ML20045C112

Rev 16 to Operating QA Manual.

ML20045C112
Person / Time
Site:	Callaway
Issue date:	06/30/1993
From:	UNION ELECTRIC CO.
To:
Shared Package
ML20045C103	List: ML20045C102 ML20045C112
References
NUDOCS 9306220089
Download: ML20045C112 (175)

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I OPERATING QUALITY ASSURANCE MANUAL (OQAM)

Rev. 16 File Code A210.0012

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l OPERATING OUALITY ASSURANCE MANUAL (OOAM)

TABLE OF CONTENTS Section Title Pace Table of Contents i Policy / Introduction lii Effective Page Listing v 1.0 Organization 1-1 2.0 Quality Assurance Program 2-1 -

3.0 Design Control 3-1 4.0 Procurement Document Control 4-1 5.0 Instructions, Procedures, and Drawings 5-1 6.0 Document Control 6-1 7.0 Control of Purchased Material, Equipment, 7-1 and Services 8.0 Identification and Cor 71 of Materials, 8-1 Parts, and Components 9.0 Control of Special Processes 9-1 10.0 Inspection 10-1 11.0 Test Control 11-1 12.0 Control of Measuring and Test Equipment 12-1 13.0 Handling, Storage, and Shipping 13-1 14.0 Inspection, Test, and Operating Status 14-1 15.0 Nonconforming Materials, Parts, or 15-1 Components 16.0 Corrective Action 16-1 17.0 Quality Assurance Records 17-1 18.0 Audits 18-1

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9. Q t

section Title Page  !

. Appendix A OQAM conformance to Applicable NRC A-l' ~

Regulatory Guides

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• o OOAP POLICY / INTRODUCTION It is the policy of Union Electric Company (UE) to develop, implement, and' maintain an Operating Quality Assurance Program l (OQAP) for Callaway Plant as required by provisions of a Nuclear Regulatory Commission (NRC) operat.4 g license and amendments thereto. The QA Program shall be apslied to those activities affecting quality (safety-related) regarding structures, systems, and components necessary to assure:

1. The integrity of the reactor coolant pressure boundary,

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

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

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

UE Company has established an organization to implement the OQAP as documented in policy, manuals, and procedures. Specific OQAP requirements and corresponding organizational responsibilities are specified in the Operating Quality Assurance Manual (OQAM).

The OQAP involves the proper functioning of many disciplines and activities. Functions, departments, groups, committees and other organizational subdivisions shall control activities affecting quality through implementation of appropriate written procedures or instructions. Documentation shall be maintained to provide objective evidence- of program implementation and effectiveness.

The OQAP shall comply with 10 CFR 50, Appendix B " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and follow the guidance of the Regulatory Position of Regulatory Guide 1.33. Clarifications, alternatives, and exceptions to this Regulatory Position are described in Appendix A of the OQAM. An eighteen (18) section format is employed with a discussion of how corresponding criteria of 10 CFR 50, Appendix B are satisfied.

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The responsibility for formulating, authorizing, and .

assuring implementation of the UE Company OQAP 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.

/

(, ild .f IlY Donald F. Schnell Date Senior Vice President-Nuclear

' < /

_ -d) < /

'/ gr Joseph V. Laux Date

/ Manager, Quality Assurance

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OQAM EFFECTIVE PAGE LISTING Pace No. Rev.

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1-1 16 1-2 16 1-3 16 1-4 16 1-5 16 1-6 16 1-7 16 2-1 15 2-2 16 2-3 15 2-4 15 2-5 16 2-6 15 3-1 14 3-2 16 3-3 15 3-4 16 3-5 16 3-6 15 4-1 15 4-2 16 4-3 16 4-4 16 4-5 16 4-6 16 5-1 16 5-2 16 6-1 16 6-2 14 6-3 14

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OQAM EFFECTIVE PAGE LISTING Pace No. Rev.

7-1 16 7-2 16 7-3 16 7-4 16 7-5 16 7-6 16 7-7 16 7-8 16 C-1 15 8-2 14 9-1 16 9-2 15 10-1 16 10-2 16 10-3 16 11-1 16 11-2 16 11-3 16 12-1 15 12-2 15 12-3 15 13-1 16 13-2 16 14-1 15 14-2 14 15-1 16 15-2 14 15-3 16 16-1 16 16-2 16 16-3 16 17-1 15 17-2 14 17-3 14 18-1 16 18-2 16 18-3 16 18-4 16 18-5 15

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• O ooAM EFFECTIVE PAGE LISTING Appendix A Pace No. Rey, A-1 15 A-2 16 A-3 15 A-4 15 A-5 15 A-6 15 A-7 15 A-8 15-A-9 15 A-10 15 A-11 15 A-12 15 A-13 16 A-14 15 A-15 15 A-16 15 A-17 15 A-18 15 A-19 15 ,

A-20 15 A-21 15 A-22 15 A-23 15 A-24 15 A-25 16 A-26 16 A-27 16 A-28 16 A-29 16 A-30 16 A-31 16 A-32 16 A-33 16 A-34 16 A-35 16 A-36 16 l

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OQAM OPERATING OUALITY ASSURANCE MANUAL (OOAM) 1.0 ORGANIZATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for! ,

the development, implementation and maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OQAP, although certain Program-activities may be delegated to others. The organi-zation responsible for implementing appropriate portions of the OQAP is shown in Section 13 of the FSAR. The Callaway Plant operating organization is also shown in Section 13 of the FSAR.

371 1.2 The Senior Vice President- Nuclear is responsible for initiating the Quality Assurance Program, formulating the policy, and authorizing and assuring Program implementation. He is responsible for directing activities within the Nuclear Divi- ,

sion which support the engineering, construction, testing, and operation of the Callaway Plant and coordinating support activities performed by others who are not under. his direct administrative control. He has corporate responsibility for the operation and physical control of the Callaway Plant. He reports to the Chairman and Chief Execu-tive Officer who has ultimate responsibility for the Callaway Plant.

398 1.3 The Manager, Quality Assurance reports to the 1790 Senior Vice President-Nuclear on Quality Assurance 1799 Program and administrative matters. QA Program matters are reported to the Chairman and Chief Executive Officer through the Senior Vice Presi-dent-Nuclear. The Manager, Quality Assurance is responsible to the Senior Vice President-Nuclear for assuring the OQAP is being effectively imple-mented for operating activities; directing the overall Quality Assurance Program for UE including Program development, maintenance, and verification of implementation. The Manager, Quality Assurance has sufficient authority, organizational freedom, and independence to effectively assure compliance with OQAP requirements as they control Callaway Plant and offsite quality activities; and shall bear no cost, schedule, or production responsibil-ities which unduly influence attention to quality matters. A communication path shall exist between the Manager, Quality Assurance and the Vice Presi-1-1 Rev. 16 6/93

. o OQAM dent, Nuclear Operations, as well as the other Nuclear Division management, thus providing a direct path to inform management regarding condi-tions affecting quality. The qualifications of the Manager, Quality Assurance are at least equivalent to those specified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel,"

l Sections 4.2.4 and 4.4.5. The Manager, Quality-Assurance is located at Callaway Plant and provides '

technical direction and administrative guidance to l

the Supervising Engineers, and the Quality Assu-rance staff.

398 1.4 The Manager, QA directs Supervising Engineers who 1799 have primary duties for assuring implementation of the OQAP and who devote full attention to this effort. The Supervising Engineer, Quality Support provides for maintenance of the operating Quality Assurance Manual (OQAM). The Supervising Engineer, Supplier Quality is responsible for audit, surveil-lance, and evaluation of nuclear supplier quality activities; and for performing those procurement document reviews assigned to him. The activities of the QA staff assure implementation of the OQAP.

1.5 The Manager and Supervising Engineers in the Quality Assurance Department are authorized by the-Senior Vice President-Nuclear to stop work on ongoing quality activities in' accordance with approved procedures. During the operating phase they have the authority to stop unsatisfactory work during repair, maintenance, and refueling activ-ities and the authority to recommend to the-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 correc-tion, or increase the extent of_the deficiency is subject to stop work action by the Quality Assur-ance Department. The Manager, Quality Assurance has no duties or responsibilities unrelated to QA that would prevent his full attention to QA matters.

1790 1.6 The authorities and duties of persons and organiza-l 2256 tions performing quality assurance functions shall be clearly established. Such persons have suffi-cient authority and organizational freedom to iden-tify quality problems; to initiate, recommend, or provide solutions; and to evaluate corrective I action. Assurance of quality by checking, auditing, inspecting, or otherwise verifying Program activ-ities shall be by personnel other than the indi-vidual or group performing the specific activity.

1-2 Rev. 16 6/93

OQAM 2184 1.7 The Manager, Nuclear Engineering reports directly to the Senior Vice President-Nuclear and directs a staff of superintendents, supervisors, supervising engineers, and quality control inspectors whose primary function is to provide technical support to the operation of Callaway Plant. This support includes, but is not necessarily limited to design; modification; configuration control; system and equipment performance; reliability, and testing; technical programs administration; and contractor support. He controls those activities and imple-ments the OQAP through the Superintendents, Design Control, System Engineering, and Project Engineer-ing. Within the System Engineering organization, QC Inspectors (ISI/NDE) report to the Supervising Engineer Performance and ISI, and perform inspec-tion and nondestructive examinations. These inspec-tors do not perform inspections or examinations which provide quality verification of Nuclear Engi-neering work activities.

2184 1.8 The Manager, Licensing and Fuels reports directly l 2293 to the Senior Vice President-Nuclear and has overall responsibility for UE nuclear fuel cycle activities including responsibility for procurement of fuel cycle goods and services, and for incore fuel management. The Manager, Licensing and Fuels is also responsible for coordinating licensing activities for Callaway Plant. The Licensing and Fuels organization provides technical support activities in the area of reactor design and radi-ological engineering.

1.9 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is respon-sible for providing administrative and management support including cost forecasting, stacus report-ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal Health Physicist. He is also responsible for the adminis-trative contact with the Institute of Nuclear Power Operations (INPO). As Principal Health Physicist, he provides a corporate level overview and guidance in the formulation and implementation of applied radiation protection programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations.

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OQAM 1.10 The Vice President, Nuclear Operations reports to '

the Senior Vice President-Nuclear _and is respon-sible for the activities of the Callaway Plant Operations Department and the Operations ~ Support Department. This responsibility includes the safe, legal and efficient operation and maintenance of the Callaway Plant and protecting the health and safety of the public and Plant personnel. He assures a high level of quality is achieved in the Plant operations and support activities.

l 1700 1.11 The Manager, Callaway Plant reports directly to the 1798 Vice President, Nuclear Operations and is respon-sible for the safe, legal, and efficient operation and maintenance of the Callaway Plant. He has overall responsibility for the execution of admin-istrative controls and the quality. ~ assurance program to assure safety. He controls Plant func-tions and implements the OQAP through the Assistant Manager, Work Control; the Superintendent, Health Physics; the Superintendent, Chemistry and Radwaste; the Superintendent, Operations; the Superintendent, Maintenance; and the Superintend-ent, I&C (see Section 13 of the FSAR). 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 inspection as described in Section 7, and nondestructive examinations and is not involved in those activities- performed by others which are considered " inspections" unto themselves, e.g.,

surveillance testing, initial startup testing, and I&C, Radiation Protection, and Chemistry group activities. Activities considered to be inspections unto themselves are covered by QA audits- and QA surveillances as discussed under Section-18. The QC Supervisor has no duties or responsibilities unre-lated to quality control that would prevent his full attention to quality control matters.

2293 1.12 The Manager, Operations Support reports to the Vice President, Nuclear Operations and is responsible for Plant support activities including training, materials management, security, and administration services activities required to support the Callaway Operating License. He controls Plant support activities and implements the OQAP through the Assistrat Manager, Materials, the Superinten- i dent, Training, the Superintendent, Security, and J the Superintendent, Administration.

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OQAM 398 1.13 General quality assurance indoctrination and training for the' Nuclear Division is the responsi-bility of UE Nuclear Operations (UENO), _ Training.

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

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

He is responsible for providing the analysis, programming, operations, hardware support, files,-

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

1.15 The Manager, Nuclear Safety and Emergency Prepared-ness (NSEP) reports directly to the Vice President, Nuclear Operations and is responsible for providing a constant independent overview of nuclear Plant safety. He directs the Supervising Engineer, Inde-pendent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP) . A communi-cation path exists between the Manager,.NSEP and the Senior Vice President-Nuclear for matters having immediate or significant safety implica-tions, thus providing a direct path to contact management personnel having corporate responsi-bility for Callaway Plant.

1790 1.16 The Supervising Engineer, ISEG and staff evaluate Callaway Plant operations from a safety perspective and compare Callaway operating experience with that of plants of similar design. In addition, they assess the conformance of Plant performance to safety requirements.

1.17 The Supervisor, EP and staff have overall responsi-bility for the development and maintenance of the Emergency Preparedness Program. This includes onsite and offsite emergency preparedness, coordi-nation of the Plant Radiological Emergency Response Plan with State and local emergency plans, and the planning and execution of emergency drills and emergency plan exercises.

1.18 The Assistant Manager, Operations and Maintenance reports directly to the Vice President, Nuclear Operations and is responsible for personnel devel-opment, organizational development, strategic planning, Fitness-For-Duty, and the Personnel department.

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OQAM 1.19 The Superintendent, Personnel (Local 148) reports directly to the Assistant Manager, operations and Maintenance and is responsible for assisting in-areas of . labor relations, organizational and personnel activities, and other matters under the guidance of UE policies. The Superintendent, Personnel (Local 1439 and 1455) reports directly to the Assistant Manager, Operations and Maintenance and is responsible for the duties above plus the Fitness-Fcr-Duty program. -

1.20 The Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative Serv '

ices. The Manager, Purchasing is responsible for commercial aspects involved in procurement of mate-rials, systems, components, and services-(excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others.

which are employed in support of Callaway Plant.

l2184 1.21 The Manager, Mechanical Engineering reports.to the Vice President-Engineering and Construction who in turn reports to the Senior Vice-President, ' Tech-nical Services. The Manager, Mechanical Engineering provides technical support, as necessary, to the Nuclear Ergineering staff.

(2184 1.22 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.

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

1.24 The Manager, Distribution Operating Department ,

reports to the Vice-President Transmission and j Distribution and is responsible for providing qual- <

ified engineers, technicians and equipment for ,

Callaway Plant battery testing and technical i support. l 1.25 Other UE divisions may provide safety-related services which augment and support selected Program activities. These organizations shall be required to implement controls consistent with the OQAP requirements applicable to their scope of activ-ities. The coordination of these activities is the responsibility of the Senior Vice President-Nuclear.

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. . OQAM 1.26 Safety review committees shall be-established to provide an independent review of those items required by the Callaway Plant Technical Specifica-tions. These committees, the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB), are described in the. Administrative Controls Section of the Callaway Plant Technical Specifications.

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OQAM 2794 2.0 QUALITY ASSURANCE PROGRAM 1799 2.1 UE has established an OQAP which controls activ-ities affecting quality. The Program encompasses those quality activities necessary to support the operating phase of the Callaway Plant and shall comply with 10 CFR 50, Appendix B " Quality Assur-ance Criteria for Nuclear Power Plants and. Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33.

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

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

1788 2.2 Lines of authority and responsibility have been established from the highest management level through intermediate levels and to the Vice Presi-dent, Nuclear Operations and the onsite operating organization. These relationships shall be docu-mented and updated, as appropriate, in the form of organization charts, functional descriptions of departmental responsibilities, and position guides for key personnel having direct operating, support, or audit responsibility. Where specific responsi-bilities are assigned within the OQAP, the prescribed individual shall retain the overall responsibility; however, subject to applicable regulatory constraints, authority may be delegated to subordinates. Considering these same regulatory constraints, the authority of a subordinate may always be assumed by a superior.

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

1824 2.4 The pertinent requirements of the OQAP apply to all 1853 activities affecting the safety-related functions 20200 of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. The safety-related struc-2-1 Rev. 15 6/92

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

systems, and components identified during the i design and construction phase and may be modified i as required during operations consistent with their importance to safety. Modifications to this list require the approval of the Manager, Quality Assur-ance and the Manager, Nuclear Engineering and shall j

be issued and controlled in accordance with Section

6. The development,. control, and use of computer j l

programs to be used in safety-related activities j are within the scope of the OQAP. The degree of controls applicable to each computer program shall j be consistent with the program's importance. to safety-related activities. Consumables which could i affect the form, fit or function of' safety-related structures, systems, and components, although not  ;

in Table 3.2-1 of the Callaway-SP FSAR, are l listed also under the control of the OQAP. l 1826 2.5 The OQAP shall be implemented throughout the oper-  :

1879 ating life of the Callaway Plant. Activities 1947 affecting quality shall be accomplished under suit-ably controlled conditions. Controlled conditions ,

include the use of appropriate equipment; suitable  !'

environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance i that all prerequisites for the given activity have been satisfied.

1789 2.6 Consistent with the schedule for accomplishing-  ;

1879 quality activities, the OQAP shall be established and documented by written policy, program manual, and procedure manuals. Persons conducting safety-related activities shall be responsible to imple-  ;

ment approved procedures. The OQAP shall utilize the following document types to describe Program objectives:

1. Operating Quality Assurance Program Policy / l Introduction Statement The Operating Quality Assurance Program Policy statement establishes governing principles in accordance with the requirements of 10 CFR 50, Appendix B.

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

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OQAM 1823 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 of the OQAM is by the Senior Vice President-Nuclear and the Manager, Quality Assurance.

1947 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 administrative controls consistent with those required by Regulatory Guide 1.33.

1800 Administrative procedures which apply to the entire staff, and revisions thereto, shall be reviewed by the Callaway Plant Onsite Review Committee (ORC) and the Quality Assurance Department. The final approval of Administra-tive Procedures and revisions thereto shall be by the Manager, Callaway Plant. The review and approval of other procedures and revisions thereto shall be in accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications.

679 2.7 UE may employ the safety-related services of archi-1746 tect engineers, NSSS suppliers, fuel fabricators, 1787 constructors, and others which provide or augment 2293 UE efforts during the operating phase. These organ-2460 izations shall be required to work under a quality assurance program whose controls are consistent with the scope of their effort. This does not preclude any organization from working under the UE OQAP. The quality assurance program of outside organizations shall be subject to review, evalua-tion and acceptance by the UE Quality Assurance Department prior to the initiation of safety-re-lated work. Vendor programs and procedures shall i also meet UE's commitment to USNRC Generic Letter i 83-28. l 2.8 Disputes which may arise between QA or QC personnel and personnel in other UE organizations which 2-3 Rev. 15 6/92

OQAM cannot be resolved shall be referred to the next '

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

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

" code" items by an Authorized Nuclear Inspector.

1795 2.10 General indoctrination and training programs shall 1916 be developed for personnel performing safety-2194 related activities to assure that responsible func-tions, departments, and individuals are knowledge-able regarding quality policy and requirements of applicable manuals and procedures. The requirements for training of Callaway Plant personnel are described in Section 13.2 of the Callaway-SA FSAR.

The training of permanent Plant personnel is the responsibility of the Superintendent, Training. UE personnel performing complex, unusual, or hazardous work shall be instructed in special indoctrination or briefing sessions. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equip-ment and systems, operating constraints, and control requirements in effect during performance of work. Training shall be conducted as required to, as a minimum, meet the requirements of UE's commitment to Regulatory Guide 1.8 (ANSI /ANS 3.1),

Regulatory Guide 1.33 (ANSI N18.7), other Regula-tory Guides as endorsed in OQAM Appendix A, and other regulatory requirements. Records of training shall be maintained as described in Section 17.

Where required by code or standard, personnel are -

trained or qualified according to written proce-dures in the principles and techniques of performing specific activities. Special equipment, environmental conditions, skills, or processes shall be provided as necessary for the effective implementation of the OOAP.

1799 2.11 An audit system shall be established to assure management is advised of Program effectiveness. The implementation and effectiveness of the OQAP shall be assessed through an audit program of quality i activities which includes design, procurement, i modification, and operation. The Manager, Quality ,

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OQAM Assurance is responsible for a system of planned

• audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance and in accordance with the require-ments of Section 18. He is responsible for conducting audits of offsite and onsite activities.

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

1799 2.12 The Senior Vice President-Nuclear provides for an 1800 independent assessment of the scope, implementa-tion, and effectiveness of the OQAP to assure compliance with policy, commitments, and the requirements of 10 CFR 50, Appendix B as set forth in this OQAM. This assessment shall be conducted biennially with a scheduling allowance of plus three months for each assessment and a combined time interval for any three consecutive assessment intervals not to exceed 6.25 years. This assessment may be by representatives of other utilities, outside consultants, or UE management representa-tives. In addition, various reports are issued to the Senior Vice President-Nuclear on a periodic basis to assist his independent assessment of the OQAP (e.g., semiannual QA trend analysis, and peri-l odic QA audit reports).

2.13 Implementation of OQAP controls over activities affecting quality assures achieving the objective of the UE OQAP to provide management with adequate confidence that activities affecting quality regarding the design, installation, modification, and operation of the Callaway Plant are performed consistent with policy. Documentation of the accomplishment of OQAP objectives is maintained in the form of records of data and other maintenance, information as necessary to support operation, repair, modification, refueling, and inservice inspection.

2.14 UE Management has established standards of perfor-mance which exceed those set forth by the Regula-tory Agencies. As a management initiative in this t area, UE has defined the word "must" to impose management directed performance standards in excess of and in addition to established Regulatory directed performance. From the viewpoint of UE employees and UE contractors, there is no differ-ence in the degree of compliance mandated by use of the words "shall" or "must." Compliance with actions initiated by use of either "shall" or "must" is audited and surveilled by the QA Depart-2-5 Rev. 16 6/93

OQAM ment. Failure to implement a "must" mandated activity requires corrective action in the same way as failure to implement a "shall" mandated activ-ity. However, from an external viewpoint, inter-nally imposed "must" requirements (i.e., those in excess of Regulatory requirements) are not intended-to be subject to enforcement action. "Must" is defined in Appendix A of this OOAM under Regulatory ,

Guide 1.74.

2-6 Rev. 15 6/92 ,

OOAM 1864 3.0 DESIGN CONTROL 2183 2974 1850 3.1 The design, modification, addition, and replacement and compo-2168 of safety-related structures, systems, appropriate 2185 nents shall be controlled to assure 2189 design control measures are implemented. Procedures 2222 shall establish requirements; assign responsibil-2187 ities; and provide control of activities regarding controlled, and orderly 2193 design in a planned, manner.

The Plant design is defined by those UE NSSS, A/E 2188 3.2 and selected supplier design drawings and specifi-arrangement cations which illustrate the general 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 func-tion.

2664 3.3 As the result of operating experience, or as systems neces-sitated by regulatory requirements, Plant and equipment may have to be changed. A design change is a modification in Plant design or opera-and is accomplished in accordance codes, with tion requirements and limitations of applicable standards, specifications, licenses, and predeter-mined safety restrictions. An alteration of Plant by equipment, structures or systems, which is not by nature operational, maintenance or replacement like kind, is considered a design change.

1850 3.4 Maintenance or modifications which may affect func-tioning 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 specifications and inspection requiremants. A suit-able level of confidence in structures, systems, or components on which maintenance or modifications have been performed shall be attained by appro-priate inspection and performance testing.

2184 3.5 Design, including related procurement efforts, may 2189 be carried out by Nuclear Engineering, Licensing 2222 and Fuels, or outside organizations.

2164 3.6 Control of design shall be specified in procedures.

These procedures shall include instructions for 2190 2191 defining typical design requirements; communicating 2192 needed design information across internal and 2196 external interfaces; preparing, reviewing, approv-3-1 Rev. 14 6/91

OQAM 2202 ing, releasing, distributing, revising, and 2221 maintaining design documents; performing design 2222 reviews and reviews of design; and controllicg 2243 field changes.

l2225 2164 3.7 Design control shall involve measures which include design a definition of design requirements; a process which includes desig.. analysis and delinea-tion of requirements through the issuance of draw-ings, specifications, and other design documents (design outputs); and design verification or review of design to verify the adequacy of design or to become acquainted with design features.

1850 3.8 Design requirements and changes thereto shall be 2195 identified, documented, reviewed and approved to 2203 assure incorporation of appropriate quality stan-2204 dards in design documents and to control departures 2205 from these standards. Modifications to structures, 2207 systems, and components shall consider, as a mini-2222 mum, the design bases described in the Callaway-SP 2664 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 superin-tendent in the Nuclear Engineering Department for seismic and quality group classification and selec-tion of quality standards. Design criteria docu-criteria, ments consist of original Plant design defining system descriptions and other documents design input which change the Plant as described in the FSAR. The design input shall be specified on a necessary timely basis and to the level of detail to permit the design activity to be carried out in a correct manner and provide a consistent basis for making design decisions, accomplishing design veri-fication measures, and evaluating design changes.

2207 3.9 Design activities shall include the correct trans-2209 lation of regulatory requirements and design bases 2210 into specifications, drawings, written procedures, 2212 and instructions (design outputs) that define the 2974 design. Design analyses regarding reactor physics, stress, thermal, hydraulic, radiation, anddocuments, accident l 2170 analyses used to produce design output shall be sufficiently detailed to permit an person.

inde-pendent review by a technically qualified method, assump-Analyses shall specify purpose, tions, design requirements, references, and units.

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

3-2 Rev. 16 6/93

h OQAM t

2165 3.10 Procedures shall'specify requirements for the. -

2166 review and approval of design ~ changes by the organ-

• 2168 izations or individuals that performed the original 2169 design or Nuclear Engineering. Design _ control activities, including design changes, may be dele-i 2243

• gated to others provided'they have access-to back-ground and technical information. Design control '

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

1934 3.11 Design activities shall also include: 1) standards; 2) reviewing reviewing the applicability- of commercial or previously approved materials, parts ,

or equipment for suitability of application; 3);re-viewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment mainte-and components for inservice inspection, for nance, and repair; 5) specifying criteria and inspection and test / retest; and 6) reviewing approving procedures for special processes. .

2164 3.12 The design process shall establish controls for 2168 releasing-design documents which are technically 2191 adequate and accurate in a controlled manner with a i' 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled by the through the use of written procedures issuer, distributor, and- user.to_ prevent inad-use of superseded documents. Document vertent the _ collection, control procedures shall govern documents, and maintenance- of design storage, I and changes.

results of design document reviews, thereto. The design documents subject to procedural control include, but are not limited to, specifica- -

tions, calculations, computer programs, system descriptions, SAR when used as-a design ' document, y

drawings including flow diagrams,. piping, and  !

and instrument diagrams, control logic diagrams, elec-trical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations.

2164 3.13 The design interfaces between UE organizations  :

2188 performing work affecting quality of design and '

2190 between UE and outside organizations shall be 2217 identified and controlled by procedures. These l 2218 procedures shall address control of the interface, 2219 responsibilities, lines of communication, and documentation of internal and external interface 2223 activities.

