ML20081H847
ML20081H847 | |
Person / Time | |
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Site: | Callaway ![]() |
Issue date: | 06/11/1991 |
From: | Laux J, Schnell D UNION ELECTRIC CO. |
To: | |
Shared Package | |
ML20081H845 | List: |
References | |
NUDOCS 9106200063 | |
Download: ML20081H847 (179) | |
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{{#Wiki_filter:- - - - - - _ _ - _ _-_ _ j ATTACHMENT 1
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OQAM, REVISION 14 UPDATED PAGES
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1 1 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 chall 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 thosa UE personnel whose activities are within the purview of the OQAP are responsible for its implementation in accordance with the requirements described herein.
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- Donald T. Schnell Date Senior Vice President-Nuclear .R/d . Jo 'ph V. Lahi j/
ahk~~ Date Ma ge , Quality Assurance i l l t 1 I 1
-iv- Rev. 14 6/91
OQAM EFFECTIVM PAGE LISTING Page No. Rev. i 12 11 13 111 13 iv 14 v 14 vi 14 vil 14 Page No. Rev. 1-1 14 1-2 14 1-3 14 1-4 14 1-5 14 1-6 14 1-7 14 2-1 14 2-2 14 2-3 14 2-4 14 2-5 14 2-6 14 3-1 14 3-2 14 3-3 14 3-4 14 3-5 14 3-6 14 4-1 14 4-2 14 4-3 14 4-4 14 4-5 14 4-6 14 5-1 14 5-2 14 6-1 14 6-2 14 6-3 14
-v- Rev. 14 6/91
OQAM EFFECTIVE PAGE LISTING Page No. Rev. 7-1 14 7-2 14 7-3 14 7-4 14 7-5 14 7-6 14 7-7 14 7-8 14 8-1 14 8-2 14 9-1 14 9-2 14 10-1 14 10-2 14 10-3 14 11-1 14 11-2 14
'1-3 14 12-1 14 12-2 14 12-3 14 l 13-1 14 1
13-2 14 14-1 14 14-2 14 15-1 14 15-2 14 15-3 14 16-1 14 16-2 14 17-1 14
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18-1 14 L8-2 14 l 18-3 14 18-4 14 18-5 14 18-6 14
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OQAM EPPECTIVE PAGE LISTING Appendix A Page No. Rev. A-1 14 A-2 14 A-3 14 A-4 14 A-5 14 A-6 14 A-7 14 A-8 14 A-9 14 A-10 14 A-ll 14 A-12 14 A-13 14 A-14 14 A-15 14 A-16 14 A-17 14 A-18 14 A-19 14 A-20 14 A-21 14 A-22 14 A-23 14 A-24 14 A-25 14 A-26 14 A-27 14 A-28 14 A-29 14 A-30 14 A-31 14 A-32 14 A-33 14 A-34 14 Figures Rev. Figure A 14 Figure B 14 Figure C 14
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OQAM OPERATING QUALITY ASSURANCE MANUAL (OQAM) 1.0 ORGANIZATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for the development, implementation and maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OOAP, although certain Program activities may be delegated to others. The organi-zation responsible for implementing appropriate portions of the OQAP is shown in Figures A and B of the OOAM. The Callaway Plant operating organization is shown in Figure C of the OQAM. 1.2 The President is responsible to the Chief Executive Officer of UE for the establishment and implementa-tion of the Quality Assurance Program requirements. He has ultimate responsibility for quality assurance, engineering, construction, and operation l of the Callaway Plant. l 1.3 Under the President, the Senior Vice President- I Nuclear is responsible for initiating the Quality Assurance Program, formulating the policy, and I authorizing and assuring Program implementation. He is responsible for directing activities within the Nuclear Division which support the engineering, construction, testing, and operation of the Callaway Plant and coordinating support activities performed by others who are not under his direct ) administrative control. He has corporate responsi-bility for the operation and physical control of the Callaway Plant. 1790 1.4 The Manager, Quality Assurance reports to the 2006 Senior Vice President-Nuclear on Quality Assurance Program and administrative matters. QA Program matters are reported to the President through the Senior Vice President-Nuclear. The Manager, Quality Assurance is responsible to the Senior Vice Presi-dent-Nuclear for assuring the OQAP is being effec-tively implemented for operating activities. The Manager, Quality Assurance is responsible for directing the overall Quality Assurance Program for UE including Program development, maintenance, and verification of implementation. The Manager, Quality Assurance has sufficient authority, organi-
; zational freedom, and independence to effectively I assuro compliance with OQAP requirements as they~
control Callaway Plant and offsite quality activ-1-1 Rev. 14 6/91
OQAM ities; and shall bear no cost, schedule, or produc-tion responsibilities which unduly influence atten- I tion to quality matters. A communicaticn path shall exist between the Manager, Quality Assurance and Vice President, Nuclear Operatione, tae Manager, Callaway Plant and the Manager, Operations Support as well as the other Department 5eads in the Nuclear Division, thus providing a direct path to inform management regarding condi ions affecting quality. The qualifications of the hs.-=ger, Quality Assurance are at least equivalent to those spec-ified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Section 4.2.4. The Manager, Quality Assurance is located at callaway Plant and provides technical direction and administrative guidance to the Superintendent, Quality Assurance; the Supervising Engineer, Quality Support, Quality Assurance; and the Quality l Assurance staff. 2012 1.5 The Superintendent, QA is located at Callaway Plant- He directs Supervising Engineers who have primary duties for assuring implementation of the i OQAP and davotes full attention to this effort. The Supervising Engineer, Quality Support, QA, located at Callaway Plant, directs a group of engineers who provide additional support activities including maintenance of the Operating Quality Assurance Manual (OQAM). Th9 activities of the groups reperting to the Superintendent combined with the activities of the group reporting to the Super-vising Engineer, Quality Support assure implementa-j tion of the OQAP. The qualifications of the Super-intendent are at least equivalent to those spec-I ified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Section 4.4.5. l 1.6 The Manager, Quality Assurance, the Superintendent, ! Quality Assurance, and Supervising Engineers in the l Quality Assurance Department are authorized by the l Senior Vice President-Nuclear to stop work on l ongoing quality activities in accordance with approved procedures. During the operating phase i they have the authority to stop unsatisfactory work during repair, maintenance, and refueling activ-ities and the authority to recommend to the l 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, 1-2 Rev. 14 6/91
i OQAM and the Superintendent, Quality Assurance have no y duties or responsibilities unrelated to QA that would prevent their full attention to QA matters. l 1790 1.7 The authorities and duties of persons and organiza-l tions performing quality assurance functions shall be clearly established. Such persons have suffi-cient authority and organizational freedom to iden-tify quality problems; to initiate, recommend, or provide solutions; and to verify corrective action. 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, j 1.8 The Manager, Nuclear Engineering reports directly to the Senior Vice President-Nuclear and directs a L staff of superintendents, supervisors, supervising engineers, and quality control inspectors whose l primary function is to provide technical support to the operation of Callaway Plant. This suppcrt. l includes, but is not necessarily limited to design; . I L modification; configuration control; system and l equipment performance; reliability, and testing; i technical programs administration; and contractor support. He controls those activities and imple-i ments the OQAP through the Superintendents, Design Control, System Engineering, and Project Engineer-l ing. Within the System Engineering organization, QC ! Inspectors (ISI/NDE) report to the Supervising Engineer Performance and ISI, and perform inspec-l tion and nondestructive examinations. These inspec-l tocs do not perform inspections or examinations which provide quality verification of Nuclear Engi-neering work activities. 1 1.9 The Manager, Licensing and Fuels reports directly to the Senior Vice President-Nuclear and has overall responsibility for UE nuclear-fuel cycle activities including responsibility for procurement i of fuel cycle goods and services, and for incore l 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, L i 1.10 The Manager, Nuclear Services reports directly to i the Senior Vice President-Nuclear and-is respon-l 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 1-3 Rev. 14 6/91 l
OQAM clerical activities, and serves as Principal Health Physicist. He is also responsible for the adminis-trative contact with the Institute of Nuclear Power Operations (INPO). As Principal Health Physicist, he provides a corporate level overview and guidance in the formulation and implementation of applied radiation protection programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations. l 1.11 The Vice President, Nuclear Operations reports to the Senior Vice President-Nuclear and is respon-sible for the activities of the Callaway Plant Operations Department and the Operations Support Department. This responsibility includes the safe, legal and efficient operation and maintenance of the Callaway Plant and protecting the health and safety of the public and Plant personnel. He assures a high level of quality is achieved in the Plant operations and suppert activities, l 1.12 The Manager, Callaway Plant reports directly to the Vice President, Nuclear Operations and is respon-sible for the safe, legal, and efficient operation and maintenance of the Callaway Plant. He controls Plant functions and implements the OQAP through the Assistant Manager, Operations and Maintenance; the Assistant Manager, Work Control; the Superinten-dent, Health Physics; and the Superintendent, Chem-istry and Radwaste (see Figure C of the OQAM). He has the primary responsibility for reactor opera-ulen and safety. Within his organization, the QC Supervisor reports to the Assistant Manager, Work Control wse reports to the Manager, Callaway Plant. The Quality control Group performs work activity inspections, receipt inspection as described in l Section 7, and nondestructive examinations and is ( not involved in those activities performed by others which are considered " inspections" unto themselves, e.g., surveillance testing, initial startup testing, and I&C, Radiation Protection, and Chemistry group activities. Activities considered to be inspections unto.themselves are covered by QA audits and QA surveillances as discussed .under Section 18. The QC Supervisor has no duties or responsibilities unrelated to quality control that would prevent his full attention to quality control matters. l 1 l 1.13 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 1-4 Rev. 14 6/91
oQAM Callaway operating License. He controls Plant support activities and implements the OQAP through the Assistant Manager, Materials, the Superinton-dent, Training, the Superintendent, Security, and the Superintendent, Administration. I 1.14 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. 1.15 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 1.16 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. 1.17 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. I 1.18 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, j 1.19 The Superintendent, Personnel (Local 1439 and 1455) reports directly to the Vice President, Nuclear Operations -and is responsible for assisting in 1-5 Rev. 14 6/91
oQAM areas of laoor relations, organizational and personnel activities, Fitness-For-Duty, and other matters under the guidance of UE policies. 1.20 The Superintendent, Personnel (Local 148) reports j l directly to the Vice President, Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel activities, and other matters under the guidance of UE policies. j 1.21 Jhe Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative Serv-ices. The Manager, Purchasing is responsible for commercial aspects involved in procurement of mate-rials, systems, components, and services (excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others which are employed in support of Callaway Plant. 1.22 The Manager, Mechanical Engineering reports to the Vice President-Engineering and Construction who in turn reports to the President. The Manager, Mechan- ) ical Engineering provides technical support, as necessary, to the Nuclear Engineering staff. The Chief Draftsman, who reports to the Manager, Mechanical Engineering provides drawing preparation ; and revision support, as requested, for design performed by Nuclear Engineering or other UE organ-izations. 1.23 The Manager, Electrical Engineering reports to the Vice President-Engineering and Construction. The ! Manager, Electrical Engineering provides technical i support, as requested,.to the Nuclear Engineering staff, i 1.24 The Manager, Quality Services reports directly to the Senior Vice President-Technical Services. The Senior Vice President-Technical Services reports to the President. The Manager, Quality Services is i responsible for supporting audit, surveillance, and evaluation of nuclear supplier quality activities, and for performir g those procurement document i reviews assigned to Quality Services. 1.25 The Manager, System Relay Services reports to the Senior Vice-President, Technical Services and is l respt ;sible for providing qualified engineers, i technisians and equipment to maintain Caliaway Plant relays. l 1-6 Rev. 14 l 6/91
OQAM 1.26 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. I 1.27 Other UE divisions may provide safety-related services which augment and support selected Program activities. These organizations shall be required to implement controls consistent with the OQAP requirements applicable to their scope of activ-ities. The coordination of these activities is the responsibility of the Senior Vice President-Nuclear. l 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 Lallaway Plant Technical Specifications. l { l I l-7 Rev. 14 6/91
OQAM 2794 2.0 QUALITY ASSURANCE PROGRAM 1799 2.1 UE has established an OQAP which controls activ- ! ities affecting quality. The Program encompasses l 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 ' l 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 OCAM. 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 OA 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 who is responsible to the Chief Executive Officer of UE for establishing and implementing the Quality Assurance Program requirements. 2.2 Lines of authority and responsibility have been established from the highest management level through intermediate levels and to the 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, fnnctional 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. 1104 2.3 Updating and revision of the OQAP as described in 1105 this OOAM shall be in accordance with the appli-cable requirements of 10 CFR 50.54 (a) and 10 CFR I 50.71. L824 2.4 The pertinent requirements of the OQAP apply to all 20200 activities affecting the safety-related functions of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health 2-1 Rev. 14 I 6/91 i
OQAr and safety of tha public. The safety-related struc-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 importance to safety. Modifications to this list require the approval of the Manager, Quality Assur-ance and the Manager, Nuclear Engineering and shall be issued and controlled in accordance with Section
- 6. The development, control, and use of computer programs to be used in safety-related activities are within the scope of the OQAP. The degree of controls applicable to each computer program shall be consistent with the program's importance to safety-related activities. Consumables which could affect the form, fit 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.
1879 2.5 The OOAP shall be implemented throughout the oper-ating life of the Callaway Plant. Activities affecting quality shall be accomplished under suit-ably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied. 1789 2.6 Consistent with the schedule for accompliching 1879 quality activities, the OOAP shall be est.nlished and documented by written policy, program manual, and procedure manuals. Persons conducting safety-related activities shall be responsible to imple-ment approved procedures. The OOAP shall utilize the following document types to describe Program objectives:
- 1. Operating Quality Assurance Program Policy /
Introduction Statement The Operating Quality Assurance Program Policy statement establishes governing principles in accordance with the requirements of 10 CFR 50, l Appendix B. l The Operating Quality Assurance Program Policy I statement and any revisions thereto shall be approved by the Senior Vice President-Nuclear. 2-2 Rev. 14 6/91 l
OOAM
- 2. Operating Quality Assurance Manual (OQAM)
The OQAM contains a delineation of the Policy statement, quality assurance requirements, assignment of responsibilities, and a defini-tion of organizational interfaces. The OOAM is the written description of the OQAP. Approval of the OQAM is by the Senior Vice President-Nuclear and the Manager, Quality Assurance.
- 3. Callaway Plant Operating Manual The Callaway Plant Operating Manual consists of a multi-volume set of Plant operating proce-dures prepared or reviewed by the staff with the aid of other SNUPPS utilities, Nuclear Engineering, the Lead A/E, the NSSS Supplier, and Fuel Fabricator. These procedures are controlled, approved, and issued in accordance with Administrative Procedures contained within l the Manual. This Manual includes administrative I controls consistent with those required by Regulatory Guide 1.33.
Administrative procedures which apply to the entire staff, and revisions thereto, shall be reviewed by the Callaway Plant Onsite Review Committee (ORC) and the Quality Assurance Department. The final approval of Administra-tive Procedures and revisions thereto shall be by the Manager, Callaway Plant. The review and approval of other procedures and revisions thereto shall be in accordance with approved Administrative Procedures which implement the requirements of the Technical Specifications. 679 2.7 UE may employ the safety-related services of archi-1746 tect engineers, NSSS suppliers, fuel fabricators, 1787 constructors, and others which provide or augment 2293 UE efforts during the operating phase. These organ-2460 izations shall be required to work under a quality l 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 or Quality Services Department prior to i the initiation of safety-related work. Vendor programs and procedures shall also meet UE's commttment to USNRC Generic Letter 83-28. 2-3 Rev. 14 6/91
OOAM 2.8 Disputes which may arise between OA or QC personnel and personnel in other UE organizations which cannot be resolved shall be referred to the next higher level of management for resolution. Disputes which cannot be resolved through these levels shall be resolved ultimately by the Chief Executive Officer. 2.9 Preservice (PSI) and inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspec-tions and other operating phase " code" activities shall comply with the requirements of the appli-cable Code Edition and Addenda of the ASKE Boiler and Pressure Vessel Code. This compliance includes the independent third party inspection coverage of
" code" items by an Authorized Nuclear Inspector.
1916 2.10 General indoctrination and training programs shall l l2037 be developed for personnel performing safety-2194 related activities to assure that responsible func-tions, departments, and individuals are knowledge-able regarding quality policy and requirements of applicable manuals and procedures. The requirements for training of Callaway Plant personnel are described in Section 13.2 of the Callaway-SA FSAR. The training of permanent Plant personnel is the responsibility of the Superintendent, Training. UE personnel performing complex, unusual, or hazardous work shall be instructed in special indoctrination or briefing sessions. Emphasis shall be on special requirenents for safety of personnel, radiation control and protection, unique features of equip-ment and systems, operating constraints, and l 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 l other regulatory requirements. Records of training l shall be maintained as described in Section 17. l Where required by code or standard, personnel are l trained or qualified according to written proce-dures in the principles and techniques of performing specific activities. Special equipment, environmental conditions, skills, or processes shall be provided as necessary for the effective implementation of the OQAP. l l 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 2-4 Rev. 14 6/91
OQAM activities which includes design, procurement, modification, and operation. The Manager, Quality Assurance is responsible for a system of planned audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance and in accordance with the require-ments of Section 18. He is responsible for conducting audits of offsite and onsite activities. Deficiencies identified during the audit process are reported to responsible management of the organization involved in the resolution and follow-up to assure corrective action. 2.12 The Senior Vice President-Nuclear provides for an independent assessment of the scope, implementa-tion, and effectiveness of the OQAP to assure compliance with policy, commitments, and the requirements of 10 CPR 50, Appendix B as set forth in this OQAM. This assessment shall be conducted biennially with a scheduling allowance of plus three months for each assessment and a combined time interval for any three consecutive assessment intervals not to exceed 6.25 years. This assessment may be by representatives of other utilities, outside consultants, or UE management representa-tives. In addition, various reports are issued to the Senior Vice President-Nuclear on a periodic basis to assist his independent assessment of the OQAP (e.g., semiannual QA report, and periodic QA audit reports). 1 l 2.13 Implementation of OQAP controls over activities affecting quality assures achieving the objective of the UE OQAP to provide management with adequate confidence that activities affecting quality regarding the design, installation, modification, and operation of the Callaway Plant are performed t consistent with policy. Documentation of the accomplishment of OQAP objectives is maintained in the form of records of data and other information as necessary to support operation, maintenance, repair, modification, refueling, and inservice inspection. l 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 compliance mandated by use of the words "shall" or "must." Compliance with 2-5 Rev. 14 6/91
OQAM I initiated by use of either "shall" or actions "must" is audited and surveilled by the QA Depart-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. 4 i 2-6 Rev. 14 6/91
I OQAM 1864 3.0 DESIGN CONTROL 2183 2974 l 1850 3.1 The design, modification, addition, and replacement 2168 of safety-related structures, systems, and compo-2185 nents shall be controlled to assure appropriate l 2189 design control measures are implemented. Procedures 2222 shall establish requirements; assign responsibil-2187 ities; and provide control of activities regarding 2193 design in a planned, controlled, and orderly manner. 2188 3.2 The Plant design is defined by those UE NSSS, A/E and selected supplier design drawings and 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-tioning of safety-related structures, systems, or components Thall be performed in a manner to ensure quality .; least equivalent to that specified in 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 2189 be carried out by Nuclear Engineering, Licensing 2222 and Fuels, or outside organizations. 2164 3.6 Control of design shall be specified in procedures. l 2190 These procedures shall include instructions for 2191 defining typical design requirements; communicating information across internal and 2192 needed design 2196 external interfaces; preparing, reviewing, approv-3-1 Rev. 14 6/91
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OQAM 2202 ing, releasing, distributing, revising, and 2221 maintaining design documents; performing design 2222 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 2195 identified, documented, reviewed and approved to 2203 assure incorporation of appropriate quality stan-2204 dards in design documents and to control departures 2205 from these standards. Modifications to structures, 2207 systems, and components shall consider, as a mini-2222 mum, the design bases described in the Callaway-SP 2664 and the Callaway-SA FSAR and the Technical Specifi-cations. Design criteria documents which are newly issued or modified in the course of design or design changes shall be reviewed by a superin-tendent in the Nuclear Engineering Department for seismic and quality group classification and selec-tion of quality standards. Design criteria docu-ments consist of original Plant design criteria, system descriptions and other documents defining design input which change the Plant as described in the FSAR. The design input shall be specified on a timely basis and to the level of detail necessary to permit the design activity to be carried out in a correct manner and provide a consistent basis for making design decisions, accomplishing design veri-fication measures, and evaluating design changes. 2207 3.9 Design activities shall include the correct trans-2209 lation of regulatory requirements and design bases 2210 into specifications, drawings, written procedures, 2212 and instructions (design outputs) that define the 2974 design. Design analyses regarding reactor physics, 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 des tqn changes . l l I 3-2 Rev. 14 6/91 l
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 ct'nges, may be dele-gated to others provided they h /e access to back-ground and technical information. Design control measures for design revisions shall be commensurate , with those applied to the original design. l
\
1934 3.11 Design activities shall also include: 1) reviewing , 2694 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; ci r 6) reviewing and approving procedures for special processes. 2164 3.12 The design process shall establish controls for 2168 releasing design documents which are technically 2191 adequate and accurate in a controlled manner with a 2220 timely distribution to responsible individuals and 2243 groups. Documents and revisions shall be controlled througn the use of writtcn 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 p rog ra.ns , 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 a.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 2218 procedures shall address control of the interface, 2219 responsibilities, lines of_ communication, and 2223 documentation of internal and external interface activities. 1934 3.14 The design process shall include design verifica-2182 tion. Design verification assures that design is 2209 adequate and meets specified design inputs. Design 3-3 Rev. 14 6/91
f OQAM 2234 control- p;ocedures shall specify requirements for 2235- the- selection and accomplishment of a-design veri-fication- program. The program depth shall be commensurate with the importance of the system or component to safety, complexity of the design, and similarity of the design to previously proven designs.- Design verification shall be conducted in accordance with proc <;n?.es which identify' the responsibilities of the verifier and the documents-tion required and which, through adherence to the 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-input dhta, and the code or other calcula-u tions, 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 c otherwise. Design verification shall be performed by compete,nt personnel other than those who i performed' the original design and other than the L designer's immediate supervisor. However, at. 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 suparvisor's management. Quality Assurance Department audits shall examine the frequeacy and the effectiveness of use of supervi-sors as design verifiers 1to guard against abuse. 1934' 3.15 Design verification, if other than by qualification testing of 'a prototype or lead production unit, 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 acticn is documented and the portions of the design output documents based on L the unverified data are appropriately identified
! and controlled. Without verification, site activ-ities associated with a design or design change must not proceed past-the point where the installa-3-4 Rev. 14 6/91
OQAM tion would become irreversible (i.e., require extensive demolition and rework). The design veri-fication shall be complete prior to relying upon the component, system, or structure to perform its safety-related function. 2200 3.16 Action shall be initiated to correct errors found in the design process. Errors and deficiencies identified in approved design documents shall be documented and the process of their correction (i.e., review and approval) shall be controlled. These actions shall assure that changes to design or installed components are controlled. 3.17 RequEIts for design changes affecting safety-related structures, systems, and components may be originated by the unit staff, Licensing and Fuels or Nuclear Engineering. Design changes shall be processed by Nuclear Engineering. Design changes engineered by Nuclear Engineering shall be the responsibility of the Manager, Nuclear Engineering. Design changes engineered by Licensing and Fuels shall be the responsibility of Licensing and Fuels, 1137 3.18 Independent of the responsibilities of the design 5844 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 l requirements imposed by Plant generating equipment. l 5844 3.19 Safety evaluations which consider the effect of the design as described in the design documents, shall be performed by the responsible UE engineering ! organization or o.tside organization (s). These evaluations shall include the basis for the deter-mination that th,7 design change does not involve an l unreviewed safety question. As deemed necessary by ! the evalua '. ing organization, detailed analyses snall be performed to support the bases of safety evaluations. All nuclear safety evaluations are 3-5 Rev. 14 l 6/91
OQAM l 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 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. 1140 3.20 The ORC shall review design change safety evalua-tions to recommend fi nal 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.
3.21 The NSRB shall review safety evaluations to verify that changes did not involve unreviewed safety questions. 1910 3.22 Procedures and instructions related to equipment or 2162 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 shall be made aware of changes affecting the performance of their duties through procedure revi-cions, or specific training in the operation of mcdified equipment or systems, or other appropriate means. 2039 3.23 Records shall be maintained which reflect current 2132 design including safety analyses, safety evalua-2163 tions, design change installation procedures, 2173 material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings. 3.24 Drawings shall be prepared under a drawing control system which provides for checking methods and review and approval requirements. Drawings shall be subject to reviews by the responsible design organ-ization for correctness, conformance to design l criteria, and compliaace with applicable codes and standards. l 3-6 Rev. 14 l 6/91
OQAM 4.O PROCURPMEVP DOCUMENT CONTHOL 975 4.1 Safety-related procurements shall be documented. 1875 Procurement document control applies to documents 1876 employed to obtain safety-related materials, parts, 1887 components, and services required to support Plant 3541 activities. Written procedures establish require-3548 ments and assign responsibility for measures to assure applicable regulatory requirements, design bases, and other requirements necessary to assure quality are included in procurement documents. 679 4.2 Written procedures shall include controls, as preparation, contr.n* review, 3559 applicable, for approval, and processing of the fol' .y related procurement documents:
- 1. Purchase Requisitions
- 2. Purchase Orders
- 3. Letters of Intent
- 4. Engineering Service Agreoments (agree. tents for engineering, construction, or consultant serv-ices) (ESAs)
- 5. Contracts
- 6. Specifications
- 7. Drawings 3560 Collectively, these procedures shall assure that 3601 technical and quality requirements are correctly stated, inspectable, and coatrollable; there art adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with Q,s Program require-ments.
