ML20140J164
| ML20140J164 | |
| Person / Time | |
|---|---|
| Site: | Callaway |
| Issue date: | 05/31/1997 |
| From: | UNION ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML20140J155 | List: |
| References | |
| NUDOCS 9705130434 | |
| Download: ML20140J164 (77) | |
Text
,
__ to ULNRC-3575 Operating Quality Assurance Manual (OQAM)
Revision 19 l
00
$000k 050004e3 PDR g
Union Etscraic a
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL (OQAM)
Rev. I9 File Code A210.0012 i
Union ELECTRIC na REVISION:
19 CALLAWAY NUCLEAR PLANT DATE: 5/97 TAllLE OF CONTENTS Section Title Pace Table of Contents i
Policy / Introduction iii 1.
Organization 1-1 2.
Quality Assurance Program 2-1 3.
Design Control 3-1 4.
Procurement Document Control 4-1 5.
Instructions, Procedures, and Drawings 5-1 6.
Document Control 6-1 7.
Control of Purchased Material, Equipment, and Services 7-1 8.
Identification and Control of Materials, Parts, and Components 8-1 9.
Control of Special Processes 9-1 10.
Inspection 10-1 11.
Test Control 11-1 12.
Control of Measuring and Test Equipment 12-1 13.
llandling, Storage, and Shipping 13-1 14.
Inspection, Test, and Operating Status 14-1 15.
Nonconforming Materials, Parts, or Components 15-1 16.
Corrective Action 16-1 17.
Quality Assurance Records 17-1 18.
Audits 18-1 Appendix A OQAM Confbrmance to Applicable NRC Regulatory Guides A-1
.i.
Union Ets.craic g-REVISION:
19 CALLAWAY NUCLEAR PLANT DATE: 5/97 OOAP POLICY / INTRODUCTIONS It is the policy of Union Electric Company (UE) to develop, implement, and maintain an Operating Quality Assunmce Program (OQAP) for Callaway Plant as required by provisions of a Nuclear Regulatory Commission (NRC) operating license and amendments thereto. The QA Program shall be applied to those activities affecting quality (safety-related) regarding structures, systems, and components necessary to assure:
- 1. The integrity of the reactor coolant pressure boundary,
- 2. The capability to shut down the reactor and maintain it in a safe shutdown condition, or
- 3. The capability to prevent or mitigate the consequences of accidents which could result in off-site exposures comparable to the guideline exposures of NRC Regulations 10 CFR 100.
These activities include operational testing, operations, maintenance, refueling, and modifications. Control over these activities as they affect quality shall be to the extent consistent with their importance to safety. (CTSN 1825)
UE Company has established an organization to implement the OQAP as documented in policies, manuals, and procedures. Specific OQAP requirements and corresponding organizational responsibilities are specified in the Operating Quality Assurance Manual (OQAM).
The OQAP involves the proper functioning of many disciplines and activities. Functions, departments, groups, committees and other organizational subdivisions shall control activities affecting quality through implementation of appropriate written procedures or instructions. Documentation shall be maintained to provide objective evidence of program implementation and effectiveness.
(CTSN 1788)
The OQAP shall comply with 10 CFR 50, Appendix B " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and follow the guidance of the Regulatory Position of Regulatory Guide 1.33. Clarifications alternatives, and exceptions to this Regulatory Position are described in Appendix A of the OQAM. An eighteen (18) section format is employed with a discussion of how corresponding criteria of 10 CFR 50, Appendix B are satisfied. (CTSN 1879,1111) ii-
i Union Etyc,mc REVISION:
19 CALLAWAY NUCLEAR PLANT DATE: 5/97 The responsibility for formulating, authorizing, and assuring implementation of the UE Company l OQAP rests with the Vice President and Chief Nuclear Officer. The policy and resultant QA Program are mandatory for Callaway Plant operational phase activities. Accordingly, personnel shall be made cognizant of QA Program requirements and responsibilities epplicable to their individual activities and interfaces. (CTSN 1799)
Ily the signatures of the undersigned, this OQAM is approved and those UE personnel whose activities are within the purview of the OQAP are responsible for its implementation in accordance with the requirements described herein.
/) d f/9/4 7
' Garry L. Ran'dolph Date Vice President and Chief Nuclear Officer
[ 7 b '?
[ Manager, Quality Assurance l/oseph V. LaK Date l
-iii-j 3
E5UnionELECTRIC
?*
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 1.
ORGANIZATION 1.1 UE has established an organization for Quality Assurance activities. This Section identifies the organizational structure; management positions and responsibilities; and delegation of authority for the development, implementation and maintenance of the Operating Quality Assurance Program (OQAP). UE shall retain responsibility for the establishment and execution of the OQAP, although certain Program activities may be delegated to others. The organization responsible for implementing appropriate portions of the OQAP is shown in Section 13 of the FSAR. The Callaway Plant operating organization is also shown in Section 13 of the FSAR.
l1.2
'lhe Vice President and Chief Nuclear Omcer 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 engineering, construction, testing, and operation of the Callaway Plant and coordinating support activities performed by others w ho are not under his direct administrative control. He has corporate responsibility for the operation and physical control of the Callaway Plant. He reports to the Presiden: and Chief Executive Officer who has ultimate responsibility for the Callaway Plant, (CTSN 371) l1.3 The Manager, Quality Assurance reports to the Vice President and Chief Nuclear Officer on Quality Assurance Program and administrative matters. QA Program matters are reported to the President and Chief Executive Omcer through the Vice President and Chief Nuclear Omcer. The Manager, Quality Assurance is responsible to the Vice President and Chief Nuclear OfGcer for assuring the OQAP is being effectively implemented for operating activities; directing the overall Quality Assurance Program for UE including Program development, maintenance, and verification ofimplementation; and providing a constant independent overview of nuclear plant safety. The Manager, Quality Assurance has sumcient authority, organizational freedom, and independence to effectively assure compliance with OQAP requirements as they control Callaway Plant and offsite quality activities; and shall bear no cost, schedule, or production responsibilities which unduly influence attention to quality matters. A communication path shall exist between the Manager, Quality assurance and the l
Vice President and Chief Nuclear Omccr as well as the other Nuclear Division management, thus providing a direct path to inform management regarding conditions affecting quality and nuclear plant safety. The qualifications of the Manager, Quality Assurance are at least equivalent to those specified in ANSI /ANS-3.1-1978, " Selection and Training of Nuclear Power Plant Personnel," Sections 4.2.4 and 4.4.5.
The Manager, Quality Assurance is located at Callaway Plant and provides technical direction and administrative guidance to the ISEG staff, the Quality Assurance staff, and the Quality Control staff.
(CTSN 1790,1799) 1.4 The Manager, QA directs Supervisors and Supervising Engineers who have primary duties for assuring implementation of the OQAP and who devote full attention to this effort. The Supervising Engineer, Operations Support provides for maintenance of the Operating Quality Assurance Manual (OQAM). The Supervising l
Engineer, Technical Support is responsible for audit, surveillance, and evaluation of nuclear supplier quality activities; and for performing those procurement document reviews assigned to him. The Supervisor Quality Control is responsible for work activity inspections, receipt inspection as described in Section 7.0, and nondestructive examinations. The activities of the QA stalTassure implementation of the OQAP.
1-1
SECTION NO.1 se REVISION-19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 1.5 The Manager and Supervising Engineers in the Quality Assurance Department are authorized by the Vice l
President and Chief Nuclear Officer to stop work on ongoing quality activities in accordance with approved procedures. During the operating phase they have the authority to stop unsatisfactory work during repair, maintenance, and refueling activities and the authority to recommend to the Manager, Callaway Plant stop work affecting the continuation of Plant operation. Other stop work authority shall be delineated in procedures. The continuance of an activity which would cover up a deficiency and preclude identification and correction, or increase the extent of the deficiency is subject to stop work action by the Quality Assurance Department. The Manager, Quality Assurance has no duties or responsibilities unrelated to QA that would prevent his full attention to QA matters.
1.6 The authorities and duties of persons and organizations performing quality assurance functions shall be clearly established. Such persons have sufficient authority and organizational freedorn to identify quality problems; to initiate, recommend, or provide solutions; and to evaluate corrective action. Assurance of quality by checking, auditing, inspecting, or otherwise verifying Program activities shall be by personnel other than the individual or group performing the specific activity. (CTSN 1790,2255) 1.7 The Manager, QA also directs the Supervising Engineer, ISEG and staff who evaluate Callaway Plant operations from a safety perspective and compare Callaway operating experience with that of plants of similar design. In addition, they assess the conformance of Plant performance to safety requirements. (CTSN 1790) 1.8 The Manager, Nuclear Engineering reports directly to the Vice President and Chief Nuclear Officer and directs a staff of superintendents, supervisors, supervising engineers, and quality control inspectors whose primary function is to provide technical support to the operation of Callaway Plant. This support includes, but is not necessarily limited to design; modification; configuration control; system and equipment performance; reliability, and testing; technical programs administration; and contractor support. lie controls those activities and implements the OQAP through the Superintendents, Design Engineering, System Engineering, and Technical Support Engineering. Within the Technical Support Engineering organization, QC Inspectors (ISlHDE) 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. (CTSN 2184) 1.9 The Manager, Licensing and Fuels reports directly to the Vice President and Chief Nuclear Officer and has merall responsibility for UE nuclear fuel cycle activities including responsibility for procurement of fuel cycle goods and services, and for incore fuel management. The Manager, Licensing and Fuels is also responsible for coordinating licensing activities for Callaway Plant. The Licensing and Fuels organization provides technical support activities in the area of reactor design and radiological engineering. (CTSN 2184,2293) 1.10 The Manager, Nuclear Services reports directly to the Vice President and Chief Nuclear Officer and is responsible for providing administrative and management support including cost forecasting, status reporting, and budgeting matters, lie is responsible for direction of the Nuclear Division General Offices clerical activities, and serves as Principal lleahh Physicist. lie is also responsible for the administrative contact with the institute of Nuclear Power Operations (INPO). As Principal Health Physicist, he provides a corporate level overview and guidance in the fomiulation and implementation of applied radiation protection programs and reviews the radiological safety programs for compliance with Federal and State standards and regulations.
1-2
SECTION NO.1 53IJNIONELECTRIC eei 7
asvisios.
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 1.11 The Vice President and Chief Nuclear Omcer reports to the-President and Chief Executive Officer and is responsible for the activities of the Callaway Plant Operations Department and the Operations Support Department. This responsibility includes:
assuring a high level of quality is achieved in the Plant operations and support activities, e
the execution of the administrative controls and quality assurance program, e
the safe, legal and emcient operation and maintenance of the Plant, e
protecting the health and safety of the public and Plant personnel e
l 1.12 The Manager, Callaway Plant reports directly to the Vice President and Chief Nuclear Omcer, and is responsible for the safe, legal, and eflicient operation and maintenance of the Callaway Plant. lie has overall responsibility for the execution of administrative controls and the quality assurance program to assure safety.
lie controls Plant functions and implements the OQAP through the Assistant Manager, Work Control; the Superintendent, Ilealth Physics, the Superintendent, Chemistry and Radwaste; the Superintendent, Operations; the Superintendent, Maintenance; and the General Supervisor,1&C (see Section 13 o~f the FSAR). He has the primary responsibility for reactor operation and safety. (CTSN 1799) l 1.13 The Manager, Operations Support reports to the Vice President and Chief Nuclear Officer, and is responsible for Plant support activities including training, materials management, security, and administration services activities required to support the Callaway Operating License. lie controls Plant support activities and implements the OQAP through the Superintendent, Materials, the Superintendent, Training, the Superintendent, Security, and the Superintendent, Administration. (CT5N 2293) 1.14 General quality assurance indoctrination and training for the Nuclear Division is the responsibility of UE Nuclear Operations (UENO), Training. The Quality Assurance Department is responsible for specific QA training as requested by Nuclear Division organizations.
1.15 The Manager, Nuclear information Services (NIS) reports to the Vice President and Chief Nuclear Officer. lie is responsible for providing the analysis, programming, operations, hardware support, files, reports, and capabilities necessary to maintain the nuclear information system and network in support of the plant.
1.16 The Manager, Emergency Preparedness and Organizational Support reports directly to the Vice President and Chief Nuclear Ollicer, and is responsible for emergency preparedness, organizational support, personnel development, process re-engineering, personnel, and fitness for duty. (CTSN 43030) 1.17 The Supervisor, EP and stafThave overall responsibility for the development and maintenance of the Emergency Preparedness Program. This includes onsite and offsite emergency preparedness, coordination of the Plant Radiological Emergency Response Plan with State and local emergency plans, and the planning and execution of emergency drills and emergency plan exercises.
1.18 The Superintendent, Personnel (Local 148) and the Superintendent, Personnel (Local 1439 and 1455) report directly to the Manager, Emergency Preparedness and Organizational Support and are responsible for assisting in the areas ofindustrial relations and other matters under the guidance of UE policies, in addition, the Superintendent, Personnel (l.ocal 1439 and 1455)is responsible for the Fitness for Duty, Access Authorization and medical physical programs.
I-3
f l
$3(INIONELECHUC
[,
CALLAWAY NUCIIAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 1.19 The Manager, Purchasing renorts directly to the Vice President-Supply Service who in tum reports to the Senior l
Vice President Energy Supply Services. The Manager, Purchasing is responsible for commercial aspects involved in procurement of materials, systems, components, and services (excluding engineering services and certain nuclear fuel cycle-related procurements) not delegated to others which are employed in support of Callaway Plant. (CTSN 43026) 1.20 The Manager, Power Plant Design Engineering reports to the Vice President Engineering and Construction who in turn reports to the Senior Vice President-Finance and Corporate Services. The Manager, Power Plant Design Engineering provides technical support, as necessary, to the Nuclear Engineering staff. (CTSN 2184) 1.21 The Manager, Electrical Engineering reports to the Vice President-Engineering and Construction. The Manager, Electrical Engineering provides technical support, as requested, to the Nuclear Engineering staff.
(CTSN 2184) l1.22 The Manager, System Relay Services reports to the Vice President-Customer Services-Division Support who in turn reports to the Senior Vice President-Customer Services and is responsible for providing qualified engineers, technicians and # quipment to maintain Callaway Plant relays. (CTSN 43027) 1.23 The Manager, Distribution Operating Department reports to the Vice President-Customer Services-Division Support and is responsible for providing quali9ed engineers, technicians and equipment for Callaway Plant battery testing and technical support. (CTSN 43027) l1.24 The Manager, Transmission Planning reports to the Vice President-Engineering and Construction and is responsible for directing all activities related to the Planning of transmission facilities. The Vice President-Engineering and Construction also provides engineering and other support services when requested by the Vice President and Chief Nuclear Officer. (CTSN 43027,43025) 1.25 Other UE divisions may provide safety-related services which augment and support selected Program activities.
These organizations shall be required to implement controls consistent with the OQAP requirements applicable to their scope of activities. The coordination of these activitics is the responsibility of the Vice President and Chief Nuclear Officer.
1.26 Safety review committees shall be established to provide an independent review of those items required below.
These committees are the Onsite Review Committee (ORC - refer to Section 1.26.1) and the Nuclear Safety Res iew floard (NSRil-- refer to Section 1.26.2) 1.26.1 The ORC shall function to advise the Manager, Callaway Plant on all matters related to nuclear safety. The Manager, Callaway Plant shall be Chairman of the ORC.
1.26.l.1 ORC membership shall include a minimum of six additional members appointed by the Chairman and an additional member appointed by the Manager, Quality Assurance. Selected members shall include, at a minimum, management responsible for the following areas of expertise:
a) Operations b) Maintenance c) Instrumentation and Controls d) Chemistry e) Radwaste f) IIcalth Physics g) Nuclear Engineering h) Quality Assurance 1-4
EEUNIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 1.26.1.2 All alternate members shall be appointed in writing by the ORC Chairman to serve on a temporary basis.
1.26.1.3 The alternate for Quality Assurance is appointed by the Manager, Quality Assurance.
1.26.l.4 The ORC shall meet at least once per calendar month and as convened by the ORC Chairman or his designated alternate.
1.26.1.5 The quorum of the ORC necessary for the performance of the ORC responsibility and authority provisions shall consist of the Chairman or his designated alternate and four members of which no more than two shall be alternates.
1.26.1.6 The ORC shall maintain written minutes of each ORC meeting that, at a minimum, document the results of all ORC activities. Copies shall be provided to the Vice President and Chief Nuclear Officer and the NSRB.
1.26.l.7 The ORC shall be responsible for:
a) Review of all Administrative Procedures; b) Review of safety evaluations for:
procedures, e
change to procedures, equipment, systems or facilities, and e
tests or experiments completed under the provision of 10CFR50.59 to verify that such actions e
did not constitute an unreviewed safety question; c) Review of proposed procedures and changes to procedure, equipment, systems or facilities which may insolve an unreviewed safety question as defined in 10CFR50.59 or involves a change in Technical Specifications; d) Review of proposed test or experiments which may involve an unreviewed safety question as defined in 10CFR50.59 or requires a change in Technical Specifications; e) Review of proposed changes to Technical Specifications or Operating License; f) Investigation of all violations of the Technical Specifications including the forwarding of reports covering evaluation and recommendations to prevent recurrence to the Vice President and Chief l
Nuclear Officer and to the NSRB; g) Review of report of operating abnormalities, deviations from ' expected performance of plant equipment and of unanticipated deficiencies in the design or operation of structures, systems or components that affect nuclear safety; h) Review of all REPORTABLE EVENTS; i) Review of the plant Security Plan and shall submit recommended changes to the NSRB; j) Review of the Radiological Emergency Response Plan and shall submit recommended changes to the NSRB; k) Review of changes to the PROCESS CONTROL PROGRAM, the OFFSITE DOSE CALCULATION MANUAL, and Radwaste Treatment Systems; l) Review of any accidental, unplanned or uncontrolled radioactive release including the preparation of reports covering evaluation, recommendations, and disposition of the corrective action to prevent recurrence and the forwarding of these reports to the Manager, Callaway Plant and to the NSRB; m) Review of Unit operations to detect potential hazards to nuclear safety; n) Investigations or analysis of special subjects as requested by the Chairman of the NSRB; e) Review of Unit Turbine Overspeed Protection Reliability Program and revisions thereto; p) Review of the Fire Protection Program and submitting recommended changes to the NSRB.
1-5
i MUurouELECTRIC
$o CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5l97 1.26.l.8 The ORC shall:
a) Recommend in writing to the Manager, Callaway Plant approval or disapproval ofitems considered under Sections 1.26.1.7.a through 1.26.1.7.e,1.26.1.7.i,1.26.1.7.j,1.26.1.7.k,1.26.1.7.1,1.26.1.7.0, and 1.26.1.7.p above, b) Render determinations in writing with regard to whether or not each item considered under Sections 1.26.l.7.b through 1.26.1.7.e, and 1.26.1.7.m, above, constitutes an unreviewed safety question; and c) Provide written notification within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the Vice President and Chief Nuclear Omcer and the NSRB of disagreement between ORC and the Manager, Callaway Plant; however, the Manager Callaway Plant shall have responsibility for resolution of such disagreements.
1.26.2 The NSRB shall function to provide independent review and audit of designated activities in the areas of; a) Nuclear power plant operations, b) Nuclear engineering, c) Chemistry and radiochemistry, d) Metallurgy, c) Instrumentation and control, O Radiological safety, g) Mechanical and electrical engineering, and h) Quality assurance practices l 1.26.2.1 The NSRB shall report to and advise the Vice President and Chief Nuclear Officer on those areas of responsibility stated in OQAM Sections 1.26.2.10 and 18.8.
1.26.2.2 The NSRB shall be composed of at least the following members:
Chairman:
Manager, Licensing and Fuels Member:
~ Manager, Nuclear Engineering Member:
Manager, Quality Assurance
' Member:
Manager, Operations Support Member:
S'upervising Engineer, Fuel Cycle Management 1.26.2.3 Additional members and Vice Chairman may be appointed by the Chairman.
1.26.2.4 The NSRB members shall hold a Bachelor's degree in an engineering or physical science field, or equivalent experience, and a minimum of 5 years of technical experience of which a minimum of 3 years shall be in one or more of the disciplines of Section 1.26.2.
1.26.2.5 All alternate members shall be appointed in writing by the NSRB Chairman to s ent on a temporary basis however, no more than two alternates shall participate as voting members in NSRB activities at any one time.
1.26.2.6 Consultants shall be utilized as determined by the NSRB C. airman to provide expert advice to the NSRB.
1.26.2.7 The NSRB shall meet at least once every 6 nonths.
1-6
MUnionELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 1.26.2.8 The quorum of the NSRil necessary for the performance of the NSRB review and audit functions herein, shall consist of the Chairman or his designated attemate and at least two thirds of the NSRB members, including alternates. No more than a minority of the quorum shall have line responsibility for operation of the unit.
1.26.2.9 Minutes of eacn NSRI) meeting, including reports of reviews encompassed by Section 1.26.2.10, shall be l
prepared, approved and forwarded to the Vice President and Chief Nuclear Officer within 14 days following each meeting.