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

i

OQAM 2234 control procedures shall specify requirem^nts for 2235 the selection and accomplishment of a design Veri-program. The program depth shall be 2198 fication 2227 commensurate eith the importance of the system or 2231 component to safety, complexity of the design, and similarity of the design to previously proven designs. Design verification shall be conducted in accordance with procedures which identify the responsibilities of the verifier and the documenta- the tion required and which, through adherence to procedures, provide for the identification of the areas, features, and pertinent considerations to be verified. Design verification shall be by either design review, alternate calculation, qualification testing, or by a combinataan of these. Where alter-nate calculations are performed to verify the be correctness of a calculation, a review shall performed to address the appropriateness of assump-tions, input data, and the code or other calcula-tion method used. UE shall perform " reviews of design" of selected documents for subcontracted design to becomo familiar with design features. An independent third-level review must be employed as an additional verification when UE judges that the design involves unique or special design features.

the The organization performing design shall have responsibility for design control unless specified otherwise. Design verification shall be performed who by competent personnel other than those performed the original design and other than the designer's immediate supervisor. However, an indi-vidual's supervisor may perform design verification indi-when he is the only technically qualified design vidual and in such instances the need for 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.

1934 3.15 Design verification, if other than by qualification 2227 testing of a prototype or lead production unit, 2230 shall be completed prior to release for procure-ment, manufacturing, construction or to another organization for use in other design activities.the In those cases where this timing cannot be met, design verification may be deferred, providing the justification for this action is documented and the on portions of the design output documents' based the unverified data are appropriately identified and controlled. Without verification, site activ- change ities associated with a design or design must not proceed past the point where the installa-3-4 Rev. 16 6/93

OOAM would become irreversible (i.e., require tion extensive demolition and rework). The design veri-upon fication shall be complete prior to relying the component, system, or structure to perform its safety-related function.

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

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

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

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

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

• by the Manager, Callaway Plant. In addi-t i, anges in the facility as described in Plant the FSA' whi'h involve a change in the Callaway incorporated in the Tech..~"O Specifications license r an unreviewed safety question require review ad approval by the NSRB and the Nuclear Regulatorj 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 3.19 Safety evaluations which consider the effect of the design as described in the design documents, shall be performed by the responsible UE engineering organization or outside organization (s). These evaluations shall include the basis for the deter-mination that the design change does not involve an unreviewed safety question. As deemed necessary by the evaluating organization, detailed analyses safety shall be performed to support the bases of evaluations. All nuclear safety evaluations are 3-5 Rev. 16 ,

6/93

OQAM submitted to the ORC. Changen involving the substi- safety tution of equivalent hardware require evaluations to assure that the design requirement changes are consistent with and do not alter the design criteria specified in existing design docu-ments. When design documents and safety evaluations its are prepared by an outside organization under N45.2.11 OA program, review and approval per ANSI all outside will be included. UE will approve organizations' design documents and safety evalua-tions, and will perform appropriate reviews neces-sary for final approval.

ORC shall review design change safety evalua-3.20 The design tions to recommend final approval of changes. Design changes which involve an unreviewed safety question or a change in the Technical Speci-NSRB for fications shall be forwarded to the review. An application for amendment of the license Regulatory shall be submitted to the Nuclear Commission for approval pursuant to 10 CFR 50.90.

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

1911 3.22 Procedures and instructions related to equipmentand or are modified shall be reviewed 2162 systems that to reflect the modification prior to updated to placing the equipment or systems in operation personnel perform safety-related functions. Plant affecting the shall be made aware of changes performance of their duties through procedure operation revi-of sions, or specific training in the modified equipment or systems, or other appropriate means.

current 2039 3.23 Records shall be maintained which reflect safety evalua-2132 design including safety analyses, procedures, tions, design change installation 2163 documents, procurement 2173 material identification documents, special process documents, equipment and installation specifications, and as-built drawings.

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

3-6 Rev. 15 6/92

OQAM 1875 4.0 PROCUREMENT DOCUMENT COffrROL 3541 3548 679 4.1 Safety-related procurements shall be . documented.

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

activities. Written procedures establish require-ments and assign responsibility for measures to design assure applicable regulatory requirements, assure bases, and other requirements necessary to quality are included in procurement documents.

procedures shall include controls, as 3559 4.2 Written review, applicable, for preparation, content, approval, and processing of the following related procurement documents:

1. Purchase Requisitions

2. Purchase Orders

3. Letters of Intent

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

5. Contracts

6. Specifications

7. Drawings 3560 Collectively, these procedures shall assure that correctly technical and quality requirements are are stated, inspectable, and controllable; there criteria; and adequate acceptance and rejection reviewed, procurement documents have been prepared, and approved in accordance with QA Program require-ments.

3572 4.3 Consideration of the verification activities to be 3607 employed for item or service acceptance should begin during the purchase requisition, ESA, or 3874 contract preparation and review stage. Planning of of verification activities shall include a review established acceptance criteria and identified the be methods which may documentation. Verification employed include certifications (certificatesor test of conformance and material certificates verification, receiving inspec-reports), source by tion, and post-installation tests established UE. Selected verification methods may be indicated as inspections, examinations, tests, or documenta-tion reviews. The extent of the acceptance methods func-and associated veri fication activities is a service's tion of the purchased item's or and relative safety significance, as complexity 4-1 Rev. 15 l 6/92 l

OQAM well as the supplier's past performance.

1892 4.4 Acceptance by source verification should be consid-3572 ered when the item or service is vital to Plant safety; or the quality characteristics are diffi-cult to verify after receipt; or the item or service is complex in design, manufacture, inspec-tion or test. Verification in this senseobservation, involves a physical presence to monitor, by designated activities for the purpose of evaluating supplier performance and product acceptability.

1875 4.5 Purchase requisitions must be employed to initiate the procurement of safety-related materials, parts, components, and services while ESAs must be used to contract for safety-related engineering, construc-tion, or consultant services. Contracts, purchase orders generated from purchase requisitions, and ESAs must be employed to procure certain goods and services associated with the nuclear fuel cycle.

Purchase requisitions for safety-related materials, parts, components, and services and ESAs for professional services may be initiated by personnel in the Quality Assurance Department.; Nuclear Engi-l neering, Nuclear Services, or Licer: sing 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 1883 codes, standards, and technical requirements which are equal to or better than the original require-ments or as may be required to reduce the proba-bility for repetition of defects. Procurement docu-ment control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifica-tions and codes equivalent to those specified orig-inally or those specified by a properly reviewed and approved revision; packaged and transported in a manner to assure the non-degradation of quality during transit; and properly documented to show compliance with applicable specifications, codes, and standards.

1876 4.7 Each item or service to be procured is evaluated by the procurement document originator to determine whether it performs a safety-related function or involves activities which affect the function of safety-related materials, parts, or components and to appraise the importance of this function to Plant or public safety. For those cases where it is unclear if an individual piece (part of a safety-4-2 Rev. 16 6/93

. .-- - = - . _ -

4 4 OQAM related structure, system, component or service) is governed by 'the OQAP, an engineering evaluation be shall. be conducted. The evaluation shall conducted by Nuclear. Engineering or Materials Engi-  !

neering and shall classify the safety relationship of the service or questionable. component, partsand or items of safety-related structures, systems, components. Evaluations shall be documented for-future reference.

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

1864 1. The scope of work and basic administrative'and 1890 technical requirements including drawings, -

2416 specifications, regulations, special instruc-3550 tions, and applicable codes and industrial ,

3551 standards and procedural requirements identi-3552 fled by titles and revision levels. Procurement process

' documents shall also include special instructions; identification of inspection, any-test and acceptance requirements; and such as special requirements for activities designing, identifying, fabricating, cleaning, and erecting, packaging, handling, shipping, storing.

1888 2. Requirement that the supplier have an accept-1890 able Quality Assurance Program which implements 3542 the appropriate sections and elements of ANSI- [

3550 N45.2-1977 or the ASME code as applicable as 3553 established for the item or service to be supplied. This requirement is not applicable to l42668 commercial grade items whichdesign' utilize a suppli-to- meet er's standard or proven published product descriptions.-

1890 3. Requirements for supplier surveillance,. audit,  ;

3550 and inspection including-provisions for UE,or 3555 agent access to facilities and records and.for ,

3573 identification of witness and hold-points. '

3867 3874 ,

1890 4. Requirements for extending applicable require-3542 ments of UE procurement documents to lower-tier

-3550 suppliers and subcontractors. These require-3554 ments shall include right-of-access to subsup-3555 plier facilities and records by UE.

4-3 Rev. 16 6/93

,. , , , - - - - . , , - - u - , - - _. ~ , 7 ..-

I 00AM 3550 5. Requirements for suppliers to obtain UE 3558 approval of nonconformances to procurement 3597 document requirements dispositioned "use-as-is" disposi-and " repair" and conditions of their tion including identification of those subject to UE approval prior to further processing.

3484 6. Applicability of 10 CFR 21 reporting require-ments.

1890 7. Documentation requirements including records 2132 to be prepared, maintained, submitted for 3550 approval, or made available for review, such 3556 as, drawings, specifications, procedures, and test procurement documents, inspection 3574 and procedural qualifica-records, personnel tions, chemical and physical test results, and for the retention, transfer, and instructions disposition of records.

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

3559 4.9 The originating organization shall perform a docu-3560 mented independent review of procurement documents 3562 to assure requirements are correctly stated, are l3563 inspectable, and controllable and that there This adequate acceptance and rejection criteria. who have review shall be performed by personnel an access to pertinent information, and who have and requirements adequate understanding of the intent of the procurement documents.

I3563 4.10 Bids or proposals shall be evaluated by the 3564 Purchasing Department, the originating organiza-3567 tion, the Quality Assurance Department, and the 3568 Licensing and Fuels Department to assure confor- the 3569 mance to procurement document requirements in of following areas as applicable to the type procurement as described below:

1. Technical considerations

2. Quality Assurance requirements

3. Research and development effort

4. Suppliers' personnel qualifications

5. Suppliers' production capability

6. Suppliers' past performance

7. Alternates

8. Exceptions e

4-4  ; Rev. 16 6/93

'E

OQAM 4.10.1 The Purchasing Department shall initiate and coor-l 3560 dinate bid evaluation activities requisitions.

for those prop- I l The l osals received in response to '

Purchasing Department shall review bids or propos-als, except those associated with ESAs or nuclear fuel cycle related goods or services, for document alter-nates or exceptions to procurement by the requirements (areas 7 and 8 above) taken Supplier. These reviews shall be documented.

or 3560 4.10.2 The originating organization shall review bids and proposals in all eight areas for ESAs; for parts, equipment, or services that are not approved original a direct replacement, or from the supplier. They shall also review areas 1 through ordered 3

above for replacement parts or equipment procurement from the original supplier as part of document preparation.

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

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

3560 4.11 Bids or proposals with alternates or exceptions 3561 identified in Section 4.10 by the Purchasing 3567 Department shall also be evaluated by the origi-3568 nating organization to provide additional assurance such 3570 that no unacceptable conditions result from changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award.

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

employed, letters of intent must normally specify until that no safety-related activities may begin ESA is an approved purchase order,-contract,be prepared, or executed. Letters of intent shall issued by Purchasing for those approved' and suppliers to be covered by purchase order, by the organization for ESA's, or by the originating nuclear Nuclear Fuel Department for contracts for However fuel cycle-related goods and/or services. the in the event a letter of intent is issued for of securing an agreement and thereby allow purpose 4-5 Rev. 16 6/93

OQAM safety-related work to begin -

r to the issuance of such documents, it shall .ac'ude the applicable quality and technical requiremencs, as specified by the originating organization.

The Purchasing Department is responsible for 3563 4.13 reviewing purchase orders to verify that the tech-nical and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisition, letter of intent, ESA, or contract shall be by an indi-vidual who has approval authority and signifies that the technical and quality review of the docu-ment has been completed. Contracts initiated for nuclear fuel cycle-related goods and/or Manager, services shall be the responsibility of the Licensing and Fuels with preparation and negotia-tion by the Licensing and Fuels Department. Nuclear profes-fuel cycle-related contracts and ESAs for the Senior sional services shall be executed by Vice President-Nuclear or another company officer corporate in accordance with Nuclear Division and procedures related to agreements or contracts for services.

Additions, modifications, exceptions, and other 975 4.14 quality and tech-3543 changes to procurement document nical requirements shall require a review equiv-3549 g

3563 alent to that of the original document anddepartment approval by the originator or the originating 3575 Commercial consideration approval authority.

[ 42587 changes shall not require review and concurrence by originator. Conditions specified on the Qual-the vendor ified Suppliers List (QSL) that apply to a may be revised without concurrence from the origi-nating organization since they are imposed without the knowledge of the originator.

i 4-6 Rev. 16 6/93

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

OQAM 2974 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 1830 5.1 The activities affecting quality associated with 1858 the operating phase shall be accomplished'and 1867 controlled by:

1916 1948

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

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

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

4. Using approved drawings,-procedures, instruc- ,

tions or checklists to accomplish an activity; The degree of control imposed shall be consistent with the relative importance ofLthe activity to l safety.

The Nuclear Division and other responsible func-1833 S.2 l 1830 tions and departments shall provide written proce-dures and drawings as required to . support the Callaway Plant operating phase. These procedures ,

shall. prescribe-those activities affecting safety-related structures,-systems, and components. It-is  :

recognized that skills"normally! possessed-by qual-ified personnel may not require detailed step-by-step delineations in written procedures..

responsible' i 5.3 The Manager, Callaway Plant shall'be for providing specific guidance via: Administrative Procedures for the development, review and approval 1 other Plant operating procedures to. govern-l of activities which . affect safety- or quality.

consistent with 'the- Technical . Specifications.- >

Similar guidance shall be.provided for'_' revisions and temporary changes to Plant- ' operating proce-dures. Procedures which implement.the Security' Plan and Radiological Emergency Response Plan shall be reviewed no less frequently than every twelve months (in accordance with Technical Specifica-tions). A revision of a procedure may constitute-a procedure review.

5-1 Rev. 16 6/93

= , - e ,.- -

~ . , - - - - - - w - - - - - , -c. - -

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

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

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

5.7 Special process procedures supplied by outside organizations shall be reviewed in accordance with l Section 9.6.

5.8 In addition to the procedures identified in Table 13.5-1 of the Callaway-SA FSAR (CALLAWAY PLANT ADMINISTRATIVE PROCEDURES), the OQAP includes procedural coverage in the following areas: design control; design change control; preparation, review, approval, and revision of specifications, drawings, requisitions, Engineering Service Agree-ments, contracts and procedures (instructions); QA indoctrination and training; auditor training; supplier evaluations; receipt and transfer of records; document control; quality program audits; corrective action; inspection; inspection, test and operating status; and special processes.

5.9 Applicable procedures shall be reviewed and revised as necessary as described in Appendix A, Regulatory Guide 1.33 (ANSI N18.7-1976, Section 5.2.15).

5-2 Rev. 16  :

6/93

OQAM 6.0 DOCUMENT CONTROL i

1916 6.1 Documents and their revisions'which control all structures, activities affecting safety-related l 1908 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 respon-'

1916 sible for OQAP implementing documents shall.be ,

1917 required to provide the necessary review and specifica-2262 approval for instructions, procedures, tions, and drawings. Reviews and. approvals shall assure that issued documents are adequate, author-ized, include proper quality and technical require-  ;

ments, and are correct for intended use. Individ- l uals or groups responsible for preparing, review-ing, and approving documents and revisions thereto shall be identified.in written procedures. Specifi-cally, the QA Department shall review Administra-tive 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. Collectively, these' reviews by the QA Department and QC personnel determine:

of

1. The need for inspection, identification inspection personnel, and documentation of

• inspection results; and

2. That the necessary inspection requirements, methods, and acceptance criteria have been identified.

1908 6.3 Changes to documents shall be reviewed and approved 1914 by the same function, department, group, or organ-ization that performed the original review and 2170 i

approval; however, UE may assume orLdelegate this responsibility. The reviewing organizations shall have access to pertinent background information upon which to base their approval and shall have-adequate understanding of requirements and intent of the original document.

• 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 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. 16 6/93

_ ._ .__ _ ~__ _ _ _ _ ._ _ _ _ ______ _ _ _ _

OQAM relating to the UE OOAP shall be 6.4 Documents docu-controlled to an extent which considers the ment type, its importance to safety, and the intended use of the document. The preparation, review, approval and revision of procedures, instructions and drawings shall adhere to the OQAP.

1828 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 1917 and the prompt transmittal of approved changes for incorporation into subsequent revisions.

Measures shall be established to prevent the inadvertent use of superseded documents.

of documents which shall be controlled 6.6 Types include the FSAR, specifications, Operating Quality proce-Manual, procurement documents, Assurance dures, design documents (e.g., calculations, draw- to ings, analyses) including documents related as-ouilt computer codes, nonconformance reports, drawings, the Callaway Plant Operating Manual, and topical reports.

6.7 The issuance of controlled documents at the General by the Office and Callaway Plant is coordinated organiza-Nuclear Services and the Administration shall be tions. The Administration organization responsible for assuring the issuance of controlled documents at the Plant Site and to the Nuclear Services Department at the General Office. Nuclear assuring the Services shall be responsible for of controlled documents at the General issuance to the Office, and for transmittal of documents into the for entry Administration organization document control system.

Document control methods shall be defined 6.8 consistent with the importance of the document to safety. Selected documents shall receive a control number. A serialized distribution list shall iden-tify selected document holders by name and control number. Acknowledgement of receipt of selected incorporation of revisions, and documents, destroying or voiding of superseded documents shall addition the be required by the distributor. In distributing organization for documents controlled periodically by a system of control numbers shall compose a master list of the documents showing the effective revision date of each.

1872 6.9 Procedures shall specify the requirements for the 2132 processing and maintenance of records. Procedures 2136 shall also be established to control instructions, 6-2 Rev. 14 6/91

OQAM 2164 procedures, and drawings governed by the OQAP.

the These procedural controls shall provide for work prompt transmittal of document revisions to locations and the removal, destruction, or voiding of obsolete / superseded documents. The unit staff other UE organizati.ons shall assure that and current documents are distributed to and used is at the location where the prescribed activity performed. It is recognized that, in certain instances, activities are controlled via the communication of documented procedural instructions the from a remote location, (i.e., separated from being location where the prescribed activity is performed). Identified, controlled copies of docu-ments 'shall be used to perform an activity. Uncon-trolled copies shall be identified.

i 6-3 Rev. 14 l 6/91

OQAM 1875 7.0 COffrROL OF PURCHASED MATERIAL, EQUIPMElff AND 3541 SERVICES 7.1 Materials, equipment, and services shall conform 4. to procurement documents as prescribed in Section activ-Provisions shall be established to control ities affecting quality associated with the procurement of material, equipment and services including:

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

2. Bid evaluation and award as described in Section 4 3565 3. Procurement source selections

4. Verification activities (surveillance, inspec-tion, and audit) required by the purchaser 3597 5. Control of nonconformances as described l 3576 in Section 15

6. Corrective action as described in Section 16

7. Material, equipment, and service acceptance 2416 8. Control of quality assurance records

9. Audits of the procurement program as described in Section 18 1891 7.2 UE shall assure that suppliers providing safety-3564 related materials, equipment, or services are 3565 acceptable procurement sources. Provisions shall 3874 be made for supplier evaluations which assess their evalua-capabilities prior to award by: 1) source tion; or 2) review for objective evidence of qual-history. When ity; or 3) a review of supplier of a evaluations are performed, the assessment shall be specific to the supplier's capability procured item, commodity, or service and the supplier's aSi"ity to provide the items or services require-in accordanes with procurement document ments. Sup1,11ers of hardware and services which are commer-manufactured prior to award, considered a cial the UE OQAP grade item, or implemented underevaluation or do not require pre-award source post-award audits which attest to their capability as a procurement source.

7-1 Rev. 16 6/93

4 .

OQAM 2337 7.3 During Callaway's operating life, procurements may l2977 be made from: 1) suppliers judged capable (prior 3564 to award) of providing items or services in accor-3874 dance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award by and whose acceptability can be determined receiving inspection, an examination of_ quality verification documentation, or other suitable means; 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAP.

Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a '

purchase order or execution of a contract or ESA, a verification of the supplier /outside organization's acceptability shall be documented. Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition), an evaluation of a Supplier's acceptability as a procurement source shall be accomplished prior to award. In the case of purchase orders, the supplier shall be verified as an acceptable procurement source for the item or service being procured. Purchase orders may be issued prior to an assessment of suppliers' capa-bility provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source.

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

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

1891 7.5 Procurement source evaluation and selection 1894 involves the Quality Assurance Department and the 3564 originating organization. The evaluation and selec-3565 tion process shall be specified in department proc-edures and may vary depending on the complexity and importance to safety of the item or relative service. Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organiza-tions may be requested to provide input to the qualification evaluations of suppliers.

7-2 Rev. 16 6/93

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

OQAM t

3565 7.6 Procurement' source selection and evaluations shall-3566 consider one or more of the following:

3564 1. Experience of users of identical'or'similar i products of the prospective supplier. NRC Licensee Contractor tand Vendor' Inspection ,

Program (LCVIP) reports, ASME Certificates of UE Authorization (C of A), . audit 'repor ts ,

procurement-records accumulated in previous 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' adequate basis for judge-ments attesting to their capability. When

.an-

• report, an audit report, or an ASME C of.

LCVIP ,

A is used to' establish a supplier's accepta- '

bility. as a procurement source, the . document-shall be identified.

2. An evaluation of the supplier's current quality '

records supported by documented qualitative and quantitative information which can be o bjec-tively evaluated. This may include review . and evaluation of the ~ supplier's -QA Program, Manual,- and Procedures, as appropriate;- and' '

responses to questionnaires.

3564 3. A source evaluation of the supplier's technical and quality capability as determined by a direct evaluation (audit or surveillance) of facilities, personnel and Quality Assurance Program implementation.

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

the following:

a. Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementation of ,

manufacturer's measures for control of 3 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 the nuclear industry), or other industry data- ANSI, bases (UL, INPO NPRDS, EPRI EQDB, .

NEMA, MIL-STDS, NRC Bulletins / Notices, and 1 Event Reports, etc.) that is Licensee 7-3 Rev. 16 6/93 n,.-. ,

l l

00AM l directly related to the item's critical  ;

characteristics and intended application. j 7.7 Procurement source evaluations involve a review of technical and quality assurance considerations.

considerations include the design or Technical manufacturing capability and technical ability of to produce or provide the design, suppliers service, item, or component. Quality assurance considerations include one of the previously defined methods of supplier evaluation and a ,

consideration of changes in a supplier's Quality Assurance Program or capabilities. The measures employed to evaluate a supplier's continued accept-ability as a procurement source (after the initial source evaluation) are described in Section 18.

1892 7.8 Organizations participating in the procurement process shall prepare procedures to monitor and evaluate suppliers' performance to procurement document requirements. These procedures shall include provisions for: 1) controlling documents generated or processed during activities fulfilling identifying and procurement requirements; 2) change information; 3) establishing a processing method of control and documentation of information exchange with the supplier; and 4) audit or surveillance of supplier activities.

3572 7.9 Depending on the complexity or scope of the itemthe or 3573 service, the Purchasing Department and/or originating organization shall initiate award activities. Meetings or other forms of communica-tion may be held to establish the intent of UE in monitoring and evaluating the supplier's perfor-mance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulfilling requirements. The depth and necessity of these activities shall be a func-tion of the relative importance, quantity, unique-ness, complexity, frequency of transactions with the same supplier, and the supplier's past perfor-mance. UE hold anC witness points shall be docu-mented as early as practicable in the procurement process.

The originating organization shall establish meas-3574 7.10 ures for monitoring supplier-generated document l

submittals against procurement document require-  ;

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

7-4 Rev. 16 6/93 l

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

Supplier monitoring activities may include:

Audits .of supplier quality assurance program 1.

implementation witnessing, or observing inspec-

2. Monitoring, tions, examinations, and-performance tests

3. Surveillance of manufacturing processes

4. Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-mances of purchased material, 2337 7.12 To support the control copies of purchase orders and other appropriate procurement documents shall be forwarded Depart- to the applicable receiving or acceptance point.

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

975 7.13 Receiving inspection instructions shall be 2337 documented. These instructions include specifying inspections or tests of commercial grade items-2416 procured from suppliers on the basis of product performance. Should it become necessary to upgrade non-safety related items to specific stocked requirements, inspections, tests, or documentation reviews may be employed to establish the items' acceptability. Documentation shall be generated as a result of UE receiving inspection activities.  !

I 975 7.14 Acceptance of items and services shall include one or more of the following: l 1891 l1892 3608 l

1. Written certifications

2. Source verification

3. Receiving inspection

4. Post-installation test (in addition to one of l

the above) 7-5 Rev.'16 6/93

OQAM 1876 7.15 Commercial grade items shall rely on proven design and utilize verification methods by the purchaser, l1892 to the extent appropriate to item application.

3565 Procedures provide for the acceptance of commercial grade items on one or more of the following:

1. Special Tests and Inspections

2. Survey of Supplier (Commercial Grade)

3. Source Verification

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

a) The established historical record is based on industry wide performance data that is directly applicable to the item's critical characteris-tics and the intended safety related applica-tion; and b) The manufacturer's measures for the control of design, process, and material changes have audit been adequately implemented as verified by (multi-licensee team audits are acceptable).

1891 7.16 Where required by Code, regulation or contract 1893 requirement, documentary evidence that items 3603 conform to procurement documents shall be available 3605 during receiving inspection or prior torequirements, use of such 3607 items. Where not precluded by other documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item accep-tance, verification of the validity of supplier certificates and the effectiveness of the certifi-cation systems shall be conducted at intervals with the supplier's past quality commensurate and performance. Certificates of conformance compliance shall be required to be signed or accom- Where panied by a signed letter of transmittal.

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

1884 7.17 Acceptance by receiving inspection shall be 3606 utilized as a prime method of verification and may be utilized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspections; and when inspections do not require operations which could adversely affectitem. the integrity, function, or cleanliness of the 7-6 Rev. 16 6/93

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

Receiving inspection shall_ be performed by 2483 7.18 (as personnel certified to ANSI N45.2.6.- .1978, clarified in OQAM Appendix A Regulatory Guide.l.58) ,

under the direction of the Quality Control-organi-zation. Other unit staff personnel qualified'toLANS-3.1 -

1978 may be utilized to perform receipt as inspections requiring specialized skills, such bulk- i receipt inspection of radioactive material, chemicals and diesel fuel. During outages, exten-sive modifications, or other special circumstances,: 3 receiving . inspection may be assigned to an outside-organization (s).

Final _ acceptance of items shall be- by Quality 2337 7.19 Control personnel or designated inspection. person-nel. The final acceptance of services shall be the responsibility of the originating organization. '

Acceptance shall be documented.

975 7.20 Receiving inspection activities shall include:. ,

2337 materials, parts, and compo-

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

A Verifying that items for acceptance.have been 2.

examined .for physical damage, correctness of ,

and identification and quality documentation, completeness of specified quality _ documenta-tion.

3. Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures tools, gages and measuring and calibrated equipment to verify the acceptability of suppli- items,

' including those from commercial ~ grade ,

ers.-

2326 4. Providing final acceptance-after determining 2329 that required verifications are' complete and .

acceptable 3

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

1 7-7 Rev. 16 l 6/93

. _ . --. - - ~ ,

OQAM i

2327 5. Verifying that received items which do not conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15.

