance with written approved procedures which Jg specify inspection scope; personnel qualification g '-

requirements; inspection method description, includ-ing any mandatory hold points; acceptance criteria; data collection requirements; and documentation approval requirements.

Inspection requirements.may be obtained from drawings, instructions, specifi-

cations, codes, standeds, or regulatory require-ments.

sin

[id 1933 10.3 Indw t control by monitoring processing methods, equipment, and personnel shall-be utilized as a L

1 control if inspection of processed items is impossi-ble 'or disadvantageous.

Both inspection and moni-toring cf processes shal1 ~. be provided when-control is inadequate without both.

p 10.4 Inspection of activities'at.the Callaway Plant shall

['d

.be at intervals based on the status and importance s

ggo of the activities.

Guidelines shall be established

'[g to indicate the minimum frequency for. inspecting maintenance, modification, and special processes-activities to provide a basis for subsequent moni-toring planning.

po] jp2[

10.5 The acceptance of an item shall be documented by

-authorized personnel.

Modification, repair or replacement of items performed subsequent to final i

inspection shall require reinspection or retest to i

verify. acceptability, s

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

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

I

- [fo3 1852 10.7 Quality Control inspection personnel or other unit 2263 staff organizations who perform " inspection" activi-2479 ties shall be qualified within their respective 2482-areas of responsibility.

The qualification of QC MO 0

10-1 Rev. -M 6 / jL9

x oOAM i

c M tl

2494

-inspection-personnel shall be defined in three 2498 levels of capability as described in ANSI.N45.2.6.

2994' Other members of the. unit staff' performing "inspec-tion" activities,shall have appropriate experience,

training, and retraining.to assure competence in

-t accordance with ANSI /ANS-3.1.

Inspection _ assign -

ments shall be consistent with the qualification of-an individual.

In instances where the education and experience' recommendations are not-mgt by QC inspec-tion personnel who are to be certify to ANSI N45.2.6, UE shall demonstrate. by documented results of.

written examinations and evaluations of-actual work prof'ciency that individuals possess comparable or equivalent competence.

fdl~2480 10.8 Personnel from outside organizations performing QC 2482 inspection activities associated with safety-related 4(7 2484 items at the Callaway Plant shall be certified as I I 2994 required by ANSI N45.2.6.

Personnel from outside

{

organizations or UE personnel who are not members of i

the unit staff who perform other activities associ-

+

ated with safety-related items at the Callaway Plant shall.either..be certified as required by-ANSI N45.2.6 or they shall meet the education and experi-ence requirements applicable to the equivalent position on the unit staff for the activities which they are performing.

2484 10.9 When contractors or vendors are retained to perform

'2485 work activities or to provide services associated L

3577 with safety-related' items at the Callaway Plant, the E

qualification of inspection personnel and the L

conduct of inspections associated with that con-tracted work activity or service shall meet.the i

l requirements stipulated in the applicable procure-ment documents..

As an example, ' if a,, ve ndor was contracted' to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing-the examination would be quali-r fled as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents...

MB3 DU 2484 10.10 An inspection personnel qualification program shall

-2488 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 of inspection personnel.

The Superintendent, Training shall be responsible for providing related technical and quality training appropriate to the certification / qualification of UE personnel.

O 10-2 Rev. F2 6 / }9fg

=

7

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00AM 4

193F 10.11 Procediares-which specify inspection activities shall

'Ceo3 -

provide - for the-following, as, required:

1)' the inclusion of independent' inspection'or monitoring of-processes. when required; ~ 2) the identification of:

~ personnel; 3)-

the documentation of inspection.

inspection results; 4) a description of the method of inspection: 5) the identification of the charac-teristics and activities to be inspected; 6) the acceptance and rejection criteria; and 7) specifying the necessary measuring and-test equipment.

Inspec-tion or testing, as appropriate, shall be employed as a means of verifying suitable -performance subse-quent to a-component replacement or repair.

10.12 Instructions, procedures, and supporting documenta-

~

tion'shall be provided to inspection personnel for bg -

use prior to performing inspection activities.-

1935 Inspection results shall be documented.

Procedures (436

-shall prescribe the review and approval authority M 62 for inspection results.

c g 2694 10.13-Nuclear Engineering shall be responsible for assur-development of preservice and-inservice N

ing the -

(PSI /ISI) inspection programs; the reference PSI /ISI examination plans for ASME Code Class 1,

2, and 3 systems' and components including steam generator eddy current examination; the NDE procedures re-

-quired by the 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.

b 2694 10.14 Nuclear Engineering shall be responsib_le for assur-24M ing the development of the inservice testing program-

-C plan for pumps and valves, the test procedures required by this plan, and the securing of' consult-ing 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 I

the Nuclear Division.

They are also responsible for-updating.the reference plans and NDE procedures subsequent to the issuance of the inservice inspec-tion-plans and procedures.

The services. of an a'~

outside organization may be secured to conduct the PSI /ISI examinations.

m 10-3 Rev. +2 6/S9g Y-nLaL_i_

2._-_

OoAM.

L' feGJF(74 "11.O ~ TEST CONTROL J

1850 11.1 ' Testing shall be performed to demonstrate that D0(2052 safety-related structures, systems, and components

~l y3 i will perform satisfactorily in service.

Testing programs include ~ such tests as. initial startup

testing, surveillance
  • ests, ISI pump and valve tests, and other tests, including those associated with Plant maintenance, modification, procedure
changes, f ailure analysis',

and the acceptance of purchased material.-

A test is performance of-those steps necessary to determine that systems or compo '

nents function in accordance with predetermined

,9 3y specifications.

g?oV{

2055 11.2' Testing programs shall be established to demonstrate 2056 item or system performance.

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, instruc-tions, procurement documents, specifications, codes, standards, and regulatory requirements.

11.3 Administrative procedures,

. test -procedures,

.or g >M36 i32.

checklists shall includes provisions.for assuring all prerequisite conditions are met; test equf

  • nent calibration requirements; testing-method instruc-tions; limiting conditions and acceptance / rejection i

criteria; -and data collection and test result approval requirements, gi3 2263 11.4 Personnel within the-various UE organizations may 2479 perform testing activities including implementing

2482 test procedures and the evaluation and reporting =of 2483 m g test results.