1.26.2.10 The NSRil shall be responsible for the review of:
a) The safety evaluations for:
changes to procedures, equipment, systems or facilities; and a
tests or experiments completed under the provision of Section 50.59,10CFR, to verify that such e
actions did not constitute and unreviewed safety question; b) Proposed changes to procedures, equipment, systems or facilities w hich involve an unreviewed safety question us defined in Section 50.59,10CFR; c) Proposed tests or experiments w hich involve an unreviewed safety question as denned in Section 50.59, 10CFR; d) Proposed changes to Technical Speci6 cations or the Operating License; e) Violations of Codes, regulations, orders, Technical Specifications, license requireraents, or of internal procedur(s or instructions having nuclear safety significance; f) Significant operating abnormalities or deviations from normal and expected performance of uait equipment that affect nuclear safety; g) ALL REPORTAllLE EVENTS; h) All recognized indications of an unanticipated deficiency in some aspect of design or operation of structures, systems or components that could affect nuclear safety; and i) Reports and meeting minutes of the ORC.
e 17
i EMTIONELECTRIC l{$
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL pgry: Sigy 2.
QUALITY ASSURANCE PROGRAM 2.1 UE has established an OQAP which controls activities alTecting 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 11 " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33. Commitments, clarifications, alternatives, and exceptions to the Regulatory Position of Regulatory Guide 1.33 are stated in Appendix A of this OQAM. In addition, the OQAP has incorporated the commitments made in responding to applicable NRC questions. The text of the NRC questions applicable to the OQAP, along with the responses, are maintained as a l
QA Record separate from the OQAM. The Vice President and Chief Nuclear OfGcer has reviewed the Program and formulated the policy in addition to authorizing Program implementation. This responsibility has been established by the President and Chief Executive OfGcer of l'E for establishing and implementing the Quality Assurance Program requirements. (CTSN 1799,2974) 2.2 Lines of authority and responsibility have been established from the President and Chief Executive Officer to the Vice President and Chief Nuclear OfGcer and the onsite operating organization. These relationships shall be documented and updated, as appropriate, in the form of organization charts, functional descriptions of departmental responsibilities, and position guides for key personnel having direct operating, support, or audit responsibility. Where speciGc responsibilities are assigned within the OQAP, the prescribed individual shall retain the overall responsibility; however, subject to applicable regulatory constraints, authority may be delegated to subordinates. Considering these same regulatory constraints, the authority of a subordinate may always be assumed by a superior, (CTSN 1788) 2.3 Updating and revision of the OQAP as described in this OQAM shall be in accordance with the applicable requirements of 10 CFR 50.54 (a) and 10 CFR 50.71.
2.4 The pertinent requirements of the OQAP apply to all activities alTecting the safety-related functions of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. The safety-related structures, systenis and components identiGed in Table 3.2-1 of the Callaway-SP Final Safety Analysis Report (FSAR). This list includes structures, systems, and components identiGed during the design and construction phase and may be modiGed as required during operations consistent with their importance to safety. Modifications to this list require the approval of the Manager, Quality Assurance and the Manager, Nuclear Engineering and shall be issued and controlled in accordance with Section 6. The development, control, and use of computer programs to be used in safety-related activities are within the scope of the OQAP. The degree of controls applicable to each computer program shall be consistent with the program's importance to safety-related activities. Consumables which could afTect the form, fit or function of safety-related structures, systems, and components, although not listed in Table 3.21 of the Callaway-SP FSAR, are also under the control of the OQAP, (CTSN 1824,1853,20200) 2.5 The OQAP shall be implemented throughout the operating life of the Callaway Plant. Activities affecting quality shall be accomplished under suitably 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. (CTSN 1879,1947) 2-1 m
I l
$EUNIONELECTRIC N
CALLAWAY NUCLEAR PLANT OPERA TING QUALITY ASSURANCE MANUAL DATE: 5/97 2.6 Consistent with the schedule for accomplishing quality activities, the OQAP shall be established and documented by written policy, program manual, and procedure manuals. Persons conducting safety related activities shall be responsible to implement approved procedures. The OQAP shall utili2e the following document types to describe Program objectives: (CTSN 1788,1879) 1.
Operatine Ouality Assurance Procram Policy / Introduction Statement The Operating Quality Assurance Program Policy statement establishes governing principles in accordance with the requirements of 10 CFR 50, Appendix B.
The Operating Quality Assurance Program Policy statement and any revisions thereto shall be approved by the Vice President and Chief Nuclear Officer.
2.
Operatine Ouality Assurance Manual (OOAM)
The OQAM contains a delineation of the Policy statement, quality assurance requirements, assignment of responsibilities, and a dennition of organizational interfaces. The OQAM is the written description of the l
OOAP, Approval of the OQAM is by the Vice President and Chief Nuclear OfScer and the Manager, Quality Assurance. (CTSN 1823) 3.
fallaway Plant Operatine Manual The Callaway Plant Operating Manual consists of a multi-volume set of Plant operating procedures prepared or reviewed by the staff with the aid of other SNUPPS utilities, Nuclear Engineering, the Lead A/E, the NSSS Supplier, and Fuel Fabricator. These procedures are controlled, approved, and issued in accordance with Administrative Procedures contained within the Manual. This Manual includes administrative controls consistent with tnose required by Regulatory Guide 1.33. (CTSN 1947)
Administrative procedures u hich 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 Gnal approval of Administrative 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 uhich implement the requirements of the Technical Speci6 cations, and this OQAM.
2.7 UE may employ the safety-related services of architect engineers, NSSS suppliers, fuel fabricators, constructors, and others which provide or augment UE efforts during the operating phase. These organizations shall be required to work under a quality assurance program whose controls are consistent with the scope of their effort.
This does not preclude any organization from working under the UE OQAP. The quality assurance program of outside organizations shall be subject to review, evaluation and acceptance by the UE Quality Assurance Department prior to the initiation of safety-related work. Vendor programs and procedures shall also meet UE's I
commitment to USNRC Generic Letter 83-28. (CTSN 679,1746,1787,2293,2460) 1 2.8 Disputes which may arise between QA or QC personnel and personnel in other UE organizations which cannot be resolved shall be referred to the next higher level of management for resolution. Disputes which cannot be resolved through these levels shall be resolved ultimately by the Chief Executive OfGcer.
l 2-2 l
j
1 t
SOTIONELECTRIC
?*
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5l97 l
2.9 Preservice (PSI) and Inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspections and other operating phase " code" activities shall comply with the requirements of the applicable Code Edition and Addenda of the ASME Boiler and Pressure Vessel Code. This compliance includes the independent third-party inspection coverage of " code" items by an Authorized Nuclear inspector.
2.10 General indoctrination and training programs shall be developed for personnel performing safety-related activities to assure that responsible functions, departments, and individuals are knowledgeable regarding quality policy and requirements of applicable manuals and procedures. The requirements for training of Callaway Plant personnel are described in Section 13.2 of the Callaway-SA FSAR. The training of permanent Plant personnel is the responsibility of the Superintendent, Training. UE personnel performing complex, unusual, or hazardous work shall be instructed in special indoctrination or briefing sessions. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equipment and systems, operating constraints, and control requirements in effect during performance of work. Training shall be conducted as required to, as a minimum, meet the requirements of UE's commitment to Regulatory Guide 1.8
( ANSI /ANS 3.1), Regulatory Guide 1.33 ( ANSI N18.7), other Regulatory Guides as endorsed in OQAM Appendix A, and other regulatory requirements. Records of training shall be maintained as described in Section
- 17. Where required by code or standard, personnel are trained or qualified according to written procedures in the principles and techniques of performing specific activities. Special equipment, environmental conditions, skills, or processes shall be provided as necessary for the effective implementation of the OQAP.
(CTSN 1795,1916,2188) 2.11 An audit system shall be established to assure management is advised of Program effectiveness. The implementation and effectiveness of the OQAP shall be assessed through an audit program of quality activities which includes design, procurement, modification, and operation. The Manager, Quality Assurance is responsible for a system of planned audits to assure OQAP compliance, with a frequency commensurate with the Program aspect's safety significance and in accordance with the requirements of Section 18. He is responsible for conducting audits of offsite and onsite activities. Deficiencies identified during the audit process are reported to responsible management of the organization involved in the resolution and follow-up to assure corrective action. (CTSN 1799) l 2.12 The Vice President and Chief Nuclear Officer provides for an independent assessment of the scope, implementation, and effectiveness of the OQAP to assure compliance with policy, commitments, and the requirements of 10 CFR 50, Appendix B as set forth in this OQAM. This assessment shall be conducted biennially with a scheduling allowance of plus three months for each assessment and a combined time interval for any three consecutise assessment intervals not to exceed 6.25 years. This assessment may be by representatives of other utilities, outside consultants, or UE management representatives. In addition, various l
reports are issued to the Vice President and Chief Nuclear Officer on a periodic basis to assist his independent assessment of the OQAP (e.g., semiannual QA trend analysis, and periodic QA audit reports).
(CTSN 1799,1800) 2.13 Implementation of OQAP controls over activitks affecting quality assures achieving the objective of the UE OQAP to provide management with adequate confidence that activities affecting quality regarding the design, installation, modification, and operation of the Callaway Plant are performed consistent with policy.
Documentation of the accomplishment of OQAP objectives is maintained in the form of records of data and other information as necessary to support operation, maintenance, repair, modification, refueling, and inservice inspection.
23
}
$3 NONELECTRIC
[
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 2.14 UE Management has established standards of performance which exceed those set forth by the Regulatu.'j 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 difference in the degree of compliance mandated by use of the words "shall" or "must." Compliance with actions initiated by use of either "shall" or "must" is audited and surveilled by the QA Department. Failure to implement a "must" mandated activity requires corrective action in the same way as failure to implement a "shall" mandated activity, liowever, from an external viewpoint, internally imposed "must" requirements (i.e., those in excess of Regulatory requirements) are not intended to be subject to enforcement action. "Must"is defined in Appendix A of this OQAM under Regulatory Guide 1.74.
2-4
i MINIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5l97 3.
DESIGN CONTROL 3.1 The design, modification, addition, and replacement of safety-related structures, systems, and components shall be controlled to assure appropriate design control measures are implemented. Procedures shall establish requirements; assign responsibilities; and provide control of activities regarding design in a planned, controlled, and orderly manner. (CTSN I850,2070,2072,2096,2168,2185,2187,2188. 2222,1864,2183,2974) 3.2 The Plant design is defined by those UE NSSS, A/E and selected supplier design drawings and specifications which illustrate the m.eral arrangement and details of safety-related structures, systems, and components and define the requirements for assuring their continued capability to perform their intended operational or safety design function. (CTSN 2188) 3.3 As the result of operating experience, or as necessitated by regulatory requirements, Plant systems and equipment may have to be changed. A design change is a modification in Plant design or operation and is accomplished m accordance with requirements and limitations of applicable codes, standards, specifications, licenses, and predetermined safety restrictions. An alteration of Plant equipment, structures or systems, which is not by nature operational, maintenance or replacement by like kind, is considered a design change.
(CTSN 2664) 3.4 Maintenance or modifications which may affect functioning of safety-related structures, systems, or components shall be performed in a manner to ensure quality at least equivalent to that specified in original design bases and requirements, materials specifications and inspection requirements. A suitable level of confidence in structures, systems, or components on which maintenance or modifications have been performed shall be attained by appropriate inspection and performance testing. (CTSN 1850,2100,2101,2105,211I) 3.5 Design, including related procurement efforts, may be carried out by Nuclear Engineering, Licensing and Fuels, or outside organizations. (CTSN 2184,2188,2222) 3.6 Control of design shall be specified in procedures. These procedures shall include instructions for defining typical design requirements; communicating needed design information across intemal and external interfaces; preparing, reviewing, approving, releasing, distributing, revising, and maintaining design documents; performing design reviews and reviews of design; and controlling field changes. (CTSN 2071,2074,2164, 2188,2221,2222,2223,2225,2243) 3.7 Design control shall involve measures which include a definition of design requirements; a design process w hich includes design analysis and delineation of requirements through the issuance of drawings, specifications, and other design documents (design outputs); and design verification or review of design to verify the adequacy of design or to become acquainted with design features. (CTSN 2164) 3.8 Design requirements and changes thereto shall be identified, documented, reviewed and approved to assure incorporation of appropriate quality standards in design documents and to control departures from these standards. Modifications to structures, systems, and components shall consider, as a minimum, the design bases described in the Callaway-SP and the Callaway-SA FSAR and the Technical Specifications. Design criteria documents which are newly issued or modified in the course of design or design changes shall be reviewed by a j
Supervising Engineer in the Nuclear Engineering Department for seismic and quality group classification and selection of quality standards. Design criteria documents consist of original Plant design criteria, system descriptions and other documents defining design input which change the Plant as described in the FSAR. He 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 verification measures, and evaluating design changes. (CTSN 1850,2188,2203,2204,2205,2207, 2222,2664) 3I
SECTION NO. 3 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 3.9 Design activities shall include the correct translation of regulatory requirements and design bases into specifications, drawings, written procedures, and instructions (design outputs) that define the design. Design analyses regarding reactor physics, stress, thermal, hydraulic, radiation, and accident analyses used to produce design output documents, shall be sufficiently detailed to pennit an independent review by a technically qualified person. Analyses shall specify purpose, method assumptions, design requirements, references, and units. When computer codes are employed, only verified codes shall be used in safety-related design and design changes. (CTSN 2207,2209,2210,2212,2974,2170) 3.10 Procedures shall specify requirements for the review and approval of design changes by the organizations or individuals that performed the original design or Nuclear Engineering. Design control activities, i'm dig design changes, may be delegated to others provided they have access to background and techncal imormation.
Design control measures for design revisions shall be commensurate with those applied to the original design.
(CTSN 2165,2 I66,2168,2169,2243) 3.11 Design activities shall also include: 1) reviewing the applicability of standards; 2) reviewing commercial or previously approved materials, parts or equipment for suitability of application; 3) reviewing the compatibility of materials used in the design; 4) reviewing the accessibility of equipment and components for inservice inspection, maintenance, and repair; 5) specifying criteria for inspection and test / retest; and 6) reviewing and approving procedures for special processes. (CTSN 1934) 3.12 The design process shall establish controls for releasing design documents which are technically adequate and accurate in a controlled manner with a timely distribution to responsible individuals and groups. Documents and revisions shall be controlled through the use of w ritten procedures by the issuer, distributor, and user to prevent inadvertent use of superseded documents. Document control procedures shall govern the collection, storage, and maintenance of design documents, results of design document reviews, and changes thereto. The design documents subject to procedural control include, but are not limited to, specifications, calculations, computer programs, system descriptions, SAR w hen used as a design document, and drawings including flow diagrams, piping, and instrument diagrams, control logic diagrams, electrical single line diagrams, structural systems for major facilities, site arrangements, and equipment locations. (CTSN 2164,2168,2188,2220,2243) 3.13 The design interfaces between UE organizations performing work affecting quality of design and between UE and outside organizations shall be identified and controlled by procedures. These procedures shall address control of the interface, responsibilities, lines of communication, and documentation ofinternal and external interface activities. (CTSN 2164,2188,2217,2218,2219,2223,2231) 3.14 The design process shall include design scritication. Design verification assures that design is adequate and meets specified design inputs. Design control procedures shall specify requirements for the selection and accomplishment of a design Verification program. The program depth shall be commensurate with the importance of the system or component to safety, complexity of the design, and similarity of the design to previously proven designs. Design verification shall be conducted in accordance with procedures which identify the responsibilities of the veritier and the documentation required and which, through adherence to the procedures, provide for the identification of the areas, features, and pertinent considerations to be verified.
Design serification shall be by either design review, alternate calculation, qualification testing, or by a combination of these. Where alternate calculations are performed to verify the correctness of a calculation, a review shall be performed to address the appropriateness of assumptions, input data, and the code or other calculation method used. UE shall perform " reviews of design" of selected documents for subcontracted design to become familiar with design features. An independent third-level review must be employed as an additional verification when UEjudges that the design involves unique or special design features. The organization performing design shall have the responsibility for design control unless specified otherwise. Design verification shall be performed by competent personnel other than those who performed the original design and other than the designer's immediate supervisor. Ilowever, an individual's supervisor may perform design 3-2
SECTION NO. 3 dm U.TIONELECTRIC REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 verification when he is the only technically qualified individual and in such instances the need for design verification by the designer's immediate supervisor shall be individually documented and approved in advance by the supervisor's management. Quality Assurance Department audits shall examine the frequency and the effectiveness of use of supervisors as design verifiers to guard against abuse. (CTSN 1934,2182,2209,2234, 2188,2227,2231) 3.15 Design verification, if other than by qualification testing of a prototype or lead production unit, shall be completed prior to release for procurement, manufacturing, construction or to another organization for use in other design activities. In those cases where this timing cannot be mct, the design verification may be deferred, providing the justification for this action is documented and the portions of the design output documents based on the unverified data are appropriately identified and controlled. Without verification, site activities associated with a design or design change must not proceed past the point where the installation would become irreversible (i.e., require extensive demolition and rework). The design verification shall be complete prior to relying upon the component, system, or structure to perform its safety-related function. (CTSN 1934,2227) 3.16 Action shall be initiated to correct errors found in the design process. 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.
(CTSN 2188,2172) 3.17 Requests for design changes affecting safety-related structures, systems, and components may be originaicd 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 Fucts.
3 18 Independent of the responsibilities of the design organization, the requirements of the Onsite Review Committee (ORC) and the Nuclear Safety Review Board (NSRB) as defined in OQAM Section 1.0 shall be satisfied.
Design changes require a safety evaluation which shall be reviewed by the ORC and approved by the Manager, Callaway Plant. In addition, changes in the facility as described in the FSAR which involve a change in the 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 acceptabilitv, and design requirements imposed by Plant generating equipment.
3.19 Safety evaluations which consider the effect of the design as described in the design documents, shall be perfonned by the responsible UE engineering organization or outside organization (s). These evaluations shall include the basis for the determination that the design change does not involve an unreviewed safety question.
As deemed necessary by the evaluating organization, dehibd analyses shall be performed to support the bases of safety evaluations. All nuclear safety evaluations are < *nitted to the ORC Changes involving the substitution of equivalent hardware require safety evalua..
^o assure that the design requirement changes are consistent with and do not 1,lter the design criteria specified in existing design documents. When design documents and safety evaluations are prepared by an outside organization under its QA program, review and approval per ANSI N45.2.1I will be included. UE will approve all outside organizations' design documents and safety evaluations, and will perform appropriate reviews necessary for final approval.
3.20 The ORC and NSRB shall review design changes pursuant to the requirements of OQAM, Section 1.0 3.20.1 Design changes which require an amendment of the license, shall be submitted on an application to the Nuclear Regulatory Commission for approval in accordance with 10CFR50.90.
33
EEUurouELECTRIC y
CALLAWAY NUCLE AR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 3.21 Procedures and instructions related to equipment or systems that are modified shall be reviewed and updated in accordance with Appendix A to this OQAM (Regulatory Guide 1.33, Section 5.2.15 of ANSI N18.7), to 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 perfonnance of their duties through procedure revkiont or specific training in the operation of modified equipment or systems, or other appropriate means.
(CTSN 1911,2164) 3.22 Records shall be maintained which reflect current design including safety analyses, safety evaluations, design change installation procedures, material identification documents, procurement documents, special process documents, equipment and installation specifications, and as-built drawings. (CTSN 2039,2132,2173) 3.23 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 organization for correctness, conformance to design criteria, and compliance with applicable codes and standards.
3-4
SECTION NO. 4 se REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 4.
PROCUREMENT DOCUMENT CONTROL 4.1 Safety-related procurements shall be documented. Procurement document control applies to documents employed to obtain safety-related materials, parts, components, and services required to support Plant activities.
Written procedures establish requirements and assign responsibility for measures to assure applicable regulatory requirements, design bases, and other requirements necessary to assure quality are included in procurement documents. (CTSN 679,975,1876,1887, !875,3541,3548) 4.2 Written procedures shall include controls, as applicable, for preparation, coment, review, approval, and processing of the following related procurement documents: (CTSN 3559) 1.
Purchase Requisitions 2.
Purchase Orders 3.
Letters ofIntent 4.
Engineering Service Agreements (agreements for engineering, construction, or consultant services)
(ESAs) 5.
Contracts 6.
Specifications 7.
Drawings Collectively, these procedures shall assure that technical and quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with QA Program requirements.
