ML20069L704
ML20069L704 | |
Person / Time | |
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Site: | Callaway |
Issue date: | 06/30/1994 |
From: | UNION ELECTRIC CO. |
To: | |
Shared Package | |
ML20069L701 | List: |
References | |
NUDOCS 9406200181 | |
Download: ML20069L704 (176) | |
Text
I ATTACHMENT 1
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OQAM, REVISION 17 UPDATED PAGES
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9406200181 940607 PDR ADOCK 05000403 P PDR
OPERATING QUALITY ASSURANCE MANUAL (OQAM)
Rev. 17 File Code A210.0012
i OPERATING OUALITY ASSURANCE MANUAL (OOAM)
TABLE OF CONTENTS Section Title Page Table of Contents i Policy / Introduction 111 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 l l
6.0 Document Control 6-1 l 7.0 Control of Purchased Material, Equipment, 7-1 and Services 8.0 Identification and Control 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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l Sectio _D Title page Appendix A OQAM Conformance to Applicable NRC A-1 Regulatory Guides Rev. 16 6/93 i
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) 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.
-iii- Rev. 16 6/93
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.
~
al -
Donald-F. Schnell c k f+
Date Senior Vice President-Nuclear b VY
~
66oseph V. Laux ' Date anager, Quality Assurance
-iv- Rev. 17 6/94
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OQAM EFFECTIVE PAGE LISTING Pace No. Eev.
i 12 11 16 111 16 iv 17 v 17 vi 17 vii 17 Pace No_._ Rev.
1-1 17 1-2 17 1-3 17 1-4 17 1-5 17 1-6 17 1-7 17 2-1 17 2-2 17 2-3 15 2-4 17 2-5 16 2-6 15 3-1 17 3-2 17 3-3 17 3-4 17 3-5 17 3-6 17 4-1 17 4-2 17 4-3 17 4-4 16 4-5 16 4-6 17 5-1 17 5-2 17 6-1 16 6-2 14 6-3 14
-V- Rev. 17 6/94 l
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OQAM EFFECTIVE PAGE LISTING Pace No2 Rev.
7-1 17 !
7-2 16 7-3 17 7-4 17 7-5 17 7-6 17 7-7 16 7-8 16 8-1 17 8-2 14 I
9-1 17 9-2 15 10-1 17 10-2 17 10-3 17 11-1 16 11-2 17 11-3 16 1 l
l 12-1 17 )
12-2 17 12-3 15 l
13-1 17 l 13-2 17 14-1 15 14-2 14 15-1 17 I 15-2 17 l 15-3 17 16-1 17 16-2 16 16-3 16 17-1 17 17-2 17 I 17-3 17 18-1 17 18-2 17 18-3 17 18-4 17 18-5 17
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i ogAM EFFECTIVE PAGE LISTING Annendix A Pace No. Rev.
A-1 15 A-2 17 A-3 15 A-4 15 A-5 15 A-6 15 1 A-7 15 l A-8 15 A-9 15 A-10 15 l A-11 15 A-12 15 A-13 16 )
A-14 15 i A-15 17 A-16 15 A-17 15 l A-18 15 A-19 17 ,
A-20 17 l A-21 15 A-22 15 '
l A-23 15 A-24 15 A-25 17 A-26 17 l A-27 16 l A-28 16 A-29 16 A-30 16 A-31 16 A-32 16 l A-33 16 A-34 16 A-35 16 A-36 16
-vii- Rev. 17 6/94
OQAM OPERATING OUALITY ASSURANCE MANUAL (OOAM) i 1.0 ORGANIZATION l 1
1.1 UE has established an organization for Quality '
l 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 i FSAR. The Callaway Plant operating organization is I 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 President 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 President 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. 17 6/94
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,"
Sections 4.2.4 and 4.4.5. The Manager, Quality Assurance is located at Callaway Plant and provides technical direction and administrative guidance to the 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-l2255 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 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. 17 6/94
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 Engineering, System Engineering, and Technical Support Engineering. Within the System Engineering organization, QC Inspectors (ISI/NDE) report to the Supervising Engineer Performance and ISI, and perform inspection and nondestructive examinations.
These inspectors do not perform inspections or examinations which provide quality verification of Nuclear Engineering work activities.
2184 1.8 The Manager, Licensing and Fuels reports directly 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. I 1.9 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is respon-sible for providing administrative and management support including cost forecasting, status report-ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal Health Physicist. He is also responsible for the adminis- !
trative contact with the Institute of Nuclear Power Operations (INPO). As Principal Health Physicist, he provides a corporate level overview and guidance i in the formulation and implementation of applied I radiation protection programs and reviews the !
radiological safety programs for compliance with l Federal and State standards and regulations.
1-3 Rev. 17 6/94 j
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 af quality is achieved in the i Plant operations and support activities.
l 1790 1.11 The Manager, Callaway Plant reports directly to the l l 1799 Vice President, Nuclear Operations and is respon-sible for the safe, Icgal, and efficient operation and maintenance of the Callaway Plant. He has overall responsibility for the execution of admin- !
istrative controls and the quality assurance l l
program to assure safety. He controls Plant func-tions and implements the OQAP through the Assistant ,
Manager, Work Control; the Superintendent, Health l Physics; the Superintendent, Chemistry and I Radwaste; the Superintendent, Operations; the l 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 i Control Group performs work activity inspections, I receipt inspection as described in Section 7, and nondestructive examinations and is not involved in those activities performed by others which are l 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 Superintendent, Materials, the Superintendent, l Training, the Superintendent, Security, and the Superintendent, Administration.
1-4 Rev. 17 6/94 J
l 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- l I
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. I 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- j pendent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP). A communi- l 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 j 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 Manager, Emergency Preparedness and Organiza-tional Support reports directly to the Vice Presi-dent, Nuclear Operations and is responsible for organizational support, personnel development, process re-engineering, personnel, and fitness for duty.
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OQAM 1.19 The Superintendent, Personnel (Local 148) and the Superintendent, Personnel (Local 1439 and 1455) report directly to the Manager, Emergency Prepared-ness and organizational Support and are responsible for assisting in the areas of industrial relations and other matters under the guidance of UE policies.
1.20 The Assistant Superintendent, Personnel reports directly to the Manager, Emergency Preparedness and organizational Support and is responsible for Fitness for Duty, medical, and other matters under the guidance of UE policies.
l4302k1.21 The Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Customer Services. The Manager, Purchasing is responsible for commercial aspects involved in procurement of materials, systems, components, and services (excluding engi-neering services and certain nuclear fuel cycle-re-lated procurements) not delegated to others which are employed in support of Callaway Plant.
2184 1.22 The Manager, Mechanical Engineering reports to the Vice President-Engineering and Construction who in turn reports to the Senior Vice-President, Finance and Corporate Services. The Manager, Mechanical Engineering provides technical support, as neces-sary, to the Nuclear Engineering staff.
2184 1.23 The Manager, Electrical Engineering reports to the Vice President-Engineering and Construction. The Manager, Electrical Engineering provides technical support, as requested, to the Nuclear Engineering staff.
'430b7 1.24 The Manager, System Relay Services reports to the Vice President-Transmission and Distribution who in turn reports to the Senior Vice-President, Customer Services and is responsible for providing qualified engineers, technicians and eq".ipment to maintain Callaway Plant relays.
(43027 1.25 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. 17 6/94 l
OQAM 43027 1.26 The Manager, Transmission, Transmission Planning reports to the Vice-President Corporate Planning and is responsible for directing all activities related to the Planning of transmission facilities.
The Vice-President Corporate Planning also provides engineering and other support services when requested by the Senior Vice-President Nuclear.
1.27 Other UE divisions may provide safety-related l
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.
1.28 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.
1-7 Rev. 17 I 6/94
OQAM l297A 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 President and Chief Executive Officer of UE for establishing and imple-menting the Quality Assurance Program requirements.
1788 2.2 Lines of authority and rasponsibility 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. 17 6/94
OQAM 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, systems, and components identified during the design and construction phase and may be modified as required during operations consistent with their inportance 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 or function of safety-related structures, systems, and components, although not listed in Table 3.2-1 of the Callaway-SP FSAR, are also under the control of the OQAP.
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.
f 1788 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 Policy /
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. 17 6/94
i I
OQAM ;
1823 2. Operatina Ouality Assurance Manual (OOAM)
The OQAM contains a delineation of the Policy statement, quality assurance requirements, l assignment of responsibilities, and a defini- I tion of organizational interfaces. The OQAM is the written description of the OQAP. Approval of the OQAM is by the Senior Vice President- I Nuclear and the Manager, Quality Assurance. l 1947 3. Callaway Plant Operatina MaDMal 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 l with Administrative Procedures contained within l the Manual. This Manual includes administrative controls consistent with those required by Regulatory Guide 1.33.
1800 Administrative procedures which apply to the 1 entire staff, and revisions thereto, shall be )
reviewed by the Callaway Plant Onsite Review !
Committee (ORC) and the Quality Assurance I Department. The final approval of Administra- !
tive Procedures and revisions thereto shall be i by the Manager, Callaway Plant. The review and l approval of other procedures and revisions j 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- l 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 also meet UE's commitment to USNRC Generic Letter 83-28.
2.8 Disputes which may arise between QA or QC personnel and personnel in other UE organizations which I
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6/92 l
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OQAM l cannot be resolved shall be referred to the next I higher level of management for resolution. Disputes j which cannot be resolved through these levels shall '
be resolved ultimately by the Chief Executive 1 l
officer.
2.9 Preservice (PSI) and inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspec- l 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 l
" code" items by an Authorized Nuclear Inspector.
1795 2.10 General indoctrination and training programs shall 1916 be developed for personnel performing safety- l f 2188 related activities to assure that responsible func- I tions, departments, and individuals are knowledge-able regarding quality policy and requirements of applicable manuals and procedures. The requirements l 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 proco-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 OQAP.
1799 2.11 An audit system shall be astablished to assure management is advised of Pro 7 ram effectiveness. The implementation and effectiveness of the OQAP shall I be assessed through an audit. program of quality activities which ir.cludes design, procurement, modification, and operation. The Manager, Quality 2-4 Rev. 17 I 6/94
OQAM 1
Assurance is responsible for a system of planned audits to assure OQAP compliance, with a frequency l commensurate with the Program aspect's safety I significance and in accordance with the require-
, monts of Section 18. He is responsible for conducting audits of offsite and onsite activities.
Deficiencies identified during the audit process
)
I 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 nrovides.for an l 1800 independent assessment of the scope, implementa- '
tion, and effectiveness of Lne 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-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 act3sities affecting quality regarding the design, installation, modification, and operation of the Callaway Plant are performed consistent with policy. Documentation of the q 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 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 compliar.ce mandated by use of the words "shall" or "must." Compliance with l actions initiated by use of either "shall" or "must" is audited and surveilled by the QA Depart-l 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 OQAM under Regulatory Guide 1.74.
A 2-6 Rev. 15 6/92
i OQAM 1864 3.0 DESIGN CONTROL 2183 2974 1850 3.1 The design, modification, addition, and replacement 2070 of safety-related structures, systems, and compo-2072 nents shall be controlled to assure appropriate 2096 design control measures are implemented. Procedures 2168 shall establish requirements; assign responsibil-2185 ities; and provide control of activities regarding 2187 design in a planned, controlled, and orderly l 2188 manner.
2222 2188 3.2 The Plant design is defined by those UE NSSS, A/E and selected supplier design drawings and specifi-cations which illustrate the general arrangement and details of safety-related structures, systems, and components and define the requirements for assuring their continued capability to perform their intended operational or safety design func-tion.
2664 3.3 As the result of operating experience, or as neces-sitated by regulatory requirements, Plant systems and equipment may have to be changed. A design change is a modification in Plant design or opera-tion and is accomplished in accordance with requirements and limitations of applicable codes, standards, specifications, licenses, and predeter-mined safety restrictions. An alteration of Plant equipment, structures or systems, which is not by nature operational, maintenance or replacement by like kind, is considered a design change.
1850 3.4 Maintenance or modifications which may affect func-2100 tioning of safety-related structures, systems, or 2101 components shall be performed in a manner to ensure 2105 quality at least equivalent to that specified in 2111 original design bases and requirements, materials specifications and inspection requirements. 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 l2188 be carried out by Nuclear Engineering, Licensing 2222 and Fuels, or outside organizations.
2071 3.6 Control of design shall be specified in procedures. ;
2074 These procedures shall include instructions for i 2164 defining typical design requirements; communicating l2188 needed design information across internal and ;
1 l
3-1 Rev. 17 6/94 l l
OQAM 2221 external interfaces; preparing, reviewing, approv-2222 ing, releasing, distributing, revising, and l2223 maintaining design documents; performing design 2225 reviews and reviews of design; and controlling 2243 field changes.
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 l 2188 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, 2170 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. 17 6/94
i i
OQAM 2165 3.10 Procedures shall specify requirements for the 2166 review and approval of design changes by the organ-2168 izations or individuals that performed the original 2169 design or Nuclear Engineering. Design control 2243 activities, including design changes, may be dele-gated to others provided they have access to back-ground and technical information. Design control measures for design revisions shall be commensurate with those applied to the original design.
1934 3.11 Design activities shall also include: 1) reviewing the applicability of standards; 2) reviewing commercial or previously approved materials, parts or equipment for suitability of application; 3) re-viewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment and components for inservice inspection, mainte-nance, and repair; 5) specifying criteria for inspection and test / retest; and 6) reviewing and approving procedures for special processes.
2164 3.12 The design process shall establish controls for 2168 releasing design documents which are technically l 2188 adequate and accurate in a controlled manner with a 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled through the use of written procedures by the issuer, distributor, and user to prevent inad-vertent use of superseded documents. Document j control procedures shall govern the collection, I storage, and maintenance of design documents, 1 results of design document reviews, and changes !
thereto. The design documents subject to procedural control include, but are not limited to, specifica- l tions, calculations, computer programs, system descriptions, SAR when used as a design document,
)
and drawings including flow diagrams, piping, and instrument diagrams, control logic diagrams, elec- .
trical single line diagrams, structural systems for l major facilities, site arrangements, and equipment locations.
2164 3.13 The design interfaces between UE organizations i 2188 performing work affecting quality of design and l k 2217 between UE and outside organizations shall be i 2218 identified and controlled by procedures. These l 2219 procedures shall address control of the interface, 2223 responsibilities, lines of communication, and
{2231 documentation of internal and external interface activities.
1934 3.14 The design process shall include design verifica- I 2182 tion. Design verification assures that design is 2209 adequate and meets specified design inputs. Design 3-3 Rev. 17 6/94
OQAM l
1 l control procedures shall specify requirements for l 2234 2188 the selection and accomplishment of a design Veri-2227 fication program. The program depth shall be 2231 commensurate with the importance of the system or component to safety, complexity of the design, and similarity of the design to previously proven designs. Design verification shall be conducted in accordance with procedures which identify the responsibilities of the verifier and the documenta- ,
tion required and which, through adherence to the I procedures, provide for the identification of the areas, features, and pertinent considerations to be verified. Design verification shall be by either design review, alternate calculation, qualification testing, or by a combination of these. Where 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 design and 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 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, l 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. 17 6/94 1
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 I safety-related function.
(2188 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 1 (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 changss 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.
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.
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- 1 mination that the design change does not involve an I 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 !
I 3-5 Rev. 17 6/94 1
OQAM submitted to the ORC. Changes involving the substi-tution of equivalent hardware require safety evaluations to assure that the design requirement changes are consistent with and do not alter the design criteria specified in existing design docu-ments. When design documents and safety evaluations are prepared by an outside organization under its QA program, review and approval per ANSI N45.2.11 will be included. UE will approve all outside organizations' design documents and safety evalua-tions, and will perform appropriate reviews neces-sary for final approval.
3.20 The ORC shall review design change safety evalua-tions to recommend final approval of design changes. Design changes which involve an unreviewed safety question or a change in the Technical Speci-fications shall be forwarded to the NSRB for review. An application for amendment of the license shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90, 1
3.21 The NSRB shall review safety evaluations to verify that changes did not involve unreviewed safety questions. ,
l 1911 3.22 Procedures and instructions related to equipment or '
l2164 systems that are modified shall be reviewed and updated to reflect the modification prior to placing the equipment or systems in operation to perform safety-related functions. Plant personnel i shall be made aware of changes affecting the 1 performance of their duties through procedure revi- i sions, or specific training in the operation of modified equipment or systems, or other appropriate means.
2039 3.23 Records shall be maintained which reflect current 2132 design including safety analyses, safety evalua-l2164 tions, design change installation procedures, 2173 material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings.
3.24 Drawings shall be prepared under a drawing control system which provides for checking methods and review and approval requirements. Drawings shall be se'.;cct to reviews by the responsible design organ-ization for correctness, conformance to design criteria, and compliance with applicable codes and standards.
3-6 Rev. 17 6/94
OQAM 1875 4.0 PROCUREMSFT DOCUMENT CONTROL 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 assure applicable regulatory requirements, design bases, and other requirements necessary to assure quality are included in procurement documents.
3559 4.2 Written procedures shall include controls, as applicable, for preparation, content, review, approval, and processing of the following related procurement documents:
- 1. Purchase Requisitions
- 2. Purchase Orders
- 3. Letters of Intent
- 4. Engineering Service Agreements (agreements for engineering, construction, or consultant serv-ices) (ESAs)
- 5. Contracts
- 6. Specifications
- 7. Drawings l I
3560 Collectively, these procedures shall assure that technical and quality requirements are correctly stated, inspectable, and controllable; there are I adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with QA Program require- j ments.
3572 4.3 Consideration of the verification activities to be 1 3580 employed for item or service acceptance should I 3582 begin during the purchase requisition, ESA, or I 3584 contract preparation and review stage. Planning of 3607 verification activities shall include a review of 3874 the established acceptance criteria and identified documentation. Verification methods which may be I employed include certifications (certificates of conformance and material certificates or test l reports), source verification, receiving inspec-tion, and post-installation tests established by UE. Selected verification methods may be indicated as inspections, examinations, tests, or documenta-tion reviews. The extent of the acceptance methods ancs associated verification activities is a func-tion of the purchased itam's or service's complexity and relative safecy significance, as 4-1 Rev. 17 6/94
OQAM l
l well as the supplier's past performance.
1892 4.4 Acceptance by source verification should be consid- j 3572 cred when the item or service is vital to Plant I l 3582 safety; or the quality characteristics are diffi-i 3584 cult to verify after receipt; or the item or service is complex in design, manufacture, inspec-l tion or test. Verification in this sense involves a physical presence to monitor, by observation, l designated activities for the purpose of evaluating supplier performance and product acceptability, i 1875 4.5 Purchase requisitions must be employed to initiate i the procurement of safety-related materials, parts, l components, and services while ESAs must be used to I i
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 requisitio.?n for safety-related materials, parts, components, ano services and ESAs for professional services may be initiated by personnel in the Quality Assurance Department; Nuclear Engi-neering, Nuclear Services, or Licensing and Fuels Department; or the unit staff. I 1
975 4.6 The procurement of spare or replacement parts for 1876 safety-related structures, systems, and components ,
l shall be subject to the QA Program controls in l cffect at the time the order is issued; and to codes, standards, and technical requirements which are equal to or better than the original require- l ments or as may be required to reduce the proba-bility for repetition of defects. Procurement docu-mont control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifica-tions and codes 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. 17 6/94
1 OQAM j l
l related structure, system, component or service) is governed by the OQAP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering and shall classify the safety relationship of the service or question-able 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.