The assignment of Plant testing 2494 personnel shall be under the direction and control of the General Manager, Nuclear Operations.

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 - staf f -

performing " testing" activities shall have appropri-ate ' experience, training, and retraining to assure y'.

competence in accordance with ANSI /ANS-3.-l.

Testing assignments shall be ' consistent with the qualifica-tion of an individual.

In instances where the education and experience recommendations are not met by QC testing personnel who are to be certified ~to I,

ANSI N45.2.6, UE shall demonstrate by documented a

13 11-1 Rev. 44 6/p9,g l

~

00AM s

.h

/1137 11.9_ Review:and approval-of tests-and experiments not-11430 described in the FSAR shall be conducted as speci-

~b fied' in the callaway' Plant Technical Specifications

'and210 CPR 50.59.

11.10 Provisions shall be established for the performance g Ig 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 Specifi-cations.

The provisions for surveillance-testing:

3 shall include the preparation? of a

surveillance Y

testing schedule (s) which reflects ;the status of.-

in-plant surveillance tests.

Qualified' personnel shall perform surveillance tests.

-2053 11.11 Appropriate tests shall also be performed-subsequent t

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 func-

-tional acceptability.

11,12'When required by procurement documents, testing-a means of' purchased material shall be--employed as and. equipment acceptance.

Acceptance. testing of this nature shall be performed during receiving inspection or subsequent to installation in accor.

dance with Section 7.

i 11.13: 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 componente shall-be

' reviewed and-evaluated to-determine whether a like kind replacement _ component can be expected to perform its function-reliably, i

.l 4

13 11-3 Rev. 22 6/p94

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OQAM i

i 12.0- CONTROL OF MEASURING AND TEST EQUIPMENT

'I 1919 12.1- ~ Measuring and test equipment utilized in activities 1920 affecting quality shall be controlled-in accordance-1969 with written procedures or instructions.

The 2042

' procedures for calibration and control'shall address 2264' the identification of test equipment, calibration

'3591 techniques, calibration frequencies, maintenance

t 3592

' control, _and storage requirements.

The equipment subject to these controls includes:

(1) M&TE (port-able measuring - instruments, test e 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).

1920 12.2 Tools, instruments, testing-equipment and measuring g

2295' devices used for measurements, tests, and calibra-2043 tion shall be of the proper range and type; and 2060' m -

shall be controlled, calibrated, adjusted and main-y 3591

-tained at specified intervals or prior to use to-assure the necessary accuracy of calibrated devices..

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

2043 12.3 Permanently installed process instrumentation shall-be afforded the control measures described herein consistent with the surveillan'ce testing program and preventive maintenance program.

.12.4 The calibration and control program established at

'the Callaway Plant shall assure that M&TE, re ference etandards, and PI maintain their required accuracy.

The Assistant Manager,. Operations.and Maintenance is i

responsible for assuring the program establishment.-

Program implementation is the' responsibility of the appropriate Department Heads.

1920 12.5 M&TE, reference standards, and PI shall be utilized 1

by various organizations as. required to' perform T

tests or other special operations.

'Each organiza-s tion.chall be responsible for. assuring that the M&TE or reference standards it uses'have been calibrated.

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

Vendors activities-performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 9 of OQAM Section 12.6 unless specified in procurement documents.

Q 12-1 Rev. b2 0$90

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i 14. 0.'- INSPECTION,-TEST, AND GPERATING STATUS-1 1

y 14.1' -Safety-related items that are received, _ stored or-

-installed at the callaway-Plant shall be identified and controlled in accordance with documented proce-dures.

11Pf 71

- [s03 2116 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.

f Prior to storage or instal'1ation, ; items shall be-1 identified by means of stamps,' tags, labels, routing

cards, segregation, or other means traceable to manufacturers' and receiving inspection documen-i tation.

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.

'1841 14.3-Plant procedures shall provide instructions relating

-1842 to the manner of. indicating the operational status 1844 of safety-related structures,

systems, and compo-y nents, including-temporary modifications, and shall require independent verifications, where appropri-ate, 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 mainte-nancet 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 1

identified.

17A g 1844

.14.4 Plant procedures shall establish controls to identi-1846 fy the status of inspection and test activities 1847 associated - with maintenance, repair, modification, l yy/

refueling, inservice inspection, and instrumentation and' -control system calibration and testing.

.The.

Technical ~

Specifications.

establish the status required for safe Plant operation, including provi-sions for periodic-and non-periodic tests and inspections of various

. structures,

systems, andM ccmoonents.

Periodic tests may be' operational tests or tests following maintenance while non-periodic tests may be made following repairs -or modifica-tions.

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l' 2337'~15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 1848 15.1 Material.nonconformances include material deficien-1870 cies (including inoperative and malfunetioning 7,f3 1907g g structures,_ systems, and components).

Material 2112 nonconformances identified under the UE OQAP shall be. controlled to prevent the inadvertent use of material, parts, or components which are defective or of indeterminate quality and to identify documen-y tation inadequacies.

Measures shall be established-regarding identification, documentation, status control, disposition, and ' notification of affected organizations.

1848 15.2 Under the UE OQAP, Nonconforming Material Reports 1903 (NMRs), nonconformance logs, or.other administrative

-1907 controls shall be employed to identify and control 2334 nonconformances.

Nonconformance logs may be em-

'j ployed to cor. trol deficiencies of a minor nature or

-t to-control documentation deficiencies both of which can be corrected by bringing the deficiency into compliance with the original requirements.

Material 1885 nonconformances shall be controlled, as appropriate, by documentation,

tagging, marking,. logging,- or physical segregation.

The ' programs describing the administrativo nonconformance controls shall delin-M t

eate the tr2thods'of identifying 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.

_ [

w' 93-ifg 15.3 Plant and other UE organization's procedures shall J

prescribe measures for the control-and disposition g

of UE purchased items and services identified by outside organizations as nonconforming.- Procurement 3558 documents shall specify those nonconformances to be 3576 submitted to UE for approval of the recommended i

3598 disposition.

As specified in procurement documents, 3599 actions taken in response to these nonconformances 3600 shall be documented and forwarded to UE along with the hardware and accompanying quality verification documentation.