(CTSN 3560)
+
4.3 Consideration of the verification activities to be employed for item or service acceptance should begin during the purchase requisition, ESA, or contract preparation and review stage. Planning of verification activities shall include a review of the established acceptance criteria and identiGed documentation. Veri 6 cation methods u hich may be employed include certincations (certificates of conformance and material certiGcates or test reports), source verification, receiving inspection, and post-installation tests established by UE. Selected verification methods may be indicated as inspections, examinations, tests, or documentation reviews. The extent of the acceptance methods and associated verification activities is a function of the purchased item's or service's complexity and relative safety significance, as well as the supplier's past performance. (CTSN 3572, 3580,3582,3584,3607,3874) 4.4 Acceptance by source verilication should be considered w hen the item or service is vital to Plant safety; or the quality characteristics are difficult to ver,fy aller receipt; or the item or service is complex in design, manufacture, inspection or test. Verification in this sense involves a physical presence to monitor, by observation, designated activities for the purpose of evaluating supplier perfonnance and product acceptability (CTSN 1892,3572,3582,3584) 4.5 Purchase requisitions must be employ ed to initiate the procurernent uf safety-related materials, parts, components, and services u hile ESAs must be used to contract for safety mlated engineering, construction, or consultant services. Contracts, purchase orders generated from purchase requisitions, and ESAs must be employed to procure certain goods and services associated with the nuclear fuel cycle. Purchase requisitions for safety-related materials, parts, components, and services and ESAs for professional services may be initiated by personnel in the Quality Assurance Department; Nuclear Engineering, Nuclear Services, or Licensing and Fuels Department; or the unit stalT. (CTSN 1875) 4-1
SECTION NO. 4 aei c'
E REVISION-19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL I) ATE: 5/97 4.6 The procurement of spare or replacemcv puts for safety-related structures, systems, and components shall be subject to the QA Program controls in effect et the time the order is issuea; and to codes, standus, and technical requirements which are equal to or better than the original requirements or as may be required to reduce the probability for repetition of defects. Procurement document control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to speci6 cations and codes equivalent to those specified originally or those specified by a properly reviewed and approved revision; packaged and transported in a manner to assure the non-degradation of quality during transit; and properly documented to show compliance with applicable specifications, codes, and standards. (CTSN 975, 1876) 4.7 Each item or service to be procured is evaluated by the procurement document originator to determine w hether it perfor ms a safety-related function or involves activities which affect the function of safety-related materials, parts, or components and to appraise the importance of this function to Plant or public safety. For those cases w here it is unclear if an individual piece (part of a safety-related structure, system, component or service) is governed by the OQAP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering and shall classify the safety relationship of the service or questionable component, parts or items of safety-related structures, systems, and components. Evaluations shall be documented for future reference. (CTSN 1876) 4.8 Provisions for the following shall be included in procurement documents as applicable. These provisions may be addressed by invoking a supplier's approved quality program in the procurement document.
1.
The scope of work and basic administrative and technical requirements including drawings, specifications, regulations, special instructions, and applicable codes and industrial standards and procedural requirements identified by titles and revision levels. Procurement documents shall also include special process instructions; identification ofinspection, test and acceptance requirements; and any special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, pacLeging, handling, shipping, and storing. (CTSN 1864, I890,2416,3550,3551,3552) 2.
Requirement that the supplier have an acceptable Quality Assurance Program which implements the appropriate sections and elements of ANSI N45.2-1977 or the ASME code as applicable as establisheJ for the item or service to be supplied. This requirement is not applicable to commercial grade items u hich utilize a supplier's standard or proven design to meet published product descriptions.
(CTSN 1888,1890,3542,3550,3553,42668) 3.
Requirements for supplier surveillance, audit, and inspection including provisions for UE or agent access to facilities and records and for identification of witness and hold points. (CTSN 1890,3550, 3555,3573,3582,3867,3874) 4.
Requirements for extending applicable requirements of UE procurement documents to lower-tier suppliers and subcontractors. These requirements shallinclude right-of-access to subsupplier facilities and records by UE. (CTSN 1890,3542,3550,3554,3555) 5.
Rquirements for soppliers to obtain UE approval of nonconformances to procurement document requirements disposcioned "use-as-is" and " repair" and conditions of their disposition including identification of tho.'s subject to UE approval prior to further processing. (CTSN 3550,3558,3597) 6.
Applicability of 10 CFR 21 reporting requirements. (CTSN 3484) 4-2
SECTION NO. 4 deea b7NIONELECTRIC asy,sios*.
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 7.
Documentation requirements including records to be prepared, maintained, submitted for approval, or made available for review, such as, drawings, specifications, procedures, procurement documents, inspection and test records, personnel and procedural quali0 cations, chemical and physical test results, and instructions for the retention, transfer, and disposition of records. (CTSN 1890,2132,3550,3556, 3574) 8.
Requirements that the supplier furnish documentation which identiDes the purchased item and provides traceability to the procurement requirements met by the item and documentation identifying any procurement requirements which have not been met.
4.9 The originating organization shall perform a documented independent review of procurement documents to assure requirements are correctly stated, inspectable, and controllable and that there are adequate acceptance and rejection criteria. This review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents.
(CTSN 3559,3560,3562,3563) 4.10 Dids or proposals shall be evaluated by the Purchasing Department, the originating organization, the Quality Assurance Department, and the Licensing and Fuels Department to assure conformance to procurement document requirements in the following areas as applicable to the type of procurement as described below:
(CTSN 3563,3564,3567,3568,3569) 1.
Technical. considerations 2.
Quality Assurance requirements 3.
Research and development effort 4.
Suppliers' personnel qualifications 5.
Suppliers' production capability 6.
Suppliers' past performance 7.
Alternates 8.
Exceptions 4.10.1 The Purchasing Department shall initiate and coordinate bid evaluation activities for those proposals received in response to requisitions. The Purchasing Department shall review bids or proposals, except those associated w ith ESAs or nuclear fuel cycle related goods or services, for alternates or exceptions to procurement document requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented. (CTSN 3560) 4.10.2 The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier. They shall also review areas 1 through 3 above for replacement parts or equipment ordered from the original supplier as part of procurement document prepa ation. (CTSN 3560) 4.10.3 1he Quality Assurance Department and the originating organization review areas 4 through 6 above as part of maintaining a supplier on the Quali0ed Supplier List as described in the OQAM, Sections 7.0 and 18.0.
(CTSN 3560) 4.10.4
'ihe Licensing & Fuels Departmer.t shall evaluate bids or proposals for fuel cycle goods or services in the above areas. (CTSN 3560) 4-3
1 SUNIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 4.11 flids or proposals with alternates or exceptions identified in Section 4.10 by the Purchasing Department shall also be evaluated by the originating organization to provide additional assurance that no unacceptable conditions result from such changes. Unacceptable conditions identified ir, bid or proposal evaluations shall be resolved prior to purchase award. (CTSN 3560,3561,3567,3568,3570) 4.12 Letters ofintent may be utilized with suppliers of materials, parts, components, and services for the purpose of reserving schedule space prior to the resolution of the commercial requirements to be included in a purchase order, contract, or ESA. If employed, letters ofintent must normally specify that no safety related activities may begin until an approved purchase order, contract, or ESA is executed. Letters ofintent 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. Ilowever in the event a letter ofintent is issued for the purpose of securing an agreement and thereby allow safety-related work to begin prior to the issuance of such documents, it shall include the applicable quality and technical requirements, as specified by the originating organization.
4.13 The Purchasing Departrnent is responsible for reviewing purchase orders to verify that the technical and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisition, letter ofintent, ESA, or contract shall be by an individual who has approval authority and signifies that the technical and quality review of the document has been completed. Contracts initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility of the Manager, Licensing and Fuels with preparation and negotiation by the Licensing and Fuels Department. Nuclear fuel cycle-related contracts l
and ESAs for professional services shall be executed by the Vice President and Chief Nuclear Officer or another company oflicer in accordance with Nuclear Division and corporate procedures related to agreements or contracts for services. (CTSN 3563) i 4.14 Additions, modifications, exceptions, and other changes to procurement document quality and technical requirements shall require a review equivalent to that of the original document and approval by the 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 (QSL) that apply to a vendor may be revised without concurrence from the originating organization since they are imposed without the knowledge of the originator. (CTSN 975,3543,3548,3563,3575,42587) l 4-4
MEIONELECTRIC
[i, CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 5.
INSTRUCTIONS, PROCEDURES.AND DRAWINGS 5.1 The activities affecting quality associated with the operating phase shall be accomplished and controlled by:
(CTSN 1830,1858,1867,1916,1948,2073,2074,2091,2974) 1.
Preparing procedures, instructions, specifications, drawings or checklists of a type appropriate to the activity and its importance to safety which specify the methods for complying with 10 CFR 50, Appendix B and the Technical Specifications; 2.
Including in these documents quantitative or qualitative acceptance criteria for verifying that an activity has been satisfactorily accomplished; 3.
Itaving responsible personnel approve these documents prior to accomplishing an activity; and 4.
Using approved drawings, procedures, instrections or checklists to accomplish an activity; The degree of control imposed shall be consistent with the relative importance of the activity to safety.
5.2 The Nuclear Division and other responsible functions and departments shall provide written procedures and drawings as required to suppon the Callaway Plant operating phase. These procedures shall prescribe those activities affecting safety-related structures, systems, and components. It is recognized that skills normally possessed by qualified personnel may not require detailed step-by-step delineations in written procedures.
(CTSN 1833,1830) 5.3 The Manager, Callaway Plant shall be responsible for providing specific guidance via Administrative Procedures for the development, review and approval of other Plant operating procedures to govern activities which affect safety or quality consistent with the Technical Specifications. Similar guidance shall be provided for revisions and temporary changes to Plant operating procedures. Procedures which implement the Security Plan and Radiological Emergency Response Plan shall be reviewed no less frequently than every twelve months (in accordance with Technical Specifications). A revision of a procedure may constitute a procedure review.
5.4 he approval, issue and control ofimplementing procedures, manuals and policy shall be prescribed in Administrative Procedures consistent with the requirements of Sections 2,5 and 6.
5.5 Administrative Procedures shall be reviewed by the Qualhy Assurance Department as described in Section 2.6, item 3.
5.6 Maintenance and modification procedures shall be reviewed in accordance with Section 6.2.
5.7 Special process procedures supplied by outside organizations shall be reviewed in accordance with Section 9.6.
5.8 In addition to the procedures identified in Table 13.5-1 of the Callaway-SA FSAR (CALLAWAY PLANT ADMINISTRATIVE PROCEDURES), the OQAP includes procedural coverage in the following areas: design control; design change control; preparation, review, approval, and revision of specifications, drawings, requisitions Engineering Service Agreements, contracts and procedures (instructions); QA indoctrination and training; auditor training; supplier evaluations; receipt and transfer of records; document control; quality program audits; corrective action; inspection; inspection, test and operating status; and special processes.
5.9 Applicable procedures shall be reviewed and revised as necessary as described in Appendix A, Regulatory Guide 1.33 (ANSI N18.7-1976, Section 5.2.15).
5-1
SECTION NO. 6 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 6.
IX)CUMENT CONTROL 6.1 Documents and their revisions which control all activities affecting safety-related structures, systems, and components shall be prepared, reviewed by knowledgeable individuals, and approved by authorized personnel prior to release or issuance in accordance with written approved procedures. (CTSN 1916,1908) 6.2 Divisions, departments, and organizations responsible for OQAP implementing documents shall be required to provide the necessary review and approval for instructions, procedures, specifications, and drawings. Reviews and approvals shall assure that issued documents are adequate, authorized, include proper quality and technical requirements, and are correct for intended use. Individuals or groups responsible for preparing, reviewing, and approving documents and revisions thereto shall be identified in written procedures. Specifically, the QA Department shall review Administrative Procedures as described in Section 2.6; QC personnel shall review maintenance and modification procedures; ' and QC personnel are responsible for the preparation ofinspection procedures and/or checklists to support maintenance and modification activities. Collectively, these reviews by the QA Department and QC personnel determine: (CTSN 1908,1916,1917,2262,4616) 1.
The need for inspection, identification ofinspection personnel, and documentation of inspection results: and 2.
That the necessary inspection requirements, methods, and acceptance criteria have been identified.
6.3 Changes to documents shall be reviewed and approved by the same function, department, group, or organization that performed the original review and approval; however, UE may assume or delegate this responsibility. The reviewing organizations shall 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.
(CTSN 1908,1914,1915,2170) 6.4 Documents relating to the UE OQAP shall be controlled to an extent which considers the document type, its importance to safety, and the intended use of the document. The preparation, review, approval and revision of procedures, instructions and drawings shall adhere to the OQAP.
6.5 The controls governing the issuance of documents shall provide for the availability of documents at the point of use prior to commencing an activity and the prompt transmittal of approved changes for incorporation into subsequent revisions. Measures shall be established to prevent the inadvertent use of superseded documents.
(CTSN 1828,1833,1908,1917) 6.6 Types of documents w hich shall be controlled include the FSAR, specifications, Operating Quality Assurance Manual, procurement documents, procedures, design documents (e.g., calculations, drawings, analyses) including documents related to computer codes, nonconformance reports, as-built drawings, the Callaway Plant Operating Manual, and topical reports.
' Work Requests (WRs) and preventive maintenance requests (PMRs) may contain instructions to workers, flowever, WRs and PMs are not considered " Maintenance procedures" which require QC review. When required, the assignment of inspection, poirts for work authorizing documents is performed by Planning Department personnel based on established criteria.
6-1
SECTION NO. 6 dIMTIONELECTRIC eei REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 6.7 he issuance of controlled documents at the General Of0ce and Callaway Plant is coordinated by the Nuclear Services and the Administration organizations. The Administration organization shall be responsible for assuring the issuance of controlled documents at the Plant Site and to the Nuclear Services Department at the General Office. Nuclear Services shall be responsible for assuring the issuance of controlled documents at the General Office, and for transmittal of documents to the Administration organization for entry into the document 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 identify selected document holders by name and control number. Acknowledgment of receipt of selected documents, incorporation of revisions, and destroying or voiding of superseded documents 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 revisio.1 date of each.
6.9 Procedures shall specify the requirem(nts for the processing and maintenance of records. Procedures shall also be established to control instructions, pmcedures, and drawings governed by the OQAP. These procedural controls shall provide for the prompt transmittal of document revisions to work locations and the removal, destruction, or voiding of obsolete / superseded documents. He unit staff and other UE organizations shall asure thet current documents are distributed to and used at the location where the prescribed activity is performed. It is recognized that, in certain instances, activities are controlled via the communication of documented procedural instructions from a remote location, (i.e., separated from the location where the prescribed activity is being perfonned). Identified, controlled copies of documents shall be used to perform an activity Uncontrolled copies shall be identified. (CTSN 1872,2132,2136,2164) i 6-2
QUmonELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITY ASSURANCEMANUAL DATE: 5/97 l
7.
CONTROL OF PURCilASED MATERIAL, FQUIPMENT AND SERVICES l
l 7.1 Materials, equipment, and services shall conform to procurement documents as prescribed in Section 4.
Provisions shall be established to control activities affecting quality associated with the procurement of material, equipment and services including: (CTSN 1875,3541) 1.
The preparation, review, and change control of procurement documents as described in Section 4 2.
Ilid evaluation and award as described in Section 4 3.
Procurement source selections (CTSN 3565) 4.
Verincation activities (surveillance, inspection, and audit) required by the purchaser 5.
Control of nonconformances as described in Section 15 (CTSN 3597,3576) 6.
Corrective action as described in Section 16 7.
Material, equipment, and service acceptance 8.
Control of quality assurance records (CTSN 2416) 9.
Audits of the procurement program as described in Section 18 7.2 UE shall assure that suppliers providing safety-related materials, equipment, or services are acceptable procurement sources. Provisions shall be made for supplier evaluations w hich assess their capabilities prior to award by: 1) source evaluation; or 2) review for objective evidence of quahty; or 3) a review of supplier history.
When evaluations are performed, the essessment 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 requirements. Suppliers of hardware and services which are manufactured prior to award, considered a commercial grade item, or implemented under the UE OQAP do not require pre-award source evaluation or post-award audits w hich attest to their capability as a procurement source. (CTSN 1891,3564,3565,3596, 3874) 7.3 During Callaway's operating life, procurements may be made from: 1) suppliers judged capable (prior to award) of providing items or services in accordance with procurement document requirements and a quality assurance program appropriate for the item or service procured; 2) suppliers and others in possession of hardware manufactured prior to award and w hose acceptability can be determined by receiving inspection, an examination of quality veri 6 cation documentation, or other suitable means; 3) suppliers of commercial grade items able to be ordered solely on the basis of published product descriptions (catalog information); and 4) outside organizations working under the UE OQAP. Regardless of the basis for the acceptability of the procurement source, prior to the issuance of a purchase order or execution of a contract or ESA, a verincation of the supplier /outside organization's acceptability shall be documented. Except in unusual circurnstances (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 veriGed as an acceptable procurement source for the item or service being procured. Purchase orders may be issued prior to an assessment of suppliers' capability provided a p ohibition on safety-related work is imposed. Such suppliers may be released to begin safety-related work when evaluated to be an acceptable procurement source. (CTSN 2337,2977. 3564,3874) 7-1
MUurouELECTRIC y
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL
- 1) ATE: 5/97 7.4 Code certified material may be obtained from an ASME accredited Material Manufacturer or Material Supplier for repair or replacement applications. Ilowever UE may also obtain Code certified materials from non-ASME accredited Material Manufacturers or Material Suppliers if such Manufacturers or Suppliers are otherwise qualined as stipulated in Sections 4 and 7 of the OQAM. These provision are consistent with ASME Code Interpretation XI 1-83-50R dated May 14,1985.
7.5 Procurement source evaluation and selection involves the Quality Assurance Department and the originating organization. 'ihe evaluation and selection process shall be specified in department procedures and may vary depending on 'hc 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. (CTSN 1891,1894,3564,3565) 7.6 Procurement source selection and evaluations shall consider one or more of the following:(CTSN 3565,3566, 3604) 1.
Experience of users ofidentical or similar products of the prospective supplier. NRC Licensee Contractor and Vendor Inspection Program (LCVIP) reports, ASME Certificates of Authorization (C of A), audit reports, UE records accumulated in previous procurement actions, and UE product-operating experience may be used in this evaluation. Supplier history shall reflect recent capability. Previous favorable quality experience with suppliers may be an adequate basis forjudgments attesting to their capability. When an LCVIP report, an audit report, or an ASME C of A is used to establish a suppliers acceptability as a procurement source, the document shall be identified. (CTSN 3564) 2.
An evaluation of the suppliefs current quality records supported by documented qualitative and quantitative information which can be objectively evaluated. This may include review and evaluation of the suppliefs QA Program, Manual, and Procedures, as appropriate; and responses to questionnaires.
3.
A source evaluation of the suppliers technical and quality capability as determined by a direct evaluation (audit or surveillance) of facilities, personnel and Quality Assurance Program implementation. (CTSN 3564) 4.
For commercial grade items, the procurement source selection should consider one or more of the following:
a.
Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementation of manufacturers 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.
7.7 Procurement source evaluations involve a review of technical and quality assurance considerations. Technical considerations include the design or manufacturing capability and technical ability of suppliers to produce or provide the design, service, item, or component. Quality assurance considerations include one of the previously denned methods of supplier evaluation and a consideration of changes in a supplier's Quality Assurance Program or capabilitics. The measures employed to evaluate a suppliefs continued acceptability as a procun ment mun e (aner the initial source evaluation) are described in Section 18.
7-2
SECTION NO, 7 53UTIONELECTRIC sei ycy,sios, CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 7.8 Organizations participating in the proctament process shall prepare procedures to monitor and evaluate suppliers' performance to procurement document requirements. These procedures shall include provisions for:
- 1) controlling documents generated or processed during activities fulfilling procurement requirements; 2) identifying and processing change information; 3) establishing a method of control and documentation of information exchange with the supplier; and 4) audit or surveillance of supplier activities. (CTSN 1892,3571) 7.9 Depending on the complexity or scope of the item or service, the Purchasing Department and/or the originating organization shall initiate award activities. Meetings or other forms of communication may be held to establish the intent of UE in monitoring and evaluating the supplier's performance, establish an understanding of procurement requirements, and identify supplier activities to be utilized in 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. (CTSN 3572,3573,3580) 7.10 The originating organization shall establish measures for monitoring supplier-generated document submittals against procurement document requirements. Similarly, measures shall be established for reviewing and approving supplier generated documents for use. Changes to procurement documents shall be in accordance with the controls described in Section 4. (CTSN 3571,3574) 7.1 i Supplier monitoring activities may be performed by personnel from Quality Assurance, Nuclear Engineering, Nuclear Services Emergency Preparedness and Organizational Support, Licensing and Fuels, the unit staff, or outside organizations in accordance with plans to perform inspections, examinations or tests. Supplier monitoring activities may include- (rTSN 3565,3584) 1.
Audits of supplier quality assurance program implementation 2.
Monitoring, witnessing, or observing inspections, examinations, and perfonnance tests 3.
Surseillance of manufacturing processes 4.
Audits of supplier records to verify certification validity and the resolution of nonconformances 7.12 To support the control of purchased material, copies of purchase orders and other appropriate procurement documents shall be forwarded to the applicable receiving or acceptance point. Departments receiving or utilizing procured items or services shall establish measures to maintain and control procurement documents until the items or services are received and accepted. These documents shall include purchase orders, drawings and specifications, approved changes, and other related documents. (CTSN 2337) 7.13 Receiving inspection instructions shall be documented. These instructions include specifying inspections or tests of commercial grade items procured from suppliers on the basis of product performance. Should it become necessary to upgrade stocked non-safety related items to specific requirements, inspections, tests, or documentation reviews may be employed to establish the items' acceptability. Documentation shall be generated as a result of UE receiving inspection activities. (CTSN 975,2337,2416) 7.14 Acceptance ofitems and services shall include one or more of the following: (CTSN 975,1891,1892,3608) 1.
Written certifications 2.
Source verification 3.
Receiving inspection 4.
Post-installation test (in addition to one of the above).