18 3 1. The scope of work and basic administrative and if J technical requirements including drawings, 2< .6 specifications, regulations, special instruc-
'o30
, tions, and applicable codes and industrial 3551 standards and procedural requirements identi-3552 fled 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, crecting, 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 3550 N45.2-1977 or the ASME code as applicable as 3553 established for the item or service to be 1 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, 3550 and inspection including provisions for UE or 3555 agent access to facilities and records and for 3573 identification of witness and hold points.
l 3582 j 3867 4 3874 )
1890 4. Requirements for extending applicable require-3542 ments of UE procurement documents to lower-tier 3550 suppliers and subcontractors. These require- l 3554 ments shall include right-of-access to subsup- !
3555 plier facilities and records by UE.
4-3 Rev. 17 1 6/94 l
2 OQAM 3550 5. Requirements for suppliers to obtain UE 3558 approval of nonconformances to procurement 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- l ments.
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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 l 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- i ment requirements met by the item and documen- I tation identifying any procurement requirements I which have not been met. j 3559 4.9 The originating organization shall perform a docu-3560 mented independent review of procurement documents 3562 to assure requirements are correctly stated, l 3563 inspectable, and controllable and that there are adequate acceptance and rejection criteria. This review shall be performed by personnel who have i access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents.
3563 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-3569 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
- 8. Exceptions 4-4 Rev. 16 6/93
~ _ _
OQAM 3560 4.10.1 The Purchasing Department shall initiate and coor-dinate bid evaluation activities for those prop-osals received in response to requisitions. The 1 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 l requirements (areas 7 and 8 above) taken by the l Supplier. These reviews shall be documented. !
l 3560 4.10.2 The originating organization shall review bids or '
proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier. They shall also review areas 1 through 3 ,
above for replacement parts or equipment ordered j from the original supplier as part of procurement document preparation.
3560 4.10.3 The Quality Assurance Department and the origin-ating organization review areas 4 through 6 above as part of maintaining a supplier on the Qualified l 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 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 1
4-5 Rev. 16 6/93 ;
i
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. i 3563 4.13 The Purchasing Department is responsible for I reviewing purchase orders to verify that the tech- ;
nical and quality requirements have been accurately 1 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 I 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, i Licensing and Fuels with preparation and negotia- l 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 i procedures related to agreements or contracts for services. !
975 4.14 Additions, modifications, exceptions, and other 3543 changes to procurement document quality and tech-l3548 nical requirements shall require a review equiv-3563 alent to that of the original document and approval 3575 by the originator or the originating department 42587 approval authority. Commercial consideration changes shall not require review and concurrence by 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. 17 6/94
OQAM 2974 5.0 INSTRUCTION
S. PROCEDURE
S AND DRAWINGS 1830 5.1 The activities affecting quality associated with 1858 the operating phase shall be accomplished and 1867 controlled by:
1916 1948 2073 2074 2091
- 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 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 5-1 Rev. 17 6/94
1 OQAM months (in accordance with Technical Specifica-tions). A revision of a procedure may constitute a procedure review.
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 l Quality Assurance Department as described in Section 2.6, item 3. I 5.6 Maintenance and modification procedures shall be reviewed in accordance with Section 6.2.
I 5.7 Special process procedures supplied by outside l 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).
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5-2 Rev. 17 6/94 l
I
00AM 6.O DOCUMENT CONTROL 1916 6.1 Documents and their revisions which control all 1908 activities affecting safety-related structures, systems, and components shall be prepared, reviewed by knowledgeable individuals, and approved by authorized personnel prior to release or issuance in accordance with written approved procedures.
1908 6.2 Divisions, departments, and organizations 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-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
'dentified.
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 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.
6-1 Rev. 16 6/93
OQAM 6.4 Documents relating to the UE OQAP shall be controlled to an extent which considers the docu-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.
6.6 Types of documents which shall be controlled ;
include the FSAR, specifications, Operating Quality Assurance Manual, procurement documents, proce-dures, design documents (e.g., calculations, draw-ings, analyses) including documents related to computer codes, nonconformance reports, as-built l drawings, the Callaway Plant Operating Manual, and !
topical reports.
6.7 The issuance of controlled documents at the General Office and Callaway Plant is coordinated by the l Nuclear Services and the Administration organiza- I tions. The Administration organization shall be !
responsible for assuring the issuance of controlled ;
documents at the Plant Site and to the Nuclear !
Services Department at the General Office. Nuclear l Services shall be responsible for assuring the I issuance of controlled documents at the General Office, and for transmittal of documents to the Administration organization for entry into the ;
document control system.
6.8 Document control methods shall be defined consistent with the importance of the document to I 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 l documents, incorporation of revisions, and destroying or voiding of superseded documents shall be required by the distributor. In addition the distributing organization for documents controlled by a system of control numbers shall periodically 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 J
2164 procedures, and drawings governed by the OQAP.
These procedural controls shall provide for the prompt transmittal of document revisions to work locations and the removal, destructicn, or voiding ,
of obsolete / superseded documents. The unit staff and other UE organizations shall assure that current documents are distributed to and used at the location where the prescribed activity is performed. It is recognized that, in certain instances, activities are controlled via the communication of documented procedural instructions from a remote location, (i.e., separated from the location where the prescribed activity is being performed). Identified, controlled copies of docu-ments shall be used to perform an activity. Uncon-trolled copies shall be identified.
f i
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6-3 Rev. 14 6/91 l
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OQAM ,
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1875 7.0 C O N T R O L O F _ P_U l g E A S E D M_ M I L I A L , EQUIPMENT AND 3541 SIRYJ_CKS 7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4. l 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 3565 3. Procurement source selections
- 4. Verification activities (surveillance, inspec-tion, and audit) required by the purchaser 3597 5. Control of nonconformances as described 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 l3596 be made for supplier evaluations which assess their 3874 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 pro-award sottree evaluation or post-award audits which attest to their capability as a procurement source.
7-1 Rev. 17 6/94
OQAM 2337 7.3 During Callaway's operating life, procurements may 2977 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 and whose acceptability can be determined by receiving inspection, an examination of quality verification documentation, or other suitable means; 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAP.
Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a purchase order or execution of a contract or ESA, a verification of the supplier /outside organization's acceptability shall be documented. Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition), an evaluation of a Supplier's acceptability as a procurement source shall be accomplished prior to award. In the case of purchase orders, the supplier shall be verified as an acceptable procurement source for the item or service being procured. Purchase orders may be issued prior to an assessment of suppliers' capa-bility provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source.
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 Supp-liers are otherwise qualified as stipulated in Sections 4 and 7 of the OQAM. These provision are consistent with ASME Code Interpretation XI 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 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.
7-2 Rev. 16 6/93 1
OQAM 3565 7.6 Procurement source selection and evaluations shall 3566 consider one or more of the following:
l3604 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 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 codes, and standards (not specific to the nuclear industry), or other industry data- i bases (UL, INPO NPRDS, EPRI EQDB, ANSI, NEMA, MIL-STDS, NRC Bulletins / Notices, and 7-3 Rev. 17 6/94 j l
OQAM Licensee Event Reports, etc.) that is directly related to the item's critical characteristics and intended application.
7.7 Procurement source evaluations involve a review of technical and quality assurance considerations.
Technical considerations include the design or manufacturing capability and technical ability of suppliers to produce or provide the design, service, item, or component. Quality assurance considerations include one of the previously defined methods of supplier evaluation and a consideration of changes in a supplier's Quality Assurance Program or capabilities. The measures employed to evaluate a supplier's continued accept-ability as a procurement source (after the initial source evaluation) are described in Section 18.
1892 7.8 Organizations participating in the procurement l3571 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 procurement requirements; 2) identifying and processing change information; 3) establishing a method of control and documentation of information exchange with the supplier; and 4) audit or surveillance of supplier activities. ,
i 3572 7.9 Depending on the complexity or scope of the item or 3573 service, the Purchasing Department and/or the l 3580 originating organization shall initiate award activities. Meetings or other forms of communica- 1 tion may be held to establish the intent of UE in i monitoring and evaluating the supplier's perfor- l mance, establish an understanding of procurement I requirements, and identify supplier activities to l 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 and witness points shall be docu-mented as early as practicable in the procurement process.
l 3571 7.10 The originating organization shall establish meas-3574 ures for monitoring supplier-generated document ;
submittals against procurement document require- i ments. Similarly, measures shall be established for reviewing and approving supplier generated docu-ments for use. Changes to procurement documents shall be in accordance with the controls described l
J 7-4 Rev. 17 6/94 l
oQAM in Section 4.
3565 7.11 Supplier monitoring activities may be performed by
}3584 personnel from Quality Assurance, Nuclear Engineer-ing, Nuclear Services, Nuclear Safety and Emergency Preparedness, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests.
Supplier monitoring activities may include:
- 1. Audits of supplier quality assurance program implementation
- 2. Monitoring, witnessing, or observing inspec-tions, examinations, and performance tests
- 3. Surveillance of manufacturing processes
- 4. Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-mances 2337 7.12 To support the control of purchased material, copies of purchase orders and other appropriate procurement documents shall be forwarded to the applicable receiving or acceptance point. Depart-ments receiving or utilizing procured items or services shall establish measures to maintain and control procurement documents until the items or services are received and accepted. These documents shall include purchase orders, drawings and speci-fications, approved changes, and other related documents.
975 7.13 Receiving inspection instructions shall be 2337 documented. These instructions include specifying 2416 inspections or tests of commercial grade items procured from suppliers on the basis of product performance. Should it become necessary to upgrade stocked non-safety related items to specific requirements, inspections, tests, or documentation reviews may be employed to establish the items' acceptability. Documentation shall be generated as a result of UE receiving inspection activities.
975 7.14 Acceptance of items and services shall include one 1891 or more of the following:
1892 3608
- 1. Written certifications
- 2. Source verification
- 3. Receiving inspection
- 4. Post-installation test (in addition to one of the above) 7-5 Rev. 17 6/94
1 OQAM 1876 7.15 Commercial grade items shall rely on proven design 1892 and utilize verification methods by the purchaser, 3565 to the extent appropriate to item application.
Procedures provide for the acceptance of commercial grade items on one or more of the following:
f 1. Special Tests and Inspections I 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 j design, process, and material changes have been adequately implemented as verified by audit (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 1 3605 during receiving inspection or prior to use of such I 3607 items. Where not precluded by other requirements, l 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.
l 1876 7.17 Acceptance by receiving inspection shall be i 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 l require operations which could adversely affect the integrity, function, or cleanliness of the item.
7-6 Rev. 17 6/94 L _ _ - - _ _ - _ - _ _ - _ _ _ _ _ _ _ _
l l
OQAM When other methods are utilized, receiving inspec-tion shall be employed to verify that items have not sustained damage.
2483 7.18 Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 - 1978, (as clarified in OQAM Appendix A Regulatory Guide 1.58) 1 under the direction of the Quality Control organi- l zation. Other unit staff personnel qualified to ANS l 3.1 -
1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, exten-sive modifications, or other special circumstances, l receiving inspection may be assigned to an outside ,
organization (s). )
2337 7.19 Final acceptance of items shall be by Quality Control personnel or designated inspection person-nel. The final acceptance of cervices shall be the responsibility of the originating organization.
Acceptance shall be documented.
975 7.20 Receiving inspection activities shall include:
2337
- 1. Verifying that materials, parts, and compo- l nents, have been identified by tagging or other means; or that they are segregated and controlled in areas separate from the storage facilities for accepted items.
- 2. Verifying that items for acceptance have been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documenta-tion.
- 3. Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures and calibrated tools, gages and measuring equipment to verify the acceptability of items, including those from commercial grade suppli-ers.
2326 4. Providing final acceptance after determining 2329 that required verifications are complete and 2328 acceptable. Items determined to be acceptable for use shall be tagged with an accept tag or other means of identification or segregation, and released for storage er use. Conditional acceptance of items by receiving inspection shall be procedurally controlled.
7-7 Rev. 16 6/93
OQAM 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 be util-ized following one of the preceding acceptance methods. Post-installation testing shall be used as the prime means of acceptance verification when it is difficult to verify item quality characteris-tics; the item requires an integrated system checkout or test; or the item cannot demonstrate its ability to perform when not in use. Post-installation test requirements and acceptance docu-mentation shall be established by UE.
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, 1876 and components shall be accomplished in accordance with documented procedures and apply to safety-related materials, parts, and components during fabrication, storage, installation or use.
Materials, parts, and components identified as nonconforming shall be controlled as described in Section 15.
1897 8.2 The identification and control requirements shall l 2089 address traceability to associated documents, as 2090 appropriate; specification of the degree of identi-l 2093 fication and control necessary; location and method 2333 of identification to preclude a degradation of the 2337 item's functional capability or quality; and proper identification of materials, parts, and components prior to release for manufacturing, shipping, construction, or installation. Materials, parts, and components manufactured or modified by UE shall be controlled and identified during manufacture.
l 1876 8.3 Documented procedures shall assure that specifica-2088 tions and other procurement documents include or reference appropriate requirements for the identi-fication and control of materials, parts, and components including partially fabricated assem-blies. Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items from storage while maintaining item identity; controlling the return to storage of issued materials, parts, or components received, stored, installed, modified, or used at the Plant site. These procedures shall assure that correct identifications are verified and documented prior to release.
1895 8.4 Physical identification shall be employed to the 1896 maximum possible extent for relating an item at any 2318 point in time to applicable design or other perti-2331 nent specifying documents including drawings, 2333 specifications, purchase orders, manufacturing and 2337 inspection documents, nonconformance reports, and 2346 physical and chemical mill test reports. Physical identification or marking shall not affect the form, fit, or function of the item being iden-tified. Where physical identification is not employed, physical separation, procedural control, tags, or other means shall be utilized. Identifica-tion shall be maintained on items, or records traceable to items through fabrication, erection, 8-1 Rev. 17 6/94
1 OQAM and installation. When unique traceability is impractical, bulk traceability may be employed consistent with the relative importance of the item to safety. When tags are used, the stock shall be made from material which will not deteriorate during storage. Tags shall be securely affixed to 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.
1 8-2 Rev. 14 6/91 l l
OQAM l
l 9.0 CONTROL OF SPECIAL PROCESSES 1851 9.1 Special processes are fabrications, tests, and 1937 final preparation processes which require in-l 2098 process controls in addition to final inspections to assure quality. Special processes also require the qualification of procedures, techniques, and personnel in accordance with the requirements of applicable codes, standards, specifications, or other special requirements to which UE is 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 personnel, procedures, or equipment shall be defined by Nuclear Engineering.
2260 9.2 Procedures for special processes shall be qualified as part of their approval process, and shall also provide for recording evidence of acceptable accomplishment of the special processes. Personnel qualifications shall be certified and equipment shall be qualified prior to use.
9.3 The responsible Plant Department Head shall assure ;
that personnel performing special processes are qualified and are employing approved procedures. QA ;
audits shall be performed to assure special ,
processes are performed by qualified and certified ;
personnel. Nondestructive examination (NDE) personnel shall be qualified in accordance with 2 procedures established to meet the requirements of l 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. i 9-1 Rev. 17 6/94
OQAM 9.6 Qualified outside organizations may be employed to perform special processes onsite and shall be required to conform to the requirements described herein. Special process procedures submitted by these organization (s) in accordance with the procurement document requirements shall receive a technical review by the responsible engineering organization and a quality review by the Quality Assurance Department.
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 1927 verify conformance with applicable documented 2094 instructions, procedures, drawings, and specifica-2095 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 be established to indicate the minimum frequency for inspecting maintenance, modification, and special ;
processes activities to provide a basis for subse- l quent monitoring planning. l 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.
10.5 Nuclear Engineering shall be responsible for ,
assuring the development of the inservice testing l program plan for pumps and valves, the test proce- I dures required by this plan, and the securing of l consulting services in this area. In addition Nuclear Engineering shall be responsible for admin-istering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division. They are also responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations. ,
10-1 Rev. 17 6/94
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 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 l2079 staff organizations who perform " inspection" 2263 activities shall be qualified within their respec-2479 tive areas of responsibility. The qualification of 2480 QC inspection personnel shall be defined in three 2481 levels of capability as described in ANSI N45.2.6.
2482 Other members of the unit staff performing "inspec-2483 tion" activities shall have appropriate experience, 2484 training, and retraining to assure competence in 2485 accordance with ANSI /ANS-3.1. Inspection assign-2994 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.
2079 10.8 Personnel from outside organizations performing QC 2097 inspection activities associated with safety-2263 related items at the Callaway Plant shall be certi- 1 2480 fled as required by ANSI N45.2.6. Personnel from !
2482 outside organizations or UE personnel who are not 2483 members of the unit staff who perform other activ-2484 ities associated with safety-related items at the i 2485 Callaway Plant shall either be certified as 1 required by ANSI N45.2.6 or they shall meet the 2994 education and experience requirements applicable to the equivalent position on the unit staff for the !
activities which they are performing. 1 2482 10.9 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 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 contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing the examination would be qual-10-2 Rev. 17 6/94 I
1 i
OQAM l ified as required by the vendor's quality assurance 1 program unless otherwise specified in the appli-cable procurement documents. l 1930 10.10 Procedures which specify inspection activities 1931 shall provide for the following, as required:
1935 1) the inclusion of independent inspection or moni-2073 toring of processes when required; 2) the identifi-2075 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, cod.es, standards, or :
regulatory requirements.
1928 10.11 The inspection function shall be conducted in 1929 accordance with written approved procedures which 1973 specify inspection scope; personnel qualification 2039 requirements; and data collection requirements.
2979 Inspection or testing, as appropriate, shall be employed as a means of verifying suitable perfor-mance subsequent to a component replacement or repair.
1936 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.
10.13 Indirect control by monitoring processing methods,
{1932 equipment, and personnel shall be utilized as a control if inspection of processed items is impos-sible or disadvantageous. Both inspection and moni-toring of processes shall be provided when control is inadequate without both.
1934 10.14 Inspection data shall be analyzed and evaluated to 1973 verify completeness of results, achievement of 2125 inspection objectives, and operational proficiency 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 replacement of items performed subsequent to final inspection shall require reinspection or retest to verify acceptability.
10-3 Rev. 17 6/94
- . - . = _ . - .- -_ - - .- - . .
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. l 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 l purchased material. A test is performance of those l steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications.
1853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-sary quality of systems and components is main-tained, that facility operations are within the ,
safety limits, and that limiting conditions for l operation can be met. The testing frequency shall ,
be as prescribed in the Callaway Plant Technical l Specifications. The provisions for surveillance i testing shall include the preparation of a surveil- 1 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 l expected results. Tests provide a level of confi-dence in structure, system or component operation or functional acceptability.
3577 11.4 When required by procurement documents, testing shall be employed as a means of purchased material and equipment acceptance. Acceptance testing of this nature shall be performed during receiving inspection or subsequent to installation in accor-dance with Section 7.
11.5 Equipment failure or malfunction analysis testing may also be performed. The causes of malfunctions shall be investigated, evaluated, and recorded.
Experience with malfunctioning 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 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 Specificationc, drawings, instructions, procurement documents, specifications, codes, standards, and regulatory requirements.
1930 11.7 Administrative procedures, test procedures, or 1938 checklists shall include: provisions for assuring l2075 all prerequisite conditions are met; test equipment 2132 calibration requirements; testing method instruc-tions including hold or witness points; limiting conditions and acceptance / rejection criteria; and data collection and test result approval require-ments.