Nuclear Engineering shall be respon-sible for assuring the processing of supplier-recom-mended dispositions for Plant-initiated procure-ments.

Similarly, other UE or outside organizations shall approve or be requested to provide a technical evaluation regarding supplier-recommended disposi-l tions of nonconformances regarding procurements they initiate.

s B

15-1 Rev. 12 6/&9 g l

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1904-15.4-Material--nonconformances shall be processed in

~~

1905 accordance with documented procedures-and shall

.)

1907..

identify the specifics of the nonconformance stating i

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 li material nonconformance.

l 1907 15.5 Material nonconformance disposition categories shall b

73$

include:

4 1.

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

" Reject" -or "not acceptable, scrap, or return l'

to vendor"

{

3.

" Rework" in accordance with approved procedures 4

4.

" Repair" in accordance with approved procedures i

Material nonconforrances.

shall be reviewed and

accepted, rejected,
repaired, reworked, or condi-4 tionally released in' accordance with documented procedures.

An approved disposition of a

nonconformance which allows a

reduction a

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.

4

'1848 15.6 Nuclear Engineering shall be responsible-for approv-1905 ing material nonconformance dispositions of.

1907

= "use-as-is" and " repair".

Licensing and Fuels shall 12335-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

-t shall be responsible'for verification that approved

' dispositions have been implemented and for the final sign-off.

E 15.7 Nonconformance documents which record defects in g

basic components or deviations.

from technical y

requirements in procurement documents shall be l

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

Signifi-cant nonconforming conditions involving a defect or r

l;' Y material noncompliance in a delivered component or

~

service which could create a

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

l I

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15-2 Rev. +2 6/89

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MJ 92 '15.8 Material'. nonconformances which wouldt impact the 1'

con uct of. a. test shall be corrected or resolved' d

4 prior to -initiation of 'the -test on 'the item.-

The i.

decision to~ proceed with the testing of a oystem or i

3 --

L\\

subsystem with outstanding-material nonconformances

.I shall consider the nature of the nonconformance, its effect on test

results, and-the need for T

supplemental Ltests' or inspections _ af ter correction-

-i ' of the nonconformance.

The evaluations shall be a

' documented, q

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i

'I 1948_ _ ' 1 5,. 9 - Repaired and-reworked items shall be reinspected or_-

1904;

'i.

tested.

Measures-may be established to condition-1906 ally release nonconforming items-whose-disposition is pending, provided that an' evaluation indicates V

2053 2332 that further work or activity will not contribute

~

adversely to the material nonconformance or preclude-g identification and correction.

15,10 The Manager,' operations support shall'have. material g

s nonconformance ; summaries prepared semiannually and analyzed for potential \\ adverse quality trends.

These summaries shall be'sentVto the Quality Assur-

_\\ ance Department for an independent, review.

The-result of this review shan be reported to' manage-ment.

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'16'.'O - CORRECTIVEeACTION L

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'18701 16.1 Measures shall be established to assure that condi-

"l4#h 2970 tions adverse = to quality are promptly. identified, Jeo) reported, and corrected.

Nonconformances shal'li be controlled in accordance with the requirements described in

.Section 15.

Each of the Nuclear Division Managers is responsible for' developing and-l

[9]

implementing-a program forLidentifyinc'and control-1 ling adverse conditions. f As a minimum each program -

p shall provide for_ developing and analyzing trends on.

4 j[

L, a

semiannual basis.

Procedures shall. provide h

m,

. instructions.for identifying, reporting, and initi-

_ t K

atingi. corrective action to preclude recurrence of

+

adverse conditions.

It is understood-that the term

" corrective-action" includes remedial action neces-sary to correct the deficiengy, as well as corree-tive: action necessary to precitide recurrence.

[87 16.2 Conditions. adverse to quality which impede the implementation - or reduce the effectiveness of the

W Me.

Operating QA Program. shall be controlled by the

.g

h. M measures described ' herein.

Adverse conditions may h

l

- fte,

.inciddeT noncompliance with procedural requirements; h

l reportable. occurrences required by regulations; adverse-nonconformance trends;

.es-deficiencies identified in the OQAPr3 L'ithin th; "I

rr;;tiv

.equees ser correesi e f.e sie.s aesie-p e e g e s =.,

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2 xy 7 Cerrectir: ?.: t i c.-

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dec rent mer: eignificant drer : cenditi:n:, :::P j,

-ee recurring conditions for which ;past corrective, a,

W action has been ineffective;or :. :ignifi::nt break-g downs in administrative and managerial-control systems which could result in a system designed: to

.4 g _.

prevent or mitigate serious events not being able to G 3."

perform its intended function.

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nep::t: ~ (C?.n:)

nd :ther gorrective ' action W

documents which record defects. in basic componenta or deviations from technical requirements in pro-i$'

4 curement documents shall be reviewed ~ for reporting applicability under 10CFR21 and other Federal reporting requirements.

t 1

16.4 Corrective action documents shall be transmitted to the-' responsible organization.

The responsible 3599 organization shall investigate the findings and

' 3600 identify the cause(s) of the deficiency, and specify W.

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and initiate - the _ action (s) necessary to correct the

-conditions and prevent recurrence.

16.5 Nuclear Engineering sh:11-review documented - condi-tions adverse ~ to-quality which involve design t

deficiencies or design changes which are recommended'..as__a'l as corrective action.

The ORC shall reviewfadverse 7

conditions identifiedbct th: p l : n t : n C.'.".;.

Licens-l

~

i ing. and Fuels should review documented conditions adverse to quality for - fuel-related issues.

i

%6 The corrective action documents shall be closed o m

by _ verifying the implementation ~ and ade'quac of I

[8),

rective action.

Summaries of corrective etion.

doc' nts shall be reviewed for the effec eness of

/g the

.c ective actions taken and alyzed for potential verse quality trends.

nese summaries dM and analyses.

11 be sent to t Quality Assurance A h.

D*Partment for a ndependent eview.

The result of~

'this review shall re ed to management.

The 4 -2 a Quality Assurance-De tment shall periodically prepare, summaries. o' CAR nd submit them to the

! l4.6 j-

~NSRB and'appropr e levels o anagement.

I 16.7 The Quali Assurance Department 11' close out

[10 CARS b rifying the implementation an adequacy of corr tive action.