3608 7.21 Acceptance by post-installation test may acceptance be util-ized following one of the preceding methods. Post-installation testing shall be used as the prime means of acceptance verification when it is difficult to verify item quality characteris-tics; the item requires an integrated system checkout or test; or the item cannot demonstrate Post-its ability to perform when'not in use.

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

k j

i 7-8 Rev. 16 6/93

OQAM 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 975 8.1 The identification and control of materials, parts, 1884 and components shall be accomplished in accordanceto with documented procedures and- apply 1885 and components safety-related materials, parts, during fabrication, storage, installation or use.

as Materials, parts, and components identified in nonconforming shall be controlled as described Section 15.

1897 8.2 The identification and control requirements shall 2090 address traceability to associated documents, as 2333 appropriate; specification of thelocation degree of identi-and method 2337 fication and control necessary; of identification to preclude a degradation of the item's functional capability or quality; and proper identification of materials, parts, and componentsshipping, prior to release for manufacturing, construction, or installation. Materials, parts, and components manufactured or modified by UE shall be controlled and identified during manufacture.

1884 8.3 Documented procedures shall assure that specifica-or 2088 tions and other procurement documents include reference appropriate requirements materials, for the identi-parts, and fication and control of assem-components including partially fabricated for blies. Procedures shall also specify measures material control including storing the and controlling issuance of accepted items; controlling accepted items from storage while maintaining storage item of identity; controlling the return to received, issued materials, parts, or components stored, installed, modified, or used at the correct Plant site. These procedures shall assure that prior identifications are verified and documented to release.

1895 8.4 Physical identification shall be employed to the 1896 maximum possible extent for relating an item at any 2318 point in time to applicable design or other perti-2331 nent specifying documents including-drawings, 2333 specifications, purchase orders, manufacturing and 2337 inspection documents, nonconformance reports, and Physical 2346 physical and chemical mill test reports.affect the identification or marking shall not being iden-form, fit, or function of the item not identification is tified. Where physical employed, physical separation, procedural control, Identifica-tags, or other means shall be utilized.

items, or records tion shall be maintained on erection, traceable to items through fabrication, 8-1 Rev. 15 6/92

OQAM installation. When unique traceability is and be employed impractical, bulk traceability may consistent with the relative importance of the item be to safety. When tags are used, the stock shall not deteriorate made from material which will during' storage. Tags shall be securely affixed to the items, and displayed 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.

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

8-2 Rev. 14 6/91  ;

OQAM 9.0 CONTROL OF SPECIAL PROCESSES 1851 9.1 Special processes are fabrications, tests, and require in-1937 final preparation processes which l3004 process controls in addition to final inspections to assure quality. Special processes also_ require the qualification of procedures, techniques, and personnel in accordance with the requirements of or applicable codes, standards, specifications, other special requirements to which UE is commit-ted. Special processes include such activities as welding, heat treating, nondestructive examination, the application of specialized coatings, and chem-ical cleaning. For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established Codes or standards; the necessary qualifications of procedures, or equipment shall be personnel, defined by Nuclear Engineering.

l 2260 9.2 Procedures for special processes shall be qualified also as part of their approval process, and shall provide for recording evidence of acceptable accomplishment of the special processes. Personnel qualifications shall be certified and equipment shall be qualified prior to use.

9.3 The responsible Plant Department Head shall assure that personnel performing special processes are qualified and are employing approved procedures. OA audits shall be performed to assure special processes are performed by qualified and certified personnel. Fondestructive examination (NDE) personnel shall be qualified in accordance with procedures established to meet the requirements of and Addenda to which. UE is the Code Edition '

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

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

1857 9.5 Planning for maintenance shall include evaluation use of special processes, equipment and of the including materials in performance of the task, and assessment of potential hazards to personnel equipment.

9-1 Rev. 16 6/93

OQAM 9.6 Qualified outside organizations may be employed to onsite and shall be perform special processes required to conform to the requirements described by herein. Special process procedures submitted the these organization (s) in accordance with procurement document requirements shall receive a technical review by the responsible engineering-organization and a quality review by the Quality Assurance Department.

9-2 Rev. 15 6/92

OQAM 2974 10.0 INSPECTION 42430 42431 1851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to documented 1927 verify conformance with applicable instructions, procedures, drawings, and specifica-tions. Inspecticns and monitoring of processes be which serve an inspection function shall perform performed by personnel qualified to assigned tasks and who are independent of individ-uals who perform the activity.

inspection of structures, 10.2 Required inservice and systems or components shall be planned executed. Inspection methods shall be established and executed to verify that the characteristics of an item remain within specified limits.

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

be responsible for 10.4 Nuclear Engineering shall and assuring the development of preservice inservice (PSI /ISI) inspection programs; the refer-ence PSI /ISI examination plans for ASME Code Class 1, 2, and 3 systems and components including steam generator eddy current examination; the NDE proce- and the dures required by the reference plans; initial updating of the reference plans and and proce-dures to reflect "as-built" conditions the Code technical requirements of the applicable Edition and Addenda prior to the issuance of the inservice inspection plans and procedures.

be responsible for 10.5 Nuclear Engineering shall testing assuring the development of the inservice j program plan for pumps and valves, the test proce- -

dures required by this plan, and the securing of consulting services in this area. In addition l Nuclear Engineering shall be responsible for admin- and istering and performing the PSI /ISI program l examination and testing- plans implementing the are developed within the Nuclear Division. They plans also responsible for updating the reference of and NDE procedures subsequent to the issuance the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations.

10-1 Rev. 16 6/93

OQAM 2483 10.6 An inspection personnel qualification program shall 2484 be established to assure inspection activities are 2485 being performed by personnel trained and qualified the to a capability necessary for performance of the activity. Plant procedures shall prescribe qualification requirements of inspection. personnel.

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

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

2483 Other members of the unit staff performing "inspec-2484 tion" activities shall have appropriate experience, 2485 training, and retraining to assure competence in 2994 accordance with ANSI /ANS-3.1. Inspection assign--

ments shall be consistant with the qualification of an individual. In instances where the education and are not met by QC experience recommendations inspection personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations possess of actual work proficiency that individuals comparable or equivalent competence.

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

When contractors or vendors are retained to perform l 2482 10.9 work activities or to provide services associated 2484 items at the Callaway Plant, 2485 with safety-related qualification of inspection personnel and the the conduct- of inspections associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procure- was ment documents. As an example, if a vendor contracted to conduct eddy current examinations of then the the Callaway Plant steam generators, performing the examination would be qual-persons 10-2 Rev. 16 6/93

. .- oga .

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

1930 10.10 Procedures which specify inspection activities--

1931 shall provide' for the -following, as required: >

1) the inclusion of independent inspection or.moni-toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta : >

tion of inspection results; 4) a description of.'the method of inspection including any mandatory ' hold points; 5) the identification of the characteris-tics and activities to be inspected;-6) the:accep -

tance and rejection criteria; and 7) specifying'the necessary measuring and test equipment. . Inspection requirements may be obtained. from~ drawings, a instructions, specifications, codes, standards, or ,

regulatory requirements.

1928 10.11 The inspection function shall be conducted in 1929 sccordance with written approved procedures which 1973 specify inspection scope; personnel' qualification 2039 requirements; and data collection requirements.

l2979 Inspection or testing, as appropriate, shall be r employed as a means of verifying suitable perfor- l mance subsequent to -a component replacement oor ,

repair.

i 1935 10.12 Instructions, procedures, and supporting documenta-1936 tion shall be provided,to inspection personnel for use prior. to performing . inspection . activities.

Inspection results shall be documented. Procedures shall prescribe the review and approval authority for inspection results. l 1932 10.13 Indirect control by monitoring processing methods, 1933 equipment, and personnel shall be utilized. as a control if inspection of processed items is impos-

• sible or disadvantageous. Both inspection and'aoni-toring of processes shall be provided when control i is inadequate without both.

1934 10.14 Inspection data shall be analyzed and evaluated to 1973 verify completeness of results, achievement of I inspection objectives, and operational proficiency 2125 2262 of equipment and systems; to identify additional 42479 inspection requirements; and-to identify necessary ,

changes to the installation inspection procedures. ,

The acceptance of an item shall be documented by authorized personnel. Modification, repair or 4 replacement of items performed subsequent to final- ,

t inspection shall require reinspection or retest to-verify acceptability.  ;

10-3 Rev. 16 _;

6/93

4 OQAM 2974 11.0 TEST CONTROL 42430 42431 1850 11.1 Testing programs shall be established to demon- '

1934 strate that safety-related structures, systems, and 2052 components will perform satisfactorily in service.

3577 Testing programs include such tests as- initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those asso-ciated with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications.

1853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-main-sary quality of systems and components is tained, that facility operations are within the and that limiting conditions for safety limits, shall operation can be met. The testing frequency be as prescribed in the Callaway Plant Technical Specifications. The provisions for surveillance testing shall include the preparation of a surveil-lance testing schedule (s) which reflects the status '

of in-plant surveillance tests. Qualified personnel shall perform surveillance tests.

1851 11.3 Appropriate tests shall also be performed subse-2053 quent to Plant modifications, maintenance or significant operating procedure changes to confirm confi-expected results. Tests provide a level ofoperation dence in structure, system or component or functional acceptability.

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

failure or malfunction analysis testing 11.5 Equipment 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 compo-nent can be expected to perform its function relia-bly.

11-1 Rev. 16 6/93

OQAM Testing shall be performed in accordance with 1938 11.6 which incorporate or reference 2055 written procedures 2056 the requirements and acceptance limits contained in applicable Callaway Plant Technical Specifications, documents, drawings, instructions, procurement regulatory specifications, codes, standards, and requirements.

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

1848 11.8 Test data shall be analyzed and evaluated by quali-1934 fled individuals or groups to verify completeness objectives, and of results, achievement of test l1973 2125 operational proficiency of equipment and systems; to to identify additional test requirements; and l 42479 identify necessary changes to the installationshall test procedures. Equipment found to be deficient identified in accordance with Section 14.

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

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

not 11.9 Review and approval of tests and experiments described in the FSAR shall be conducted as speci-fied in the Callaway Plant Technical Specifications and 10 CFR 50.59.

2039 11.10 A program shall be established to assure testing 2481 activities are performed by personnel trained and 2482 qualified to a capability necessary for performance 2483 of the activity. Plant procedures and procurement 2484 documents shall prescribe the qualification 2485 requirements for testing personnel. Provisions may be made for on-the-job training of individuals not super-qualified to the program provided they are vised or overseen by qualified individuals for the Superintendent, activities being performed. The Training shall be responsible for providing related technical and quality training for UE personnel who perform testing.

2263 11.11 Personnel within the various UE organizations may 2479 perform testing activities including implementing 2480 test procedures and the evaluation and reporting of 2482 test results. The assignment of Plant testing l

11-2 Rev. 16 6/93

OQAM 2483 personnel shall be under the direction and control 2484 of the Vice President, Nuclear Operations. The 2485 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 appro- ,

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

Testing assignments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC testing personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that indi-viduals possess comparable or equivalent compe-tence.

2263 11.12 Personnel from outside organizations or UE 2480 personnel who are not members of the unit staff l2482 who perform other testing activities associated 2483 with safety-related items at the Callaway' Plant 2484 shall either be certified as required by ANSI 2485 N45.2.6 or they shall meet the education and expe-rience requirements applicable to the equivalent position on the unit staff for the activities which they are performing.

2483 11.13 When contractors or vendors are retained to perform 2484 work activities or to provide services associated 2485 with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct of tests associated with that contracted work activity or service shall meet the require-ments stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway Plant, then the persons performing the testing / valve settingsquality would be qualified as required by the vendor's assurance program unless otherwise specified in the applicable procurement documents, 11-3 Rev. 16 6/93

OQAM 12.0 CONTROL OF MEASURING AND TEST EQOIPMENT 1319 12.1 Measuring and test equipment utilized in activities 1930 affecting quality shall be controlled in accordance 1969 with written procedures or instructions. The 2042 procedures for calibration and control shall 2264 address the identification of test equipment, cali-bration techniques, calibration frequencies, main-tenance control, and storage requirements. The equipment subject to these controls includes:equip- (1)

M&TE (portable measuring instruments, test ment, tools, gages, and non-destructive test safety-equip-ment used in measuring and inspecting 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 1851 devices used for measurements, tests, and calibra-2295 tion shall be of the proper range and type; and 2044 shall be controlled, calibrated, adjusted and main-at specified intervals or prior to use to 2060 tained of calibrated assure the necessary accuracy reference standards shall be devices. M&TE and tagged or labeled indicating the date of calibra-tion and the due date for recalibration.

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

12.4 The calibration and control program established at refer-Callaway Plant shall assure that M&TE, required the ence standards, and PI maintain their respon-accuracy. The Manager, Callaway Plant is sible 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 perform by various organizations as required to organiza-tests or other special operations. Each tion shall be responsible for assuring the.t the l M&TE or reference standards it uses have been cali-brated. Outside organizations using M&TE or refer-ence standards at the Callaway Plant in activities affecting quality shall be required to implement with j calibration and control measures consistent section. l the applicable requirements of this Vendors activities performed offsite, other than l calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and l

9 of OQAM Section 12.6 unless specified ir procure-12-1 Rev. 15 6/92

OQAM ment documents. Vendor-provided calibration services for Callaway Plant M&TE or PI are required8 to be consistent with the requirements of item and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) usinc M&TE 17- or reference standards at the Callaway Plant .. .,

ities affecting quality shall be required to imple-consistent ment a calibration and control program with the requirements described herein, or control reference their activities relating to M&TE or standards via the Callaway Plant calibration and control program. ,

12.6 The calibration and control program shall provide for:

1923 1. The assignment of specific calibration inter- specify vals, calibration procedures which calibration methods, and instrument accuracy requirements. Interval selection shall be a of the equipment type, inherent function stability and reliability, intended use, required accuracy, and other conditions which may affect calibration. Records shall be main-tained to permit a determination of calibration intervals. A calibration shall be performed when the accuracy is suspect.

2. The unique identification of items.

3. The traceability to calibration test data.

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

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

The maintenance and control of items not in 6.

use.

7. Provisions to control the purchase requirements and acceptance tests for items sent out for items calibration and for new or replacement accuracy, including the requirements for stability, and repeatability.

shall be calibrated from reference stan-

8. M&TE dards with an accuracy ratio of at least four-12-2 Rev. 15 6/92

OQAM .

Calibra-to-one (Reference' standard to M&TE).

tion accuracy ratios of less than 4.0 but-equal to to or better than 1.0 (Reference standard to-be acceptable when- equipment M&TE) shall meet specified requirements is not commercially available. The basis of acceptance in- these cases shall be documented.

9. M&TE used for calibrating Plant P1 shall have ,

calibration ranges, precisions, and accuracies main-such that the PI can be calibrated and PI' tained to achieve its.specified accuracy.

shall be calibrated from M&TE with'an accuracy

-ratio of at least two-to-one'(M&TE to PI).

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

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

Calibration and control measures shall not apply to-rulers, tape measures, levels, and other adequate devices-when normal- commercial practice affords accuracy.

of 2044 12.8 M&TE and reference standards found to be' out calibration shall require an investigation to eval- test, measuring, uate the validity of previous inspection, and calibration results and the acceptability of impacted items. Investigations shall evaluate the necessity of repeating original measurements, inspections, tests, or calibrations to establish the acceptability of such items. When the calibration history of an item shows it to be consistently out'of calibration, the item shall be replaced,. or the calibration interval repaired, l modified.

I l

12-3 Rev. 15 6/92

. _ . __ _ _ 4 _ _ - _ . _ _ . .,

n. .

OQAM 13.0 HANDLING,-STORAGE. AND SHIPPING ,

975 13.1 Safety-related items including safety-related parts .

2293 of structures, systems, and components.and related 2417 -consumables -shall be handled, stored, shipped, cleaned, and preserved in'accordance.with proce- ,

dures, instructions or. drawings, to assure that the quality of items is preserved .from fabrication '

until incorporation -in the Callaway' Plant. The procedures shall also establish responsibilities for determining applicable requirements for=packag- ,

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

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

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

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

i 2354 13.3 Deviations which relax-manufacturer's recommenda-tions shall involve an engineering ~ evaluation. This= .

may be appropriate when unrealistic requirements are recommended and such recommendations.are' not reasonably necessary to preclude equioment degrada-  ;

tion.

2416 13.4 The requirements for' activities described in this Section shall be divided into. levels with respect-to protective measures to prevent damage, deterio-ration, or contamination of items. These levels are based upon the important physical characteristics and not the important functional characteristics ~of the item with respect to safety, reliability, and operation. The specific. environmental, special measures or other conditions applicable to each level shall be described in implementing procedures.

13.5 The Superintendent, Maintenance shall establish an inspection program for Plant material' handling equipment that provides for routine maintenance and inspection in accordance with documented procedures '

which specify acceptance criteria. Routine inspec- i tions shall-determine the acceptability of equip-ment and rigging. Routine inspections shall be supplemented by nondestructive examinations- and r proof tests as delineated in procedures for items requiring special handling. Personnel performing 13-1 Rev. 16 6/93

OQAM nondestructive examination and proof testing shall be qualified.

2325 13.6 Procedures shall be prepared for items that require 2356 special handling and shall be available prior to.

2416 the time items are to be handled. Items not speci-2984 fically addressed by procedures shall be handled in accordance with sound material ~ handling practice.

Fuel assemblies, which require unique equipment and handling, shall be handled under.the direction of a Licensed Senior Reactor Operator during core alter-ations. Other material handling activities may involve personnel from various Plant organizations.

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

2416 13.7 Procurement documents or procedures shall address l2304 packaging requirements which afford protection from the possible degradation of quality during ship-ping, handling, or storing. The packaging protec-tion specified may vary in degree consistent with the item's protection classification. Similarly, the mode of transportation employed shall be consistent with the protection classification of items.

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

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

13-2 Rev. 16 6/93

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

1847 14.2 Items received at or installed in the Plant shall 2116 be identified in accordance with procedures as to their status regarding required inspections and 2331 tests before the items are stored, issued or oper-ated. Prior to storage or installation, itemslabels, shall be identified by means of stamps, tags, routing cards, segregation, or other means trace-receiving inspection able to manufacturers' and documentation. In the event traceability is not available, the item (s) shall be considered noncon-forming and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications.

1841 14.3 Plant procedures shall provide instructions 1842 relating to the manner of indicating the structures, opera-1844 tional status of safety-related systems, and components, including temporary modi-fications, and shall require independent verifica-tions, where appropriate, to assure necessary meas-ures, such as tagging equipment, have been imple-mented correctly. These procedures shall address measures for the release and control of equipment during periods of maintenance; thereby maintaining personnel and reactor safety and avoiding the unau- and thorized operation of equipment. Equipment systems in a controlled status to prevent unau-thorized operation, shall be identified.

972 14.4 Plant precedures shall establish controls to 1844 identify .N e status of inspection and test activ-1846 ities associated with maintenance, repair, modifi-1847 cation, refueling, inservice inspection, and 1851 instrumentation and control system calibration and testing. The Technical Specifications establish the status required for safe Plant operation, including provisions for periodic and non-periodic tests and and inspections of various structures, systems, components. Periodic tests may be operational tests or tests following maintenance while non-periodic be made following repairs or modifica-tests may tions.

inspections, tests, and 1848 14.5 Required safety-related operations and their sequencing are performed in accordance with Plant operating procedures which the are reviewed and approved in accordance with requirements of the Technical Specifications.

In 14-1 Rev. 15 6/92

OQAM required documentary evidence is not cases where available with respect to whether an item has satisfactorily passed required inspections and tests, the associated equipment or materials must be considered nonconforming in accordance with Section 15. Except in the case of temporary changes (non-intent changes) which are allowed by the Tech-nical Specifications and which are administratively controlled, any deviations from procedural require-ments shall be subject to the original or equiv-alent review and approval controls.

1 i

i l

14-2 Rev. 14 6/91 1

OQAM i

15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS l

1848 15.1 Material nonconformances include material deficien-1870 cies (including inoperative and malfunctioning 1907 structures, systems, and components). Material 2045 nonconformances identified under the UE OQAP shallof use 2112 be controlled to prevent the inadvertent material, parts, or components which are defective or of indeterminate quality and to identify docu-mentation inadequacies. Measures shall be estab-documentation, lished regarding identification, status control, disposition, and notification of affected organizations.

1848 15.2 Under the UE OQAP, Nonconforming Material Reports 1885 (NMRs), nonconformance logs, or other administra-1903 tive controls shall be employed to identify and 1907 control nonconformances. Nonconformance logs may be 2328 employed to control deficiencies of a minor natureof 2334 or to control documentation deficiencies both deficiency which can be corrected by bringing the into compliance with the original requirements.

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

1906 15.3 Plant and other UE organization's procedures shall 3558 prescribe measures for the control and disposition 3598 of UE purchased items and services identified by 3600 outside organizations as m.nconforming. Procurement documents shall specify those nonconformances to be UE for approval of the recommended submitted to disposition. As specified in procurement documents, actions taken in response to these nonconformances 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-recommended dispositions for Plant-initiated procurements. Similarly, other UE or outside organ-izations shall approve or be requested to provide a technical evaluation regarding supplier-recommended dispositions of nonconformances regarding procure-ments they initiate.

15-1 Rev. 16 6/93

OOAM 1904 15.4 Material nonconformances shall be processed in 1905 accordance with documented procedures and shall 1907 identify the specifics of the nonconformance stating the particular drawing, specification or shall record the disposition; other requirement; and shall register the signature of an approval authority. Procedures shall prescribe the individ-and uals or groups assigned the responsibility authority to approve and verify the implementation of the disposition of material nonconformance.

1907 15.5 Material nonconformance disposition categories 2334 shall include:

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

" Reject" or "not acceptable, scrap, or return 2.

to vendor"

3. " Rework" in accordance with approved procedures

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

1848 15.6 Nuclear Engineering shall be responsible for 1905 approving material nonconformance dispositions of 1907 "use-as-is" and " repair". Licensing and Fuels 2335 shall be responsible for approving material noncon-formance dispositions of "use-as-is" and

" repair" on nuclear fuel which are generated prior to the of such fuel at the Callaway Plant.

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

Nonconformance documents which record defects in 15.7 basic components or deviations from technical shall be requirements in procurement documents reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Signifi-cant nonconforming conditions involving a defect or material nonconpliance in a delivered component or service which could create a substantial safety hazard shall be reported to the Nuclear Regulatory Commission pursuant to the requirements of 10CFR21.

15-2 Rev. 14 6/91

OQAM 1906 15.8 Material nonconformances which would impact the conduct of a test shall be corrected or resolved prior to initiation of the test on the item. The decision to proceed with the testing of a system or subsystem with outstanding material nonconformances nonconformance, shall consider the nature of the its effect on test results, and the need for supplemental tests or inspections after correction of the nonconformance. The evaluations shall be documented.

1848 15.9 Repaired and reworked items shall be reinspected or 1904 tested. Measures may be established to condition-1906 ally release nonconforming items whose disposition 2053 is perding, provided that an evaluation indicates 2328 that further work nr activity will not contribute '

2332 adversely to the material nonconformance or preclude identification and correction.

15.10 Material nonconformance summaries shall be prepared and analyzed for potential adverse quality trends semiannually. For nonconformances discovered upon receipt inspection of new purchases or discovered after an item has been accepted by receipt inspec-issue from the warehouse, the tion but before Manager, Operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered installed, the Manager, Nuclear Engineering shall have the trend analysis prepared. The Quality Assurance Department shall perform an independent review of these analyses through' routine audit and surveillance shall activities. The result of these assessments be reported to management.

15-3 Rev. 16 6/93

OQAM 16.0 CORRECTIVE ACTION  ;

1870 16.1 Measures shall be established to assure that condi-1871 tions adverse to quality are promptly identified,.

1903 reported, and corrected. Such measures shall be 2978 established in a program or programs which are proceduralized. These procedures, as a minimum, shall:

1. Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.

2. Define responsibility for verifying that reme-dial action was taken for conditions adverse to quality.

3. Define responsibilities for determination of conditions adverse to quality which are signif-icant. Significant conditions- adverse to quality will require both remedial action and action to prevent recurrence.

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

5. Provide a method for documenting the identifi-cation of conditions adverse to quality. This documentation shall also include the root cause or causes and the action implemented to prevent recurrence for significant conditions adverse to quality.

6. Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct address, distribution of copies, electronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.

7. Provide methods for submitting reports required by external agencies concerning conditions adverse to quality.

1800 8. Provide for developing and analyzing trends on at least a semiannual basis. Trending of condi-tions adverse to quality identified at suppli-ers' facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12.

16-1 Rev. 16 6/93

. . OQAM 16.2 Conditions adverse to quality which are classified as nonconformances shall be controlled in accor-dance with the additional requirements described in OQAM, Section 15.

16.3 Conditions adverse to quality which impede the implementation or reduce the effectiveness of the Operating QA Program shall be considered signifi-cant conditions adverse to quality. Significant conditions adverse to quality may include, but are not limited to, noncompliance with procedural requirements which impact nuclear or personnel safety; reportable occurrences required by regula-tions; adverse nonconformance trends; deficiencies identified in the OQAP; recurring conditions for which past corrective action has been ineffective; and managerial controls which could result in the failure of a plant system to perform it's intended function. Examples of such conditions include those which match the descriptions in Callaway- Plant Technical Specification 6.5.1.6f, g, h, 1, m (potential hazards to nuclear safety) and NPDES violations.

16.4 Conditions adverse to quality which involve defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Repor-table conditions adverse to quality are classified as significant.

16.5 The nature of the condition adverse to quality may be such that remedial actions must be taken imme-diately, whereas development and implementation of corrective action to preclude recurrence may take substantially longer.

1871 16.6 Nuclear Engineering personnel shall review condi-tions adverse to quality which involve design defi-ciencies cnr which involve recommending design changes as corrective action. Licensing and Fuels should review conditions adverse to quality for fuel-related issues. The ORC shall review signifi-cant conditions adverse to quality.

16.7 Corrective action documents shall be closed by verifying the implementation and adequacy _ of corrective action. The closure of corrective action documents shall be accomplished as promptly as practicable after the corrective action taken has been verified. Verification may be accomplished through direct observations, written communica-tions, re-audit, surveillances, or other approp-riate means.

16-2 Rev. 16 6/93

. . OQAM 1871 16.8 Copies of completed corrective action documents :'

shall be available for management review (hard copy or electronic media). The Quality Assurance Depart-ment shall periodically review corrective action documents and identify significant conditions.

Summaries of significant _ conditions adverse to quality shall be submitted to the NSRB and approp-riate levels of management.

1800 16.9 Corrective action documents shall be reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends.

Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the accepta-bility of actions taken on these trends through routine audit and surveillance activities. The results of these assessments shall be reported to management.

I 16-3 Rev. 16 6/93  ;

l l

i

OQAM 17.0 OUALITY ASSURANCE RECORDS 1851 17.1 Quality assurance record systems governing the 2130 collection, storage, and maintenance of records 2173 shall be estuolished by UE. They shall apply to records associated with startup testing, operation, maintenance, repair, refueling, and modification of safety-related structures, systems, and components at the callaway Plant.