1848 11.8 Test data shall be analyzed and evaluated by quali-1934 fled individuals or groups to verify completeness 1973 of results, achievement of test objectives, and l2075 operational proficiency of equipment and systems; 2125 to identify additional test requirements; and to 42479 identify necessary changes to the installation test procedures. Equipment found to be deficient shall be identified in accordance with section 14.
Surveillance test procedure results which fail to meet the requirements and acceptance criteria of .
Callaway Plant Technical Specifications shall be I documented and reviewed in accordance with Section
- 15. Deficiencies identified as nonconforming shall be processed in accordance with Section 15.
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.
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 qualified to the program provided they are super-vised or overseen by qualified individuals for the ,
activities being performed. The Superintendent, j 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 j 11-2 Rev. 17 6/94
OQAM 2483 persor.nel 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 persont.el who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written esaminations 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 2482 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 i line safety valves at the Callaway Plant, then the I persons performing the testing / valve settings would l be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents.
1 i
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OQAM 12.0 QONTROL OF MEASURING AND TEST EOUIPMENT 1919 12.1 Measuring and test equipment utilized in activities 1920 affecting quality shall be controlled in accordance 1969 with written procedures or instructions. The 2042 procedures for calibration and control shall 2081 address the identification of test equipment, cali-2083 bration techniques, calibration frequencies, main-2264 tenance control, and storage requirements. The equipment subject to these controls includes: (1)
M&TE (portable measuring instruments, test equip-ment, tools, gages, and non-destructive test equip-ment used in measuring and inspecting safety-related structures, systems, and components); (2) reference standards (primary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).
1920 12.2 Tools, instruments, testing equipment 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-2060 tained at specified intervals or prior to use to assure the necessary accuracy of calibrated l2080 devices. M&TE and reference standards shall be tagged or labeled indicating the date of calibra-tion and the due date for recalibration.
12.3 Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program.
12.4 The calibration and control program established at the Callaway Plant shall assure that M&TE, refer-ence standards, and PI maintain their required accuracy. The Managar, Callaway Plant is respon-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 l 2084 by various organizations as required to perform tests or other special operations. Each organiza-tion shall be responsible for assuring that the M&TE or reference standards it uses have been cali-brated. Outside organizations using M&TE or refer-ence standards at the Callaway Plant in activities affecting quality shall be required to implement calibration and control measures consistent with the applicable requirements of this section.
Vendors activities performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 9 of OQAM Section 12.6 unless specified in procure-12-1 Rev. 17 6/94
. _ - - - - - - ~ - - - - - - = . . . .- - -. .
OQAM ment documents. Vendor-provided calibration services for Callaway Plant M&TE or PI are required to be consistent with the requirements of item 8 and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using M&TE or reference standards at the Callaway Plant in activ-ities affecting quality shall be required to imple- ,
ment a calibration and control program consistent with the requirements described herein, or control their activities relating to M&TE or reference standards via the Callaway Plant calibration and control program.
2082 12.6 The calibration and control program shall provide for:
1923 1. The assignment of specific calibration inter-vals, calibration procedures which specify calibration methods, and instrument accuracy requirements. Interval selection shall be a function of the equipment type, inherent stability and reliability, intended use, required accuracy, and other conditions which may affect calibration. Records shall be main-tained to permit a determination of calibration intervals. A calibration shall be performed when the accuracy is suspect.
- 2. The unique identification of items.
- 3. The traceability to calibration test data.
standards and the periodic revalidation of l reference standards. ]
l
- 5. The maintenance of records which indicate the l status of each item, maintenance history, cali- i bration results, anomalies, and most recent and !
next scheduled calibration dates. A recall l system shall be established to assure that ;
calibration intervals are not exceeded.
- 6. The maintenance and control of items not in use.
- 7. Provisions to control the purchase requirements j and acceptance tests.for items sent out for calibration and for new or replacement items
- including the requirements -for accuracy, stability, and repeatability.
- 8. M&TE shall be calibrated from reference stan-
- dards with an accuracy ratio of at least four-12-2 Rev. 17 6/94 i
OQAM to-one (Reference standard to M&TE). Calibra-tion accuracy ratios of less than 4.0 but equal to or better than 1.0 (Reference standard to M&TE) shall be acceptable when equipment to meet specified requirements is not commercially available. The basis of acceptance in these cases shall be documented.
- 9. M&TE used for calibrating Plant PI shall have calibration ranges, precisions, and accuracies such that the PI can be calibrated and main-tained to achieve its specified accuracy. PI shall be calibrated from M&TE with an accuracy ratio of at least two-to-one (M&TE to PI).
Calibration accuracy ratios of less than 2.0 but equal to or better than 1.0 shall be acceptable when equipment to meet specified requirements is not commercially available. The basis of acceptance in these cases shall be documented.
12.7 Calibration shall be performed against certified equipment or reference standards having known rela-tionships to nationally recognized standards. Where no national standard exists, provisions shall be established to document the basis for calibration.
Calibration and control measures shall not apply to rulers, tape measures, levels, and other devices when normal commercial practice affords adequate accuracy.
2044 12.8 M&TE and reference standards found to be out of calibration shall require an investigation to eval-uate the validity of previous measuring, test, inspection, and calibration results and the acceptability of impacted items. Investigations shall evaluate the necessity of repeating original measurements, inspections, tests, or calibrations to establish the acceptability of such items. When the calibration history of an item shows it to be consistently out of calibration, the item shall be repaired, replaced, or the calibration interval modified.
12-3 Rev. 15 6/92
.- __ _-. .- __ . . ~. .
OQAM 13.0 HANDLING, BTORAGE, AND SHIPPING 975 13.1 Safety-related items including safety-related parts of structures, systems, and components and related l 2093 2293 consumables shall be handled, stored, shipped, 2417 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 g 2349 prepared for application to these activities; 2416 however, detailed procedures or instructions shall 41668 be prepared for the handling, cleaning, storing, maintaining while stored, or shipping of certain items and types of equipment or material.
2354 13.3 Applicable manufacturer instructions and recommen-dations, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review. Deviations which relax manufacturer's recommendations shall involve an engineering evaluation. This may be appropriate when unreal-istic requirements are recommended and such recom-mendations are not reasonably necessary to preclude equipment degradation.
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 i which specify acceptance criteria. Routine inspec- 1 tions shall determine the acceptability of equip- !
ment and rigging. Routine inspections shall be l supplemented by nondestructive examinations and proof tests as delineated in procedures for items requiring special handling. Personnel performing nondestructive examination and proof testing shall 13-1 Rev. 17 6/94 l
I l
OQAM be qualified.
2325 13.6 Procedures shall be prepared for items that require
! special handling and shall be available prior to 2356 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 2304 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. 17 6/94
i OQAM 14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 Safety-related items that are received, stored or installed at the Callaway Plant shall be identified and controlled in accordance with documented procedures.
1847 14.2 Items received at or installed in the Plant shall 2116 be identified in accordance with procedures as to 2331 their status regarding required inspections and tests before the items are stored, issued or oper-ated. Prior to storage or installation, items shall be identified by means of stamps, tags, labels, routing cards, segregation, or other means trace-able to manufacturers' and receiving inspection documentation. In the event traceability is not available, the item (s) shall be considered noncon-forming and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications.
1841 14.3 Plant procedures shall provide instructions 1842 relating to the manner of indicating the opera-1844 tional status of safety-related structures, 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-thorized operation of equipment. Equipment and systems in a controlled status to prevent unau-thorized operation, shall be identified.
972 14.4 Plant procedures shall establish controls to 1844 identify the status of inspection and test activ-1846 ities associated with maintenance, repair, modifi-1847 cation, refueling, inservice inspection, and 1851 instrumentation and control system calibration and testing. The Technical Specifications establish the status required for safe Plant operation, including provisions for periodic and non-periodic tests and inspections of various structures, systems, and components. Periodic tests may be operational tests or tests following maintenance while non-periodic tests may be made following repairs or modifica-tions.
1848 14.5 Required safety-related inspections, tests, and :
operations and their sequencing are performed in l accordance with Plant operating procedures which i are reviewed and approved in accordance with the requirements of the Technical Specifications. In I
14-1 Rev. 15 6/92 l
_________-________a
OQAM cases where required documentary evidence is not available with respect to whether an item has satisfactorily passed required inspections and tests, the associated equipment or materials must be considered nonconforming in accordance with Section 15. Except in the case of temporary changes (non-intent changes) which are allowed by the Tech-nical Specifications and which are administratively controlled, any deviations from procedural require-ments shall be subject to the original or equiv-alent review and approval controls.
14-2 Rev. 14 6/91
OQAM 15.0 NONCONFORMING MATERIAL, PARTS, OF COMPONENTS 1848 15.1 Material nonconformances include material deficien-1870 cies (including inoperative and malfunctioning 1907 structures, systems, and components) . Material 2045 nonconformances identified under the UE OQAP shall 2112 be controlled to prevent the inadvertent use of material, parts, or components which are defective or of indeterminate quality and to identify docu-mentation inadequacies. Measures shall be estab-lished regarding identification, documentation, status control, disposition, and notification of affected organizations.
1848 15.2 Under the UE OQAP, Nonconforming Material Reports l1876 (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 nature or to control documentation deficiencies both of (2334 3600 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.
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 l 3599 outside organizations as nonconforming. Procurement 3600 documents shall specify those nonconformances to be submitted to UE for approval of the recommended disposition. As specified in procurement documents, actions taken in response to these nonconformances shall be 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- l izations shall approve or be requested to provide a I technical evaluation regarding supplier-recommended I dispositions of nonconformances regarding procure- I ments they initiate. I 15-1 Rev. 17 6/94
OQAM 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 other requirement; shall record the disposition; and shall register the signature of an approval authority. Procedures shall prescribe the individ-uals or groups assigned the responsibility and authority to approve and verify the implementation of the disposition of material nonconformance.
1907 15.5 Material nonconformance disposition categories 2334 shall include:
- 1. "Use-as-is" or " acceptable" (including condi-tional releases)
- 2. " Reject" or "not acceptable, scrap, or return to vendor"
- 3. " Rework" in accordance with approved procedures
- 4. " Repair" in accordance with approved procedures Material nonconformances shall be reviewed and accepted, rejected, repaired, reworked, or condi-tionally released in accordance with documented procedures. An approved disposition of a nonconfor-mance which allows a reduction in the requirements of a safety-related structure, system, or compo-nent, shall be treated as a design change subject to the controls prescribed in Section 3.
1848 15.6 Nuclear Engineering shall be responsible for 1905 approving material nonconformance dispositions of 1907 "use-as-is" and " repair". Licensing and Fuels 2335 shall be responsible for approving material noncon- l formance dispositions of "use-as-is" and " repair" l I
on nuclear fuel which are generated prior to the arrival of such fuel at the Callaway Plant. I&C shall be responsible for approving material noncon-formance dispositions of "use-as-is" and " repair" for items under their control. Regarding material nonconformances identified on-site, QC personnel shall be responsible for verification that approved i dispositions have been implemented and for the '
final sign-off.
15.7 Nonconformance documents which record defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Signifi-cant nonconforming conditions involving a defect or material noncompliance in a delivered component or service which could create a substantial safety hazard shall be reported to the Nuclear Regulatory Commission pursuant to the requirements of 10CFR21.
15-2 Rev. 17 6/94
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 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 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 by the Manager, Nuclear Engineering.
The Quality Assurance Department shall perform an independent review of these analyses and report the results to management through routine audits and surveillances.
15-3 Rev. 17 6/94 i
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 3599 proceduralized. These procedures, as a minimum, 3600 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 l 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. 17 6/94
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 l implementation or reduce the effectiveness of the l 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 or which involve recommending design changes as corrective action. Licensing and Fuels should review conditions adverse to quality for fuel-related issues. The ORC shall review 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.
16-3 Rev. 16 6/93
i OQAM 17.0 QUALITY ASSURANCE RECORDS r
1851 17.1 Quality assurance record systems governing the 2126 collection, storage, and maintenance of records 2127 shall be established by UE. They shall apply to 2130 records associated with startup testing, operation, 2173 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.
i 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 l 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 l recorder I'
- 4. Evaluation of the acceptability of the results
- 5. Action taken in connection with any deficien-cies noted 17-1 Rev. 17 6/94
l 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 I
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 I a timely manner in accordance with documented procedures.
2129 17.6 Record systems shall be established by the Adminis-l 2130 tration organization for the Nuclear Division and 2136 shall be controlled in accordance with written l 2145 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.
g 2145 17.8 The requirements regarding receipt of records shall 2148 define the requirements for the receipt of documen-tation generated by others during the operation of the Callaway plant. These requirements shall assure that records are submitted and that designated authorities are responsible for organizing and' implementing a system of records receipt control. '
- 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.
17-2 Rev.-17 6/94
OQAM l
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
! 2153 requirements for the maintenance, preservation, and 2155 protection of quality assurance records. These requirements shall include methods for maintaining control of, access to, and accountability for records; storing records in a manner to preclude deterioration; and providing record storage 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.
17.10 Record storage systems shall provide for an accu- l l 2157 rate retrieval of information without undue delay.
Those records maintained by an outside organization shall be required to be accessible to the buyer or UE; in the case of lifetime records for the life of the items involved, or for designated retention times for nonpermanent records.
2160 17.11 Record disposition practices shall establish l 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.
Noncermanent records shall be retained for the spe'cified retention period; after the specified retention period they are no longer required to be maintained as records.
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17-3 Rev. 17 6/94 g
OQAM l
1875 18.0 AUDITS 2180 3869 41639 g 2186 18.1 A comprehensive audit program shall be established 2188 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 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 persunnel 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 13866 Team Leader (ATL) who is a certified Lead Auditor.
3877 A Lead Auditor is an individual certified as qual-3892 ified to direct an audit, perform an audit, report 18-1 Rev. 17 l 6/94 l l
l
~
OQAM 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 i audits as an auditor, a qualification examination, i 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 l 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. 17 6/94
1 1
OQAM l 3865 18.5 The Manager, Quality Assurance shall be responsible l for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Quality Assurance has suffi-cient authority and organizational freedom to schedule and perform both internal and external audits. He has the organizational responsibility to measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality.
The Manager, Quality Assurance has direct access to the Senior Vice President-Nuclear.
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.
Judit results shall be periodically reviewed by the OA Department for quality trends and results reperted to the appropriate management. The Hanager, 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 2188 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 ;
such as design control and document the OQAP, control, and each area of Plant operations shall be ;
audited. )
l 2666 18.8 Supplementary to the biennial requirement to audit 2681 safety-related functions, other <ctivities shall be 2847 audited under the cognizance cf the NSRB at the i 3873 frequencies indicated in Section 6.5.2.9 of the l 41777 Technical Specifications and the Radiological Emer- )
gency Response Plan. In addition to audits conducted under the cognizance of the NSRB, the 18-3 Rev. 17 6/94
I l
OQAM !
l 1
following areas shall be audited per the frequency specified in applicable regulations:
o Special Nuclear Material Accountability program o Radiological Protection program o Security program o Fitness-For-Duty program 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 3584 Department as a method for the evaluation of 3596 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 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 3565 programs shall be audited (post-award) on a l3596 triennial basis. Audits generally should be 3878 initiated when sufficient work is in progress to 3872 determine whether the organization is complying with the established quality assurance provisions.
Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same supplier shall be considered in estab-lishing audit requirements. In addition, the need for a triennial audit may be precluded upon evalua-tion and documentation by the QA Department that the results of mini-audits performed during source verification and source surveillance activities confirm the adequacy and implementation of the supplier's QA Program.
18-4 Rev. 17 6/94
. _ - . . . ... ~- . _ . - - . , _
OQAM l 3565 18.12 Supplementary to audits, annual evaluations of 3566 suppliers shall be performed which take into
{3596 account, as applicable: 1) the review of supplier furnished documents such as certificates of confor-mance, nonconformance notices, and corrective actions; 2) results of previous source verifica-tions, audits, and receiving inspections; 3) oper-ating experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources. ;
3565 18.13 Audits shall also be conducted when: 1) significant 3872 changes are made in functional areas of the Quality l3874 Assurance Program such as significant reorganiza- i 3883 tion or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assur- i ance Program; or 3) when a systematic, independent assessment of Program effectiveness is considered 1 necessary; or 4) when it is necessary to verify l implementation of required corrective action.
3876 18.14 Audits shall be conducted using written plans in i 3878 accordance with QA Department procedures. The 1 3881 procedures require evaluation of work areas, activ-ities, processes, goods, services, and the review of documents and records for quality-related prac- !
tices, procedures, and instructions to determine the effectiveness of the implementation of the OQAP I and compliance with 10 CFR 50, Appendix B and the ,
Callaway Plant Technical Specifications. The audit l plan shall identify the audit scope, the require-ments, the activities to be audited, organizations to be notified, the applicable documents, the schedule, and the written procedures or checklists as appropriate. The audit plan and any necessary I reference documents shall be available to the audit I' team members.
3877 18.15 An audit team consists of one or more auditors. A Lead Auditor shall be appointed Audit Team Leader.
The Audit Team Leader shall be responsible for the written plans, checklists, team orientation, audit notification, pre-audit conference, audit perfor-mance, post-audit conference, reporting, records, and follow-up activity to assure corrective action.
Any adverse findings shall be reported in a post-audit conference with team members and the audited organization subject to the clarification of Section 4.3.3 of ANSI N45.2.12 in Appendix A. When a post-audit conference is held it shall be, to discuss items and arrive at a general agreement on the identification of the findings. Formal audit reports shall be prepared and submitted to the audited organization within thirty days after the post-audit conference or last day of the audit, whichever is later.
18-5 Rev. 17 6/94
l OPERATING OUALITY ASSURANCE MANUAL (OOA)Q I APPENDIX A i OOAM CONFORMANCE TO APPLICABLE NRC REGULATORY GUIDES This Appendix briefly discusses the extent to which Union Elec- i tric's Operating Quality Assurance Program (OQAP) conforms to NRC !
published Regulatory Guides for the Callaway Plant. All state- ;
ments within the Regulatory Position Section (C) of the Regula-tory Guides are considered requirements unless a specific excep-tion or clarification has been proposed by Union Electric and accepted by the NRC. This is true regardless of the qualifier ,
(i.e., "shall" or "should") which prefaces the statement. Unless l further qualified by a statement within the corresponding Regula- 1 tory Guide, ANSI /ANS Standards "shall" statements denote require-ments while "should" statements denote recommendations. Clarifi-cations, alternatives, and exceptions to these Regulatory Guides l are identified herein. Union Electric's position on other Regula-tory Guides is give.. in Appendix 3A of the Callaway-SA and calla- l way-SP Final Safety Analysis Reports (FSARs).
In each of the ANSI standards referenced by one of the listed Regulatory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either identified at the point of reference or are described in a special section of the standard. The specific applicability or acceptability of these listed standards, codes regulations or appendices is either covered in other specific areas in'the FSAR or this Operating QA Manual (OQAM), including tables, or such documents are not considered as requirements, although they may be used as guidance. When sections are refer-enced within a standard, it is understood that UE shall comply with the referenced section as clarified.-
REGULATORY GUIDE 1.8 REVISION 2 DATED 4/87 Qualification and Training of personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor (Section 4.3.1.1), Senior Operator (Section 4.3.1.2), Licensed Operators (Section 4.5.1.2), Shift Technical Advisor (Section 4.4.8), and Radiation Protection (Manager) (Section 4.4.4) only, and ANSI /ANS 18.1-1971 for all other positions).