Copies of completed s shal1~

b transmitted to management to keep them"a

-ised of conditions adverse to quality.

If 1 44,4-The~ close"-Net of corrective action documents shall be accomplished as.promptly as practicable but shall b.M.

occur only after the corrective action. taken has_

q been verified..

. Verification may be accomplished through direct observations', written communications, j

re-audit, surveillances, or other appropriate means, d

The nature of the deficiency. may be such that i

remedial. actions n'eed to be taken immediately whereas development and implementation of corrective 3

s action to preclude recurrence may take substantially s

. longer.

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-16.6

' Corrective action documents shall be closed.by-verifying.the I

implementation and adequacy of-corrective! action. The Quality-9 Assurance Department shall close QA-originated corrective a

action documents by verifying the implementation arid adequacy.

~

offcorrective action.. _ Copies of completed corrective action

documents shall be available for-management re*/iew (hardcopy or-electronic-media) to keep them apprised of conditions adverse:

1 to quality.; The Quality Assurance Department shall-

-periodically. prepare. summaries of significant corrective action 1

- s

(documents - and submit them to the NSRB and appropriate levels of-lt management.

q INSERT B ll.

/[p3 16 '.- 8 '-

Summaries of corrective action documents shall be reviewed for' 3

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 the,se trends through-m' routine audit and surveillance activities; and shall report the results of-these assessments to management.-

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N 17.0 = QUALITY ASSURANCE RECORDS

[dj 0

17.1 Quality assurance record systems governing the 34 collection,

storage, and maintenance of records shall be established by UE.

They shall typly to records associated with startup testing,~ operation, maintenance, repair, refueling, and modification ~of safety-related' structures, systems, and components at the Callaway Plant.

['d li4o 1150 17.2 During the operating phase, quality assurance

/D #2128 records shall be maintained to furnish documentary.

2132 evidence of the quality of items and activities 2138 affecting quality.

Applicable design specifica-n ll13.

tions,.. procurement documents, test procedures, operational procedures or other documents shall t

specify the quality assurance records to be gener-ated 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 finite 2133 retention period shall be specified.

Records shall 2137'

. provide sufficient information-to permit identifica-tion to the item or activity to which -it applies, and be retrievable.

l@

139 17.3 Quality assurance records include, but are not-l.i 2364 limited to, operating logs; - maintenance ' and modifi-3 97 26(,f cation procedures and inspection results; reportable ~

gj occurrences; results of reviews; inspections, tests, audits and material analyses;. qualification of v

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 n

performance (e.g.,

surveillance).

g sq [

17.4 Inspection and test records shall contain the g

following as a minimum:

1.

A description of the type of observation 2.

The date and results of the inspection or test 3.

Identification of the inspector or data record-er 4.

Evaluation of the acceptability of the results 5.

Action taken in connection with any deficien-cies noted 17.5 Quality assurance records generated by others are transferred or made accessible to UE as systems and equipment or services are transferred or delivered from A/E's, NSSS suppliers, fuel fabricatorr

.ws

{

17-1 Rev. 12 6/B9 4

?

OVM M 'Wd 00AM "m

m.. a constructors, or others.

Records maintained by'an

'. 1} '

outside organization prior to and subsequent to final transfer are required to be accessible to UE.

Records generated internally shall be processed in a timely manner in accordance with documented' proce-J

N CA DO heAda,,,,,Jash 2129-17.6 Record systems shall be established by +" "' rt and 2131. p.A r tu rrrr:1 ;;;1a; and shall be controlled in-e Mb7 2147 DW* accordance with written procedures.

The implement-v ing procedures shall address records administration;-

'h

- receipt of records; storage, preservation and safe-J.I keeping. of records record retrieval; and the.

-1 disposition of records.

The.* % :::ti;.. E:rerds NK (MW. organization is responsible for assuring the handling and maintenance of quality assurance records generated, received, and temporarily stored a

I at the General Of fices. -

shall a4+e provide for the administration of the quality assurance record system at the Callaway Pla tye Sendu4A Ory~m,/'*

2135 17.7 The requirements regarding hard-copy records admin-2149 istration shall require that-quality assurance 2150 records ~be listed in an index.

The index shall be established prior to the receipt of records and shall indicate the location. of' records.

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

The-distributing and handling of records,:

the correcting or supplementing -of quality assurance

records, and specifying the retention period of record types shall be delineated 'in written proce-duresi The retention - period - of records generated*

prior jto commercial operation shall begin on December 19, 1984; the date of commercial. operation.

The requirements regarding receipt of records shall 2145 17.8 2146 define the requirements for the receipt of documen-

.tation generated by others during the operation of i

the Callaway Plant.

These requirements shall assure that records are submitted and that designated authorities are responsible for-organizing and control..

implementing a system of records receipt 2148 The records' receipt. control shall permit an assess-ment of the status of records during the receiving process.

t o

  • 0cilaway was declared available for unrestricted loading by the UE Company 1,oad Dispatcher on December 19, 1964.

The PSC Commercial Operation date is April 9,

1985.

The PM and EQ programs use the PSC date.

Refer to UO 86-107.

0 Rev. Or2 17-2 d

t i

OQAM o

- 081 2150 ~ 17.9 The requirements regarding storage, preservation, 151 andisafekeeping of records shall establish storage 21 2153:

requirements for the maintenance, preservation, and 2155 protection of quality assurance records.

These-t 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 facili-ties' which protect contents f rom possible. destruc-tion.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 needL not be uniquely controlled in each storage area, but.

may be the prevailing building temperature.and-humidity.

2157 17.10 Record storage systems shall provide for an accurate-2159-retrieval of information 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 forL nonpermanent records.

2160 17.11 Record disposition practices shall establish re-2161 quirements 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 writt'en 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.

a s

A 17-3 Rev. F2 o

t

.i -

- J

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((jkitt W 3.-

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x h

3869 18.0 AUDITS I

2186 18.1 A comprehensive audit program shall be established w

and implemented by UE to verify internal and exter-

-2199-nal quality &ctivities'. compliance with the OQAP.

2978 The audit program shall assure that all applicable 2988 elements of the Program have been developed, docu-3586

.mented, and are being effectively implemented and 3865

shall provide for the reporting and review of audit-3867 DU.