3572 4.3 Consideration of the verification activities to be 3579 employed for item or service acceptance should 3580 begin during the purchase requisition, ESA, or 3582 contract preparation and review stage. Planning of 3584 verification activities shall include a review of 3585 the established acceptance criteria and identified 3607 documentation. Verification methods which may be employed include certifications (certificates of conformance and material certificates or test reports), source verification, receiving inspec-tion, and post-installation tests established by UE. Selected verification methods may be indicated as inspections, examinations, tests, or documenta-tion reviews. The extent of the acceptance methods and associated verification activities is a func-tion of the purchased item's or service's complexity and relative safety significance, as well as the supplier's past performance. 4-1 Rev. 14 6/91
00AM 3572 4.4 Acceptance by source verification should be consid-3580 ered when the item or service is vital to Plant safety; or the quality characteristics are diffi-cult to verify after receipt; or the item or service is complex in design, manufacture, inspec-tion or test. Verification in this sense involves a physical presence to monitor, by observation, designated activities for the purpose of evaluating supplier performance and product acceptability. 1875 4.5 Purchase requisitions must be employed to initiate the procurement of safety-related materials, parts, components, and services while ESAs must be used to contract for safety-related engineering, construc-tion, or consultant services. Contracts, purchase orders generated from purchase requisitions, and ESAs mast 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 or Quality Services Departments; Nuclear Engineering, Nuclear Services, or Licensing and Puela Department; or the unit staff. 975 4.6 The procurement of spare or replacement parts for 1876 safety-related structures, systems, and components 1877 shall be subject to the OA Program controls in 1878 effect at the time the order is issued; and to 1883 codes, standards, and technical requirements which are equal to or better than the original require-ments or as may be required to reduce the proba-bility for repetition of defects. Procurement docu-ment control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifica-tions and codes equivalent to those specified orig-inally or those specified by a properly reviewed and approved revision; packaged and transported in a manner to assure the non-degradation of quality du r i r.g transit; and properly documented to show l compliance with applicable specifications, codes, l and standards. , 1876 4.7 Each item or service to be procured is evaluated by l the procurement document originator to determine whether it performs a safety-related function or involves activities which affect the function of I safety-related materials, parts, or components and l to appraise the importance of this function to l Plant or public safety. Por those cases where it is unclear if an individual piece (part of a safety-related structure, system, component or service) is 4-2 Rev. 14 l 6/91
00AM governed by the 00AP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering or Materials Engi-neering and shall classify the safety relationship of the service or questionable component, parts or items of safetv-related structures, systems, and components. Evaluations shall be documented for future reference. I a 1 4.8 Provisions for the following shall be included in j procurement documents as applicables j l' 1864 1. The scope of work and basic administrative and 1890 technical requirements including drawings, 2416 specifications, regulations, special instruc-3550 tions, applicable codes and industrial stan-3551 dards and procedural requiremento identified 3552 ey titles and revision levels; special process instructions; test and examination requirements l with corresponding acceptance criteria; and special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, packaging, handling, shipping, and storing. 1888 2. Requirement that the supplier have an accept-1890 able Quality Assurance Program which implements , 3542 the appropriate sections and elements of ANSI ' 3553 N45.2-1977 or the ASME code as applicable as established for the item or service to be supplied. This requirement is not applicable to commercial grade items which utilize a suppli- 1 er's standard or proven design to meet 1 published product descriptions. ! 1890 3. Requirements for supplier surveillance, audit, 3542 and inspection including provisions for UE or 3555 agent access to facilities and records and for 3573 identification of witness and hold points. 35,4 1890 4. Requirements for extending applicable require-3543 ments of UE procurement documents to lower-tier 3555 suppliers and subcontractors. These require-ments shall include right-of-access to subsup-plier facilities and records by UE. 3550 5. Requirements for suppliers to obtain UE 3558 approval of nonconformancen to procurement 3576 document requirements dispositioned "use-as-is" and " repair" and conditions of their disposi-tion including identification of those subject to UE approval prior to further processing. l 4-3 Rev. 14 6/91
.- - - _ . - - --- - = - . = _ -
OOAM 3484 6. Applicability of 10 CFR 21 reporting require-ments. 1890 7. Documentation requiremento including records 2132 to be prepared, maintained, submitted for 3550 approval, or made available for review, such 3556 an, drawings, specifications, procedures, procurement documents, inspection and test records, personnel and procedural qualifica-tions, chemical and physical test results, and instructions for the retention, transfer, and disposition of records.
- 8. Requirements that the supplier furnish documentation which identifies the purchased !
item and provides traceability to the procure-ment requirements met by the item and documen-tation identifying any procurement requirements which have not been met. 13559 4.9 The originating organizatior, shall perform a docu-3560 mented independent review of procurement documento 3562 to assure requirements are correctly stated, inspectable, and controllable and that there are adequate acceptance and rejection criteria. This review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents. I3564 4.10 Dids or proposals shall be evaluated by the 3568 Purchasing Department, the originating organira-3569 tion, the Quality Services Departnient, and the Licensing and Fuels Department to assure confor-mance to procurement document requirements in the following areas as applicable to the type of procurement as described below:
- 1. Technical considerations
- 2. Quality Assurance requirements
- 3. Research and development effort
- 4. Suppliers' personnel qualifications
- 5. Suppliern' production capability
- 6. Suppliers' past performance
- 7. Alternates
- 8. Exceptions 13560 4.10.1 The Purchasing Depa r tmer shall initiate and coor-3567 dinate bid evaluation activities for those propos-3563 als received in response to requisitions. The Purchasing Department shall review bido or propon-alc, except those associated with ESAs or nuclear fuel cycle related goods or services, for alter-nates or exceptions to procurement document 4-4 Rev. 14 6/91
- ~ , - .
00AM requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented. l 3560 4.10.2 The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier. They shall also review areas 1 through 3 i above for replacement parts or equipment ordered l from the original supplier as part of procurement document preparation. I 3560 4.10.3 The Quality Services Department and the originating organization review areas 4 through 6 above as part of maintaining a supplier on the Qualified Supplier List as described in the OQAM, Sections 7.0 and 18.0. I 3560 4.10.4 The Licensing & Tuols Department shall evaluate bids or proposals fc7 fuel cycle goods or services in the above areas. 1 3560 4.11 Bids or proposals with alternates or exceptions 3561 identified in Section 4.10 by the Purchasing 3568 Department shall also be evaluated by the origi-3570 nating organization to provide additional assurance that no unacceptable conditions result from such changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award, l 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 I resolution of the commercial requirements to be included in a purchase order, contract, or ESA. If j 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 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, l l l l i 4-5 Rev. 14 6/91 ( t
OQAM l 3563 4.13 The Purchasing Department is responsible for reviewing purchase orders to verify that the tech-nical and quality roquirements have been accurately transferred from the requisi. ion to the purchase order. Approval of the purchase requisition, letter of intent, ESA, or contract shall be by an indi-vidual who has approval authority and signifies that the technical and quality review of the docu-mont has been completed. Contracts initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility of the Manager, Licensing and Fuels with preparation and negotia-tion by the Licensing and Fuels Department. Nuclear fuel cycle-related contracts and ESAs for profes-sional services shall be executed by the Senior Vice President-Nuclear or another company officer in accordance with Nuclear Division and corporate procedures related to agreements or contracts for services. I 975 4.14 Additions, modifications, exceptions, snd other 3543 changes to procurement document qualir.y aim tech-3549 nical requirements shall require a review equiv-3555 alent to that of the original document and approval 3575 by the originator or the originating department 3576 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. 14 6/91
OQAM l 2974 5.0 IN DIRUCTJ OH L _E RO.CID.VR E D-_AN D_DRAWI N Q D 1830 5.1 The activities affecting quality associated with 1855 the operating phase shall be accomplished and 1861 controlled by: 1916 l 1948 )
- 1. Preparing procedurco, instructions, specifica- 1 tions, drawings or checklists of a type appro- l 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. llaving responsibic 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 relativa importance of the activity to safety, i 1833 5.2 The Nuclear Division and other responsible func-tions and departments shall provide written proce-dures and drawings as required to support the callaway Plant operating phase. These procedures shall prescribe those activities affecting safety-related structures, systems, and componentn. It is recognized that skills normally possessed by qual-ified personnel may not require detailed step-by-stop delineations in written procedures.
I 5.3 The Manager, Callaway plant shall be responsibic for providing specific guidance via Administrative Procedures for the development, review and approval of other e Plant operating procedures to govern activities, whigh affect safety or quality consistent' with the Technical Specifications. Similar guidance shall be provided for revisions and temporary changes to Plant operating procc-dures. Procedures which implement the Security Plan and Radiological Emergency Response Plan shall be reviewed no less frequently than overy twelve months (in accordance with Technical Specifica-tions). A revision of a procedure may constitute a procedure review. 5-1 Rev. 14 6/91
00AM l 5.4 The approval, issue and control of implementing proceduren, manuals and policy shall be prescribed in Administrative Procedures consistent with the requirements of Sections 2, 5 and 6. l 5.5 Administrative Procedures shall be reviewed by the Quality Assurance Department as described in Section 2.6, item 3. l 5.6 Maintenance and modification proceduren shall be reviewed in accordance with Section 6.2. l 5.7 Special process procedures supplied by outside organizations shall be reviewed in accordance with g Section 9.4 l 5.8 In addition to the procedures identified in Table 13.5-1 of the Callaway-SA FSAR (CALLAWAY PLANT ADMINISTRATIVE PROCEDURES), the OOAP includes procedural coverage in the following arean: design control; design change control; preparation, review, approval, and revision of specifications, drawings, requisitions, Engineering Service Agree-ments, contractn and procedures (instructions); OA indoctrination and training; auditor trainings supplier evaluations; receipt and transfer of records; document control; quality program audits; corrective action; inspection; inspection, test and operating status; and special processes. 5-2 Rev. 14 6/91
OOAM 6.0 DOCUMENT CONTROL 1906 6.1 Documents and their revisions which control all 1916 activities affecting safety-related structuren, systems, and componento chall be prepared, reviewed by knowledgeable individuals, and approved by authorized personnel prior to release or issuance in accordance with written approved proceduren. 1908 6.2 Divisions, departments, and organizationo respon-1916 sible for OQAP implementing documento shall be 1917 required to provide the necessary review and 2262 approval for instructions, procedures, specifica-tions, and drawings. Reviews and approvalo shall assure that locued documento are adequate, aut. hor-ized, include proper quality and technical require-mento, and are correct for intended use. Individ-ualo or groups responsible for preparing, review-ing, and approving documents and revisions thereto shall be identified in w~1tten procedures. Specifi-cally, the QA Departmes shall review Administra-tive Procedures ao det bed in Section 2.6; QC personnel shall review m.- tenance and modification
- and QC per anel are responsible for procedures; the preparation of inspo.. tion proceduren and/or checklists to support maintenance and modification activitien. 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 requiremento, methods, and acceptance criteria have been identified.
1908 6.3 Changes to documents shall be reviewed and approved 1914 by the same function, department, group, or organ-2170 ization that performed the original review and approval; however, UE may assume or delegate this responsibility. The reviewing organizations shall have access to pertinent background information upon which to base their approval and shall have adequate understanding of requirements and intent of the original document.
- Work Requests (WRn) and preventi'e .
cenance requests (PHRs) may contain instructions to worker e 'e r , WRn and PMRs are not considered " Maintenance prvcedu. i' .iich require QC review. When required, the assignment of inspection pointo for work authorizing documents is performed by Planning Department personnel based on establis'ted cr iteria. 6-1 Rev. 14 , 6/91 l
OQAM 6.4 Documents relating to the UE 00AP chall 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 OOAP. 1828 6.5 The controla 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 subseg"~r revisions. Measures shall be established to 9r VL.it the inadvertent use of superseded documents. 6.6 Types of documents which shall be controlled include the FSAR, specifications, Operating Quality Assurance Manual, procurerent documents, proce-dures, design documents (e.g., calculations, draw-ings, analyses) including documents related to computer codes, nonconformance reports, as-built 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 Nuclear Services and the Administration organiza-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 Services nhall be responsible for assuring the issuance of controlled documents at the General Office, and for transmittal of documents to the Administration organization for entry into the document control system. 6.8 Document control methods shall be defined consistent with the importance of the document to safety. Selected documents shall receive a control number. A serialized distribution list shall iden-tify selected document holders by name and control number. Acknowledgement of receipt of selected 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. 6-2 Rev. 14 6/91 i l
00AM 1872 6.9 Proceduren shall specify the requirements for the 2132 processing and maintenance of records. Procedures 2136 shall also be established to control inntructions, 2164 procedures, and drawingo governed by the OQAP. These procedural controls shall provide for the prompt transmittal of document revisions to work locations and the removal, dentruction, or voiding of obsolete /nuperseded documents. The unit staff and other UE organizationo chall assure that current documents are distributed to and used at the location where the prescribed activity in performed. It to recognized that, in certain instances, activition are controlled via the communication of documented procedural instructions from a remote location, (i.e., separated from the location where the preacribed activity 10 being performed). Identified, controlled copies of docu-mento chall be used to perform an activity. Uncon-trolled copies shall be identified. 4 6-3 Rev. 14 6/91
._ . - . . ~ _ _ _ _ - _ - _ _ - _
OOAM 7.0 CONTROL OF PURCIIASED MATERIAL, EQUIPMENT AND SERVICES 1892 7.1 Materials, equipment, and services shall conform to 3541 procurement documents as prescribed in Section 4. Provisions shall be established to control activ-ities affecting gn=11ty associated with the procurement of materisl, 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
- 3. Procurement source selections
- 4. Verification activities (surveillance, inspec-tion, and audit) required by the purchaser
- 5. Control of nonconformances as described in Section 15
- 6. Corrective action as described in Section 16
- 7. Material, equipment, and service acceptance 2416 8. Control of quality assurance records
- 9. Audits of the procurement program as described in Section 18 1875 7.2 UE shall assure that suppliers providing safety-3541 related materials, equipment, or services are 3564 acceptable procurement sources. Provisions shall 3879 be made for supplier evaluations which assess their capabilities prior to award by: 1) source evalua-tion; or 2) review for objective evidence of qual-ity; or 3) a review of supplier history. When evaluations are performed, the assessment of a supplier's capability shall be specific to the procured item, commodity, or service and the supplier's ability to provide the items or services in accordance with procurement document require-ments. Suppliers of hardware and services which are manufactured prior to award, considered a commer-cial grade item, or implemented under the UE OOAP do not require pre-award source evaluation or post-award audits which attest to their capability as a procurement source.
2337 7.3 During Callaway's operating life, procurements may 2977 be made from: 1) suppliers judged capable (prior 7-1 Rev. 14 6/91
j OQAM 3564 to award) of providing items or services in 3874 accordance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and whose acceptability can be determined by 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 cource 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. l 7.4 Code certified material may be obtained from an ASME accreditad 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 Matnrial Suppliers if such Manufacturers or Suppliers are otherwise qualified as stipulated in Sections 4 and 7 of the OQAM. These provisions are consistent with ASME Code Interpretation XI-1-83-50R dated May 14, 1985. 1894 7.5 Procurement source evaluation and selection 3564 involves the Quality Services Department and the originating organization. The evaluation and selec-tion process shall be specified in department proc-edures and may vary depending on the complexity and relative importance to safety of the item or service. Nuclear Engineering, Licensing and Fuels, Nuclear Services, the unit staff or other organiza-tions may be requested to provide input to the qualification evaluations of suppliers. Suppliers of hardware and services which are manufactured prior to award, considered a commercial grade item, 7-2 Rev. 14 j 5/91
OQAM or implemented under the OQAP do not require pre-award source evaluation audits which attest to a suppliers capaollity as a procurement source. l 3566 7.6 Procurement source selection and evaluations shall consider one or more of the following: 3564 1. Experience of users of identical or similar products of the prospective supplier. NRC Licensco Contractor and Vendor Inspection Program (LCV1P) 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 oc objec-tively evaluated. This may include review and ovaluation of the supplier's QA Program, Manual, and Procedures, as appropriate; and responses to questionnaires. -
3564 3. A source evaluation of the cupplier's 3605 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 chould 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 performar.ce record utilizing monitored performance of the item, industry product tests, national l
codes, and standards (not specific to the nuclear industry), or other industry data-l 7-3 Rev. 14 6/91 1
OQAM bases (UL, INPO NPRDS, EPRI EQDD, ANSI, NEMA, MIL-STDS, NRC Bulletins / Notices, and Licensee Event Reports, etc.) that is directly related to the item's critical characteristics and intended application. I 7.7 Procurement source evaluations involve a review of technical and quality assurance considerations. 1 Technical considerations include the design or ! manufacturing suppliers to capability and technical ability of l produce or provide the design, i service, item, or component. Quality assurance considerations include one of the previously defined methods of supplier evaluation and a consideration of changes in a supplior's Quality Assurance Program or capabilities. The measures employed to evaluato a supplier's continued accept-ability as a procuremont source (after the initial source ovaluation) are described in Section 18. l 3571 7.8 organizations participating in the procurement process shall preparo 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 exchange of control and documentation of information with the supplior; and 4) audit or surveillance of supplier activities. l 3571 7.9 Depending on the complexity or scope of the item or 3572 service, the Purchasing Department and/or the 3573 originating organization shall initiato award 3580 activities. Meetings or other forms of communica-3585 tion may be held to establish the intent of UE in monitoring and ovaluating the supplier's perfor-mance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in fulfilling requirements. The depth and necessity of these activitics shall be a func-tion of the relative importance, quantity, unique-ness, complexity, frequency of transactions with tP.a 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 3574 7.10 The originating organization shall establish meas-ures for monitoring supplier generated submittals against procurement document document require-monts. Similarly, measures shall be established f-or revlewing and approving supplier generated docu-7-4 Rev. 14 6/91
00AM l monts for use. Changes to procuromont shall documents in Section be in4.accordance with the controls described i I 3577 7.11 3578 Supplier monitoring activities may be performed by 3584 personnel from Quality Assurance, Quality Services, I Nucioar Engineering, Nuclear Services, Nuclear Safety and Emergency Preparodness, Licensing and Fuola, the unit staff, or outsido organizations in accordance with plans to perform inspections, exam-inations may includer or tests. Supplier monitoring activities i
- 1. Audits of supplier quality assurance implementation program
- 2. Monitoring, witnessing, or observing inspec-tions, examinations, and performance tests
- 3. Surveillance of manufacturing processos
- 4. Audits of supplier records to verify cortifica-tion validity and the resolution of nonconfor-mances 1 2337 7.12 To support the control of purchased copies of purchase orders and other material, appropriato procurement documents shall be forwarded applicable receiving or acceptance point. to the monts receiving or utilizing procured Depart-services items or shall control procurement establish measures to maintain and documents until the items or services are received and accepted. Those documents shall include purchase orders, drawings and speci-fications, approved changes, and other documents. related
! 975 7.13 Receiving inspection instructions shall be 2337 2416 documented.
inspections or These instructions include specifying tests of commercial grado items procured from suppliers on the basis of product performance. stocked Should it become necessary to upgrado 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. 7-5 Rev. 14 6/91
l OOAM 975 7.14 Acceptance of items and services shall include one 1891 or more cf the following: 3601 3606
- 1. Written certifications
- 2. Source verification
- 3. Receiving inspection
- 4. Post-installation test (in addition to one of the above) 1876 7.15 Commercial grade items shall rely on proven design 3601 and utilize verification methods by the purchaser, to the extent appropriate to item application.
Procedures provide for the acceptance of commercial grade items on one or more of the following:
- 1. Special Tests and Inspections
- 2. Survey of Supplier (Commercial Grade)
- 3. Source Verification
- 4. Acceptable Supplier / Item Performance Record Method 4 should not be used alone unless:
a) The established historical record is based on industry wide performance data that is directly applicable to the item's critical characteris-tics and the intended safety related applica-tion; and b) The manufacturer's teasures for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable). l 1891 7.16 Where required by code, regulation or contract 1893 requirement, documentary evidence that items 3601 conform to procurement documents shall be available 3603 during receiving inspection or prior to use of such 3605 items. Where not precluded by other requirements, 3607 documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item accep-tance, verification of the validity of supplier certificates and the effectiveness of the certifi-cation systems shall be conducted at intervals commensurate with the supplier's past quality performance. Certificates of conformance and compliance shall be required to be signed or accom-panied by a signed letter of trancmittal. Where acceptance is based upon source verification, docu-mented evidence of these surveillances shall be furniched to the Plant Quality Control organization b y. *ne responsible UE organization or their desig-nat.4 agent prior to acceptance. 7-6 Rev. 14 6/91 L- _ --- -- - - - - - - - - - - - - - - - - _ _ _ - - _ - . - - _ - - - - - - - _ - - - - _ - _ - - _ _ - - _ _
i OOAM 1 l 11884 7.17 Acceptance by receiving inspection shall be 3606 utilized as a prime method of verification and may be utilized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspections; and when inspections do not require operations which could adversely affect the integrity, function, or cleanliness of the item. When other methods are utilized, receiving inspec-tion shall be employed to verify that items have not sustained damage. 13578 7.18 Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 - 1978, (as clarified in OOAM Appendix A Regulatory Guide 1.58) under the direction of the Quality control organi-zation. Other unit staff personnel qualified to ANS 3.1 - 1978 may be utilized to perform receipt inspections requiring specialized sk. ills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, exten-sive modifications, or other special circumstances, receiving inspection may be assigned to an outside organization (s). 12337 7.19 Final acceptance of items shall be by Quality 3601 Control personnel or designated inspection person-nel. The final acceptance of services shall be the responsibility of the originating organization. Acceptance shall be documented. I 975 '.20 Receiving inspection activities shall include: 2337
- 1. Verifying that materials, parts, and compo-nents, have been identified by tagging or other means; or that they are segregated and 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 cpecified quality documenta-tion.
2325 3. Verifying that received items conform to 3577 procurement documents by inspecting or, where 3591 appropriate, testing using approved procedures 3592 and calibrated tools, gages and measuring equipment to verify the acceptability of items, including those from commercial grade suppli-era. 7-7 Rev. 14 6/91
OQAM 2326 4 2329 Providing final acceptanco after datormining 2328 that required verifications aro completo and acceptable. Items dotormined to be acceptable for use shall be tagged with an accept tag other means of identification or segregation, or and released for storago or uso. acceptance of items by reco1ving Conditional l inspection shall be procedurally controlled. 2327 5. Verifying that received items which do not 3576 conform to procuromont documents are segregated (if practicable) and processed in accordance with Section 15, 3608 7.21 Acceptance by post-installation test may be ized following one of the procoding acceptanco util-methods. Post-installation testing shall be used as the primo means of acceptanco 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. 14 6/91
OQAM 8.0 1DPNTIPICATION AND CONTROL OP MATERIALS, PARTS AND COMPONENTS _ 975 8.1 The identification and control of materials, parts, 1884 and components shall be accomplished in accordance 1885 with documented procedures and apply to safety-related materials, parts, and components during fabrication, storage, installation or use. Materials, parts, and components identified as nonconforming shall be controlled as described in Section 15. 1897 8.2 The identification and cont.01 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 of identification to preclude a degradation of the item's functional capability or quality; and proper identification of materials, parts, and componenta prior to release for manufacturing, shipping, construction, or installation. Materials, parts, and components manufactured or modified by UE chall be controlled and identified during manufacture. 1884 8.3 Documented procedures shall assure that specifica-2088 tions and other procurement documents include or reference appropriate requirements for the identi-fication and control of materials, parts, and components including partially fabricated assem-blies. Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items from storage while maintaining item identity; controlling the return to storage of issued materials, parts, or components received, stored, installed, modified, or used at the Plant site. These procedures shall assure that correct identifications are verified and documented prior to release. 1895 8.4 Physical ideatification shall be employed to the 1896 maximum possible extent for relating an item at any 2333 point in time to applicable design or other perti-2337 nent specifying documents including drawings, 2346 cpecifications, purchase orders, manufacturing and 3593 inspection documents, nonconformance reports, and 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. 14 6/91 !
OOAM 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. l 8-2 Rev. 14 6/91 p.