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications and exceptions:
Revision 1, dated 9/75, applies to the position of Radiation Protection Manager only, in accordance with the Callaway Plant Technical Specifications.
A-1 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.8 (contul The experience, training, and education requirements for the positions of Shift Supervisor, Operating Supervisor, and Reactor Operator, and personnel fulfilling the duties of Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANSI /ANS 3.1-1981 as endorsed by the 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 will be qualified for assigned tasks either by Union Electric or by Vendors with Union Electric approved training and qualification programs. Inspection, exami-nation and testing personnel shall meet the requirements for cc::tification 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: l This Regulatory Guide is not applicable to the operating phase. j 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).
l 1
A-2 Rev. 17 6/94
~
OQAM APPENDIX A REGULATORY GUIDE 1.30 INITIAL ISSUE DATED 8/72 1
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) j DISCUSSION: ;
i UE complies with the recommendations of this Regulatory Guide )
with the following clarifications:
For maintenance and modification activities UE shall comply with the Reaulatory Position established in this Regulatory Guide in )
that QA programmatic / administrative requirements included therein '
(subject to the clarifications below) shall apply to these main- )
tenance and modification activities even though such 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.
A-3 Rev. 15 6/92
OQAM 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-monts.
Section 2.5.2 - Calibration and Control covers three classes of instrumentation used by UE: (1) M&TE (portable measuring instru-ments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related struc-tures, systems, and components); (2) reference standards (pri-mary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).
With respect to the first sentence, M&TE and reference standards shall be included in a calibration program and shall either be calibrated at prescribed intervals or shall be calibrated prior to use. With respect to the last sentence, personnel shall be trained and procedures shall require that the calibration label or tag shall be reviewed to determine calibration status prior to 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.
A-4 Rev. 15 6/92
OQAM l 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 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 i these subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in UE's commitment to Regulatory Guide 1.33 (ANSI N18.7), Section 5.2.6; the requirements as set forth in that commitment shall be implemented in lieu of the requirements stated here. In every case either identical or equivalent controls are provided in the Sections of the referenced Standards or documents.
Section 5.2 - Tests, including subsections 5.2.1 through 5.2.3, shall be implemented as set forth in OQAM Sections 3 and 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 - Data Analysis and Evaluation shall be implemented as stated herein after adding the clarifying phrase "Where used" at the beginning of the paragraph. This clarification accounts for the fact that some testing will not generate " Data" as such.
Section 8 - Fecords 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
l OQRM 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.5.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 I 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 Reauire-ments for the Onsite Operatina Oroanization:
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 1.8 (ANSI /ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2.6-1978) or as otherwise included as part of the Callaway operating license.
UE's methods of documenting and otherwise meeting the remainder of the requirements of this Section are set forth in OQAM Section 2, in the callaway Plant Technical Specifications, and in other licensing commitments.
With regard to Section 4.1 of ANSI N18.7 - 1976 titled General:
The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, OQAM Section 18, and the Callaway Plant Technical Specifications.
A-7 Rev. 15 6/92
i l
OQAM i APPENDIX A l
REGULATORY GUIDE 1.33 (cont.) I
)
With regard to Section 4.2 of ANSI N18.7 - 1976 titled Procram l pescrintion: Two aspects are addressed in this Section: audits I and independent reviews. The independent review program shall be j implemented as required by the Technical Specifications. The UE ;
audit program shall be described in accordance with and to meet j the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as i endorsed in this Appendix, the Callaway Plant Technical Specifi-cations, and OQAM Section 18.
With regard to Section 4.3 of ANSI N18.7 - 1976 titled Independ- !
ent Review Process: The requirements of this Section, including I of its subparts, shall be met by compliance with the Technical j Specification requirements and the OQAM. !
l With regard to Section 4.5 of ANSI N1L.7 - 1976 titled Audit Procram: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI l N45.2.12) as endorsed in this Appendix, the OQAM, and the ;
Callaway Plant Technical Specifications. l With regard to Section 5.1 of ANSI N18.7 - 1976 titled Procram Rescription: The fourth sentence in this Section requires a " sum-mary document." UE's OQAM is organized in accordance with the 18 criteria of 10 CFR 50, Appendix B. UE interprets this OQAM and applicable Regulatory Guides as endorsed in this Appendix to fulfill the requirements for a " summary document."
With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Proced-ure Adherence: The temporary change requirements of this Section are delineated in the Technical Specifications for activities occurring after the Operating License (OL) is issued; the requir-ements of the Callaway Plant Technical Specifications shall be used to control temporary changes.
With respect to Section 5.2.6 of ANSI N18.7 - 1976 titled Eaulo-ment Control: UE shall comply with the " independent verification" requirements based on the definition of this phrase as given under our commitment to Regulatory Guide 1.74 in this Appendix.
Since UE sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with: " Suitable means include identification numbers or other descriptions which are traceable to records of the status of inspections and tests."
The first sentence in the seventh paragraph shall be met after clarifying " operating personnel" to mean trained employees assigned to, or under the control of, Plant management at Calla-way.
A-8 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1. 3 3 (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 the first sentence of this Section to modify ONLY the words
" design' bases." This interpretation is to assure that original inspection requirements are not imposed, without appropriate review, on modifications or maintenance activities which are similar in nature to original construction activities. In devel-oping means to assure the quality of maintenance or modification activity, inspection requirements from associated construction activities shall be considered. Operational inspection require-ments shall assure quality at least equivalent to the original quality.
Since some emergency situations could arise which might preclude preplanning of all activities, UE shall comply with an alternate to the first sentence in the second paragraph which reads:
"Except in emergency or abnormal operating conditions 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.
Where written procedures would be required and are not used, the activities that were accomplished shall be documented after-the-fact and receive the same degree of review as if they had been proplanned."
With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 titled Main-tenance Procrams: UE shall comply with the requirements of the first sentence of the fifth paragraph, where practical. This clarification is needed since it is not always possible to promptly determine the cause of the malfunction. UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. QA is involved via both audits and surveillances, and QC is involved in inspection of maintenance inspection activities.
With regard to Section 5.2.8 of ANSI N18.7 - 1976 titled Surveil-lance Testina and Inspection Schedule: In lieu of a " master surveillance schedule," the following requirement shall be met:
" Schedules shall be established reflecting the status of in-plant l surveillance tests and scheduled inspections."
With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled Plant Security and Visitor Control: The requirements of the Security Plan shall be implemented in. lieu of these general requirements.
When compliance with an NRC accepted program (e.g., Callaway '
Security Plan) is referenced, UE has substituted the NRC accepted '
program for applicable regulatory requirements in lieu of the )
general requirements of the Quality Assurance program standards. i l
1 A-9 Rev. 15 6/92
i OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.)
With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled House-keepino 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 l 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. l l
With regard to Section 5.2.15 of ANSI N18.7-1976 titled Review.
Anoroval 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 i routine performance of activities. Examples of such reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identified deficiencies or events, evaluation of events occurring at other plants, evaluation of procedure changes necessary to implement modifications, evaluation of procedure 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 prior 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.
A-10 Rev. 15 6/92
OQAM APPENDIX A BEGULATORY GUIDE 1.33 (cont.)
The following is a clarification to the sixth paragraph:
Inspections may not require generation of a separate inspection report. Inspection requirements may be integrated into approp-riate procedures or other documents with the procedure or docu-ment serving as the record. However, records of inspections shall be identifiable and retrievable.
With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control of Special Processes: UE shall comply with the following sentence in lieu of the last sentence of the referenced Section.
For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established codes or standards, personnel, equipment and procedure qualification shall be defined by engineering.
With regard to Section 5.3.5(4) of ANSI N18.7 - 1976 titled Suonortina Maintenance Documents: UE may choose to include mate-rial from vendor manuals in any of three ways. (1) The applicable section of a manual may be duplicated, referenced in, and attached to the procedure. (2) The procedure may reference the technical manual or a specific section; the manual may then be used in conjunction with the procedure for performing the activ-ity. (3) The material, either as originally written or as modified by the 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 shall be available when the procedure is being considered for approval. In option (3), this material receives the same review and approval as the procedure since it is part of the procedure.
In any of the options, Union Electric is NOT reviewing and accepting the entire manual. UE reviews and accepts that portion of each vendor manual that is used by UE.
With regard to Section 5.3.9 of ANSI N18.7 - 1976 titled Emercen-cv Procedures: UE's Emergency Procedures are in the format spec-ified by the NRC in the Callaway Safety Evaluation Report, as required for issuance of the Operating License, in lieu of the requirements given here.
With regard to Section 5.3.9.2 of ANSI N18.7 - 1976 titled Events of Potential Emorcency: The licensing FSAR identified natural occurrences which affect the Callaway Plant. Therefore, UE shall interpret item (11) to mean the natural occurrences which were ealuated in the licensing FSAR.
A-11 Rev. 15 l 6/92 ;
1 I
OQAM APPENDIX A 1
l REGULATORY GUIDE 1.33 (cont.)
With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Proc-edures for Imolementina Emercency Plan: UE's NRC accepted Emer- !
gency Plan shall be implemented in lieu of the requirements in this section. When compliance with an NRC accepted program (e.g.,
Callaway Plant Radiation Emergency Response Plan) is referenced, UE has substituted the NRC accepted program for applicable regu-latory requirements in lieu of the general requirements of the Quality Assurance Program standards.
REGULATORY GUIDE 1.37 INITIAL ISSUE DATED 3/73 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.1-1973)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following 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 maintenance and modifications shall be equal to or better than the original requirements (e.g., code require-ments, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.
Specific clarifications for this Regulatory Guide and ANSI N45.2.1 - 1973 are indicated below by Sections.
With regard to Paragraph C.3 of Regulatory Guide 1.37: The water quality for final flushing of fluid systems and associated compo-nents shall be at least equivalent to the quality of the oper-ating system water except for the oxygen and nitrogen content; but this does not infer that chromates or other additives, normally in the system water, are added to the flush water.
With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indic-ating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT penetrant materials and couplants, dessicants, which contact stainless steel or nickel alloy surfaces shall not contain lead, zinc, copper, mercury, cadmium and other low melting points metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall A-12 Rev. 15 6/92 l
OQAM APPENDIX A REGULATORY GUIDE 1.37 (cont.)
I be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ- f mental conditions, except as provided for in approved design !
documents. No more than 1000 ppm sulfur shall be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environmental condi-tions, except as provided for in approved design documents.
With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion Cleanina: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precluded, as determined by engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
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:
With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Defini-tions: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Plann-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. i l
A-13 Rev. 16 )
6/93 i
I OQAM I APPENDIX A REGULATORY GUIDE 1.38 (cont.)
With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Person-nel Oualifications: Specific requirements for personnel qualifi-cations are set forth in the OQAM description and in the commit-ments in this Appendix. These requirements shall be implemented in lieu of the general requirements stated in this Section. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or document.
With regard to Section 2.7 of ANSI N45.2.2 - 1972 titled Classi-f_ication of Items: UE may choose not to explicitly use the four level classification system. However, the specific requirements of the Standard that are appropriate to each class are generally applied to the items suggested in each classification and to similar items, as determined by engineering. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.
Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 3.2.1 of ANSI N45.2.2 - 1972 titled Level A Items: As an alternate to the requirements for packaging and containerizing items in storage to control contaminants (Items (4) and (5)), UE may choose a storage atmosphere which is free of harmful contaminants in concentrations that could produce damage to stored items, as determined by engineering. Similarly (for Item (7)) UE may obviate the need for caps and plugs, as determined by engineering, with an appropriate storage atmos-phere, and may choose to protect weld-end preparations and threads by controlling the manner in which the items are stored.
These clarifications apply whenever items (4), (5) or (7) are subsequently referenced and to Section 3.5.1 titled Caos and Eluas and Section 3.4 titled Methods of Prevention. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.
Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Clean-ing: (Third sentence) UE interprets "docume.nted cleaning methods" to allow generic cleaning procedures to be written which shall be implemented, as necessary, by trained personnel. Each particular cleaning operation shall be either governed by an individual cleaning procedure or by a generic procedure either of which shall specify method (s) of cleaning or type (s) of solvent (s) that may be used in a particular application. 1 l
l A-14 Rev. 15 l 6/92 i
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 requirements subject to the clarifications of Section 3.2.1 (4) and (5) above, and the definition of the phrase " deleterious corrosion" to mean that corrosion which cannot be subsequently removed and which adversely affects form, fit, or function.
With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrier and Wrap Material and Dessicants: This Section requires the use of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the UE position.
With regard to Section 3.7.1 of ANSI N45.2.2 - 1972 titled Containers: Cleated, sheathed boxes may be used up to 1000 lbs.
rather than 500 lbs. as specified in 3.7.1(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs. Other national standards allow this (see Federal Specification PPP-B-601). Special qualification testing shall be required for loads above 1000 lbs.
With regard to Section 3.7.2 of ANSI 45.2.2 - 1972 titled Crates and Skids: Crates shall be used for equipment in excess of 1000 lb. in weight. Skids or runners shall be used on boxes with a gross weight of approximately 100 lb. or more, allowing suffi-cient floor clearance for forklift tines (as nominally provided by 4 inch lumber).
With regard to Section 4.2.2 of ANSI N45.2.2 - 1972 titled Closed Carriers: The use of fully enclosed furniture vans, as recom-mended in (2) of this Section, is not considered a requirement.
Stated for information only, UE shall assure adequate protection from weather or other environmental conditions by a combination of vehicle enclosure and item packaging.
With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Shio-Dino Damace Inspection: Stores personnel shall normally visually scrutinize incoming shipments for damage of the types listed in this Section; this activity is not necessarily performed prior to unloading. Since required items receive the Item Inspection of Section 5.2.2, separate documentation of the Shipping Damage Inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping A-15 Rev. 17 6/94
i l OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)
Damage Inspection. Any nonconformance noted shall be documented and dispositioned as required by OQAM Section 15. The person performing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regula- j 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.
With regard to Section 5.2.2 of ANSI N45.2.2 - 1972 titled Item Inspection: The second division of this subsection requires six .
additional inspection activities if an item was not inspected or !
examined at the source. Engineering shall determine and document the extent of receipt inspection based on consideration 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 committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of Storace: Subpart (2) is replaced with the following:
(2) Level B items shall be stored within a fire resistant, weathertight, and well ventilated building or equivalent enclosure in which measures have been taken against vandal-ism. This building shall be situated and constructed so that it is not normally be subject to flooding; the floor shall be paved or equal, and well drained. If any outside waters should come in contact with stored equipment, such equipment shall be labeled or tagged nonconforming, and then the nonconformance document shall be processed and evaluated in accordance with OQAM Section 15. Items shall be placed on pallets or shoring or shelves to permit air circulation. The building shall be provided with heating and temperature control or its equivalent to reduce conden-sation and corrosion. Minimum temperature shall be 40' F and maximum temperature shall be 140' F or less if so stip-ulated by a manufacturer.
With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to Storace Areas: Items which fall within the Level D classifica-tion of the standard shall be stored in an area which may be posted to limit access, but other positive controls such as fencing or guards shall not normally be provided, with engineer-ing's concurrence. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review A-16 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.)
by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Stor-aae of Food and Associated Items: The sentence is replaced with the following: "The use or storage of food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas where such use or storage is not deleterious to stored items, with engineering's concurrence."
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 (QA is a permanent member of this committee). For other activ-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 Meas-uros to Prevent Entrance of Animals: The sentence is replaced with the following: " Exterminators or other appropriate measures shall be used to control animals to minimize possible contamina-tion and mechanical damage to stored material."
With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Stor-ace of Hazardous Materials: The sentence is replaced with the following: " Hazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed safety-related systems." The placement of hazardous material storage lockers in the Plant is based upon installed safety-re-lated systems, not particular components.
With regard to Section 6.4.2 of ANSI N45.2.2 - 1972 titled Care of Items: The following alternates are provided for the indicated ,
subparts: 1 (5) " Space heaters in electrical equipment shall be energized unless a documented engineering evaluation determines that such space heaters are not required."
(6) "Large (greater than or equal to 50 HP) rotating electrical equipment shall be given insulation resistance tests on a scheduled basis unless a documented engineering evaluation determines that such tests are not required."
(7) " Prior to being placed in storage, large (greater than or equal to 50 HP or when designed to be used with a prime mover of greater than or equal to 50 HP) horizontal rotating equipment shall be evaluated by engineering to determine if shaft rotation in storage is required: the A-17 Rev. 15 l 6/92 I
l 1
OQAM APPENDIX A H_EGULATORY GUIDE 1.38 (cont.)
results of the evaluation shall be documented. If rotation is required, it shall be performed at specified intervals, be documented, and be conducted so that parts receive a coating of lubrication where applicable and so that the shaft does not come to rest in the same position occupied prior to rotation. For long shafts or heavy equipment subject to undesirable bowing, shaft orientation after rotation shall be specified and obtained."
(8) Maintenance requirements specified by the manufacturer's instructions are addressed in this OQAM, Section 13.3. l With regard to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal of Items from Storace: UE does not consider the last sentence of this Section to be applicable to the Operating Phase due to the relatively short period of time between installation and use. The first sentence of the Section is replaced with: "UE shall develop, issue, and implement a procedure (s) which cover (s) the removal of items from storage. The procedure (s) shall assure that l the status of material issued is known, controlled, and approp-riately dispositioned." l With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Inspection of Eauipment and Ricaino: Stated for information only, it is UE's position that this relates to the operability of the hoisting equipment and does not preclude l rerating as allowed by Section 7.3.
REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 j Housekeeping Requirements for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.3-1975)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide l with the following clarifications:
For maintenance and modification activities UE shall comply with the Reaulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these main-tenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance or modification shall be equal to or better than the original requirements (e.g., code require-ments, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.
A-18 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.39 (cont.)
Specific clarifications for ANSI N45.2.3 - 1973 are indicated below by Sections.
Section 1.4 - Definitions: Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
Section 2.1 - Plannino: UE may choose not to utilize the five-level zone designation system, but shall utilize standard jani-torial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeep-ing, Plant and personnel safety, and fire protection.
Cleanliness shall be maintained, consistent with the work being performed, so as to prevent the entry of foreign material into safety-related systems. This shall include, as a minimum, docu-mented cleanliness inspections which shall be performed prior to system closure. As necessary, (e.g. the opening is larger than the, tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, refusting, modification or repair.
Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.
Section 3.2 - Control of Facilities: UE may choose not to utilize the five-level zone designation system, but shall utilize standard janitorial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeeping, Plant and personnel safety, and fire protection.
Cleanliness shall be maintained, consistent with the work being performed, so as to prevent the entry of foreign material into safety-related systems. This shall include, as a minimum, docu-mented cleanliness inspections which shall be performed prior to system closure. As necessary, (e.g. the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, modification, refueling or repair.
Additional housekeeping requirements shall be implemented as ,
required for control of radioactive contamination. '
Section 4 -
Records: The requirements of OQAM Section 17 and '
Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix shall be implemented in lieu of the requirements of-the Section. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or docu-ments.