3883

results by. management.

The audit system as de-ol'M9 scribed in manuals and procedures.

Nonconformances and program deficiencies shall be identified and' corrective action shall be initiated and. verified.

See Section 3.13 for a specific audit topic.

The UE audit system shall include the performance of Lol ui ' 18.2

~

audits and. surveillances by the Quality Assurance 4

Audits determine, and Quality Services Departments.

l i

through investigation, the adequacy of and adherence to established procedures, instructions, specifica-tions, codes, and other applicable contractual and

)

licensing requirements and the effectiveness of l

implementation.

Surve111ances involve the periodic or continuous monitoring of.the operation er perfor-mance of a supplier, item',

component, or system.

.i, l

Surveillance in this audit-sense - should not be

-i confused with inspections for the purpose of process l}

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 f acility operations j

are within the safety limits, and that limiting conditions of operations are being met (surveillance 1

g tests).

OA and QS personnel performing surveil-lances should be familiar with the area to be 1'

surveilled and the applicable implementing proce-governing surveillances.

Surveillances may-dure (s) also be performed by personnel ' rom other organiza-fications er certifications (ene,=f Me personnel cuali-tions, but these recuire no unicue

~

prL,.,,/ 6,w&d-j' f

pj awpiume). See Shcd410 7,104, IMi tts, neef t9 4.

The Manager, Quality Assurance shall establish a 2244 18.3 program which provides for the qualification and audit and surveil-1 2250 l2255 training of QA and CS Department 2963 lance personnel.

Audits shall.be directed by an Team Leader (ATL) who is a certified Lead 3866 Audit A Lead Auditor is an individual certified 3877 Auditor.

as qualified 'to direct an audit, perform an audit, repcrt audit findings, and to evaluate corrective l

action.

Other personnel may assist Lead Auditers in j

the conduct of audits; namely, technical special-ists, manager 9nt representatives, aud2 tors and other

, )

1818 Lead Auditor:.

The penons having direct responsi-bility for performance of the activities being O

Rev. 'A 18-1 6 /J#g

5 Olmt GN 00AM g:

audited shall not be involved in the selection of

~

the' audit team.

Personnel selected for OA auditing or. surveillance assignments shall have training or 3892-experience commensurate with the scope, complexity, or, special nature of the activities to be reviewed or investigated and shall have no direct responsi -

bility for the area being evaluated.

The OA person-nel' training program shall provide general orienta-A tion and specific training which develop competence for performing, audits. or surveillances.

Training

, n..

records shall provide a history of QA personnel

-;,b.

3

training, evaluations, qualification,-

certifica-

. m -

e n,.

3 tions, and retraining.

. h;[*&. A 6u.lG Assurene ed klQ9rMIA-i 2245 18.4 ersonnel who perform audit and surveillance activ-ties shall'be qualified in accordance with the re-

~f p

2246 3 M 2 M47-quirements prescribed.in Quality Assura.nce' Depart-Lead Auditor qualification ment procedures.

2259 requirements shall include education or professional 3866

status, previous work experience or
training, n

training received through UE, on-the-job performance and participation in surveillances or audits as an qualification examination, and other L

auditor, a

factors ' applicable to auditing not defined by-procedure.

The qualification certification of Lead 2244 Auditors shall be based on an - evaluation of these The factors by the Manager, Quality Assurance.

maintenance of proficiency by Lead Auditors shall be r

2253 accomplished by active participation in the audit a

review of Program, codes,. standards, process; related to procedures and other document revisions the OOAP; or participation in training programs.

The Manager, Quality Assurance. shall provide for 2249 annual assessments of each Lead Auditor to determine proficiency.

As'long as a Lead Auditor is perform-l ing satisfactorily and is maintaining prciiciency, is no limit on the period of certification.

3 there However if at anytime the Lead Auditor's performance is evaluated as being unacceptable, Lead Auditor certification shall be rescinded. In addition.the 2254 i

failure to. maintain proficiency for a period of.two years or more shall be basis for Lead Auditor 1

l certification revocation.-

If certification is

,~~

rescinded or

revoked, requalification shall be required prior to recertification.

Quality Asstrance shall be responsible a

3865 18.5 The Manager, a comprehensive for assuring the implementation of system of planned audits to verify compliance with the OOAP.

The

Manager, Quality Assurance has sufficient authority and organizational freedom to schedule and perform both internal and external He has the organizational responsibility to audits. and assure the overall effectiveness of the measure
  1. 3 Bev. ?!

18-2 6 / Mg x

y, p

OQAM-n OOAP and is: independent of the economic pressures ofl

-i

~

production ' when. opposed to safety =or quality.

The:

a Manager,-Quality Assurance has dire'et access to the t

Senior Vice President-Nuclear.

The Senior Vice President-Nuclear has-direct access to the President.

18.6 The Manager, Quality Assurance is responsible to the Senior Vice President-Nuclear for assuring the OOAP f,

is being-effectively implemertp, for operating activities and supervises Superintendents,- Quality Assurance who direct full attention 'to~ this effort.

The Manager, Quality Assurance shall be. knowledge-able' and experienced in nuclear power plant activi-ties and shall bear no cost, schedule, or production

\\

responsibilities.

He reports on the - Program ef fec-O tiveness directly to the Senior Vice President-

,aclear.

A communication path shall exist between the. Manager, Quality Assurance and General. Manager, j

Nuclear Operations, the Manager, Callaway Plant and the Manager, Operations Support as well as the other t

g Department Heads in the Nuclear Division thus providing a direct path to inform management regard-ing conditions affecting quality.

3871 18.7 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 _-co' ordination and scheduling of audit _ activities.

The Manager,-

l

' Quality Assurance shall review the OQAP audit-program annually. to assure audits. are - being accom-plished in accordance with the requirements de-pf2 scribed herein.-

'063 vftb

.i 3873 18.8 Internal audits shall be conducted by the Quality l

Assurance Department and shall be performed with a-frequency commensurate with their safety signifi-cance.

An audit of safety-related functions shall-be completed in accordance with formal audit sched-ulos within a period of two (2) years.