OQAM 9.0 CONTROL OF SPECIAL PROCESSES 9.1 Special processes are fabrications, testa, and final preparation processes which require the qual-ification of procedure, technique, and personnel and which are performed in accordance with appli-cable codes and standards. Special processes require in-process controls in addition to final inspection to assure quality. 11851 9.2 Special processes include such activities as 1852 welding, heat treating, nondestructive examination, 1937 the application of specialized coatings, and 2260 chemical cleaning; and shall be accomplisheo under controlled conditions by qualified personnel in accordance with the technical requirements of applicable codes, standards, specifications, or other special requirements to which UE is commit-ted. Qualified personnel and approved procedures shall be employed. Procedures for special processes shall be qualified as part of their approval process; personnel qualifications shall be certified; and equipment shall be qualified prior to use. The responsible Plant Department Head shall assure that personnel performing special processes are qualified and are employing approved proce-dures. Procedures shall also be established for recording evidence of acceptable accomplishment of special processes using qualified procedures, equipment, and personnel. Quality Control personnel shall be responsible for assuring that personnel performing nondestructive examinations are qual-fled and are employing approved procedures, h(ndestructive examination (NDE) personnel shall be q),7.lified in accordance with procedures established toi meet the requirements of the Code Edition and Achenda to which UE is committed at the time the NDE is performed. When non-code NDE is performed, personnel shall be qualified to the version of SNT-TC-1A used to meet UE's current commitment to l the ASME B&PV Code. 9.3 Special process equipment that may require periodic adjustment and whose performance cannot be verified through direct monitoring of appropriate parameters shall be subject to the controls described in Section 12. 9.4 Qualified outside organizations may be employed to perform special processes onsite and shall be required to conform to the requirements described l herein. Special process procedures submitted by these organization (s) in accordance with procure-ment document requirements shall receive a tech-9-1 Rev. 14 6/91
00AM nical review by the responsible engineering organi-zation and a quality review by the Quality Assur-ance Department. 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 pctential hazards to personnel and equipment. l l l t I 9-2 Rev. 14 6/91
OOAM 2974 10.0 INSPECTION 1851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to documented 1927 verify conformance with applicable instructions, procedures, drawings, and specifica-tions. 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. structures, I 10.2 Required inservice inspection of 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, 11850 10.3 Inspection of activities at the Callaway Plant and 1937 shall be at intervals based on the status importance of the activities. Guidelines shall be established to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subse-quent monitoring planning. I2694 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 tne 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. I2694 10.5 Nuclear Engineering shall be responsible for assuring the development of the inservice testing program plan for pumps and valves, the test proce-dures required by this plan, and the securing of consulting services in this area. In addition Nuclear Engineering shall be responsible for admin-istering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division. They are also responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations. 10 1 Rev. 14 6/91
OQAM i 11851 10.6 Quality Control inspection personnel or other unit 2263 staff organizations who perform " inspection" 2479 activities shall be qualified within their respec-2481 tive areas of responsibility. The qualification of 2482 QC inspection personnel shall be defined in three 2483 levels of capability as described in ANSI N45.2.6. 2494 Other members of the unit staff performing "inspec-2498 tion" activities shall have appropriate experience, 2994 training, and retraining to assure competence in accordance with ANSI /ANS-3.1. Inspection assign-ments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC 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. 12483 10.7 An inspection personnel qualification program shall 2484 be established to assure inspection activities are 2488 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. 2480 10.8 Personnel from outside organizations performing QC 2482 inspection activities associated with safety-2484 related items at the Callaway Plant shall be certi-2485 fled as required by ANSI N45.2.6. Personnel from 2994 outside organizations or UE personnel who are not members of the unit staff who perform other activ-ities associated with safety-related items at the callaway Plant shall either be certified as required by ANSI N45.2.6 or they shall meet the education and experience requirements applicable to the equivalent position on the unit staff for the activities which they are performing. 2484 10.9 When contractors or vendors are retained to perform 2485 work activities or to provide services associated 3577 with safety-related items at the Callaway Plant, the qualification of inspection personnel and the i conduct of inspections associated with that contracted work activity or service shall meet the l requirements stipulated in the applicable procure-l ment documents. As an example, if a vendor was i contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the - persons performing the examination would be qual-10-2 Rev. 14 l 6/91
00AM ified as required by the vendor's quality assurance program unless otherwise specified in the appli-cable procurement documents. 1930 10.10 Procedures which specify inspection activities l2124 shall provide for the following, as required:
- 1) the inclusion of independent inspection or moni-toring of processes when required; 2) the identifi-cation of inspection personnel; 3) the documenta-tion of inspection results; 4) a description of the method of inspection including any mandatory hold points; 5) the identification of the characteris-tics and activities to be inspected; 6) the accep-tance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from drawings, specifications, codes, standards, or instructions, regulatory requirements.
1928 10.11 The inspection function shall be conducted in 1929 accordance with written approved procedures which 1930 specify inspection scope; personnel qualification 1931 requirements; and data collection requirements. 2039 Inspection o. testing, as appropriate, shall be 2124 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 2262 use prior to performing inspection activities. Inupection results shall be documented. Procedures shall prescribe the review and approval author 3ty for inspection results. [1932 10.13 Indirect control by monitoring processing m9thods, 1933 equipment, and personnel shall be utilizvd as a i 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. 2124 10.14 Inspection data shall be analyzed and evaluated to 2125 verify completeness of results, achievement of inspection objectives, and operational proficiency of equipment and systems; to identify additional inspection requiremento; 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 -o final < inspection shall require reinspection or :p t to verify acceptability. l ! 10-3 v. 14
./91
OQAM 2974 11.0 TEST CORTROL 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. Testing programs include such tests an initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those asso-I clated with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications. l1853 11.2 Provisions shall be established for the performance 1865 of surveillance testing to assure that the neces-sary quality of systems and components 10 main-tained, that facility operations are within the safety limits, and that limiting conditions for operation can be met. The testing frequency shall be as prescribed in the Callaway Plant Technical Specifications. The provisions for surveillance testing shall include the preparation of a surveil-lance testing schedule (s) which reflects the status of in-plant surveillance tests. Qualified personnel shall perform surveillance tests. l 2053 11.3 Appropriate tests shall also be performed subse-quent to Plant modifications, maintenance or significant operating procedure changes to confirm expected results Testo provide a level of confi-dence in structure, system or component operation or functional acceptability. I 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. I 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. I1938 11.6 Testing shall be performed in accordance with 2039 writ.en procedures which incorporate or reference 2055 the requirements and acceptance limits contained in 205C applicable Callaway Plant Technical Specifications, 1 i l 11-1 Rev. 14 6/91 l
OQAM drawings, instructions, procurement documents, specifications, codes, standards, and regulatory requirements. l1938 li.. Administrative procedures, test procedures, or 2132 teecklists shall include: provisions for assuring alt p requisite conditions are met; test equipment caliv._- 7n requirements; testing method instruc-tions 11 Sudiag hold or witness points; limiting conditions .ne .rceptance/ rejection criteria; and data crelle .:n One test result approval require-ments. 1848 11.8 Test data shall be analyzed and evaluated by quali-1934 fled individ als or groups to verify completeness 2124 of results, achievement of test objectives, and 2125 operational proficiency of equipment and systems; to identify additional test requirements; and to identify necessary changes to the installation test procedures. Equipment found to be iaficient shall be identified in accordance af ch Section 14. Surveillance test procedure resu.to which fall to meet the requirements and accordance criteria of Callaway Plant Technical Specjrications shall be documented and reviewed in accordance with Section
- 15. Deficiencies identified as nonconforming shall be processed in accordance with Section 15.
1137 11.9 Review and approval of tests and experiments not 1140 described in the PSAR shall be conducted as speci-fled in the Callaway Plant Technical SpecificLtions and 10 CPR 50.59. l 2481 11.10 A program shall be established to assure testing 2483 activities are performed by personnel trained and 2484 qualified to a capability necessary for performance 2488 of the activity. Plant procedures and procurement 2498 documents shall prescribe the qualification requirements for testing personnel. Provisions may be made for on-the-job training of individuals not qualified to the program provided they are super-vised or overseen by qualified individuals for the activities being performed. The Superintendent, Training shall be responsible for providing related technical and quality training for UE personnel who perform teating. l 2263 11.11 Personnel within the various UE organizations may 2479 perform testing activities including implementing 2482 test procedures and the evaluation and reporting of 2483 test results. The assignment of Plant testing 2484 perspnnel shall be under the direction and control l 2494 of the Vice President, Nuclear Operations. The quali!ication of QC testing personnel shall be 11-2 Rev. 14 6/91
OQAM defined in three levels of capability as described in ANSI N45.2.6. Other members of the unit staff performing " testing" activities shall have appro-priate experience, training, and retraining to assure competence in accordance with ANSI /ANS-3.1. Testing assignments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC testing personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that indi-viduals possess comparable or equivalent compe-tence. l2263 11.12 Personnel from outside organizations or UE 2480 personnel who are not members of the unit staff 2483 who perform other testing activities associated 2484 with safety-related items at the Callaway Plant 2485 shall either be certified as required by ANSI N45.2.6 or they shall meet the education and expe-rience requirements applicable to the equivalent position on the unit staff for the activities which
' hey are performing.
l 2483 11.13 When contractors or vendors are retained to perform 2484 work activities or to provide services associated 2485 with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct of tests associated with that contracted work activity or service shall meet the require-ments stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway Plant, then the persons performing the testing / valve settings would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents. 11-3 Rev. 14 6/91
OQAM 12.0 COff1'ROL GP MEASURING AND TEST EQUIPMFXi' 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 calibrat')n and control shall 2264 address the identification of test equipment, cali-3591 bration techniques, calibration frequencies, main-3592 tenance control, and storage requirements. The equipment subject to these controls includes: (1) M&TE (portable measuring ir.struments, 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) permanentty installed process instrumentation (PI). l
- 1920 12.2 Tools, instruments, testing equipment and measuring l 11851 devices used for measurements, tests, and calibra-2295 tion shall be of the proper range ead type; and 2044 shall be controlled, calibrated, acjusted and main-2060 tained at specified intervals or pilor to use to 3591 assure the necessary accuracy of calibrated devices. M&TE and reference standards shall be l tagged or labeled indicating the date of calibra-tion and the due date for recalibration.
I 12.3 Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program. 12.4 The calibration and control program established at ( the Callaway Plant shall assure that M&TE, refer-ence standards, and PI maintain their required accuracy. The Assistant Manager, Operations and i Maintenance is responsible for assuring the program l establishment. Program implementation is the l responsibility of the appropriate Department Heads. 1920 12.5 M&TE, reference standards, and PI shall be utilized by various organizations as required to perform tests or other special operations. Each organiza-tion shall be responsible for assuring that the M&TE or reference standards it uses have been cali-brated. Outside organi7ations using M&TE or refer-ence standards at the Callaway Plant in activities l affecting quality shall be required to implement L calibration and control measures consistent with ! the applicable requirements of this section. Veadors activities performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet the requirements of item 8 and 12-1 Rev. 14 6/91
OQAM 9 of OQAM Section 12.6 unless specified in procure-ment documents. Vendor-provided calibration services for Callaway Plant M&TE or PI are required 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. 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 mhin-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.
3592 4. The traceability of reference standards and thereby M&TE and PI, to nationally recognized l standards and the periodic revalidation of reference standards. l 3593 5. The maintenance of records which indicate the status of each item, maintenance history, cali-bration results, anomalies, and most recent and next scheduled calibration dates. A recall system shall be established to assure that calibration intervals are not exceeded.
- 6. The maintenance and control of items not in use.
- 7. Provisions to control the purchase requirements and acceptance tests for items sent out for calibration and for new or replacement items including the requirements for accuracy, stability, and repeatability.
12-2 Rev. 14 6/91
OOAM
- 8. M&TE shall be calibrated from reference stan-dards with an accuracy ratio of at least four-to-one (Reference standard to M&TE). Calibra-tion accuracy ratios of less than 4.0 but equal to or better than 1.0 (Reference standard to M&TE) shall be acceptable when equipment to meet specified 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 accuracias 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 ration of less that 2.0 but equal to or better than 1.0 shall be acceptable when equipment to meet specified requirements is not commercially available. The basis of acceptance in these cases st il be documented. 3592 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 3591 calibration shall require an investigation to l 3594 evaluate the validity of previous measuring, test, inspection, and calibration results and the acceptability of impacted items. Investigations shall evaluate the necessity of repeating original measu ements, inspections, tests, or calibrations to establish the acceptability of such items. When j the calibration history of an item shows it to be consistently out of calibration, the item shall be l repaired, replaced, or the calibration interval modified. l l l l I 12-3 Rev. 14 6/91
00AM 13.0 HANDLING, STORAGE, AND SHIPPING 1975 13.1 Safety-related items including safety-related parts 2293 of structures, systems, and components and related 2417 consumables shall be handled, stored, shipped, cleaned, and preserved in accordance with proce-dures, instructions or drawings, to assure that the quality of items is preserved from fabrication until incorporation in the Callaway Plant. The procedures shall also establish responsibilities for determining applicable requirements for packag-ing, shipping, receiving, storage, and handling activities. 2293 13.2 Generic procedures or instructions shall be 2349 prepared for application to these activities; 2416 however, detailed procedures or instructions shall 12427 be prepared for the handling, cleaning, storing, 41668 maintaining while stored, or shipping of certain items and types of equipment or material. Appli-cable manufacturer instructions and recommenda-tions, or procurement requirements shall be reviewed and invoked in gorerning procedures when determined appropriate based on an engineering review. 2427 13.3 Deviations from manufacturer's recommendations may impose more stringent requirements or may relax the requirements. The relaxation of manufacturer's requirements shall involve an engineering evalua-tion and is appropriate when unrealistic require-ments are recommended and such recommendations are not reasonably necessary to preclude equipment degradation. 2343 13.4 The requirements for activities described in this 2416 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. 2427 13.5 The Superintendent. Maintenance shall establish an l inspection program for Plant material handling equipment that provides for routine maintenance and inspection in accordance with documented procedures l which- apecify acceptance criteria. Routine inspec-tionn :nall determine the acceptability of equip-ment md rigging. Routine inspections shall be 13-1 Rev. 14 l 6/91 1 __.
OQAM supplemented by nondestructive examinations and proof tests as delineated in procedures for requiring special handling. Personnel items performing nondestructive examination and proof testing shall be qualified. 2325 13:6 2356 Procedures shall be prepared for items that require special handling and shall be 'vailable prior to 2416
) 2984 the time items are to be handled. Items not speci-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 equipment. or trained in the use of 2416 13.7 Procurement decuments or procedures shall address packaging the requirements which afford protection from 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 consistent with the protection classification be shall of. items. 13.8 Measures shipping shall also be established to control of licensed radioactive materials the in accordance with 10 CFR 71. 2341 13.9 Procedures 2981 shall provide instructions for the 1 2984 storage of materials and equipment to minimize the possibility of damage from the time an stored following receiving inspection, until item is the time the item is removed frnm cr orage and placed in its final location. Periodic inspections shall be performed to assure that storage areas are properly maintained. Material and equipment being be placed in a storage level commensurate with shall protection level the of items. The storage shall correspond to prescribed various levels of environ-mental conditions which are procedurally defined. 13-2 Rev. 14 l 6/91 [ l
00AM 14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 lafety-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 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 , 2 1842 telating 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 l 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 Technica) Specifications establish the status required 'or safe Plant operation, including provisions for periodic and non-periodic tests and and inspections of various structures, systems, components. Periodic tests may be operational tests or tests following maintenance while non-periodic 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 accordance with Plant operating procedures which are reviewed and approved in accordance with the 14-1 Rev. 14 6/91
OOAM requirements of the Technical Specifications. In cases where required documentary evidence is not svallable 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 reqCire-ments shall be subject to the original or equiv-alent review and approval controls.
J l l l l i-l l 14-2 Rev. L4 6/91
i OQAM l 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 nonceaformance disposition categories 2334 shall include:
- 1. "Use-as-is" ot ".cceptable" (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-formance dispositions of "use-as-in" and " repair" on nuclear fuel which are generated prior to the arrival of such fuel at the Callaway Plant. Regarding material nonconformances identified on-site, QC personnel shall be responsible for verification that approved dispositions have been implemented and for the final sign-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 Comniasion pursuant to the requirements of 10CFR21. 15-2 Rev. 14 6/91
OOAM 1906 15.8 Material nonconformances which would impact the 1992 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 2332 that further work or activity will not contribute adversely to the material nonconformance or preclude identification and correction. 15.10 Material nonconformance summaries shall be prepared and analyzed for potential adverse quality trends semiannually. For nonconformances discovered upon receipt inspection of new purchases or discovered after an item has been accepted by receipt inspec-tion but before issue from the warehouse, the Manager, Operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered installed, the Manager, Nuclear Engineering shall have the trend analysis prepared. These analyses shall be sent to the Quality Assurance Department for an independent review. The result of this review shall be 'eported to management. 15-3 Rev. 14 6/91
OQAM 16.0 CORRECTIVE ACTION 324 16.1 Measures shall be established to assure that condi-1870 tions adverse to quality are promptly identified, 1903 reported, and corrected. Nonconformances shall be 2978 controlled in accordance with the requirements described in Section 15. Each of the Nuclear Divi-sion Managers is responsible for developing and implementing a program for identifying and control-ling adverse conditions. This responsibility may be satisfied by one or more programs. As a minimum each program shall provide for developing and anal-yzing trends on a semiannual basis. Trending of conditions adverse to quality identified at suppli-er's facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12. Proce-dures shall provide instructions for identifying, reporting, and initiating corrective action to preclude recurrence of adverse conditions. It is understood that the term " corrective action" includes remedial action necessary to correct the deficiency, as well as corrective action necessary to preclude recurrence. 16.2 Conditions sdverse to quality which impede the implementation or reduce the effectiveness of the Operating QA Program shall be controlled by the measures described herein. Adverse conditions may include, but are not limited to, noncompliance with procedural requirements; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies identified in the OQAP; recur-ring conditions for which past corrective action has been ineffective; or breakdowns in administra-tive and managerial control systems which could result in a system designed to prevent or mitigate serious events not being able to perform its intended function. 16.3 Corrective action documents which record defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. 3599 16.4 Corrective action documents shall be transmitted 3600 to the responsible organization. The responsible organization shall investigate the findings and identify the cause(s) of the deficiency, and spectfy and initiate the action (s) necessary to correct the conditions and prevent recurrence. 16-1 Rev. 14 6/91
i OQAM 16.5 Nuclear Engineering shall review documented condi-tions adverse to quality which involve design defi-ciencies or design changes which are recommended as corrective action. Licensing and Puels should review documented conditions adverse to quality for fuel-related issues. The ORC shall review signifi-cant adverse conditions. Examples of such condi-tions include those identified by Callaway Plant Technical Specifications 6.5.1.6(f), 6.5.1.6(g), 6.5.1.6(h), 6.5.1.6(1), and 6.5.1.6(m); and NPDES violations. 16.6 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action. The Quality Assurance Department shall close QA-originated corrective action docu-ments by verifying the implementation and adequacy of corrective action. Copies of completed correc-tive action documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to qual-ity. The Quality Assurance Department shall period-ically prepare summaries of significant corrective action documents and submit them to the NSRB and appropriate levels of management. 16.7 The closure of corrective action documents shall be accomplished as promptly as practicable but shall occur only after the corrective action taken has been verified. Verification may be accomplished through direct observations, written communica-tions, re-audit, surveillances, or other appro-priate means. The nature of the deficiency may be such that remedial actions need to be taken imme-diately whereas development and implementation of corrective action to preclude recurrence may take substantially longer. 16.8 Summaries of corrective action documents shall be reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends. Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trends through routine audit and surveillance activities; and shall report the results of these assessments to management. I l 16-2 Rev. 14 6/91 l
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 records associated with startup testing, operation, maintenance, repair, refueling, and modification of safety-related structures, systems, and components at the Callaway Plant. 1140 17.2 During the operating phase, quality assurance 1150 records shall be maintained to furnish documentary 1851 evidence of the quality of items and activities 2128 affecting quality. Applicable design specifica-2132 tions, procurement documents, test procedures, 2133 operational procedures or other documents shall 2137 rpecify the quality assurance records to be gener-2138 ated by, supplied to, or held by UE. Documents 2173 shall be considered quality assurance records when completed. Records may be maintained for varying periods and shall be identified as lifetime or ' nonpermanent records in 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. 1139 17.3 Quality assurance records include, but are not 1140 limited to, operating logs; maintenance and modifi-2337 cation procedures and inspection results; report-2364 able occurrences; results of reviews; inspections, 2666 tests, audits and material analyses; qualification 2681 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). 11936 17.4 Inspection and test records shall contain the following as a minimum:
- 1. A description of the type of observation
- 2. The date and results of the inspection or test
- 3. Identification of the inspector or data recorder
- 4. Evaluation of the acceptability of the results
- 5. Action taken in connection with any deficien-cies noted 17-1 Rev. 14 l 6/91
__ ~ - . - . . - ~ .. -. .- _ _ - -.-.--.-.- - . . 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, NSFS 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 shell be processed in a timely manner in accordance with documented procedures.
-2129 17.6 Record systems shall be established by the Adminis-2131 tration organization for the Nuclear Division and 2136 shall be controlled in accordance with written 2147 procedures. The implementing procedures shall address records administration; receipt of records; storage, preservation and safekeeping of records; record retrieval; and the disposition of records.
The Nuclear. Services organization is responsible for assuring the handling and maintenance of quality assurance records generated, received, and temporarily . stored at the General Offices. The Administration organization shall provide for the administration of the quality assurance record system at the Callaway Plant. 2135 .17.7 The requirements regarding hard-copy records 2149 administration shall require-that quality assurance 2150 records tue 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 AND N45.2.9 as stated in Appendix A. The distributing and handling of records, the correcting or supplementing.of: quality assurance records,' and specifying the retention . period of record types shall be delineated in written proce-
-dures. -The retention period of records generated prior to commercial operation shall begin on December 19, 1984; the date of commercial ' opera-tion.
2145 -17.8 The requirements regarding' receipt-of records shall 2146 define the requirements for the receipt of 2148 documentation generated by others during the opera-tion of the Callaway Plant. These requirements shall assure- that records are submitted and that designated authorities are responsible for organ-
'* Callaway was declared available for unrestricted loading by the-UE Load Dispatcher,on December 19, 1984. The PSC Commercial Operation date is April 9, 1985. The PM and EQ programs use the PSC date. Refer-to O 86-107.
I i-t- 17-2 Rev. 14 6/91
00AM izing and implementing a system of records receipt contro?. The records' receipt control shall permit an asnessment of the status of records during the receiving process. 2150 17.9 The requirements regarding storage, preservation, 2151 and safekeeping of records shall establish storage 2152 requirements for the maintenance, preservation, and 2153 protection of quality assurance records. These 2155 requirements shall include methods for maintaining control of, access to, and accountability for records; storing records in a manner to preclude deterioration; and providing record storage facil-ities which protect contents from possible destruc-tion by causes such as fire. An alternative to the establishment of a single record storage facility shall be the maintenance of a duplicate copy of records in a remote location. Where duplicate storage is employed, the storage environment need not be uniquely controlled in each storage area, but may be the prevailing building temperature and humidity. 2157 17.10 Record storage systems shall provide for an 2159 accurate retrieval of information without undue delay. Those records maintained by an outside organization shall be required to be accessible to the buyer or UE; in the case of lifetime records for the life of the items involved, or for desig-nated retention times for nonpermanent records. 2160 17.11 Record disposition practices shall establish 2161 requirements for the transfer of records from others to UE. Upon final transfer, records shall be
- inventoried against any transmittal forms and l processed in accordance with written procedures.
Nonpermanent records shall be retained for the specified retention period; after the specified i retention period they are no longer required to be maintained as records. l l 17-3 Rev. 14 6'91 f
i aDQAM 2180 18.0 AUDITS
- 3869 2186 18.1 A comprehensive audit program shall be established
-2199 and_ implemented-by UE to verify internal-and 2978 _ external quality activities' compliance with the 2988 3586 OQAP. The audit program shall assure _that all appli 3865 cable elements of the Program have been developed, 3867 documented, and are being effectively-implemented 3883 and shall provide for the' reporting and review of 41949 audit results by management. The audit system is described in manuals and procedures. Nonconfor-mances and and program deficiencies shall be identified corrective action stall be initiated
{ verified. See Section 3.14 for a specific and : topic. audit 324 18.2 The UE audit system shall include the performance l 2245 of audits and surveillances by the Assurance and Quality-Services Departments.Quality Audits determine, through investigation, the adequacy and adherence to established procedures, of tions, instruc-specifications, codes, and other applicable contractual and licensing requirements effectiveness of implementation. and_ the Surveillances involve. the periodic or continuous monitoring the operation.or performance of a supplier, of item, componer.t, or system. Surveillance in this sense audit should not be confused with inspections for tre purpose of process control or product accep-tance or with requirements relating to test, cali-bration or-inspection to assure that the necessary quality of systems and components is maintained, that facility operations are within- the limits, safety and are- being met that limiting conditions of operations personnel 1 performing(surveillance tests). QA and <QS y _surveillances should familiar with the_ area to be surveilled be j applicable and the implementing' procedure (s) governing l surveillances. Surveillances may also be performed by personnel from other organizations, but require these no unique personnel qualifications- or " certifications (except when performed for product acceptance). See Sections 10.7,f10.8, 11.4, 11.6, 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 and QS Department audit and 2255 surveillance personnel. Audits shall be directed 2963 by an- Audit Team Leader (ATL) who is a certified 3866 3877 Lead Auditor. A Lead Auditor is an individual 3892 certified an audit, as qualified to direct an audit, perform report audit findings, and to evaluate 18-1 Rev. 14 6/91
OQAM l corrective action. Other personnel may assist Lead Auditors in the conduct of audits; namely, tech-nical 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 activ-ities to be reviewed or investigated and shall have no direct responsibility for the area being evalu-ated. 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 Quality Assurance and Quality Services personnel 2245 who perform audit and surveillance activities 2246 shall be qualified in accordance with the require-2247 ments prescribed in Quality Assurance Department 2259 procedures. Lead Auditor qualification requirements status, 3866 shall include education or professional previous work experience or training, training l and received through UE, on-the-job performance participation in surveillances or audits as an auditor, a qualification examination, and other factors applicable to auditing not defined by procedure. The qualification certification of Lead Auditors shall be based on an evaluation of these factors by the Manager, Quality Assurance. The maintenance of proficiency by Lead Auditors shall be accomplished by active participation in the audit process; a review of Program, codes, stand-ards, 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. 14 f 6/91
OQAM 3865 18.5 The Manager, Quality Assurance shall be responsible for assuring the implementation of a comprehensive system- of planned audits to verify compliance with the OQAP. The Manager, Quality Assurance has suffi-cient authority and organizational freedom to schedule and perform both internal and external audits. He has the organizational responsibility to measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality. The Manager, Quality Assurance has direct access to the Senior Vice President-Nuclear. The Senior Vice President-Nuclear has direct access to the Presi-dent. l 18.6 The audit nystem shall include internal and l3871 external audits. The system shall be planned, docu-mented, and conducted to assure coverage of the applicable elements of the OQAP, and overall coor-dination and scheduling of audit activities. Audit results shall be periodically reviewed by the Quality Assurance Department for quality trends and results reported to the appropriate management. The Manager, Quality Assurance shall monitor the OQAP audit program to assure audits are being accomp-lished in accordance with the requirements described herein and for overall Program effective-ness. The NSRB shall selectively review audit reports of onsite audits. The NSRB shall also peri-odically review the onsite audit program as devel-oped by the Quality Assurance 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 copics 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 Quality Assurance Department. l1792 18.7 Internal audits shall be conducted by the Quality 1816 Assurance Department and shall be performed with a 3873 frequency commensurate with their safety signifi-cance. An audit of safety-related functions shall be completed in accordance with formal audit sched-ules 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. l l 2666 18.8 Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be ~ 2847 audited at the frequencies indicated in Section 3873 6.5.2.9 of the Technical Specifications and under l 18-3 Rev. 14 6/91
OOAM 41777 the cognizance of the NSRB. In addition to audits conducted under the cognizance of the NSRB, the following areas shall be audited at least once per 12 months: o Special Nuclear Material Accountability program o Radiological Protection program o Radiological Emergency Response program o Security program o Fitness-For-Duty program 13873 18.9 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program require-ments are properly implemented. 13577 18.10 External audits shall be conducted by or for the Quality Assurance Department as a method for the evaluation of procurement sources and as a post-award source verification of conformance to procurement documents. Audits conducted by other organizations (with similar orders with the same supplier), including other utilities or A/E's, may be employed as a means of post-award source verifi-cation in lieu of UE performed audits and may not
- necessarily audit specific items furnished to UE.