A-19 Rev. 17 6/94
OQAM APPENDIX A REGULATORY GUIDE 1.58 REVISION 1 DATED 9/80 Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
The qualification of UE QC or contracted QC personnel performing work at the Plant shall be in accordance with Regulatory Guide 1.58 (ANSI N45.2.6-1978). Other personnel performing inspection, examination, and testing activities shall have appropriate expe-rience, training, and retraining to assure competence in accor-dance with Regulatory Guide 1.8 (ANSI /ANS 3.1-1978). This posi-tion is consistent with Regulatory 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-tions of actual work proficiency that these individuals possess comparable or equivalent competence. Persons performing Nondes-tructive Examinations (NDE) as may be required by Section III or XI of the ASME B&PV Code shall be qualified and certified as required by the Edition and Addenda of the Code to which UE is committed at the time the NDE is performed. However, when qual-ifying personnel to perform visual examinations VT-2, VT-3, and VT-4 in accordance with IWA-2300 of Section XI, Division 1, ANSI /ASME N45.2.6-1978 may be used instead of ANSI N45.2.6-1973 (Code Case N-424). Persons certified to perform NDE for Code work shall also be considered as qualified to perform non-Code NDE (e.g. crane hook inspection) unless more rigorous qualification or certification requirements are imposed by UE's commitments or government regulations.
A-20 Rev. 17 6/94
OQAM APPENDIX A REGULATORY GUIDE 1.58 (cont.)
With regard to Section 1.2 of ANSI N45.2.6 -1978 titled Anolica-bility: The third paragraph requires that the Standard be used in conjunction with ANSI N45.2; UE no longer specifically commits to ANSI N45.2 in the Operating QA Manual. The fourth paragraph requires that the Standard be imposed on personnel other than UE employees; the applicability of the Standard to suppliers shall be documented and applied, as appropriate, in the procurement documents for such suppliers.
With regard to Section 1.4 of ANSI N45.2.6 - 1978 titled Defini-tions: Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
With regard to Section 2.5 of ANSI N45.2.6 - 1978 titled Physi-gal: UE shall implement the requirements of this Section with the stipulation that, where no special physical characteristics are required, none shall be specified. The converse is also true: if no special physical requirements are stipulated by UE, none shall be considered necessary.
REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.11-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
When uniqueness or special design considerations warrant or are judged to be appropriate, an independent third-level review may be employed.
With regard to Paragraph C.2(1) of Regulatory Guide 1.64: If the designer's immediate Supervisor is the only technically qualified individual available, this review may be conducted by the Super-visor, provided that: (a) the other provisions of the Regulatory Guide are satisfied and (b) the justification is individually documented and approved in advance by the Supervisor's manage-ment, and (c) quality assurance audits cover frequency and effec-tiveness of use of the Supervisors as design verifiers to guard against abuse.
With regard to Section 1.4 of ANSI N45.2.11 - 1974 titled Defini-tions: Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in this Appendix.
A-21 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.64 (cont.)
With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12, under Procram Reauirements, and Section 11 (including i subsections 11.1 through 11.7) of ANSI N45.2.11 - 1974, titled i Audits: UE's audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, OQAM Sections 16 and 18, and the requirements of the Callaway Plant Technical Specifica-tions. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or docu-monts.
BEGULATORY GUIDE 1.74 INITIAL ISSUE DATED 2/74 1
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 Sectic.is of the Operating QA Manual.
In addition to the Standard's definition of " Inspection," UE shall use the following: " Inspection (when used to refer to activities that are NOT performed by QA or QC personnel) - Exam-ining, viewing closely, scrutinizing, looking over or otherwise checking activities. Personnel performing these functions are not necessarily certified to Regulatory Guide 1.58 (ANSI N45.2.6)."
These activities are controlled by the Callaway Plant Operating Manual.
When UE intends for Inspection to be performed in accordance with the Operating QA Program by personnel certified as required by that Program and for activities defined by " Inspection" in ANSI N45.2.10, appropriate references to QC group or the procedures to be used for performing the activity shall be made. If such refer-ences are NOT made, inspections are to be considered under the additional definition given above.
In addition to the Standard's definition of " procurement docu-ments," UE shall utilize the definition given in ANSI N45.2.13.
The compound definition is given as follows: Procurement docu-ments - Contractually binaing documents that identify and define the requirements which items or services must meet in order to be considered acceptable by the purchaser. They may include docu-ments which authorize the seller to perform services or supply equipment, material or facilities on behalf of the purchaser A-22 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)
(e.g. Engineering Service Agreement agreements for engineering, construction, or consulting services), contracts, letters of intent, purchase requisitions, purchase orders, or proposals and their acceptance, drawings, specifications, or instruction which define requirements for purchase.
" Bids" -
Supplier quotation submitted in response to specified technical and quality requirements for which price and delivery are primary considerations.
" Proposals" - Supplier offerings that define the scope of supply as well as specific technical and quality requirements for a product or service. Such offerings usually require negotiation prior to acceptance as either a purchase order, contract, or Engineering Service Agreement.
" Program Deficiencies" (Not defined in ANSI N45.2.10, but used and defined differently in Regulatory Guide 1.144 (ANSI N45.2.12)) -
Failure to develop, document or implement effec-tively any applicable element of the Operating QA Program.
" Quality Assurance Program Requirements" (Not defined in ANSI N45.2.10 but used and defined differently in ANSI N45.2.13) -
Those individual requirements of the Operating QA Program which, when invoked in total or in part, establish the requirements of the quality assurance program for the activity being controlled.
Although not specifically used in the Operating QA Program, ANSI N45.2 may be imposed upon UE's suppliers.
" Independent Verification" - Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed. Such verifi-cation need not require confirmation of the identical action when other indications provide assurance or indication that the pres-cribed activity is in fact complete. Examples include, but are not limited to: verification of a breaker opening by observed remote breaker indication lights; verification of a set point (made with a voltmeter or ammeter for example) by observing the actuation of status or indicating lights at the required Panel-meter indicated value; verification that a valve has been positi-oned by observing the starting or stopping of flow on meter indi- ,
cations or by remote value positions indicating lights.
" Audit" (This is a modification of the word's definition - to allow the use of subjective evidence if no evidence is available as defined in Section 1.4 of ANSI N45.2.12 - 1977 (Regulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23 - 1978 (Regula-tory Guide 1.146) as opposed to the definition given in ANSI N45.2.10 - 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 l
1 OQAM APPENDIX A FEGULATORY GUIDE 1,74 (cont.)
evidence may be used when objective evidence is not available),
that applicable elements of the Quality Assurance Program have been developed, documented and effectively implemented in accor-dance with specified requirements. An audit should not be confused with surveillance or inspection for the sole purpose of process control or product acceptance.
1 "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 organization" described (but not defined) in ANSI N18.7-1976, Section 3.4.2; the " unit staff" as used in the OQAM and in Callaway Plant Technical Specifications Section 6.3 and its subparts and Section 6.5.2.9.b; the " unit organization" described in the Callaway Plant Technical Specifications Section 6.2.2.
"Like kind replacements" - (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 PATED 10/76 Collection, Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (Endorses ANSI N45.2.9-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled 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 the form, needs to be complete to furnish documented " evidence of activities affecting quality".
With regard to Section 3.2.2 of ANSI N45.2.9 - 1974 titled Index:
The phrase "an index" is clarified to mean a collection of docu-ments or indices which, when taken together, supply the informa-tion attributed to "an index" in the Standard.
A-24 Rev. 15 !
6/92
l l
OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.).
The specific location of a record "within a storage area" may not be delineated. (e.g. The specific location within a computer record file may not be constant. Further, UE may utilize a computer 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 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 . . . , " is clarified to mean that internal Callaway Plant generated records received are in agree-ment with procedural guidelines contained in Callaway Plant Admi-nistrative procedures. If a transmittal does exist (e.g. on supp-lier-generated documents, etc.), the records received will be verified against the transmittal 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.
With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safe-keepina: 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. 17 6/94
OQAM APPENDIX A BEGULATORY GUIDE 1.88 (cont.)
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 docurents 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).
Paragraph 4, subsection 3 is clarified to require a two-hour minimum fire rating to be consistent with the 1979 version of the Standard and NRC Criteria for Records Storace Facilities (Gui-dance-ANSI N45.2.9, Section 5.6) issued 7/1/80.
Paragraph 4, subsection 9 is clarified to read: "No pipes or penetrations except those providing fire protection, lighting, temperature / humidity control, or communications are to be located within the facility and they shall comply with a minimum two-hour fire protection rating."
Where duplicate storage is employed, no special precautions or provisions (including vault storage, special humidity and tempe-rature recorders and similar items) are required.
Paragraph 5 is clarified to read the same as our commitment to subsection 5.4.3. Both paragraphs address the same requirement and therefore the commitment must be the same.
With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits:
These specific activities in sub-sections 1, 2 and 3 are accomp-lished through the establishment of administrative controls by the responsible management.
Audits of these administrative controls are performed in accor-dance with this OQAM, Section 18 and commitments to Reg. Guide 1.144 in this Appendix.
REGULATORY GUIDE 1.94 REVISION 1 DATED 4/76 Quality Assurance Requirements for Installation, Inspection and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plants. (Endorses ANSI N45.2.5-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide i with the following clarifications:
l i
l A-26 Rev. 17 l 6/94 l i
OQAM APPENDIX A PEGULATORY GUJDE 1.94 (cont.)
For modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA program-matic/ administrative requirements included therein (subject to the clarifications below) shall apply to these modification activities even though such requirements may not have been in effect originally. Technical requirements associated with modifi-cations shall be equal to or better than the original require-ments (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements),
or as required to preclude repetition of defects.
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 Earsonnel Qualification: Union Electric will comply with Regulatory Guide 1.58 as endorsed in this OQAM in lieu of the requirements of this standard.
In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled Calibra-tion and Control: The last sentence is clarified as follows:
"UE's inspection or test results conducted with M&TE found to be discrepant are to be evaluated as described in the OQAM, Section 12.8."
With regard to Section 5.4 of ANSI N45.2.5-1974 titled High Strenath Boltina: In lieu of the first two sentences in the first paragraph, UE will comply with the following: " Bolts for friction type connections may be tightened using direct tension indicators in accordance with the AISC Specification for Structural Joints Using ASTM A325 or A490 Bolts, approved May 8, 1974."
In lieu of (1) in the second paragraph, UE will comply with the following: "The requirement for the acceptance of tightened bolt assemblics is, the length of the bolts shall be such that the point of the bolt shall be flush with or outside of the face of the nut when completely installed."
REGULATORY GUIDE 1.116 REVISION 0-R DATED 5/77 Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems (Endorses ANSI N45.2.8-1975)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
A-27 Rev. 16 6/93
OQAM APPENDIX A REGULATORY GUIDE 1.116 (cont.)
For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein 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 1.121 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 i which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) I 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 ResDonsibilities: 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 PreDaration. Review and Chance ConU nA: The phrase "the same degree of control" is stipulated to mesh " equi-valent level of review and approval." The changed document may not always be re-reviewed by'the originator; however, at least an equivalent level of supervision shall review and approve any l changes. l With regard to Section 3.4 of ANSI N45.2.13 - 1976 titled Procurement Document Control: UE shall meet the requirements of OQAM Sections 4 and 7 in lieu of the requirements specified in this section. In every case either identical or equivalent controls are provided in the sections of the referenced docu-monts.
I
-A-28 Rev. 16 6/93 i
OQAM APPENDIX A l l
REGULATORY GUIDE 1.123 (coni 111 With regard to Section 5.3 of ANSI N45.2.13 - 1976 titled Prea-Ward Evaluation: UE shall comply with an alternate paragraph l which reads: "Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition at Callaway), an evaluation of the suppli-er's acceptability as a procurement source shall be performed as required by the Operating QA Manual." While it is not the intent to make " unusual circumstances" determinations without Engi-neering or QA involvement, Callaway Operations Support is ulti-mately responsible for the decision. QA audit and surveillance activities assure against abuse.
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."
With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source Verification Activities and Section 12 of ANSI N45.2.13 - 1976 titled 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.
With regard to Section 7.5 of ANSI N45.2.13 - 1976 titled Person-nel Oualifications: The phrase: " Personnel responsible for performing verification activities shall be qualified in accor-dance with ANSI N45.2.6 as applicable", is subject to the following clarification: Qualification of personnel performing verification activities for the Callaway Plant shall be in accor-dance with Union Electric's position on Regulatory Guide 1.58.
With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disoo-sition: The third sentence of item b is revised to read:
Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist of one or more of the following shall be submitted to the Purchaser for approval of the recommended disposition prior to ship-ment when the nonconformance could adversely affect the end use of a module
- or shippable component relative to safety, interchangeability, operability, reliability, integrity, or maintainability:
- 1) Technical or material requirement is violated;
- 2) Requirement in Supplier documents, which have been approved by the Purchaser, is violated; A-29 Rev. 16 6/93
1 OQAM APPENDIX A )
l 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 or equipment which is shipped as an individual item and which has been evaluated by inspection and/or test for conformance to procurement requirements regarding end use.
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 ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74. The one excepted definition and a clar-ified definition (of audit) relevant to this Standard are defined in this Appendix under Regulatory Guide 1.74.
With regard to Section 2.1 of ANSI N45.2.12-1977 titled General:
Identical or equivalent controls are provided in this OQAM, Section 18.3 regarding the second paragraph discussing audit team selection.
With regard to Section 2.2 of ANSI N45.2.12 - 1977 titled Person-nel Oualification: The qualification of UE audit personnel shall be accomplished as described to meet the requirements of Regula-tory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
I i
l A-30 Rev. 16 6/93
OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.)
With regard to Secti n 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titicd Training: The training of UE audit personnel shall be accomplished as described to meet the require-ments of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Mainte-nance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the require-monts of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essen-tial Elements of the Audit System: UE shall comply with subsec-tion 3.3.5 as it was originally written (subsection 3.2.5) in ANSI N45.2.12, Draft 3, Revision 4: " Provisions for reporting on the effectiveness of the Quality Assurance Program to the respon-sible management." For the auditing organization (UE), effective-ness shall be reported as required by the Callaway Plant Tech-nical Specifications. Other than audit reports, UE may not directly report on the effectiveness of the quality assurance programs to the audited organization when such organizations are outside of UE.
Subsection 3.3.6 requirements are considered to be fulfilled by compliance with the organization and reporting measures outlined in this Operating QA Manual and the Callaway Plant Technical Specifications. In every case either identical or equivalent controls are provided in the sections of the referenced docu-monts.
Subsection 3.3.7 requires verification of effective corrective action on a timely basis.
Verification of the implementation of corrective action is performed as indicated in Section 16 of this OQAM, Corrective action program effectiveness is determined through audit or surveillance as described in Section 18 of this OQAM, using previously issued corrective action documents as input to the scope of audits and surveillances. Additionally, trending of corrective action documents will be used to reveal potentially ineffective corrective actions and the effectiveness of the corrective action program.
With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planning: Identical or equivalent controls are provided in this OQAM, Section 18.
A-31 Rev. 16 6/93
OQAM APPENDIX A l
REGULATORY GUIDE 1.144 (cont.)
With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Sched-ulina: Identical or equivalent controls are provided in this OQAM, Section 18 for the requirements of Subsections 3.5.1 and 3.5.2. Subsection 3.5.3.1 is interpreted to mean that UE may procedurally control qualification of a contractor's or suppli-er's quality assurance program prior to awarding a contract or purchase order by means other than audit. The measures outlined in Sections 4 and 7 of this OQAM address the requirements of Subsection 3.5.3.1.
With regard to Section 4.3.1 of ANSI N45.2.12 - 1977 titled Pre-Audit Conference: UE shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the first sentence. This clarification is required because, in the case of certain unannounced audits or audits of a particular operation or work activity, a pre-audit conference might inter-fere with the spontaneity of the operation or activity being audited. In other cases, persons who should be present at a pre-audit conference may not always be available: such lack of avai-lability should not be an impediment to beginning an audit. Even in the above examples, which are not intended to be all inclu-sive, the material set forth in Section 4.3.1 shall normally be covered during the course of the audit.
With regard to Section 4.3.2 of ANSI N45.2.12 - 1977 titled Audit Process:
(a) Subsection 4.3.2.2 could be interpreted to limit auditors to the review of only objective evidence; sometimes and for some Program elements, no objective evidence may be availa-ble. UE shall comply with an alternate sentence which reads:
"When available, objective evidence shall be examined for compliance with Quality Assurance Program requirements. If subjective evidence is used (e.g. personal interviews, direct observations by the auditor), then the audit report must indicate how the evidence was obtained."
(b) Subsection 4.3.2.4 is modified as follows to take into account the fact that some nonconformances are virtually
" obvious" with respect to the needed corrective action:
"When a nonconformance or Quality Assurance Program defi-ciency is identified as a result of an audit, unless the apparent cause, extent, and corrective action are readily ;
evident, further investigation shall be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required."
A-32 Rev. 16 6/93
OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.l (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 to account for the fact that immediate notification is not always possible:
" conditions requiring immediate corrective action (i.e. ,
those which are so severe that any delay would be undesira-ble) shall be reported immediately to the audited organiza-tion and as soon as practical to the management thereof."
With regard to Section 4.3.3 of ANSI N45.2.12 -
1977 titled l Post-Audit Conference: UE shall substitute and comply with the following paragraph: "For external audits, a post-audit confer-ence shall be held with management of the audited organization to present audit findings and clarify misunderstandings; where no adverse findings exist, this conference may be waived by manage-ment of the audited organization: such waiver shall be documented in the audit report. Unless unusual operating or maintenance conditions preclude attendance by appropriate managers /supervi-sors, a post-audit conference shall be held with managers / super-visors for internal audits for the same reasons as above. Again, if there are no adverse findings, management of the internal audited organization may waive the post-audit conference: such waiver shall be documented in the audit report."
With regard to Section 4.4 of ANSI N45.2.12 - 1977 titled Renort- l ina:
(a) This Section requires that the audit report shall be signed by the Audit Team Leader ( ATL) ; this is not always the most expeditious route to take to assure that the audit report is issued as soon as practical. UE shall comply with Section 4.4 as clarified in the following opening: "An audit report, which shall be signed by the Audit Team Leader (ATL), or the ATL's supervisor in the ATL's absence, shall provide: . . . "
In cases where the audit report is not signed by the ATL due to absence, one record copy of the report must be signed by the ATL upon return. The report shall not require the ATL's review / concurrence / signature if the ATL is no longer employed by UE at the time the audit report is issued.
(b) UE shall comply with subsection 4.4.3 clarified to read:
" Supervisory level personnel with whom significant discus-sions were held during the course of pre-audit (where conducted) audit, and post-audit (where conducted) activ-ities."
A-33 Rev. 16 6/93
)
OQAM APPENDIX A 1
EfGQi.ATORY Q GUIDE 1.144 (cont.)
(c) Audit reports may not necessarily contain an evaluation statement regarding the offectiveness 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 Orcanization: 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 ,
I organization has not already investigated and found the cause, etc.) to determine and schedule appropriate remedial action. The audited organization shall assure documentation of remedial action taken is provided. Adverse audit findings shall be evalu-ated to determine the need for action to prevent recurrence. If such action is deemed necessary, the results of the investigation (root cause analysis), the corrective action taken or planned to prevent recurrence, and a schedule for implementation shall be provided by the audited organization. Such evaluations and 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 Auditina Orcanization: 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 l by the audited organization as described in Section 16 of this OQAM. The internal audit program implemented in Section 18 of this OQAM provides assurance that the corrective action program requirements are properly implemented. By sampling responses to l
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 l 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 l
A-34 Rev. 16 6/93
r OQAM APPENDIX A REGULATORY GUIDE 1.146 INITIAL ISSUE DATED 8/80 Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants (Endorses ANSI N45.2.23-1978)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
With respect to Section 1.4 of ANSI N45.2.23-1978 titled Defini-tiong: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used: " Audit" which is included in this Standard and ANSI N45.2.10 shall be used as clarified in this Appendix under Regulatory Guide 1.74.