Each element 3

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

$ol 2666

'18.9 Supplernentary to the biennial requirement to audit 2681 safety ; elated = functions, other activities shall be 2847 audited at the frequencies indicated in Section 3873 6.5.2.9 of the Technical ' Specifications and under.

p" 4 077 the cognizance of the NSRB.

In addition to audits conducted under the cognizance of the NSRB, the following areas shall be audited -at least once per 12 months:

Special Nuclear Material Accountability program G

18 3 Rev. 12

\\

g 6/84 hi

~

)<, e,Q

OM - Q 40 #

- ogAg Radiological Protection program Radiological Emergency Response program

='

l Security program y.

. F.htm - cer D*dyL l'r*4***'

L 3873 18.10-During Plant modifications or other ' major unique activities, audits shall be scheduled.as required to assure that Quality Assurance Program requirements

?

are properly implemented.

?

18.11 External audits shall be conducted by or for the -

! A l3577 Quality Assurance Department as a. method for the

.o*J.

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, may3 be employed as a means of post-award source verifi-1 cation in lieu of UE performed. audits and may net; necessarily audit specific items - fufnished to UE. :

Audits and surveillances may also be performed for the Quality Assurance Department by the Quality Services-Department.

These audits and surveillances-shall utilize personnel qualified in accordance with this oQAM and shall be conducted in accordance with s

I this OCAM and Quality Assurance Department proce-dures.

Commercial crade items do not recuire s

fd pec-

=pplier y= 14 # 4 "+ b 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.

l

'1780-18.12 Applicable elements of suppliers' quality assurance 3578 programs shell be audited (post-award) on'a trienni-3872 al 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 which

.significantly enlarge the scope of activities by the same supplier shall be considered in establishing audit require-ments.

In addition, the need for a triennial audit may be precluded upon evaluation and documentation l.

by the QA or QS Department that the results cf mini-audits. performed during source inspection and source surveillance activities confirm the adequacy and implementation of the supplier's QA Program.

18.13 Supplementary to

audits, annual evaluations of suppliers shall be performed which take into ac-
count, as applicable:

2) the review of supplier 4,

furnished documents such as certifica.es Of confor-0 W

18-4 Rev. M 6/ %

=,

f

, 9;

,7

60kM.

[N 90-0 L

~l' OPERATING OUAL7't'Y ASSURANCE MANUAL (OQAM)

APPENDIX A l

OQAM CONFORMANCE TO APPLICABLE NRC REGULATORY GUIDES l

This Appendix briefly discusses the extent to which Union Electric's Operating Quality Assurance Program (OQAP) conforms to NRC published Regulatory Guides for the Callaway Plant.

Clarifications, alterna-

tives, and exceptions to these Regulatory Guides are identified herein.

Union Electric's position on other Regulatory Guides is given m}

in Appendix 3A of the Callaway-SA and Callaway-SP Final Safety Analy-sis Reports (FSARs).

In each of the ANSI standards referenced by one o_f the listed Regula-r tory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either identified at the point of reference or are described in a special section of the standard.

The specific applicability or acceptability of these listad standards, codes regulations or appendi-ces is either covered in other specific areas in the PSAR or this Operating QA Manual (OQAM), including tables, or such documents are 4

not considered as requirements, although they may be used as guidance.

When sections are referenced within a standard, it is understood that

-l UE shall comply with the referenced section as clarified.

PEGULATORY GUIDE 1.8

  • PROPOSED REVISION 2
  • DATED 2/79
  • Revision 1 dated 9/75 for the position of Radiation Protection Manager only, in accordance with the callaway Plant Technical Specifi-cations.

l i'

. Personnel Selection and Training (Endorses ANSI /ANS 3.1-19"8) l DISCUSSION:

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

hefer to Callaway-SA FSAR Section 13.1 for a discussion of the quali-fications of personnel responsible for Plant operation and support.

Personnel responsib'.e for directing or supervising the ccnduct of safety-related preoperational and startup tests and for review and sI approval of' safety-related preoperational and startup test procedures er results met the cualifications of the Regulatory Guide, but were N

not required to be ce'rtified.

mS8C 19 8 titled Documenta-pyppet With regt.rd to Section 5.6 of ANSI /ANS 3.1 lp i tion: UE sha.ll maintain records in accordance with and te meet tne requirements of OOAM Section 17 and ANSI N45.2.9 as specified herein.

A-1 Rev. 9 6/86

OCAM CN 90-01

[7]

With regard to section 5.2 titled Training of-Candidates to-be-Licensed by the NRC and section 5.5, Operator Retraining and Replacement Training of ANSI /ANS 3.1-1978:

In lieu of the-training and retraining requirements for licensed reactor operators and senior reactor operators outlined in these sections, UE shall follow training and qualification in accordance with INPO accredited progrms referenced ~in Chapter 13.2 of the FSAR.

(

l i

2 l

A-la

'\\).

OGAM APPEN0!X A I-REGULATORY GU:DE 1.33 (cent.)

l Paragraph C.5.f of Regulatory Guide

1. 33 - (and Section 5.2.19(2) of ANS: N16.7 which it references) shall be implemented with the substi-tution'of the word
  • practicable" for the werd *possible" in the last sentence.

The action referenced in this Section is the responsibility.

of the Callaway-Plant Operating Organi:ation, and includes QA/QC involvement.

QA is involved through audit and surveillance activi-ties.

OC 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 which 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 manage-ment personnel.

Management personnel includes OA through cross-disciplinary reviews and through QA permanent membership on the 4

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 document-ed.

The documentation shall be retained as lifetime records.

With recard to Section 3.4.2 of ANSI N16.7 - 1976 titled Recuirements for the"Onsite Operatine Orcanizatien:

Training standards iederenced

.n nis sect:on are
,mplementec as described in this-Appendix's commitments to Regulatory Guide 1.6 (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 f orth - in OOAM Section 2, in the Callaway Plant Cechnical Specifica-tions, and in other licensing commitments.

Some of UI's technical support organizations are physically located at the Callaway site.

Therefore the second sentence of nis Section shall be implemented as follows: " Initial incumbents er 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 acccrdance with the provi-1 g

sions of ANSI /ANS 3.1

',978 as committed to in the OQAM."