Audits and surveillances may also be performed for i the Quality Assurance Department by the Quality Services Department. These audits and surveillances shall utilize personnel qualified in accordance t with this OOAM and shall be conducted in accordance l with this OQAM and Quality Assurance Department procedures. Commercial grade items do not require l pre- or post-award audits. Similarly, items which l are relatively simple and standard in design and manufacture may not require supplier qualification or post-award audits to assure their quality. 11780 18.11 Applicable elements of suppliers' quality assurance 3578 programs shall be audited (post-award) on a 3872 triennial basis. Audits generally should be i initiated when sufficient work is in progress to determine whether the organization is complying with the established quality assurance provisions. Subsequent contracts or contract modifications l 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 or QS Department 18-4 Rev. 14 6/91
OQAM that the results of mini-audits performed during source inspection and source surveillance activ-ities confirm the adequacy and implementation of the supplier's QA Program, i 18.12 Supplementary to audits, annual evaluations of suppliers shall be performed which take into account, as applicable: 1) the review of supplier furnished documents such as certificates of confor-mance, nonconformance notices, and corrective actions; 2) results of previous source verifica-tions, audits, and receiving inspections; 3) oper-ating experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources. 13872 18.13 Audits shall also be conducted when: 1) significant 3875 changes are made in functional areas of the Quality Assurance Program such as significant reorganiza-tion or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assur-ance Program; or 3) when a systematic, independent assessment of Program effectiveness is considered necessary; or 4) when it is necessary to verify implementation of required corrective action. 13876 18.14 Audits shall be conducted using written plans in 3878 accordance with Quality Assurance Department 3881 procedures. The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for qual-ity-related practices, procedures, and instructions to determine the effectiveness of the implementa- 50, tion of the OOAP and compliance with 10 CFR Appendix B and the Callaway Plant Technical Speci-fications. The audit plan shall identify the audit scope, the requirements, the activities to be audited, organizations to be notified, the appli-cable documents, the schedule, and the written procedures or checklists as appropriate. The audit plan and any necessary reference documents shall be available to the audit team members. 13877 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 conf erence, 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 18-5 Rev. 14 6/91
OQAM 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. I l l i l l l 18-6 Rev. 14 6/91
OPERATING QUALITY ASSURANCE MANUAL (OQAM)- APPENDIX A OQAM CONFORMANCE TO APPLICABLE NRC REGULA'IORY GUIDES This Appendix briefly_ discusses the extent to which Union Elec-tric's Operating Quality Assurance Program (OQAP) conforms to NRC published Regulatory Guides for the Callaway Plant. Clarifica-tions, alternatives, and exceptions to these Regulatory Guides are identified herein. Union Electric's position on other Regula-tory Guides is giveniin Appendix 3A of the Callaway-SA and Calla-way-SP Final Safety Analysis Reports (FSARs). In each of the ANSI' standards referenced by one of the listed
-Regulatory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of L
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 l U Qualification and-Training of personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor .(Section H 4.3.1.1), Senior Operator (Section 4.3.1.2), Licensed Operators i (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 jTechnicalSpecifications.
the
!=The experience,- training, and education requirements for
! positions of Shift Supervisor, Operating Supervisor,- Reactor l; Operator, and Shift Technical Advisor shall meet or-exceed- the l-requirements and recommendations of ANSI /ANS 3.1-1981 as endorsed t by the Regulatory. Guide 1.8. A-1 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GU".DE 1.8 (cont.) 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 l 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 1 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 l 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 positions or else they shall meet the requirements for certification as inspection, examination or testing personnel as set forth in UE's commitment to ANSI N45.2.6-1978 given else-where in this Appendix. REGULATORY GUIDE 1.28 REVISION 2 DATED 2/79 i Quality Assurance Program Requirements (Design and Construction) (Endorses ANSI N45.2-1977) DISCUSSION: l This Regulatory Guide is not applicable to the operating phase. However, ANSI N45.2-1977 will be applied to suppliers of safety related items, components or services, as appropriate, as described under Regulatory Guide 1.123 (ANSI N45.2.13-1976). REGULATORY GUIDE 1.30 INITIAL ISSUE DATED 8/72 Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electronic Equipment (Safety iGuide 30) (Endorses ANSI N45.2.4-1972/IEEE 336-1971) DISCUSSION: A-2 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.30 (cont.) UE complies with the recommendations of this Regulatory Guide with the following clarifications: For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to 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. l 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 l ANSI N45.2.10 shall be used as clarified in UE's commitment to l Regulatory Guide 1.74. Section 2.1 - Planning requirements, as determined by engineer-ing, shall be incorporated into modification procedures. Engi-neering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are 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-l ements of the Quality Assurance program standards. Section 2.4 - Results shall be implemented as set forth in OQAM Sections 10, 11 and 17 and by compliance with ANSI N18.7 as set forth in this Appendix in lieu of the requirements set forth here. In (very case either identical or equivalent controls are provided in the sections of the referenced Standards or docu-ments. A-3 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.30 (cont.) Section 2.5.2 - Calibration and Control covers three classes of instrumentation used by UE: (1) M\TE (portable measuring instru- l ments, test equipment, tools, gages, and non-destructive test i 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 sentencer M\TE and reference standards shall be included in a calibration program and shall either Le 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 l sentences 2, 3 and 4. 1 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 l 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-l 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. Procedures for these activities receive a cross-disciplinary review as well as-review by the Onsite Review Committee (QA is a l permanent member of this committee). For other activities, OA l audits and surveillances, and QC inspection activities assure QA/QC involvement, A-4 Rev. 14 6/91
* " -'" ^"
OQAM APPENDIX A REGULATORY GUIDE 1.30 (cont.) 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. 5.1.2, Section 5.1 - Inspections, including subsections 5.1.1, 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 OC, those items listed in these subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in UE's commitment to Regulatory Guide 1.33 (ANSI N18.7), Section 5.2.6; the 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 OOAM 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. l l Section 8 - Records shall be implemented by conformance with OQAM i Section 17 and Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix. REGULATORY GUIDE 1.33 REVISION 2 DATED 2/78 L Quality Assurance Program Requirements (Operation) (Endorses ANSI l N18.7-1976/ANS 3.2) i DISCUSSION: A-5 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.) 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 which the applicable Callaway Plant Technical Specifications define " Subjects Requiring Independent Review." Paragraph C.4.a of Regulatory Guide 1.33 (and Section 4.5 of ANSI by N18.7 which it references) shall be implemented as required applicable Callaway Plant fechnical Specifications wh i ct. the define the " audit program" to be conducted. The audit prograin is further defined and shall be implemented as required by the commitment to Regulatory Guide 1.144 (ANSI N45.2.12) as ste 6ed 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 in these requirements are not considered practicable, a review accordance with the provisions of 10 CFR 50.59 shall be conducted and documented. Engineering actions performed in accordance with this Section of the Regulatory Guide are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of ORC). For other activities, QA audits and surveillances, and QC inspec-tion activities assure QA/QC involvement. Paragraph C.S.e of Regulatory Guide 1.33 and Section 5.2.13.4 of ANSI N18.7 which it references shall be implemented subject to the same clarifications made for Regulatory Guide 1,38 (ANSI N45.2.2). Paragraph C.S.f of Regulatory Guide 1.33 (and Section 5.2.19(2) of ANSI N18.7 which it references) shall be implemented with the substitution of the word " practicable" for the word "possible" in the last sentence. The action referenced in this Section is the responsibility of the Callaway Plant Operating Organization, and includes OA/QC involvement. QA is involved through audit and surveillance activities. QC is involved in maintenance inspection activities. 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 is (should) which the Regulatory Guide converts to "shall." Itpara-UE's intent to faily comply with the requirements of this graph, and any conditions which do not fully comply shall be A-6 Rev. 14 i 6/91
COAM APPENDIX A REGULATORY CUIDE 1.33 tcont.) documented and approved by management personnel. Manager - personnel includes QA through cross-disciplinary reviews through QA permanent membership on the Callaway Onsite Rev.c Committee. QA has and shall conduct audits or surveillances oL 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 Require-ments for the Onsite Operating Organization: Training standards referenced in this Section are implemented as described in this Appendix's commitments to Regulatory Guide 1.8 (ANSI /ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2.6-1978) or as otherwise included as part of the Callaway operating license. UE's methods of documenting and otherwise meeting the remainder of the requir-ements of this Section are set forth in OQAM Section 2, in the Callaway Plant Technical Specifications, and in other licensing commitments. 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. With regard to Section 4.1 of ANSI N18.7 - 1976 titled General: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANS1 N45.2.12) as endorsed in this Appendix, OQAM Section 18, and the Callawai Plant Technical Specifications. With regard to Section 4.2 of ANSI N18.7 - 1976 titled Program
Description:
Two aspects are addressed in this Section: audits and independent reviews. The independent review program shall be implemented as required by the Technical Specifications. The UE audit program shall be described in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, the Callaway Plant Technical Specifi-cations, and OQAM Section 18. With regard to Section 4.3 of ANSI N18.7 - 1976 titled Independ-ent teview Process: The requirements of this Section, including of its subparts, shall be met by compliance with the Technical Specification requirements and the OQAM. A-7 Rev. 14 6/91
OOAM APPENDIX A REGULATORY GUIDE 1.33 (cont.J With regard to Section 4.5 of ANS1 N18.7 - 1976 titled Audit ' Pro _ gram The UE audit program shall be implemented in accordance wFth and to neet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, the OQAM, and the Callaway Plant Technical Specifications. With regard to Section 5.1 of ANSI N18.7 - 1976 titled Program -
Description:
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 an 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 Equip-cent Control UE shall comply with the " independent verification' requirements base <1 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 inLpections 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. 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 maintenarice or modification activity, inspection requirements from associated construction - activities shall be considered. Operational inspection require- l ments shall assure quality equivalent to the original quality.
l l A-8 Rev. 14 6/91
OOAM APPENDIX A REGULATORY GUID,E 1.33 (cont.J Since some emergency situations could arise which might preclude preplannii.g 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 actionn 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 preplanned." With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 titled Main-tenance Programs: UE shall comply with the requirements of the first sentence of the fifth paragraph, where practical. This clarification is needed since it is not always possible to promptly determine the cause of the malfunction. UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. QA is involved via both audits and surveillances, and OC is invnived in inspection of maintenance inspection activities. With regard to Section 5.2.8 of ANSI N18.7 - 1976 titled Survell-lance Testing and Inspection Schedule In lieu of a ~" mister surveiTTance schedule," the fol G Wng requirement shall be met:
" Schedules shall be established raficcting the status of in-plant surveillance tests and scheduled inspections."
With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled Plant Security and Visitor Control: The requirements of the Security Plan shall be implemented in lieu of these general requirements. When compliance with an NRC accepted program (e.g., Callaway Security Plan) is referenced, UU has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards. With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled House-keeping and Cleanliness Control The requirements of this Section, beginning with the last centence of the first paragraph and continuing through the end of the Section, shall be imple-mented as described in UE's commitn.ents to Regulatory Guide 1.39 (ANSI N45.2.3) and Regulatory Guide 1.37 (ANSI N45.2.1) as set forth in this Appendix. In every case either identical or equi-valent controls are provided in the Sections of the reference standards or documents. With regard to Section 5.2.13.1 of ANSI N18.7 - 1976 titled Procurement Document Control: UE shall comply with the following sentence in lieu of the last sentence of the referenced Section. A-9 Rev. 14 6/91 L . . - _ _. _ _ _ . __ ~_ __ __ ._ . .___ __ _, . .
- . - -.-- - - -_ - -- - - - - = . - - - - - . . - - - - - . - .
OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.1 Where changen are made to the technical or quality requirements on procurement documenta, they shall be nubject to an equivalent llevel of review and approval by the origincting organization. With regard to Section 5.2.15 of ANSI N18.7-1976 titled Review, Approval and Control of Procedures; in lieu of the ErWnij starting with the cecond 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 chall be jrevised as nececoary. These revialono may he based on reviewn
! conducted by knowledgeable personnel during routine performance lof activitico. Examples of such reviews include evaluations- of evalua-j problems encountered during performance of a procedure, ition of corrective actions for self-identified deficienclea or } events, evaluation of events occurring at other planta, _ evalua-l tion of procedure changen necessary to implement modifications, jevaluation of procedure changes necessary to implement License, , Technical Specification, FSAR or OQAM reviolonn as well as evaluations of changes necennary to resolve Regulatory Innues.
Such changen shall be implemented as neceanary. In some situa-tions such implementation will be completed prior to completion of the in-proccan activity. Guidance on the need to revise proc-edures shall be provided in plant administrative controla." With regard to Section 5.2.17 of ANSI N18.7 - 1976 titled Inspec-tion: The third paragraph in replaced with the following: Inspections for maintenance and modification activitien similar in nature to construction activities shall be conducted as indi-cated in our reference to Section 5.2.7 of this atandard. i 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 innpections shall be identifiable cnd retrievable. With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control of Special Processes: UE shall comply with the following centence in lieu of tEi last sentence of the referenced Section. For special processen not covered by exiating codes or
- standards, or where item quality requiremento exceed I the requirements of established codes or standards, I personnel, equipment and procedure qualification nhall be defined by engineering.
A-10 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.33 (cont.J With regard to Secticq 5.3.5(4) of ANSI N18.7 - 1976 titled Supporting ___Haintenance Dopuments: UE may choose to include mate-ital trom vendor manuals In any of three ways. (1) The applicable section of a manual may bu duplicated, referenced in, and attached to the procedure. (2) The procedure may reference the technical manual or a specific se7cion; the manual may then be used in conjunction with the proccduze for performing the actis-ity. (3) The material, either as originally written or as modified by the procedure's author, may oe 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 procedurend 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 Emergen-cy 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 Emergency: The licensing PSAR identified natural , occurrences which affect the Callaway Plant. Therefore, UE chall interpret item (11) to mean the natural occurrences which were evaluated in the licensing PSAR. With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Proc-edures for Implementing Emergency Plan: UE's NRC accepted Emer-gency Plan shall be implemented in IIeu of the requirements in this Section. When compliance with an NRC accepted program (e.g., callaway Plant Radiation Emerger.cy Response Plan) is referenced, UE has substituted the NRC accepted prol am for applicable regu-latory requirements in lieu of the general requirements of the Quality Assurance Program standards. REGULATORY GUIDE 1.37 IMITIAL ISSUB DATED 3/73 Quality Assurance Requireinents for Cleaning of Pluid 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: A-11 Rev. 14 6/91
WM APPENDIX A REGULATORY CUIDE 1.37 (cont.1 For maintenance and modification activities UE chall comply with the Re_gulatory Position established in this Regulatory Guide in that QA programmat W / 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 or fluid systems and associated compo- oper-nents shall be at least equivalent to the quality of the ating system water except for the oxygen and nitrogen content; other additives, but this does not infer that chromates or normally in the system water, are added to the flush water. With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indic-ating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants: NDT penetrant materials and couplants, dessicants, which contact stainless steel or nickel alloy surfaces shall not contain lead, zinc, copper, mercury, cadmium and other low melting points metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall be allowed where such elements are leachable or where they could be released by breakdown of the compounds under expected environ-mental conditions. With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installa-tion _ Cleaning: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precludede as determined by engineering or Chemistry. Engineering actions performed in accor-dance with this Section of the Standard are conducted with QA/QC involvrment and are subject to QA audit. Procedures for -tese activities receive a cross-disciplinary review as well at view by the Onsite Review committee (QA is a permanent member of this For other activities, QA audits and surveillances, committee). and QC inspection activities assure QA/QC involvement. A-12 Rev. 14 6/91
OQAM APPENDIX A 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 recommendationa of this Regulatory Guide with the following clarificationn: With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Defini-tions: Definitions in this Standard which are not included in N45.2.10 shall be used; definitions which are included in ANSI 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-(First sentence) The specific items to be governed by3.2-1, ingt the Standard shall be identified in Callaway-SP FSAR Table 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 OOAM 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. With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Person-nel Qualifications: Specific requirements for personnel qualfTIZ cations are set forth in the OOAM 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. lWith regard of to Section 2.7 of ANSI N45.2.2 - 1972 titled Classi-Items: UE may choose not to explicitly use the four fication level classifTeation 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 Onnite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and OC inspection activities assure QA/QC involvement.. A-13 Rev. 14 ) 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.1 With regard to Section 3.2.1 of ANSI N45.2.2 - 1972 titled Level A Items: As an alternate to the requirementn 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)) engineering, UE may obviate the need for caps and plugs, as determined by with an appropriate storage atmos-phere, and may choose to protect weld-end preparations and threads by controlling the manner in wP h the items are stored. These clarifications apply whenever i; (4), (5) or (7) are subsequently referenced and to Sectic .5.1 titled Caps and Plugs and Section 3.4 titled Methods of avention. Enginee r fhg actions performed in accordance with thFh sect 1on of the Standard 7 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 oy the Onsite Review Committee (QA ic a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities annare QA/QC involvement. With regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Clean-ing: (Third sentence) UE interprets " documented cleaning methods" to aliaw generic cleaning procedures to be written which shall be implemented, as necessary, by trained personnel. Each particular cleaning operation shall be either governed by an individual cleaning procedure or by a generic procedure either of which shall specify method (s) of cleaning or type (s) of solvent (s) that may be used in a particular application. With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Methods of Preservation: (First sentence) UE shall comply with these requirements subject to the clarifications of Section 3.2.1 (4) and (5) above, and the definition of the phrase " deleterious corrosion" to mean that corrosion which cannot be subsequently removed and which adversely affects form, fit, or function. With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Harrier and Wrap _ Material and Densicants: This Section requires the une of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the UE position. With regard to Section 3.7.1 of ANSI N45.2.2 - 1972 titled Containers: Cleated, sheathed boxes may be used up to 1000 lbs, rather than 500 lbs. as specified in 3.7.l(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs. Other national standards allow this (see Federal Specification PPP-B-601). Special qualification testing shall be required for loads above 1000 lbs. A-14 Rev. 14 6/91
OOAM APPENDIX A REGULATORY GUIDE 1.38 (cont.) With regard to Section 3.7.2 of ANSI 45.2.2 - 1972 titled Craten and Skids: Crates shall be used for equipment in excess of f000 Tb. In weight. Skids or runnero shall be used on boxes with a
- gross weight of approximately 100 lb. or more, allowing suffi-cient floor clearance for forklift tines (ao 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 Sections. 4.3, 4.4 and 4.5 of ANSI N45.2.2 - 1972 titled, respectively, Precautions During Loading and Transit, Identification and Marking, and Shipment from Countries Outside the United States: UE shall comply with the requirements of these Sections subject to the clarifications taken to other Sections which are referenced therein. With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Ship-ping Damage Inspection: Stores personnel shall normally visually scrutinize incomTng 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, separato 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 Damage Inspection. Any nur onformance noted shall be documented nd dispositioned as required by OQAM Section 15. The person performing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regula-tory GL.de 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 j in Section 5.2.2. Engineering actions performed in accordance 6 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. A-15 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.) With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of_Sterage Subpart (2) 10 replaced with the following: (2) Level B itemn shall be stored within a fire resiatant, weathertight, and well ventilated building or equivaleit enclosure in which measures have been taken against v a ndal-inm. This building shall be nituated 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, auch 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 corroolon. 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 Storage Areas: Items which fall within the Level D classifica-tion of the standard shall be atored in an area which may be posted to limit accesa, but other positive controls auch 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 by the Onsite Review Committee (OA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement. With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Stor-age of Food and Associated Items: The sentence is replaced with the following: "The une 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 croso-dis-ciplinary review as well as review by the Onsite Review Committee (OA is a permanent member of this committee). For other activ-ities, QA audits and surveillances, and QC inspection activities aPaure QA/QC involvement. l l l Rev. 14 A-16 ( 6/91 1
, . - , - -. . . , - , -, - -i- - -w , - - = - - - --- -- -
w = " - -
DOAM APPENDIX A REGULATORY GUIDE 1.38_,(contj With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled Meas-Prevent Entrance of Animals: The sentence is replacid ures to t heTollowHisi~'lTxTeiminators or other apprcpriate measures
~
with 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-age 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 tc lastalled 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: (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 I 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 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 L prior to rotation. For long shafts or heavy equipment subject to undesirabic bowing, shaft orientation after rotation shall be specified and obtained." (8) Maintenance requirements specified by the manufacturer's Instructions are addressed in this OOAM, Section 13.3. l l-l l l A-17 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.38 (cont.) With regard to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal of_.I_tems from Storage: UE does not consider the last sentence oT this Secti6n to be applicable to the Operating Phase due to the relatively short period of time between installation and use. The first sentence of the Section is replaced with: "UE shall develop, issue, and implement a procedure (s) which cover (s) the removal of items from storage. The procedure (s) shall assure that the status of material issued is known, controlled, and approp-riately dispositioned." i With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Inspection of Equji_ ment and Rigging: Stated for information only, it is Uni s positfon that this relates to the operability of the hoisting equipment and does not preclude rerating as allowed by Section 7.3. REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 Housekeeping Requirements for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.3-1975) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guido in that QA programmatic / administrative requirements included therein (subject to the clarifications below) chall 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 i 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 N45.2.3 - 1973 are indicated below by Sections. Section 1.4 - Definitions: Definitions in this Standard which are not- included ~ln 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 - Planning: UE may choose not to utilize the five-l 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. 1 ( A-18 Rev. 14 j 6/91 l l . . . _ .
OQAM APPENDIX A REGULATORY GUIDE 1.39 [ con _t . ) Cleanliness shall be maintained, consiM.ent with the work being performed, so as to prevent the entry of foreign material into safety-related systemu. 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 l I the tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, refueling, modification or repair. Additional housekeeping requirements shall be implemented as required for control of radioactive contamination. Section 2.2 - Procedures and Inutructions: Appropriate procedures shall be written and implemented. , Section 3.2 - Control of Pacilities: UE may choose not to utilize l the five-level zone designation system, but shall utilize standard janitorial and work practices to maintain a level of l 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 in larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established wnen 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. 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 complica with the recommendations of this Regulatory Guide with the following clarifications: A-19 Rev. 14 6/91 l l L -- - _-, . _
OOAM APPENDIX A REGULATORY GUIDE 1,55 (cont _.] 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.f-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 in 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. With regard to Section 1.2 of ANSI N45.2.6 -1978 titled Applica-bility: The third paragraph requires that the Standard be used in conjunction with ANSI N45.2; UE no longer 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 Phys _l-cal: 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. A-20 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 Quality Accurance Requiremerits for the Design of Nuclear Power Planto (Eudoroes ANSI N45.2.ll-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'n immediate Supervisor in 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 satlofied and (b) the justification in individually documented and approved in advance Fy the Supervisor's manage-ment, and (c) quality assurance auditL cover frequency and effec-tiveness of use of the Supervisors as design verifiers to guard against abuse. With rew ard to Section 1.4 of ANSI N45.2.11 - 1974 titled Defini-tions: Definitionn in thin 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 chall be used ao clarified in this Appendix. With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12, under Program Requiremento, and Section 11 (including subsections 11.1 through 11.1) of ANSI N45.2.11 - 1974, titled Audits: UE's audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, 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-
- menta.
REGULATORY GUIDE 1.74 INITIAL ISSUE DATED 2/74 l 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. A-21 Rev. 14 l 6/91
DOAM APPENDIX A REGULATORY GUIDE 1.74 (cont.) 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 Sectior.s 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 binding documents that identify ant 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 neller to perform services-or supply equipment, material or facilities on behalf of the purchaser I fe.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.
"Dids" -
Supplier quotation sabmitted in response to specified technical and quality requirements for which price and delivery are primary considerations. t " Proposals" - Supplier offerings that define the scope of supply ! as well as specific technical and quality requirements for a I 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. l l A-22 Rev. 14 6/91
COAM APPENDIX A REGULATORY GUIDE 1.74 (cont.)