With respect to Section 2.2 of ANSI N45.2.23 - 1978 titled Ouali-fication of Auditors: Subsection 2.2.1 references an ANSI B54.2 (presumed to be standard N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 which reads:
Orientation to provide a working knowledge and understanding of the Operating QA Manual, including the ANSI standards and Regulatory Guides included in this Appendix and UE's proced-uros for implementing audits and reporting results.
With respect to Section 3.2 of ANSI N45.2.23 -
1978 titled Main-tenance of Proficiency: UE shall comply with the requirements of this Section by defining " annual assessment" as one which takes places every 12 + or - 3 months and which uses the initial date of certification (not the calendar year) as the starting date for determining when such annual assessment is due. The combined time interval for any three consecutive assessment intervals shall not exceed 3.25 years.
With respect to Section 4.1 of ANSI N45.2.23 -
1978 titled Oraan-izational Responsibility: UE shall comply with this Section with the substitution of the following sentence in place of the last sentonce in the Section:
The Manager, Quality Assurance; Supervising Engineer, QA; or Lead Auditor shall, prior to commencing the audit, assign personnel who collectively have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.
A-35 Rev. 16 6/93 ,
OQAM APPENDIX A 1 I
REGULATORY GUIDE 1.146 (cont.)
With respect to Section 5.3 of ANSI N45.2.23 -
1978 titled Undat-inn of Lead Auditor's Records: UE shall substitute the following sentonce for this Section:
Records for each Lead Auditor shall be maintained and updated during the period of the annual management assess-ment as defined in Section 3.2 (as clarified).
With respect to Section 5.4 of ANSI N45.2.23 -
1978 titled Records Retention: UE shall substitute the following sentence for this Section:
Qualification records shall be generated and maintained as required by OQAM Section 17 and by commitment to Regulatory Guide 1.88 (ANSI N45.2.9) as clarified in this Appendix .
In every case either identical or equivalent controls are provided in the sections of the referenced Standards and docu-monts.
A-36 Rev. 16 6/93 m
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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, j 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-K l;, 3tive -officer who has ultimate responsibility for 1
Lb Um E " the callaway Plant.
gr 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-M -Executiva_Off-icer- through the Senior Vice Presi-A '
dent-Nuclear. The Manager, Quality Assurance is
/jl (Lup responsible to the Senior Vice President-Nuclear g 3'.'*g'" ,, 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
]
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 j 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 l 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 G256
- tions performing quality assurance functions shall
" 2L55 be clearly established. Such persons have suffi- l I
cient authority and organizational freedom to iden-tify quality problems; to initiate, recommend, or provide solutions; and to evaluate corrective l 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 i_
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 j o , d,fg v, o3% , Control yS stem Engineering andgP roject-Engineer-
-ingINithin the System EngineerTng organization, oc
~
I f i ldwi al Inspectors (ISI/NDE) report to the Supervising
,%PiLpa'j' 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, status report-ing, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal Health )
Physicist. He is also responsible for the adminis-trative contact with the Institute of Nuclear Power i Operations (INPO). As Principal Health Physicist, l he provides a corporate level overview and guidance in the formulation and implementation of applied radiation protection programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations.
1-3 Rev. 16 '
6/93 l
m _ _ . _ _ _ . __ _ - - - _ - -
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 1 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 1790 1.11 The Manager, Callaway Plant reports directly to the
-F796- Vice President, Nuclear Operations and is respon-s py3q 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 s su ort activities and implements the OQAP through
-* Assistant-Manager) Materials, the Superinten-3g [ dent, E Training, the Superintendent, Security, and the Superintendent, Administration.
1-4 Rev. 16 6/93
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 hTh~e~ Assistant Manager, Operations and Mainteff5iic^e s reports directly to the Vice P e&iden't, Nuclear N Operations and is responsi or personnel devel- !
opment, organization & development, strategic planning, Fi sC?or-Duty, and the Personnel departman .
l a 1
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\f 1-5 Rev. 16 6/93
ogAM
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. _ _ . ~ . . . - . ;
1.19 The Superintendent, Personnel (Local 148) reports l directly to the Assistant Manager, Operatil: ins and i l Maintenance and is responsible,for' assisting in I areas of labor relatiorls,' organizational and personnel activities,-and other matters under the !
g guidance of .UE' policies. The Superintendent, Personne,1-(Lo , cal 1439 and 1455) reports directly to
.'M
,' 'P /
n.
p the
-an'd Assistant Manager, Operations and Maintenance is responsible for the duties above plus the
%l M)
, u Fitness-For-Quty_ program. J j
[~yp2 () -1 r20-- The Manager, Purchasing reports directly to the f45 /g, 1. 2.1 Vice President, Supply Service who in turn reports to the Senior Vice Presidentpdministrativu Serv-
/ C obe v- Ices 7 The~~~Ma nager , Purchasing is responsible for
@s 5 e %.g 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, -1T2 The Manager, Mechanical Engineering reports to the ,
g.2 2-- Vice President-Engineering and Construction who in I turn reports to the Senior Vice-Presidents--4'eche i r .. -nicaL Services, The Manager, Mechanical Engineering h g ,s.> ,,w r c provides technical support, as necessary, to the Sv* #.. Nuclear Engineering staff.
(2184 -1722-- The Manager, Electrical Engineering reports to the
,y 12.5 Vice President-Engineering and Construction. The c0 Manager, Electrical Engineering provides technical support, as requested, to the Nuclear Engineering ,
staff. '
b23 ir2+ The Manager, System Relay Services reports to the
/h l 2d --Senior 41ce-President , Technica-1--Services and is i l V2A 9 - responsible for providing qualified engineers, technicians and equipment to maintain Callaway r< w .., , , , , u d b o vA #w a; ,, Plant relays, ius es n u n tus
%;u v, -1T24 The Manager, Distribution Operating Department i b , ld (m % , 2 I >; reports to the Vice-President Transmission and l I ; Distribution and is responsible for providing qual-g
'* ified engineers, technicians and equipment for W( 4 4 3 0'Lh [ Callaway support.
Plant battery testing and technical l
l 1.25- Other UE divisions may provide safety-related ,
p ut3 services which augment and support selected Program !
2.7 activities. These organizations shall be required I
- to implement controls consistent with the OQAP '
i requirements applicable to their scope of activ-ities. The coordination of these activities is the responsibility of the Senior Vice President- l l
Nuclear. l
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OQAM
\ 207/
d 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 A Vice President-Nuclear has initiated the Program
/h~. p____
and formulated the policy in addition to author-r
%% t w '~1 zing This haheen Program implementation.Nhairman-and
~bstablished by the -Chiefresponsibility C L. " t am tJ KExecutive-Off-icer of UE for establishing and imple- '
oRo e< 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-meated 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 pettinent requirements of the OOAP 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 l and safety of the public. The safety-related struc-2-1 Rev. 15 6/92
I l
OQAM 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, systems, and components identified during the design and construction phase and may be modified l 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 conputer Section
- 6. The development, control, and use of 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 to be consistent with the program's importance safety-related activities. Consumables which could affect the form, fit or function of safety-related not structures, systems, and components, although 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.
Consistent with the schedule for accomplishing gg36 789- 2. 6 1879 quality activities, the OQAP shall be established manual, and documented by written policy, program safety-and procedure manuals. Persons conducting imple-related activities shall be responsible to utilize ment approved procedures. The OQAP shall Program following document types to describe 1
the objectives:
Quality Assurance Program Policy /
- 1. Operating 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 be statement and any revisions thereto shall approved by the Senior Vice President-Nuclear.
l 2-2 Rev. 16 )
6/93
't OQAM cannot be resolved shall be referred to the next higher level of management for resolution. Disputes l which cannot be resolved through these levels shall be resolved ultimately by the Chief Executive l I
Officer.
2.9 Preservice (PSI) and inservice (ISI) inspection, ,
testing, and examination activities may be l performed by outside organizations. These inspec- l 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-
-2194-2t86 related activities to assure that responsible func-A tions, departments, and individuals are knowledge-
/S 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 00AM 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- 7 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 OQAP.
1799 2.11 An audit system shall be established to assure management is advised of Program effectiveness. The implementation and effectiveness of the OQAP shall ,
be assessed through an audit program of quality !
activities which includes design, procurement, modification, and operation. The Manager, Quality 2-4 Rev. 15 6/92
i l
l OQAM l 1864 3.0 DESIGN CONTROL 2183 ;
2974 I 1850 3.1 The design, modification, addition, and replacement and compo-r'#2168 of safety-related structures, systems, nents shall be controlled to assure appropriate gov 2185
-2189.25gg design control measures are implemented. Procedures qt 7p qg shall establish requirements; assign responsibil-19 2222 2187 ities; and provide control of activities regarding controlled, and orderly
-2193-- design in a planned,
/23 manner.
A/E 2188 3.2 The Plant design is defined by those UE NSSS, and selected supplier design drawings and specifi-arrangement cations which illustrate the general and details of safety-related structures, systems, requirements for and components and define the perform assuring their continued capability to func-their intended operational or safety design tion.
2664 3.3 As the result of operating experience, or as neces-sitated by regulatory requirements, Plant systems changed. A design and equipment may have to be change is a modification in Plant design or opera- with tion and is accomplished in accordance codes, 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- or tioning of safety-related structures, systems, 7,pa components shall be performed in a manner to ensure quality at least equivalent to that specified in 23a0g-l materials A 16 original design bases and requirements, L L'g specifications and inspection requirements. A suit-able level of confidence in structures,modifications systems, or components on which maintenance or by appro-have been performed shall be attained priate inspection and performance testing.
2184 3.5 Design, including related procurement efforts, may Licensing 2189-1168 be carried out by Nuclear Engineering, 7 2222 and Fuels, or outside organizations.
Control of design shall be specified in procedures.
/
[ 101 2164 3.6
-2190-2t6b These procedures shall include instructions for
-2191__ defining typical design requirements; communicating 221 4
-2192- needed design information across internal and external interfaces; preparing, reviewing, approv-
)> -2t196~
3-1 Rev. 14 l 6/91 1
OOAM
-4202- ing, releasing, distributing, revising, and 2221 maintaining design documents; performing design s 222 reviews and reviews of design; and controlling 2243 field changes.
[2225 2164 3.7 Design control shall involve measures which include
) a definition of design requirements; a design 22L3 1 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.
N 1850 3.8 Design requirements and changes thereto shall be J1 -,214rf 2 t B D identified, documented, reviewed and approved to 2203 aosure 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, j system descriptions and other documents defining I design input which change the Plant as described in j 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 i 2210 into specifications, drawings, written procedures, l 2212 and instructions (design outputs) that define the 2974 design. Design analyses regarding reactor physics, stress, thermal, hydraulic, radiation, and accident l 2170 analyses used to produce design output documente, 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 1 design changes. l l
3-2 Rev. 16 6/93
l 1
OOAM i 2165 3.10 Procedures shall specify requirements for the 2166 review and approval of design changes by the organa 2168 izations or individuals that performed the original 2169 design or Nuclear Engineering. Design control 2243 activities, including design changes, may be dele-gated to others provided they have access to back-ground and technical information. Design control measures for design revisions shall be commensurate with those applied to the original design.
1934 3.11 Design activities shall also include: 1) reviewing the applicability of standards; 2) reviewing commercial or previously approved materials, parts or equipment for suitability of application: 3) re-viewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment and components for inservice inspection, mainte-nance, and repair; 5) specifying criteria for inspection and test / retest; and 6) reviewing and approving procedures for special processes.
2164 3.12 The design process shall establish controls for 2168 releasing design documents which are technically
-2191- 2L9S adequate and accurate in a controlled manner with a 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled through the use of written procedures by the issuer, distributor, and user to prevent inad-vertent use of superseded documents. Document control procedures shall govern the collection, storage, and maintenance of design documents, results of design document reviews, and changes thereto. The design documents subject to procedural control include, but are not limited to, specifica-tions, calculations, computer programs, system descriptions, SAR when used as a design document, and drawings including flow diagrams, piping, and instrument diagrams, control logic diagrams, elec-trical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations.
2164 3.13 The design 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 4 2218 procedures shall address control of the interface, 2219 responsibilities, lines of communication, and 2223 documentation of internal and external interface Mi 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
i OQAM l 2234 p2 control procedures shall specify requirementsVeri- for w223 V the selection and accomplishment of a design
-2198-2)b g fication program. The program depth shall be with the importance of the system or 2227 commensurate 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 combination of these. Where alter-the nate calculations are performed to verify be shall correctness of a calculation, a review performed to address the appropriateness of assump- calcula-tions, input data, and the code or other 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 The organization performing design shall have responsibility for design control unless specified otherwise. Design verification shall be performed those who by competent personnel other than 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 in shall be individually documented and approved advance by the supervisor's management. Quality Assurance Department audits shall examine the frequency and the effectiveness of use of supervi-nors 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, procure-be completed prior to release for another g
j;ik
~
-3230 shall ment, manufacturing, construction or to In organization for use in other design activities. the 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 identifiedbased the unverified data are appropriately and controlled. Without verification, site activ-design change ities associated with a design or must not proceed past the point where the installa-3-4 Rev. 16 6/93
OQAM tion would become irreversible (i.e., require 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 9gbh -2204 3.16 Action design process. Errors and deficiencies
" in the 2
/,, 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 bn 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.
of the responsibilities of the design l 3.18 Independent 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 and evaluation which shall be reviewed by the ORC approved by the Manager, Callaway Plant. In addi- the tion, changes in the facility as described in 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 criteria acceptability, and design acceptance 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 evaluating organization, detailed analyses the shall be performed to support the bases of safety evaluations. All nuclear safety evaluations are 3-5 Rev. 16 6/93
1 1
l l
l OQAM l 1
submitted to the ORC. Changes involving the substi- safety tution of equivalent hardware require evaluations to assure that the design requirement the changes are consistent with and do not alter criteria specified in existing design docu-l design ments. When design documents and safety evaluations 'its are prepared by an outside organization under OA program, review and approval per ANSI N45.2.11 will be included. UE will approve all outside organizations' design documents and safety evalua-tions, and will perform appropriate reviews neces-sary for final approval.
ORC shall review design change safety evalua-3.20 The design to recommend final approval of tions changes. Design changes which involve an unreviewed safety question or a change in the Technical Speci-for shall be forwarded to the NSRB fications review. An application for amendment of the license shall be submitted to the Nuclear Regulatory Commission for approval pursuant to 10 CFR 50.90.
3.21 The NSRB shall review safety evaluations to safety verify that changes did not involve unreviewed questions.
1911 3.22 Procedures and instructions related to equipmentand or that are modified shall be reviewed la bi systems to reflect the modification prior to updated to placing the equipment or systems in operation personnel perform safety-related functions. Plant the changes affecting shall be made aware of performance of their duties through procedure revi-sions, or specific training in the operation of modified equipment or systems, or other appropriate means.
current 2039 3.23 Records shall be maintained which reflect evalua-
\ 2132 design including safety analyses, safety procedures, tions, design change installation J -E163-3Jlet identification documents, procurement 2173 material documents, special process documents, equipment and installation specifications, and as-built drawings.
3.24 Drawings shall be prepared under a drawing control and which provides for checking methods system review and approval requirements. Drawings shall be subject to reviews by the responsible design organ-ization for correctness, conformance to design criteria, and compliance with applicable codes and standards.
3-6 Rev. 15 i 6/92
OQAM 1875 4.0 PROCUREMENT DOCUMENT COfffROL 3541 3548 Safety-related procurements shall be documented.
679 4.1 975 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-measures to ments and assign responsibility for design assure applicable regulatory requirements, assure bases, and other requirements necessary to quality are included in procurement documents.
controls, as 3559 4.2 Written procedures shall include content, review, applicable, for preparation, 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 "f3607 employed for item or service acceptance should or j
begin during the purchase requisition, ESA, 3874 /
contract preparation and review stage. Planning of of verificatien activities shall include a review
/
) 1 the establinhed acceptance criteria and identified be documentation. Verification methods which may employed include certifications (certificates 35130 of i 3782 conformance and material certificates or test gggq reports), source verification, receiving inspec-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 and associated verificationitem's activities or a func-is service's tion of the purchased as complexity and relative safety significance, 4-1 Rev. 15 6/92 i
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-35Qsl cult to verify after receipt; or the item. or Zs" jggq 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 Licensing and Fuels Department; or the unit staff.
975 4.6 The procurement of spare or replacement parts for
, 1876 safety-related structures, systems, and components
'j\ '1977-' shall be subject to the QA Program controls in effect at the time the order is issued; and to
/J -1970 ~~ codes, standards, and technical requirements which
-r883--
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
OQAM I l
related structure, system, component or service) evaluationis l governed by the OQAP, an engineering The evaluation shall be shall be conducted.
conducted by Nuclear Engineering-or-Materials Engi- i l
-neering#'and shall classify the safety relationship s
Jjh the service or questionable component, partsand or of items of safety-related structures, systems, for Evaluations shall be documented components.
future reference.
4.8 Provisions for the following shall be included in procurement documents as applicable. These provi-invoking a supplier's sions may be addressed by 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, and any test and acceptance requirements; such as special requirements for activities 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 3550 N45.2-1977 or the ASME code as applicable as .
3553 established for the item or is service to be not applicable to supplied. This requirement l42668 commercial grade items which utilize a suppli-meet er's standard or proven design to l published product descriptions.
audit, 1890 3. Requirements for supplier surveillance, 3550 and inspection including provisions for UE or 3555 agent access to facilities and records and for g
357 3931 identification of witness and hold points.
/\
P 386 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
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.
The Purchasing Department is responsible for 3563 4.13 reviewing purchase orders to verify that the tech-nical and quality requirements have been accurately purchase transferred from the requisition to the '
order. Approval of the purchase requisition, letter intent, ESA, or contract shall be by an indi- ,
of signifies vidual who has approval authority and 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 be the responsibility of the shall Licensing and Puels 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 officer Vice President-Nuclear or another company corporate in accordance with Nuclear Division and procedures related to agreements or contracts for services.
975 4.14 Additions, modifications, exceptions, and other 3543' changes to procurement document quality and tech- i nical requirements shall require a review equiv-g 3649-3f4 B alent to that of the original document and approval 3563 3575 by the originator or the originating department approval authority. Commercial consideration l 42587 changes shall not require review and concurrence by the originator. Conditions specified on the vendor Qual-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 gd13 1. Preparing procedures, instructions, specifica-tions, drawings or checklists of a type appro-j> ,2? g q
,, . priate to the activity and its importance to 1PMI 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 an activity has been satisfactorily that accomplished;
- 3. Having responsible personnel approve these prior to accomplishing an activity; documents and Using approved drawings, procedures, instruc-4.
tions or checklists to accomplish an activity; The degree of control imposed shall be consistent activity to with the relative importance of the safety.
Division and other responsible func- ,
1833 5.2 The Nuclear and departments shall provide written proce-l 1830 tions 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 l
recognized that skills normally possessed by qual-step-by-l ified personnel may not require detailed i
step delineations in written procedures. l 5.3 The Manager, Callaway Plant shall be responsible l for providing specific guidance via Administrative Procedures for the development, review and approval l of other Plant operating procedures to govern which affect safety or quality activities 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 be and Radiological Emergency Response Plan shall reviewed no less frequently than every twelve months (in accordance with Technical Specifica-tions). A revision of a procedure may constitute a j procedure review.