IM86 i

56 t, $66 With regard to Section 4.1 of ANS! N18.7 - 1976 titled General, The A ku UE audit program shall be implemented in accordance with anc to meet the requirements of Regulatory Guide 1.144 (ANS: N45.2.12) as endorsed 1

in this Appendix, OOAM Section 18, and the Callaway Plant Technica' Specifications.

1 1976 titled Procram De-With regard to Section 4.2 cf ANSI NIE.7 L

scription:

Two aspects are addressed in this Section:

auc:,t s and l

incependent reviews.

The independent review program shall be imple-mented as required by the Technical Specifications.

The UE audit l

program shall be described in accordance with and to meet the require-ments of Regulatory Guide 1.144 (ANS: N45.2.12) as endorsed

,n this

Appendix, t hat Callavey Plant Technical Specifications, and OOAM Section IE.

I ')

A-6 Rev. 2 6 /Skqn

r i -:-

J

&}$16hl CfQ Gl

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.7/ ; INSERT [#'J

!?

t 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.

1 s

5 i

1..

,1

-1 A-ea

hC[/h CN 00AM W.of APPENDIX A REGULATORY GUIDE 1.74 (cont.)

Regulatory Guide 1.58 (ANSI N45.2.6)."

These activities are con-trolled 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 OC 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 definition of " procurement documents,"

UE shall utilize the definition given in ANSI N45.2.13.

The compound definition is given as follows:

Procurement documents - Contractually binding documents that identify and define the requirements which items er services must meet in order to be considered acceptable by the purchacer.

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 agree-ments for engineering, construction, or consulting services), con-tracts letters of intent, purchase requisitions, purchase orders, or h-proposa,lsandtheiracceptance, drawings, specifications, or instruc-tion which define requirements for purchase.

NM Program Deficiencies" (Not defined in ANSI N45.2.10, but used and P

pg defined differently in Regulatory Guide 1.144 (ANSI N45.2.12))

Failure to develop, document or implement ef fectively any applicable j

element of the Operating CA Program.

" Quality Assurance Program Requirements" (Not defined in ANSI N45.2.10 but used and defined differently in ANSI N45.2.13)

_Those indivicual requirements of the Operating CA Program which, when invoked in':ctal 1

or in part, establish the requirements cf the quality assurance program for the activity being controlled.

Although not specifically used in the Operating OA Program, ANSI N45.2 may be imposed upon UE's suppliers.

"Independen Verification" - Verification by an tndtvidual other than the person who performed the operation or activity being verified that required actions have been ecmpleted.

Such verification need not require confirmation of the identical action when other indications provide assurance or indication that the prescribed activity is in fact complete.

Examples include, but are not limited to: verification of a breaker cpening 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 stepping of flow en meter indications or by remote value positions indicating lights.

O A-20 Rev. M 6/%

00AM CN #89-06 1

1P INSERT A00 deflu1Lic..

Le Re Cuid: 1.75 :

follove:

v.

" 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 c

order, contract, or Engineering Service Agreement."

l l

1 h

i Page A-20a

OQAM ggjpggg qp.gl APPENDIX.A REGUI.ATORY GUIDE 1. 8 8 (cont.I f0 With regard -to Section 5.7 of ANSI N45.2.9-1974 titled Audits:

4:f;;. tin'. :: :pi r:12.t :::tr::: ::: pr:cir:f i-this 00AM, Section 18 I"p j and commitments to Reg. Guide 1.144 in this Appendix.

Yf

\\ M 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

.NRC Criteria for Records Storace Facilities (Guidance-ANSI N45.2.9, Section 5.6) issued 7/1/80.

-y Paragraph 4, subsection 9 is clarified to read: "No pipes or penetra-

-)

tions except those providing fire protection, lighting, temperature /

humidity control, or communications are to be located within the facility and they shall comply with a minfe'im two-hour fire protection rating."

Where duplicate storage is employed, no special precautions or provi-siens (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 subsee-tion 5.4.3.

Both paragraphs address the same requirement and there-fore the commitment must be the same.

REGUI.ATORY GUIDE 1.94 P2 VISION 1 DATED 4/76 s

.I Quality Assurance Requirements for Installation, Inspection and Testing of Structural Conarete and Structural Steel During the Con-struction Phhse of Nuclear Power Plants.

(Endorses ANSI N45.2.5-1974)

DISCUSSION:

UE complies with the. recommendations of this Regulatiory Guide with the

-following clarifications:

For. modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in

nau QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these modification activities even though such requirements may not have been in effect originally.

Technical requirements associated with 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.

[

A-23 Rev, 12 6/89

i

)

OQAM CN 90-01

-INSERT fil3 These specific activities in sub-sections 1, 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

-~

.)

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i A-23a

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CHr IR CED Nb/

it PRESI VICE-WAN

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SR. V.P.

SENIOR VICE ADMN PRESIDENT SERVICES NUCLEAR VICE. PRES.

SUPPLY SERVICES MANAGER r.

i.

PURCHASNG b

P; T\\d

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4-l-

MANAGER MANAGER MANAGER MANAGER HUC SAFETY.

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NUCLEAR LICENSNG NUCLEAR AND EMERG ENGNEERNG

& FUELS SERVICES PREPARDNESS

) ;

i k

4

__j L______________L_____________ _1____________

t____

+

ENGNEERNG STAFF STAFF STAFF STAFF (SEE RG B)

(SEE RG B)

(SEE OG.C)

ISEE FIG.B) i 4a-k k~

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I SI wr APERTURE CARD Also Availabic On en Aperture Card y

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SEMOR YP TECHMCAL l'

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VICE k.

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GENERAL-i WANAGER NUCLEAR f'

OPERATIONS L

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WANAGER-

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MANAGER WANAGER WANAGER WANAGER.