" Quality Assurance Program Requitemento" (Not defined in ANSI N45.2.10 but used and defined differently in ANSI N45.2.13) -
Those individual requiremento of the Operating QA Program which, when invoked in total or in part, establich 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'a 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 pren-cribed activity in in fact complete. Examples include, but are not limited tot verification of a breaker opening by observed remote breaker indication lights; verification of a act 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 han been positi-oned by observing the starting or stopping of flow on meter indi-cations or by remote value positions indicating lights. " Audit" (This in a modification of the word's definition - to allow the use of cubjective evidence if no evidence is available an defined in Section 1.4 of ANSI N45.2.12 - 1977 (Hegulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23 - 1978 (Hegula-tory Guide 1.146) an opposed to the definition given in ANSI N45.2.10 - 1973) - A documented activity performed in accordance with written procedures or checklista to verify, by examination and evaluation of objective evidence where available, (subjective evidence may be used when objective evidence is not available),
that applicable elements of the Quality Assurance Program have been developed, documented and effectively implemented in 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.
"Must" -
(Not defined in any ANSI Standard) - An internally auditable requirement imposed by UE management upon its employees, contractora, and agents - above and in exccas of the legally binding requirements of the appropriate regulatory body. Such items are internally required but not externally enforcea-ble. (See additional discussion under Section 2.15 of the OOAM.) l A-23 Rev. 11 6/91 l
OOAM APPENDIX A RECULATORY CUIDE 1,74 { cont.}, _
" Unit staff" - (Not defined la 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 00AM 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. R_EGULATORY GUIDE 1.88 REVISION 2 DATED 10/76 Collection, Storage, and Maintenance of Nucicar 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.'.9 - 1974 titled Gener-ation of Quality Assurance Records: The phrase " completely Illled out d la clarified to mean that JuTficient 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: l 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. Thq specific location of a record "within-a storage area" may not be delineated. (e.g. The specific locaticn within a computer record file may not be constant. Further, UE may utilize a computet 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-l ness: UE's' contractual agreement with its contractors and supp-l liers shall constitute fulfillment of the requirements of this Section. A-24 Rev. 14 6/91 1
_ __ _ _. . _ ._ _ _ .- _ _ _ _ _ _ _ _ _-. _ ._-- _ _~ _- _. _ -._ OQAM APPENDIX A RI:GULATORY GUIDE 1.88 (cont.) The following clarification is substituted for the current subsection 5.4.31 " Provisions shall ha 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-keeping: Routine General Offices and Plant site security systems and access controls shall be provided: no special security systems are required to be established for record storage areas. With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Pacil-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 nature (e.g. nonconforming item logs and control room log books)-- are not considered as QA records since they are not
" complete." These types of documents shall become QA recorde 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).
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 OOAM, Section 18 and commitments to Reg. Guide 1.144 in this Appendix. Paragraph 4, subsection 3 is clarified to require a two-hour minimum fire rating to be consistent with the 1979 version of the Standard and NRC Criteria for Records Storage Pacilities (Gui-dance-ANSI N45.2.9, Section 5.6) issued 7/1/80. A-25 Rev. 14 6/91
OQAM APPENDIX A REGULATORY CUIDE 1.88 (cont.) Paragraph 4, subsection 9 10 clarified to read: "No pipen or penetrations except thoac providing fire protection, lighting, temperature / humidity control, or communicationn 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 came an our commitment to subsection 5.4.3. Both paragraphs addreon the same requirement and therefore the commitment must be the same. REGULATORY CUIDE 1.94 REVISION 1 DATED 4/76 Quality Annurance Requirements for Installation, Inspection and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Planta. (Endoraes ANSI N45.2.5-1974) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: For modification activities UE chall comply with the Regulatory Position established in thin Regulatory Guide in that QA program-matic/idministrative requirements included therein (nubject to these modification the clarifications below) ana11 apply to activitien 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 requirementa, material properties, deolgn margins, manufacturing processen, and inspection requirements), or as required to preclude repetition of defects. The recommendationn for structural concrete, structural steel, and other Plant components shall be met an indicated by the applicable design documents with the following exceptionn:
- a. Bolta for friction type connections may be tightened using direct tension indicators in accordance with the AISC Specification for Structural Joints Using ASTM A 235 or A 490 bolts, approved May 8, 1974.
- b. Section 5.4(1) of ANSI N45.2.5 doco not apply. The requirement for the acceptance of tightened bolt assem-blies 10: "The length of the bolts shall be such that the point of the bolt shall be flunh with or outside of the face of the nut when completely installed."
A-26 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.116 REVISION 0-R DATED 5/77 Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems (Endorses ANSI N45.2.8-1975) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: For maintenance and modification activities UE shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic /ad5inistrative 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 1.123 REVISION 1 DATED 7/77 Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants (Endorses ANSI N45.2.13-1976) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: With regard to Section 1.3 of ANSI N45.2.13 - 1976 titled Defini-tions: With two exceptions (Procurement Dccument and Quality Assurance Program Requirements) definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74. The two exceptions are defined in this Appendix under Regu-latory Guide 1.74. With regard to Section 1.2.2 of ANSI N45.2.13 -1976 titled Purchaser's Responsibilities: Item C is one of the options which may be used by UE to asmtre quality; however, any of the options given in 10 CPR 50, Appendix B, Criterion VII as implemented by OQAM Sections 4 and 7 may also be used. i i A-27 Rev. 14 6/91
OOAM APPENDIX A REGJLATORY GUIDE 1.123 (cont.) With regard to Section 3.1 of ANSI N45.2.13 - 1976 titled Procurement Document Preparation, Review and Change _ Control: The phrase 'the same degree of control" is stipulated to mean " equi-valent level of review and approval." The changed document may not always be re-reviewed by the originator; however, at least an equivalent level of supervision shall review and approve any changes. With regard to Section 3.4 of ANSI N45.2.13 - 1976 titled Procurement Document Control: UE shall meet the requirements of OQAM Sections 4 and 7 in lieu of the requirements specified in this Section. In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments. With regard to Section 5.3 of ANSI N45.2.13 - 1976 titled Prea-ward Evaluation: UE shall comply with an alternate paragraph which reads: "Except in unusual 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 Changes in Items of Services: The phrase "the Operating QA Program" is inserted in lieu of " ANSI N45.2, Section 7." With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Dispo-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 l 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; l
- 2) Requirement in Supplier documents, which have been approved by the Purchaser, is violated;
- 3) Nonconformance cannot be corrected by continuation of f the original manufacturing process or by rework; and/or l
l A-28 Rev. 14 6/91
OQAM , APPENDIX A REGULATORY GUIDg ,1 123 (cont.) l
- 4) The item does not conform to the original requirement even tho u gh the item can be restored to a condition such that the capability of the item to function is unimpaired.
*A module is an assembled device, instrument, or piece of equip-ment identified bY serial number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable compo-nent is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an individual item and which has been evaluated by inspection and/or test for conformance to procurement requirements regarding end use.
With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source l Verification Actgties and Section 12 of ANSI N45.2.13 -776 titled Audit of y curement Program: o The US audit program shall
~
be impicmented in accordance with and to meet the requirements of Regulatory Guide 1,144 (ANSI N45.2.12) as endorsed in this Appen-dix, 00AM Sections 16 and 18, and the requirements of the callaway Plant Technical Specifications. REGULATORY GUID M REVISION 1 DATED 9/80 Auditing of Quality Assurance Programs for Nuclear Power Plants ! (Endorses ANSI N45,2.12-1974) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: With regard to Section 1.4 of ANSI N45.2.12 - 1977 titled Defini-tions: With one e x ception (Program Deficiencies) the definitions in this Standar d 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 rc9arding the second paragraph discussing audit team selection. With regard to Section 2.2 of ANSI-N45.2.12 - 1977 titled Person-nel Qualification: The qualification of UE audit personnel shalf be accomplishid~5s described to meet the requirements of Regula-tory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OOAM Section 18. A-29 Rev. 14 6/91 i
OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.) With regard to Section 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titled Training: The training of UE audit personnel shall be accomplished an 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-ments 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-ments. Subsection 3.3.7 requires verification of effective corrective action on a " timely basis." Timely basis is interpreted to mean within the framework or period of time for completion of correc-tive action that is accepted by the Quality Assurance Department or Quality Services Department. Each finding requires a response and a corrective action completion date; these dates are subiect to revision (with the approval of the Quality Assurance Depart-ment or Quality Services Department) and must be escalated to higher authority when there is a disagreement between the audited and the auditing organizations on what constitutes " timely corrective action." With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planning: Identical or equivalent controls are provided in this OQAM, Section 18. i i ! A-30 Rev. 14 6/91
- - . . - _ - . - ~ . - - - - - - _ - - _ - . - - . - - - - - .
OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.) With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Sched-uling: Identical or equivalent controls are provided in this OQAM, Section 18 for the requirements of Subsections 3.5.1 and 3.5.2. Subsection 3.5.3.1 is interpreted to mean that UE may procedurally control qualification of a contractor's or suppli-er's quality assurance program prior to awarding a contract or purchase order by means other than audit. The measures outlined in Sections 4 and 7 of this OQAM address the requirements of Subsection 3.5.3.1. With regard to Section 4.3.1 of ANSI N54.2.12 - 1977 titled Pre-Audit Conference: UE st.all 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-fore 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 l " obvious" with respect to the needed corrective action: l "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 I audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required." l A-31 Rev. 14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.144 (cont.) (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 Post-Audit Conference: UE shall substitute and comply with the To11owing 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 reasono as above. Again, if there are no adverse findings, management of the internal audited organization may waive the post-audit conferences such waiver sh/411 be documented in the audit report." With regard to Section 4.4 of ANSI N45.2.12 - 1977 titled Report- _i ng : (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-32 Rev. 14 6/91 t
GQAM APPENDIX A l
-REGULATORY GUIDE 1.144 (cont.)
(c) Audit reports may not necce;arily contain an evaluation statement regarding the effectiveness of the Quality Assu-rance Program elements which were audited, as required by subsection 4.4.4, but they shall provide a summary of the audited areas and the results which identify the importance of any adverse fli' dings. With regard to Section 4.5.1 oJ ANSI N45.2.12 - 1977 titled By Audited Organization: UE shall comply with the following clarifl-cation of the Section: Management of the audited organization or activity shall review and investigate _ adverse audit findings, as necessary, (e.g. where the cause is not already known, another. organization- has not already investigated and found the cause, etc.) to determine and schedule appropriate corrective action including action to prevent recurrence. They shall clearly state the corrective action taken or planned to prevent recurrence and i the results of-the investigation, if conducted. In the event that corrective action is not completed within thirty days, the I audited organization response shall include a scheduled date i for completion of ply ..ted corrective action. The audited organi-zation shall take appropriate action to assure that corrective action is accomplished as scheduled. Since the auditing organiza-tion tracks scheduled corrective action completion dates and verifies corrective action completion, a follow-up response by the audited organization stating the corrective action taken and the date that the action was completed is not necessary, provided corrective actions are completed as specified. If corrective actions are not completed as specified, the audited organization shall provide a revised response stating the corrective action that has been taken, the corrective action yet to be completed, and the date that all corrective action will be completed, y l REGULATORY GUIDE 1.14j INITIAL ISSUE DATED 8/80 Qualification of Qual.ity Assurance Program Audit Personnel for Nuclear Power PJants (Endorses AN3I N45.2.23-1978) DISCUSSION: UE crsnplies with'the recommendations of this Regulatory Guide with-the following clarifications: With1 respect to Section-1.4 of ANSI N45.2.23-1978- titled Defini-tions: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used _" Audit" which is included in this Standard and ANSI N45.2.10 shall be used as clarified in this Appendix under Regulatory Guide 1.74. l l A-33 Rev.:14 6/91
OQAM APPENDIX A REGULATORY GUIDE 1.146 (cont.) With respect to Section 2.2 of ANSI N45.2.23 - 1978 titled Quali-fication of Auditors: Subsection 2.2.1 references an ANSI BS4.2 (presumed to be standard N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 which reads: Orientation to provide a working knowledge and understanding of the Operating QA Manual, including the ANSI standards and Regulatory Guides included in this Appendix and UE's proced-ures for implementing audits and reporting results. With respect to Section 3.2 of ANSI N45.2.23 - 1978 titled Main-tenance of Proficiency: UE shall comply with the requirements of this Section by defining " annual assessment" as one which takes places every 12 + or - 3 months and which uses the initial date of certification (not the calendar year) as the starting date for determining when such annual assessment is due. The combined time 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 Organ-12ational Responsibility: UE shall comply with this Section with the substitution of the following sentence in place of the last sentence in the Section. The Manager, Quality Assurance; a Superintendent, Quality Assurance; Supervising Engineer, QA; or Lead Auditor shall, prior to commencing the audit, assign personnel who collec-tively have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited. With respect to Section 5.3 of ANSI N45.2.23 - 1978 titled Updat-ing of Lead Auditor's Records: UE shall substitute the following sentence 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 . l In every case either identical or equivalent controls are provided in the sections of the referenced Standards and docu-ments. i ( l A-34 Rev. 14 6/91
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OQAM, REVISION 14 IDENTIFICATION OF CHANGES
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e . OQAM OPERATING QUALITY 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 organ-ization responsible for implementing appropriate portions of the OQAP is shown in Figures A and B of the OQAM. The Callaway Plant operating organization is shown in Figure C of the OQAM. 1.2 The President is responsible to the Chief Executive Officer of UE for the establishment and implementa-tion of the Quality Assurance Program requirements. He has ultimate responsibility for quality assurance, engineering, construction, and operation of the Callaway Plant. 1.3 Under the President, 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 Division which support the angineering, construction, testing, and operation of the Callaway Plant and coordinating support activities performed by others who are not under his direct administra-tive control. He has corporate responsibility for the operation and physical control of the Callaway Plant. b 1790 1.4 The Manager, Quality Assurance reports to the Senior 2006 Vice President-Nuclear on Quality Assurance Program and administrative matters. QA Program matters are reported to the President through the Senior Vice President-Nuclear.? The Manager, Quality Assurance pi l5 # ' is responsib'I f for directing the overall Quality 65 '$ Assurance Program for UE including Program develop-NN ment, maintenance, and verification of implementa-The Manager, Quality Assurance has sufficient tion. authority, organizational freedom, and independence f+or "Moa i n nenee-f r om , ar-res pvu o iin.li ty -fer, roe m"i Fchcdule that he can effectively assure compliance with OQAP requirements as they control Callaway Plant and offsite quality activities
- Re e,4-* . _ = a ality assur y D aw& 4dee
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00AM them technical---direot-lon---and administrative guidance. He-ie-responsible Jor-establishing-end implement-ing-a. mmprehensive_ audit-program. The qualifications of the Manager, Quality Assurarce are at least equivalent to those specified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Section 4. 2. 4. The Manager, Quality Assurance is located at callaway Plant and provides technical direction and i administrative guidance to the Quality As surance; and- the Supervising Engineer,#/ Superintendent, f Quality Support, Quality AssuranceJ M 2012 1.5 The Superintendent, QA is located at Callaway Plant. b He directs Supervising Engineers who have primar p.. duties for assuring implementation of the OQAP. Te ge d (- d3 Supervising Engineer, Quality Support, QA, located g at Callaway Plant, directs a croup of engineers who provide additional support activities- including maintenance of the Operating Quality Assurance Marual (00AM). The activities of the groups report-t ing to the Superintendent combined with the activ-ities of the group reporting to the Supervising Engineer, Quality support assure implementation of I the OOAP. The qualifications of the Superintendent are at least equivalent to those specified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Section 4.4.5. I 1.6 The Manager, Quality Assurance, the Superintendent, Quality Assurance, and Supervising Engineers in the Quality Assurance Department are authorized by the Senior Vice President-Nuclear to stop work on ongoing quality activities in accordance with approved procedures. During the operating phase they have the authority to stop unsatisfactory work t during repair, maintenance, and refueling activities and the authority to recommend to the Manager, Callaway Plant stop work affecting the continuation of Plant operation. Other stop work authority shall be delineated in procedures. The continuance of an activity which would cover up a deficiency and preclude identification and correction, or increase the extent of the deficiency is subject to stop-work l action by the Quality Assurance Department. The l Manager, Quality Assurance, and the Superintendent, l Quality Assurance have no duties or responsibilities I unrelated to QA that would prevent their full j attention to OA matters, if 1-2 Rev. M 6/90 m
$. 4 OQAM M g 1.4 The Manager, Quality Services reports directly to the Senior Vice President-Technical Services. The Senior Vice President-Technical Services reports to the President. The Manager, Quality Services is responsible for supporting audit, surveillance, and evaluation of nuclear supplier quality activities, and for perfo7 ming those procurement document b reviews d84W4 & d to Quality Services, by Qniny
?. :urcncc.
d 1.Y General quality assurance indoctrination and train-ing for the Nuclear Division is the responsibility of UE Nuclear Operations (UENO), Training. The Quality Assurance Department is responsible for specific QA training as requested by Nuclear Division organizations. 1790 1. The authorities and duties of persons and organiza-g tions performing quality assurance functions shall be clearly established. Such persons have suffi-cient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify corrective action. Assurance of quality by checking, auditing, inspecting, or otherwise verifying Program activi-ties sha.1 be by personnel other than the individual or group performing the specific activity. 8 M 1.M 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 implements the OQAP through the Superintendents, [ "-~i"^^""~ Design Control, System Engineering, and Pro]ect 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.
'I d 1.1-1 The Manager, Licensing and Fuels reports directly to the Senior Vice President-Nuclear and has overall responsibility for UE nuclear fuel cycle activities including responsibility for procurement of fuel cycle goods and services, and for incore fuel a
1-3 Rev. d 6/B9 f/
,.. e .
l OQAM Mdl M @~N i i management. The Manager, Licensing and Fuels is also responsible for coordinating licensing Activi- W k2 ties for Callaway Plant. The Licensing and Fuels organization provides technical support and radiological activities in the area of reactor design engineering, 10 g 1.4-2 The Manager, Nuclear Services reports directly to the Senior Vice President-Nuclear and is responsible for providing administrative and management support including cost forecasting, status reporting, and budgeting matters. He is responsible for direction of the Nuclear Division General Offices clericalHealth activities, and serves as Principal Physicist. He is also responsible for the adminis-trative contact with the Institute of Nuclear Power As Principal Health Physicist, Operations (INPO). 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. I8 V4 P,es.% d-The Generai-Mane <fer , Nuclear Operations reports to d d 1.11 the Senior Vice President-Nuclear and is responsible for the activities of the Callaway Plant Operations Department and the Operations Support Department. This responsibility includes the safe, legal and efficient operation and maintenance of the Callaway Plant and protecting the health and safety of the public and Plant personnel. He assures a high level of cuality is achieved in the Plant operations and support activities. i2 b 1.44 The Manager, Callaway Plant reports directly to the ya f,ew/c:bGene-r41 ":neger, Nuclear Operations and is responsi-ble for the safe, legal, and efficient operation and maintenance of the Callaway Plant. He controls Plant functions and implements the OQAP through the Assistant Manager, Operations and Maintenance, the A;;istant ":n a ge-r ,
. Technical Ocevi-ec e , and th:
Assistant Manager, Work Controp (see Figure C of the
-{LA fYg 'JM f g%,,, fr M p '[ OCAM) reactor .
He has operation the primary responsibility for and safety. Within his organization, the QC Supervisor reports to the b f dg$ Assistant Manager, Work Control who reports to the gTgg Qfj tt Manager, Callaway Plant. The Quality Control Group performs work activity inspections, receipt inspec-e tion as described in Section 7, and nondestructive examinations and is not involved in those activities performed by others which are considered "inspec-tions" unto themselves, e.g., surveillance testing, init;al startup testing, and I&C, Radiation Protec-ticr. and Chemistry group activities. Activities cen2..ered to be inspections unto themselves are H 1-4 Rev. 14 6/9p (
}
OOAM covered by QA audits and QA surveillances as dis-cussed under Section 18. The QC Supervisor has no duties or responsibilities unrelated to quality control that would prevent his full attention to quality control matters. gg 1. b The Manager, Operations Support reports to the m, Nuclear Operations and is responsi-N p [dConeral ble forM:.ne Plant support activities including training, materials management, security, and administration services activities required to support the Callaway i Operating License. He controls Plant support i activities and implements the OQAP through the l Assistant Manager, Materials, the Superintendent, Training, the Superintendent, Security, and the l Superintendent, Administration. i % g. Pe e 4M i dd 1. h{ The Manager, reports to the Nuclear Information Services neral Managen Nuclear Operations. (NIS) 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. va M& l (( 1. d- The Manager, Nuclear Safety and Emergency Prepared-ness (NSEP) reports directly to the Gene h nager, Nuclear OperationF and is responsible for providing ! a constant independent overview of nuclear Plant I safety. He directs the Supervising Engineer, Independent Safety Engineering Group (ISEG) and the Supervisor, Emergency Preparedness (EP). 6-k 1.bO The Supervising Engineer, ISEG and staff evaluate Callaway Plant operations from a safety perspective l and compare Callaway operating experience with that of plants of similar design. .In addition, they assess the conformance of Plant performance to safety requirements. 4 The Supervisor, EP and staff bb b d, have overall responsibility for the development and maintenance of the Emergency Preparedness Program. This includes onsite and offsite emergency prepared-ness, coordination .of the Plant Radiological Emer-gency Response Plan with State and local emergencyf plans, and the planning and execution of emergency I drills and emergency plan exercisepJ ~A communica- T l Ton path exists between the Manager, NSEP and the h l Senior Vice President-Nuclear for matters having d immediate or significant safety implications, thus providing a direct path to contact management personnel having corporate responsibility for Callaway Plant. ,
'4 1-5 Rev. 13 6/90 1 - .,a.-. -
OQAM y.e Vp *h lg 1.19 The Superintendent, Personnel (Local 1439 and 1455) reports directly to the Genera l-Manager , Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel I activities, Fitness-For-Duty, and other matters under the guidance of UE policies.
- v. 3 Vre vfd d 1.20 The Superintendent, Personnel (Local 148) reports directly to the Genera-1-Marrager, Nuclear Operations and is responsible for assisting in areas of labor relations, organizational and personnel activities, and other matters under the guidance of UE policies.
1.21 The Manager, Purchasing reports directly to the Vice President, Supply Service who in turn reports to the Senior Vice President-Administrative Services. The Manager, Pur' chasing is responsible for commercial aspects involved in procurement of materials. systems, components, and services (excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others which are enployed in support of Callaway Plant. 1.22 The Manager, Mechanical Engineering reports to the Vice President-Engineering and Construction who in turn reports to the President. The Manager, Mechanical Engineering provides technical support, as necessary, to the Nuclear Engineering staff. The Chief Draftsman, who reports to the Manager, Mechanical Engineering provides drawing preparation and revision support, as requested, for design performed by Nuclear Engineering or other UE organ-izations. 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 g n c L'T y staff. Fe W 17
- may safety-related d 1.34 Other UE divisions provide services which augment and support selected Program activities. These organizations shall be required tc implement controls consistent with the OOAP requirements applicable to their scope of activi-ties. The coordination of these activities is the responsibility of the Senior Vice President-Nuclear.
W 1-6 Rev. F3 6/90 m l
OQAM g 1.25
')f Safety review committees snall be established to provide an independent review of those items re-quired by the Callaway Plant Technical Specifica-tions. These couni t t e e s , the Onsite Review Commit-tee (ORC) and the Nuclear Safety Review Board (NSRB), are described in the Administrative Controls Section of the Callaway Plant Technical Specifica-tions.
1-7 Rev. 6/90 i
l OQAM CN 90-00 i i- INSERT 4 1.25 The Manager, System Relay Services reports to the Senior Ji Vice-President, Technical Services and is responsible for
'g /S providing qualified engineers, technicians and equipment to maintain callaway Plant relays, j$$1.$ The Manager, Distribution operating Department reports to the Vice-President Transmission and Distribution and is /kh responsible for providing qu 211fied engineerc, technicians ; and equipment for Callaway Plant battery testing and f: technical support. '4 .
9 0 4 Page 1-7a l
U OQAM 12974 2.0 QUALITY ASSURANCE PROGRAM 1799 2.1 UE has established an OQAP which controls activities affecting quality. The Program encompasses those quality activities necessary to support the operating phase of the Callaway Plant and shall comply with 10 CFR 50, Appendix B - " Quality 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 OOAM. In addition, the OQAP haa 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 authorizing Program implementation. This responsibility has been establisned by the President who is responsible to the Cnief Executive Officer of UE for establish-ing and implementing the Quality Assurance Program requirements. 2.2 Lines of authority and responsibility have been g established through from intermediate the highest levels and management to the level Generel u fo5'I 4 Mawdr , 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 responci-
- bilities are assigned within the OQAP, the - pre-l scribed individual shall retain the overall respon-sibility; however, subject to applicable regulatory constraints, authority may be delegated to subordi-nates. Considering these same regulatory con-straints, the authority of a subordinate may always be assumed by a superior.
I 1104 2.3 Updating and revision of the OOAP as described in i
,1105 thic OQAM shall be in accordance with the applicable ' requirements of 10 CFR 50.54 (a) and 10 CFR 50.71.
1824 2.4 The pertinent requirements of the OQAP apply to all activities affecting the safety-related functions of those structures, systems, and components that ! prevent or mitigate tha consequences of postulated l accidents that could cause undue risk to the health
- and safety of the public. The safety-related l
l 2-1 Rev. H l 6/90 l I l l
- . .. _. - - . - -. .= . . .