7-3
SECTION NO. 7 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL I) ATE: 5/97 7.15 Commercial grade items shall rely on proven design and utilize verification methods by the purchaser, to the extent appropriate to item application. Procedures provide for the acceptance of commercial grade items on one or mon of the following: (CTSN 1892,3565,1876) 1.
Special Tests and Inspections 2.
Survey of Supplier (Commercial Grade) 1 Source Verification 4.
Acceptable Supplier / Item Performance Record Method 4 should not be used alone unless:
The established historical record is based on industry wide performance data that is directly applicable a.
to the item's critical characteristics and the intended safety-related application; and b.
The manufacturer's measures for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).
7.16 Where required by Code, regulation or contract requirement, documentary evidence that items confonn to procurement documents shall be available during receiving inspection or prior to use of such items. Where not precluded by other requirements, documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means ofitem acceptance, verification of the validity of supplier certificates and the effectiveness of the cenification systems shall be conducted at intervals commensurate with the supplier's past quality performance. Certificates ofconformance and compliance shall be required to be signed or accompanied by a signed letter of transmittal. Where acceptance is based 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.
(CTSN 1891,1893,3603,3605,3607) 7.17 Acceptance by receiving inspection shall be utilized as a prime method of verification and may be utilized as the sole means ofitem acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; w hen items are adaptable to standard or automated inspections; and w hen inspections do not require operations uhich could adversely affect the integrity, function, or cleanliness of the item. When other methods are utilized, receiving inspection shall be employed to verify that items have not sustained damage.
(CTSN I876,3606) 7.18 Receiving inspection shall be performed by personnel cenified to ANSI N45.2.6 - 1978,(as clarified in OQAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization. Other unit staff personnel qualified to ANS 3.1 - 1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, extensive modifications, or other special circumstances, receiving inspection may be assigned to an outside organization (s). (CTSN 2483) 7.19 Final acceptance ofitems shall be by Quality Control personnel or designated inspection personnel. The final acceptance of services shall be the responsibility of the originating organization. Acceptance shall be documented. (CTSN 2337) 7-4
SECTION NO. 7 m
REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5l97 7.20 Receiving inspection activities shall include: (CTSN 975,2337) 1.
Verifying that materials, parts, and components, have been identified by tagging or other means; or that they are segregated and controlled in areas separate from the storage facilities for accepted items.
2.
Verifying that items for acceptance have been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documentation.
3.
Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures and calibrated tools, gages and measuring equipment to verify the acceptability ofitems, including those from commercial grade suppliers.
4.
Providing final acceptance aller determining that required verifications are complete and acceptable.
Items determined to be acceptable for use shall be tagged with an accept tag or other means of identification or segregation, and released for storage or use. Conditional acceptance of items by receiving inspection shall be procedurally controlled. (CTSN 2326,2329,2328) 5.
Verifying that received items which do not conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15. (CTSN 2327) 7.21 Acceptance by post installation test may be utilized following one of the preceding acceptance methods.
Post-installation testing shall be used as the prime means of acceptance verification when it is difficult to verify item quality characteristics; the item requires an integrated system checkout or test; or the item cannot demonstrate its ability to perform when not in use. Post-installation test requirements and acceptance documentation shall be established by UE. (CTSN 3608) 7-5
SECTION NO. 8 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITY ASSURANCE MANUAL
- 1) ATE: 5/97 8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 8.1 The identification and control of materials, parts, and components shall be accomplished in accordance with documented procedures and apply to safety-related materials, parts, and components during fabrication, storage, installation or use. Materials, parts, and components identified as nonconforming shall be controlled as described in Section 15. (CTSN 975) 8.2 The identincation and control requirements shall address traceability to associated documents, as appropriate; specification of the degree ofidentification and control necessary; location and method ofidentification to preclude a degradation of the item's functional capability or quality; and proper identification of materials, parts, and components prior to release for manufacturing, shipping, construction, or installation. Materials, parts, and components manufactured or modified by UE shall be controlled and identified during manufacture.
(CTSN 1897,2089,2090,2093,2333,2337) 8.3 Documented procedures shall assure that specifications and other procurement documents include or reference appropriate requirements for the identification and control of materials, parts, and components including partially fabricated assemblies. Procedures shall also specify measures for material control including storing and controlling accepted items; controlling the issuance of accepted items from storage while maintaining item identity; controlling the return to storage ofissued 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. (CTSN 1876,2088) 8.4 Physical identifica Ln shall be employed to the maximum possible extent for relating an item at any point in time to applicabl; design or other pertinent specifying documents including drawings, specifications, purchase orders, manufwturing and inspection documents, nonconformance reports, and physical and chemical mill test reports. PF,sical identificatio" or marking shall not affect the form, fit, or function of the item being identified.
Where r',iysical identification is not employed, physical separation, procedural control, tags, or other means sha. ne utilized. Identification shall be main 6ined on items, or records traceable to items through fabrication, er ction, and installation. When unique traceability is impractical, bulk traceability may be employed consistent
- ith 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 it readily accessible. (CTSN 1895, I896,2318,2331,2333,2337,2346) 8.5 Changing on correcting any marking on a code stamp name plate is prohibited, unless authorized by the manufacture'. whose serial number is applied. (CTSN 2336) 8.6 In the event the identification or traceability of an item is lost, it shall be handled as nonconforming in accordance with Section 15, if the disposition is other than to scrap or to retain for non-safety related applications. (CTSN 1895) i i
81 1
SECTION NO. 9 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 9.
CONTROL OF SPECI AL PROCESSES 9.1 Special processes are fabrications, tests, and final preparation processes which require in-process controls in addition to final inspections to assure quality. Special processes also require the qualification of procedures, techniques, and personnel in accordance with the requirements of applicable codes, standards, specifications, or other special requirements to w hich UE is committed. Specir.1 processes include such activities as welding, heat treating, nondestructive examination, the application of specialized coatings, and chemical cleaning. For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established Codes or standards; the necessary qualifications of personnel, procedures, or equipment shall be defined by Nuclear Engineering. (CTSN 1851,1937,2098) 9.2 Procedures for special processes shall be qualified as part of their approval process, and shall also provide for recording evidence of acceptable accomplishment of the special processes. Personnel qualifications shall be certified and equipment shall be qualified prior to use.
9.3 The responsible Plant Department llead shall assure that personnel performing special processes are qualified and are employing approved procedures. QA audits shall be performed to assure special processes are performed by qualified and certified personnel. Nondestructive examination (NDE) personnel shall be qualified in accordance with procedures established to meet the requirements of the Code Edition and Addenda to which UE is committed at the time the NDE is performed. When non-code NDE is performed, personnel shall be qualified to the version of SNT-TC-I A used to meet UE's current commitment to the ASME B&PV Code, 9A Special process equipment that may require periodic adjustment and whose performance cannot be verified through direct monitoring of appropriate parameters shall be subject to the controls described in Section 12.
9.5 Planning for maintenance shall include evaluation of the use of special processes, equipment and materials in performance of the task, including assessment of potential hazards to personnel and equipment. (CTSN 1857) 9.6 Qualified outside organizations may be employed to perform special processes onsite and shall be required to conform to the requirements described herein. Special process procedures submitted by these organization (s)in accordance with the procurement document requirements shall receive a technical review by the responsible engineering organization and a quality review by the Quality Assurance Department.
9-1
SECTION NO.10 EMMTIONELECTRIC aEylsioNt 1,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL
- 1) ATE: 5/97 10.
INSPECTION 10.1 A program for the inspection of safety-related activities shall be established and executed to verify conformance with applicable documented instructions, procedures, drawings, and specifications. Inspections and monitoring of processes which serve an inspection function shall be performed by personnel qualified to perform assigned tasks and who are independent ofindividuals who perform the activity. (CTSN 1851,1926,1927,2094,2095, 2974,42430,42431) 10.2 Required inservice inspection of structures, systems or components shall be planned and executed. Inspection methods shall be established and executed to verify that the characteristics of an item remain within specified limits.
10.3 Inspection of activities at the Callaway Plant shall be at intervals based on the status and importance of the activities. Guidelines shall be established to indicate the minimum frequency for inspecting maintenance, modification, and special processes activities to provide a basis for subsequent monitoring planning.
(CTSN 1850,1937) 10.4 Nuclear Engineering shall be responsible for assuring the development of preservice and inservice (PSI /ISI) inspection programs; the reference PSI /ISI examination plans for ASME Code Class 1,2, and 3 systems and components including steam generator eddy current examination; the NDE procedures required by the reference plans; and the initial updating of the reference plans and procedures to reflect "as-built" conditions and the technical requirements of the applicable Code Edition and Addenda prior to the issuance of the inservice inspection plans and procedures.
10.5 Nuclear Engineering shall be responsible for assuring the development of the inservice testing program plan for pumps and valves, the test procedures required by this plan, and the securing of consulting services in this area.
In addition Nuclear Engineering shall be responsible for administering and performing the PSI /ISI program and implementing the examination and testing plans developed within the Nuclear Division. They are also responsible for updating the reference plans and NDE procedures subsequent to the issuance of the inservice inspection plans and procedures. The services of an outside organization may be secured to conduct the PSI /ISI examinations. (CTSN 2049) 10.6 An inspection personnel qualification program shall be established to assure inspection activities are being performed by personnel trained and qualified to a capability necessary for performance of the activity. Plant procedures shall prescribe the qualification requirements ofinspection personnel. The Superintendent, Training shall be responsible for providing related technical and quality training appropriate to the certification' qualification of UE personnel. (CTSN 2483,2484,2485) 1 10.7 Quality Control inspection personnel or other unit staff organizations who perform " inspection" activities shall be qualified within their respective areas of responsibility. The qualification of QC inspection personnel shall be defined in three levels of capability as described in ANSI N45.2.6. Other members of the unit staff
]
performing " inspection" activities shall have appropriate experience, training, and retraining to assure i
competence in accordance with ANSI /ANS-3.1. Inspection assignments 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. (CTSN 1851,2079,2263,2479,2480,2481,2482,2483,2484,2485,2994)
I 10-1
SECTION NO,10 ea 7
REVISION:
19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5l97 10.8 Personnel from outside organizations performing QC inspection activities associated with safety-related items at the Callaway Plant shall be certified as required by ANSI N45.2.6. (CTSN 2079,2097,2263,2480,2482, 2483,2484,2485,2994) 10.8.1 Personnel frc m outside organizations or UE personnel who are not members of the unit staff selected to perform other activities associated with safety-related items at the Callaway Plant shall meet one or more of the following for the activities which they are performing:
be certified as required by ANSI N45.2.6, o
meet the education and experience requirements applicable to the position, e
be qualified through UEs " systematic approach to training",
e be qualified through a vendor's training and qualification program, w hich has been approved by UE.
e 10,9 When contractors or vendors are retained to perform work activities or to provide services associated with safety-related items at the Callaway Plant, the qualification ofinspection personnel and the conduct of inspections associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procurement documents. As an example, if a vendor was contracted to conduct eddy current examinations of the Callaway Plant steam generators, then the persons performing the examination would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents. (CTSN 2482,2484,2485) 10.10 Procedures which specify inspection activities shall provide for the follow ing, as required: 1) the inclusion of independent inspection or monitoring of processes w hen required; 2) the identification ofinspection personnel;
- 3) the documentation of inspection results; 4) a description of the method ofinspection including any mandatory hold points; 5) the identification of the characteristics and activities to be inspected; 6) the acceptance and rejection criteria; and 7) specifying the necessary measuring and test equipment. Inspection requirements may be obtained from drawings, instructions, specifications, codes, standards, or regulatory requirements. (CTSN 1930,1931,1935,2073,2075) 10.11 The inspection function shall be conducted in accordance with written approved procedures which specify inspection scope; personnel qualification requirements; and data collection requirements. Inspection or testing, as appropriate, shall be employed as a means of verifying suitable performance subsequent to a component replacement or repair. (CTSN 1928,1929,1973,2039,2979) 10.12 Instructions, procedures, and supporting documentation shall be provided to inspection personnel for use prior to performing inspection activities. Inspection results shall be documented. Procedures shall prescribe the review and approval authority for inspection results. (CTSN 1935,1936) 10.13 Indirect control by monitoring processing methods, equipment, and personnel shall be utilized as a control if inspection of processed items is impossible or disadvantageous. Both inspection and monitoring of processes shall be provided when control is inadequate without both. (CTSN 1932) 10.14 Inspection data shall be analyzed and evaluated to verify completeness of results, achievement of inspection objectives, and operational proficiency of equipment and systems; to identify additional inspection requirements; and to identify necessary changes to the installation inspection procedures. The acceptance of an item shall be documented by authorized personnel. Modification, repair or replacement ofitems performed subsequent to final inspection shall require reinspection or retest to verify acceptability. (CTSN 1934,1973, 2125,2262,42479) 10-2
SECTION NO.11 MSIONEtscraic
.sv,,es, 1,
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 11.
TEST CONTROL 11.1 Testing programs shall be established to demonstrate that safety-related structures, systems, and components will perform satisfactorily in service. Testing programs include such tests as initial startup testing, surveillance tests, ISI pump and valve tests, and other tests, including those associated with failure analysis and the acceptance of purchased material. A test is performance of those steps necessary to determine that systems or components function in accordance with predetermined specifications. (CTSN 1850,1934,2052,3577,2974, 42430,4243I)
.11.2 Provisions shall be established for the performance of surveillance testing to assure that the necessary quality of systems and components is maintained, that facility operations are within the safety limits, and that limiting conditions for operation can be met. The testing frequency shall be as prescribed in the Callaway Plant Technical Speci0 cations. The provisions for surveillance testing shall include the preparation of a surveillance testing schedule (s) which renects the status ofin-plant surveillance tests. Qualified personnel shall perform surveillance tests. (CTSN 1853,1865)
IL3 Appropriate tests shall also be performed subsequent to Plant modifications, maintenance or significant operating procedure changes to conGrm expected results. Tests provide a level ofconfidence in structure, system or component operation or functional acceptability. (CTSN 1851,2053) 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 accordance with Section 7. (CTSN 3577) 11.5 Equipment failure or malfunction analysis testing may also be performed. The causes of malfunctions shall be investigated, evaluated, and recorded. Experience with malfunctioning equipment and similar components shall be reviewed and evaluated to determine w hether a like kind replacement component can be expected to perform its function reliably.
11.6 Testing shall be performed in accordance with written procedures which incorporate or reference the requirements and acceptance limits contained in applicable Callaway Plant Technical Specifications, drawings, instructions, procurement documents, specifications, codes, standards, and regulatory requirements.
(CTSN 1938,2055,2056) 11.7 Administrative procedures, test procedures, or checklists shall include: provisions for assuring all prerequisite conditions are met; test equipment calibration requirements; testing method instructions including hold or witness points; limiting conditions and acceptance / rejection criteria; and data collection and test result approval requirements. (CTSN 1930,1938,2075,2132) 11.8 Test data shall be analyzed and evaluated by qualified individuals or groups to verify completeness of results, achievement of test objectives, and operational pronciency of equipment and systems; to identify additional test requirements; and to identify necessary changes to the installation test procedures. Equipment found to be deficient shall be identified in accordance with Section 14. Surveillance test procedure results u hich fail to meet the requirements and acceptance criteria of Callaway Plant Technical Specifications shall be documented and reviewed in accordance with Section 15. Deficiencies identified as nonconforming shall be processed in accordance with Section 15. (CTSN 1848,1934,1973,2075,2125,42479) l 1.9 Review and approval of tests and experiments not described in the FSAR. shall be conducted as specified in the Callaway Plant Technical Specifkations and 10 CFR 50.59.
Il-1
MLTNIONELECNC CALLAWAY NUCLEAR PLANT OPERATING QUALITY ASSURANCE MANUAL I) ATE: 5/97 11.10 A program shall be established to assure testing activities are performed by personnel trained and qualified to a capability necessary for performance of the activity. Plant procedures and procurement documents shall prescribe the qualification requirements for testing personnel. Provisions may be made for on-the-job training cfindividuals not qualified to the program provided they are supervised or overseen by qualified individuals for the activities being performed. The Superintendent, Training shall be responsible for providing related technical and quality training for UE personnel who perform testing. (CTSN 2039,2481,2482,2483,2484,2485)
I1.11 Personnel within the various UE organizations may perform testing activities including implementing test procedures and the evaluation and reporting of test results. The assignment of Plant testing personnel shall be l
under the direction and control of the Vice President and Chief Nuclear Officer. The qualification of 0C testing personnel shall be delined in three levels of capability as described in ANSI N45.2.6. Other members of the unit staff performing " test:ng" activities shall have appropriate 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 individuals possess comparable or equivalent competence. (CTSN 2263,2479,2480,2482,2483,2484,2485) 11.12 Personnel from outside organizations or UE personnel who are not members of the unit staff selected to perform other testing activities associated with safety-related items at the Callaway Plant shall meet one or more of the following for the activities which they are performing: (CTSN 2263,2480,2482,2483,2484,2485) be certified as required by ANSI N45.2.6, e
meet the education and experience requirements applicable to the position, e
be qualified through UEs " systematic approach to training,"
o be qualified through a vendor's training and qualification program,which has been approved by UE.
e 11.13 When contractors or vendors are retained to perform work activities or to provide services associated with safety-related items at the Callaway Plant, the qualification of testing personnel and the conduct of tests associated with that contracted work activity or service shall meet the requirements stipulated in the applicable procurement documents. As an example, if a vendor were contracted to conduct testing of the main steam line safety valves at the Callaway Plant, then the persons nerforming the testing / valve settings would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents. (CTSN 2483,2484,2485)
Il-2
f SECTION NO.12
$EMTIONELECTRIC iggygSION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 12, CONTROL OF MEASURING AND TEST EQUIPMENT 1
12.1 Measuring and test equipment utilized in activities affecting quality shall be controlled in accordance with written procedures or instructions. The procedures for calibration and control shril address the identification of test equipment, calibration techniques, calibration frenomcies, maintenance control, and storage requirements.
The equipment subject to these controls includes: (1). ATE (portable measuring instruments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related structures, systems, and components); (2) reference standards (primary, secondary, transfer, and working); and (3) pennanently installed process instrumentation (PI). (CTSN 1919,1920,1969,2042,2081,2083,2264) 12.2 Tools, instruments, testing equipment and measuring devices used for measurements, tests, and calibration shall be of the proper range and type; and shall be controlled, calibrated, adjusted and maintained at specified intervals or prior to use to assure the necessary accuracy of calibrated devices. M&TE and reference standards shall be tagged or labeled indicating the date of calibration and the due date for recalibration. (CTSN 1920, I851,2295,2044,2060,2080) 12.3 Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program.
12.4 The calibration and control program established at the Callaway Plant shall assure that M&TE, reference standards, and P1 maintain their required accuracy. The Manager, Callaway Plant is responsible for assuring the program establishment. Program implementation is the responsibility of the appropriate Department lieads.
12.5 M&TE, reference standards, and PI shall be utilized by variuus organizations as required to perform tests or other special operations. Each organization shall be responsible for assuring that the M&TE or reference standards it uses have been calibrated. Outside organizations using M&TE or reference standards at the Callaway Plant in activities affecting quality shall be required to implement calibration and control measures consistent with the applicable requirements of this section. Vendors activities performed offsite, other than calibration sers ices for Callaway Plant M&TE or PI, do not need to meet the requirements ofitem 8 and 9 of OQAM Section 12.6 unless specified in procurement documents. Vendor-provided calibration services for Callaway Plant M&TE or P1 are required to be consistent with the requirements ofitem 8 and 9 of OQAM Section 12.6. Other UE organizations (e.g. relay testing, battery testing) using M&TE or reference standards at the Callaway Plant in activities affecting quality shall be required to implement a calibration and control program consistent with the requirements described herein, or control their activities relating to M&TE or reference standards via the Callaway Plant calibration and control program. (CTSN 1920,2084) 12.6 The calibration and control program shall provide for: (CTSN 2082) 1.
The assignment of specific calibration intervals, calibration procedures 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 maintained to permit a determination of calibration intervals. A calibration shall be performed when the accuracy is suspect. (CTSN 1923) 2.
The unique identification ofitems.
3.
The traceability to calibration test data.
4.
The traccability of reference standards and thereby M&TE and Pl. to nationally recognized standards and the periodic revalidation of reference standards.
12-1
SECTION NO. i2 53UIONELECTRIC acy,siOxt i,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 5.
The maintenance of records which indicate the status of each item, maintenance history, calibration results, anomalies, and most recent and next scheduled calibration dates. A recall system shall be established to assure that calibration intervals are not exceeded.
6.
The maintenance and control 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.
8.
M&TE shall be calibrated from reference standards with an accuracy ratio of at least four-to-one (Reference standard to MATE). Calibration accuracy ratios ofless 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 availabic. The basis of acceptance in these cases shall be documented 9.
M&TE used for calibrating Plant Pl shall have calibration ranges, precisions, and accuracies such that the Pl can be calibrated and maintained to achieve its specified accuracy. PI shall be calibrated from M&TE with an accuracy ratio of at least two-to-one (M&TE to PI). Calibration accuracy ratios ofless than 2.0 but equal to or better than 1.0 shall be acceptable when equipment to meet specilled requirements is not commercially available. The basis of acceptance in these cases shall be documented.