1851 17.2 During the operating phase, quality assurance 2128 records shall be maintained to furnish documentary 2132 evidence of the quality of items and activities 2133 affecting quality. Applicable design specifica-2137 tions, procurement documents, test procedures, 2138 operational procedures or other documents shall-2173 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 retention period shall be specified. Records shall provide sufficient information to permit identifi-cation to the item or activity to which it applies, and be retrievable.

2337 17.3 Quality assurance records include, but are not 2364 limited to, operating logs; maintenance and modifi-cation procedures and inspection results; report-able occurrences; results of reviews; inspections, tests, audits and material analyses; qualification of personnel, procedures, and equipment; and other documentation including drawings, specifications, procurement documents, nonconformance documenta-tion, corrective action documents, calibration procedures and results, and the results of moni-toring work performance (e.g., surveillance).

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

1. A description of the type of observation

2. The date and results of the inspection or test

3. Identification of the inspector or data recorder

4. Evaluation of the acceptability of the results

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

OQAM 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. fabricators, constructors, or others. Records maintained by an outside organization- prior to and subsequent to final transfer are required to be accessible to UE.

Records generated internally'shall be processed in a timely manner in accordance with documented procedures.

2129 17.6 Record systems shall be established by the Adminis-2131 tration organization for the Nuclear Division and ,

2136 shall be controlled in accordance with written 2147 procedures. The implementing 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 temporarily stored at the General Offices. The Administration organization shall provide for the administration of the quality assurance record system at the Callaway Plant.

2135 17.7 The requirements regarding hard-copy records 2149 administration shall require that quality assurance 2150 records be listed in an index. The index shall be established prior to the receipt of records and shall indicate the location of records. Microform records shall be controlled as indicated in UE's commitment to ANSI N45.2.9 as stated in Appendix A.

The distributing and handling of records, the correcting or 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 opera-tion.

2145 17.8 The requirements regarding receipt of records shall 2146 define the requirements for the receipt of 2148 documentation generated by others during the opera-tion of the Callaway Plant. These requirements shall assure that records are submitted and that designated authorities are responsible for organ-

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

1 17-2 Rev. 14 6/91

OQAM izing- and implementing a system of records receipt control. The records' receipt control shall-permit' an assessment of the status of records during the receiving process.

2150 17.9 The requirements regarding storage,-preservation, 2151 and safekeeping of records shall establish storage 2152 requirements for the maintenance, preservation, and 2153 protection of quality assurance records. These 2155 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 facil-ities which protect contents from possible destruc-tion by causes such as fire. An alternative to the establishment of a single record storage facility shall be the 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 humidity.

2157 17.10 Record storage systems shall provide for an 2159 accurate 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 desig-nated retention times for nonpermanent records.

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

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

17-3 Rev. 14 6/91

OQAM 1875 18.0 AUDITS 2180 3869 41639 2186 lb.1 A comprehensive audit program shall be established 2199 and implemented by UE to verify internal and 2978 external quality activities' compliance with the 2988 OQAP. The audit program shall assure that all 3865 applicable elements of the Program have been 3867 developed, documented, and are being effectively 3883 implemented and shall provide for the reporting and

! review of audit results by management. The audit system is described in manuals and procedures.

Nonconformances and program deficiencies shall be identified and corrective action shall be initiated and verified. See Section 3.14 for a specific audit topic.

1800 18.2 The UE audit system shall include the performance 2245 of audits and surveillances by the Quality l Assurance (QA) Department. Audits determine, through investigation, the adequacy of and adher-ence to established procedures, instructions, spec-ifications, codes, and other applicable contractual and licensing requirements and the effectiveness of implementation. Surveillances involve the periodic or continuous monitoring of the operation or performance of a supplier, item, component, or system. Surveillance in this audit sense should not be confused with inspections for the purpose of process control or product acceptance or with requirements relating to test, calibration or inspection to assure that the necessary quality of systems and components is maintained, that facility operations are within the safety limits, and that limiting conditions of operations are being met (surveillance tests). QA personnel performing surveillances should be familiar with the area to be surveilled and the applicable implementing proc-edure(s) governing surveillances. Surveillances may 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). See Sections 10.6, 10.7, 10.8, 11.10, 11.11, 11.12, and 18.4.

1818 18.3 The Manager, Quality Assurance shall establish a 2244 program which provides for the qualification and 2250 training of QA Department audit and surveillance 2255 personnel. Audits shall be directed by an Audit 2963 Team Leader (ATL) who is a certified Lead Auditor.

3866 A Lead Auditor is an individual certified as qual-18-1 Rev. 16 6/93

OQAM 3877 ified to direct an audit, perform an audit, report 3892 audit findings, and to evaluate corrective action.

Other personnel may assist Lead Auditors in the-conduct of audits; namely, technical specialists, management representatives, auditors and other Lead Auditors. The persons having direct responsibility for performance of the activities being audited shall not be involved in the selection of the audit team. Personnel selected for QA auditing or surveillance assignments shall have training or experience commensurate with the scope, complexity, or special nature of the activities to be reviewed or investigated and shall have no direct responsi-bility for the area being evaluated. The QA personnel training program shall provide general orientation and specific training which develop competence for performing audits or surveillances.

Training records shall provide a history of QA personnel training, evaluations, qualification, certifications, and retraining.

2244 18.4 QA Department personnel who perform audit and 2245 surveillance activities shall be qualified in 2259 accordance with the requirements prescribed in 3866 QA Department procedures. Lead Auditor qualifica-tion requirements shall include education or professional status, previous work experience or training, training received through UE, on-the-job performance and participation in surveillances or audits as an auditor, a qualification examination, and other factors applicable to auditing not defined by procedure. The qualification certifica-tion of Lead Auditors shall be based on an evalua-tion of these factors by the Manager, Quality Assu-rance. The maintenance of proficiency by Lead Audi-tors shall be accomplished by active participation in the audit process; a review of program, codes, standards, procedures and other document revisions related to the OQAP; or participation in training programs. The Manager, Quality Assurance shall provide for annual assessments of each Lead Auditor to determine proficiency. As long as a Lead Auditor is performing satisfactorily and is maintaining proficiency, there is no limit on the period of certification. However if at anytime the Lead Audi-tor's performance is evaluated as being unaccept-able, Lead Auditor certification shall be rescinded. In addition the failure to maintain proficiency for a period of two years or more shall be basis for Lead Auditor certification revocation.

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

18-2 Rev. 16 6/93

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

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

1790 18.6 The audit system shall include internal and 1799 external audits. The system shall be planned, 1800 documented, and conducted to assure coverage of 3871 the applicable elements of the OQAP, and overall coordination and scheduling of audit activities.

Audit results shall be periodically reviewed by the QA Department for quality trends and results reported to the appropriate management. The Manager, Quality Assurance shall monitor the OQAP audit program to assure audits are being accomp-lished in accordance with the requirements described herein and for overall Program effective-ness. The NSRB shall selectively review audit reports of onsite audits. The NSRB shall also peri-odically review the onsite audit program as devel-oped by the QA Department, to assure that audits are being performed in accordance with Callaway Plant Technical Specification requirements and the OQAP. Appropriate levels of management shall be provided copies of internal and external audit reports. The audits described in the Callaway Plant Technical Specifications which are performed under the cognizance of the NSRB shall be conducted by the QA Department.

1792 18.7 Internal audits shall be conducted by the QA 1816 Department and shall be performed with a frequency l 2193 commensurate with their safety significance. An 3873 audit of safety-related functions shall be completed in accordance with formal audit schedules within a period of two (2) years. Each element of the OQAP, such as design control and document control, and each area of Plant operations shall be audited.

2666 18.8 Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be 2847 audited under the cognizance of the NSRB at the 3873 frequencies indicated in Section 6.5.2.9 of the Technical Specifications and the Radiological Emer-l41777 gency Response Plan. In addition to audits 18-3 Rev. 16 6/93

4 . .i OOAM i i

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conducted. under- the cognizance of the NSRB, the j following areas shall be audited at least once per t 12 months:

o Special Nuclear Material Accountability program  !

o Radiological Protection program o Security program o Fitness-For-Duty program

]

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

3577 18.10 External audits shall be conducted-by or for the QA' l Department- as a method for the evaluation' of  !

procurement sources and as a post-award source-verification of conformance to procurement- docu-ments. Audits conducted by other organizations  ;

(with similar orders with the same. supplier),

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

as a means of post-award source verification in lieu of UE performed audits'and may not necessarily audit specific items furnished to UE. These: audits  ;

and surveillances shall utilize personnel. qualified  ;

in accordance with this OQAM and shall be conducted in accordance with this OQAM and; QA Department. .

procedures. Commercial grade items do not require j pre- or post-award audits. Similarly,. items' which -!

are relatively simple and standard in design- and i manufacture may not require supplier qualification or post-award audits to assure their-quality.

1780 18.11 Applicable elements of' suppliers' quality assurance '{

3565 programs shall be audited (post-award) on a 4 3878 triennial basis. Audits generally should be i 3872 initiated when sufficient work is in progress 'to I determine whether the organization is complying  ;

with the established quality assurance provisions.

Subsequent contracts or- contract modifications '

which significantly enlarge.the scope of activities by the same supplier shall be considered in estab- i lishing audit requirements. In addition, the need i for a triennial audit may be precluded upon evalua-  !

tion. and documentation by the QA Department that '

4 the results of mini-audits performed during source verification and source. surveillance activities j confirm the adequacy and implementation of the  !

supplier's QA Program.  ;

4 r

18-4 Rev. 16 6/93-  ;

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-. .. . - .. .- .- . -~ . - -. -

'1 OQAM -l 3565 1;8.12 ' Supplementary to audits, annual evaluations of' I 3566- suppliers shall be.' performed- which- take into j account, as: applicable: _1) the review of , supplier furnished documents such as certificates of confor-mance, nonconformance notices,- and corrective'  !

actions; 2) results of previous source- verifica- j tions, audits, and receiving' inspections; 3) oper-  ;

ating experience of identical or similar products, j furnished by the same; supplier; and 4) results of'  :

audits from other sources. ,

j 3565 18.13 Audits shall also be conducted when: 1) significant 3872 changes are made in functional areas'of the Quality  !

AssuranceLProgram such as significant reorganiza-

~

3875 -}

3883 tion- or procedure revisions; or 2): when it is j suspected that the quality of the -item is_ in jeopardy due to deficiencies'in the Quality Assur- 1 ance Program; or 3) when a systematic, independent. ,

assessment of Program effectiveness.is considered necessary; or 4) when it is necessary to~ verify i implementation of required corrective action.- 1 3876 18.14 Audits shall be conducted using written plans in 3878 accordance with QA Department procedures. The 3881 procedures require evaluation of~ work areas, activ  ;

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

tices, procedures, and instructions to_ determine  ;

the effectiveness of the implementation of-the OQAP .]

and compliance with 10 CFR 50, Appendix B and the  !

Callaway Plant Technical Specifications. The audit f plan shall identify the audit' scope, the require- d ments, the activities to be audited,' organizations to be notified, the applicable ' documents, the i schedule, and the written procedures or checklists .

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

3877 18.15 An audit team consists of one or more auditors. A Lead- Auditor shall be appointed Audit Team Leader. .;

The Audit Team Leader shall be responsible for the i 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. j o

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

a post-audit conference is held it shall be, to' ,

discuss- items and arrive at a general agreement on the identification of the findings. Formal audit  ;

reports shall be prepared and submitted to the j audited organization within thirty days after the i post-audit conference or last day of the audit, whichever is later. j 18-5 Rev. 15 l 6/92 ji

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OPERATING QUALITY ASSURANCE MANUAL (OQAM)

APPENDIX A ,

OQAM CONFORMANCE TO APPLICABLE NRC REGULATORY GUIDES Union toElec-This Appendix briefly discusses the extent to which conforms NRC  ;

tric's Operating Quality Assurance Program (OQAP) published Regulatory Guides for the Callaway Plant..All state- ,

Regula-ments within the Regulatory Position Section (C) of the tory Guides are considered requirements unless a specific excep-Electric and tion or clarification has been proposed by Union accepted by the NRC. This is true regardless of the qualifier (i.e., "shall" or "should") which prefaces the statement. Unless further qualified by a statement within the corresponding Regula-  !

tory Guide, ANSI /ANS Standards "shall" statements denote require- '

ments while "should" statements denote recommendations. Clarifi-cations, alternatives, and exceptions to these Regulatory Guides are identified herein. Union Electric's position on other Regula-tory Guides is given in Appendix 3A of the Callaway-SA and Calla-way-SP Final Safety Analysis Reports (FSARs).

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

codes applicability or acceptability of these listed standards, other specific i regulations or appendices is either covered in including areas in the FSAR or this Operating QA Manual (OQAM),

as. requirements, tables, or such documents are not considered refer- {

although they may be used as guidance. When sections are comply ~

enced within a standard, it is understood that UE shall l

with the referenced section as clarified.

REVISION 2 DATED 4/87 REGULATORY GUIDE 1.8  ;

Qualification and Training of personnel for Nuclear Power Plants 3.1-1981 for Shift Supervisor (Section ,

(Endorses ANSI /ANS 4.3.1.1), Senior Operator (Section 4.3.1.2), Licensed Operators  !

4.5.1.2), Shift Technical Advisor (Section 4.4.8), and (Section Protection (Manager) (Section 4.4.4) only, and ANSI /ANS f

Radiation 18.1-1971 for all other positions). l i

DISCUSSION:

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

Radiation Revision 1, dated 9/75, applies to the position of ,

Plant .;

Protection Manager only, in accordance with the Callaway Technical Specifications.

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A-1 Rev. 15  ;

6/92  ;

l

OOAM APPENDIX A REGULATORY GUIDE 1.8 (cont.)

The experience, training, and education requirements for the positions of Shift Supervisor, Operating Supervisor, and Reactor l Operator, and personnel fulfilling the duties of Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANSI /ANS 3.1-1981 as e*1dorsed by the Regulatory Guide 1.8.

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

Refer to Callaway-SA FSAR Section 13.1 for a discussion of the qualifications of personnel responsible for plant operation and support.

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

With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Documen-tation: 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 and I&C technicians and QC inspectors. When used to perform safety-related activities, these personnel shall meet the education and experience requirements of ANSI /ANS 3.1 - 1978 for equivalent UE staff positions. If no equivalent positions exist, these personnel may be qualified for assigned tasks either by Union Electric or by Vendors with Union Electric approved training and qualification programs. Inspection, examination and testing personnel shall meet the requirements for certification as inspection, examination and 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 N45.2-1977)

DISCUSSION:

This Regulatory Guide is not applicable to the operating phase.

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

A-2 Rev. 16 6/93

OQAM APPENDIX A 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 N45.2.4-1972/IEEE 336-1971)

DISCUSSION:

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

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

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

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

Section 2.1 - Plannina requirements, as determined by engineer-ing, shall be incorporated into modification procedures. Engi-neering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disci-plinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activ-ities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.

Section 2.3 - Procedures and Instructions shall be implemented as set forth in OQAM Sections 2, 3, 5, 10 and 11 and by compliance with the Callaway Plant Technical Specifications and Regulatory Guide 1.33 (ANSI N18.7) as set forth in this Appendix in lieu of the requirements set forth here. When compliance with an NRC accepted program (e.g., Callaway Plant Technical Specifications) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requir-ements of the Quality Assurance program standards.

l l

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l A-3 Rev. 15 6/92 l

CQAY APPENDIX A ')

REGULATORY GUIDE 1.30 (cont.)

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

Section 2.5.2 - Calibration and Control covers three classes of instrumentation used by UE: (3) M&TE (portable measuring instru-ments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related struc-tures, systems, and components); (2) reference standards (pri- .

mary, secondary, transfer, and working); and (3) permanently '

installed process instrumentation (PI).

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

With respect to the 3rd sentence, UE uniquely identifies each safety-related item of permanently installed process instrumenta-tion. This identification provides traceability to calibration data. These actions are UE's alternative to the tagging or labeling of items to indicate the calibration date and the iden-tity of the person who performed the calibration. Permanently installed process instrumentation 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 implemented with the clarification that " approved instruction manuals" shall be interpreted to mean the manuals provided by the supplier as required by the procurement order - these manuals are not necessarily reviewed and approved, per se, by UE: (3) no special checks shall be required to be made by the person with-drawing a replacement part from the warehouse - equivalent controls are assured by compliance with Regulatory Guide 1.38 (ANSI N45.2.2) as set forth in this Appendix; and, (4) shall be complied with as determined by engineering or by individual tech-nicians as part of the modification process. Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit.

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OQAM APPENDIX A REGULATORY GUIDE 1.30 (cont.)

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

Section 4 - Installation shall be implemented as stated and as follows: Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive ,

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

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

Section 5.1 - 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 Section 10. The inspection program shall incorpo-rate, as determined by engineering and QC, those items listed in these subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in UE's commitment to Regulatory Guide 1.33 (ANSI N18.7), Section 5.2.6; the requirements as set forth in that commitment 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, i shall be implemented as set forth in OQAM Sections 3 and 11. In some cases Surveillance testing may be used to meet the approp- '

riate requirements of this Section.

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 engi-neering or QC, the elements described in this Section shall be used in the development and implementation of inspection and testing programs as described in OQAM Sections 3, 10 and 11.

Section 7 - Rata Analysis and Evaluation shall be implemented as ,

stated herein after adding the clarifying phrase "Where used" at the beginning of the paragraph. This clarification accounts for the fact that some testing will not generate " Data" as such.

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

A-5 Rev. 15 6/92

OQAM APPENDIX A 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."

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.S.d of Regulatory Guide 1.33 (and Section 5.2.7.1 of ANSI N18.7 which it references) shall be implemented by adding the clarifying phrase "When determined by engineering" in front of the fourth sentence of the fifth paragraph. It is not always practicable to test parts prior to use. For modifications where ,

these requirements are not considered practicable, a review in accordance with the provisions of 10 CFR 50.59 shall be conducted and documented. Engineering actions performed in accordance with this Section of the Regulatory Guide are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of ORC) .

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

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

N45.2.2).

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

A-6 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

Paragraph C.S.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 para-graph, and any conditions which do not fully comply shall be documented and approved by management personnel. Management personnel includes QA through cross-disciplinary reviews and through QA permanent membership on the callaway Onsite Review Committee. QA has and shall conduct audits or surveillances of preoperational testing. In cases where conditions do not fully comply, the reason for the exception shall also be documented.

The documentation shall be retained as lifetime records.

With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Recuire-ments for the Onsite Operatina Oraanization:

Some of UE's technical support organizations are physically located at the Callaway site. Therefore the second sentence of this Section shall be implemented as follows: " Initial incumbents or replacements for members of the onsite or offsite technical support organizations shall have appropriate experience, training and retraining to assure that necessary competence is maintained in accordance with the provisions of ANSI /ANS 3.1 - 1978 as committed to in the OQAM."

In the third sentence, UE interprets "QA" to be "QC", consistent with the intent of Regulatory Guide 1.58 (ANSI N45.2.6-1978) and the OQAM.

Training standards referenced in this Section are implemented as described in this Appendix's commitments to Regulatory Guide J.8 (ANSI /ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2.6-1978) or as otherwise included as part of the Callaway operating license.

UE's methods of documenting and otherwise meeting the remainder of the requirements of this Section are set forth in OQAM Section 2, in the Callaway Plant Technical Specifications, and in other licensing commitments.

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

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

A-7 Rev. 15 6/92 l

}

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

Program With regard to Section 4.2 of ANSI N18.7 - 1976 titled audits

Description:

Two aspects are addressed in this Section:

• and independent reviews. The independent' review' program shall_be: UE

' implemented _ as required by the Technical Specifications. The meet audit program shall be described in accordance with and to the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as in this Appendix, the Callaway Plant Technical Specifi-endorsed i cations, and OQAM Section 18.

titled Independ-With regard to Section 4.3 of ANSI N18.7 - 1976 including ent Review Process: The requirements of this Section, Technical of its subparts, shall be met by compliance.with the .

Specification requirements and the OQAM.

titled Audit.

With regard to Section 4.5 of ANSI N18.7 - 1976 't The UE audit program shall be implemented in accordance '

program:with and to meet the requirements of Regulatory Guide-1.144 (ANSI this Appendix, the OQAM, and the N45.2.12) as endorsed in Callaway Plant Technical Specifications.

-i With regard to Section 5.1 of ANSI N18.7 - 1976 titled' Program

Description:

The fourth sentence in this Section requires a " sum- i mary document." UE's OQAM is organized in accordance with theand 18 criteria of 10 CFR 50, Appendix B. UE interprets this 02AM Appendix to applicable Regulatory Guides as endorsed in this fulfill the requirements for a " summary document." .

With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Proced-ure Adherence: The temporary change requirementsfor of this Section in the Technical Specifications activities are delineated is issued; the requir- ,

occurring after the Operating License (OL) be ements of the Callaway Plant Technical Specifications shall used to control temporary changes.

titled Equip-With ment Control:

respect to Section 5.2.6 of ANSI N18.7 - 1976UE shall comply with requirements based on the definition of this phrase _ as given under our commitment to Regulatory Guide 1,74 in this Appendix. I' Since UE sometimes uses descriptive names to designate equipment, .:

the sixth paragraph, second sentence is replaced with: " Suitable '

means include identification numbers or other descriptions which

• are traceable to records of the status of inspections and tests."

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

A-8 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

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

" design bases." This interpretation is to assure that original appropriate inspection requirements are not imposed, without which are review, on modifications or maintenance activities similar in nature to original construction activities. In devel-oping means to assure the quality of maintenance or construction modification activity, inspection requirements from associated activities shall be considered. Operational inspection original require-ments shall assure quality at least equivalent to the quality.

Since some emergency situations could arise which might preclude preplanning of all activities, UE shall comply with which an alternate reads:

to the first sentence in the second paragraph "Except in emergency or abnormal operating conditions where imme-diate 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 accordance with written procedures. the Where written procedures would be required and are not used, activities that were accomplished shall be documented after-the-fact and receive the same degree of review as if they had been preplanned."

titled Main-With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 tenance Programs: UE shall comply with the requirements of the first sentence of the fifth paragraph, where practical. This possible to clarification is needed since it is not always promptly determine the cause of the malfunction.

UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. QA is involved via both audits and surveillances, and QC is involved in inspection of maintenance inspection activities.

With regard to Section 5.2.8 of ANSI N18.7 - 1976 titled of a Surveil-

" master lieu lance Testing and Inspection Schedule: In surveillance schedule," the following requirement shall be met:

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

Plant With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled Security and Visitor Control: The requirements of the Security Plan shall be implemented in lieu of these general requirements.

(e.g., Callaway When compliance with an NRC accepted program Security Plan) is referenced, UE has substituted the NRC accepted the program for applicable regulatory requirements in lieu of general requirements of the Quality Assurance program standards.

A-9 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)

With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled House-keeping 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 imple-mented as described in UE's commitments to Regulatory Guide 1.39 (ANSI N45.2.3) and Regulatory Guide 1.37 (ANSI N45.2.1) as set forth in this Appendix. In every case either identical or equi-valent controls are provided in the Sections of the reference standards or documents.

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

Where changes are made to the technical or quality requirements '

on procurement documents, they shall be subject to an equivalent level of review and approval as the original document by the originating organization.

With regard to Section 5.2.15 of ANSI N18.7-1976 titled Review, Approval and Control of Procedures; in lieu of the wording starting with the second sentence in the third paragraph of this section beginning with "The frequency of ...," through the end of the fourth paragraph, which ends "... a procedure review.", UE' provides the following alternative guidance: " Procedures shall be revised as necessary. These revisions will generally be initiated '

through reviews conducted by knowledgeable personnel during routine performance of activities. Examples of such reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identified i deficiencies or events, evaluation of events occurring at other plants, evaluation of procedure changes necessary to implement modifications, evaluation of procedure changes necessary to implement License, Technical Specification, FSAR or OQAM revi-sions as well as evaluations of changes necessary to resolve Regulatory Issues. Such changes shall be implemented as neces-sary. In some situations such implementation will be completed pr ic-r to completion of the in-process activity. Guidance on the need to revise procedures shall be provided in plant administra-tive controls."

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

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

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i OQAM APPENDIX A f

REGULATORY GUIDE 1.33 (cont.) ,

The following is a clarification to the sixth paragraph:

inspection  !'

Inspections may not require generation'of a separate report. Inspection requirements may be integrated into approp- docu- j riate procedures.or other documents with the procedure or j ment serving as the record. However,. records of inspections shall i be identifiable and retrievable. ,

l With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control' 'i 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 Supporting Maintenance Documents: UE may choose to include mate-l r

rial from vendor manuals in any of three ways. (1) The-applicable and section of a manual. may be duplicated, referenced in, attached to the procedure. (2) The procedure may reference- the technical manual or a specific section; the manual may then- be .j used in conjunction with the procedure for performing written theor activ as- 1 material, either as originally ity. (3) The l

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 level of review and approval as operating procedures" by virtue of the review'and approval of the maintenance procedure. In option (2), the manual l 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 partNOT of the procedure.

, l options, Union Electric is reviewing and '!

In any of the accepting the entire manual. UE reviews and accepts that portion of each vendor manual that is used by UE. l With regard to Section 5.3.9 of ANSI N18.7 - 1976 titled Emergen-cy' Procedures: UE's Emergency Procedures are in the format spec-Report, as ified by the NRC in the Callaway Safety Evaluation i required for issuance of the Operating License, in lieu of -the l l

requirements given here. l With regard to Section 5.3.9.2 of ANSI N18.7 - 1976 titled natural Events' 1

of Potential Emergency: The licensing FSAR identified occurrences which affect the Callaway Plant. Therefore, UE shall l

were  ;

interpret item (11) to mean the natural occurrences which evaluated in the licensing FSAR. l i

l A-ll 'Rev. 15-6/92

l i

OQAM f APPENDIX A REGULATORY GUIDE 1.33 (cont.) ,

With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Proc-edures for Implementing Emergency Plan: UE's NRC accepted Emer- in gency Plan shall be implemented in lieu of the requirements this Section. When compliance with an NRC uccepted program (e.g.,

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

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

DISCUSSION:

Regulatory Guide UE complies with the recommendations of this 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 the clarifications below) shall apply to these main-tenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modifications shallcode be equal to require-or better than the original requirements (e.g., manufacturing properties, design margins, ments, material to inspection requirements), or as required processes, and preclude repetition of defects.

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

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

quality for final flushing of fluid systems and associated compo-nents shall be at least equivalent to the quality of thecontent; oper-ating system water except for the oxygen and nitrogen additives, or other but this does not infer that chromates normally in the system water, are added to the flush water.

With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indic-ating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT which contact penetrant materials and couplants, dessicants, stainless steel or nickel alloy surfaces shall notmelting contain points lead, zinc, copper, mercury, cadmium and other low metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall t A-12 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.37 (cont.)

be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ-conditions, except as provided for in approved design more than 1000 ppm sulfur shall be allowed where l mental documents. No such elements are leachable or where they could be released by the compounds under expected environmental condi-breakdown of tions, except as provided for in approved design documents.

With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion Cleaning: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the determined by use of other removal means is not precluded, as engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted with for QA/QC these involvement and are subject to QA audit. Procedures activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent surveillances, member of this committee). For other activities, QA audits and and QC inspection activities assure QA/QC involvement.