OQAM 2.8 Disputes which may arise between QA or QC personnel and personnel in other UE organizations which cannot d be resolved shall be referred to the next higher level of management for resolution. Disputes which cannot be resolved through these levels shall be resolved ultimately by the Chief Executive Officer. 2.9 Preservice (PSI) and inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspections and other operating phase " code" activities shall comply with the requirements of the applicable Code Edition and Addenda of the ASME Boiler and Pressure Vessel Code. This compliance includes the independent third-party inspection coverage of " code" items by an Authorized Nuclear Inspector. General indoctrination and training programs shall
.g 3 1916 2.10 be developed for personnel performing safety-related P194 o activities to assure that responsible functions, depar*.ments, and individuals are knowledgeable regarding quality policy and requirements of appli-cable 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 respon-sibility of ..ie 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, ur.ique features of equipment and systems, operating constraints, and control requirements in effect during performance of work.
Training shall be conducted as required to, as a minimum, meet the requirements of UE's commitment to Regulatory Guide 1.8 (ANSI /ANS 3.1), Regulatory Guide 1.33 (ANSI N18.7), other Regulatory Guides as endorsed in OQAM Appendix A, and other regulatory requirements. Records of training shall be main-tained as described in Section 17. Where required by code or standard, personnel are trained or qualified according to written procedures in the principles and techniques of performing specific activities. Special equipment, environmental conditions, skills, or processes shall be provided as necessary for the effective implementation of the OQAP. 2.11 An audit system shall be established to assure l management in advised of Program effectiveness. The implementation and effectiveness of the 00AP shall be assessed through an audit program of quality l activities which includes design, procurement, Uf 2-4 Rev. & slag n
, _ .. _ . . _ . _ _ . _ - . _ . _ _ _ ____m .
..y__ \ l 00AM public safety. For those cases where it is unclear if an individual piece (part of a safety-related structure, system, component or nervice) is governed by the OOAP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering or Materials Engineering and shall classify the safety relationship of the service or questionable component, parts or items of safety-related structures, systems, and components.
Evaluations shall be documented for future reference. 1876 ,J<J Commercial grade items shall rely on proven design 3601 7ss- and utilize verification methods by the purchaser, to g the extent appropriate to item application. dures provide for the acceptance of commercial grade Proce-items based on one or more of the following:
- 1. Special Tests and Inspections
- 2. Survey of Supplier (Commercial Grade)
- 3. , Source Verification
- 4. Acceptable Supplier / Item Performance Record Method 4 should not be used alone unless:
a) The established historical record is based on industry wide performance data that is directly spplicable to the item's critical characteris-tics and the intended safety related applica-tion; and b) The manufacturer's measures for the control of design, process, and material changes have been adequately implemented as - verified by audit (multi-licensee team audits are acceptable). d 4.f Provisions for the following shall be included in procurement documents as applicable: i 1864 1. The scope of work and basic administrative and 1890 technical requirements including drawings, 2416 specifications, regulations, special instruc-3550 tions,_epplicable_ codes and industrial standards 3551 and procedural requirements identified by titles 3552 and revision levels; special process instruc-tione; test and examination requirements with corresponding acceptance criteria; and special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, l packaging, handling, shipping, and storing. 4-3 Rev. F3 l 6/90 I
t OQAM 3559 4. 4 The originating organization shall perform a docu-3560 mented independent review of procurement documents to assure requirements are correctly stated, inspectable, and controllable and that there are adequate acceptance and rejection criteria. This 3562 , review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents. 3567 4.h Bids or proposals shall be evaluated by the 3568g purchasing Department, the originating organization, 3563 the Quality Services Department, and the Licensing and Fuels Department to assure conformance to procurement document requirements in the following areas as applicable to the type of procurement as described below:
- 1. Technical considerations
- 2. Qualicy Assurance requirements
- 3. Research and development effort
- 4. Suppliers' personnel qualifications
- 5. Suppliers' production capability
- 6. Suppliers' past performance 7 Alternates
- 8. Exceptions 10 3560 4 .M .1 The Purchasing Department shall initiate and 3567 g coordinate bid evaluation activities for those proposals received in response to requisitions. The Purchasing Department shall review bids or proposals, except those associated with Engineeri5 sar" ice g Agreements .TESAsh or nuclear fuel cycle related goods or services, for alternates or exceptions to-procurement document requirements (areas 7 and 8 above) taken by the Supplier. These reviews 3563 shall be documented.
"4\ 3560 4. .2 The originating organization shall/rbw bids or 8
proposals in all eight areas for ESAsj and for parts, services the originalapeAot that a direct equipment, f(o~rg_from replacement or 1pproved supplier. They shal y so review areas 1 through 3 above for replacement parts or equipment ordered- from the-original supplier as part of procurement document preparation. tO 3560 4.H.3 The Quality Services Department and the originating organization review areas 4 through 6 above as part of maintaining a supplier on the , qualified , supplier
. list as described in the OCAM, Sections 770 and 18.0.
If 4-5 Rev. W 6/97 I
OQAM 10 , 3560 4 .)d . 4 The Licensing & Fuels Department shall evaluate bids g or proposals for fuel cycle goods or services in the above areas. I o 3560 4. M - Bids or proposals with alternates or exceptions 3561 identified in Section 4.11 by the Purchasing Depart-3568 ment shall also be evaluated by the originating 3570 organization to provide additional assurance that no unacceptable conditions result from such changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award. M 4..h Letters of intent may be utilized with suppliers of materials, parts, components', and services for the
, purpose of reserving schedule space prior to the
(* *d * *'I 7e s o l u t ion of t W requirements to be included in a purchase order, contract, or ESA. If employed, l~ letters of intent must normally specify that no safety-related activities may begin until an approved purchase order, contract, or ESA is execute g However in the event a letter of intent is issued for the purpose of securing an agreement and thereby allow safety-related work to begin prtoy to the issuance of such documents, it shall VLj@hy th9 applicable quality and technical requirements 3 J-Letter: cf 1-atent chall be prepared by the Purchasing Department or the orig 4-nating c ryi-sat-lonr-reviewe d by the or-19 1nating--organ 44a4:4erer--and-approved and issued by l Purohas-i ng . Le t-tw of intent-iesued-pr4er--tc the exsout4cn of a centraot for reuclear f ue+ -cy- ! elc-related gccdc and/cr cervice: chall be prepared, revieued and ircued by the Muclear Fuc1 Department. Lettern of intent iccued prier to tM cr.ccutier of 2n
% f FU chall bc - prepared ,- rev cued, and iccued by the- ,
The chave reviewt,-shatt-be p hai[g AC,. originating organization. to- -aemo_-th t :pprcpriate rc;uirwr. ant h: = b-en impece6 l fa rcbs< ln.-
. hbS e$ idsrf d"0 h ryf*th;Gynn><NtKmt f aa,
~ orp-geskuw. W es% 4 J Ga,farJn ac.y y 4 orp.ta u.J,sdp,,a,,s w -y Q nulrPr hHef qcle-t b ' f 5 N Y M a*.
. l 'f 4-6 Rev. M 6/90 I
j
'OQAM '
3563 4. The Purchasing Department is responsible _for
, reviewing purchase orders to verify that- the d.
technical. and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisi-tion, letter of intent, En9eeri. g Service Aqseen 85' meat, or contract shall be by an' individual who-has approval authority and signifies that the technical and quality review of the -document has been completed. . Contracts _ initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility ' of the . Manager, Licensing . and Fuels with preparation and negotiation by the Licensing and Fuels . Department. . ; Nuclear fuel cycle-related contracts- ands Enginaaring sarvira Agreemente for W3 ' professional services shall be executed by the Senior Vice President-Nuclear or another company officer in accordance with Nuclear . Division' and corporate-procedures related to agreements- or contracts for
. services.
975 4.b Additions, modifications, exceptions, and other , 3549 changes to procurement document quality and-l- 3575 4 technical requirements shall require a review equiva-3576 lent to that of the original document and approval by the originator or the originating department approval authority. Commercial _ consideration changes shall not require review and concurrence by the originator. Conditions specified on the Qualified Suppliers List feet) that apply to a vendor may be revised without-concurrence from ~ the originating organization since they are imposed without the knowledge of the origi-nator, t 4 4-7 Rev. 13 6/96,
- 4 OQAM 12974 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS A 1830 5.1 The activities affecting quality associated with the 1858 operating phase shall be accomplished .in-aeeor-deneec+wI l1861 wi th-documented instruct 4onsar-ocedures , d rawimys ty/6 or-cheelell sp4hich specify the methods for comply-gS i15o[ with 10 CFR 50, Appendix B and the Technical ~
ecifications dhe degree ~ of control imposed shall be consistent with the relative importance of the activity to safety J 1948 Jd Aet-i-vities-af-f-eeting-quality shall he controlled by: preparing procedures, instructions, specifi-l1. cations, drawings or checklists of a type ( appropriate to the activity and its importance , C to s_a_fet's; ;
- 2. including in these documents quantitative or qualitative acceptance criteria for verifying that an activity has been satisfactorily !
accomplished; l
- 3. having responsible personnel approve these documents prior to accomplishing an activity; and t83& 4. using approved drawings, procedures, instruc-IM6 tions or checklists to accomplish an activity.
't C g 1833 ~., . / The Nuclear Division and other responsible functions and departments shall provide written procedures and drawings as required to support the Callaway Plant operating phase. These procedures shall prescribe those activities affecting safety-related struc-tures, systems, and components. It is recognized that skills normally possessed by qualified person-nel may not require detailed step-by-step delinea-tions in written procedures.
2 dgh 54 The Manager, Callaway Plant shall be responsible for via Administrative providing specific guidance Procedures for the development, review and approval of other Plant operating procedures to govern activities which affect safety or quality consistent with the Technical Specifications. Similar guidance shall be provided for revisions and temporary changes to Plant operating procedures. Pitmt
/ opera 44rg p rn cedures----sh a 11 -
ha reviewed nn lass ( frn~mmtly *han every two yaava *n riatarM ne if I c h a n ges-ar-e-necessary o r de sirab-le . A revision of a
'( procedure my constituteg a procedure review. \
Ck % 6"
- IN #lF # I* '##' O*wf M dMl _
ew<<yyLal F esgse%(L 4M Le whola be5nk; (a, a La .,,.h TsM/ pdJn). n .sug 5-1 Rev. 6/9f
OQAM approval, implementing k 5. The issue and control of procedures, manuals and policy shall be prescribed ./ in Administrative Procedures consistent with the requirements of Sections 2, 5 and 6. l b 5 Administrative Procedures shall be reviewed by tne Quality Assurance Department as described in Section 2.6, item 3. k 5. Maintenance and modification procedures shall be reviewed in accordance with Section 6.2. 7 process by k 5.) Special procedures supplied organizations shall be reviewed in accordance with outside Section 9.4. g -mig 54 A lica .e procedures shall be reviewed following an un u incident, such as an accident, an unexpected trang nt, significant operator error, or equipment ma lf'u nc t n. k 5. In addition to the procedures identified in Table 13.5-1 of the Callaway-SA FSAR (CALLAWAY PLANT ADMINISTPATIVE PROCEDURES), the OQAP includes procedural coverage in the following area= : design control; design change control; preparation, review, approval, and revision of specifications, Agreements, drawings, requisitions. Engineering Service contracts and procedures (instructions); OA indoct-rination 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. l t l l 5-2 Rev. 12 6/49 9/ I
OQAM accordance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and whose acceptability can be determined by receiv-
, ing inspection, an examination of quality verifi-cation documsntation, or other stitable means; 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); an4 4) outside organizations working under the UE OQAP. Regardless of the basis for the acceptability of the procure-ment source, prior to the issuance of a purchase order or execution of a contract or ESA, a verifi, cation of the supplier /outside organization's 2977 acceptability shall be documented. Except in unusual circumstances (e . g . replacement parte are needed to preclude the development of some unsafe cr undesirable condition), an evaluation of a Suppli-er's acceptability as a procurement source shall be accomplished prior to award. In the case 3874 of purchase ordeps, the supplier shall be verified as an acceptable procurement source for the item or service being procured. Purchase orders may be issued prior to an assessment of suppliers' capabil-ity provided a prohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an accept-able procurement source.
4, l2337 7.4 To support the control of purchased material, copies g of purchase orders and other appropriate procurement documents shall be forwarded to the applicable receiving or acceptance point. Departments receiv-ing or utilizing procured items or services shall establish measures to maintain and control procure-ment -documents until. the items or services are received and accepted. These documents shall include purchase orders, drawings and specifi-cations, approved changes, and other related docu-p_ ments. ^ 7.5 Without any further evaluation,the suppliers to UE i or its agents during the design and construction i phase may be regarded as qualified procurement I sources for replacement parts during the first three ! years of Callaway's operating phase as the procure- i ment source evaluation measures employed previously / have identified these suppliers as qualified pro- / curement sources. Callaway's operating phase began j/ on June 11, License. 1984 with issuance of the operating ', ld 7-2 Rev. H 6/99 I
OQAM
/
h 1894 7.J Procurement source evaluation and selection involves 3565 the Quality-Assuranos-and Quality Services Depart-g ment)( and the originating organization. tion. and selection process shall be specified in The evalua-department procedures 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 organizations may be requested to provide input to the qualification evaluations of suppliers. Suppli - ers of hardware and services which are manufactured prior to award, considered a commercial grade item, or implemented under the 00AP do not require pre-award source evaluation audits which attest to a suppliers capability as a procurement source. 6 h 13566 7.J Procurement source selection and evaluations shall consider one or more of the following: 13564 1. Experience of users of identical or similar products of the prospective supplier. NRC
, Licensee Contractor and Vendor Inspection Program (LCVIP) reports, ASME Certificates of I Authorization (C of A), audit reports, UE records accumulated in previous procurement actions, and U2 product-operating experience may be used in this evaluation. Supplier history shall reflect recent capability.
Previous fdvorable quality experience with suppliers may he an adequate basis for judgements attesting to their capability. When an LCVIP report, an audit report, or an ASME C of A is used to er,tablish a supplier's accept-ability as a procurement source, the i 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 3605 and quality capability as determined by a direct evaluation (audit or surveillance) of facilities, personnel and Quality Assurance Program implementation. l tt 7-3 Rev. 4-3 6/90 I
OQAM 4., For commercial grade items, the procurement source selection should consider one or more of 1 the followings a) Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementa-tion of manufacturer's measures for control of design, process, and material changes.
-b) Acceptable supplier / item performance record utilizing monitored performance of the item, industry product tests, national codes, and standards (not specific to the nuclear industry), or other- industry databases (UL, INPO NPRDS, EPRI EQDB, ANSI, NEMA, MIL-STDS, NRC Bulletins /-
Notices, and Licensee Event Reports, etc.) that is directly related to the item's critical characteristics and -intended
. application.
jb 7 7'1 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 considera-tions include one of the previo/ssurance usly defined methods of: supplier evaluation and a consideration of 3 changes in a supplier's Quality Assurance Program or capabilities. The measures employed to evaluate a supplier's continued acceptability as a procurement i source (after the initial source evaluation) are l _ described in Section 18. bl2337 7. Receiving intrection instructions shall be document-2416 ed. The:S instructions include specifying inspec-tions or test.'of commercial grade - items procured from suppliers on-the basis of product performance. Should it become necessary to upgrade stocked i non-safety related -- items to specific requirements, inspections, tests,_or documentation reviews may be employed to establish the items' acceptability.
-l975 Documentation shall be. generated as a result of UE receiving inspection activities, b 13571 7. Organizations participating in the procuremen_t process 'shall prepare- procedures to monitor and evaluate suppliers' performance to procurement -document requirements. These procedures shall include provisions for: 1) controlling documents M
7-4 Rev. t3 6/9.0 I i l l
I l
- OQAM generated or_ processed during activities fulfilling procurement requirements; 2) identifying and pro-cessing change information 3) establishing a method of control and documentation of information-exchange with the suppliers and- 4) audit or surveillance of supplier activities. 'I '
l3571 7. H Depending on the complexity or scope of the item or 3572 service, the Purchasing Department and/or the 357 originating organization shall initiate award
-3580 activities. Meetings or other forms of communica-3585 tion may be held to establish the intent of UE in monitoring and evaluating the supplier's perfor-mance, establish an understanding of procitrement r1quirements, and identify supplier activities to be utilized in fulfilling requirements. The depth and necessity _of these activities shall be a function of the relative importance, quantity, uniqueness, complexity, frequency of transactions with the same supplier, and the supplier's past performance. UE hold and witness points shall be documented as early as practicable in the procurement process.
to 13574 7.M The criginating organization shall establish mea-sures for monitoring supplier-generated document submittals against procurement document requirements. Similarly, measures shall be estab-lished for reviewing and approving supplier generat-ed documents for use. Changes to procurement documents shall be in accordance with the controls described in Section 4.
- Il 13577- 7.M Supplier monitoring activities may be performed by 3578d personnel from Quality Assurance, Quality Services, 13584 Nuclear Engineering, 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 activi-ties 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 norconfor-mances d
7-5 Rev . 1-3 6/99
- 1
l OQAM l975 7.14 Acceptance of items and services shall include one M 1891 or more of the following: 3601 3608
- 1. Written certifications l 2. Source verification
- 3. Receiving inspection
- 4. Post-installation test (in addition to one of jj, .g r yb the above)
- 7. b Where required by code, regulation or contract fi(r l'
3 11891 1893 g requirement, documentary evidence that items conform 3601 to procurement documents shall be available during 3603 receiving inspecticn or prior to use of such items. 3605 Where not precluded by other requirements, documen-3607 tary evidence may take the form of written certifi-cates of conformance. When certificates of confor-mance are employed as a means of item acceptance, verification of the validity of supplier certifi-cates and the effectiveness of the certification systems shall be conducted at intervals commensurate with the supplier's past quality performance. Certificates of conformance and compliance shall be required to be signed or accompanied by a signed letter of transmittal. Where acceptance is based I upon source verification, documented evidence of these surveillances shall be furnished to the Plant Quality Control organization by the responsible UE organization or their designated agent prior to acceptance.
'7 11884 7 . b5 Acceptance by receiving inspection shall be utilized 3606g- as a prime method of verific-tion and may be uti-lized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspec-tions; and when inspections do not require opera-tions which could adversely affect the integrity, function, or cleanlinees of the item. When other methods are utilized, receiving inspection shall be employed to verify that items have not sustained damage.
If 13578 7.H Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 - 1978, (as clarified in k OOAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization. Other unit staff personnel qualified to ANS 3.1 - 1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt ins;.; tion of radioactive material, bulk chemicals and .. -el fuel. During outages, extensive modifi-i~ 7-6 Re v . 1-3 6/90 m
OQAM cations, or other special circumstances, receiving inspection may be assigned to an outside organiza-tion (s). w l 975 7.44 Receiving inspection activities shall include: 2337 d
- 1. Verifying that materials, parts, and compo-nents, have been identified by tagging or other means; or that they are segregated and con-trolled in areas separate from the storage facilities for accepted items.
- 2. Verifying that items for acceptance have been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documenta-tion.
2325 3. Verifying that received items conform to 3577 procurement documents by inspecting or, where 3591 appropriate, testing using approved procedures 3592 and calibrated tools, gages and measuring equipment to verify the acceptability of items, including those from commercial grade suppli-ers. 2326 4. Providing final acceptance after determining 2329 that required verifications are complete and acceptable. Items determined to be acceptable l for use shall be tagged with an accept tag or other means of identification or segregation, and released for storage or use. Conditional acceptance of items by receiving inspection
.2328 shall be procedurally controlled.
2327 5. Verifying that received items which do not 3576 conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15.
- q 13608 7.M Acceptance by post-installation test may be utilized l
g following one of the preceding acceptance methods. Post-installation testing shall be used as the prime means of acceptance verification when it is diffi-cult to verify item quality characteristics; the item requires an integrated system checkout or test; or the item cannot demonstrate its ability to perform when not ir use. Post- installation test requirements and acceptance documentation shall be established by UE. rv 7-7 Rev. 1-3 6/90 n,
00AM 2337 7.db Final acceptance of items shall be by Quality d 36014 control personnel or designated inspection person-a nel. The final acceptance of services shall be the responsibility of the originating organization. Acceptance shall be documented. I 7.k Code certified material may be obtained from an ASME g accredited Material Manufacturer or Msterial Suppli-er 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 Suppli-ers are otherwise qualified as stipulated _ in Sec-tions 4 and 7 of the 00AM. These provisions are co.isistent with ASME Code Interpretation XI-1-83-50R dated May 14, 1985. l l
) *f 7-8 Re v . J-3 6/90 l "I
l OOAM 9.0 CONTROL OF SPECIAL PROCESSES 9.1 Special processes are fabricationt, tests, and final preparation processes which require the qualifica-tion of procedure, technique, and personnel and which are performed in accordance with applicable codes and standards. Special processes require in-process controls in addition to final inspection to assure quality. lisi d 1852 9.2 Special processes include such activities as weld-1937 ing, heat treating, nondestructive examination, the 2200 application of specialized coatings, and chemical cleaning, and shall be accomplished under controlled conditions by qualified personnel in accordance with . the technical requiremeits of applicable codes, standards, specifications, or other special require-ments to which UE is committed. Qualified personnel and approved procedures shall be employed. Proco-dures for special processes shall be qualified as part of their approval process; personnel qualifica-tions shall be certified; and equipment shall be qualified prior to use. The responsible Plant Department Head shall assure that personnel perform-ing special processes are qualified and are employ-ing approved procedures. Procedures shall also be established for recording evidence of acceptable accomplishment of special processes using qualified procedures, equipment, and personnel. Quality , control personnel shall be responsible for assuring ( that personnel performing nondestructive c.camina-tions are qualified and are employing approved procedures. Nondestructive examination (NDE) personnel shall be qualified in accordance with procedures established to meet the requirements of the Code Edition and Addenda to which UE is commit- , ted at the time the NDE is performed. When non-code ! NDE is performed, personnel shall be qualified to the version of SNT-TC-1A used to meet UE's current commitment to the ASME B&PV Code. 9.3 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 dercribed in Section 12. 9.4 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 l there organization (s) in accordance with procurement l (~ document requirements shall receive a technical review by the responsible engineering organization 9-1 Rev. 6/.99
*tl
OQAM 12974 10.0 INSPECTION 11851 10.1 A program for the inspection of safety-related 1926 activities shall be established and executed to 11927 verify conformance with applicable documented instructions, procedures. drawings, and specifica-tions. Inspections and monitoring of processes which serve an inspection function shall be per-formed by personnel qualified to perform assigned tasks and who are independent of individuals who perform the activity. 11928 10. The inspection function chall be conducted in b 1929 li accordance with written approved procedures which specify inspection scope personnel qualification d 1930 1931 requirements; i.aspsotion nothnd desor4Pttonr-4nolue j 2039 1ri = y--c.andatwy-.hca4-@ tot acceptanee-er4+er4a : p ,i q data collection requirements + -and-tieeumentatwn
& g, o approw:Arequiseunth Inspection requirements may' instructions, specifi- @ <d L /* 'a Te oMHhTd~f f 6E drawing s ,
cations, codes, standards, or regulatory requires ments. 15 Indirect control by monitoring processing methods, A (1932 1933 10.) equipment, and personnel shall be utilized as a control if inspection of processed items is impossi-ble or disadvantageous. Both inspection and moni-toring of processes shall be provided when control is inadequate without both, g 10. Inspection of activities at the Callaway Plant shall be at intervals based on the sca*.us and importance 1850 of the activities. Guidelines shall be established 1937 to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subsequent moni-toring planning,
- 10. The acceptance of an item shall be documented by personnel. Modification, repair or b[~/u wAT b i>1 authorized replacement of items performed 'ubsequent to final inspection shall require reinspection or rotest to
]A verify acceptability.
I u . L. h .1&.T Required inservice inspection of structures, systems or components shall be planned and executed. Inspection methods shall be established and executed l to verify that the characteristics of an item remain l within specified limits, b 11851 10. Quality Control inspection personnel or other unit l_ 2263 staff organizations who perform " inspection" activi-
- 2479 ties rhall be qualified within their respective l The qualification of QC 1 12481 areas f responsibility.
1 I N M'l l l l LN W DATA beta L L UL ANALYl(D AND (VALUAflO IO Vthlf y CDMPL t i t Ptl S$ Of kt$VLlt. A( Hi t Vt Mt.N 1 UF INSelCllON 44 x w costcuvt s. Ano vets Anon At euveicuun o, muieutnr Anu Rev. F3 svsitusi io iotsilev Aouin onAL iwsetriton e t kauosstuturs 6/p0 6ee- tit *+, t ; AND TO IDENilfv utstSSARY CHANGLS TO THE INSTALLAllON y! . INLel(110N __ ikot t Dukt s .