12.7 Calibration shall be performed against certified equipment or reference standards having known relationships to nationally recognized standards. Where no national standard exists, provisions shall be established to document the basis for calibration. Calibration and control measures shall not apply to rulers, tape measures, levels, and other devices when normal commercial practice affords adequate accuracy.
12.8 M&TE and reference standards found to be out of calibration shall require an investigation to evaluate the validity of previous measuring, test, inspection, and calibration results and the acceptability of impacted items.
Insestigations shall evaluate the necessity of repeating original measurements, inspections, tests, or calibrations to establish the acceptability of such items. When the calibration history of an item shows it to be consistently out of calibration, the item shall be repaired, replaced, or tne calibration interval modified. (CTSN 2044) 12-2
SECTION NO.13 eea%7NIONEtscraic
,,,,, 0, *.
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL I) ATE: 5/97 U.
IIANDLING, STORAGE, AND SillPPING 13.1 Safety-related items including safety-related parts of structures, systems, and components and related consumables shall be handled, stored, shipped, cleaned, and preserved in accordance with procedures, instructions or drawings, to assure that the quality ofitems is preserved from fabrication until incorporation in the Callaway Plant. The procedures shall also establish responsibilities for determining applicable requirements for packaging, shipping, receiving, storage, and handling activities. (CTSN 975,2093,2293,2417) 13.2 Generic procedures or instructions shall be pretored for application to these activities; however, detailed procedures or instructions shall be prepared for the handling, cleaning, storing, maintaining while stored, or shipping of certain items and types of equipment or material. (CTSN 2293,2349,2416,41668) 13.3 Applicable manufacturer instructions and recommendations, or procurement requirements shall be reviewed and invoked in governing procedures when determined appropriate based on an engineering review. Deviations which relax manufacturer's recommendations shall involve an engineering evaluation. This may be appropriate when unrealistic requirements are recommended and such recommendations are not reasonably necessary to preclude equipment degradation. (CTSN 2354,2105) 13.4 The requirements for activities described in this Section shall be divided into levels with respect to protective measures to prevent damage, deterioration, or contamination ofitems. These levels are based upon the important physical characteristics and not the important functional characteristics of the item with respect to safety, reliability, and operation. The specific environmental, special measures or other conditions applicable to each level shall be described in implementing procedures. (CTSN 2416) 13.5 The Superintendent, Maintenance shall establish an inspection program for Plant material handling equipment that provides for routine maintenance and inspection in accordance with documented procedures which specify acceptance criteria. Routine inspections shall determine the acceptability of equipment and rigging. Routine inspections shall be supplemented by nondestructive examinations and proof tests as delineated in procedures for items requiring special handling. Personnel performing nondestructive examination and proof testing shall be qualified.
13.6 Procedures shall be prepared for items that require special handling and shall be available prior to the time items are to be handled. Items not specifically addressed by procedures shall be handled in accordance with sound material handling practice. Fuel assemblies, w hich require unique equipment and handling, shall be handled under the direction of a Licensed Senior Reactor Operator during core alterations. Other material handling activities may involve personnel from various Plant organizations. Operators of special handling and lifting equipment shall be experienced or trained in the use of equipment. (CTSN 2325,2356,2416,2984) 13.7 Procurement documents or procedures shall address packaging requirements which afford protection from the possible degradation of quality during shipping, handling, or storing. The packaging protection 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 ofitems. (CTSN 2416,2304) 13.8 Measures shall also be established to control the shipping oflicensed radioactive materials in accordance with 10 CFR 71.
13 1
i i
SECTION NO.13 i
REVISION:
19 CALLAWAY NUCLEAR PLANT j
OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 13.9 Procedures shall provide instructions for the storage of materials and equipment to minimize the possibility of damage from the time an item is stored following receiving inspection, until the time the item is removed from storage and placed in its final location. Periodic inspections shall be performed to assure that storage areas are being properly maintained. Material and equipment shall be placed in a storage level commensurate with the protection level of items. The various levels of storage shall correspond to prescribed environmental conditions which are procedurally defined. (CTSN 2341,2981,2984) 13-2
55UnionEtscraic CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 14.
INSPECTION, TEST, AND OPERATING STATUS 14.1 Safety-related items that are received, stored or installed at the Callaway Plant shall be identified and controlled in accordance with documented procedures.
14.2 Items received at or installed in the Plant shall be identified in accordance with procedures as to their status regarding required inspections and tests before the items are stored, issued or operated. Prior to storage or installation, items shall be identified by means of stamps, tags, labels, routing cards, segregation, or other means traceable to manufacturers' and receiving inspection documentation. In the event traceability is not available, the item (s) shall be considered nonconforming and handled in accordance with Section 15, if the disposition is other than to scrap or retain for non-safety related applications. (CTSN 1847,2116,2331) 14.3 Plant procedures shall provide instructions relating to the manner ofindicating the operational status of safety-related structures, systems, and components, including temporary modifications, and shall require independent verifications, where appropriate, to assure necessary measures, such as tagging equipment, have been implemented correctly. These procedures shall address measures for the release and control of equipment during periods of maintenance; thereby maintaining personnel and reactor safety and avoiding the unauthorized operation of equipment. Equipment and systems in a controlled status to prevent unauthorized operation, shall be identified. (CTSN 1841,1842,1844) 14.4 Plant procedures shall establish controls to identify the status ofinspection and test activities associated with maintenance, repair, modification, refueling, inservice inspection, and instrumentation and control system calibration and testing The Technical Specifications establish the status required for safe Plant operation, including provisions for periodic and non-periodic tests and inspections of various structures, systems, and components. Periodic tests may be operational tests or tests following maintenance while non-periodic tests may be made following repairs or modifications. (CTSN 972, I844,1846,1847, I851) 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 requirements of the Technical Specifications. In cases where required documentary evidence is not available with respect to whether an item has satisfactorily passed required inspections and tests, the associated equipment or materials i
must be considered nonconforming in accordance with Section 15. Except in the case of temporary changes (non-intent changes) which are allowed by the Technical Specifications and which are administratively controlled, any deviations from procedural requirements shall be subject to the original or equivalent review and approval controls. (CTSN 1848) l i
14-1 5
l SECTION NO.15 m
REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 15.
NONCONFORMING M ATERI AL, PARTS, OR COMPONENTS 15.1 Material nonconformances include material denciencies (including inoperative and malfunctioning structures, systems, and components). Material nonconformances identified under the UE OQAP shall be controlled to prevent the inadvertent use of material, parts, or components which are defective or of indeterminate quality and to identify documentation inadequacies. Measures shall be established regarding identification, documentation, l
status control, disposition, and noti 0 cation of affected organizations. (CTSN 1848,1861,1862,1870,1907, 2045,2112) 15.2 Under the UE OQAP, Nonconforming Material Reports (NMRs), nonconformance logs, or other administrative controls shall be employed to identify and control nonconformances. Nonconformance logs may be employed to control deficiencies of a minor nature or to control documentation de0ciencies both of which can be corrected by bringing the deficiency into compliance with the original requirements. Material nonconformances shall be controlled, as appropriate, by documentation, tagging, marking, logging, or physical segregation. The programs describing the administrative nonconformance controls shall delineate the methods ofidentifying corrective action to be taken for a nonconforming item or series of nonconforming items. Until suitable documentary evidence is available to show the equipment or material is in conformance, affected systems shall be considered inoperable and reliance shall not be placed on such systems to falfill their intended safety function. (CTSN 1848,1876,1903,1907,2328,2334,3600) 15.3 Plant and other UE organization's procedures shall prescribe measures for the control and disposition of UE purchased items and services identified by outside organizations as nonconforming. Procurement documents shall specify those nonconformances to be submitted to UE for approval of the recommended disposition. As specified in procurement documents, actions taken in response to these nonconformances shall be documented and forwarded to UE along with the hardware and accompanying quality verification documentation. Nuclear Engineering shall be responsible for assuring the processing of supplier-recommended dispositions for Plant-initiated procurements. Similarly, other UE or outside organizations shall approve or be requested to provide a technical evaluation regarding supplier-recommended dispositions of nonconfonnances regarding procurements they initiate. (CTSN 1906,3558,3598,3599,3600) 15.4 Material nonconformances shall be processed in accordance with documented procedures and shall identify the specifics of the nonconformance stating the particular drawing, snecificatian or a$er requirement; shall record the disposition; and shall register the signature of an approval authority. Procedures shall prescribe the individuals or groups assigned the responsibility and authority to approve and verify the implementation of the disposition of material nonconformance. (CTSN 1904, 1905,1907) 15.5 Material nonconformance disposition categories shall include: (CTSN 1907,2334)
- 1. "Use-as-is" or " acceptable"(including conditional releases)
- 2. " Reject" or "not acceptable, scrap, or retum 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 conditionally released in accordance with documented procedures. An approved disposition of a nonconformance which allow s a reduction in the requirements of a safety-related structure, system, or component, shall be treated as a design change subject to the controls prescribed in Section 3.
15-1
SECTION NO.15 EUniouELECTRIC
- acyisios, CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 15.6 Nuclear Engineering shall be responsible for approving material nonconformance dispositions of"use 3 is" and
" repair". Licensing and Fuels shall be responsible for approving material nonconformance dispositions of "use-as-is" and " repair" on nuclear fuel which are generated prior to the arrival of such fuel at the Callaway Plant. Regarding material nonconformances identified on-site, QC personnel shall be responsible for verification that approved dispositions have been implemented and for the final sign-oft. (CTSN 1848,1905, 1907,2335) 15.7 Nonconformance documents which record defects in basic components shall be reviewed for reporting applicability under 10CFR21 and other Federal reporting requirements. Significant nonconfonning conditions involving a defect or material noncompliance in a receipt accepted component or a service w hich has commenced which could create a substantial safety hazard shall be reported to the Nuclear Regulatory Commission pursuant to the requirements of 10CFR21. (CTSN 1862) 15.8 Material nonconformances which would impact the conduct of. te" 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 sul, system with outstanding material nonconfonnances shall consider the nature of the nonconfonnance, its effect on test results, and the need for supplemental tests or inspections after correction of the nonconformance. The evaluations shall be documented. (CTSN 1906) 15.9 Repaired and reworked items shall be reinspected or tested. Measures may be established to conditionally release nonconforming items w hose disposition is pending, provided that an evaluation indicates that further work or activity will not contribute adversely to the material nonconformance or preclude identification and correction. (CTSN 1848,1904,1906,2053,2328,2332) 15.10 Material nonconformance summaries shall be prepared and analyzed for potential adverse quality trends semiannually in accordance with Section 16 15-2
SECTION NO.16 eei CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL o g g: 519 7 16.
CORRECTIVE ACTION 16.1 Measures shall be established to assure that conditions adverse to quality are promptly identified, reported, and corrected. Such measures shall be established in a program or programs which are proceduralized. These procedures, as a minimum, shall: (CTSN 1870,1871,1903,2970,2973,2978,3599,3600.42244) 1.
Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.
2.
Define responsibility for verifying that remedial action was taken for conditions adverse to quality.
3.
Define responsibilities for determination of conditions adverse to quality which are significant.
Significant conditions adverse to quality will require both remedial action and action to prevent recun ence.
4.
Define responsibility for performing root cause evaluation, determining necessary actions to prevent recurrence, implementing those actions and verifying comple' ion of those actions for significant conditions adverse to quality.
5.
Provide a method for documenting the identification of conditions adverse to quality. This documentation shall also include the root cause or causes and the action implemented to prevent recurrence for significant conditions adverse to quality.
6.
Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct address, distribution of copies, el:ctronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.
7.
Provide methods for submitting reports required by external agencies concerning conditions adverse to quality.
8.
Provide for developing and analyzing trends on at least a semiannual basis. Trending of conditions adverse to quality identified at suppliers' facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12. (CTSN 1800) 16 2 Conditions adverse to quality which are classified as nonconformances shall be controlled in accordance with the additional requirements described in OQAM, Section 15.
16.3 Conditions adverse to quality which impede the implementation or reduce the effectiveness of the Operating QA Program shall be considered significant conditions adverse to quality. Significant conditions adverse to quality may include, but are not limited to, noncompliance with procedural requirements which impact nuclear or personnel safety; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies identified in the OQAP; recurring conditions for which past corrective action has been ineffective; and managerial controls which could result in the failure of a plant system to perform it's intended function.
Examples of such conditions include those which match the descriptions in Sections 1.26.l.7.f, g, h, I, m (potential hazards to nuclear safety) of this OQAM and National Pollutant Discharge Elimination System (NPDES) violations.
l 16-1
l
/
P3UnionELECTRIC
[,
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 16A Conditions adverse to quality which involve defects in basic components shall be revievied for reporting applicability under 10CFR21 and other Federal reporting requirements. Reportable colditions adverse to quality r.re classified as significant.
16.5 The nature of the condition adverse to quality may be such that remedial actions must be taken immediately, vhereas development and implementation of corrective action to preclude recurrence may take substantially loager.
16.6 Nuclear Engineering personnel shall review conditions adverse to quality which involve design deficiencies or which involve recommending design changes as corrective action. Licensing and Fuels should review conditions adverse to quality for fuel-related issues. The ORC shall review significant conditions adverse to quality. (CTSN 1871,2171,2172) 16.7 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action.
The closure of corrective action documents shall be accomplished as promptly as practicable after the corrective action taken has been verified. Verification may be accomplished through direct observations, written communications, re-audit, surveillances, or other appropriate means. (CTSN 3870) 16.8 Copies of completed corrective action documents shall be available for management review (hard copy or electronic media). The Quality Assurance Department shall periodically review corrective action docurnents and identify significant conditions. Summaries of significant conditions adverse to quality shall be submitted to the NSRil and appropriate levels of management. (CTSN 1871) 16.9 Corrective action documents shall be reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends. Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trends through routine audit and surd!!ance activities.
The results of these assessments shall be reported to management. (CTSN 1800)
~
16-2
SECTION NO.17 REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL
- 1) ATE: 5/97 17.
QUALITY ASSURANCE RECORDS 17.1 Quality assurance record systems governing the collection, storage, and maintenance of records shall be established by UE. They shall apply to records associated with startup testing, operation, maintenance, repair, refueling, and modi 0 cation of safety-related structures, systems, and components at the Callaway lant.
p (CTSN 1851,2126,2127,2130,2173. 3002) 17.2 During the operating phas% quality assurance records shall be maintained to furnish documentary evidence of the quality ofitems and activ@ affecting quality. Applicable design specifications, procurement documents, test procedures, operational procedures or other documents shall specify the quality assurance records to be generated by, supplied to, or held by UE. Documents shall be cons:dered quality assurance records when completed. Records may be maintained for varying periods and shah be identined as lifetime or nonpermanent records in that a lifetime or Gnite retention peEnd.ha!! be specified. Records shall provide suHicient information to pennit identification to the item or activity to which it app'ies, and be retrievable.
(CTSN 1851,2128,2132. 2133,2137,2138,2173) 17.3 Quality assurance records include, but are not limited to, operating logs; maintenance and modiGeation procedures and inspection results; reportable occurrences; results of reviews; ORC meeting minutes; inspections, tests, audits and material analyses; qualification of personnel, procedures, and equipment; and other documentation including drawigs, specifications, procurement documents, nonconformance documentation, corrective action documents, calibration procedures and results, and the results of monitoring work performance (e.g., surveillance). (CTSN 2140,2258,2259,2337,2364,3002,40635) 17.4 Inspection and test records shall contain the following as a minimum: (CTSN 1936) 1.
A description of the type of observation 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 deliciencies 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 delis cred from A/E's, NSSS suppliers, fuel fabricators, constructors, or others. Records maintained by an outside organization prior to and subsequent to final transfer are required to be accessible to UE. Records generated internally shall be processed in a timely manner in accordance with documented procedures.
17.6 Record systems shall be established by the Administration organization for the Nuclear Division and shall be controlled in accordance with written procedures. The implementing procedures shall address records administratiot'; receipt of records; storage, preservation and safekeeping of records; record retrieval; and the disposition of ords. 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 lant. (CTSN 2129,2130,2136,2145) p 17-1
l SECTION NO.17 ea 7
REVISION-19 CALLAWAY NUCLEAR Pl. ANT OPERATING QUALITYASSURANCE MANUAL
() ATE: 5/97 17.7 De requirements regarding hard-copy records administration shall require that quality assurance records be listed in an index. The index shall be established prior to the receipt of records and shall indicate the location of l
records. Microfilm or optical disk records shall be controlled as indicated in UE's commitment to ANSI N45.2.9 as stated in Appendix A. The distributing and handling of records, the correcting or st.pplementing of quality assurance records, and specifying the retention period of record types shall be delineated in written procedures. The retention period of records generated prior to commercial operation shall begin on ' December 19,1984; the date of commercial operation. (CTSN 2135,2149,2150) 17.8 The requirements regarding receipt of records Gall define the requirements for the receipt of documentation generated by others during the operation of the Callaway Plant. These requirements shall assure that records are submitted and that designated authorities are responsible for orgrnizing and implementing a system of records receipt control. The records' receipt control shall permit an assessment of the status of records during the receiving process. (CTSN 2145,2148) 17,9 The requirements regarding storage, preservation, and safekeeping of records shall establish storage requirements for the maintenance, preservation, and protection of quality assurance records. These requirements shall include methods for maintaining control of, access to, and accountability for records; storing records in a manner to preclude deterioration; and providing record storage facilities w hich protect contents from possible destruction by causes such as fire. An attemative 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. (CTSN 2150,2151,2153,2155) 17.10 Record storage systems shall provide for an accurate retrieval ofinformation without undue delay. Those records maintained by an outside organization shall be required to be accessible to the buyer or UE; in the case oflifetime records for the life of the items involved, or for designated retention times for nonpermanent records.
(CTSN 2157) 17.11 Record disposition practices shall establish requirements for the transfer of records from others to UE. Upon final transfer, records shall be inventoried against any transmittal forms and processed in accordance with written procedures. Nonpermanent records shall be retained for the specified retention period; after the specified retention period they are no longer required to be maintained as records. (CTSN 2160)
' Callaway was declared available for unrestricted loading by the UE Load Dispatcher on December 19,1984. The PSC Commercial Operation date is April 9,1985. The PM and EQ programs use the PSC date. Refer to UO 86-107, 17-2
SECTION NOo 18
[idJNIONEL,ECTRIC ae 7
acy,sios.
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5/97 18.
AUDITS 18.1 A comprehensive audit program shall be established and implemented by UE to verify internal and external quality activities' compliance with the OQAP. The audit program shall assure that all applicable elements of the Program have been developed, documented, and are being effectively implemented and shall provide for the reporting and review of audit results by management. The audit system is described in manuals and procedures.
Nonconformances and program deficiencies shall be identified and cor. :tive action shall be initiated and l
verified. See Section 3.14 for a specific audit topic. (CTSN 2037,2186,2188,2978,2988,3865,3867,3883, 2180,3869,41639) 18.2 The UE audit system shall include the performance of audits and surveillances by the Quality Assurance (QA)
Department. Audits determine, through investigution, the adequacy of and adherence to established procedures, instructions, specifications, codes, and other applicable contractual and licensing requirements and the effectiveness ofimplementation. Surveillances involve the perkdic or continuous monitoring of the operation or performance of a supplier, item, component, or system. Surveillance in this audit sense should not be confused with inspections for the purpose of process control or oroduct acceptance or with requirements relating to test, calibration or inspection to assure that the necessary quah:v of systems and components is maintained, that facility operations are within the safety limits, and that limiting conditions of operations are being met (surveillance tests). QA personnel performing surveillances should be familiar with the area to be surveilled and the applicable implementing procedure (s) governing surveillances. Surveillances may also be performed by personnel from other organizations, but these require no unique personnel qualifications or cedfications (except when performed for product acceptance). See Sections 10.6,10.7,10.8,11.10,11.1.1,11.12, and 18.4.
(CTSN 1800,2037,2245) 18.3 The Manager, Quality Assurance shall establish a program which provides for the qualification and training of Q'. Department audit and surveillance personnel Audits shall be directed by an Audit Team Leader (ATL) wrie is 0 ertified Lead Auditor. A Lead Auditor is an individual certified as qualified to direct an audit, perforte a audit, report audit findings, and to evaluate corrective action. Other personnel may assist Lead Auditors in the conduct of audits; namely, technical specialists, management representatives, auditors and other Lead Auditors. The persons having direct responsibility for performance of the activities being audited shall not be involved in the selection of the audit team. Personnel selected for QA auditing or surveillance assignments shall have training or experience commensurate with the scope, complexity, or special nature of the activities to be reviewed or investigated and shall have no direct responsibility for the area being evaluated. The QA personnel training program shall provide general orientation and specific training which develop competence for performing audits or surseillances. Training records shall provide a history of QA personnel training, evaluations, qualification, certifications, and retraining. (CTSN 1818,2037,2244,2245,2247,2248,2250, 2252,2253,2254,2255,2257,2968,3001,3866,3877,3892,40635) 18.4 QA Department personnel who perform audit and surveillance activities shall be qualified in accordance with the requirements prescribed in QA Department procedures. Lead Auditor qualification requirements shall include education or professional status, previous work experience or training, training received through UE, on-the-job performance and participation in surveillances or audits as an auditor, a qualification examination, and other factors applicable to auditing not defined by procedure. The qualification certification of Lead Auditors shall be based on an evaluation of these factors by the Manager, Quality Assurant The maintenance of proficiency by Lead Auditors shall be accomplished by active participation in the audit process; a review of program, codes, standards, procedures and other document revisions related to the OQAP; or participation in training programs. The Manager, Quality Assurance shall provide for annual assessments of each Lead Auditor to determine proficiency. As long as a Lead Auditor is performing satisfactorily and is maintaining proficiency, there is no limit on the period of certification. Ilowever if at anytime the Lead Auditor's performance is evaluated as being unacceptable, Lead Auditor certification shall be rescinded. In addition the failure to 18-1 1
SECTION NO.18 ase REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL
- 1) ATE: 5/97 maintain proficiency for a period of two years or more shall be basis for Lead Auditor certification revocation.