5-1 Rev. 16 6/93
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 '
OQAM l
1875 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND 3541 SERVICES i
7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4.
activ-Provisions shall be established to control ities affecting quality associated with 'the procurement of material, equipment and services !
including: l
- 1. The preparation, review, and change control of procurement documents as described in Section 4 l
- 2. Bid evaluation and award as described in Section 4 ,
3565 3. Procurement source selections
- 4. Verification activities (surveillance, inspec- l 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 .
l 2416 8. Control of quality assurance records l
- 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 j
, acceptable procurement sources. Provisions shall l g '9 3565 3874 be made for supplier evaluations which assess their evalua-l capabilities prior to award by: 1) source tion; or 2) review for objective evidence of qual-ggsf6 ity; or 3) a review of supplier history. ofWhena evaluations are performed, the assessment shall be specific to the supplier's capability procured item, commodity, or service and the I supplier's ability to provide the items or services require-l in accordance with procurement document ments. Suppliers of hardware and services which are commer-manufactured prior to award, considered a OQAP cial grade item, or implemented under the UE evaluation or do not require pre-award source post-award audits which attest to their capability as a procurement source.
i 7-1 Rev. 16 ,
6/93 l t
OQAM 3565 7.6 Procurement source selection and evaluations shall 3566 consider one or more of the following:
y 3Gv4 3564 1. Experience of users of identical supplier. or similar NRC products of the prospective Contractor and Vendor Inspection Licensee Program (LCVIP) reports, ASME Certificates of Authorization (C of A), previous audit reports, UE records accumulated in procurement actions, and UE product-operating experience be used in this evaluation.
Supplier may capability.
history shall reflect recent experience with Previous favorable quality judge-stpoliers may be an adequate basis for ments attesting to their capability. When an LCV.P 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-evaluated. This may include review and tively Program, evaluation of the supplier's QA Procedures, as appropriate; and Manual, 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.
commercial grade items, the procurement
- 4. For ;
source selection should consider one or more of l the following:
- a. Survey of documented supplier controls over ,
critical characteristics and that supplier items the activities adequately control supplied, and verify the implementation of l manufacturer's measures for control of design, process, and material changes.
- b. Acceptable supplier / item performanceofrecord the utilizing monitored performance item, industry product tests, national codes, and standards !.not specific to the nuclear industry), or other industry EQDB, data-ANSI, bases (UL, INPO NPRDS, EPRI NEMA, MIL-STDS, NRC Bulletins / Notices, and ,
I Reports, etc.) that is Licensee Event 7-3 Rev. 16 !
6/93
]
T OQAM directly related to the item's critical 7.7 characteristics and intended application.
Procurement technical andsource quality evaluations involve a review of Technical considerations assurance manufacturing include considerations.
the design or suppliers to capability produce or andprovide technical ability of um service, item, or component.
the design, considerations Quality defined methods include of supplier one of the assurance previously consideration of evaluation and a Assurance Program changes in a supplier's Quality or capabilities. The measures employed ability to evaluate a supplier's continued accept-as a procurement source (after the initial 1892 7.8 source evaluation) are described in Section 18.
Organizations 3 s 71 process shall participating in the procurement evaluate prepare procedures to monitor suppliers' performance to and document requirements. These procurement include provisions procedures shall for: 1) controlling documents generated or requirements; procurement processed during activities fulfilling processing change information; 2)
- 3) identifying and method establishing a exchange of control with theand documentation of information l supplier; and 4) audit surveillance of supplier activities. or 3572 7.9 Dependin i A 3573 g\ 3rga service,g on thethePurchasing complexity or scope of the item or originating organization Department and/or the activities. Meetings or other forms shall initiate of communica- award tion monitoring andmay be held to establish the intent of UE in mance, establish evaluating the supplier's perfor-requirements, an understanding of procurement be and utilized in fulfilling requirements. Theand depth toidentify suppli tion necessity of these activities shall be a func-ness, ofcomplexity, the relative importance, quantity, unique-the frequency of transactions with mance.same UE supplier, and the supplier's past perfor-mented hold and witness points shall be docu-process. as early as practicable in the procurement 3574 7.10 The ures originating for monitoring organization shall establish meas-submittals against supplier generated procurement document document require-ments.
reviewing Similarly, and measures shall be established for ments for shall use. approving Changes tosupplier generated docu-procurement documents in Section 4.be in accordance with the controls described
_. --' ,, _ . . - - ^~'
OOAM 3565 7.11 Supplier monitoring activities may be performed by pa9 personnel from Quality Assurance, Nuclear Engineer-i ing, Nuclear Services, Nuclear Safety and Emergency Preparedness, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests.
Supplier monitoring activitics may include:
- 1. Audits of supplier quality assurance program a implementation
- 2. Monitoring, witnessing, or observing inspec-tions, examinations, and performance tests
- 3. Surveillance of manufacturing processes
- 4. Audits of supplier records to verify certifica-tion validity and the resolution of nonconfor-mances 2337 7.12 To support the control of purchased material, copies of purchase orders and other appropriate procurement documents shall be forwarded to the applicable receiving or acceptance point. Depart-ments receiving or utilizing procured items or services shall establish measures to maintain and control procurement documents until the items or services are received and accepted. These documents shall include purchase orders, drawings and speci-fications, approved changes, and other related documents.
975 7.13 Receiving inspection instructions shall be 2337 documented. These instructions include specifying 2416 inspections or tests of commercial grade items procured from suppliers on the basis of product performance. Should it become necessary to upgrade stocked non-safety related items to specific requirements, inspections, tests, or documentation reviews may be employed to establish the items' acceptability. Documentation shall be generated as a result of UE receiving inspection activities.
975 7.14 Acceptance of items and services shall include one 1891 or more of the following:
l 1892 3608
- 1. Written certifications
- 2. Source verification
- 3. Receiving inspection
- 4. Post-installation test (in addition to one of the above) 7-5 Rev. 16 6/93
OQAM Commercial grade items shall rely on proven design 1876 7.15 and utilize verification methods by the purchaser, l1892 to the extent appropriate to item application.
3565 Procedures provide for the acceptance of cohmercial 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 by audit adequately implemented as verified (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 of certificates of conformance. When certificates conformance are employed as a means of item accep- supplier tance, verification of the validity of certificates and the effectiveness of the certifi-at intervals cation systems shall be conducted past quality commensurate with the supplier's of conformance and performance. Certificates compliance shall be required to be signed or accom- Where by a signed letter of transmittal.
panied acceptance is based upon source verification, docu- be mented evidence of these surveillances shall furnished to the Plant Quality Control organization by the responsible UE organization or their desig-nated agent prior to acceptance.
7
-1864- 7.17 Acceptance by receiving inspection shall be 3606 utilized as a prime method of verification and may acceptance be utilized as the sole means of item when items are relatively simple and standard in design and manufacture, such as certain spare when items are adaptable to standard or parts; 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
I OQAM IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND 8.0 COMPONENTS 975 8.1 The identification and control of materials, parts,
-1884- and components shall be accomplished in accordance to and documented procedures apply '
with components 7
_.=b -1885-[g 7(o safety-related materials, parts, and during fabrication, storage, installation or use. :
as l Materials, parts, and components identified in nonconforming shall be controlled as described l Section 15. ,
1897 8.2 The identification and control requirements shall 2090 address traceability to associated documents, as
(#
2333 appropriate; specification of the degree of identi-2337 fication and control necessary; location and method 2pdi of identification to preclude a degradation of the item's functional capability or quality; and proper j;p(3 identification of materials, parts, and components manufacturing, shipping, prior to release for parts, construction, or installation. Materials, and components manufactured or modified by UE shall be controlled and identified during manufacture.
-189+ 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 fabricat<;d blies. Procedures shall also specify measures for material control including storing and controlling of items; controlling the issuance acceptei accepteo 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 identifications are verified and documented prior to release.
1895 8.4 Physical identification shall be employed to the maximum possible extent for relating an item at any I
1896 in time to applicable design or other perti-2318 point 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. the identification or marking shall not affect form, fit, or function of the item being iden-identification is not tified. Where physical employed, physical separation, procedural control, tags, or other means shall be utilized.
items, Identifica-or records tion shall be maintained on erection, traceable to items through fabrication, 8-1 Rev. 15 6/92
OQAM 9.0 CONTROL OF SPECIAL PROCESSES 1851 9.1 Special processes are fabrications, tests, and require in-1937 final preparation processes which
(-1004 "2- process controls in addition to final inspections ys g;qd to assure quality. Special processes also require and 13 the qualification of procedures, techniques, personnel in accordance with the requirements of specifications, or applicable codes, standards, 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 be personnel, procedures, or equipment shall defined by Nuclear Engineering.
l 2260 9.2 Procedures for special processes shall be qualified also as part of their approval process, and shall acceptable provide for recording evidence of accomplishment of the special processes. Personnel qualifications shall be certified and equipment shall be qualified prior to use.
9.3 The responsible Plant Department Head shall assure that personnel performing special processes are qualified and are employing approved procedures. QA audits shall be performed to assure special processes are performed by qualified and certified personnel. Nondestructive examination (NDE) personnel shall be qualified in accordance with procedures established to meet thetorequirements which UE is of the Code Edition and Addenda 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.
Planning for mainterance shall include evaluation ,
1857 9.5 equipment and I of the use of special processes, including materials in performance of the task, l assessment of potential hazards to personnel and l equipment.
9-1 Rev. 16 6/93
OQAM 2974 10.0 INSPECTION l
42430 42431 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-j(h gpqq Inspections and monitoring of processes tions. be gyq5r which serve an inspection function to shall by personnel qualified perform performed assigned tasks and who are independent of individ-uals who perform the activity.
inspection of structures, 10.2 Required innervice planned and systems or components shall be 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 the status and 1937 shall be at intervals based on be l
importance of the activities. Guidelines shall for established to indicate the minimum frequency inspecting maintenance, modification, and special processes activities to provide a basis for subse-quent monitoring planning.
10.4 Nuclear Engineering shall be responsible for development of preservice and assuring the 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 proce-and the dures to reflect "as-built" conditions requirements of the applicable Code technical Edition and Addenda prior to the issuance of the !
inservice inspection plans and procedures.
Engineering shall be responsibletesting for ,
10.5 Nuclear l assuring the development of the inservice program plan for pumps and valves, the test proce- of dures required by this plan, and the securing In addition consulting services in this area.
Nuclear Engineering shall be responsible for admin- and istering and performing the PSI /ISI program plans examination and testing implementing the are developed within the Nuclear Division. They plans l 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 l
to conduct the PSI /ISI examinations.
l 10-1 Rev. 16 (
6/93
7- _. -
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 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.
\
10.7 Quality Control inspection personnel or other unit f]3[~"18512263 staff organizations who perform " inspection" 2479 activities shall be qualified within their respec-7,y 3 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.
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-l?M7 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.
l 2482 10.9 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 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 contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing the examination would be qual-i 10-2 Rev. 16 6/93
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 1931 shall provide for the following, as required:
Pf;r73 1) the inclusion of independent inspection or moni-
);) g,g g toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta-tion of inspection results; 4) a description of the M3I 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 1973 specify inspection scope; personnel qualification 2039 requirements; and data collection requirements.
Inspection or testing, as appropriate, shall be l2979 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.
1 1932 10.13 Indirect control by monitoring processing methods, ,
--1933 equipment, and personnel shall be utilized as a l control if inspection of processed items is impos- ;
sible or disadvantageous. Both inspection and moni-toring of processes shall be provided when control is inadequate without both, i
1934 10.14 Inspection data shall be analyzed and evaluated to 4 verify completeness of results, achievement of ,
l 1973 2125 inspection objectives, and operational proficiency 2262 of equipment and systems; to identify additional :
42479 inspection requirements; and to identify necessary l changes to the installation inspection procedures. 1 The acceptance of an item shall be documented by authorized personnel. Modification, repair or i replacement of items performed subsequent to final inspection shall require reinspection or retest to verify acceptability.
10-3 Rev. 16 6/93 l
OQAM performed in accordance with 1938 11.6 Testing shall be reference written procedures which incorporate or 2055 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 all prerequisite conditions are met; test equipment instruc-
{8hl32 calibration requirements; testing method limiting 2o75 hold or witness points; tions including 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-verify completeness 1934 fled individuals or groups to and 1973 of results, achievement of test objectives, 125 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 14.
3 13 be identified in accordance with Section 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-fled 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 activities being performed. The Superintendent, l Training shall be responsible for providing related technical and quality training for UE personnel who l perform testing. l 2263 11.11 Personnel within the various UE organizations may 2479 perform testing activities including implement.ing 2480 test procedures and the evaluation and reporting of test results. The assignment of Plant testing l 2482 11-2 Rev. 16 6/93
OQAM 12.0 CONTROL OF MEASURING AND TEST EQOIPMENT 1919 12.1 Measuring and test equipment utilized in activities 1920 affecting quality shall be controlled in accordance 1969 with written procedures or instructions. The 2042 procedures for calibration and control shall cali-address the identification of test equipment,
/"2264 bration techniques, calibration frequencies, requirements.
main-The tenance control, and storage (1) 1081 equipment subject to these controls includes:
s 3336 test equip-M&TE (portable measuring instruments, ment, tools, gages, and non-destructive test safety- equip-used measuring and inspecting ment in (2) related structures, systems, and components);
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- to 2060 tained at specified intervals or prior to use calibrated assure the necessary accuracy of reference standards shall be
}{5 203D devices. M&TE and tagged or labeled indicating the date of calibra- ,
l tion and the due date for recalibration.
12.3 Permanently installed process instrumentationherein shall l be afforded the control measures described program with the surveillance testing consistent and preventive maintenance program. 1 12.4 The calibration and control program established at refer-l the Callaway Plant shall assure that M&TE, required 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 to perform 7,g" zo64 by various organizations as required organiza-tests or other special operations. Each that the tion shall be responsible for assuring M&TE or Outside reference standards it using organizations uses have M&TEbeen cali-or refer-j brated. I ence standards at the Callaway Plant in activities implement affecting quality shall be required to with calibration and control measures consistentthis section.
applicable requirements of the than Vendors activities performed offsite, other calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 9 of OQAM Section 12.6 unless specified in procure- ,
1 12-1 Rev. 15 6/92
OQAM ment documents. Vendor-provided calibration services for Callaway Plant METE or PI are required to be consistent with the requirements of item 8
and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using M&TE or reference standards at the Callaway Plant in activ-ities affecting quality shall be required to imple-ment a calibration and control program consistent with the requirements described herein, or control or reference their activities relating to M&TE standards via the Callaway Plant calibration and control program.
\
12.6 The calibration and control program shall provide
- gg gpg l_ for:
1923 1. The assignment of specific calibration inter-vals, calibration procedures which specify calibration methods, and instrument accuracy be a requirements. Interval selection shallinherent function of the equipment type, stability and reliability, intended use, which required accuracy, and other conditions 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 ,
dates. A recall next scheduled calibration 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 calibration and for new or replacement items requirements for accuracy, including the stability, and repeatability.
l stan-
- 8. M&TE shall be calibrated from reference f dards with an accuracy ratio of at least four-i 12-2 Rev. 15 6/92 l
OQAM 13.0 HANDLING, STORAGE, AND SHIPPING p75 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-2Ld 3 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; however, detailed procedures or instructions shall 2416 be prepared for the handling, cleaning, storing, 41668 maintaining while stored, or shipping of certain e'l items and typesofequipmentormaterial.f?Appli- (}y cable manufacturer instructions and recommenda-j tions, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering
' review.
2354 13.3 I 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 equipment 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 1
which specify acceptance criteria. Routine inspec-tions shall determine the acceptability of equip-ment and rigging. Routine inspections shall be supplemented by nondestructive examinations and proof tests as delineated in procedures for items l requiring special handling. Personnel performing I
l l 13-1 Rev. 16 l
6/93
OQAM l
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 l 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 15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 1848 15.1 Material nonconformances include material deficien-1870 cies (including inoperative and malfunctioning 1907 structures, systems, and components). Material 2045 nonconformances identified under the UE OQAP 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
-180S'jBl%g (NMRs), nonconformance logs, or other administra-1903 tive controls shall be employed to identify and
,-)
}{x 1907 control nonconformances. Nonconformance logs may be employed to control deficiencies of a minor natureof 2328 2334 or to control documentation deficiencies both deficiency which can be corrected by bringing the original requirements.
3600 into compliance with the shall be controlled, as Material nonconformances marking, appropriate, by documentation, tagging, The programs logging, or physical segregation.
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 to reliance 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 nonconforming. Procurement documents shall specify those nonconformances to be
]) ( submitted to UE for approval of the recommended 3591 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 besupplier-respon-sible for assuring the processing of 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 )
J dispositions of nonconformances regarding procure-
)
ments they initiate.
15-1 Rev. 16 6/93 ,
I l
OQAM 1904 15.4 Material nonconformances shall be processed in I 1905 accordance with documented procedures and shall identify the specifics of the nonconformance ,
1907 particular drawing, specification or !
stating the I other requirement; shall record the disposition; and shall register the signature of an approval i authority. Procedures shall prescribe the individ-responsibility and uals or groups assigned the 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) return
- 2. " Reject" or "not acceptable, scrap, or to vendor"
- 3. " Rework" in accordance with approved procedures
- 4. " Repair" in accordance with approved procedures Material nonconformances shall be reviewed and condi-accepted, rejected, repaired, reworked, or documented tionally released in accordance with procedures. An approved disposition of a nonconfor-mance which allows a reduction in the requirements safety-related structure, system, or subject compo-of a 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 p
of such fuel at the Callaway Plant.
arrival identified
\yC(LuH d4 Regarding material nonconformances responsible for on-site, OC personnel shall be h m p.ua,Le iof that approved dispositions have been g,m g , , %lwul verification implemented and for the final sign-off.
l
% ,4 4 Nonconformance documents which record defects in MUf# "S 15.7 components or deviations from technical u ' 4 ke L p basic be requirements in procurement documents shall g y( bg lof for reporting applicability under 10CFR21 I reviewed jggf'>'" (6' and other Federal reporting requirements. Signifi-i
' MM " A I - cant nonconforming conditions involving a defect or material noncompliance in a delivered component or I
service which could create a substantial safety hazard shall be reported to the Nuclear Regulatory Commission pursuant to the requirements of 10CFR21.
l, l
15-2 Rev. 14 6/91 l
r e.- s.- - -
1 l
OQAM l
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 <:he 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 l 1904 tested. Measures may be established to condition- !