I OOAM 2482 inspection personnel shall be defined in three # 12483 levels of capability as described in ANSI N45.2.6. 2494 other members of the unit staff performing "inspec-2498 tion" activities shall have appropriate experience, 2994 training, and retraining to assure competence in accordance with ANSI /ANS-3.1. Inspection assign-ments shall be consistent with the qualification of an individual. In instances where the education and experience recommendations are not met by QC inspec-tion personnel who are to be certified to ANSI N45.2.6, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent ecmpetence. 2480 10.8 Personnel from outside organizations performing QC 2482 inspection activities associated with safety-related 2484 items at the Callaway Plant shall be certified as (2485 required by ANSI N45.2.6. Personnel from outside 2994 organizations or UE ,ersonnel who are not mambers of the unit staff who perform other activities associ-ated with safety-related items at the Callaway Plant shall either be certified as required by ANSI N45.2.6 or they shall meet the education and experi-ence requirements applicable to the equivalent position on the unit staff for the activities which they are performing. 2484 10.9 When contractors or vendors are retained to perform 2485 work activities or to provide services associated 3577 with safety-related items at the Callaway Plant, the qualification of inspection personnel and the conduct of inspections associated with that con-tracted work activity or service shall meet the requirements stipulated in the applicable procure-ment documents. As an example, if a vendor was contracted to conduct oddy current examinations of the Callaway Plant steam generators, then the persons performing the examination wou.' be quali-fled as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents. 1 d12483 10.+0 An inspecticn personnel qualification program shall 2484 be established to assure inspection activities are 2488 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, Trainino shall be responsible for providing related technical and quality training appropriate to the certification / qualification of UE personnel. 8 10-2 Rev. &3 6/90 (
_ _ . _ _m ._ ._ _ . _ _ - _ _ _ _ _ _ ... _ _ _ . _ - _ - . _ - _ _ . _ _ _ _ _ l I ogAM
..i-1 / r edures whi h specify inspection activities shall AA l193 2.u.g ;v provide for the following, as required: 1) the d inclusion of independent inspection or monitoring of processes when required; 2) the identification of inspection personnel; 3) the documentation of inspection results; 4) a description of the method
_. of inspec h ; 5) the identification of the charac-l **f 7 teristics and activities to be inspected; 6) the 4 [f[,,,fs acceptance and rejection criteria; and 7) specifyings % M the necessary measuring and test equipment. "Inspec r tion or testing, as appropriate, shall be employed 6 as a means of verifying suitable performance subse- " ' *
- quent to a component replacement or repair.
10.12 Instructions, procedures, and supporting documenta-tion shall be provided to inspection personnel for use prior to performing inspection activities. A MM 1936 Inspection :.esults shall be documented. Procedures shall prescribe the review and approval authority 2262 for inspection results. gI 2694 10.'34 Nuclear Engineering shall be respousible for assur-4 ing the development of preservice and inservice (PSI /ISI) inspection programs; the reference PSI /ISI examination plans for ASME Code Class 1, 2, and 3 systems and components including steem generator eddy current exaaination; the NDE procedures re-quired by the reference plans; and the !nitial updating of the reference plans and procedures to reflect "as-built" conditions and the technical requirements of the applicable Code Edition and Addenda prior to the issuance of the inservice inspection plans and procedures. A 2694 10*.}4 Nuclear Engineering shall be responsible for assur-LC i f ing the development of the inservice testing program plan for pumps and valves, the test procedures required by this plan, and the securing of consult-ing services in this area. In addition Nuclear Engineering shall be responsible for administering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division. They are also responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspec-tion plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations. 10-3 Rev. I 6/9@ l .
00AM 12974 11.0 TEST CONTROL 1850 g 11934 11.1 ,Te, sling shali hhperformed w demonstTate that
/ safety-related structures, systems, and components Testing 2052
[will perform satisfactorily in service. programs include such tests as initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those associated with Mant%a bitenanu , d itirat-i c a , proceduv # ohanges, failure analysis, and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or compo-nents function in accordance with predetermined specifications, gg 1938 11./ Testingprogramsshallbeestablished_todemonstrate) 2039 6 1. tam-or-eys t e r .- per-forfaanoe . [7esting shall be 2055 performed in accordance with written procedures 2056 which incorporate or reference the requirements and acceptance limits contained in applicable Callaway Plant Technical Specifications, drawings, instruc-tions, procurement documents, specifications, codes, standards, and regulatory requirements, g g 1938 11. Administrative procedures, test procedures, or 2132 checklists shall includes provisions for assuring all prerequisite conditions are met; test equipment calibratien requirements; testing method instruc-g . ld b tions;; limiting conditions and acceptance /re]ection criteria; and data collection and test result
,w, %l,.rs approval requirements.
g 2263 11.fPersonnelwithinthevariousUEorganizationsmay 2479 d perform testing activities including implementing 2482 test procedures and the evaluation and reporting of 2483 test results. The assignment of Plant testing 12484 personnel chall be under the direction and control 2494 of the G@fBI M M eeger, Nuclear Operations. The qualification of QC testing personnel shall be defined in three levels of capability as described in ANSI N45.2.6. Other members of the unit staff performing " testing" activities shall have appropri-ate experience, training, . and retraining to assure competence in accordance with ANSI /ANS-3.1. Testing assignments shall be consistent with the qualifica-tion of an individual. In instances where the education and experience recommendations are not met by QC testing personnel who are to be certified to g, ANSI N45.2.6, UE shall demonstrate by documented 5 y [,,% n Q *:s tsck;< } Hua y d - dfq3 pnwlms d .,p a pa+ %.n..w. ,; f,.:fao.!,inw&ah -r, L m.,,L a;n( st~d~y 4 4 . L( i . W f: s yf J f s h n
\1 11-1 Rev. H 6/9f I
OQAM results of written examinations individuals and evaluations possess of ' actual work proficiency that comparable or equivalent competence, w g2481 11.,5 A program shall be established to assure testing 2483 activities are performed by personnel trained and 2484 qualified to a capability necessary for performance 2488 of the activity. Plant procedures and procurement 2498 documents shall prescribe the qualification require-ments for testing personnel. Provisions may be made for on-the-job training of individuals not qualified to the program provided they are supervised or overseen by qualified individuals for the activities being performed. The Superintendent, Training shall be responsible for providing related technical and quality training for UE personnel who perform testing. 11.I Personnel from outside organizations or UE personnel d 2263 2480 who are not members of the unit staff who perform 2483 cther testing activities associated with safety-2484 related items at the Callaway Plant shall either be 2485 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. b 2483 11. When contractors or vendors are retained to perform 2484 work activities or to provide services associated 248S with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct work of tests associated with that contracted activity or service shall meet the requirements stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway Plant, then the persons performing the testing / valve settings would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable pro-curement documents. 1840 11.8 Test men W h il be J h wn WJ, ieviewed,snd 1934 6 app.oved by qualified individuals or groups. 2 m > 2125 Equipment found to be deficient shall be identified gdg in ac:ordance with Section 14. Surveillance test procedure results which fail to meet the require-ments and acceptance criteria of Callaway Plant Technical Specifications shall be documented and reviewed in accordance with Section 15. Deficien-cies identified as nonconforming shall be processed in accordance with Section 15. - ja . ^t if51 DA1A SM A t L ($ t, ANAlvlLD AND tVALUAltDa1U s vtklIV COM0Lt1&NLS5 Of kt 50L15, ALNltytMEN1 OF L 1 t 51 O t> > t t i l V t h , AND DPLFAllONAL PMDFICltNLV Of LQUIPMtNI AND SYSitM5; 10 10tN11Fv AUpillDNAL In - it $7 kf DUlktMf NI S AND 10 IDLN11f v t< t C E 5 5 Ak y ( HA N' t S 10 THE INST AL L AllON
-4*a+.4 12, , - itsi P90ttbouts* Rev. -4r 6 /M 'ff .
ogAM 1137 11.9 Review and approval of tests and experiments not 1140 described in the PSAR shall be conducted as speci-fied in the Callaway Plant Technical Specifications and 10 CFR 50.59. L 1853 11.44 Provisions shall be established for the performance nje,f' of surveillance testing to assure that the necessary quality of systems and components is maintained, that facility operations are within the safety limits, and that limiting conditions for operation can be met. The testing frequency shall be as prescribed in the Callaway Plant Technical Specifi-cations. The provisions for surveillance testing shall include the preparation of a surveillance testing schedule (s) which reflects the status of in-plant surveillance tests. Qualified personnel l shall perform surveillance tests. 3 2053 11.1+ Appropriate tests shall also be performed subsequent to Plant modifications, maintenance or significant operating procedure changes to confirm expected results. Tests provide a level of confidence in structure, system or component operation or func-tional acceptability. 4 documents, testing by d 11.H When required procurement 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. k 11. Equipment failure .or malfunction analysis testing may also re performed. The causes of malfunctions sha investigated, evaluated, and recorded. Expe ice with malfunctioning equipment and similar components shall be reviewed and evaluated to determine whether a like kind replacement component can be expected to perform its function reliably. I' l 11-3 Rev.4s] 6/97 l-l
. _ - _ _ _ . _ . _. _ __ _-.m...--_ _ . _ . _ _ _ - _ _ _ _ . _ _ . - - _
OQAM 13.0 . HANDLING, STORAGE, AND SHIPPING 2293 W 13.1 Safety-related items including safety-related parts 2417 of structures, systems, and components and related consumables shall be handled, stored, shipped, cleaned, and preserved in accordance with proco-dures, instructions or drawings, to assure that the quality of items is preserved from fabrication uncil incorporation in the Callaway Plant. The procedures shall also establish responsibilities for determining applicable requirements for packaging, shipping, receiving, storage, and handling activities, g 2293 13.2 Generic procedures or instructions shall be prepared 2349 for application to these activities; however, 2416 detailed procedures _or instructions shall be pre-p p 41668 pared for the handling, cleaning, storing, maintain-ing while stored, or shipping of certain items and types of equipment or material. Applicable manufac-turer instructions and recommendations, or procure-ment requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review. 2427 13.3 Deviations from manufacturer's recommendations may impose more stringent requirements or may relax the requirements. The relaxation of manufacturer's requirements shall involve an engineering evaluation and is appropriate when unrealistic requirements are recommended and such recommendations are not reason-ably necessary to preclude equipment degradation. 2343 13.4 The requirements for activities described in this 2416 Section shall be divided into levels with respect to protective measures to prevent damage, deteriora-tion, 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. 2427 13.5 The Superintendent, Maintenance shall establish an-inspection program for Plant material handling equipment that provides for routine maintenance and inspection in accordance with documented procedures which specify acceptance criteria. Routine inspec-l tions shall determine the acceptability of equipment t and rigging. Routine inspections shall be M 13-1 Rev. +2 6/B-9 l
. . - , . . , - --- .. - , - a,--. , - - . . . .--.,...,.,-..m--~w,. - . ~ . , . . - - cn
OOAM 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 1919 12.1 Measuring and test equipment utilized in activities 1920 affecting quality shall be controlled in accordance 1969 with written procedures or instructions. The 2042 procedures for calibration and control shall address 2264 the identification of test equipment, calibration 3591 techniques, calibration frequencies, maintenance 3592 control, and storage requirements. The equipment subject to these controls includes: (1) M&TE (port-able measuring instruments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related structures, systems, and components); (2) reference standards (primary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).
,gg y 19 ~20 12.2 Tools, instruments, testing equipment and measuring -
3 le 2 95 2043 devices used for measurements, testa, and calibra-tion shall be of the proper range and type; and
]
12044 shall be controlled, calibrated, adjusted and main- ,s 2060 tained at specified intervals or prior to use to a 3591 assure the necessary accuracy of calibrated devices. 1 M&TE and reference standards shall be tagged or j labeled indicating the date of calibration and the due date for recalibration. g E&&L 12.3 Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program. 12.4 The calibration and control program established at the Callaway Plant shall assure that M&TE, reference standards, and PI-maintain their required accuracy. The Assistant Manager, Operations and Maintenance is responsible for assuring the program establishment. Program implementation is the responsibility of the appropriate Department Heads. 1920 12.5 M&TE, reference standards, and PI shall be utilized by various organizations as required to perform tests or other special operations. Each orga'niza-tion shall be 1esponsible for assuring that the M&TE or reference standards it uses have been calibrated. Outside organizations using M&TE or reference stan-dards at the Callaway Plant in activities affecting quality shall be required to implement calibration and control measures consistent with the applicable requirements _ of this section. Vendors activities performed offsite, other than calibration services for Callaway Plant M&TE or PI, do not need to meet r- the requirements of item 8 and 9 of 00AM section 12.6 unless specified in procurement documents. 12-1 Rev dh 6/90 m
00AM supplemented by nondestructive examinations and d proof tests as delineated in procedures for items requiring special handling. Personnel performing nondestructive examination and proof testing shall be qualified. 2325 13.6 Procedures shall be prepared for items that require 2356 special handling and shall be available prior to the 2416 time items are to be handled. Items not specifical-dg ly addressed by procedures shall be handled in accordance with sound raaterial handling practice, ruel assemblics, which require unique equipment and handling, shall be handled under the direction of a Licensed Senior Reactor Operator during core altera-tions. Other material handling activities may involve personnel from various Plant organi:ations, 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 packaging requirements which afford protection from the possible degradation of quality during shipping, handling, or storing. The packaging protection 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 g M gl storage of materials and equipment to minimize the possibility of damage from the time an item is 2 981 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 i 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 environmental conditions which are procedurally defined. H 13-2 Rev. +f 6/69 , e1
hbh w % 4b
*1992 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 er 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 af ter correction of the nonconformance. The evaluations shall be documented.
1848 15.9 Repaired and reworked items shall be reinspected or f 1904 tested. Measures may be established to condition-1906 ally release nonconforming items whose disposition i 2053 is pending, provided that an evaluation indicates 2332 that further work or activity will not contribute adversely to the material nonconformance or preclude identification and correction. M bs
- 15.10 Ihr Manager, Operationa h ppert they have nonconformance summaries \ prepared (semianhf. ar material nd r adverse quality ~ tr e n 's*.
jnalyzedy4+s These !L _ _ . potential shall be sent to the Quality Assur-ance Department for an independent review. The l result of this review shall be reported to manage- I ment. fFornonconformancesdiscovereduponreceiptinspection
,of new purchases or discovered after an item has been j accepted by receipt inspection but before issue from 1 the warehouse, the Manager, operations Support shall have the trend analysis prepared. For nonconformances discovered after issue or on items considered installed, the Manager, Nuclear Engineering shall have the trend ic.Ls -
analysis prepared.
' /96 /
h 15-3 Rev. 11 6/39 f/
OQAM 16.0 CORRECTIVE ACTION i 324 16.1 Measures shall be established to assure that condi-1870g tions adverse to quality are promptly identified, 1903 reported, and corrected. Nonconformances shall be 1-945d\. controlled in accordance with the requirements 2978 described in Section 15. Each of the Nuclear Division Managers is responsible for developing and implementing a program for identifying and control-ling adverse conditions. This responsibility may be satisfied by one or more programs. As a minimum each program shall provide for developing and analyzing trends on a semiannu C basis s Procedures
'_/ rm/sg *I %/ % .. d hall provide in s t ruc tioiis~ for identifying, and initiating corrective action to m urse 4 -<,/7 reporting, " - ^), f,lf /. 5 / preclude recurrence of adverse conditions. It is " **'ju'y understood that the term " corrective action"
[m/did U . f*'"Y s includes remedial action necessary to correct the J ,J- 4 //u d ~'a d deficiency, as well as corrective action necessary to preclude recurrence. e lu h i fer Op/M Gle M 16.2 Conditions adverse to quality which impede the implementation or reduce the effectiveness of the Operating QA Program shall be controlled by the measures described herein. Adverse conditions may 3 include, but are not limited to, noncompliance with procedural requirements; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies identified in the OOAP; recurring- conditions for which past corrective i action has been ineffective; or breakdowns in administrative and managerial control systems which could result in a system designed to prevent or mitigate serious events not being able to perform its intended function. I 16.3 Corrective action documents which record defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. 16.4 Corrective action documents shall be transmitted to the responsible organization. The responsible 3599 organization shall investigate the findings and 3600 identif, the cause(s) of the deficiency, and specify in 16-1 Rev. 14 6/SO N(
oQAM CQu e n 40 o$ and initiate the action (s) necessary to correct the conditions and prevent recurrence. # g 16.5 Nuclear Engineering shall review documented condi-tions adverse to quality which involve design deficiencies or design changes which are recommended as corrective action. , The ORC sha ( significant adverse conditions. f N de}n). g__gy1,e Qg cn j o,fg, i e r tit.e 3 t - 4-- %,~.,. m ,+ u those identified by Callaway Plant Technical Specifications
- 6. 5.1. 6 ( f) , 6.5.1.6(g) and 6.5.1.6(111 and NPDES violationsM, 6. 5.1. icensing6 (h) ,and fuels should eview docunented conditions adverse to quality for fuel-related asues.
16.6 Correctiv- action documents shall be closed by verifying the implementation and adequacy of correc':ive action. The Quality Assurance Department shall close QA-originated corrective action de c .ane nt s by verifying the implementation and adequacy of corrective action, copies of completed corrective action documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to quality. The Quality Assurance Department shall periodically prepare summaries of significant corrective action documents and submit them to the NSRB and appropriate levels of management. I16.7 The closure of corrective action documents shall be accomplished as promptly as practicable but shall occur only after the corrective action taken has been verified. Verification may be accomplished through direct observations, written communications, re-audit, surveillances, or other appropriate means. The nature of the deficiency may be such that remedial actions need to be taken immediately whereas development and implementation of corrective action to preclude recurrence may take substantially longer. [16.8 Summar es of corrective action documents shall be I reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends. Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trends through routine audit and surveillance activities; and shall report the results of these assessments to management, i 16-2 Rev. 6/90 l ?r
. . - _ - - -..- - -_-- _.- - .-.-. - -.-~.-.._---_ _ . - .- - l I OCAM 17.0 QUALITY ASSURANCE RECORDS 11851 17.1 Quality assurance record systems governing the 2130 collection, storage, and maintenance of records 12173 shall be established by UE. They shall apply to records associated with startup testing, operation, maintenance, repair, refueling, and modification of i safety-related structures, systems, and components at the Callaway plant. 11140 17.2 During the operating phase, quality assurance 1150 records shall be maintained to furnish documentary 11851 evidence of the quality of items and activities 2128 affecting quality. Applicable design specifica-2132 tions, procurement documents, test procedures, 2138 operational procedures or other documents shall 12173 speci fy the quality assurance records to be gener-ated by, supplied to, or held by UE. Docur"nts shall be considered quality assurance records when completed. Records may be maintained for varying periods and shall be identified as lifetime or nonpermanent records in that a lifetime or finite , 2133 retention period shall be specified. Records shall 2137 provide sufficient information to permit identifica-tion to the item or activity to which it applies, and be retrievable. 1139 17.3 Quality assurance records include, but are not l1140 limited to, operating logs; maintenance and modifi-12337 cation procedures and inspection results; reportable 2364 occurrences; results of reviews; inspections, tests, 2666 audits and material analyses qualification of 2681 personnel, procedures, and equipment; and other documentation including drawings, specifications, procurement documents, nonconformance documentation, corrective action documents, calibration procedures and results, and the results of monitoring work performance (e.g., surveillance), k&44 17.4 Inspection and test records shall contain the 1936 following as a minimum:
- 1. A description of the type of observation
- 2. The date and results of the inspection or test
- 3. Identification of the inspector or data record-er
- 4. : valuation of-the acceptability of the results
- 5. Action taken in connection with any deficien-cies noted 17.5 Quality assurance records generated by others are transferred or made accessible to UE as systems and equipment or services are transferred or delivered from A/E's, NSSS suppliers, fuel fabricators, I4 17-1 Rev. tt 6/97 i
OQAM A ti d th 3869 18.0 AUDITS 2186 18.1 A comprehensive audit program shall be established 2199 and implemented by UE to verify internal and exter-2978 nal quality activitics' compliance with the OQAP. 2988 The audit program shall assure that all applicable 3586 elements of the Program have been developed, docu-3865 mented, and are being effectively implemented and 3867 shall provide for the reporting and review of audit 3883 results by management. The audit system is de-141949 scribed in manuals and procedures. Nonconformances and program deficiencies shall be identified and corrective action shall be initiated and verified. b See Section 3.13 for a specific audit topic. 4 1 324 18.2 The UE audit system shall include the performance of audits and surveillances by the Quality Assurance and Quality Services Departments. Audits determine, through investigation, the adequacy of and adherence to established procedures, instructions, specifica-tions, codes, and other applicable contractual and licensing requirements and the offectiveness of implementation. Surveillances involve the periodie or continuous monitoring of the operation or perfor-mance 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
&s 2N, tests). QA and QS personnel performing surveil-lances should be familiar with the area to be surveilled and the applicable implementing proce-dure (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 10.7, 10.8, 11.4, 11.6, and 16.4.
2244 18.3 The Manager, Quality Assurance shall establish a 2250 program which provides for the qualification and 2255 training of QA and QS Department audit and surveil-2963 lance personnel. Audits shall be directed by an 3866 Audit Team Leader (ATL) who is a certified Lead 3877 Auditor. A Load Auditor is an individual certified as qualified to direct an audit, perform an audit, report audit findings, and to evaluate corrective action. Other personnel may assist Lead Auditors in the conduct of audits ; . namely, technical special-ists, ranagement repressutatives, auditors and other 18-1 Rev. 6/90 N .
+ .
00AM 1818 Lead Auditors. The persons having direct responsi- > bility for performance of the activities being audited shall notPersonnel be involved in the selection of selected for QA auditing the audit team. 3892 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 person-nel training program shall provide general orienta-tion and specific training which develop competence for performing audits or surveillances. Training records shall provide a history of QA personnel training, evaluations, qualification, certifica-tions, and retraining. 12245 18.4 Quality Assurance and Quality Servicen personnel who 2246 perform audit and surveillance activities shall be 12:47 qualified in accordance with the requirements pre-2259 scribed in Quality Assurance Departmer.t procedures. 3866 Lead Auditor qualification requirements shall ' i include education or professional status, previous work experience or training, training received through UE, on-the-job performance and participation in surveillances or audits as an auditor, a qualifi-cation examination, and other factors applicable to auditing not defined by procedure. The qualifica-2244 tion certification of Lead Auditors shall be based on an evaluction of these factors by the Manager, Quality Assurance.- The maintenance of proficiency g M&3 by Lead Auditors shall be accomplished by active participation in the audit process; a review of Program, codes, standards, procedures and other document revisions related to the OQAPI or partic-ipation in training programs. The Manager, Quality M44 Assurance shall provide for annual assessments of each Lead Auditor to determine proficiency. As long as a Lead Auditor is performing satisf actorily and is maintaining proficiency, there is no limit on the period of certification. However if at anytime the Lead Auditor's performance is evaluated as being unacceptable, Lead Auditor certification shall be GM4, rescinded. In addition the failure to maintain proficiency for a period of two years or more shall be basis for Lead Auditor certification revocation. It certification is rescinded or revoked, requalifi-cation shall be required prior to recertification. 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. 00AP. The Manager, Quality Assurance has sufficient authority and organizational freedom to ' i schedule and perform both internal and external l 18-2 Rev. 6/90 1, l , .- - _ _ . _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ __ _ ______ _ _
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UC^" 'W-~ y $,, J 6 e. i *: w F.c ,, audits. He has the organizational responsibility to measure and assure the overall effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality. The Manager, Quality Assurance has direct access to the Senior Vice President-Nuclear. The Senior Vice President-Nuclear has direct access to the President. g "" "18,, 6^ The Manager, Quality Assurance is responsible to the Senior Vice President-Nuclear for assuring the OQAP
" " # d is being effectively implemented _for operating _
_a c t i v i t i e sf a nd--su po p44es-bupe r i n tenden ter--Gua k4 t y
,, , , v Assurance-who-direct full attention to this effort. '~'j , f The-Hartager r -quality--Assuranoe-shah--be-kne+1+dge-
- C abis -- e nd experienced-in nuolear-powec-Mont-ceHvi _
_-ties /and shall bear no cost, schedule, or production
,. responsibilities. He re port s - on-the-Program-e f f ee- o 4 * " , , ,) tivenees-d4++et4y to-4 he--Gen io r--V i-ce-Pres iden t-o W' Nuclear. A communication path shaQ exip$ gtween g the Manager, Quality Assurance and tierWidF-%na'ger, Nuclear Operations, the Manager, Callaway Plant and the Manager, Operations Support as well as the other Department Heads in the Nuclear Division thus providing a direct path to inform management regard ing conditions affeeting quality. __
f (, d g 3871 18./ The audit system shall include internal and external audits. The system shall be planned, documented, b and conducted to assure coverage of the applicable elements of the OQAP, and overall coordination anditd' 0 scheduling of audit activities, fliii~ Ma W r, b*d h ' Quality Assurance chall M'V Mw the OQAP audit program annue My to assure audits are being accom-plished in accordance with the requirements de-scribed herein , ,) p ., (,. car ; ' ~ r; W) e 'mN 7 *, 4"~ / g 'M
-7 g 1792 1826 18.5 Internal audits shall be conducted by the Quality Assurance Department and shall be performed with a 3873 frequency commensurate with their safety signifi-cance. An audit of safety-related functions shall be completed in accordance with formal audit sched-ules 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. Supplementary to the biennial requirement to audit 2681 safety-related functions, other activities shall be 2847 audited at the frequencies indicated in Section 3873 6.!.:.9 of the Technical Specifications and under 141777 the v. zance of the NSRB. In addition to audits ccu "1 under the cognizance of the NSRB, the fo; . . areas shall be audited at least once per 12 - ' V1 18-3 Rev. la 6/30 M
a . OQAM Special Nuclear Material Accountability program
- Radiological Protection program Radiological Emergency Response program Security program i
- Fitness-For-Duty program d 3873 18.1 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements ,
are properly implemented. b 3577 18. N External audits shall be conducted by or for the Quality Assurance Department as a method for the evaluation of procurement sources and as a post-award source verification of conformance to procurement documents. Audits conducted by other organizations (with similar orders with the same supplier), including other utilities or A/E's, may be employed as a means of post-award source verifi-cation in lieu of UE performed audits.and may not necessarily audit specific items furnished to UE. Audits and surveillances may also be performed for the Quality Assurance Department by the Quality Services Department. These audits a.,d surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted in accordance with this 00AM and Quality Assurance Department proco-dures. Commercial grade items do not require i 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. g 1780 18.lbApplicableelementsofsuppliers'qualityassurance 3578 programs shall be-audited (post-award) on a trienni-3672 al basis. Audits generally should be initiated when sufficient work is in progress to determine whether the organization is complying with the established quality assurance provisions. Subsequent contracts or contract modifications which- significantly enlarge the scope of activities by the same supplier shall be considered in establishing audit require-ments. In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the QA or QS Department that the results of mini-audits performed during source inspection and-source surveillance activities confirm the adequacy and implementation of the supplier's QA Program. 1 i L 18-4 Rev. 13 6/90 (> a .. . - . - - - - - .
t . OQAM (1 A 18.14 Supplementary to audits, annual evaluations of S suppliers shall be performed which take into ac-count, as applicable: 1) the review of supplier furnished documents such as certificates of confor-mance, nonconformance notices, and corrective actions; 2) results of previous source verifica-tions, audits, and receiving inspections 3) operat-ing experience of identical or similar products furnished by the same supplier; and 4) results of audits from other sources, b3872 3875
- 18. Audits shall also be conducted when: 1) significant changes are made in functional areas of the Quality Assurance Program such as significant reorganization or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assurance _ Programs or 3) when a systematic, independent assessment of Program effectiveness-is considered necessary; or 4) when it is necessary to verify implementation of required corrective aqtiorin / The NSRB shall selectively g *gp review audit reports of onsite audits.
shall also periodically review the onsite audit The NSRB program as developed by the Quality Assurance Department, to assure that audits are being per-4Wb formed in accordance with callaway Plant Technical Specification requirements and the OQAP.- Appro-priate levels of management shall be provided copies of internal and external audit reports. The audits described in the Callaway Plant Technical Specifica-tions which are performed under the cognizance of the NSRD shall be conducted by the Quality Assurance Department. 3876 18.1 Audits shall be conducted using written plans in 3878 accordance with Quality Assurance Department proce-3881 dures. The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for quality-related practices, procedures, and instructions to determine the effectiveness of the implementation of the OQAP and compliance with 10 CFR 50, Appendix B and the Callaway Plant Technical Specifications. The audit plan shall identify the audit scope, the. requirements, the activities to be audited, organ-izations to be notified, the applicable documents, the schedule, and the written procedures or check-lists as appropriate. The audit plan and any necessary reference do'cuments shall be available to the audit team members. 18-5 Rev. 6/.90 14
- . _ _ - ._ = - . -. _ - - . . = _ _ ~ _ - - . . . - _ . -.