If certifict. tion is rescinded or revoked, requalification shall be required prior to recertification. (CTSN 2244, 2245,2246,2247,2248,2249,2250,2251,2252,2253,2254,2257,2259,2969,3866,40862) 18.5 The Manager, Quality Assurance shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Quality Assurance has sufficient authority and organizational freedom to schedule and perform both internal and external audits. lie 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 Vice President and Chief Nuclear Officer. (CTSN 3865,1790) 18.6 The audit system shall include internal and external audits. The system shall be planned, documented, and conducted to assure coverage of the applicable elements of the OQAP, and overall coordination and scheduling of audit activities. Audit results shall be periodically reviewed by the QA Department for quality trends and results repcited to the appropriate management. The Manager, Quality Assurance shall monitor the OQAP audit program to assure audits are being accomplished in accordance with the requirements described herein and for overall Program effectiveness. The NSRIl shall selectively review audit reports of onsite audits. The NSRB shall also puriodically review the onsite audit program as developed by the QA Department, to assure that audits are bung per:ormed in accordance with the OQAP. Appropriate levels of management shall be provided copies ofinternal and external audit reports. (CTSN 1790,1799,1800,3871) 18.7 Intcmal nudits shall be conducted by the Q A Department and shall be performed with a frequency cimmensumte with their safety significance. An audit of safety-related functions shall be completed in acordance with formal audit schedules within a period of two (2) years. Each element of the OQAP, such as design control and document control, and each awa of Plant operations shall be audited. (CTSN 1792,1816, 2188,3873) 18.8 Supplementary to the biennial requirements to audit safety-related functions, audits of Unit activities (listed below) SilALL be: (CTSN 2666,2681,2847,3873,41777) performed under the cognizance of the NSRB, and e
conducted on a perfonnance based frequency by the QA Department, not to exceed 24 months e
a) ne conformance of Unit operation to provisions contained within the Technical Specifications and applicable license conditions; b) The performance, training and qualifications of the entire Unit staff; c) The results of actions taken to correct deficiencies occurring in Unit equipment, structures, systems or method of operation that affect nuclear safety; d) The perfomtance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B,10CFR Part 50; c) The Fire Protection equipment, programmatic controls, and implementing procedures utilizing either a qualified o!Tsite licensee Fire Protection Engineer or an outside independent Fire Protection Consultant (non-Union Electric). Ilowever, an outside independent Fire Protection Consultant (non-Union Electric)
SilALL be used at least ev:ry third year.
f) The Radiological Environmental Monitoring Program and the results thereof; g) The OFFSITE DOSE CALCULATION MANUAL and implementing procedures; 18-2
$NNIONELECTRIC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL I) ATE: 5l97 h) The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wastes; i) The performance of activities required by the Quality Assurance Program for efnuent and environmental monitoring; and j) Any other area of Unit operation considered appropriate by the NSRB or the Vice President and Chief Nuclear Officer.
18.8.1 In addition to audits conducted under the cognizance of the NSRB, the following areas shall be reviewed or audited per the frequency specified in applicable regulations:
o Special Nuclear Material Accountability program
=> Radiological Protection program
=> Security program
=> Fitness-For-Duty program
=> Radiological Emergency Response Plan 18.9 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements are properly implemented. (CTSN 1799,1800,3871) 18.10 External audits shall be conducted by or for the QA Department as a method for the evaluation of procurement sources and as a post-award source verification of conformance to procurement documents. Audits conducted by other organizations (with similar orders with the same supplier), including other utilities or A/E's, may be employed as a means of post-award source verification in lieu of UE performed audits and may not necessarily audit specific items furnished to UE. These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted in accordance with this OQAM and QA Department procedures. Commercial grade items do not require pre-or post-award audits. Similarly, items which are relatively simple and standard in design and manufacture may not require supplier qualification or post-award audits to assure their quality. (CTSN 3577,3584,3596) 18.11 Applicable elements of suppliers' quality assurance programs shall be audited (post-award) on a triennial basis.
Audits generally should be initiated w hen 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 requirements. In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the QA Department that the results of mini-audits performed during source verification and source surveillance activities confirm the adequacy and implementation of the supplier's QA Program. (CTSN 1780, 3565,3596.3878,3872) 18.12 Supplementary to audits, annual evaluations of suppliers shall be performed which take into account, as applicable: 1) the review of supplier furnished documents such as certificates of conformance, nonconformance notices, and corrective actions; 2) results of previous source verifications, audits, and receiving inspections: 3) operating experience ofidentical or similar products furnished by the same supplier; and 4) results of audits from other sources. (CTSN 3565,3566,3596) 18-3
I EEUniouELECMC N,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 18.13 Audits shall also be conducted when: 1) significant changes are made in functional areas of the Quality Assurance Program such as significant reorganization or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assurance Program; or 3) w hen a systematic, independent assessment of Program effectiveness is considered necessary; or 4) when it is necessary to verify implementation of required corrective action. (CTSN 3565,3872,3874,3883) 18.14 Audits shall be conducted using written plans in accordance with QA Department procedures. The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for quality-related practices, procedures, and instructions to determine the effectiveness of the implementation of the OQAP and compliance with 10 CFR 50, Appendix 13. The audit plan shall identify the audit scope, the requirements, the activities to be audited, organizations to be notified, the applicable documents, the schedule, and the written procedures or checklists as appropriate. The audit plan and any necessary reference documents shall be avr.ilable to the audit team members. (CTSN 3876,3878,3881,3889) 18.15 An audit team consists of one or more auditors. A Lead Auditor shall be appointed Audit Team Leader. The Audit Team Leader shall be responsible for the written plans, checklists, team orientation, audit notification, pre-audit conference, audit performance, post-audit conference, reporting, records, and follow-up activity to l
assure corrective action. (CTSN 3877,3889)
The audited organization should be informed of adverse findings. Agreement or disagreement with a finding may be expressed in the response from the audited organization. (refer to Appendix A, Subsection 4.3.2.5 of ANSI N45.2.12)
Any adverse findings shall be reported in a post-audit conference with team members and the audited organization, unless the post-audit conference is waived by the management of the audited organization. (refer to Appendix A, Section 4.3.3 of ANSI N45.2.12) 18.15.1 Formal audit reports shall be prepared and submitted within 30 days after the post-audit conference (or last day of the audit, whichever is later) to:
the audited organization for internal audits conducted in accordance with the Sections described herein, e
and specifically, the Vice President and Chief Nuclear Officer for audits conducted under the cognizance of e
the NSRil in accordance with Section 18.8.
18-4
APPENDIX A REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 OOAM CONFORM ANCE TO APPLICAHLE NRC REGULATORY GUIDES This Appendix briefly discusses the extent to which Union Electric's Operating Quality Assurance Program (OQAP) conforms to NRC published Regulatory Guides for the Callaway Plant. All statements within the Regulatory Position Section (C) of the Regulatory Guides are considered requirements unless a specific exception or clarification has been proposed by Union Electric and accepted by the NRC. This is true regardless of the qualifier (i.e., "shall" or "should")
which prefaces the statement. Unless further qualiGed by a statement within the corresponding Regulatory Guide, ANSI /ANS Standards "shall" statements denote requirements while "should" statements denote recommendations.
Clarifications, alternatives, and exceptions to these Regulatory Guides are identified herein. Union Electric's position on other Regulatory Guides is given in Appendix 3 A of the Callaway-SA and Callaway-SP Final Safety Analysis Reports (FSARs).
In each of the ANSI standards referenced by one of the listed Regulatory Guides, other documents (i.e. other standards, codes, regulations or appendices) required to be included as a part of the standard are either 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 referenced within a standard, it is understood that UE shall comply with the referenced section as clariGed.
r---------------------------------
1 i REGULATORY GUIDE I.8 REVISION 2 DATED 4/87 i
L_________________________________________________________________J Qualification and Training of personnel for Nuclear Power Plants (Endorses ANSI /ANS 3.1-1981 for Shift Supervisor (Section 4.3.1.1), Senior Operator (Section 4.3.1.2), Licensed Operators (Section 4.5.1.2), Shift Technical Advisor (Section 4.4.8), and Radiation Protection (Section 4.4.4) only, and ANSI /A'NS 18.1-1971 for all other positions).
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications and exceptions:
Revision I, dated 9/75, applies to the position of Radiation Protection Manager only, in accordance with the Callaway Plant Technical Secifications.
The experience, training, and education requirements for the positions of Shift Supervisor, Operating Supervisor, and Reactor Operator, and personnel fulfilling the duties of Shift Technical Advisor shall meet or exceed the requirements and recommendations of ANS!!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 qualitications 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 w ere not required to be certified.
A-1 i
APPENDIX A 53UTIONELECTRIC yevisiost i,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 UE may use additional Union Electric employees or contract personnel to augment the unit staff. These groups include, but are not limited to UE personnel from outside the Nuclear Division as well as supplemental llP 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 speciGed education and experience requirements for non-equivalent positions. As an alternative, these personnel can be qualified for assigned tasks either by UE through its systematic approach to training or by Vendors with UE approved training and qualification programs. Inspection, examination and testing personnel shall meet the requirements for certification as inspection, examination or testing personnel as set forth in UEs commitment to ANSI N45.2.6-1978 given elsewhere in this Appendix.
With regard to Section 5.6 of ANSI /ANS 3.1 - 1978 titled Documentation: UE shall maintain records in accordance with and to meet the requirements of OQAM Section 17 and ANSI N45.2.9 as specified herein.
r-----------------------------------------------------------------i i REGULATORY GUIDE 1.28 REVISION 2 DATED 2/79 i
L_________________________________________________________________J Quality Assurance Program Requirements (Design and Construction)(Endorses ANSI N45.2-1977)
DISCUSSION:
This Regulatory Guide is not applicable to the operating phase. Ilowever, ANSI N45.2-1977 will be r.pplied to suppliers of safety-related items, components or services, as appropriate, as described under Regulatory Guide 1.123 (ANSI N45.2. I 3-1976).
i r---------------------------------LISSUE DATED 8/72 e REGULATORY GUIDE I.30 INITIA L_________________________________________________________________J Quality Assurance Requirements for the Installation, Inspection, and Testing ofInstrumentation and Electronic Equipment (Safety Guide 30)(Endorses ANSI N45.2.4-1972/IEEE 336-1971)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
For maintenance and modification activities UE shall comply with the Regulatorv Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.
Specific clarifications for ANSI N45.2.4 - 1972 are indicated below by sections.
Section 1.4 - Definitions in this Standard w hich are not included in ANSI N45.2.10 shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
Section 2.1 - Planninn requirements, as detennined by engineering, shall be incorporated into modification procedures.
Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA!QC involvement.
A-2
MUNIONELECTRIC o,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 Section 2.3 - Procedures andJnstructions shall be implemented as set forth in OQAM Se:tions 2,3,5.10 and 11 and by compliance with the Callaway Plant Technical Speci0 cations and Regulatory Guide 1.33 VNSI N18.7) as set forth in this Appendix in lieu of the requirements set forth here. When compliance with an NRC accepod program (e.g., Callaway Plant Technical Speci0 cations) is referenced, UE has substituted the NRC accepted program fc. appUcable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards.
Section 2.4 - Results shall be implemented as set forth in OQAM Sections 10,11 and 17 and by compliance with ANSI l
N18.7 as set forth in this Appendix in lieu of the requirements set forth here. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.
Section 2.5.2 Calibration and Control covers three classes ofinstrumentation used by UE:
(1) M&TE (portable measuring instruments, test equipment, tools, gages, and non-destructive test equipment used in measuring and inspecting safety-related structures, systems, and components);
(2) reference standards (primary, secondary, transfer, and working); and (3) permanently installed process instrumentation (PI).
With respect to the Grst sentence, tu rri and reference standards shall be included in a calibration program and shall either be calibrated at prescribed intervals or shall be calibrated prior to use. With respect to the last sentence, personnel shall be trained and procedures shall require that the calibration label or tag shall be reviewed to determine calibration status prior i
to use: This label or tag shall be considered to clearly identify equipment w hich is out of calibration. Lack of a label or tag shall require the organization responsible for calibrating the M&TE to review records and amx a new label or tag based on i
calibration data. M&TE and reference standards shall comply with sentences 2,3 and 4.
)
I With respect to the 3rd sentence, UE uniquely identines each safety-related item of permanently installed process
{
instrumentation. This identiGcation provides traceability to calibration data. These actions are UE's alternative to the i
tagging or labeling of items to indicate the calibration date and the identity of the person who performed the calibration.
Permanently installed process instrumentation shall comply with sentences 1,2, and 5.
Section 3 - Preconstruction Veri 0 cation shall be implemented as follows:
(1) shall be required only for modincations; l
(2) shall be implemented with the clari6 cation that " approved instruction manuals" shall be interpreted to mean the manuals provided by the supplier as required by the procurement order - these manuals are not necessarily reviewed and approved, per se, by UE; (3) no special checks shall be required to be made by the person withdrawing a replacement part from the w arehouse - equivalent controls are assured by compliance with Regulatory Guide 1.38 (ANSI N45.2.2) as set forth in this Appendix; and, (4) shall be complied with as determined by engineering or by individual technicians as part of the modification process. Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement and are subject to QA audit.
Procedures for these actisities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committec). For other activities, QA audits and surveillances, and QC inspection activities assure QMQC involvement.
A-3
^
$lhTIONELECRUC CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL
- 1) ATE: 5/97 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 othe activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
Section 5.1 - Inspe:tions, including subsections 5.1.1,5.1.2, and the first sentence in 5.1.3, shall be implemented as set forth in OQAM Section 10. The inspection program shall incorporate, as determined by engineering and QC, those items listed in these subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in UE's commitment to Regulatory Guide 1.33 (ANSI N18.7), Section 5.2.6; the requirements as set forth in that commitment shall be implemented in lieu of the requirements stated here. In every case either identical or equivalent controls are provided in the Sections of the referenced Standards or documents.
Section 5.2 - Tests, including subsections 5.2.1 through 5.2.3, shall be implemented as set forth in OQAM Sections 3 and i1. In some cases Surveillne testing may be used to meet the appropriate requirements of this Section.
Section 6 Post-Construction Verification is not generally considered applicable at operating facilities because of the scope of d,e work and the relatively short interval between installation and operation. Where considered necessary by engineering or QC, the elements described in this Section shall be used in the development and implementation ofinspection and testing programs as described in OQAM Sections 3,10 and 11.
Section 7 - Data Analysis and Evaluation shall be implemented as sttted herein after adding the clarifying phrase "Where used" at the beginning of the paragraph. This clarification accounts for the fact that some testing will not generate " Data" as such.
Section 8 - Records shall be implemented by conformance with OQAM Section 17 and Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix.
i REGULATORY GUIDE I.33 REVISION 2 DATED 2/78 i
L_________________________________________________________________J Quality Assurance Program Requirements (Operation)(Endorses ANSI N18.7-1976'ANS 3.2)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
Paragraph C.3 of Regulatory Guide 1.33 (and Section 4.3.4 of ANSI N18.7 which it references) shall be implemented as reyrired by the applicable Callaway Plant Technical Specifications w hich define " Subjects Requiring independent Review."
Paragraph C.4.a of Regulatory Guide 1.33 (and Section 4.5 of ANSI N18.7 which it references) shall be implemented as l required by OQAM Section 18 which defines the " audit program" to be conducted. The audit program is further defined and shall be implemented as required by the commitment to Regulatory Guide 1.144 (ANSI N45.2.12) as stated in this Appendix.
A-4
$MNIONELECTRIC
$l$s CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 Paragraph C 5 4 of Regulatory Guide 133 (and Section 5.211 of ANSI N18.7 which it references) shall be implemented by adding the clarifying phrase "When determined by engineering" in front of the founh sentence of the fifth paragraph. It is not always practicable to test parts prior to use. For modifications where these requirements are not considered practicable, a review in accordance with the provisions of 10 CFR 50.59 shall be conducted and documented. Engineering actions performed in accordance with this Section of the Regulatory Guide are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of ORC). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
Paragraph C.5.c of Regulatory Guide 1.33 and Section 5.2.13.4 of ANSI N18.7 which it references shall be implemented subject to the same clarifications made for Regulatory Guide 1.38 (ANSI N45.2.2).
Paragraph C.5.f of Regulatory Guide 1.33 (and Section 5.2.19(2) of ANSI N18.7 which it references) shall be implemented with the substitution of the word " practicable" for the word "possible" in the last sentence. The action referenced in this Section is the responsibility of the Callaway Plant Operating Organization, and includes QA/QC involvement. QA is involved through audit and surveillance activities. QC is involved in maintenance inspection activities.
Paragraph C.5.g of Regulatory Guide 1.33 (and Section 5.2.19.1 on ANSI N18.7 which it references) shall be implemented with the addition of the modifier "normally" after each of the verbs (should) which the Regulatory Guide converts to "shall." It is UE's intem to fully comply with the requirements of this paragraph, and any conditions w hich do not fully comply shall be documented and approved by management personnel. Management personnel includes QA through cross-disciplinary reviews and through QA permanent membership on the Callaway Onsite Review Committee. QA has and shall conduct audits or surveillances of preoperational testing. In cases where conditions do not fully comply, the reason for the exception shall also be documented. The documentation shall be retained as lifetime records.
With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Renuirements for the Onsite Oneratine Orcanization:
Some of UE's technical support organizations are physically located at the Callaway site. Therefore the second sentence of this Sec' ion shall be implemented as follows:
" Initial incumbents or replacements for members of the onsite or offsite technical support organizations shall have appropriate experience, tuining 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 OOAM.
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 pan of the Callaway operating license. UE's inethods of documenting and otherwise meeting the remainder of the requirements of this Section are set forth in OQAM Section 2, in the Callaway Plant Technical Specifications, and in other licensing commitments.
With regard to Section 4.1 of ANSI N18.7 1976 titled General: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, and OQAM Section 18.
A-5
APPENDIX A
'3MrIONELECTRIC i
aevisioNt i9 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 With regard to Section 4.2 of ANSI N18.7 - 1976 titled Procram
Description:
Two aspects are addressed in this Section:
audits and independent reviews. The independent review program shall be implemented as required by the Technical Speci6 cations. 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, and OQAM Section 18.
With regard to Section 4.3 of ANSI N18.7 1976 titled independent Review Process: The requirements of this Section, including ofits subpans, shall be met by compliance with the Technical Specification requirements and the OQAM.
With regard to Section 4.5 of ANSI N18.7 - 1976 titled Audit Procram: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, and OQAM Section 18.
With regard to Section 5.1 of ANSI N18.7 - 1976 titled Procram
Description:
The founh sentence in this Section requires a " summary document." UE's OQAM is organized in accordance with the 18 criteria of 10 CFR 50, Appendix B. UE interprets this OQAM and applicable Regulatory Guides as endorsed in this Appendix to fulfill the requirements for a
" summary document."
With regard to Section 5.2.2 of ANSI N18.7 - 1976 titled Procedure Adherence: The temporary change requirements of this Section are delineated in the Technical Specifications for activities occurring after the Operating License (OL) is issued; the requirements of the Callaway Plant Technical Specifications shall be used to control temporary changes.
With respect to Section 5.2.6 of ANSI N18.7 - 1976 titled Fouipment Control: UE shall comply with the " independent verification" requirements based on the definition of this phrase as given under our commitment to Regulatory Guide 1.74 in this Appendix.
Since UE sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with:
" Suitable means include identification numbers or other descriptions which are traceable to records of the status ofinspections and tests."
The first sentence in the seventh paragraph shall be met aller clarifying " operating personnel" to mean trained employees assigned to, or under the con'.rol of, Plant management at Callaway.
With regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Maintenance and Modification: UE shall interpret the word
" original" in the first sentence of this Section to modify ONLY the words " design bases." This interpretation is to assure that original inspection requirements are not imposed, without appropriate review, on modifications or maintenance activities w hich are similar in nature to original construction activities. In 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 equivalent to the original quality.
Since some emergency situations could arise which might preclude preplanning of all activities, UE shall comply with an alternate to the first sentence in the second paragraph which reads:
"Except in emergency or abnormal operating conditions where immediate actions are required to protect the heahh 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 afler-the-fact and receive the same degree of review as if they had been preplanned."
A-6
$NINIONELECTRIC
{.,
s CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 With regard to Section 5.2.7.1 of ANSI N18.7 - 1976 titled Maintenance Procrams: UE shall comply with the requirements of the first sentence of the fifth paragraph, where practical. This clarification is needed since it is not always possible to promptly determine the cause of the malfunction. UE shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. QA is involved via both audits and surveillances, and QC is involved in inspection of maintenance inspection activities.