REVISION 2 DATED 5/77 REGULATORY GUIDE 1.38 Receiv-Quality Assurance Requirements for Packaging, Shipping, Nuclear Storage, and Bandling of Items for Water-Cooled ing, Power Plants (Endorses ANSI N45.2.2-1972)

DISCUSSION:

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

With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Defini-included in tions: Definitions in this Standard which are not ANSI N45.2.10 shall be used; definitions which are included in to ANSI N45.2.10 shall be used as clarified in UE's commitment Regulatory Guide 1.74.

Section 2.1 of ANSI N45.2.2 - 1972 titled Plann-With regard tosentence) the ing: (First The specific items to be governed by3.2-1, ,

Standard shall be identified in Callaway-SP FSAR Table which lists those structures, systems and components to which the UE QA Program is applied.

titled Results:

With regard to Section 2,3 of ANSI N45.2.2 - 1972 tests and The specific methods for performing and documenting require-inspections are given in OQAM Sections 10 and 11. The of the ments in these Sections shall be implemented in lieu In every case either identical or general requirements here. refer-equivalent controls are provided in the sections of the enced Standards or documents.

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4 ,

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Person-nel Qualifications: Specific requirements for personnel qualifi-cations are set forth in the OOAM description and in the commit-implemented ments in this Appendix. These requirements shall be In in lieu of the general requirements stated in this Section. provided every case either identical or equivalent controls are in the sections of the referenced Standards or document.

titled Classi-With regard to Section 2.7 of ANSI N45.2.2 - 1972 fication of Items: UE may choose not to explicitly use the four requirements level classification system. However, the specific of the Standard that are appropriate to each class are generally and to applied to the items suggested in each classification similar items, as determined by engineering. Engineering Standard actions are performed in accordance with this section of the audit.

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

1972 titled With regard to Section 3.2.1 of ANSI N45.2.2 -

Level A Items: As an alternate to the requirements for packaging to control contaminants and containerizing items in storage (Items (4) and (5)), UE may choose a storage atmosphere which is free of harmful contaminants in concentrations that couldSimilarly produce damage to stored items, as determined by engineering. plugs, as (for Item (7)) UE may obviate the need for caps and storage atmos-determined by engineering, with an appropriate weld-end preparations and phere, and may choose to protect threads by controlling the manner in which the items are (7) stored.

are These clarifications apply whenever items (4), (5) or Caps and subsequently referenced and to Section 3.5.1 titled Engineering and Section 3.4 titled Methods of Prevention.

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

cross-disciplinary  ;

activities receive a Procedures for these '

review as well as review by the Onsite Review Committee (QA is a activities, QA permanent member of this committee). For otheractivities assure audits and surveillances, and QC inspection  ;

QA/QC involvement.

titled Clean-With regard to Section 3.3 of ANSI N45.2.2 - 1972 f ing: (Third sentence) UE interprets " documented cleaning methods"  :

to allow generic cleaning procedures to be written which shall be implemented, as necessary, by trained personnel. Each particular shall be either governed by an individual cleaning operation cleaning procedure or by a generic procedure either of which  ;

)

shall specify method (s) of cleaning or type (s) of solvent (s) that l may be used in a particular application.

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OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Methods of Preservation: (First sentence) UE shall comply with these (4) requirements subject to the clarifications of Section" 3.2.1 deleterious and (5) above, and the definition of the phrase subsequently corrosion" to mean that corrosion which cannot be removed and which adversely affects form, fit, or function.

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.

1972 titled With regard to Section 3.7.1 of ANSI N45.2.2 -

Containers: Cleated, sheathed boxes may be used up to 1000 lbs.

box rather than 500 lbs. as specified in 3.7.1(1). This type of is safe for, and has been tested for, loads up to 1000 lbs. Other PPP-B-national standards allow this (see Federal Specification loads 601). Special qualification testing shall be required for 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 1000a with lb. in weight. Skids or runners shall be used on boxes suffi-gross weight of approximately 100 lb. or more, allowingprovided cient floor clearance for forklift tines (as nominally by 4 inch lumber).

With regard to Section 4.2.2 of ANSI N45.2.2 - 1972 titled Closed The use of fully enclosed furniture vans, as recom-Carriers:

mended in (2) of this Section, is not considered a requirement.

Stated for information only, UE shall assure adequatecombination protection from weather or other environmental conditions by a of vehicle enclosure and item packaging.

With regard to Sections. 4.3, 4.4 and 4.5 of ANSI N45.2.2 - 1972 and Transit, titled, respectively, Precautions During Loading Outside Identification and Marking, and Shipment from Countries the United States: UE shall comply with the requirements of these Sections subject to the clarifications taken to other Sections which are referenced therein.

With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Ship-ping Damage Inspection: Stores personnel shall normally visually in scrutinize incoming shipments for damage of the types listed this Section; this activity is not necessarily performed prior to of unloading. Since required items receive the Item Inspection Section 5.2.2, separate documentation of the Shipping Damage Inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping l

A-15 Rev. 15 ,

6/92 I

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

Damage Inspection. Any nonconformance noted shall be documented and dispositioned as required by OOAM Section 15. The person performing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regula-tory Guide 1.74; therefore, while he shall be trained to perform this function, he may not necessarily be certified to Regulatory Guide 1.58 (ANSI N45.2.6) as an Inspector.

Item With regard to Section 5.2.2 of ANSI N45.2.2 - 1972 titled Inspection: The second division of this subsection requires .six additional inspection activities if an item was not inspected or examined at the source. Engineering shall determine and document the extent of receipt inspection based on consideration 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 cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this surveillances, committee). For other activities, QA audits and and OC inspection activities assure QA/QC involvement.

With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of Storage: Subpart (2) is replaced with the following:

resistant, (2) Level B items shall be stored within a fire weathertight, and well ventilated building or equivalent enclosure in which measures have been taken against vandal-ism. This building shall be situated and constructed so that it is not normally be subject to flooding; the floor outside shall be paved or equal, and well drained. If any waters should come in contact with stored equipment, such equipment shall be labeled or tagged nonconforming, and and then the nonconformance document shall be processed evaluated in accordance with OQAM Section 15. Items shall be placed on pallets or shoring or shelves to permit air circulation. The building shall be provided with heating and temperature control or its equivalent to reduce conden-F sation and corrosion. Minimum temperature shall be 40 F or less if so stip-and maximum temperature shall be 140 ulated by a manufacturer.

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 classifica-may be tion of the standard shall be stored in an area which as posted to limit access, but other positive controls such fencing or guards shall not normally be provided, with engineer-ing's concurrence. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review A-16 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

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

With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Stor- with age of Food and Associated Items: The sentence is replaced and salt the following: "The use or storage of food, drinks, and tablet dispensers in any storage area shall be controlled 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 conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-dis-ciplinary review as well as review by the Onsite Review Committee For other activ-(QA is a permanent member of this committee).

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

With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled is Meas-replaced ures to Prevent Entrance of Animals: The sentence with the following: " Exterminators or other appropriate measures shall be used to control animals to minimize possible contamina-tion and mechanical damage to stored material."

With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Stor-with the age of Hazardous Materials: The sentence is replaced and other following: "Bazardous chemicals, paints, solvents, materials of a like nature shall be stored in approved cabinets proximity to installed or containers which are not in close safety-related systems." The placement of hazardous material storage lockers in the Plant is based upon installed safety-re-lated systems, not particular components.

titled Care With regard to Section 6.4.2 of ANSI N45.2.2 - 1972 of Items: The following alternates are provided for the indicated subparts:

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

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

(7) " Prior to being placed in storage, large (greater than or with a prime equal to 50 HP or when designed to be used horizontal mover of greater than or equal to 50 HP) engineering to rotating equipment shall be evaluated by shaft rotation in storage is required: the determine if A-17 Rev. 15 6/92

OOAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)

results of the evaluation shall be documented. If rotation is required, it shall be performed at specified receive intervals,a be documented, and be conducted so that parts coating of lubrication where applicable and so that the occupied shaft does not come to rest in the same position or heavy equipment prior to rotation. For long shafts orientation after subject to undesirable bowing, shaft rotation shall be specified and obtained."

requirements specified by the manufacturer's (8) Maintenance instructions are addressed in this OQAM, Section 13.3.

titled Removal With regard to Section 6.5 of ANSI N45.2.2 - 1972 of Items from Storage: UE does not consider the last sentencethe of this Section to be applicable to the Operating Phase due to relatively short period of time between installation and"UE use.shall The first sentence of the Section is replaced with:

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

With regard to Section 7.4.2, a subsection to Section 7.4 ofStated ANSI N45.2.2-1972 titled Inspection of Equipment and Rigging:

information only, it is UE's position that this relates to operability of the hoisting equipment and does not preclude for the rerating as allowed by Section 7.3.

REVISION 2 DATED 9/77 REGULATORY GUIDE 1.39 Plants Housekeeping Requirements for Water-Cooled Nuclear Power (Endorses ANSI N45.2.3-1975)

DISCUSSION:

Regulatory Guide UE complies with the recommendations of this 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 the clarifications below) shall apply to these main-tenance and modification activities even though such requirements requirements may not have been in effect originally. Technical associated with the maintenance or modification shall be equal to code require-or better than the original requirements (e.g., manufacturing ments, material properties, design margins, to inspection requirements), or as required processes, and preclude repetition of defects.

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OQAM APPENDIX A REGULATORY GUIDE 1.39 (cont.)

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

Section 1.4 - Definitions:

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

five-Section 2.1 - Planning: UE may choose not to utilize the jani-level zone designation system, but shall utilize standard cleanliness torial and work practices to maintain a level of commensurate with Program requirements in the areas of housekeep-ing, Plant and personnel safety, and fire protection.

being Cleanliness shall be maintained, consistent with the work into performed, so as to prevent the entry of foreign material docu-safety-related systems. This shall include, as a minimum, mented cleanliness inspections which shall be performed prior to than system closure. As necessary, (e.g. the opening is larger the tools being used) control of personnel, tools, equipment, and opened supplies shall be established when the reactor system is for inspection, maintenance, refueling, modification or repair.

requirements shall be implemented as Additional housekeeping required for control of radioactive contamination.

Section 2.2 - Procedures and Instructions: Appropriate procedures shall be written and implemented.

Section 3.2 - Control of Facilities: UE may choose not to utilize but shall utilize the five-level zone designation system, of standard janitorial and work practices to maintain a level commensurate with Program requirements in the areas cleanliness of housekeeping, Plant and personnel safety, and fire protection.

Cleanliness shall be maintained, consistent with the work being into performed, so as to prevent the entry of foreign material docu-safety-related systems. This shall include, as a minimum, mented cleanliness inspections which shall be performed prior to than system closure. As necessary, (e.g. the opening is larger the tools being used) control of personnel, tools, equipment, and opened supplies shall be established when the reactor system is for inspection, maintenance, modification, refueling or repair.

requirements shall be implemented as Additional housekeeping required for control of radioactive contamination.

A-19 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.39 (cont.)

Records: The requirements of OQAM Section 17 and '

Section 4 -

in this Regulatory Guidi 1.88 (ANSI N45.2.9) as set forth Appendix shall be implemented in lieu of the requirements of the controls Section. In every case either identical or equivalent are provided in the sections of the referenced Standards or docu-ments.

REVISION 1 DATED 9/80 REGULATORY GUIDE 1.58 Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)

DISCUSSION:

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

The qualification of UE QC or contracted QC personnel performing Guide work at the Plant shall be in accordance with Regulatory 1.58 (ANSI N45.2.6-1978). Other personnel performing inspection, examination, and testing activities shall have appropriate accor-expe-rience, training, and retraining to assure competence in posi-dance with Regulatory Guide 1.8 (ANSI /ANS 3.1-1978). This tion 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 demon-strate by documented results of written examinations and evalua- possess of actual work proficiency that these individuals or equivalent competence. Persons performing Nondes-tions comparable tructive Examinations (NDE) as may be required bycertified Section III or as XI of the ASME B&PV Code shall be qualified and is required by the Edition and Addenda of the Code to which UE qual-committed at the time the NDE is performed. However, when ifying personnel to perform visual examinations XI, VT-3, and VT-2,Division 1, VT-4 in accordance with IWA-2300 of Section ANSI /ASME N45.2.6-1978 may be used instead of ANSI N45.2.6-1973 Persons certified to perform NDE for Code work (Code Case N-424). non-Code NDE shall also be considered as qualified to perform qualification (e.g. crane hook inspection) unless more rigorous or certification requirements are imposed by UE's commitments or government regulations.

A-20 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.58 (cont.)

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

requires that the Standard be imposed on personnel other than UE shall employees; the applicability of the Standard to suppliers the procurement be documented and applied, as appropriate, in documents for such suppliers.

With regard to Section 1.4 of ANSI N45.2.6 - 1978 titled Defini-included in tions: Definitions in this Standard which are not 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.

With regard to Section 2.5 of ANSI N45.2.6 - 1978 titled Physi-cal: UE shall implement the requirements of this Section with the are stipulation that, where no special physical characteristics required, none shall be specified. The converse is also true: if no special physical requirements are stipulated by UE, none shall be considered necessary.

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

DISCUSSION:

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

When uniqueness or special design considerations warrant or are may judged to be appropriate, an independent third-level review be employed.

With regard to Paragraph C.2(1) of Regulatory Guide 1.64: If the designer's immediate Supervisor is the only technically qualified individual available, this review may be conducted by the Super-visor, provided that: (a) the other provisions ofisthe individually Regulatory Guide are satisfied and (b) the justification manage-documented and approved in advance by the Supervisor's ment, and (c) quality assurance audits cover frequency and effec- guard tiveness of use of the Supervisors as design verifiers to against abuse.

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

A-21 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.64 (cont.)

With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12, under Program Requirements, and Section 11 (including subsections 11.1 through 11.7) of ANSI N45.2.ll - 1974, titled accordance Audits: UE's audit program shall be implemented in with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, OQAM Sections 16 and 18, and the requirements of the Callaway Plant Technical Specifica-tions. In every case either identical or equivalent controlsdocu- are provided in the sections of the referenced Standards or ments.

REGULATORY GUIDE 1.74 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.

addition to the Standard's definition of " Inspection,"

UE In shall use the following: " Inspection (when used to refer to activities that are NOT performed by QA or QC personnel) - Exam-ining, viewing closely, scrutinizing, looking over or otherwise checking activities. Personnel performing these functions are not necessarily certified to Regulatory Guide 1.58 (ANSI N45.2.6)."

These activities are controlled by the Callaway Plant Operating Manual.

When UE intends for Inspection to be performed in accordance with the Operating OA Program by personnel certified as required by that Program and for activities defined by " Inspection" in ANSI N45.2.10, appropriate references to QC group or the procedures to be used for performing the activity shall be made. If such refer-ences are NOT made, inspections are to be considered under the additional definition given above.

In addition to the Standard's definition of " procurement docu-ments," UE shall utilize the definition given in ANSI N45.2.13.

docu-The compound definition is given as follows: Procurement ments - Contractually binding documents that identify and define the requirements which items or services must meet in order to be considered acceptable by the purchaser. They may include docu-supply ments which authorize the seller to perform services or equipment, material or facilities on behalf of the purchaser A-22 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)

Engineering Service Agreement agreements for engineering, (e.g. letters of construction, or consulting services), contracts, intent, purchase requisitions, purchase orders, or proposals and their acceptance, drawings, specifications, or instruction which ,

define requirements for purchase.

specified

" Bids" - Supplier quotation submitted in response to delivery technical and quality requirements for which price and are primary considerations.

" Proposals" - Supplier offerings that define the scope of supply for a as well as specific technical and quality requirements product or service. Such offerings usually require contract, negotiation or prior to acceptance as either a purchase order, Engineering Service Agreement.

" Program Deficiencies" (Not defined in ANSI N45.2.10, but used differently in Regulatory Guide 1.144 (ANSI and defined effec-N45.2.12)) - Failure to develop, document or implement tively any applicable element of the Operating QA Program.

" Quality Assurance Program Requirements" (Not defined in ANSI N45.2.13)

N45.2.10 but used and defined differently in ANSI Those individual requirements of the Operating QA Program which, of when invoked in total or in part, establish the requirements the quality assurance program for the activity being controlled. ,

Although not specifically used in the Operating QA Program, ANSI N45.2 may be imposed upon UE's suppliers.

" Independent Verification" - Verification by an individual other being person who performed the operation or activity than the verified that required actions have been completed. Such verifi-cation need not require confirmation of the identical action when other indications provide assurance or indication that the pres-cribed activity is in fact complete. Examples include, but are-by observed not limited to: verification of a breaker opening set point remote breaker indication lights; verification of a the (made with a voltmeter or ammeter for example) by observingPanel-actuation of status or indicating lights at the required meter indicated value; verification that a valve has been positi-oned by observing the starting or stopping of flow on meter indi-cations or by remote value positions indicating lights.

definition - to

" Audit" (This is a modification of the word's allow the use of subjective evidence if no evidence is(Regulatory available as defined in Section 1.4 of ANSI N45.2.12 - 1977 (Regula-Guide 1.144) and Section 1.4.3 of ANSI N45.2.23 - 1978 in ANSI tory Guide 1.146) as opposed to the definition given N45.2.10 - 1973) - A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of objective evidence where available, (subjective A-23 Rev. 15 6/92

e p OQAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)

evidence may be used when objective evidence is not available),

i that applicable elements of the Quality Assurance Program have been developed, documented and effectively implemented in accor-- be dance with specified requirements. An audit should not i confused with surveillance or inspection for the sole purpose of process control or product acceptance.

"Must" -

(Not defined in any ANSI Standard)'- An internally auditable requirement imposed by UE management upon its  ;

employees, contractors, and agents - above and in excess of the legally binding requirements of the appropriate' regulatory body.

Such items are internally required but not externally enforce-able. (See additional discussion under Section 2.14 of the OQAM.)  ;

" Unit staff" - (Not defined in any ANSI standard) - Means those  ;

personnel who report to the Vice President, Nuclear Operations.  ;

This term shall also be synonymous with the "onsite: operating N18.7-1976, organization" described (but not defined) in ANSI Section 3.4.2; the " unit staff" as used in the OQAM and in ,

Callaway Plant Technical Specifications Section 6.3 and its

' subparts and Section 6.5.2.9.b; the " unit organization" described ~

in the Callaway Plant Technical Specifications Section 6.2.2.

"Like kind replacements" - (Not defined in any ANSI standard)

Like kind replacements include both exact item replacements and other item replacements which are not " exact" but meet the orig-inal design requirements.

REGULATORY GUIDE 1.88 REVISION 2 DATED 10/76 Collection, Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (Endorses ANSI N45.2.9-1974) ,

i DISCUSSION:

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

With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled Gener-  ;

ation of Quality Assurance Records: The phrase " completely filled ,

out" is clarified to mean that sufficient information is recorded to fulfill the intended purpose of the record. It is the informa-  ;

tion, not the form, that is the record. Thus the information, not i the form, needs to be complete to furnish documented " evidence of '

activities affecting quality".

1 With regard to Section 3.2.2 of ANSI N45.2.9 - 1974 titled Index: q The phrase "an index" is clarified to mean a collection of docu-I ments or indices which, when taken together, supply the informa-tion attributed to "an index" in the Standard.

A-24 Rev. 15 6/92 i

I

. o OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

The specific location of a record "within a storage area" may not be delineated. (e.g. The specific location within a computer record file may not be constant. Further, UE may utilize a computer 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 of a file locations change with time, the specific location record within that file may not always be documented.

With regard to Section 4.2 of ANSI N45.2.9 - 1974 titled Timeli-ness: UE's contractual agreement with its contractors and supp-liers shall constitute fulfillment of the requirements of this Section. .

With regard to Section 5.3.3 of ANSI N45.2.9-1974: The phrase "A method for verifying that the records received are in agreement with the transmittal document and that the records are in good condition", is clarified to mean that internal Callaway Plant generated records received are in agreement with procedural guid-elines contained in Callaway Plant Administrative procedures. If a transmittal does exist (e.g. on supplier-generated documents, etc.), the records received will be verified against the trans-mittal document.

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. l With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safe-keeping: Routine General Offices and Plant site security systems and access controls shall be provided: no special security systems are required to be established for record storage areas.

With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Facil-ity: This Section provides no distinction between temporary and permanent facilities. To cover temporary storage, the following clarification is added: " Active records (those completed but not yet duplicated or placed on microfilm) may be temporarily stored in one-hour fire rated file cabinets. In general, records shall not be maintained in such temporary storage for more than three-months after completion without being duplicated (for dual stor-age) or being placed on microfilm. Open-ended documents --those revised or updated on a more-or-less continuing basis over an extended period of time (e.g. personnel qualification and training documents, equipment history cards, master audit or master surveillance schedules) and those which are cumulative in A-25 Rev. 16 6/93

o .

OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

nonconforming item logs and control room log nature (e.g.

not considered as QA records since they are not books)-- are

" complete." These types of documents shall become QA records when they are issued as a specific revision (e.g., the master (e.g.

audit log schedule); when they are filled-up or discontinued books or equipment history cards); on a predefined periodic basis shall be when the completed portion of the on-going document transferred to document control as a " record" (e.g. training and qualification records).

With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits:

2 and 3 are accomp-These specific activities in sub-sections 1, by lished through the establishment of administrative controls the responsible management.

Audits of these administrative controls are performed in accor-Guide dance with this OQAM, Section 18 and commitments to Reg.

1.144 in this Appendix.

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

Paragraph 4, subsection 9 is clarified to read: "No pipes or penetrations except those providing fire protection, lighting, control, or communications are to be temperature / humidity located within the facility and they shall comply with a minimum two-hour fire protection rating."

or Where duplicate storage is employed, no special precautions provisions (including vault storage, special humidity and tempe-rature recorders and similar items) are required.

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

REGULATORY GUIDE 1.94 REVISION 1 DATED 4/76 Assurance Requirements for Installation, Inspection and Quality Testing of Structural Concrete and Structural Steel During the Power Plants. (Endorses ANSI Construction Phase of Nuclear N45.2.5-1974)

DISCUSSION:

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

l A-26 Rev. 16 6/93 l

OQAM APPENDIX A REGULATORY GUIDE 1.94 (cont.)

For modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA program-included therein (subject to matic/ administrative requirements shall apply to these modification the clarifications below) been in activities even though such requirements may not have effect originally. Technical requirements associated withrequire- modifi-cations shall be equal to or better than the original design properties, ments (e.g., code requirements, material requirements),

margins, manufacturing processes, and inspection or as required to preclude repetition of defects.

The recommendations for structural concrete, structural steel, and other Plant components shall be met as indicated by the applicable design documents with the following exceptions:

With regard to Section 2.4 of ANSI N45.2.5-1974 titled Personnel Guide Qualification: Union Electric will comply with Regulatory 1.58 as endorsed in this OQAM in lieu of the requirements of this standard.

Calibra-In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled as follows:

tion and Control: The last sentence is clarified "UE's inspection or test results conducted with M&TE found to be discrepant are to be evaluated as described in the OQAM, Section 12.8."

titled High With regard to Section 5.4 of ANSI N45.2.5-1974 Strength Bolting: In lieu of the first two sentences in the first paragraph, UE will comply with the following: " Bolts for friction type connections may be tightened using direct tension indicators Joints in accordance with the AISC Specification for Structural 1974."

Using ASTM A325 or A490 Bolts, approved May 8, In lieu of (1) in the second paragraph, UE will comply with the following: "The requirement for the acceptance of tightened bolt that the assemblies is, the length of the bolts shall be such of point of the bolt shall be flush with or outside of the face the nut when completely installed."

REVISION 0-R DATED 5/77 REGULATORY GUIDE 1.116 Quality Assurance Requirements for Installation, Inspection, and ANSI Testing of Mechanical Equipment and Systems (Endorses N45.2.8-1975)

DISCUSSION:

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

P A-27 Rev. 16 6/93

• o OOAM APPENDIX A

! REGULATORY GUIDE 1.116 (cont.)

For maintenance and modification activities UE shall comply with the Regulator,1 Position established in this Regulatory Guide in l that QA programmatic / administrative requirements included therein i shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally.

Technical requirements associated with maintenance and modifica-tions shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as ,

required to preclude repetition of defects. ,

REGULATORY GUIDE 1.123 REVISION 1 DATED 7/77 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:

With regard to Section 1.3 of ANSI N45.2.13 - 1976 titled Defini-tions: With two exceptions (Procurement Document and Quality Assurance Program Requirements) definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide ,

1.74. The two exceptions are defined in this Appendix under Regu- '

latory Guide 1.74.

With regard to Section 1.2.2 of ANSI N45.2.13 - 1976 titled Purchaser's Responsibilities: Item C is one of the options which may be used by UE to assure quality; however, any of the options given in 10 CFR 50, Appendix B, Criterion VII as implemented by OOAM Sections 4 and 7 may also be used.

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

With regard to Section 3.4 of ANSI N45.2.13 - 1976 titled Procurement Document Control: UE shall meet the requirements of in OOAM Sections 4 and 7 in lieu of the requirements specified this Section. In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments.

A-28 Rev. 16 6/93 l

OQAM APPENDIX A REGULATORY GUIDE 1.123 (cont.)

Prea-With 1976 titled regard to Section 5.3 of ANSI N45.2.13 -alternate paragraph ward Evaluation: UE shall comply with an replacement which reads: "Except in unusual circumstances (e.g. or parts are needed to preclude the development of some unsafe undesirable condition at Callaway), an evaluation of the suppli-er's acceptability as a procurement source shall be performed as required by the Operating QA Manual." While it iswithout not the intent Engi-to make " unusual circumstances" determinations neering or QA involvement, Callaway Operations Support is ulti-surveillance mately responsible for the decision. QA audit and activities assure against cbuse.

With regard to Section 6.4 of 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."

titled Source With regard to Section 7.3.1 of ANSI N45.2.13-1976 1976 Verification Activities and Section 12 of ANSI N45.2.13 -

titled Audit of Procurement 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 Appen-requirements of the dix, OQAM Sections 16 and 18, and the Callaway Plant Technical Specifications.

titled Person-With regard to Section 7.5 of ANSI N45.2.13 - 1976responsible

" Personnel for nel Qualifications: The phrase:

performing verification activities shall be qualified subject in toaccor-the is dance with ANSI N45.2.6 as applicable", performing following clarification: Qualification of personnel verification activities for the Callaway Plant shall be in accor-dance with Union Electric's position on Regulatory Guide 1.58.

titled Dispo- ,

With regard to Section 8.2 of ANSI N45.2.13 - 1976 sition: The third sentence of item b is revised to read:

Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist Purchaser of one or more of the follcwing shall be submitted to the for approval of the recommended disposition prior to ship-ment when the nonconformance could adversely affect the end use of a module

• or shippable component relative to safety, interchangeability, operability, reliability, integrity, or maintainability:

1) Technical or material requirement is violated; Supplier documents, which have been

2) Requirement in approved by the Purchaser, is violated; A-29 Rev. 16 6/93

o OQAM APPENDIX A REGULATORY GUIDE 1.123 (cont.)

3) Nonconformance cannot be corrected by continuation of the original manufacturing process or by rework; and/or ,

4) The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

• A module is an assembled device, instrument, or piece of equip-ment identified by serial number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable compo-nent is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an individual item and which has to been evaluated by inspection and/or test for conformance procurement requirements regarding end use.