1906 ally release nonconforming items whose disposition l 2053 is pending, provided that an evaluation indicates i l
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 semiannuallyfPor--nonconforences diseevered-upon--
-receipt- inspection-of-new-purchasse er discovered-
-afte r an-item-has-been-accepted by-ceceipt inspec.-
] -t-ion-bu t_be f o re--i ssue-E-rom--the-warehouse , Lhe Licud
-Manager , Operat-lons Supper L shah-have-the analysis-prepared. Foi nonconformances discavered
--af ter-issue-or-on-items-cone-idered-inst 611ed, the O.L Manager, Nuclear Engineeringtsha-ll have t-hc trend
-anal-ysis-preparedr-The Quality Assurance Department shall perform an independent review of these analysesj through routine audits and surveillance n activRies, The-result-of-these-assessmente-sha-11--
[_
quk re[ooe t -be-repor ted--to -management N L L vtsa lb S rw a w g c,wc.vP 1
l 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 3699 proceduralized. These procedures, as a minimum,
-g oa 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 i by external agencies concerning conditions I 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 l 18.12. i l
16-1 Rev. 16 1 6/93 l 1
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 established by UE. They shall apply to j
records associated with startup testing, operation, maintenance, repair, refueling, and modification of 2dgg safety-related structures, systems, and components 16 3 at the Callaway Plant.
s 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 af the inspector or data recorder
- 4. Evaluation of the acceptability of the results
- 5. Action taken in connection with any deficien-cies noted l
17-1 Rev. 15 6/92 l
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.
s 2129 17.6 Record systems shall be established by the Adminis-2 ytrTr~ tration organization for the Nuclear Division and 2136 shall be controlled in accordance with written e449- procedures. The implementing procedures shall address records administration; receipt of records; 73 99 -239$ 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 P -M 46--
The requirements regarding receipt of records shall 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.
17-2 Rev. 14 6/91
. I l
l OQAM l
izing control.and implementing a system of records receipt an The records' receipt control shall permit i receiving process. assessment of the status of records during the 2150 17.9 2151 The requirements regarding storage, preservation, elae
~~'
and safekeeping requirements of records for the shall establish storage maintenance 2153 2155 protection of quality assurance r,ecords. preservation, and requirements These a control of, shall include access to, and methods for maintaining records; storing accountability for deterioration; records in a manner to preclude and providing record storage facil-ities tion which protect contents from possible destruc-by causes such establishment of a single as fire. An alternative to the shall be record storage facility the records in a remote maintenance of a duplicate copy of storage location. Where duplicate not be is employed, the storage environment need but uniquely controlled in each storage area, humidity. be the prevailing building temperature and may A 2157 17.10
\
'2159-- Record storage systems shall provide for an accurate Those recordsof information retrieval delay. without undue organization maintained by an outside the buyer or shall UE; be required to be accessible to for in the case of lifetime records the life of the items involved or for nated retention times for nonpermane,nt records.desig-
/ 2160 17.11
/ --4161 Record disposition practices shall establish requirements I for the transfer of others to UE. Upon final transfer, records shallfrom records be inventoried against any processed in transmittal forms and Nonpermanent recordsaccordance with written procedures.
specified retention period shall be retained for the retention period they are no; after the specified maintained as records. longer required to be 17-3 Rev. 14 6/91
OOAM 1875 18.0 AUDITS 2180 3869 41639 2186 18.1 A comprehensive audit program shall be established dx 2199 2t89 and implemented by UE to verify internal and
- 2978 external quality activities' compliance with the 2988 OQAP. The audit program shall assure that all g
3865 applicable elements of the Program have been 3867 developed, documented, and are being effectively 3883 mplemented 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 Assurance (QA) Department. Audits determine, l
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 componenta is maintained, that facility operations are within the safety limits, and that limiting conditions of operations are being met (surveillance tests). QA personnel performing to surveillances should be familiar with the area 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 s 2250 training of QA Department audit and surveillance 2255 personnel. Audits shall be directed by an Audit I 796-3 JL 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
OOAM 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.
1 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
I i
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 I measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures !
of production when opposed to safety or quality. l The Manager, Quality Assurance has direct access to l 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 l 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- l I
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 l provided copies of internal and external audit i reports. The audits described in the Callaway Plant I Technical Specifications which are performed under l the cognizance of the NSRB shall be conducted by 1 the QA Department. I l
1792 18.7 Internal audits shall be conducted by the QA 1816 Department and shall be performed with a frequency l t143- 2 M, commensurate with their safety significance. An 3873 audit of safety-related functions shall be I 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 l 2681 safety-related functions, other activities shall be 1 2847 audited under the cognizance of the NSRB at the l 3873 frequencies indicated in Section 6.5.2.9 of the Technical Specifications and the Radiological Emer-l l 41777 gency Response Plan. In addition to audits 18-3 Rev. 16 t
r 6/93
l OQAM conducted under the cognizance of the NSRB, the 3 following areas shall be audited at-least-once per 33 12-monthee (W W %urncg yed h ed + aff Q LQ ,
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 S
Mg 3534 Department as a method for the evaluation of
,Mi 333 6 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 OOAM and shall be conducted in accordance with this OQAM and QA Department procedures. Commercial grade items do not require pre- or post-award audits. Similarly, items which are relatively simple and standard in design and manufacture may not require supplier qualification or post-award audits to assure their quality.
1780 18.11 Applicable elements of suppliers' quality assurance 3565 programs shall be audited (post-award) on a P3878 triennial basis. Audits generally should be g' initiated when sufficient work is in progress to jdb)3872 determine whether the organization is complying 33q L with the established quality assurance provisions.
Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same supplier shall be considered in estab-lishing audit requirements. In addition, the need for a triennial audit may be precluded upon evalua-tion and documentation by the QA Department that the results of mini-audits performed during source verification and source surveillance activities confirm the adequacy and implementation of the supplier's QA Program.
18-4 Rev. 16 6/93
OQAM 3565 18.12 3566 Supplementary to audits, annual evaluations of suppliers shall be performed which
- 3 3546 account, as applicable
- 1) the review of take into supplier furnishednonconformance mance, documents such as certificates of confor-notices, actions; and corrective
- 2) results of previous source tions, verifica-ating experience of identical or similar 3) oper-audits, and receiving inspections; furnished by the same sup products audits from other sources. plier; and 4) results of 3565 18.13 mm 3872 Audits shall also be conducted when: 1) significant g 9895- 33% changes are made in functional areas of the Quality 3883 Assurance Program such as significant reorganiza-tion or procedure revisions; or 2) when it is suspected that the quality of the jeopardy item is in ance due to deficiencies in the Quality Assur-Program; or 3) when a systematic, independent assessment of Program effectiveness is necessary; or 4) when it is necessary considered to verify implementation of required corrective action.
3876 18.14 3878 Audits shall be conducted using written plans in 3881 accordance with QA Department procedures. The procedures ities, require evaluation of work areas, activ-of processes, goods, services, and the review tices, documents and records for quality-related prac-procedures, and instructions to determine the effectiveness of the implementation and compliance with 10 CFR 50, Appendix B and of the OQAP Callaway Plant Technical Specifications. The audit the plan shall identify the audit scope, the ments, require-to the be notified, activities to be audited, organizations the applicable documents, the schedule, and the written procedures or checklists as appropriate.
The audit plan and any necessary reference team members. documents shall be available to the audit 3877 18.15 An audit Lead Auditor team consists of one or more auditors. A The shall be appointed Audit Team Leader.
Audit Team Leader shall be responsible for tbs written plans, checklists, team orientation, audit notification, pre-audit conference, audit mance, perfor-post-audit conference, reporting, records, and follow-up activity to assure corrective action.
Any adverse findings shall be reported in a audit post-organizationconference with team members and the audited subject to the Section 4.3.3 of ANSI N45.2.12 in clarificationAppendix A. When of a post-audit discuss conference is held it shall be, to items and arrive at a general agreement on the identification of the findings. Formal audit reports shall be prepared and submitted audited organization within thirty days after to the post-audit the conference or last day of the audit, whichever is later.
18-5 Rev. 15 6/92
ya S OOAM APPENDIX A REGULATORY GUIDE 1.8(cont.)
The experience,
' positions training, Operator, of Shift Supervisor, Operating Supervisorand for theeducation lAdvisorshallmeetorexceedthand personnel , and Reactor fulfilling th of ANSI /ANS 3.1-1981 echnical i For as endorsed by the Regul te requirements and recomme*
a ory Guide 1.8.
all other with ANSI positions, qualification and traini
/ANS 3.1-1978 Refer to as clarified belo w: ng shall comply qualificationsCallaway-SA FSAR Section 13.1 for a di support. scussion of the of personnel responsible for plant operation and safety-relatedPersonnel responsible for directing and approval preoperational procedures or and startup tests and foror supervising the of safety-related preoperational andrsta up t review Guide, but were not required to beresults met the qualifications test of the With re certified. Regulatory
_tation: gard to Section 5.6 of ANSI /ANS the requirements of OOAM Section herein. 17UE 3.1 - 1978 nce titledshall with Documen-and to maintain meet recor and ANSI N45.2.9 as specified UE may use additional non-Callaway personnel report to augment employees or are not to the Manager-Callaway Plant.the unit staff. These contract persons may o ma supplemental limited to, UE personnel from These groups other pl include,y not but k to EP and I&C technicians and QC inspect ants as well as t
the perform safety-related activities, these pe ors. When used for equivalent Wb education and experience requirements rsonnel of shallANSImeet /
existT by rhese personne~13meUE staff positions.
If no ANS equivalent 3.1 - 1978 Union Electric or by Vendors wiy be qualified for positions training assigned tasks either testing and qualification programs.th Union Electric approved as inspection, toexamination and testinpersonnel shall meet the re 4
UE's Appendix. commitment certification ANSI N45.2.6-1978g personnel as set forth in given elsewhere in this
' REGULATORY GUIDE 1.28 REVISION 2 Quality DATED 2/79 (Endorses ANSI N45.2-1977) Assurance Program Requirements (Desi gn and Construction)
DISCUSSION:
This Re However,gulatory related ANSI items,N45.2-1977 Guide will beisapplied not applicable to su to the operating phase.
components or ppliers of services, as safety described under Regulatory Guide . 1 123 (Aappropriate, as NSI N45.2.13-1976).
A-2
OOAM 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 ofphrase Section" 3.2.1 deleterious and (5) above, and the definition of the 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 use and Wrap Material and Dessicants: This Section requires the of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the UE position.
N45.2.2 - 1972 titled With regard to Section 3.7.1 of ANSI lbs.
Containers: Cleated, sheathed boxes may be used up to 1000 rather than 500 lbs. as specified in 3.7.l(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs. PPP-B- Other 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 ofwith1000a lb. in weight. Skids or runners shall be used on boxes suffi-gross weight of approximately 100 lb. or more, allowing provided 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 use of fully enclosed furniture vans, requirement. as recom-Carriers: The mended in (2) of this Section, is not considered a Stated for information only, UE shall assure adequate protection from weather or other environmental conditions by a combination e:C
- M'q of vehicle enclosure and item packaging. ___
_7 l With regard to Sections.Precautions 4.3, 4.4 and 4.5 of ANSI-N45'.'2.2 During Loading and Transit,
- 1972 f
titled, respectively, ;'$
Identification and Marking, and Shipment from Countries outside the United States: UE shall-comply with the requirements of these Sections i
- l. subject to the clarifications taken to other Sections / )
I which are referenced therein. -- - - . - ~ \
l 3 . titled Ship-With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 ping Damage Inspection: Stores personnel shall normally visually in scrutinize incoming shipments for damage of the types listed I
this Section; this activity is not necessarily performed prior to of l
Since required items receive the ItemShipping Inspection l unloading. Damage l Section 5.2.2, separate documentation of the l Inspection is not necessary. Release of the transport agent after l unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping A-15 Rev. 15 l 6/92
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: Definitions in Regulatory Guide 1.74 in (ANSI this Standard N45.2.10)which shall arebe not included 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 zone 2.1 - Planning: UE may choose not to utilize the five- jani-level 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 As inspections which shall be performed prior necessary, (e.g. the opening is larger thanto system closure. and the tools being used) control of personnel, tools, equipment, opened supplies shall be establishedrefueling, when the reactor system is modification or repair.
for inspection, maintenance, housekeeping requirements shall be implemented as Additional required for control of-radioactive contamination.-- _ _.--_ _-._ g.. y I
Section 2.2 - Procedures and Instructions: Appropriate procedures
-)d\ shall be written and implemented.
\
~
J ([h
(, .
_f _ _._ _ _ _ _ -
"Section 3.2 - Control of Facilities: UE may choose not to utilize but shall utilize system, the five-level zone designation of standard janitorial and work practices to maintain a level areas cleanliness commensurate with Program requirements in the 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 refueling or repair.
for inspection, maintenance, modification, implemented as Additional housekeeping requirements shall be required for control of radioactive contaminaticn.
A-19 Rev. 15 6/92
i OQAM )
APPENDIX A l 1
j REGULATORY GUIDE 1.39 (cont.)
Records: The requirements of OOAM Section 17 and Section 4 -
this Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in 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.
REGULATORY GUIDE 1,58 REVISION 1 DATED 9/80 ;
Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)
DISCUSSION:
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 expe-rience, training, and retraining to assure competence in accor- 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 tions of actual work proficiency that these individuals comparable or equivalent competence. Persons performing Nondes-tructive Examinations (NDE) as may be required bycertified Section III or as XI of the ASHE 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 VT-3, and ifying personnel to perform visual examinations XI, VT-2,Division 1, VT-4 in accordance with IWA-2300 of Section N45.2.6-1973 ANSI /ASKE N45.2.6-1978 may be used instead of ANSI (Code Case N-424). Persons certified to perform NDE for Code work non-Code NDE shall also be considered as qualified to perform (e.g. crane hook inspection) unless more rigorous qualification or certification requirements are imposed by UE's commitments or government regulations.
A-20 Rev. 15 6/92
OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)
The specific location of a record "within a storage area" may not sithin a computer be delineated. (e.g. The specific location may not be constant. Further, UE may utilize a record file computer assisted random access filing system where such location be could not be readily " documented," or would such a location
" relevant.") The storage location shall be delineated, but where with time, the specific location of a file locations change record within that file may not always be documented.
With regard to Section 4.2 of ANSI N45.2.9 - 1974 titled Timell-ness: UE's contractual agreement with its contractors and supp-shall constitute fulfillment of the requirements of this liers Section.
"A With regard to Section 5.3.3 of ANSI N45.2.9-1974: The phrase agreement ,
method for verifying that the records received are inrecordt are-in good . .
t- h p L with the transmittal document -anddhat- Callaway Plant
/> -condi-td on" , is clarified to mean that internal 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.
following clarification is substituted for the current The subsection 5.4.3: " Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microfilm from excessive light, and magnetic media) to prevent damage electromagnetic fields, temperature and humidity as stacking, 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-keeping: Routine General Offices and Plant site security systems be provided: no special security and access controls shall systems are required to be established for record storage areas.
Facil-With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled and ity: This Section provides no distinction between temporary 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-
--those age) or being placed on microfilm. Open-ended documents over an revised or updated on a more-or-less continuing basis and extended period of time (e.g. personnel qualification documents, equipment history cards, master audit or training master surveillance schedules) and those which are cumulative in A-25 Rev. 16 6/93
l 1
i i
OQAM APPENDIX A REGULATORY GUIDE 1.88 (cont.)
room log !
(e.g. nonconforming item logs and control I nature are not books)-- are not considered as QA records since they
" complete." These types of documents shall becomethe QAmaster records audit when l they are issued as a specific are revision (e.g.,
filled-up or discontinued (e.g. log nchedule); when they l books or equipment history cards); on a predefined periodic shall basis be when the completed portion of the on-going document transferred to document control as a " record" (e.g. training and j qualification records).
titled Audits:
' With regard to Section 5.7 of ANSI N45.2.9-1974 2 and 3 are accomp- ,
These by l specific through activities in sub-sections 1,the establishment of administrativ l lished the responsible management. 1 l
Audits of these administrative controls are performed in accor- Guide this OQAM, Section 18 and commitments to Reg.
dance with 1.144 in this Appendix.
require a two-hour x, Paragraph 4, subsection 3 is clarified to i ,
minimum fire rating to be consistent with the 1979 version of(Gui- the Standard and NRC Criteria for Records Storage Facilities
' dance-ANSI N45.2.9, Section 5.6) issued 7/1/80.
4, subsection 9 is clarified to read: "No pipes lighting, or l Paragraph penetrations except those providing fire protection, are to be control, or communications temperature / humidity within the facility and they shall comply with a minimum located j3 two-hour fire protection rating."
or Where duplicate storage is employed, no special precautions l
provisions (including vault storage, special humidity and tempe-
! rature recorders and similar items) are required.
i to I
Paragraph 5 is clarified to read the same as our commitment requirement subsection 5.4.3. Both paragraphs address the same
_,y and therefore the commitment must be the same.
DATED 4/76 REVISION 1 REGULATORY GUIDE 1.94 and Quality Assurance Requirements for Installation, Inspection the Testing of Structural Concrete and Structural Steel During I
Plants. (Endorses ANSI Nuclear Power l
Construction Phase of N45.2.5-1974)
I DISCUSSION:
Regulatory Guide UE complies with the recommendations of this l
with the following clarifications:
I Rev. 16 A-26 6/93
o ATTACHMENT 3
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OQAM, REVISION 17 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGES TO THE OQAM
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Attachment to ULNRC-3015 Page 1 of 2 i
Description of and Justifications for Proposed Changes to the Operating Quality Assurance Manual (OQAM)
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The bracketed numbers [ ] in this attachment may apply to several changes. The affected OQAM sections are referenced following each justiGcation. It should be noted some sections may appear under more than one justification. Based on Union Electric's evaluations, the proposed changes do not represent a reduction in the Operating Quality Assurance Program (OQAP) as previously accepted by the NRC.
The OQAM continues to meet the requirements of 10CFR50, Appendix B.
[1] Organization changes made to improve interdepartment and/or intradepartment coordination and efficiency. (Sections 1.2, 1.3, 1.7, 1.12, 1.18-1.21, 1.23, 1.26, 2.1, 4.7, 15.10)
[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 1.6, 1.11, 1.21, 1.24, 1.25, 2.0, 2.6, 2.10, 3.1, 3.4, 3.5, 3.6, 3.8, 3.12, 3.13, 3.14, 3.15, 3.16, 3.22, 3.23, 4.3, 4.4, 4.6, 4.8, 4.14, 5.1, 7.2, 7.6, 7.8, 7.9, 7.10, 7.11, 7.17, 8.1, 8.2, 8.3, 9.1, 10.1, 10.7, 10.8, 10.10, 10.13, 11.7, 11.8, 12.1, 12.2, 12.5, 12.6, 13.1, 13,2, 15.2, 15.3, 16.1, 17.1, 17.6, 17.8, 17.9, 17.10, 17.11, 18.1, 18.3, 18.7, 18.10, 18.11, 18.12, 18.13)
[3] Editorial changes made to remove redundancy, clarify references, clarify terminology, reformat in a more logical sequence or to clarify meaning.
(Sections 1.20-1.26, 13.2, Appendix A Reg. Guide 1.38, Reg. Guide 1.39, Reg.
Guide 1.88)
[4] Minor wording changes (clarifications) made based on an NRC telecon on 9/3/93 dealing with the initial OQAM Revision 16 submittal. These changes do not increase or reduce any previous commitments. (Sections 15.10, Appendix A Reg. Guide 1.8, Reg. Guide 1.88)
4 Attachment to ULNRC-3015 Page 2 of 2
[5] Changed wording on the frequency required for audits not under the cognizance of the NSRB and Technical Specifications. Since regulations now associated with these areas require annual audits, this is not a reduction in commitment. The change will, however, allow frequency changes in the future if the associated regulation changes. (Section 18.8)
[6] This change will allow the most appropriate department to disposition nonconformances. I&C has been previously allowed to perform these design related dispositions by delegation per OQAM Section 3.10. These evaluations will be performed in accordance with plant procedures which require an engineer to perform them. Because I&C engineers have access to the same technical and background information and are equivalent as far as qualifications, this is not a reduction in any previous commitment. it is merely a clarification to clearly state I&C is allowed to perform these dispositions. (Section 15.6) 4 J