With regard to Section 5.2.8 of ANSI N18.7 - 1976 titled Surveillance Testine and Inspection Schedule: In lieu of a
" master surveillance schedule," the following requirement shall in met: " Schedules shall be established reflecting the status ofin plant surveillance tests and scheduled inspections."
With regard to Section 5.2.9 of ANSI N18.7 - 1976 titi A Pknt Security and Visitor Control: The requirements of the Security Plan shall be implemented in lieu of these geneml requirements. When compliance with an NRC accepted program (e g., Callaway Security Plan) is referenced, UE has substituted the NRC accepted program for anplicable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards.
With regard to Section 5.2.10 of ANSI N18.7 - 1976 titled flousekeepine and Cleanliness Control: The requirements of this Section, beginning with the last sentence of the first oaragraph and continuing through the end of the Section, shall be implemented as described in UE's commitments to Regulatory Guide 1.39 (ANSI N45.2.3) and Regulatory Guide 1.37
( ANSI N45.2.1) as set forth in this Appendix. In every case either identical or equivalent controls are provided in the Sections of the reference standards or documents.
With regard to Section 5.2.13.1 of ANSI N18.7 - 1976 titled Procurement Document Control: UE shall comply with the following sentence in lieu of the last sentence of the referenced Section.
Where changes are made to the technical or quality requirements on procurement documents, they shall be subject to an
)
equivalent level of review and approval as the original document by the originating organization.
With regard to Section 5.2.15 of ANSI N18.7-1976 titled Review. Annroval and Control of Procedures; in lieu of the wording starting with the second sentence in the third paragraph of this section beginning with "The frequency of..,"
through the end of the fourth paragraph, which ends ". a procedure review.", UE provides the following alternative guidance:
" Procedures shall be revised as necessary. These revisions will generally be initiated through reviews conducted by knowledgeable personnel during routine performance of activities. Examples of such reviews include evaluations of problems encountered during performance of a procedure, evaluation of corrective actions for self-identified 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 revisions as well as evaluations of changes necery to resche Regulatory issues. Such changes shall be implemented as necessary. In some situations such implementation will be completed prior to completion of the in-process activity. Guidance on the need to revise procedures shall be provided in plant administrative controls."
With regard to Section 5.2.17 of ANSI N18.7 - 1976 titled Inspection: The third paragraph is replaced with the following:
Inspections for modifications and nonroutine maintenance shall be conducted as indicated in our reference to Section 5.2.7 of this standard.
1 A-7 l
APPENDIX A
$EATIONEtscraic
,Ev,s,es, CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 The following is a clari0 cation to the sixth paragraph:
Inspections may not require generation of a separate inspection report, insption requirements may be integrated into appropriate procedures or other documents with the procedure or document serving as the record. Ilowever, records of inspections shall be identi0able and retrievable.
With regard to Section 5.2.18 of ANSI N18.7 - 1976 titled Control of Special Processes: UE shall comply with the following sentence in lieu of the last sentence of the referenced Section:
For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established codes or standards, personnel, equipment and procedure quali0 cation shall be denned by engineering.
With regard to Section 5.3.5(4) of ANSI N18.7 1976 titled Supportine Maintenance Documents: UE may choose to include material from vendor manuals in any of three ways.
(1) The applicable section of a manual may be duplicated, referenced in, and attached to the procedure, (2) The procedure may reference the technical manual or a specinc section; the manual may then be used in conjunction with the procedure for performing the activity.
(3) The material, either as originally written or as modified by the procedure's author, may be reproduced within the body of the procedure.
in options (1) and (2) above, the material shall be considered as having received "the same level of review and approval as operating procedures" by virtue of the review and approval of the maintenance procedure. In option (2), the manual shall be available when the procedure is being considered for approval, in option (3), this material receives the same review and approval as the procedure since it is part of the procedure. In any of the options, Union Electric is NOT reviewing and accepting the entire manual. UE reviews and accepts that portion of each vendor manual that is used by UE.
With regard to Section 5.3.9 of ANSI N18.7 - 1976 titled limercency Procedures: UE's Emergency Procedures are in the format speciGed by the NRC in the Callaway Safety Evaluation Report, as required for issuance of the Operating License, in lieu of the requirements given here.
With regard to Section 5.3.9.2 of ANbi N18.7 - 1976 titled fivents of Potential Emercency: The licensing FSAR identiGed natural occurrences w hich affect the Callawny lant. Therefore, UE shall interpret item () I) to mean the natural p
occurrences whlch were evaluated in the licensing FSAR.
With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Procedures for Imnlementine Emercency Plan: UE's NRC accepted Emergency Plan shall be implemented in lieu of the requirements in this Section When compliance with an NRC accepted program (e.g., Callaway Plant Radiological Emergency Response Plan) is referenced, UE has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance Program standards.
A-8
APPENDIX A METNIONELECTRIC REVISION:
19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97
i r - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - D A T E D 3/73 i REGULATORY GUIDE I.37 INITIAL ISSUE i
L----------------------------------------------------------------
J Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.1-1973)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
For maintenance and modification activities UE shall comply with the Renulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modifications shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.
Specific clarifications for this Regulatory Guide and ANSI N45.2.1 - 1973 are indicated below by Sections.
With regard to Paragraph C.3 of Regulatory Guide 1.37: The water quality for final flushing of fluid systems and associated components shall be at least equivalent to the quality of the operating system water except for the oxygen and nitrogen content; but this does not infer that chromates or other additives, normally in the system water, are added to the flush water.
With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indicating sticks; tapes; gummed labels; wrapping materials (other than polyethylene); water soluble dam materials; lubricants; NDT penetrant materials and couplants, desiccants, which contact stainless steel or nickel alloy surfaces shall not contain lead, zinc, copper, mercury, cadmium and other low melting points metals, their alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall be allowed where such elements are teachable or where they could be released by breakdown of the compounds under expected envimnmental conditions, except as provided for in appmved design documents. No more than 1000 ppm sulfur shall be allowed where such elements are teachable or w here they could be released by breakdown of the compounds under expected environmental conditions, except as provided for in approved design documents.
With regard to Section 5 of ANSI N45.2.1 - 1973 titled Installation Cleanine: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that local rusting may be removed mechanically, but the use of other removal means is not precluded, as determined by engineering or Chemistry.
Engineering actions performed in accordance with this Section of the Standard are conducted with QA/QC involvement j
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 committec). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
l A-9
APPENDIX A REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97
i r - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - D AT E D 5/7 7 i REGULATORY GUIDE 1.38 REVISION 2 i
L_________________________________________________________________J Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling ofitems for Water-Cooled Nuclear Power Plants (Endorses ANSI N45.2.2-1972)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Definitions: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Planninn: (First sentence) The specific items to be governed by the Standard shall be identified in Callaway-SP FSAR Table 3.2 1, which lists those structures, systems and components to which the UE QA Program is applied.
With regard to Section 2.3 of ANSI N45.2.2 - 1972 titled Results: The specific methods for performing and documenting tests and inspections are given in OQAM Sections 10 and 11. The requirements in these Sections shall be implemented in lieu of the general requirements here. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.
With regard to Section 2.4 of ANSI N45.2.2 - 1972 titled Personnel Oualifications: Specific requirements for personnel qualifications are set forth in the OQAM description and in the commitments in this Appendix. These requirements shall be implemented in lieu of the general requirements stated in this Section. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or document.
With regard to Section 2.7 of ANSI N45.2.2 - 1972 titled Classification ofitems: UE may choose not to explicitly use the four level classification system. Ilowever, the specific requirements of the Standard that are appropriate to each class are generally applied to the items suggested in each classification and to r:milar items, as determined by engineering.
Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committec). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 3.2.1 of ANSI N45.2.2 - 1972 titled 1.evel A Items: As an alternate to the requirements for packaging and containerizing items in storage to control contaminants (Items (4) and (5)), UE may choose a storage atmosphere which is free of harmful contaminants in concentrations that could produce damage to stored items, as detennined by engineering. Similarly (for item (7)) UE may obviate the need for caps and plugs, as determined by engineering, with an appropriate storage atmosphere, and may choose to protect weld-end preparations and threads by controlling the manner in which the items are stored. These clarifications apply whenever items (4), (5) or (7) are subsequently referenced and to Section 3.5.1 titled Cans and Plues and Section 3.4 titled Methods of Prevention.
Engineering actions performed in accordance with this section of the Standard are conducted with QA!QC involvement and 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 committec). For other activities, QA audits and surveillances, and QC inspection activities assure Q A!QC involvement.
A-10
MUurouELECTRIC
[s[ ky CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: F197 With regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Cleanine:(Third sentence) UE interprets " documented cleaning methods" to allow generic cleaning procedures to be written which shall be implemented, as necessary, by trained personnel. Each particular cleaning operation shall be either governed by an individual cleaning procedure or by a generic procedure either of which shall specify method (s) of cleaning or type (s) of solvent (s) that may be used in a particular application.
With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Methods of Preservation: (First sentence) UE shall comply with these requirements subject to the clarifications of Section 3.2.1 (4) and (5) above, and the definition of the phrase
" deleterious corrosion" to mean that corrosion w hich cannot be subsequently removed and which adversely affects form, 6t, or function.
With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrier and Wran Material and Desiccants: This Section requires the use of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the UE position.
With regard to Section 3.7.1 of ANSI N45.2.2 - 1972 titled Containers: Cleated, sheathed boxes may be used up to 1000 lbs. rather than 500 lbs. as specified in 3.7.!(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs.
Other national standards allow this (see Federal Specification PPP-B-601). Special qualification testing shall be required for loads above 1000 lbs.
With regard to Section 3.7.2 of ANSI 45.2.2 - 1972 titled Crates and Skids: Crates shall be used for equipment in excess of 1000 lb. in weight. Skids or runners shall be used on boxes with a gross weight of approximately 100 lb. or more, allowing sufficient floor clearance for forklif1 tines (as nominally provided by 4 inch lumber).
With regard to Section 4.2.2 of ANSI N45.2.2 - 1972 titled Closed Carriers: The use of fully enclosed furniture vans, as recommended in (2) of this Section, is not considered a requirement. Stated for information only, UE shall assure adequate protection from weather or other environmental conditions by a combination of vehicie enclosure and item packaging.
With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Shinnine Damace inspection: Stores personnel shall normally visually scrutinize incoming shipments for damage of the types listed in this Section; this activity is not necessarily performed prior to unloading. Since required items receive the item inspection of Section 5.2.2, separate documentation of the Shipping Damage Inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment may be all of the only action taken to document completion of the Shipping Damage Inspection. Any nonconformance noted shall be documented and dispositioned as required by OQAM Section 15. The person perforn:ing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regulatory Guide 1.74; therefore, w hile 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 Insnection: The second division of this subsection requires six additional inspection activities if an item was not inspected or examined at the source. Engineering shall determine and document the extent of receipt inspection based on consideration ofitems in Section 5.2.2. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
A-l1
APPENDIX A MEIONELECTRIC
- ycyisios, CA LLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled I.evels of Storace: Subpart (2)is replaced with the following:
(2) Level B items shall be stored within a Hre resistant, weathertight, and well ventilated building or equivalent enclosure in which measures have been taken against vandalism. This building shall be situated and constructed so that it is not normally be subject to Dooding; the Door shall be paved or equal, and well drained. If any outside waters should come in contact with stored equipment, such equipment shall be labeled or tagged nonconforming, and then the nonconformance document shall be processed and evaluated in accordance with OQAM Section 15. Items shall be placed on pallets or shoring or shelves to permit air circulation. The building shall be provided with heating and temperature control or its equivalent to reduce condensation and corrosion. Minimum temperature shall be 40 F and maximum temperature shall be 140 F or less if so stipulated by a manufacturer.
With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to Storace Areas: Items which fall within the Level D classincation of the standard shall be stored in an area which may be posted to limit access, but other positive controls such as fencing or guards shall not normally be provided, with engineering's concurrence. Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit.
Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a permanent member of this committee). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Storace of Food and Associated items: The sentence is replaced with the following:
"The use or storage of food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas w here such use or storage is not deleterious to stored items, with engineering's concurrence."
Engineering actions performed in accordance with this section of the Standard are conducted with QA/QC involvement and are subject to QA audit. Procedures for these activities receive a cross-disciplinary review as well as review by the Onsite Review Committee (QA is a pennanent member of this committec). For other activities, QA audits and surveillances, and QC inspection activities assure QA/QC involvement.
With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled Measures to Prevent Entrance of Animals: The sentence is replaced with the follow ing:
" Exterminators or other appropriate measures shall be used to control animals to minimize possible contamination and mechanical damage to stored material."
With regard to Section 6.3.3 of ANSI N45.2.2 - 1972 titled Storace ofIlarardous Materials: The sentence is replaced with the following:
- llazardous chemicals, paints, solvents, and other materials of a like nature shall be stored in approsed cabinets or containess w hich are not in close proximity to installed safety-related systems."
The placement of hazardous material dorage lockers in the Plant is based upon installed safety-related 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."
A 12
$UNIONEtscraic
- 7::^
CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL I) ATE: 5/97 (6)
"Large (greater than or equal to 50 IIP) rotating electrical equipment shall be given insulation resistance tests on a scheduled basis unless a documented engineering evaluation determines that such tests are not required."
(7)
" Prior to being placed in storage, large (greater than or equal to 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 oflubrication where applicable and so that the shaft does not come to rest in the same position occupied prior to rotation. For long shans or heavy equipment subject to undesirable bowing, shaft orientation afler rotation shall be specined and obtained."
(8)
Maintenance requirements specified by the manufacturer's instructions are addressed in this OQAM, Section 13.3.
With regard to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal ofitems from Storace: UE does not consider the last sentence of this Section to be applicable to the Operating Phase due to the relatively short period of time between installation and use. The Hrst sentence of the Section is replaced with:
"UE shall develop, issue, and implement a procedure (s) which cover (s) the removal ofitems from storage. The procedure (s) shall assure that the status of material issued is known, controlled, and appropriately dispositioned."
With regard to Section 7.4.2, a subsection to Section 7.4 of ANSI N45.2.2-1972 titled Inspection of Eauinment and Rincine Stated for information only, it is UE's position that this relates to the operability of the hoisting equipment and does not preclude re-rating as allowed by Section 7.3.
r----------------------------------------------------------------
1 i REGULATORY GUIDE 1.39 REVISION 2 DATED 9/77 i
L_________________________________________________________________1
!!ousekeeping 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 clariGcations:
for maintenance and modi 0 cation activities UE shall comply with the Renulatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein (subject to the clari6 cations below) shall i
apply to these maintenance and modiGcation activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance or modi 0 cation shall be equal to or better than the original requirements (e g., code requirements, material properties, design margins, manufacturing processes, and inspection iequirements), or as required to preclude repetition of defects.
Specific clari0 cations for ANSI N45.2.3 - 1973 are indicated below by Sections.
Section 1.4 - Definitions: Dennitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; dennitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74.
Section 2.1 - Danning: UE may choose not to utilize the Ove-level zone designation system, but shall utilize standard janitorial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeeping, Plant and personnel safety, and fire protection.
A-13
APPENDIX A ME1ouELECTRIC
- atvisios, CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 Cleanliness shall be maintained, consistent with the work being performed, so as to prevent the entry of foreign material into safety-related systems. This shall include, as a minimum, documented cleanliness inspections which shall be performed prior to system closure. As necessary,(e.g. the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance, refueling, modification or repair.
Additional housekeeping requirements shall be implemented as required for control ofradioactive contamination.
Section 3.2 - Control of Facilities: UE may choose not to utilize the five-level zone designation system, but shall utilize standard janitorial and work practices to maintain a level of cleanliness commensurate with Program requirements in the areas of housekeeping, Plant and personnel safety, and fire protection.
Cleanliness shall be maintained, consistent with the work being performed, so as to prevent the entry of fueign material into safety-related systems. This shall include, as a minimum, documented cleanliness inspections which shall be performed prior to system closure. As necessary, (e.g. the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when the reactor system is opened for inspection, maintenance.
modification, refueling or repair.
Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.
Section 4 - Records: The requirements of OQAM Section 17 and Regulatory Guide 1.88 (ANSI N45.2.9) as set forth in this Appendix shall be implemented in lieu of the requirements of the Section. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.
r----------------------------------------------------------------
1 REGULATORY GUIDE I.58 REVISION I DATED 9/80 L_________________________________________________________________;
Quatincation of Nuclear Power Plant inspection, Examination, and Testing Personnel (Endorses ANSI N45.2.6-1978)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
The qualification of UE QC or contracted QC personnel performing work at the Plant shall be in accordance with Regulatory Guide 1.58 (ANSI N45.2.6-1978). Other personnel performing inspection, examination, and testing activities shall have appropriate experience, training, and retraining to assure competence in accordnce with Regulatory Guide 1.8 (ANSI /ANS 3.1 1978). This position is consistent with Regulatory Guide 1.33 (ANSI N18.7-1976/ANS-3.2, Section 3,4.2). (CTSN 3739,42434)
In instances where the education and experience recommendations of ANSI N45.2.6-1978 are not met by QC personnel, UE shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that these individuals possess comparable or equivalent competence. Persons performing Nondestructive Examinations (NDE) as may be required by Section ill or XI of the ASME B&PV Code shall be qualified and certified as required by the Edition and Addenda of the Code to which UE is committed at the time the NDE is performed. Ilowever, when qualifying personnel to perform visual examinations VT-2, VT-3, and VT-4 in accordance with IWA-2300 of Section XI, Division I, ANSl/ASME N45.2.6-1978 may be used instead of ANSI N45.2.6-1973 (Code Case N-424). Persons certified to perform NDE for Code work shall also be considered as qualified to perform non-Code NDE (e.g. crane hook inspection) unless more rigorous qualification or certification requirements are imposed by UE's commitments or government regulations.
A-14
EEUnionELECTRIC s
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL I) ATE: 5/97 With regard to Section 1.2 of ANSI N45.2.6 -1978 titled Applicability: The third paragraph requires that the Standard be used in conjunction with ANSI 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 Definitions: Definitions in this Standard which are not included in Regulatory Guide 1.74 ( ANSI N45.2.10) shall be used; definitions w hich 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 - 15.78 titled P_bysical: UE shall implement the requirements of this Section with the stipulation that, where no special physica ch acteristics 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.
1 r-----------------------------------------------------------6/76 REGULATORY GUIDE I.64 REVISION 2 DATED L_________________________________________________________________J Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.11-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
When uniqueness or special design considerations warrant or are judged to be appropriate, an independent third-level review may be employed.
With regard to Paragraph C.2(1) of Regulatory Guide 1.64: If the designer's immediate Supervisor is the only technically qualified individual available, this review may be conducted by the Supervisor, provided that:
(a) the other provisions of the Regulatory Guide are satisfied, and (b) the justification is individually documented and approved in advance by the Supervisor's management, and (c) quality assurance audits cover frequency and effectiveness of use of the Supervisors as design verifiers to guard against abuse.
With regard to Section 1.4 of ANSI N45.2.li - 1974 titled Definitions: Definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in this Appendix.
With regard to the 4th paragraph of subsection 2.1 and subsection 2.2.12, utider Procram Requirements. and Section i1 (including subsections 11.1 through i1.7) of ANSI N45.2.11 - 1974, titled Audits: UE's audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in l this Appendix, and OQAM Sections 16 and 18. In every case either identical or equivalent controls are provided in the sections of the referenced Standards or documents.
A-15
EEUNIONELECTRIC
{.,
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97
,___________________________________________________________ED2/74 i REGULATORY GU10E I.74 INITI AL ISSUE DAT i
L_________._______________________________________________________J Quality Assurance Terms and Definitions (Endorses ANSI N45.2.10-1973)
DISCUSSION:
UE complies with ihe recommendations of this Regulatory Guide with the following clarifications.
UE reserves the right to define additional words or phrases which are not included in this Standard. Such additional definitions shall be documented in appropriate procedures or in Sections of the Operating QA Manual.
In addition to the Standard's definition of" Inspection," UE shall use the following: " Inspection (when used to refer to activities that are NOT performed by QA or QC personnel)- Examining, 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 references are NOT made, inspections are to be considered under the additional definition given above.
In addition to the Standard's definition of" procurement documer" " UE shall utilize the definition given in ANSI N45.2.13. The compound definition is given as follows: Proct m. ent documents - Contractually binding documents that identify and define the requirements which items or services mmt meet in order to be considered acceptable by the purchaser. They may include documents which authorize the c... :, @ fum services or supply equipment, material or facilities on behalf of the purchaser (e.g. Engineering Service Agreement agraments for engineering, construction, or consulting services), contracts, letters ofintent, purchase requisitions,,.c.ase orders, or proposals and their acceptance, drawings, specifications, or instruction which define requirements for purchase.
"llids" Supplier quotation submitted in response to specified technical and quality requirements for which price and delivery are primary considerations.
" Proposals" - Supplier ofTerings that define the scope of supply as well as specific technical and quality requirements for a product or service. Such offerings usually require negotiation prior to acceptance as either a purchase order, contract, or Engineering Service Agreement.
" Program Deficiencies"(Not defied 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 effectiv ely any applicable element of the Operating QA Program.