00AM 16 d 3877 18.16 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 memb1rs 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.
,sWTD g&' iht7 Audit results shall be periodically reviewed by the Ouality Assurance Department for quality trends and iu st L T loverall Program effectiveness. gesults Of th000 48 ' g P "revdWi~44s44- be reported ~~tifiTpplropriate management, i+>-yhdio-sun.a.ary reporte e f audi t aetivities, l
l l M 18-6 Rev. 13 6/90 M _ _ _ . . _ _ _ . _ _ . . ~ . _ _ . _ . _ _ _ _ _ _ . _ . . _ , . . _ . _ _ _ _ _ - . _ . , __
OPERATING QUALITY ASSURANCE MANUAL (OQAM) APPENDIX A OQM1 CONFOPFANCE TO APPLICABLE NRC REGULATORY GUIDES This Appendix briefly discusses the extent to which Union Electric's Cperating Quality Assurance Program (0QAP) conforms Clarifications, to NRC published alterna-Fagulatory Guides for the CallawayRegulatoryPlant. Guides are identified tives, and exceptions to these herein. Union Electric's position on other Regulatory Guides is given in Appendix 3A of the Callaway-SA and Callaway-SP Final Safety Analy-sis Reports (FSARs). In each of the ANSI standards referenced by one of the listed Regula-tory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either identified at the point of reference or are described in aor special section of the standard. The specific applicability acceptability of these listed standards, codes regulations or appendi-ces is either covered in other specific areas in the FSAR or this Operating QA Manual (OCAM), including tables, or such documents are not considered as requirements, although they may be used as guidance. When sections are referenced within a standard, it is understood that UE shall comply with the referenced section as clarified. 4/$7 REGULATORY GUIDE 1.8 APPOPOGEO REVISION 2 MDATED N M b N dated 9/75 for the position of Radiation Pp tWetion
*Re M ion ly, 1 in acecrdance with the Callaway Plant Tech def1 Specifi-Manage Cations.
Personnel Sel (and Training (Enderses APSi ANS 3.1-1978) DISCUSSION: UE complies with tne recommenda,i s of this Regulatory Guide with the
/
followingclarifications:/ iscussion of the quali-Refer to Callaway-SA F,SKR Section 13.1 for fications of persor,m51 responsible for Plant op tion and support.
/ for directing or supervising - conduct of Personnel responsible r elat'e d preeperational and startup tests and for iew and safetygof safety-related preoperational and approv startup test pr dures or yetults met the qualifications of the Regulatory Guide, but were npt required to be certified, wpd7 A .~
p gg. & A-1 Rev. N 6/M 6
N 00AM CN 90-07 , INSERT A Qualification and Training of Personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor (Section 4 t3.1.1), Senior Operator (Section 4.3.1.2), Licensed Operators-(Section '"s 4.5.1.2), Shift Technical Advisor (Section 4.4.8),-and Radiation N Protection (Manager) (Lection 4. 4. 4 ) only, and ANSI /ANS 4x4-1971 for N all other positionsj. / lb/ [k Rgub I.inaz, DISCUSSION: 1 "I W
> Fn n , ( '
UE complies with the recommendations of this Regulatory Guide w'ith - 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. The experience, training, and education requirements for the positions of Shif t Supervisor, Operating Supervisor, Reactor Operator, and Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANSI /ANS 3.1-1981 as endorsed by the Regulatory Guide 1.8. For all other positions, qualification and training shall comply with ANSI /ANS 3.1-1978 as clarified below: Refer to Callaway-SA FSAR Section 13.1 for a discussion of the qualifications of personnel responsible for plant operation and ' support. Personnel responsible for directing or supervising the conduct of safety-related preoperational and startup tests and for review and l approval of safety-related preoperational and startup test procedures l or results met the qualifications of the Regulatory Guide, but were : not required to be certified. l l l i A-la
__ _- ..m ._ _ .__ _ _ _ _.. . . _ _ _ _ _ _ _ _ . . _ . _ _ . _ _ _ _ _ . _ _ . OQAM APPENDIX A FEGULATORY GUIDE 1.8 (cont.) , regar4/ to section 5.2 titled Training of Candidates to be With Retraining and y\'p Licensed )(y the NRC and section 5.5, Operator In lieu of the training k Replacement Training of ANSI /ANS 3.1-1978: and retr /Aning requirements for licensed reactor operators and senior reactos/ operators outlined in these sections, UE accredited shall follow programs training and gualification in accordance with INPO referenced in Chapter 13.2 of the FSAR. With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Documenta-tion: UE shall maintain records in accordance with and to meet the requirements of OQAM Section 17 and ANSI N45.2.9 as specified herein. to UE may use additional non-Callaway employees or contract personnel augment the unit staff. These These persons may or may not report to the Manager-Callaway Plant. groups include, but are not limited to, UE personnel from other plants as well as supplemental HP and I&C When used to perform safety-related technicians and QC inspectors. activities, these personnel shall meet the education and experience requirements of ANSI /ANS 3.1 - 1978 for equivalent positions or else they shall meet the requirements for certification as inspection, examination or testing personnel as set forth in UE's commitment .to ANSI N45.2.6-1978 given elsewhere in this .*.ppendix. REVISION 2 DATED 2/79 REGULATORY GUIDE 1.29 Quality Assurance Program Requirements (Design and Construction) (Endorses ANSI N45.2-1977) DISCUSSION: This Regulatory Guide is not applicable to the operating phase. However, ANSI S45.2-1977 will be applied to suppliers .of safety related items, ccmponents or services, as appropriate, as described under Regulatory Guide 1.123 (ANSI N45.2.13-1976). ' REGULATORY GUIDE 1.30 INITIAL ISSUE DATED 8/72 Quality Assurance Requirements for. the Installation, Inspection, and b Testing of Instrumentation and Electronic Equipment (Safety Guide 30) (Endorses ANSI N45.2.4-197(/IEEE 336-1971) l 1. DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the following clarifications: A-2 Rev. ] 6/M
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l e . OQAM d6@M C/Y @@T APPENDIX A ; i REGULATORY GUIDE 1.33 (cont.) I O l With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Procedure I Adherence The temporary change requirements of this Section are l delineated in the Technical Specifications for activities occurring after the operating License (OL) is issued; the requirements of the Callaway Plant Technical Specifications shall be used to control temporary changes. With respect to Section 5.2.6 of ANSI N18.7 - 1976 titled Equipment control UE shall comply with the " independent verification" require-ments based on the definition of this phrase as given under our-commitment to Regulatory Guide 1.74 in this Appendix. Since UE sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with: " Suitable means t include identification numbers or other descriptions which are trace-l able to records of the status of inspections and tests." l The first sentence in the seventh paragraph shall be met after clari-fying " operating personnel" - to mean trained employees assigned to, or i under the control of, Plant management at Callaway. With regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Maintenance and Modification: UE shall interpret the word " original" in the first sentence of this Section to modify ONLY the words " design bases." 9+mr ! interpretatier le te arrure that.-osiginal inspectica require-ente are i enly required for --ed i fi c a t ion: and meintenance thet are riril : in i N# ,' : ::iginal cenet+weMer 20t444-41e:. Thi: mehe: netur: :nd entent l W" .hseeti+n--oonstneuwth Sectier-5.2.1' ofiathe*ccordeace Standerd."ith0 er:- N tienal inspection requirements 55211 h '? E ' s ceritment te Sectier 5.2.l? Of the Standard and, i." conjuncti-on aath the--uao- M+A l f ie d -a4Menance perse-.el and a pp r+ved-proodu r+e , , ehell 22:ure quality ,. leset er ;ccd ac the original quality. Since some emergency situations could arise which might preclude preplanning of all activities, UE shall comply with an alternate "Except in to ' the first sentence in tne ?.cond paragraph which reads: emergency or abnormal operating conditions where immediate actions are required to protect the health and safety of the public, to protect equipment or personnel, or to prevent the deterioration of Plant conditions to a possibly unsafe or unstable level, maintenance or modification of equipment shall be preplanned and performed in accor-dance with written procedures. Where written procedures would be
-required and are not used, the activities that were accomplished shall be documented after-the-fact and receive the same degree of review as if they had been preplanned."
1 it A-8 Fev. e 6iM fl
~ . . . .- - - - , - - - - , - - -
09AM C!l 90-09 5.2.7 . . . This interpretation is to assure that original inspection requirements are not imposed,without appropriate review, on modificatir, ** or maintenance activities which are similar in n cure to original construction activities. In developing means to assure the quality of maintenance or modification activity, inspection requirements from associated construction activities shall be considered. Operational inspection requirements shall assure quality at least-an equivalent as the original quality. to I A-Ba
OCAM 0(4fM CN 'M O'f APPENDIX A REGULATORY GUIDE 1.33 (cont.) With regard to Section 5.2.7.1 of ANS N18.7 - 1976 titled Maintenance Programs: UE shall comply with the requirements of the first sentence of tne fifth paragraph, where practical. This clarification is needed since it is not always porsible 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 CC is involved in inspection of maintenance inspecticn activities. With regard to Section 5.2.8 of ANSI N18.7 - 1976 titled Surveillance Testing 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 surveillance tests and scheduled inspections." With regard to Section 5.2.9 of ANSI N18.7 - 1976 titled Plant Securi-ty and Visitor Control: The requirements of the Security Plan shall be implemented in lieu of tnese general requirements. When compliance with an NRC accepted program (e.g., Callaway Security Plan) is refer-l enced, UE has substituted the NRC accepted program for applicable i regulatory requirements in lieu of the general requirements of the Quality Assurance program standards. With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled Housekeep-ing and Cleanliness Control: The requirements of this Section, beginning with tne last sentence of the first paragraph and continuing
- through the end of the Section, shall be implemented as described in i
UE's commitments to Regulatory Guide 1.39 (ANSI N45.2.3) and Regulato-l ry Guide 1.37 (ANSI N45.2.1) as set forth in this Appendix. In every I case either identical or equivalent controls are provided in the Sections of the reference standards or documents. With regard to Section 5.2.13.1 of ANSI N18.7 - 1976 titled Procure-ment Document Control UE shall comply with the folloting sentence in lieu of the last sentence of the referenced Section. Where changes are made to the technical or quality requirements on pisT g procurement documents, they shall be subject to an equivalent level of I review and approvalj by the originating o rgani z a t ion., e nd--O? r c /i c w. eM W " H tv. u s HI e o y =Q/e,. n 4 l l p k > ith W regard to Section 5.2.17 of ANSI N18.7 - 1976 titled Inspection: Qfy r Inspections Inspection may not require generation of a requirements may be integrated separate inspection into appropriate ch report. F d procedures or other documents with the procedure or document serving as the record. However, records of inspections shall be identifiable and retrievable. l l A-9 Rev. 6/ M
*/
l
With regard to Section 5.2.15 of ANSI 1118.7-1976 titled Feviegt 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 alternativa guidance: " Procedures shall be revised as necessary. These revisions will generally be initiated through reviews conducted by knowledgeable personnel during routine performance of activities. Examples of such reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identified 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 proceduros shall be provided in plant administra-tive controls." A-9a
c 5.2 11 The third paragraph is replaced with the following. Inspections for modification and non-routine mainto e r s shall be conducted as indicated in our reference to Section L.2 of this standard. The following is a clarification to the sixth paragraph: l l A-9b l-l
i . CQAM APPENDIX A REGULATORY GUIDE 1.39 fcont.) i tt ree to Section 6.6 of ANSI N45.2.2 - 1973 titled Storace g "Reco d/:fard UE shall comply with the requirements of this Section with tne efarification that, for record purposes, only the access of non-UE empi ykes or contractors into indoor storage areas shall be recorded. Un1 adihy or pick-up of material shall not be considered " access," nor sh 11 inspection by NRC or other regulatory agents, nor shall tours by n n-UE employees who are accompanied by UE employees. N With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Insceetion of Ecuiement and Riccing: Stated ror information only, it is UE's posation :nat enis relates to the oneza-bility of the hoisting equipment and does not preclude rerari.tg as allowed i t' Section ' 3. RIGULATORY GUIDE 1.39 RIv!SION 2 DATED 9/77 __ Housekeeping Requirements for Water-Cooled Nuclear Power Plana (Endorses ANSI N45.2.3-1975)
- . DISCUSSION
UE complies with the recommendations of this Regulatory Guide w C,h sne following clarifications: l For maintenance and modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA programmar.ac/ad= nistrative requirements included therein (subject to the clarificctions below) shall apply to these maintenance and modifi-cation activities even though such requirements may not have been in effect originally. Technical requirements associated with the mainte-nance or modification shall be equal to or better than the original requiremeits (e.g., code requirements, material properties, design margins, aanufacturing processes, and inspection requirements), or as required to preclude repetition of defects. Specific clarifications for ANSI N45.2.3 - 1973 are indicated belew by Sections, t 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 - Planning: UE may choose not to utill:e the five-level l :ene designation system, but shall utilize standard janiterial and l work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of hous.ekeeping, Plant and personnel safety, and fire protection. e A-16 Rev. && 6 / &9
'fl
00AM APPENDIX A REGULATORY GUIDF 1.74 (cont.) A/-
" Unit staff" - (Not defined in any ANSI standard) -
Means those b personnel who report to the Gener- -Manager, 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 00AM and in callaway Plant Technical Specifications Section 6.3 and its subparts and Section 6.5.2.9.br the " unit organization" described in the Callaway Plant Technical Specifi-cations Section 6.2.2. "Like kind replacements" - (Not defined in any ANSI standard) - Like kind replacements include both eract item replacements and other item replacements which are not " exact" but meet the original design requirements.
REGULATORY GUIDE 1.88 REVISION 2 DATED 10/76 Collection, . Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (Endorses ANSI N45.2.9-1974) DISCUSSION: UE complies with the recommendations of this Regulatory Guide with the fellowing clarifications: With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled Generation of Ouali,tv Assurance Records _: The phrase " completely filled out" is clarifisd to mean that sufficN it information is recorded to fulfill the intended purpose of the record. It is the information, not the form, that is the record. Thus the information, not the form, needs to be complete to furnish documented " evidence of activities affecting quality". With regard to Section 3.2.2 of ANSI N45.2.9 - 1974 titled Index: The phrase "an index" is clarified to mean a collection of documents or indices which, when taken together, supply the information attributed to "an index" in the Standard. 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 Timeliness: UE's contractual agteement with its contractors and suppliers shall
- constitute fulfillrent of the requirements of this Section.
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OQAM, REVISION 14 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGES TO THE OQAM
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3 - Attachment 3 5 Page 2 of 6 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGED I TO THE OPERATING QUALITY ASSURANCE MANUAL (OQAM)
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The brac'cted numbers [ ] in this attachment refer to corres-ponding numbers which appear near the proposed changes in Attach-ment 2. Each explanation / justification may apply to several changes within Attachment 2. The affected OQAM sections ace referenced following &ach justification. It should be noted some sections appear under more than one justification. Based on Union Electric's evaluation, only the proposed change designated as [6] represents a reduction in the Operating Quality Assurance Program (OQAP) as previously accepted by the NRC. Union Electric considers this reduction to ba justified and the OQAM to continue to meet the requirements of 10CFR50, Appendix B. [1] Editorial changes (e.g., remove redundancy and unnecessary verbiage, clarify meaning, reformat to put in a more logical sequence; clarify applicability and references; make wording consistent with intent). (Sections 1.4, 1.5, 1.16, 1.18, 1.24, 4.10.1-4.10.3, 4.12, 4.13, 5.1, 7.5, 10.10, 10.11, 11.1, 11.6, 11.7, 18.6; Appendix A, Reg. Guide 1.30, 1.33) [2] Organization changes made to improve interdepartment coordi-nation and efficiency. (Sections 1.8, 1.11, 1.12, 1.13, 1.15, 1.16, 1.19, 1.20, 2.2, 11.11; Appendix A, Reg. Guide 1.74; Figures A, B, and C) [3] Added sections or changed text based on the review of Union Electric commitments to various documents. (Sections 1.25, 1.26, 10.14, 11.8; Figure A) [4] Renumbering of Sections. The section number shown is the new number. (Sections i.7-1.24, 1.27, 1.28, 4.8-4.14, 5.2-5.8, 7.4-7.13, 7.15-7.21, 10.2-10.7, 10.10, 10.11, 10.13, 10.14, 11.2-11.7, 11.10-11.13, 18.6-18.15) [5] Deleted a historical commitment. (old Section 7.5) [6] Elimination of two-year review cycle. Section 5.Q This change more clearly defines our program and expecta-tions for procedure reviews. Such reviews are part of a continuous process of operating the plant in a safe and efficent manner. Maintaining procedures in an accurate and useful condition
Attachment 3 Page 3 of 6 is a dynamic process..The need for change may be identificd at various times for various reasons and such changea must be evaluated for implementation at the time of identifica-tion. Requiring a static review process, such as the bien-nial review currently in ANSI N18.7, either in lieu of or in addition to the above evaluation is unnecessary and may be counterproductive. We have established management guidance on the evaluation of the need for and timing of procedure changes. Such guidance requires that if the activity cannot be performed in accor-ance with the procedure, or the procedure governing the activity should not be followed, the activity shall be stopped pending a procedure revision or supervisory guidance. In addition, various other management controls exist which require knowledgeable personnel to review and modify plant procedures. Some examples are:
- 1. The plant modification program requires a review of the proposed modification by all affected groups. This review requires identification of procedures needing revision to support a return of the system to operable status. Such changes must be made concurrent with modi-fication implementation.
- 2. The corrective action program requires root causes for plant conditions or events be determined and corrective action implemented. Review of procedures and their subsequent revision is an integral part of that process.
- 3. The operating experience review program includes reviews of items such as NRC bulletins, notices, and generic letters; INPO Significant Event Reports, Signficiant Operating Event Reports, and other NETWORK communiques for applicability and action. Actions may include proc-edure revision.
- 4. Vendor bulletins and notices are also evaluated-for applicability and actions. Actions may include procedure revisions.-
- 5. Evaluation of changes to the License, Technical Specifi-cations, FSAR, or OQAM includes identification of the need to revise procedures. If necessary, such procedure changes are issued. concurrent with the source document revision.
- 6. Corrective actions for NRC inspections or regulatory issues also provide for the evaluation and revision of procedures as necessary.
- 7. Revisions to regulations are reviewed by cognizant personnel and procedure changes are made as necessary.
Attachment 3 Page 4 of 6
- 8. When procedure changes are in order but immediate revi-sion is not required, the department responsible for revising the procedure tracks such changes until they are implemented.
- 9. The plant reference tracking system also provides a procedure cross reference database. This system provides responsible departments with a notice to review their procedures for possible revisions when a referenced procedure or document has changed.
This change will support a more effective allocation of plant resources. Rather than review procedures which are used infrequently, or which are not likely to be used in the near term, simply to satisfy a two-year review cycle, plant resources can be more focused on supporting planned activ-ities and addressing current problems. Section 5.9 fold) This specific section is no longer necessary as we have revised our interpretation of ANSI N18.7, Section 5.2.15, which was the source of oQAM, Section 5.9. As indicated in the justification to the change in OQAM, Section 5.3 events, which include accidents, unexpected transients, operator errors or equipment malfunctions are evaluated through our corrective action program to identify necessary procedure changes. (Appendix A, Reg. Guide 1.33) (7) Transfer analysis and trending of NMRs associated with installed equipment to Nuclear Engineering. Transferring a portion of NMR trending more clearly defines organization responsibilities in identifying and analyzing trends and places responsibility and authority for such trending in a more appropriate portion of our organization. (Section 15.10) (8) Clarify corrective action trending internal to UE as separate from external organizations. This clarification is required due to the implementation of a single corrective action program for Callaway Plant, which necessitated development of a separate supplier corrective action program. The semiannual periodicity was established in the OQAM during initial license development. It was not our intent to trend supplier related conditions adverse to quality semiannually. Suppliers are audited triennially, or more often as needed. In addition, annual evaluations of suppliers are performed which include review of audits performed as well as supplier performance reported in other Nuclear Division programs for identifying and controlling adverse. conditions (e.g., SOSs and NMRs) which are described
Attachment 3 Page 5 of 6 in OQAM, Section 18.12. This documented evaluation serves as a trend analysis of individual suppliers. UE believes this periodicity is appropriate and since it was our original intent, this is simply an OQAM clarification, and does not represent a lessening of the original quality program. (Sec-tion 16.1) [9] Revise wording per NRC request, dated 09/07/90. (Section 16.5) [10] Clarify Manager, QA, and NSRB responsibilities for assessing audit planning, audit results, and program offectiveness. The Manager, QA monitors the audit program on a continuous basis to assure audits are offective, meet requirements, and provide appropriate coverage. He does this through review and approval of quarterly audit schedules, attendance at audit meetings, involvement in selected audit finding issues, and review of audit reports. This is considered a clarification to existing commitments. (Section 18.6) [11] Change endorsement of Reg. Guide 1.8 to Rev. 2 for Shift Supervisor, Operating Supervisor, Reactor Operator, and Shift Technical Adviser. This brings training and qualification of licensed operators in line with current requirements. (Appendix A, Reg. Guide 1.8) [12] Clarify an existing interpretation for QC inspection and frequencies. QC inspections and frequencies are defined in the OQCM or procedures as described in our commitment to Reg. Guide 1.33 (ANSI N18.7-1976, Section 5.2.17). This change only clar-ifies an existing interpretation and does not reduce existing commitments for QC involvement in maintenance or modification activities. QC inspections, including frequency and type, are determined on an activity basis by Engineering and Quality Control personnel. Once determined, the inspec-tions are documented in an Operating Quality Control Manual (OQCM) which is used by job planners or protadure writers to define hold and witness points applicable to an activity. Initially, the inspections defined in the OQCM were estab-lished by considering the type and frequency of inspections used in construction procedures and specifications. Review of the current inspection effectiveness is continual and includes consideration of new industry techniques, manufac-turer's recommendations, plant and equipment performance, as well as actual inspection results. As such, inspections may not necessarily duplicate those performed during construc-tion. Changes to the OQCM inspections are authorized by Engineering and Quality Control personnel. This program I
Attachment 3 Page 6 of 6 implements the guidance in ANSI N18.7 and ensures quality at least equivalent to the original construction (Appendix A, Reg. Guide 1.33) [13] Delete clarification to ANSI N45.2.2-1972, Section 6.6. Clarification no longer needed. (Appendix A, Reg. Guide 1.38) (14] Removed first line supervisors from organization charts (except those identified in the OQAM, Section 1.0). This is justified per guidance in NUREG-0800, Section 17.2; and Reg. Guide 1.33 (ANSI N18.7-1976, Section 3.2) which only requires lines of authority, responsibility, and communica-
- ion be established from the highest management level
.hrough intermediate levels for those organizational units assigned safety related activities. (Figures B and C)
[15] Commitment Tracking System (CTS) number (number in left margin) changes, additions, or relocations. This is an internal tracking system for UE commitments and has no impact on the stated commitments. (Sections 2.10, 9.2, 10.10, 10.11, 10.12, 10.14, 11.2, 11.8, 12.2, 12.3, 13.1, 13.2, 13.6, 13.9, 16.1, 17.4, 18.0, 18.2, 18.4) Pages with no revision bars have text moved to another page due to use of new word processing software. No changes have been made to the text. l _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ - _ _ _ __________ -}}