REGULATORY GUIDE 1.144 REVISION 1 DATED 9/80 Auditing of Quality Assurance Programs for Nuclear Power Plants (Endorses ANSI N45.2.12-1977)

DISCUSSION:

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

With regard to Section 1.4 of ANSI N45.2.12 - 1977 titled Defini-tions: 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 to ANSI N45.2.10 shall be used as clarified in UE's commitment Regulatory Guide 1.74. The one excepted definition and a clar-ified definition (of audit) relevant to this Standard are defined in this Appendix under Regulatory Guide 1.74.

With regard to Section 2.1 of ANSI N45.2.12-1977 titled General: '

this OQAM, Identical or equivalent controls are provided in Section 18.3 regarding the second paragraph discussing audit team selection. 1 With regard to Section 2.2 of ANSI N45.2.12 - 1977 titled Person- f nel Qualification: The qualification of UE audit personnel shall l

l be accomplished as described to meet the requirements of Regula- l tory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.

A-30 Rev. 16 6/93 i

OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

With regard to Section 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titled Training: The training of UE audit personnel shall be accomplished as describedN45.2.23 to meet-the1978) require-as ments of Regulatory Guide 1.146 (ANSI endorsed in this Appendix and OOAM Section 18.

With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Mainte-nance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the require-N45.2.23 - 1978) as ments of Regulatory Guide 1.146 (ANSI endorsed in this Appendix and OOAM Section 18.

With regard to Section 3.3 of ANSI N45.2.12 - 1977 titledsubsec- Essen-tial Elements of the Audit System: UE shall comply with tion 3.3.5 as it was originally written (subsection 3.2.5) in ANSI N45.2.12, Draft 3, Revision 4: " Provisions for reporting on the effectiveness of the Quality Assurance Program to the respon-sible management." For the auditing organization (UE), effective- Tech-ness shall be reported as required by the Callaway Plant audit reports, UE may not nical Specifications. Other than quality assurance directly report on the effectiveness of the 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 Plant Technical in this Operating QA Manual and the Callaway In every case either identical or equivalent Specifications. referenced docu- -

controls are provided in the sections of the ments.

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

of corrective action is Verification of the implementation Corrective performed as indicated in Section 16 of this through OQAM.

audit or action program effectiveness is determined this OQAM, using surveillance as described in Section 18 of previously issued corrective action documents as input to the scope of audits and surveillances. Additionally, trending of to reveal potentially corrective action documents will be used effectiveness of the l

ineffective corrective actions and the corrective action program.

titled Audit l With regard to Section 3.4 of ANSI N45.2.12-1977 Planning: Identical or equivalent controls are provided in this ,

OQAM, Section 18. l A-31 Rev. 16 6/93 l

l

OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled in Sched-this uling: Identical or equivalent controls are provided and OQAM, Section 18 for the requirements of Subsections 3.5.1 may UE 3.5.2. Subsection 3.5.3.1 is interpreted to mean that control qualification of a contractor's or suppli-procedurally er's quality assurance program prior to awarding a contract or outlined purchase order by means other than audit..The measures requirements of in Sections 4 and 7 of this OQAM address the Subsection 3.5.3.1.

titled Pre-With regard to Section 4.3.1 of ANSI N45.2.12 - 1977requirements of this Audit Conference: UE shall comply with Section by inserting the word "Normally" at the beginning of the first sentence.

This clarification is required because, in the of a particular case of certain unannounced audits or audits '

operation or work activity, a pre-audit conferenceactivity might inter-being fere with the spontaneity of the operation or audited. In other cases, persons who should be present at a pre-audit conference may not always be available: such lack of avai- Even lah lity should not be an impediment to beginning an audit.inclu-ir. the above examples, which are not intended to be all sive, the material set forth in Section 4.3.1 shall normally be covered during the course of the audit.

With regard to Section 4.3.2 of ANSI N45.2.12 - 1977 titled Audit Process:

(a) Subsection 4.3.2.2 could be interpreted to limit auditors and for to the review of only objective evidence; sometimes some Program elements, no objective evidence may be availa-ble. UE shall comply with an alternate sentence which reads:

"When available, objective evidence shall be examined for If compliance with Quality Assurance Program requirements. interviews, subjective evidence is used (e.g. personal report direct observations by the auditor), then the audit must indicate how the evidence was obtained."

is modified as follows to take into (b) Subsection 4.3.2.4 are virtually account the fact that some nonconformances action:

' obvious" with respect to the needed corrective defi-

"When a nonconformance or Quality Assurance Program ciency is identified as a result of an audit, unless the apparent cause, extent, and corrective action are readily evident, further investigation shall be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required."

A-32 Rev. 16 6/93

I i

. s OQAM APPENDIX A l

J REGULATORY GUIDE 1.144 (cont.) i (c) Subsection 4.3.2.5 contains a recommendation which is clar-ified with the definition of " acknowledged by a member of the audited organization" to mean that "a member of the audited organization has been informed of the findings."

Agreement 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 toalways account for the possible:

fact that immediate notification is not

" Conditions requiring immediate corrective action (i.e.

those which are so severe that any delay would be undesira-ble) shall be reported immediately to the audited organiza-tion and as soon as practical to the management thereof."

1977 titled With regard to Section 4.3.3 of ANSI N45.2.12 -

Post-Audit Conference: UE shall substitute and comply with the confer-following paragraph: "For external audits, a post-audit ence shall be held with management of the audited organization no to present audit findings and clarify misunderstandings; where adverse findings exist, this conference may be waived by manage-ment of the audited organization: such waiver shall be documented or maintenance in the audit report. Unless unusual operating conditions preclude attendance by appropriate managers /supervi-sors, a post-audit conference shall be held with managers / super-visors for internal audits for the same reasons as above. Again, there are no adverse findings, management of the internal if such audited organization may waive the post-audit conference:

waiver shall be documented in the audit report."

titled Report-With regard to Section 4.4 of ANSI N45.2.12 - 1977 ing:

(a) This Section requires that the audit report shall be signed by the Audit Team Leader (ATL); this is not always the most expeditious route to take to assure that the audit report is Section issued as soon as practical. UE shall comply with 4.4 as clarified in the following opening: "An audit report, which shall be signed by the Audit Team Leader (ATL), .or. .the" ATL's supervisor in the ATL's absence, shall provide:

In cases where the audit report is not signed by the ATL due to absence, one record copy of the report must be signed by the ATL upon return. The report shall not require no the longer ATL's review / concurrence / signature if the ATL is employed by UE at the time the audit report is issued.

to read:

(b) UE shall comply with subsection 4.4.3 clarified discus-

"tapervisory level personnel with whom significant sions were held during the course of pre-audit (where audit, and post-audit (where conducted) activ-conducted) ities."

A-33 Rev. 16 6/93

DOAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)

(c) Audit reports may not necessarily contain an evaluation statement regarding the effectiveness of the Quality Assu-rance Program elements which were audited, as required by subsection 4.4.4, but they shall provide a summary of the audited areas and the results which identify the importance ,

of any adverse findings.

With regard to Section 4.5.1 of ANSI N45.2.12 - 1977 titled By Audited Organization: UE shall comply with the following clarifi-cation of the Section: Management of the audited organization or activity shall review and investigate adverse audit findings, as necessary, (e.g. where the cause is not already known, another organization has not already investigated and found the cause, i etc.) to determine and schedule appropriate remedial action. The audited organization shall assure documentation of remedial j action taken is provided. Adverse audit findings shall be evalu-If ated to determine the need for action to prevent recurrence.

l such action is deemed necessary, the results of the investigation (root cause analysis), the corrective action taken or planned be to prevent recurrence, and a schedule for implementation shall provided by the audited organization. Such evaluations and imple-mentation of actions shall be scheduled and performed consistent with the safety significance of the item. The audited organiza-tion shall take appropriate action to assure corrective action is accomplished as scheduled. In the event the action or schedule'of implementation must be changed, the audited organization shall provide a revised response on or before the originally scheduled completion date which statuses the corrective action and states its completion date. Evaluation progress and corrective action implementation will be performed and tracked in accordance with provisions of Section 16 of the Union Electric Operating Quality Assurance Manual.

With regard to Section 4.5.2 of ANSI N45.2.12-1977 titled By Auditing Organization: UE shall comply with the following clari-fication of the section: For internal audits, performed by or for the Quality Assurance Department, follow-up actions will be taken by the audited organization as described in Section 16 of 18 this The internal audit program implemented in Section of OQAM.

this OOAM provides assurance that the corrective action program to requirements are properly implemented. By sampling responses conditions adverse to quality, the adequacy of root cause analy-sis, implementation of remedial action, and action to prevent recurrence are verified to assure effective corrective action program implementation. Therefore, the auditing organization will not necessarily evaluate the adequacy and assure action is iden-tified and accomplished for each adverse finding. External audits shall comply with section 4.5.2 of ANSI N45.2.12-1977.

l A-34 Rev. 16 6/93

OQAM APPENDIX A INITIAL ISSUE DATED 8/80 REGULATORY GUIDE 1.146 for Qualification of Quality Assurance Program Audit Personnel Nuclear Power Plants (Endorses ANSI N45.2.23-1978)

DISCUSSION:

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

titled Defini-With respect to Section 1.4 of ANSI N45.2.23-1978 included in tions: Definitions in this Standard which are not this ANSI N45.2.10 shall be used: " Audit" which is included in in this Standard and ANSI N45.2.10 shall be used as clarified Appendix under Regulatory Guide 1.74.

With respect to Section 2.2 of ANSI N45.2.23 - 1978 titled Quali- B54.2 fication of Auditors: Subsection 2.2.1 references an ANSI (presumed to be standard N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 which reads:

Orientation to provide a working knowledge and understanding of the Operating QA Manual, including the ANSI standards and Regulatory Guides included in this Appendix and UE's proced-ures for implementing audits and reporting results.

titled Main-With respect to Section 3.2 of ANSI N45.2.23 - 1978 tenance of Proficiency: UE shall comply with the requirements of takes this Section by defining " annual assessment" as one which date places every 12 + or - 3 months and which uses the initial as the starting date for of certification (not the calendar year) determining when such annual assessment is due. The combined time interval for any three consecutive assessment intervals shall not exceed 3.25 years.

titled Organ-With respect to Section 4.1 of ANSI N45.2.23 - 1978 izational Responsibility: UE shall comply with this Section with last the substitution of the following sentence in place of the sentence in the Section:

or l

The Manager, Quality Assurance; Supervising Engineer, QA; assign Lead Auditor shall, prior to commencing the audit, training experience or personnel who collectively have commensurate with the scope, complexity, or special nature of the activities to be audited.

A-35 Rev. 16 6/93 l

OQAM APPENDIX A REGULATORY GUIDE 1.146 (cont.)

titled Updat-With respect to Section 5.3 of ANSI N45.2.23 - 1978 ing of Lead Auditor's Records: UE shall substitute the following sentence for this Section:

each Lead Auditor shall be maintained and Records for updated during the period of the annual management assess-ment as defined in Section 3.2 (as clarified).

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

records shall be generated and maintained as Qualification required by OOAM Section 17 and by commitment to Regulatory Guide 1.88 (ANSI N45.2.9) as clarified in this Appendix .

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

I A-36 Rev. 16 6/93

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-ii- Rev. 12 6/89

r OOAP POLICY /INTROAUCTION C.oy P p ,g g%gm,l It is t olicy of Union Electric Company (UE) to develop, implement, d maintain an Operating Quality Assurance Program (OQAP) for -- utilizat4on-faci-14 ties -reguleted- by provisions of a Nuclear Regulatory Commission (NRC) operating license and amendments thereto. The QA Program shall be applied to those activities affecting quality (safety-related) regarding structures, systems, and components necessary to assure:

1. The integrity of the reactor coolant pressure boundary,

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

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

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

UE Company has established an organization to implement the OQAP as documented in policy, manuals, and procedures. Specific OQAP requirements and corresponding organizational responsibilities are specified in the operating Quality Assurance Manual (OQAM).

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

The OQAP shall comply with 10 CFR 50, Appendix B " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and follow the guidance of the Regulatory Position of Regulatory Guide 1.33. Clarifications, alternatives, and exceptions to this Regulatory Position are described in Appendix A of the OQAM. An eighteen (18) section format is employed with a discussion of how corresponding criteria of 10 CFR 50, Appendix B are satisfied.

-lii- Rev. 13 6/90

F j OQAM EFFECTIVE PAGE LISTING Pace No. Rev.

i 12 11 _w /6 iii 471 b iv 45-I b v J&3b vi 46- l 6 vii 1-T I b Pace No. Rev.

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Pace No. Rev.

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-vil- Rev. 15 '

6/92

e-

.oggg OPERATING OUALITY ASSURANCE MANUAL (OOAM) l.0 ORGANIIATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for the development,' implementation and maintenance of the Operating Quality Assurance Program (OQAP) .. UE:

shall retain responsibility for the establishment and execution of the OQAP, although certain Program activities may be delegated to others. The.organi-zation responsible for implementing appropriate portions of the OQAP is shown in 34 l

the-OQAM. The Callaway Plant operb;ures A :..d 0 vf-ng organization

~ ' ~

is shown in re ft o g3 g g .

p ~ $&g PSME.

/h3 1 1P7 l 1.2 The Senior Vice President- Nuclear is responsible for initiating the Quality Assurance Program, formulating the policy, and authorizing and assuring Program implementation. He is responsible for directing activities'within the Nuclear Divi -

sion which support the engineering, construction,.

testing, and operation of the Callaway Plant and coordinating support activities performed by others who are not under his direct administrative control. He has corporate responsibility for. the operation and. physical control of the Callaway Plant. He reports to the Chairman and Chief Execu-tive Officer who has ultimate responsibility for the Callaway Plant.

8 398 1.3 The Manager, Quality Assurance reports to the 1790 Senior Vice President-Nuclear on Quality Assurance 4006- Program and administrative matters. QA Program

. 3444 matters are reported to the Chairman and Chief ~

l'79#I Executive Officer through the Senior Vice Presi-dent-Nuclear. The Manager,. Quality Assurance is responsible to the Senior Vice President-Nuclear for assuring the OQAP is being effectively imple-mented for operating activities; directing the overall Quality Assurance Program for UE including Program development, maintenance, and verification of implementation. The Manager, Quality Assurance has sufficient authority, organizational freedom, and independence to' effectively assure compliance with OQAP requirements as they control Callaway.

Plant and offsite quality activities; and shall bear no cost, schedule, or production responsibil-ities which unduly influence attention to quality matters. A communication path shall exist between 1-1 Rev. 15 6/92

y i

OQAM the Manager, Quality Assurance and the Vice Presi-dent, Nuclear Operations, as well as the other Nuclear Division management, thus providing a direct path to inform management regarding condi-tions affecting quality. The qualifications of the Manager, Quality Assurance are at least equivalent A to those specified in ANSI /ANS-3.1-1978, " Selection g' and Training of Nuclear Power Plant Personnel,"

Section$ The Manager, Quality Assurance is aul 4.4.6 M ocated at 4.2 4,llaway Ca Plant and provides technical direction and administrative guidance to--the-super -

-intendent7-QuaFity-Assurancer the Supervising Engi-neerg -Quality--Support , the Superxising-Engineer 7-

-suppl-ier-Qua-14ty1- and the Quality Assurance staf f.

pnasage A I 398 1.4 Theg6uperbendent, --QA-i-s--located- et Cat 13way

/Q l799 1 -Plant. He directs Supervising Engineers who have primary duties for assuring implementation of the OQAP and devotes full attention to this effort. The Supervising Engineer, Quality Supporter-located-at-

-Catleway-Plant , d i rects-a-g rou p-o f-eng ineers-- -who-provides -edditicasi owpport activitie; includ-ing -

fo r maintenance of the Operating Quality Assurance Manual (OQAM). The Supervising Engineer, Supplier Quality is responsible for audit, surveillance, and evaluation of nuclear supplier quality activities; and for performing those procurement document reviews assigned to him. The activities of the QA

[ - staff4f assure implementation of the OQAP.-The cat-ions-of-the-Superintendent-ere &t-leest quali equi--

- va l <m t- en thnse-.specif4ed-itt-ANGUANS 3.1-19~f 97-

-"S election-and Traittiftg--of-Nuclear-Power Plant-Personnel, " ' Section- 4. 4. 5.

1. The Managery-Qua-14ty-Assurance, the-superintendent ~7 3

-Qua14ty-Assurance 7- and Supervising Engineers in the Quality Assurance Department are authorized by the Senior Vice President-Nuclear to stop work on ongoing quality activities in accordance with approved procedures. During the operating phase they have the authority to stop unsatisfactory work during repair, maintenance, and refueling activ-ities and the authority to recommend to the 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 correc-tion, or increase the extent of the deficiency is subject to stop work action by the Quality Assur-ance Department. The Manager, Quality Assurance, b4 M3 -and the Super-intendentr-Quality-Assurance-have- no duties or responsibilities unrelated to QA that would prevent'/t-heir- full attention to QA matters.

his 1-2 Rev. 15 6/92

OQAM 1790 1.6 The authorities and duties of persons and organiza-7;gS(; tions performing quality assurance functions shall be clearly established. Such persons have suffi-cient authority and organizational freedom to iden-tify quality problegt; to initiate, recommend, or

. / provide solutions; and4to-ver4ft corrective action.

Yl2 EVn M C Assurance of quality _ by checking, auditing, inspecting, or otherwise verifying Program activ-ities shall be by personnel other than the indi-vidual or group performing the specific activity.

l 2184 1.7 The Manager, Nuclear Engineering reports directly to the Senior Vice President-Nuclear and directs a staff of superintendents, supervisors, supervising engineers, and quality control inspectors whose primary function is to provide technical support to the operation of Callaway Plant. This support includes, but is not necessarily limited to design; modification; configuration control; system and equipment performance; reliability, and testing; technical programs administration; and contractor support. He controls those activities and imple-ments the OQAP through the Superintendents, Design Control, System Engineering, and Project Engineer-ing. Within the System Engineering organization, QC Inspectors (ISI/NDE) report to the Supervising Engineer Performance and ISI, and perform inspec-tion and nondestructive examinations. These inspec-tors do not perform inspections or examinations which provide quality verification of Nuclear Engi-neering work activities.

I 2184 1.8 The Manager, Licensing and Fuels reports directly 9

~ 22f03 to the Senior Vice President-Nuclear and has overall responsibility for UE nuclear fuel cycle activities including responsibility for procurement of fuel cycle goods and services, and for incore fuel management. The Manager, Licensing and Fuels is also responsible for coordinating licensing activities for Callaway Plant. The Licensing and Fuels organization provides technical support activities in the area of reactor design and radi-ological engineering.

1.9 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is respon-sible for providing administrative and management support including cost forecasting, status report-ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal Health l Physicist. He'is also responsible for the adminis- l trative contact with the Institute of Nuclear Power 1-3 Rev. 15 6/92 1

OQAM Operations (INPO). As Principal Health Physicist,_ ,

he provides a corporate level overview and guidance '

in the formulation and implementation ofL applied, radiation protection programs and . reviews Lthe radiological safety programs fortcompliance- with-Federal and State'standardsiandLregulations. i 1.10 The Vice President, Nuclear' Operations reports 'to -

the Senior Vice President-Nuclear and'is- respon-sible 'for- the activities:of the Callaway- Plant' Operations Department .and.the Operations Support.

Department. This responsibility includes.the_ safe, legal and efficient operation and maintenancef of the Callaway ' Plant and protecting the' health; and safety of _the public and Plant personnel. ;He; assures a high levelj of quality' is ' achieved :iri the :i Plant operations and support activities.- .

l 1798 1.11 The Manager, Callaway Plant reports directly'to the l190 Vice President, Nuclear Operations and.is respon-:

sible for the safe, legal, and efficient operation and maintenance- of .the Callaway Plant. .He -has overall' responsibility for~the execution of admin-istrative controls and the quality assurance-program to assure safety.-He controls Plant func -

tions and implements the OQAP through_the Assistant ~

l Manager, Work Control;Lthe Superintendent,- Health- "

Physics; the Superintendent, Chemistry. and; Radwaste; the- Superintendent, Operations;. the-Superintendent, Maintenance; and the;-Euperfising- .i Sqefute d e J e ginacr, I&C (see rigure-C'cf the ^Q.".M). He has-the primary resp ibility for reactor . operation

/ safety. Within~his organization, the QC Super l g

setfan13 gp and visor- reports .to the. Assistant Manager,: Work- >

-hke PSAGL Control who reports to the Manager,-Callaway Plant.

The Quality Control Group performs work activity.

inspections, receipt inspection as' described :irt Section 7, and nondestructive examinations and is '

not involved in those activities performed by '!

others which are considered " inspections"- unto themselves, e.g., surveillance testing, initial startup testing, and I&C, Radiation Protection, and Chemistry group activities. Activities considered  !

to be inspections unto themselves are covered by'QA ,

audits and QA surveillances as discussed under Section 18. The QC Supervisor has no duties or responsibilities unrelated to quality control that would prevent his full attention to quality control

• matters. ,

.i i

1-4 Rev. 15 l 6/92  ;

OQAM emergency plan exercises.

1 The Superintendent, Personnel (Local 1439 and 1 co( reports directly to the Vice President, Nuclear Opdrations and is responsible for assisting in 9'h .. areas of labor relations, organizational and g)QwM g A* personnel N q ivities, Fitness-For-Duty, and other matters under thq guidance of UE policies.

1.19 The Superintendent)' Personnel (Local 148) reports directly to the Vice Presidqnt, Nuclear Operations and is responsible for assisting in areas of labor relations, activities, and organizational other matters under and per3Dnnel'nc the guida of UE

[; policies.

~

1.20 The Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative Serv-ices. The Manager, Purchasing is responsible for commercial aspects involved in procurement of mate-rials, systems, components, and services (excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others which are employed in support of Callaway Plant.

1 2i84 1.21 The Manager, Mechanical Engineering reports to the Vice President-Engineering and Construction who in turn reports to the Senior Vice-President, Tech-nical Services. The Manager, Mechanical Engineering provides technical support, as necessary, to the Nuclear Engineering staff.

LISQ 1.22 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.

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

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

1-6 Rev. 15 6/92

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.OQAM

&nd- safsty-of-the pubi-icr-The-eafety-rei1tted dwc-tures, systems and components are identified in Table 3.2-1 of the Callaway-SP Final Safety Anal-

• ysis Report (FSAR). This list includes structures, j' systems, design and and components identified during the construction phase and may be modified as required during operations consistent with their importance to safety. Modifications to this list require the approval of the Manager, Quality Assur-ance and the Manager, Nuclear Engineering and shall be issued and controlled in accordance with Section

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

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

1789 2.6 Consistent with the schedule for. accomplishing 1879 quality activities, the OQAP shall be established and documented by written policy, program manual, and procedure manuals. Persons conducting safety-related activities shall be responsible to imple-ment approved procedures. The OQAP shall utilize the following document types to describe Program objectives:

1. Operatina Ouality Assurance Procram Poliev/

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

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

2-2 Rev. 15 6/92

OQAM Assurance is responsible for a-system of planned' audits to assure OQAP compliance, with a frequency:

commensurate with- the Program aspect's -safety significance and in accordance with the require-ments of Section '18.- He is. responsible- for conducting audits of offsite and onsite activities.

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

1799 2.12 The Senior Vice President-Nuclear provides for an-1800 independent assessment of the scope, implementa-tion, and effectiveness of the OQAP to assure compliance with policy, commitments, and the requirements of 10 CFR 50, Appendix B.as set forth-in this OQAM. This assessment shall be conducted biennially with a scheduling allowance' of plus three. months for each assessment and a combined-time interval for any three consecutive assessment intervals not to exceed 6.25 years. This assessment may be by representatives of other utilities, outside consultants, or UE management representa-tives. In addition, various reports are issued to the Senior Vice President-Nuclear 'on a periodic basis to assist his independent assessment of the OQAP (e.g., semiannual Q ,r0 pert, and periodic QA audit reports). had 5a 2.13 Implementation of OQAP' controls- over activities affecting quality assures achieving the- objective of the UE OQAP to provide ~ management with' adequate confidence that activities affecting quality ~

regarding. the' design, installation, modification, and operation or the Callaway Plant are : performed consistent with . policy. Documentation- of. the accomplishment- of OQAP objectives is maintained in the form of records-of data and other information as necessary to support operation, maintenance, repair, modification, refueling, and inservice inspection.

2.14 UE Management has established standards of perfor-mance which exceed those set forth by the Regula-tory Agencies. As a management initiative in this area, UE has defined the word "must" to impose management dilected performance standards in excess of and in addition to established Regulatory.

directed performance. From the viewpoint. of. UE employees and UE contractors, there is no differ-ence in the degree of compliance mandated by use of the words "shall" or "must." Compliance with actions initiated by use of either "shall" or "must" is audited and surveilled by the QA Depart-2-5 Rev. 15 6/92

OQAM 2202 ing, releasing, distributing, revising, and 2221 maintaining design documents; performing design 2222 reviews and reviews of design; and controlling A 2243 field changes.

p 221f 2164 3.7 Design control shall involve measures which include a definition of design requirements; a design process which includes design analysis and delinea-tion of requirements through the issuance of draw-ings, specifications, and other design documents (design outputs); and design verification or review of design to verify the adequacy of design or .to-become acquainted with design features.

1850 3.8 Design requirements and changes thereto shall be 2195 identified, documented, reviewed and approved to 2203 assure incorporation of appropriate quality stan-2204 dards in design. documents and to control departures 2205 from these standards. Modifications to structures, 2207 systems, and components shall consider, as a mini-2222 mum, the design bases described in the Callaway-SP 2664 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 superin-tendent in the Nuclear Engineering Department for seismic and quality group classification and selec-tion of quality standards. Design criteria docu-ments consist of original Plant design criteria, system descriptions and other documents defining design input which change the Plant as described in the FSAR. The design input shall be specified on a timely basis and to the level of detail necessary to permit the design activity to be carried out in a correct manner and provide a consistent basis for making design decisions, accomplishing design veri-fication measures, and evaluating design changes.

2207 3.9 Design activities shall include the correct trans-2209 lation of regulatory requirements and design bases 2210 into specifications, drawings, written procedures, 2212 and instructions (design outputs) that define the 2974 design. Design analyses regarding reactor physics, 1170 stress, thermal, hydraulic, radiation, and accident analyses used to produce design output documents, shall be sufficiently detailed to permit an inde-pendent review by a technically qualified person.

Analyses shall specify purpose, method, assump-tions, design requirements, references, and units.

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

3-2 Rev. 14 6/91

~

r 2234 control procedures shall specify requirements for.  !

2235 'the : selection'and accomplishmentfof a1 design veri-

. 2, 4 B fication program. The- program . depth-'shall be.

-12.2.'7 commensurate with the importance of the-system or 2.1L3 / component to safety, complexity _of: the design, and similarity of the ' design to.'previously proven designs. Design verification-shall-be conducted in accordance with- procedures :which identify the= .

responsibilities of the verifier and the'documenta-v tion required and which, through' adherence to. the procedures, . provide for-the identification'of the areas, features,:and pertinent considerations to_bef  ;

verified. Design verification shall be by. either- _,

-design review, alternate calculation,-qualification testing, or.by a combination _of these. Where alter-

_ nate 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: 'calcula -

tion method used. UE shall perform--" reviews' of design" of selected documents for- subcontracted design to become familiar with design features. An independent third-level. review must be employed as an additional verification;when UE judges that the design involves unique or special. design _ features.