WANAGER-QUALITY MECHANICAL ELECTRICAL

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NFORMATION CALLAWAY

++++++++++ QUALITY g

PLANT ASSURANCE SERVICES -

ENGINEERING ENGNEERING SUPPORT SERVICES 4

s___ __2______ __m____

__s________a.___________.

mEF DRAFTSWAN PLANT OPERATIONS NS STAFF SPRT STAFF STAFF (SEE FIG C)

(SEE FIG C1 4

A 1

++++++++ 0 A WATTERS UNION ELECTRIC i

--- COMMUNCATION PATH CALLAWAY PLANT I

- ADWINISTRATION PATH figo EA i

e LOCATED ON SITE UNION ELECTRIC ORGANIZATION REV.It/3 6/.88 90 soonossS-o e

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ATTACHMENT 3 OQAM, REVISION 13 i

' EXPLANATIONS OF AND JUSTIFICATIONS-FOR PROPOSED CilANGES TO Tile OOAM

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~ EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGES TO THE

-l OPERATING'0UALITY ASSURANCE MANUAL (OQAM)

[

t The bracketed numbers -[ ] in this attachment refer to correspond-ing. numbers-which appear near the proposed changes in Attach-ment 2. Each-explanation / justification may apply txt several changes within Attachment 2.

The affected 00AM sectiont are, referenced following each justification.

It should be :.ated some sectionsfappear'under more than one justification. - Based on

-Union Electric's evaluation, only the proposed change designated 5

as (91 represents a: reduction in the Operating Quality Assurance Program _ (OOAP) f as previously accepted by the NRC.

Union Electric considers this: reduction to be justified and the 00AM to continue-to meet the requirements of 10CFR50,-Appendix B.

[1]

Editoria) changes (e.g., remove redundancy and unnecessary verbiage, clarify meaning, reformat to put in a more logical sequence; clarify applicability and references; make wording consistent with intent.

(Sections 1.4,'1.5, 1.14, 1.19,-

1

-3.19, 4.1, 4.2, 4.5, 4.6,

4. 9 (1), 4.10, 4.14, 7.7, 7.9, 16.7, 18.2, 18.4;. Appendix A; Reg. Guide 1.33, 1.74, 1.88) i

[ 2 ]'

organization changes made to improve interdepartment coordi-

nation and. efficiency.and delete references to Coordinating Agency for Supplier Evaluation (CASE) since this organiza-tion has'been dissolved.

(Sections 1.4, 1 ; 5 ', 1.6, 1.15, 11.19, 1,20, 3.19, 6.7, 7. 7 (1),.17. 6, Figures A, B, and C)

-(3]

Added sections or changed text based onTtheoreview of Union l

-Electric commitments to various documents.

(Sections 3.4, 4.10, 4.14, 18.9)

'i (4) ' Renumbering of Sections.

The section number shown is the new number.

(Sections-1.21-1.25, 3.5-3.24, 4.3-4.15, 7.1 (2), 7.1 (3), 7.9-7.21, 16.7) 4

~(5]' Clarify responsibilities.for bid and proposal evaluations to

-agree with-current' organization responsibilities.

The

' revised; wording of the 00AM represents'a reassignment of existing commitments to other organizations.

(Sec-tions 4.11, 4.12)

(6)

Revise commercial grade item requirements to agree with EPRI NP-5652.

UE considers-this a strengthening of the current program.

(Section 4.3, 4.4, 4.8, 4.9(2),

7. 7 (4),

7 '. 1 4, 7.15, 18.11) 9 t

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[7]

Revisions to 10CFR55 allow the use of the INPO accredited UE program to replace the existing commitment to ANSI /ANS 3.1~

for licensed training / retraining.

(Appendix A, Reg.

Guide 1. 8)

(8)

Remove references to specific corrective action programs that are being~ deleted as a result of consolidation into a new corrective action program.

Make process changes and clarifications necessary as a result of this consolidation J

of programs.

Make other administrative-changes to improve

-flow of requirements for clarify.

Establishing a more consolidated corrective action program should improve the effectiveness and efficiency of the corrective action and trend analysis processes.

(Sections 16.1-16.3, 16.5, 16.6, 16.8)

[ 9]

Delete the-Quality Assurance or Quality Services "in-line" l

review of procurement-documents as a requirement.

The revised wording of the OQAM represents a justifiable lessen-ing of.UE's commitments'to the NRC based on operating experience.

-l NUREG 0800'and N45.2.13 do not require an in-line review of J

procurement documents be completed by the groups identified in the Callaway-OQAM (Quality Assurance or Supplier Quali-ty).

A review must be performed of the procurement dceu-ments to assure the originator'has included all appropriate

. quality and technical' requirements.

Our existing programs j

require a review of procurement documents be completed prior to-their submittal to QA or SQ for another review of the adequacy of the specified quality requirements. -This QA or SQ review was self-imposed during our response to NRC question'260.61C generated during review of OQAM,1Rev. 4 submitted 08/31/81.-

Results of QA and'SO'in-line reviews and independent QA

+ audits and surveillances have demonstrated these in-line reviews are not necessary to-assure' satisfactory incorpora-tion of quality and technical requirements into procurement "d

documents.

Accordingly, deletion of the QA and/or SO' review will not adversely affect-the continued acceptability of the 1

UE~ procurement process.

An independent. review of the l

procurement initiator's work will continue to be a required.

portion of our program; however, the in-line second review by-QA or SQ will be eliminated, if this change is approved by the NRC.

QA will continue to audit the procurement process in accordance with Chapter 18 of the OQAM.

As implemented, this includes periodic sampling of procure-ment documents to verify the' adequacy of the quality and j

technical requirements specified there-in.

UE believes this j

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approach?ismin conformance witheregulatory. requirements.

L(Sections.4.3, 4.,7, 4.10, 4.11, 4.13)

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[10) Commitment Tracking System -(CTS) ^ number 1(number in 'lef t-margin): changes,, additions, or relocations. -This is an

.internalitracking system for UE commitments and has no-impact on.the stated' commitments.

(Sections 2.0, 2.3, 2.7,.

-3,0,-3.1, 3.2, 3.4-3.15, 3;18, 3.23,--4.1, 4.3-4.6~,-

4. 9 (1) -4. 9 ( 4 ), -4.10, 4.15, 5.0, 5.1, 6.2, 6.3, 6.5,-7.2,-

7.4, i7.7(1),- 7.9,- 7.13, 7.14, 7.18,17s20, 8.1-8.3, 8.6, 10.0-10.5, 10.7, 10.8, 10.10-10.14, 11.0-l'1.4, 11.9, 11.10,.

12.2, 14.2,;14.4, 15.1, 15.3, 15.5, 16.1,117.1-17.4,117.6,7 1 7. 9, 1 8. I',-; 1 8.~2, 18.4, 18.8, 18.9) lr.

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