The organization performing design shall have the responsibility for design control.unless specified otherwise. Design verification shall be performed .

by competent personnel other. than those who-  !

performed the_. original designLand other than the designer's immediate supervisor.,However, an indi -  !

vidual's supervisor may perform design verification when he is the only technically ' qualified indi- >

vidual 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 ofLuse of.supervi-sors as design verifiers to guard.against; abuse.

1934 3.15 Design verification, if other than by qualification GCUZ7 testing. of a prototype or lead production unit,_

1;23 o shall be completed prior to release for procure-ment, manufacturing, construction or to another

~

organization for use in other design activities. In those cases where this timing cannot be met, -the design verification may be deferred, providing the justification for this action.is documented'and the portions of the design output' documents' based on the unverified- data are appropriately identified and controlled. Without verification, site activ-ities associated with a design ~or _ design. change must not proceed past the point where the installa-3-4 Rev. 14 6/91

e

• OQAM tion would become irreversible (i.e., require extensive demolition and rework). The design veri-fication shall be complete prior to relying upon the component, system, or structure to perform its safety-related function.

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

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

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

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

I

- 5844-- 3.18 Independent of the responsibilities of the design organization, the requirements of the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB) as defined in the Technical Specifications shall be satisfied. Design changes require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, Callaway Plant. In addi-tion, changes in the facility as described in the FSAR which involve a change in the Callaway Plant Technical Specifications incorporated in the license or an unreviewed safety question require review and approval by the NSRB and the Nuclear Regulatory Commission prior to implementation. When design is performed by an outside organization, UE shall 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.

/ 1 -5844-- 3.19 Safety evaluations which consider the effect of the design as described in the design documents, shall be performed by the responsible UE engineering organization or outside organization (s). These evaluations shall include the basis for the deter-mination that the design change does not involve an unreviewed safety question. As deemed necessary by the evaluating organization, detailed analyses shall be performed to support the bases of safety evaluations. All nuclear safety evaluations are 3-5 Rev. 15 6/92

-OQAM well as_the supplier's past performance.. j L 1892 .4.4 Acceptance by' source verification should-be;consid-  !

3572 ered ,when the item or service is vital- to Plant? Lt

' safety; or the quality' characteristics are diffi : ,

cult ~Eto verify after receipt;-or the item or j service is complex in design, manufacture, inspec- j tion or test. Verification in this sense' involves a i physical presence to monitor, -by . observation,  ;

designated activities for.the purpose of evaluating ,

supplier performance and-product acceptability. 'i 1875 4.5 Purchase requisitions must-be employed to initiate  ;

the procurement of safety-related materials, parts,

~ l!

components, and services while ESAs must be used to '!

contract for safety-related engineering,-construc-tion, or consultant services. Contracts,- purchase'

• orders generated from purchase requisitions, and .;

ESAs must be employed to. procure certain goods and .i services associated with the nuclear fuel . cycle.  !

Purchase requisitions'for safety-related. materials, l parts, . components,_ and services and ESAs :for .

i professional services may be initiated by~ personnel-in the Quality Assurance er Outlity Saruice==

. I Departmentf; Nuclear Engineering, Nuclear-Services, j or Licensing and Fuels. Department; or the. unit i staff.

975 4.6 The procurement of spare or replacement parts for i 1876 safety-related structures, systems, and components i 1877 shall be subject to the QA Program controls in' i 1878 effect at the time 1the order is issued; and'to  ;

1883 codes, standards, and technical requirements which are equal to or better'than the original- ' require-ments .or as may be required to reduce the proba-bility for repetition of defects. Procurement docu-  !

ment control preparation measures shall- further  :

assure that safety-related components, piece parts,  !

materials, and services are purchased to specifica- .

tions and codes equivalent to those specified orig- .l inally or those specified by a. properly reviewed and approved revision; packaged and transported in.  ;

a manner.to assure the non-degradation of quality

, during transit; and properly documented to show '

4 compliance with applicable specifications, fcodes, and standards. l t

1876 4.7 Each item or service to be procured is evaluated by j the procurement document originator to determine i whether' it. performs-a-safety-related' function or-involves activities which affect the function of ,

safety-related materials, parts, or components and ,

to appraise the- importance of this function to ,

Plant or public safety. For those cases where it is i t

4-2 Rev. 15 6/92

__ _s., _ _

.-~ , . .

OQAM 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 Engi-neering 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.

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

1864 1. The scope of work and basic administrative and 1890 technical requirements including drawings, 2416 specifications, regulations, special instruc-3550 tions, and applicable codes and industrial 3551 standards and procedural requirements identi-3552 fied by titles and revision levels. Procurement documents shall also include special process instructions; identification of inspection, test and acceptance requirements; and any special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, packaging, handling, shipping, and storing.

1888 2. Requirement that the supplier have an accept- ,

1890 able Quality Assurance Program which implements 3542 the appropriate sections and elements of ANSI' l 3550 N45.2-1977 or the ASME code as applicable as 3553 established for the item or service to be 42668 supplied. This requirement is not applicable to commercial grade items which utilize a suppli-er's -standard or proven design to meet published product descriptions.

1890 3. Requirements for supplier surveillance, audit, t 3550 and inspection including provisions for UE or 3555 agent access to facilities and records and for 3573 identification of witness and hold points.

3867 3874 1890 4. Requirements for extending applicable require-3542 ments of UE procurement documents to lower-tier 3550 suppliers and subcontractors. These require-3554 ments shall include right-of-access to subsup j 3555 plier facilities and records by UE.

i l

l 4-3 Rev. 15 6/92 l

OQAM 3550 5. Requirements for suppliers to obtain UE 3558 approval of nonconformances to procurement I 3597 document requirements dispositioned "use-as-is" and " repair" and conditions of their disposi-tion including identification of those subject to UE approval prior to further processing.

3484 6. Applicability of 10 CFR 21 reporting require-ments.

1890 7. Documentation requirements including records 2132 to be prepared, maintained, submitted for 3550 approval, or made available for review, such 3556 as, drawings, specifications, procedures, l 3574 procurement documents, inspection and test records, personnel and procedural qualifica-tions, chemical and physical test results, and instructions for the retention, transfer, and disposition of records.

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

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

, 39G3 inspectable, and controllable and that there are adequate acceptance and rejection criteria. This review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents.

3564 4.10 Bids or proposals shall be evaluated by the 3567 Purchasing Department, the originating organiza-1 3568 tion, the Quality Assurance Department, and the 3569 Licensing and Fuels Department to assure confor-mance 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

6. Suppliers' past performance

7. Alternates i

8. Exceptions 4-4 Rev. 15 6/92

)

OQAM A 3560 4.10.1 The Purchasing Department shall initiate and coor-DI 3503- dinate bid evaluation activities for those propos-als received in response to requisitions. The

. Purchasing Department shall review bids or propos-als, except those associated with ESAs or nuclear fuel cycle related goods or services, for. alter- -

nates or exceptions to procurement document requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented.

3560 4.10.2 The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier. They shall also review areas 1 through 3 above for replacement parts or equipment ordered from the original supplier as part of procurement '

document preparation.

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

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

3560 4.11 Bids or proposals with alternates or exceptions 3561 identified in Section 4.10 by the Purchasing I 3567 Department shall also be evaluated by the origi-3568 nating organization to provide additional assurance 3570 that no unacceptable conditions result from such changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award.

4.12 Letters of intent may be utilized with suppliers of materials, parts, components, and services for the purpose of reserving schedule space prior to the resolution of the commercial requirements to be included in a purchase order, contract, or ESA. If employed, letters of intent must normally specify that no safety-related activities may begin until an approved purchase order, contract, or ESA is executed. Letters of intent shall be prepared, approved and issued by Purchasing for those suppliers to be covered by purchase order, by the originating organization for ESA's, or by the Nuclear Fuel Department for contracts for nuclear fuel cycle-related goods and/or services. However in the event a letter of intent is issued for the purpose of securing an agreement and thereby allow l

l 4-5 Rev. 15 6/92 l

l

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

3563 4.13 The Purchasing Department is responsible for reviewing purchase orders to verify that the tech-nical and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisition, letter of intent, ESA, or contract shall be by an ~indi-vidual who has approval authority and signifies that the technical and quality review of the docu-ment has been completed. Contracts initiated. for nuclear fuel cycle-related goods and/or services shall be the responsibility of the Manager, Licensing and Fuels with preparation and negotia-tion by the Licensing and Fuels Department. Nuclear fuel cycle-related contracts and ESAs for profes-sional services shall be executed by the Senior Vice President-Nuclear or another company officer in accordance with Nuclear Division and corporate procedures related to agreements or contracts for services.

975 4.14 Additions, modifications, exceptions, and other 3543 changes to procurement document quality and tech-3549 nical requirements shall require a review equiv-

-3555- alent to that of the original document and approval i I 3563 by the originator or the originating department 2\ 3575 approval authority. Commercial consideration 1 -49569- changes shall not require review and concurrence by tVITB7 the originator. Conditions specified on the Qual-ified Suppliers List (QSL) that apply to a vendor may be revised without concurrence from the origi-nating organization since they are imposed without the knowledge of the originator.

4-6 Rev. 15 6/92

OQAM 2974 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 1830 5.1 The activities affecting quality associated with ,

1858 the operating phase shall be accomplished and 1867 controlled by:

1916 1948

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

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

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

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

1833 5.2 The Nuclear Division and other responsible func-1830 tions and departments shall provide written proce-dures and drawings as required to support the Callaway Plant operating phase.' These procedures shall prescribe those activities affecting safety-related structures, systems, and components. It is recognized that skills normally possessed by qual-ified personnel may not require detailed step-by-step delineations in written procedures.

5.3 The Manager, Callaway Plant shall be responsible for providing specific guidance via Administrative Procedures for the development, review and approval of other Plant operating procedures to govern ,

activities which affect safety or quality l consistent with the Technical Specifications. i Similar guidance shall be provided for revisions I and temporary changes to Plant operating proce- l dures. Procedures which implement the Security Plan and Radiological Emergency Response Plan shall be reviewed no less frequently than every twelve months (in accordance with Technical Specifica-tions). A revision of a procedure may constitute a procedure review.

5-1 Rev. 15 6/92

OQAM l

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

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

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

5.7 Special process procedures supplied. by outside

- organizations shall be reviewed in accordance.with

• Section-0.". 9.fo.

5.8 In addition io the procedures identified in. Table '

13.5-1 of the Callaway-SA FSAR (CALLAWAY -PLANT '

ADMINISTRATIVE PROCEDURES), the OQAP' includes procedural coverage in the following areas: design control; design change control; preparation, i review, approval, and revision of specifications, drawings, requisitions, Engineering Service Agree-ments, contracts and procedures ~(instructions); QA indoctrination and training; auditor. training;-

supplier evaluations; receipt and transfer of records; document control;. quality program audits; .

corrective action; inspection; inspection, test and operating status; and special processes.

5.9 Applicable procedures shall be reviewed and revised as necessary as described in Appendix A, Regulatory Guide 1.33 (ANSI N18.7-1976, Section 5.2.15). ,

f i

i 5-2 Rev. 14 8/91 i

- .-.- 4

OQAM 6.0 DOCUMENT CONTROL 4H)OG 6.1 Documents and their revisions which control all- '

1916 activities affecting safety-related structures, 1908 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 respon-1916 sible for OQAP implementing documents shall be 1917 required to provide the necessary review and 2262 approval for instructions, procedures, specifica-tions, and drawings. Reviews and approvals shall assure that issued documents are adequate, author- t ized, include proper quality and technical require-ments, and are correct for intended use. Individ-uals or groups responsible for preparing, review-ing, and approving documents and revisions thereto-shall be identified in written procedures. Specifi-cally, the QA Department shall review Administra-tive 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. Collectively, 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.

1908 6.3 Changes to documents shall be reviewed and approved 1914 by the same function, department, group, or organ-2170 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 understanding of requirements and intent i of the original document.

i I

• 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 review.

When required, the assignment of inspection points for work authorizing documents is performed by Planning Department personnel based on established criteria.

6-1 Rev. 14 I 6/91 i

l

OQAM 1875 '/ . 0 CONTROL OF PURCHASED MATERI E J OUIPMENT AND 3541 SERVICES-l 7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4.

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

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

2. Bid evaluation and award as described in Section 4 l 3565 3. Procurement source selections

4. Verification activities (surveillance, inspec-tion, and audit) required by the purchaser i 3597 5. Control of nonconformances as described 3 r 14, in Section 15

6. Corrective action as described in Section 16

7. Material, equipment, and service acceptance 2416 8. Control of quality assurance records

9. Audits of the procurement program as described in Section 18 l 1891 7.2 UE shall assure that suppliers providing safety-3564 related materials, equipment, or services ere 3565 acceptable procurement sources. Provisions shall 3874 be made for supplier evaluations which assess their capabilities prior to award by: 1)' source evalua-tion; or 2) review for objective evidence of qual-ity; or 3) a review of supplier history. When evaluations are performed, the assessment of a supplier's capability shall be specific to the procured item, commodity, or service and the supplier's ability to provide the items or services in accordance with procurement document require-ments. Suppliers of hardware and services which-are manufactured prior to award, considered a commer-cial grade item, or implemented under the UE OQAP do not require pre-award source evaluation or post-award audits which attest to their capability as a procurement source.

7-1 Rev. 15 6/92

OQAM i

During Callaway's operating life, procurements may 2S50 72337 7.3 3564 be made from: 1) suppliers judged capable-(prior g 3874 to award) of providing items or services in accor-dance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and whose acceptability can be determined by receiving inspection, an examination of quality verification documentation, or other suitable means; 3) suppliers of commercial grade itema able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAP.

Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a purchase order or execution of a contract or ESA, a verification of the supplier /outside organization's acceptability shall be documented. Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some -unsafe or undesirable condition), an evaluation of a supplier's acceptability as a procurement source shall be accomplished prior to award. In the case of purchase orders, the supplier shall be verified as an acceptable procurement source for the item or service being procured. Purchase orders may be issued prior to an assessment of suppliers' capa-bility provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source.

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

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

1891 7.5 Procurement source evaluation and selection 1894 involves the Quality Assurance Department and the 3564 originating organization. The evaluation and selec-t 3565 tion process shall be specified in department proc-edures and may vary depending on the complexity and relative importance to safety of the item or service. Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organiza-tions may be requested to provide input to the qualification evaluations of suppliers. -SuppHers--

]

7-2 -Rev. 15 6/92

OQAM

-o f-h a r dwa re-a nd-s e rv ice s.--wh ichm r e manufacLureT prior-to-awardv considered-a-commercial grade -item

_.or-implemented-under-the OOAP do-not re@ ire r -e--

[ award-source avaluaLivu audits which attesL Lv &

.supp1-iers-capabi-1-ity-as-a g vcurement--source .

I 3565 7.6 Procurement source selection and evaluations shall 3566 consider one or more of the following:

3564 1. Experience of users of identical or similar products of the prospective supplier. NRC Licensee Contractor and Vendor Inspection Program (LCVIP) reports, ASME Certificates of Authorization (C of A), audit reports, UE records accumulated in previous procurement actions, and UE product-operating experience may be used in this evaluation. Supplier history shall reflect recent ~ capability.

Previous favorable quality experience with suppliers may be an adequate basis for judge-ments attesting to their capability. When 'an LCVIP report, an audit report, or an ASME C of A is used to establish a supplier's accepta-bility as a procurement source, the document shall be identified.

2. An evaluation of the 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.

3564 3. A source evaluation of the supplier's 3

technical and quality capability as determined by a direct evaluation (audit or surveillance) of facilities, personnel and Quality Assurance-Program implementation.

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

a. Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementation of manufacturer's measures for control of design, process, and material changes.

b. Acceptable supplier / item performance record utilizing monitored performance of the item, industry product tests, national 7-3 Rev. 15 6/92

OQAM i

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

,gqg g)J891 3608

1. Written certifications

2. Source verification

3. Receiving inspection

4. Post-installation test (in addition to one of the above) 7.15 Commercial grade items shall rely on proven design 2 g ggF 3'1876 3565 and utilize verification methods by the purchaser, to the extent appropriate to item application.

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

1. Special Tests and Inspections

2. Survey of Supplier (commercial Grade)

3. Source Verification

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

a) The established historical record is based on industry wide performance data that is directly applicable to the item's critical characteris-tics and the intended safety related applica-tion; and b) The manufacturer's measures for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).

s 1891 7.16 Where required by code, regulation or contract 1893 requirement, documentary evidence that items 3603 conform to procurement documents shall be available 3605 during receiving inspection or prior to use of such 3607 items. Where not precluded by other requirements, documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item accep-tance, verification of the validity of supplier certificates and the effectiveness of the certifi-cation systems shall be conducted at intervals commensurate with the supplier's past quality performance. Certificates of conformance and compliance shall be required to be signed or accom-panied by .a signed letter of transmittal. Where acceptance is based upon source verification, docu- '

mented evidence of these surveillances shall be furnished to the Plant Quality Control organization by the responsible UE organization or their desig-nated agent prior to acceptance.

7-6 Rev. 15 6/92 l

OQAM 9.0 CONTROL OF SPECIAL PROCESSES 1851 9.1 Special processes are fabrications, tests, and 1937 final preparation processes which require in-pro-7oof cess controls in addition to final inspections to assure quality. Special processes also require the qualification of procedures, techniques, and personnel in accordance with the requirements of applicable codes, standards, specifications, or other special requirements to which UE is commit-ted. Special processes include such activities as welding, heat treating, nondestructive examination,

( M he ap g ation nf specialized coatings, and chem-or wher c i4cm gua i ical cleaning. For specla processes not covered by rep;remp (s grc ud 4 existing codes or standar o, the necessary qualifi-refu:ee.uf*h ot es Mla kc) cations of personnel, procedures, or equipment 92cle; = ^ 54""da<dr) shall be defined by Nuclear Engineering.

2740 9.2 Procedures for special processes shall be qualified

~

as part of their approval process, and shall also l provide for recording evidence of acceptable I

accomplishment of the special processes. Personnel qualifications shall be certified and equipment i shall be qualified prior to use.

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

CA udhs gT'6 s h kN -Qua44ty -Control-personnel-shall-be-respons-ible f w pedo <mcd ; Ju c355 e e_ _ assuring that-personne4-perform-ing nondes n uc Live-y c e l pvc.cyre y g y --examinatrions --are-qualified-and are employing-po'"""j g approved procedurese Nondestructive examination Pd ch ccM tied m'm-,c y Sy"'[~[t (NDE) personnel shall be qualified in accordance with procedures established to meet the require-2'vP' J,'chpersonrcl. ments of the Code Edition and Addenda to which UE is committed at the time the NDE is performed. When non-code NDE is performed, personnel shall be qual-ified to the version of SNT-TC-1A used to meet UE's current commitment to the ASME B&PV Code.

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

1857 9.5 Planning for maintenance shall include evaluation of the use of special processes, equipment and materials in performance of the task, including assessment of potential hazards to personnel and equipment.  ;

9-1 Rev. 15 6/92 1

1

OQAM gg, 2974 10.0 INSPECTION NN I 1851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to 1927 verify conformance with applicable documented ,

instructions, procedures, drawings, and specifica-tions. Inspections and monitoring of processes which serve an inspection function shall be performed by personnel qualified to perform assigned tasks and who are independent of individ-uals who perform the activity.

10.2 Required inservice inspection of structures, systems or components shall be planned and executed. Inspection methods shall be established and executed to verify that the characteristics of an item remain within specified limits.

1850 10.3 Inspection of activities at the Callaway Plant 1937 shall be at intervals based on the status and importance of the activities. Guidelines shall .1xt established to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subse-quent monitoring planning.

I 10.4 Nuclear Engineering shall be responsible for assuring the development of preservice and inservice (PSI /ISI) inspection programs; the refer-ence PSI /ISI examination plans for ASME Code Class 1, 2, and 3 systems and components including steam generator eddy current examination; the NDE proce-dures required by the reference plans; and the initial updating of the reference plans and proce-dures to reflect "as-built" conditions and the technical requirements of the applicable Code Edition and Addenda prior to the issuance of the inservice inspection plans and procedures.

I 10.5 Nuclear Engineering shall be responsible for assuring the development of the inservice testing program plan for pumps and valves, the test proce-dures required by this plan, and the securing of consulting services in this area. In addition Nuclear Engineering shall be responsible for admin-istering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division. They are-also responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ICI examinations.

l 10-1 Rev. 15 I 6/92 )

l i

OQAM 2483 10.6 An inspection personnel qualification program shall 2484 be established to assure inspection activities are 1 2485 being performed by personnel trained and qualified to a capability necessary for performance of the activity. Plant procedures shall prescribe the qualification requirements of inspection personnel.

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

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

2483 Other members of the unit staff performing "inspec-2484 tion" activities shall have appropriate experience, 2485 training, and retraining to assure competence in 2994 accordance with ANSI /ANS-3.1. Inspection assign-ments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC inspection personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent competence.

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

"\ 2484 10.9 When contractors or vendors are retained to perform 2485 work activities or to provide services associated I with safety-related items at the Callaway Plant, the qualification of inspection personnel and the conduct of inspections associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procure- )

ment documents. As an example, if a vendor was i contracted to conduct eddy current examinations of 1 the Callaway Plant steam generators, then the persons performing the examination would be qual-10-2 Rev. 15 6/92

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

1930 10.10 Procedures which specify inspection activities i l 1931 shall provide for the following, as required:

/\ 21-2 4--- 1) the inclusion of independent inspection or moni-toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta-tion of inspection results; 4) a description of the method of inspection including any mandatory hold points; 5) the identification of the characteris-tics and activities to be inspected; 6) the accep-tance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from drawings, instructions, specifications, codes, standards, or regulatory requirements.

1928 10.11 The inspection function shall be conducted in 1929 accordance with written approved procedures which i 1973 specify inspection scope; personnel qualification 2039 requirements; and data collection requirements.

,\

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

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

' use prior to performing inspection activities.

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

i 1932 10.13 Indirect control by monitoring processing methods, 1933 equipment, and personnel shall be utilized as a control if inspection of processed items is impos-sible or disadvantageous. Both inspection and moni- l toring of processes shall be provided when control is inadequate without both.

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

a 2262 inspection requirements; and to identify necessary Lply79 changes to the installation inspection procedures.

The acceptance of an item shall be documented by authorized personnel. Modification, repair or replacement of items performed subsequent to final inspection shall require reinspection or retest to verify acceptability.  !

10-3 Rev. 15 6/92

OQAM

$2.430 2974 11.0 TEST COffrROL ,

4243I 1850 11.1 Testing programs shall be established to demon-1934 strate that safety-related structures, systems, and 2052 components will perform satisfactorily in service. {

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

I 1853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-sary quality of systems and components is main-l tained, that facility operations are within .the safety limits, and that limiting conditions for operation can be met. The testing frequency shall j

be as prescribed in the Callaway Plant Technical Specifications. The provisions for surveillance .

I testing shall include the preparation of a surveil-lance testing schedule (s) which reflects the status of in plant surveillance tests. Qualified personnel shall perform surveillance tests.

I i1851 11.3 Appropriate tests shall also be performed subse 1 2053 quent to Plant modifications, maintenance or significant operating procedure changes to confirm expected results. Tests provide a level of confi- .

dence in structure, system or component operation or functional acceptability.

1 3577 11.4 When required by procurement documents, testing shall be employed as a means of purchased material i and equipment acceptance. Acceptance testing of this nature shall be performed during receiving inspection or subsequent to installation in accor-dance with Section 7. ,

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

Experience with malfunctioning equipment and 3 similar components shall be reviewed and evaluated to determine whether a like kind replacement compo-nent can be expected to perform its function relia-  ;

bly, i

1938 11.6 Testing shall be performed in accordance with 2055 written procedures which incorporate or reference 2056 the requirements and acceptance limits contained in applicable Callaway Plant Technical Specifications, 11-1 Rev. 15 6/92 h-__ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ - _ _ - . __ _ _ _____

4 9 OQAK drawings, instructions, procurement documents,  !

specifications, codes,- standards, and regulatory _

requirements. ,

I '1930 11.7 Administrative procedures, test procedures, or.

1938 checklists shall include:' provisions.for assuring; 2132 all prerequisite conditions are met; test equipment calibration requirements; testing method instruc-tions - including hold.or witness points; limiting.

conditions and acceptance / rejection criteria;- and data collection and test result approval require--

ments. ,

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

1 1973 of results, achievement of ' test -objectives,_ and

-21:4- operational proficiency of equipment and systems; 2125 to identify additional test requirements; and to-

,- ) 42ep79 identify necessary changes to the. installation test.  ;

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

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

15. Deficiencies identified as nonconforming-shall ,

be processed in accordance with Section=15. ,

f 11.9 Review and approval of tests and experiments' not described in the FSAR shall be conducted as speci- ,

fled in the Callaway Plant Technical Specifications and 10 CFR 50.59.

I 2039 11.10 A program shall be established to assure testing 2481 activities are performed.by personnel trained and I 2482 qualified to a capability necessary for performance 2483 of the activity. Plant procedures and procurement.

2484 documents shallfprescribe the qualification 2485 requirements for-testing-personnel.' Provisions-may  ;

l be made for on-the-job training of individuals not qualified to the program provided they are super-vised or-overseen by qualified individuals for'the activities being performed. The Superintendent, Training shall be responsible;for-providing related technical and quality training,for UE personnel who- ';

perform testing.

1 2263 11.11 Personnel within the various~UE organizations may Z 2479 perform testing activities including implementing g i test procedures and the' evaluation and reporting of i 248 1 3"2480 2483 test results. The assignment of Plant testing 2484 personnel shall be under the direction and control i 2485 of the Vice President, Nuclear Operations. The qualification of QC testing personnel' shall be 11-2 Rev. 15 6/92.

OQAM defined in three levels of capability as described  ;

in ANSI N45.2.6. Other members of the unit staff performing " testing" activities shall.have appro-priate experience, training, and retraining to assure competence in accordance with ANSI /ANS-3.1.

Testing assignments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC testing personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that indi-viduals possess comparable or equivalent compe-tence.

2263 11.12 Personnel from outside organizations or UE personnel who are not members of the unit staff 248L S"2480 2483 who perform other testing activities associated 2484 with safety-related items at the Callaway Plant 2485 shall either be certified as required by ANSI N45.2.6 or they shalf meet the education and expe-rience requirements applicable to the_ equivalent position on the unit staff for the activities which they are performing.

2483 11.13 When contractors or vendors are retained to perform 2484 work activities or to provide services associated 2485 with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct of tests associated with that contracted work activity or service shall meet the require-ments stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway plant, then the persons performing the testing / valve settings would be qualified as required by the vendor's quality l assurance program unless otherwise specified in the applicable procurement documents. l l

i 1

)

11-3 Rev. 14 6/91 j l

OQAM .

13.0 HANDLING, STORAGE. AND SHIPPING 975 13.1 Safety-related items including safety-related parts 2293 of structures, systems, and components and related 2417 consumables shall be handled, stored, shipped, cleaned, and preserved in accordance with proce-dures, instructions or drawings, to assure.that the-quality of items is preserved from. fabrication until incorporation in the callaway Plant. The procedures shall also establish responsibilities for determining applicable requirements for packag-ing, shipping, receiving, storage, and handling activities.

I 2293 13.2 Generic procedures or instructions shall be 2349 prepared for application to these activities; I 2354 however, detailed procedures or instructions shall 2416 be prepared for the handling, cleaning, storing, 41668 maintaining while stored, or shipping of -certain items and types of equipment or material. Appli-cable manufacturer instructions and recommenda-tions, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering.

review.

d:ch rela)c I 2354 13.3 DeviationsA from manuf acturer's recommendations -may-impose were stringent requi-rements-or-mey rel-ax-the requiraments. The rtilaxationwf-manufacturer 4s-rsquirements. shall involve an engineering evalua-

%( ) [~ mentstion,are and-i# appropriate recommended andwhen such unrealistic require-recommendations are not reasonably necessary to preclude equipment degradation.

i 2416 13.4 The requirements for activities described in this Section shall be divided into levels with respect to protective measures to prevent damage, deterio-ration, or contamination of items. These levels are based upon the important physical characteristics and not the important functional characteristics of the item with respect to safety, reliability, and operation. The specific environmental, special measures or other conditions applicable to each level shall be described in implementing procedures.

I 13.5 The Superintendent, Maintenance shall establish an inspection program for Plant material handling equipment that provides for routine maintenance and-inspection in accordance with documented procedures which specify acceptance criteria. Routine inspec-tions shall determine the acceptability of equip-ment and rigging. Routine inspections shall be 13-1 Rev. 15 6/92

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

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

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

_ involve personnel from various Plant organizations.

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

i s 2416 13.7 Procurement documents or procedures shall address Is 23o4 packaging requirements which afford protection from the possible degradation of quality during ship-ping, handling, or storing. The packaging protec-tion specified may vary in degree consistent with the item's protection classification. Similarly, the mode of transportation employed shall be consistent with the protection classification of items.

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

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

13-2 Rev. 14 6/91

OQAM l --t877 15 . 0 NONCONFORMING MATERIAL. PARTS, OR COMPONENTS

~2339~ l 1848 15.1 Material nonconformances include material deficien-1870 cies (including inoperative and malfunctioning 1907 structures, systems, and components). Material 2045 nonconformances identified under the UE OQAP shall' 2112 be controlled to prevent the inadvertent use of material, parts, or components which are defective or of indeterminate quality and to identify docu-mentation inadequacies. Measures shall be estab-lished regarding identification, documentation, status control, disposition, and notification of affected organizations.

- 1848 15.2 Under the UE OQAP, Nonconforming Material Reports 1885 (NMRs), nonconformance logs, or other administra-1903 tive controls shall be employed to identify and 1907 control nonconformances. Nonconformance logs may be 1 2328 employed to control deficiencies of a minor nature 2334 or to control documentation deficiencies both of which can be corrected by bringing the deficiency into compliance with the original requirements.

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

t 1906 15.3 Plant and other UE organization's procedures shall 3558 prescribe measures for the control and disposition

\ 3598 of UE purchased items and services identified by

- -9599-- outside organizations as nonconforming. Procurement 3600 documents shall specify those nonconformances to be submitted to UE for approval of the recommended disposition. As specified in procurement documents, actions taken in response to these nonconformances shall be 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-recommended dispositions for Plant-initiated procurements. Similarly, other UE or outside organ-izations shall approve or be requested to provide a technical evaluation regarding supplier-recommended dispositions of nonconformances regarding procure-ments they initiate.

15-1 Rev. 15 6/92

OQAM i

1906 15.8 Material nonconformances which would impact the conduct of a test shall be corrected or resolved prior to initiation of the test on the item. The decision to proceed with the testing of a system or subsystem with outstanding material nonconformances shall consider the nature of the nonconformance, its effect on test results, and the need .for supplemental tests or inspections after correction of the nonconformance. The evaluations shall be documented.

1848 15.9 Repaired and reworked items shall be reinspected or 1904 tested. Measures may be established to condition-1906 ally release nonconforming items whose disposition 2053 is pending, provided that an evaluation indicates s t 2328 that further work or activity will not contribute 2332 adversely to the material nonconformance or preclude identification and correction.

15.10 Material nonconformance summaries shall.be prepared and analyzed for potential adverse quality trends semiannually. For nonconformances discovered upon receipt inspection of new purchases or discovered after an item has been accepted by receipt inspec-tion but before issue from the warehouse, the Manager, Operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered installed, the Manager, Nuclear Engineering shall have the trend analysis prepared.-Thecc analyssa shall ha sent-to

--the-Quslity Asom ance Depsi-tinent f cr an indepen 'cirt

-review, The result o -this review shall be reported to mana ement. +hese avessme.dr The. Gua.1 dq 8 s s sw _ Degadwt rM mm o

&E en S e-S hve}

isbefevsAr d rtd <%)

enM whh ank wvalha ach:v: lies.

15-3 Rev. 15 6/92

OQAM g . 1875 16.0 CORRECTIVE ACTION l 800 16.1 Measures shall be established to assure that-condi-p 1 70 tions adverse to quality are promptly identified,

' Ya h Y

19 2976 reported, and corrected. Nonconformances shall be controlled in accordance with the requirements

• o 1 3598 described in Section 15. Each of the Nuclear Divi-g g dn sion Managers is responsible for. developing and implementing a program for identifying and control-gg ling adverse conditions. This responsibility may be

\ satisfied by one or.more programs. As a minimum each program shall provide for developing and anal-

@ pring trends on a semiannual basis. . Trending .of 25 conditions adverse to quality identified at suppli-

'$(4 U er's\ f acilities is performed as part of - the annual supplier evaluation per OQAM, Section 18.12.-Proce-s o() dures spall provide instructions for identifying, reporting g and initiating corrective action to preclude of adverse conditions. It- is understoodgcurrence g that the term " corrective action" includes remgdial action necessary.to correct the deficiency, ag well as corrective action necessary to preclude recu rence.

16.2 Conditions advers to quality which impede the implementation or rgduce the effectiveness of the Operating QA Progra shall be controlled by the measures described h in. Adverse conditions may include, but are not li ted to, noncompliance with procedural -

occurrences required by requirements regulations \; adverse reportablenonconformance trends; deficiencies identi(ied in the OQAP; recur-ring conditions for which bast corrective action has been ineffective; or bre4 downs in administra-tive and managerial control b which could ,

result 'in a system designed to(stemsrevent or mitigate serious events not being able to perform its intended function.

16.3 Corrective action documents which re rd defects in basic components or deviations fbpm technical requirements- in procurement documents shall be reviewed for reporting applicability uh er 10CFR21 and other Federal reporting requirements.

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

1 2

16-1 Rev. 15 6/92

OQAM

~_

4 16.5 Nuclear Engineering shall review documented condi-tions adverse to quality which involve design defi-N g~ y \ ciencies or design changes which are recommended as p \ corrective action. Licensing and- Fuels should

- \ review documented conditions adverse to quality for

1. g .

\ fuel-related issues. The ORC shall review signifi-y' N cant adverse conditions. Examples of such condi-include those identified by Callaway Plant ff

')

t

)

\tions Technical Specifications 6.5.1.6(f), 6.5.1.6(g),

6,5.1.6(h), 6.5.1.6(1), and 6.5.1.6(m); and NPDES vfolations.

\

16.6 Corrective action documents shall be closed by verifyi.ng the implementation and adequacy of corrective action. The Quality Assurance Department shall close QA-originated corrective action docu-ments by verifying the implementation and adequacy of corrective action. Copies of completed correc-tive action \ documents shall be available for management review (hardcopy or electronic media) to keep them appri' sed of conditions adverse to qual-ity. The Quality Assurance Department shall period-ically prepare summaries of significant corrective action documents and submit them to the NSRB and appropriate levels of ina agement.

16.7 The closure of corrective' action documents shall be accomplished as promptly a'ss practicable but shall occur only after the corrective action taken has been verified. Verification 'may be accomplished through direct observations, 'vritten communica-tions, re-audit, surveillances,'\or other appro-priate means. The nature of the deficiency may be such that remedial actions need to'be taken imme-diately whereas development and imp 1'amentation of corrective action to preclude recurrence may take substantially longer.

I 1800 16.8 Summaries of corrective action documents 'shall be reviewed for the effectiveness of the co'rrective actions taken and analyzed for potential adverse quality trends. Quality Assurance shall evaluate the analyses, the identification of adverse trAnds,

}

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.

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16-2 Rev. 15 6/92

OQAM 16.0 CORRECTIVE ACTION 1870 16.1 Measures shall be established to assure that condi-1871 tions adverse to quality are promptly identified, 1903 reported, and corrected. Such measures shall be 2973 established in a program or programs which are proceduralized. Those- procedures, as a minimum, WN y shall:

d.'O 1. Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.

o @a -

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I 7 2. Define responsibility for verifying that reme-fg dial action was taken for conditions adverse to

, j quality.

3. Define responsibilities for determination of

-t, hose- conditions adverse to quality which are significant. significant conditions adverse to quality will require both remedial action and action to prevent recurrence.

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

5. Provide a method for documenting the identifi-cation of conditions adverse to quality. This documentation shall also include the root cause or causes and the action implemented to prevent recurrence for significant conditions adverse to quality.

6. Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct address, distribution of copies, electronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.

7. Provide methods for submitting reports required by. external agencies concerning conditions adverse to quality.

1800 8. Provide for developing and analyzing. trends on

\ at least a semiannual basis. Trending of condi-

\ tions adverse to quality identified at evppli-

\

er e-s facilities is performed as part of the 59lus annual supplier evaluation per OQAM, Section

\

i 18.12.

16-1 Rev. 16 l 6/93 <

1 l

OQAM f 16.2 Conditions adverse to quality which are classified as nonconformances shall be controlled in accor-dance with the additional requirements described in OQAM, Section 15.

Conditions adverse to quality which impede the the 16.3 implementation or reduce the effectiveness of Operating QA Program shall be considered signifi- Significant cant conditions adverse to quality.

conditions adverse to quality may include, but are not limited to, noncompliance with procedural personnel requirements which impact nuclear t.

safety; reportable occurrences required by regula-tions; adverse nonconformance trends; deficiencies-identified in the OQAP; recurring conditions for M'W hlch _past corrective action has been ineffective; bro kdowns a inistrative and anageriall y _M (A

or control in stems which could result in system a

~M designed revent or m igate serious even not) g 45 b g being able t erform its i ended function ~ C  ::-

.tt ; ~ p such conditions imclude Liics which

" L k V " g'piamplestheor descriptions in Callaway Plant Technical

' Pjr

- match 1, m (potential 6.5.1.6f, g, h, 7eP pg Specification hazards to nuclear safety) and NPDES violations.

g Ard t 16.4 Conditions adverse to quality which involve defects

/ in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements.

s Repor-g conditions adverse to quality are classified

[ < table as significant.

as f 4 , 4- ) 16.5 The nature of the condition adv- se to quality may remedial actions %ccd-to be taken /

(g be such that immediately, whereas development and implementation of corrective action to preclude recurrence may take substantially longer.

Engineering personnel shall review condi-1871 16.6 Nuclear

) tions adverse to quality which involve designdesign defi-ciencies or which involve recommending changes as corrective action. Licensing and Puels conditions adverse to quality for should review issues. The ORC shall review signifi-fuel-related cant conditions adverse to quality.

action documents shall be closed by 16.7 Corrective the implementation and adequacy of verifying corrective action. Theaccomplished closure of corrective action as promptly as documents shall be practicable -but shall occur-enly-af terVerification the correc-tive action taken has been verified. observations,

\ may be accomplished through direct s

written communications, re-audit, surveillances, or other appropriate means. ,

16-2 Rev. 16 6/93

l OQAM

,s completed corrective action documents- re=c) 1871 16.8 Copies of shall be available for management review (har opy  ;

or electronic media) .-t5 keep thc= apprised --a&-

-_cendibinne 2dverse to quality = The Quality Assu-i rance Department shall periodically review correc-significant tive action documents and identify conditions. Summaries of significant conditions j

adverse to quality shall be submitted.to the NSRB.

, p i and appropriate levels.of management. .!

2 r e6 3#y !1800 16.9 Corrective action documents shall be reviewed for [

i the effectiveness of the corrective actions taken

'("k and analyzed for' potential adverse quality trends.

Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the accepta-through' bility of actions taken on these trends 1

( routine audit and surveillance activitiesp, enut- 1

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N eball report The results of these assessments \/ to management. SLII k 9M

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16-3 Rev. 16 6/93 -.

OQAM l 1875 18.0 AUDITS 2180 3869 l 41639 2186 18.1 A comprehensive audit program shall be. established 2199 and implemented by UE to verify internal and 2978 external quality activities' compliance with the 2988 OQAP. The audit program shall assure that all appli

-iWB&- cable elements of the Program have been developed, 3865 documented, and are being effectively implemented and shall provide for the' reporting and review of  ;

3867 3883 audit results by management. The audit system is

+--414 3 - described in manuals and procedures. Nonconfor-mances and program deficiencies shall be identified and corrective action shall be initiated and verified. See Section 3.14 for a specific audit topic.

I 1800 18.2 The UE audit system shall include the performance 2245 of audits and surveillances by the Quality I i 3586- Assurance (QA) Department. Audits determine, through investigation, the adequacy of and adher-ence to established procedures, instructions, spec-ifications, codes, and other applicable contractual and licensing requirements and the effectiveness of implementation. Surveillances involve the periodic or continuous monitoring of the' operation or performance of a supplier, item, component, or system. Surveillance in this audit sense should not be confused with inspections for the purpose of process control or product acceptance or with requirements relating .to test, calibration or inspection to assure that the necessary quality of systems and components is maintained, that facility.

operations are within the safety limits, and that ,

limiting conditions of operations are being met I

(surveillance tests). QA personnel performing surveillances should be familiar with the area to be surveilled and the applicable implementing proc-edure(s) governing surveillances. Surveillances may 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). See Sections 10.6, 10.7, 10.8, 11.10, 11.11, 11.12, and 18.4.

1818 18.3 The Manager, Quality Assurance shall establish a 2244 program which provides for the qualification and i 2250 training of QA Department audit and surveillance 2255 personnel. Audits shall be directed by an Audit i 2963 Team Leader (ATL) who is a certified Lead Auditor.

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

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

The Manager, Quality Assurance has direct access to 1740 the Senior Vice President-Nuclear.

/ g 1799 1 1800 18.6 The audit system shall include internal and 3871 external audits. The system shall be planned, docu-mented, and conducted to assure coverage of the applicable elements of the OQAP, and overall coor-dination and scheduling of audit activities. Audit I results shall be periodically reviewed by the QA Department for quality trends and results reported to the appropriate management. The Manager, Quality Assurance shall monitor the OQAP audit program to assure audits are being accomplished in accordance with the requirements described herein and for overall Program effectiveness. The NSRB shall selectively review audit reports of onsite audits.

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

3- i 1792 18.7 Internal audits shall be conducted by the QA 4 816 Department and shall be performed with a frequency gg# )}3873 commensurate with their safety significance. An audit of safety-related functions shall be completed in accordance with formal audit schedules within a period of two (2) years. Each element of the OQAP, such as design control and document control, and each area of Plant operations shall be audited.

2666 18.8 Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be 2847 audited under the cognizance of the NSRB at the 3873 frequencies indicated in Section 6.5.2.9 of the 417 7 Technical Specifications and the Radiological Emer-gency ResponsejrProgr-am. In addition to audits conducted und t the cognizance of the NSRB, the Plcb1  ;

18-3 Rev. 15 6/92 l l

I

00AM following areas shall be audited at least once per 12 months:

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

• 1 1800 18.9 'During Plant modifications or other major-unique 3873 activities, audits shall be scheduled as- required to assure that Quality Assurance Program require-ments are properly implemented.

I 3577 18.10 External audits shall be conducted by or for the QA Department as a method for the evaluation of-procurement sources and_ as a post-award source verification of conformance to procurement docu- '

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

including other utilities or A/E's, may be employed as a means of post-award source verification- in lieu of UE performed audits and may not necessarily-l audit -specific items furnished to UE. These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted i in accordance with this OQAM and QA Department procedures. Commercial grade items do not require pre- or post-award audits. Similarly, items which are relatively simple and standard in design and '

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

~

1780 18.11 Applicable elements of suppliers' quality assurance' I 3565 programs shall be audited (post-award) on a 3878 triennial basis.. Audits generally should be 3872 initiated when sufficient. work is in progress to determine whether the organization is complying- '

with the established quality assurance provisions.

Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same supplier shall be considered in estab- 1 lishing audit requirements. In addition, the need for a triennial audit may be precluded upon evalua-l tion and' documentation by the QA Department that the results of mini-audits performed during source Ye cdion --i-nspection and source surveillance activities.

confirm the adequacy and implementation of the supplier's QA Program.

18-4 Rev. 15 6/92 r

s

OQAM APPENDIX A REGULATORY GUIDE 1.8-(cont.(-(W W The experience,[ift raining, and education requirements for the positions of ph Supervisor, Operating Supervisor, Reactor Operator, and

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

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

Refer to Callaway-SA FSAR Section 13.1 for a discussion of the qualifications of personnel responsible for plant operation and support.

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

With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Documen-tation: 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 g~ .e supplemental HP and I&C technicians and QC inspectors. When used to perform safety-related activities, these personnel shall meet

1. " "r T( the educatica and experience requirements of ANSI /ANS 3.1 - 1978 foFdi[6nalent? positions e-requirements fer-c ert-ific a t-ion-a g1n s p,ection, examinatio or-e lse-they-sh " testing personnel aH-me M as set forth in TTE~'s commitment to ANSI N45.2.6-1978 given else-

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

(Endorses ANSI N45.2-1977)

DISCUSSION:

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

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

related items, components or services, as appropriate, as y described under Regulatory Guide 1.123 (ANSI N45.2.13-1976).

\ L E g., ep;s.de,.t gesMr C r (4fa.u. g2en..~wd g k %l :Nel b arsipl y ,u e;h u L y L%% W c d < %. u L h .Je> n a:b  %% Gledvit.-

m ed +d. n. q d 9 w l; red ro., ns, A-2 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.37 (cont.)

be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ-mental conditions, exce

• as provided for in approved design documents. No more tha & ppm sulfur shall be allowed where such elements are leac ble or where they could be released by breakdown of the compounds under expected environmental condi-tions, except as provided for in approved design documents.

With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion Cleaning: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precluded, as determined by engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA auaits and surveillances, and QC inspection activities assure QA/QC involvement.

REGULATORY GUIDE 1.38 REVISION 2 DATED 5/77 Quality Assurance Requirements for Packaging, Shipping, Receiv-ing, 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

• i l

With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Defini- l tions: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.

With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Plann-ing: (First sentence) The specific items to be governed by the Standard shall be identified in Callaway-SP FSAR Table 3.2-1, which lists those structures, systems and components to which the UE QA Program is applied.

With regard to 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 require-ments in these Sections shall be implemented in lieu of the general requirements here. In every case either identical or equivalent controls are provided in the sections of the refer-enced Standards or documents.

1 1

A-13 Rev. 15 6/92

OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)

The specific location of a record "within a storage area" may not be delineated. (e.g. The specific location within a computer record file may not be constant. Further, UE may utilize a computer assisted random access filing system where such location could not be readily " documented," or would such a location be

" relevant.") The storage location shall be delineated, but where file locations change with time, the specific location of a record within that file may not always be documented.

With regard to Section 4.2 of ANSI N45.2.9 - 1974 titled Timeli-ness: UE's contractual agreement with its contractors and supp-liers shall constitute fulfillment of the requirements of this N, Y l (3 y Section.

The following clarification is substituted for the currant fa1 C 3 A/I subsection 5.4.3: " Provisions shall be made for special processed

(<vgr~ 7 , records (such as radiographs, photographs, negatives, microfilm f* c and magnetic media) to prevent damage from excessive light, stacking, electromagnetic fields, temperature and humidity as appropriate to the records type." Consideration shall be given to manufacturer's recommendation.

With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safe-keenino: Routine General Offices and Plant site security systems and access controls shall be provided: no special security systems are required to be established for record storage areas.

With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Facil-ity: This Section proviCes no distinction between temporary and permanent facilities. To cover temporary storage, the following clarification is added: " Active records (those completed but not yet duplicated or placed on microfilm) may be temporarily stored in one-hour fire rated file cabinets. In general, records shall not be mainteined in such temporary storage for more than three months after completion without being duplicated (for dual stor-age) or being placed on microfilm. Open-ended documents --those revised or updated on a more-or-less continuing basis over an extended period of time (e.g. personnel qualification and training documents, equipment history cards, master audit or master surveillance schedules) and those which are cumulative in nature (e.g. nonconforming item logs and control room log books)-- are not considered as QA records since they are not

" complete." These types of documents shall become QA records when they are issued as a specific revision (e.g., the master audit schedule); when they are filled-up or discontinued (e.g. log books or equipment history cards); on a predefined periodic basis when the completed portion of the on-going document shall be transferred to document control as a " record" (e.g. training and qualification records).

A-25 Rev. 15 6/92

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With regard to Section 6.4 of ANSI N45.2.13 - 1976 titled Control of Chances in Items of Services: The phrase "the Operating QA Program" is inserted in lieu of " ANSI N45.2, Section 7."  ;

/ $fWith regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disoo-sition: The third sentence of item b is revised to read:

Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist of one or more of the following shall be submitted to the Purchaser

}p$e/y for approval of the recommended disposition prior to ship-gf ment when the nonconformance could adversely affect the end

) e use of a module

• or shippable component relative to safety, iJ4( Shrq r I

interchangeability, operability, reliability, integrity, or M (c"f maintainability:

_,j3 1) Technical or material requirement is violated;

2) Requirement in Supplier documents, which have been approved by the Purchaser, is violated;

3) Nonconformance cannot be corrected by continuation of the original manufacturing process or by rework; and/or

4) The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

• A module is an assembled device, instrument, or piece of equip-ment identified by serial number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable compo-nent is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an individual item and which has been evaluated by inspection and/or test for conformance to y procurement requirements _regarding_end_use,___

With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source '

i Verification Activities and Section 12 of ANSI N45.2.13 - 1976 titled Audit of Procurement Procram: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appen-dix, OQAM Sections 16 and 18, and the requirements of the Callaway Plant Technical Specifications. '

l A-29 Rev. 15 I 6/92 i

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ATTACHMENT 3

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OQAM, REVISION 16 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGES TO THE OQAM

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Attachment 3 ULMRC-2809 Page 2 of 4  !

DESCRIPTION OF AND JUSTIFICATIONS FOR PROPOSED CHANGE TO THE OPERATING QUALITY ASSURANCE MANUA.L (OQAM)

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The bracketed numbers [ ] in this attachment may apply to several changes. The affected OQAM sections are referenced following each justification. It should be noted some sections appear under more than one justification. Based on Union Electric's evaluations, the proposed changes with one exception, do not represent a reduction in the Operating Quality Assurance Program (OQAP) as previously accepted by the NRC. This exception is described in item [3] below and was approved by the NRC on 5/29/92. The OQAM continues to meet the requirements of 10CFR50, Appendix B.

[1] Organization changes made to improve interdepartment and/or intradepartment coordination and efficiency (Sections 1.3, 1.4, 1.5, 1.11, 1.18, 1.19, 4.5, Appendix A, Reg. Guide 1.8, Reg. Guide 1.146).

[2] Changes to Commitment Tracking System numbers. These numbers appear in the left margin. They are an internal tracking system for UE commitments and have no impact on the stated text. (Sections 1.2, 1.3, 1.4, 1.6, 1.8, 1.11, 1.21, 1.22, 3.6, 3.9, 3.14, 3.15, 3.18, 3.19, 4.8.2, 4.9, 4.10, 4.10.1, 4.14, 5.2, 6.1, 7.1.5, 7.3, 7.14, 7.15, 9.1, 9.2, 10.0, 10.9 10.10, 10.11, 10.14, 11.0, 11.8, 11.11, 11.12, 13.7, 15.0, 15.3, 16.0 thru 16.9, 18.1, 18.2, 18.6, 18.7)

[3] Changes made to the QA department's role in the corrective l action program. These changes were presented as a reduction in commitment in ULNRC-2630 dated 5/15/92 and I approved by the Division of Reactor Safety on 5/29/92. l (Sections 16.0 thru 16.9, Appendix A, Reg. Guide 1.144) l

[4] Change to limit on sulfur based on correspondence between UE and the Division of Reactor Safety dated 7/28/92 (ULNRC-2665) and 7/30/92 (NRC approval of change).

(Appendix A, Reg. Guide 1.37)

[5] This change deletes the statement that QC is responsible for assuring personnel performing NDE are qualified and employing approved procedures. This change merely results i

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Attachment 3-ULNRC-2809 Page 3 of 4 in the responsibility for this activity being shifted to the organization controlling or coordinating the actual work activity in all cases. As a result, the responsible department or organization must assure-personnel performing any special process are qualified and employing approved procedures. A requirement was also included for QA to perform audits of this specific activity as an added measure of assurance. (Section 9.3)

[6] Added or changed text based on review of Union Electric commitments to various documents. (Sections 1.3, 9.1)

[7] Editorial changes made to remove redundancy, clarify references, clarify terminology, reformat in a more logical sequence or to clarify meaning. (Page lii, Sections 1.6, 2.4, 2.12, 5.7, 7.5, 13.3, 18.8, 18.11, Appendix A, Reg. Guide 1.38, Reg. Guide 1.123).

[8] Changes text to more clearly describe QA review of nonconformance summaries. Because the independent review and reporting are still to be performed by QA, this is not considered to be a reduction in commitment. (Section 15.10)

[9] Clarify endorsement to N45.2.13-1976 to be consistent with

• Reg. Guide 1.58 (Appendix A, Reg. Guide 1.123)

The change clarifies Union Electric's position on this Regulatory Guide to be consistent with Union Electric's commitment to Regulatory Guide 1.58. The change is due to an apparent oversight in previous OQAM revisions.

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[10] Remove the Organization Charts, Figures A, B, and C. All references to Figures A, B, and C will be changed to reference Section 13 of the FSAR and Section 1 of the OQAM (Page 11; Sections 1.1, 1.11; Figures A, B, and C).

This change is being made to reduce the duplication of Organization Charts in the OQAM and the FSAR and the burden on UE to maintain these duplicate charts. It has been recognized by the NRC that many of the details shown on Organization Charts are not essential to the safe operation of facilities. In addition, Section 1 of the OQAM clearly describes the organizational elements which i function under the QA Program, and the lines of )

responsibility of these organizational elements. j l

1

Attachment 3 ULNRC-2809 Page 4 of 4

[11] Clarification made to Union Electric's use of ANSI /ANS 3.1-1978 (Appendix A, Reg. Guide 1.8).

This change clarifies when ANSI /ANS 3.1-1978 requirements will be imposed on personnel performing safety related activities. When personnel are performing activities for positions equivalent to those of the unit staff, ANSI /ANS 3.1-178 will be imposed. For new or specialized activities not normally performed by the unit staff, the responsible organization will establish appropriate training, education, and experience requirements for the specific activity on a case-by-case basis. This is viewed by Union Electric as a clarification and is not a reduction in quality assurance or in previous commitments.