" Quality Assurance Program Requirements"(Not defined in ANSI N45.2.10 but used and defined differently in ANSI N45.2.13)- Those individual requirements of the Operating QA Program which, when invoked in total or in part, establish the requirements of the quality assurance program for the activity being controlled. Although not specifically used in the Operating QA Program, ANSI N45.2 may be imposed upon UE's suppliers.
A-16
APPENDIX A ses 7
REVISION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 "Indeper. dea Wrification"- Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed Such verification need not require confirmation of the identical action when other indications provide assurance or indication that the prescribed activity is in fact complete. Examples include, but are not limited to: verification of a breaker opening by observed remote breaker indication lights; verification of a set point (made with a voltmeter or ammeter for example) by observing the actuation of status or indicating lights at the required Panel-meter indicated value; verification that a valve has been positioned by observing the starting or stopping of flow on meter indications or by remote value positions indicating lights.
" Audit"(This is a modification of the word's definition - to allow the use of subjective evidence if no evidence is available
- as defined in Section 1.4 of ANSI N45.2.12 - 1977 (Regulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23 - 1978 (Regulatory Guide 1.146) as opposed to the definition given in ANSI N45.2.10 - 1973)- A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of 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 accordance with specified requirements. An audit should r.ot be confused with surveillance or inspection for the sole purpose of process control or product acceptance.
"Must"-(Not defined in any ANSI Standard)- An internally auditable requirement imposed by UE management upon its employees, contractors, and agents - above and in excess of the legally binding requirements of the appropriate regulatory body. Such items are internally required but not externally enforceable. (See additional discussion under Section 2.14 of the OQAM.)
l " Unit start"-(Not defined in any ANSI standard)- F eans those personnel who report to the Manager, Callaway Plant.
This term shall also be synonymous with the "onsite perating organization" described (but not defined) in ANSI N18.7-1976, Section 3.4.2; the " unit stafl" as used in the OQAM and in Callaway Plant Technical Specifications Section 6.2,6.3 and its subparts; inchiding " operating staft" and " unit organization" as described in the Callaway Plant Technical Specifications Section 6.2.1 and 6.2.2, respectively; and personnel having "line responsibility for operation of the unit" as used in the OQAM.
"Like kind replacements"-(Not defined in any ANSI standard)- Like kind replacements include both exact item replacements and other item replacements w hich are not " exact" but meet the original design requirements.
r----------------------------------------------------------------
1 i REGULATORY GUIDE 1.88 RI VISION 2 DATED 10/76 i
L______________________________.
._________________________________J Collection, Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records (Endorses ANSI N45.2.9-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled Generation of Ouality Assurance Records: The phrase
" completely filled out" is clarified to mean that sufficient information is recorded to fulfill the intended purpose of the record. It is the information, not the form, that is the record. Thus the 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.
A-17
APPENDIX A P3UurouELECTRIC ggygSION:
19 CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 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 Time!iness: UE's contractual agreement with its contractors and suppliers shall constitute fulfillment of the requirements of this Section.
With regard to Section 5.3.3 of ANSI N45.2.9-1974: The phrase "A method for verifying that the records received are in agreement with the transmittal document...", is clarified to mean that internal Callaway plant geterated records received are in agreement with procedural guidelines contained in Callaway Plant Administrative procedur:s. If a transmittal does exist (e.g. on supplier generated documents, etc.), the records received will be verified against the transmittal document.
The following clarification is substituted for the current subsection 5.4.3: Trovisions shall be made for special processed records (such as radiographs, photographs, negatives, microfilm and magnetic media) to prevent damage from excessive light, stacking, electromagnetic fields, temperature and humidity as appropriate to the records type." Consideration shall be given to manufacturer's recommendation.
With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safekeeping: Routine General Offices and Plant site security systems and access controls shall be provided: no special security systems are required to be established for record storage areas.
With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Facility: This Section provides no distinction between temporary and permanent facilities. To cover tempom,, sicrage, 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 aller completion without l being duplicated (for dual storage).-being placed on microfilm or optical disk. Open-ended documents --those revised or updated on a more-or-less continuing basis over an extended period of time (e.g. personnel qualification and training documents, equipment history cards, master audit or master surveillance schedules) and those w hich are cumulatis e in nature (e.g. nonconforming item logs and control room log books)-- are not considered as QA records since they are not
" complete." These types of documents shall become QA records w hen they are issued as a specific revision (e.g., the master audit schedule); when they are filled-up or discontinued (e.g. log books er equipment history cards); on a predefined periodic basis when the completed portion of the on-going document shall be transferred to document control as a " record" (e.g. training and qualification records).
Paragraph 4, subsection 3 is clarified to require a two-hour minimum fire rating to be consistent with the 1979 version of the Standard and NRC Criteria for Records Storace Facilities (Guidance-ANSI N45.2.9, Section 5.6) issued 7/1/80.
Paragraph 4, subsection 9 is clarified to read:
"No pipes or penetrations except those providing fire protection, lighting, temperature! humidity control, or communications are to be located within the facility and they shall comply with a minimum two-hour fire protection rating "
Where duplicate storage is employed, no special precautions or provisions (including vault storage, special humidity and temperature recorders and similar items) are required.
paragraph 5 is clarified ti read the same as our commitment to subsection 5.4.3. Iloth paragraphs address the -same requirement and therefo* e Ge commitment must be the same.
A-18
MUniouELECTRIC
)SION:
R 19 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: S/97 With regard to Section 5.7 of ANSI N45.2.9-1974 titled Audits: These specific activities in sub-sections I,2 and 3 are accomplished through the establishment of administrative controls by the responsible management.
Audits of these administrative controls are performed in accordance with this OQAM, Section 18 and commitments to Reg.
Guide 1.144 in this Appendix.
r---------------------------------------------------------------i i REGit. FORY GUIDE I.94 REVISION I DATED 4/76 i
L__.,_____________________________________________________________J Quality Assurance Requiremen.4 for Installation, inspection and Testing of Structural Concrete and Structural Steel During the Construction Phw 4 Nuc! car Power Plants. (Endorses ANSI N45.2.5-1974)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
For modiGcation activities !!E sball comply with the Reculatory Position established in this Regulatory Guide in that QA programmatic / administrative requireents included therein (subject to the clarifications below) shall apply to tnese modification activities even taough such requirements may not have been in effect originally. Technical requirements essociated with modincations shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects. The recommendations for structural concrete, structural steel, and other Plant components shall be met as indicated by the applicable design documents with the following exceptions:
With regard to Section 2.4 of ANSI N45.2.5-1974 titled Personnel Ouali6 cation: Union Electric will comply with Regulatory Guide 1.58 as endorsed in this OQAM in lieu of the requirements of this standard.
In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled Calibration and Control: The last sentence is clarined as follows:
"UE's inspection or test results conducted with M&TE found to be discrepant are to be evaluated as described in the OQAM, Section 12.8."
With regard to Section 5.4 of ANSI N45.2.5-1974 titled flich Strencth Bolting: In lieu of the first two sentences in the Hrst paragraph, UE will comply with the following:
" Bolts for friction type connections may be tightened using direct tension indicators in accordance with the AISC Speci0 cation for Structural Joints Using ASTM A325 or A490 Bolts, approved May 8,1974."
In lieu of(l) in the second pr.igraph, UE will comply with the following:
"The requirement for the acceptance of tightened bolt assemblies is, the length of the bolts shall be such that the point of the bolt shall be flush with or outside of the face of the nut when completely installed."
A-19 i
ENIONELECMC
$ ^,,
^"
CALLAWAY NUCLEAR PLANT OPERA TING QUALITYASSURANCEMANUAL DATE: 5/97 r----------------------------------------------------------------i l
8 REGULATORY GUIDE I.I16 REVISION 0-R DATED 5/77 i
L____--__________--_______--___-_________--____-____--___-_------
J Quality Assurance Requirements for Installation, inspection, and Testing of Mechanical Equipment and Systers (Endorses ANSI N45.2.8-1975)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clari5 cations:
For maintenance and modification activities UE shall comply with the Reculatory Position established in this Regulatory Guide in that QA programmatic / administrative requirements included therein shall apply to these maintenance and modincation activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modifications shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.
With regard to Section 2.7 of ANSI N45.2.8 - 1975 titled Personnel Oualifications: Personnel performing inspection and testing activities, shall be qualified consistent with the qualification requirements of OQAM Section 10 and, as endorsed in this Appendix, Regulatory Guide 1.58 [ ANSI N45.2.6-1978] and Regulatory Guide 1.8 [ ANSI /ANS 3.1-1978].
r----------------------------------------------------------------
1 REGULATORY GUIDE I.123 REVISION I DATED 7/77 i
L_________________-_________-__-___________________--_____-_______J Quality Assurance Requirements for Control of Procurement ofitems and Services for Nuclear Power Plants (Endorses ANSI N45.2.13 1976)
CaCUSSlON:
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 Definitions: With two exceptions (Procurement Document and Quality Assurance Program Requirements) definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74. The two exceptions are defined in this Appendix under Regulatory Guide 1.74.
With regard to Section 1.2.2 of ANSI N45.2.13 - 1976 titled Purchaser's Responsibilities: Item C is one of the options which may be used by UE to assure quality; however, any of the options given in 10 CFR 50, Appendix B, Criterion Vil as implemented by OQAM Sections 4 and 7 may also be used.
With regard to Section 3.1 of ANSI N45.2.13 - 1976 titled Procurement Document Prenaration. Review and Chance I
l Control: The phrase "the same degree of control" is stipulated to mean " equivalent level of review and approval." The i
changed document may not always be re-review ed 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 I
requirements of OQAM Sections 4 and 7 in lieu of the requirements specified in this Section. In every case either identical or equivalent controls are provided in the sections of the referenced documents.
A-20
$E&IONEucmc
^""":
^
CALLAWAY NUCLEAR PLA! T OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 With regard to Section 5.3 of ANSI N45.2.13 - 1976 titled Preaward Evaluation: UE shall comply with an alternate paragraph which reads:
"Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition a: Callaway), an evaluation of the supplier's acceptability as a procurement source shall be performed as required by the Operating QA Manual."
While it is not the intent to make " unusual circumstances" determinations without Engineering or QA involvement, Callaway Operations Support is ultimately responsible for the decision. QA audit and surveillance activities assure against abuse.
With regard to Section 6.4 of ANSI N45.2.13 - 1976 titled Control of Chances in items of Services: The phrase "the Operating QA Program" is inserted in lieu of" ANSI N45.2, Section 7."
With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source Veri 0 cation Activities and Section 12 of ANSI N45.2.13 - 1976 titled Audit of Procurement Procram: The UE audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, and OQAM Sections 16 and 18.
With regard to Section 7.5 of ANSI N45.2.13 - 1976 titled Personnel Ouali0 cations: The phrase: " Personnel responsible for performing verincation activities shall be qualined in accordance with ANSI N45.2.6 as applicable", is subject to the following clari0 cation: Qualincation of personnel performing verincation activities for the Callaway Plant shall be in accordance with Union Electric's position on Regulatory Guide 1.58.
With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disposition: The third sentence ofitem b is revised to read:
Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist of one or more of the following shall be submitted to the Purchaser for approval of the recommended disposition prior to shipment when the nonconformance could adversely affect the e nd use of a module' or shippable component relative to safety, interchangeability, operability, reliability, integrity, or maintainability:
- 1) Technical or material requirement is violated;
- 2) Requirement in Supplier documents, which have been approved by the Purchaser, is violated;
- 3) Nonconformance cannot be corrected by continuation of the original manufacturing process or by rework; and'or
- 4) rhe item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.
' A module is an assembled device, instrument, or piece of equipment identined 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 component 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.
A-21
33UNIONELECTRIC y 10 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 5/97 r-----------------------------------------------------------------i i REGULATORY GUIDE I.144 REVISION I DATED 9/80 i
t_________________________________________________________________)
- Auditing of Quality Assurance Programs for Nuclear Power Plants (Endorses ANSI N45.2.12-1977)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clarifications:
With regard to Section 1.4 of ANSI N45.2.12 - 1977 titled Definitions: With one exception (Program Deficiencies) the definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in UE's commitment to Regulatory Guide 1.74. The one excepted definition and a clarified definition (of audit) relevant to this Standard are defined in this Appendix under Regulatory Guide 1.74.
With regard to Section 2.1 of ANSI N45.2.12-1977 titled General: Identical or equivalent controls are provided in this OQAM, Section 18.3 regarding the second paragraph discussing audit team selection.
With regard to Section 2.2 of ANSI N45.2.12 - 1977 titled Personnel Oualification: The qualification of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
With regard to Section 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titled Traininc: The training of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Maintenance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the requirements of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.
With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essential Elements of the Audit System: UE shall comply with subsection 3.3.5 as it was originally written (subsection 3.2.5)in ANSI N45.2.12, Draf) 3, Revision 4: " Provisions for reporting on the elTectiveness of the Quality Assurance Program 6 the responsible management." For the auditing l organization (UE), effectiveness shall be repor ed as required by OQAM Section 18. Other than audit reports, UE may not directly report on the ef fectiveness of the qua' ty assurance programs to the audited organization when such organizations cre outside of UE.
Subsection 3.3.6 requirements are considerec to be fulfilled by compliance with the crganization and reporting measures l outlined in this OQAM. In every case either identical or equivalent controls are provided in the sections of the referenced documents.
Subsection 3.3.7 requires verification of effective corrective action on a timely basis.
Verification of the implementation of corrective action is performed as indicated in Section 16 of this OQAM. Corrective action program effectiveness is determined through audit or surveillance as described in Section 18 of this OQAM, using previously issued corrective action documents as input to 16 scope of audits and surveillances. Additionally, trending of corrective action documents will be used to reveal potentially ineffective corrective actions and the effectiveness of the corrective action program.
~
A-22
APPENDIX A EBrIONEucmc msv,,eN, CALLAWAY NUCLf AR PLANT OPERA TING QUALITYASSURANCE MANUAL DATE: 5/97 With regard to Section 3.4 of ANSI N45.2.12-1977 titled Audit Planning: Identical or equivalent controls are provided in this OQAM, Section 18.
With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Scheduline: Identical or equivalent controls are provided in this OQAM, Section 18 for the requirements of Subsections 3.5.1 and 3.5.2. Subsection 3.5.3.1 is interpreted to mean that UE may procedurally control qualification of a contractor's or supplier's quality assurance program prior to awarding a contract or purchase order by means other than audit. The measures outlined in Sections 4 and 7 of this OQAM address the requirements of Subsection 3.5.3.1.
With regard to Section 4.3.1 of ANS! N45.2.12 - 1977 titled Pre-Audit Conference: UE shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the first sentence. This clarification is required because, in the case of certain unannounced audits or audits of a particular operation or work activity, a pre-audit conference might interfere with the spontaneity of the operation or activity being audited. In other cases, persons who should be present at a pre audit conference may not always be available: such lack of availability should not be an impediment to beginning an audit. Even in the above examples, which are not intended to be all inclusive, the material set forth in Section 4.3.1 shall normally be covered during the course of the audit.
With regard to Section 4.3.2 of ANSI N45.2.12 - 1977 titled Audit Process:
(a) Subsection 4.3.2.2 could be interpreted to limit auditors to the review of only objective evidence; sometimes and for somt: Program elements, no objective evidence may be available. UE shall comply with an alternate sentence which reads: "When available, objective evidence shall be examined for compliance with Quality Assurance Program requirements. If subjective evidence is used (e.g. personal interviews, direct observations by the auditor), then the audit report must indicate how the evidence was obtained."
(b) Subsection 4.3.2.4 is modified as follows to take into account the fact that some nonconformances are virtually
" obvious" with respect to the needed corrective action: "When a nonconformance or Quality Assurance Program deficiency is identified as a result of an audit, unless the apparent cause, extent, and corrective action are readily evident, further investigation shall be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required."
(c) Subsection 4.3.2.5 contains a recommendation which is clarified with the definition of" acknowledged by a member of the audited organization" to mean that "a member of the audited organization has been informed of the findings."
Agreement or disagreement with a finding may be expressed in the response from the audited organization.
(d) Subsection 4.3.2.6 is modified as follows to account for the fact that immediate notification is not always possible:
" Conditions requir:ng immediate corrective action (i.e. those which are so severe that any delay would be undesirable) shall be reported immediately to the audited organization and as soon as practical to the management thereof."
With regard to Section 4.3.3 of ANSI N45.2.12 - 1977 titled Post-audit Conference: UE shall substitute and comply with the following paragraph:
"For external audits, a post-audit conference shall be held with management of the audited organization to present audit findings and clarify misunderstandings; where no adverse findings exist, this conference may be waived by management of the audited organization: such waiver shall be documented in the audit report. Unless unusual operating or maintenance conditions preclude attendance by appropriate managers / supervisors, a post-audit conference shall be held with managers / supervisors for internal audits for the same reasons as above. Again, if there are no adverse findings, management of the internal audited organization may waive the post audit conference: such 1
waiver shall be documented in the audit report."
A-23 j
I l
MUviouELECMC
[s"i s
^
i, CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCEMANUAL DATE: 5/97 With regard to Section 4.4 of ANSI N45.2.12 - 1977 titled Reportina:
(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 clarined 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 clarined to read: " Supervisory level personnel with whom signi0 cant discussions were held during the course of pre-audit (w here conducted) audit, and post-audit (where conducted) activities."
(c) Audit reports may not necessarily contain an evaluation statement regarding the effectiveness of the Quality Assurance i rogram 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 Gndings.
With regard to Section 4.5.1 of ANSI N45.2.12 - 1977 titled By Audited Ornanization: UE shall comply with the following clari0 cation of the Section: Management of the audited organization or activity shall review and investigate adverse audit Gndings, as necessary, (e.g. w here the cause is not already known, another organization has not already investigated and found the cause, etc.) to determine and schedule appropriate remedial action. The audited organization shall assure documentation of remedial action taken is provided. Adverse audit findings shall be evaluated to determine the need for action to prevent recurrence. If such action is deemed necessary, the results of the investigation (root cause analysis), the corrective action taken or planned to prevent recurrence, and a schedule for implementation shall be provided by the audited organization. Such evaluations and implementation of actions shall be scheduled and performed consistent with the safety signiGcance of the item. The audited organization shall take appropriate action to assure corrective action is accomplished as scheduled. In the event the action or schedule ofimplementation must be changed, the audited organization shall provide a revised response on or before the originally scheduled complecion date wish statuses the corrective action and states its completion date. Evaluation progress and corrective action impkmentatior, will be performed and tracked in accordance with provisions of Section 16 of the Union Electric Operating Quality Assurance Manual.
With regard to Section 4.5.2 of ANSI N45.2.12-1977 titled By Auditine Ornanization: UE shall comply with the following clarification of the section: For internal audits, performed by or for the Quality Assurance Department, follow-up actions will be taken by the audited organization as described in Section 16 of this OQAM. The internal audit program implemented in Section 18 of this OQAM provides assurance that the corrective action program requirements are properly implemented. By sampling responses to conditions adverse to quality, the adequacy of root cause analysis, implementation of remedial action, and action to prevnd s ecurrence are veriGed to assure effective corrective action program implementation. Therefore, the auditing organization will not necessarily evaluate the adequacy and assure action is identined and accomplished fr: each adverse Gnding. External audits shall comply with section 4.5.2 of ANSI N45.2.12-1977.
A-24
i
$$NIONELECTRIC s
CALLAWAY NUCLEAR PLANT 1
OPERATING QUALITY ASSURANCE MANUAL I) ATE: 5l97 r----------------------------------------------------------------
i a REGULATORY GUIDE 1.146 INITIAL ISSUE DATED 8/80 i
t_________________________________________________________________;
QualiGcation of Quality Assurance Program Audit Personnel for Nuclear Power Plants (Endorses ANSI N45.2.23-1978)
(CTSN 2247,2248,2249,2250,2251,2252,2254,2257,2258,2259,2968,2969,2986,3739)
DISCUSSION:
UE complies with the recommendations of this Regulatory Guide with the following clari6 cations:
With respect to Section 1.4 of ANSI N45.2.23-1978 titled Dennitions: Definitions in this Standard which are not included in ANSI N45.2.10 shall be used: " Audit" which is included in this Standard and ANSI N45.2.10 shall be used as clarified in this Appendix under Regulatory Guide 1.74.
With respect to Section 2.2 of ANSI N45.2.23 - 1978 titled Ouali6 cation of Auditors: Subsection 2.2.1 references an ANSI B54.2 (presumed to be standard N45.2); therefore, UE shall comply with an alternate subsection 2.2.1 which reads:
(CTSN 2246)
Orientation to provide a working knowledge and understanding of the Operating QA Manual, including the ANSI standards and Regulatory Guides included in this Appendix and UE's procedures for implementing audits and reporting results.
With respect to Section 3.2 of ANSI N45.2.23 - 1978 titled Maintenance of Proficiency: UE shall comply with the requirements of this Section by defining " annual assessment" as one which takes places every 12 + or - 3 months and which uses the initial date of certification (not the calendar year) as the starting date for determining w hen such annual assessment is due. The combined time interval for any three consecutive assessment intervals shall not exceed 3.25 years.
(CTSN 2253)
With respect to Section 4.1 of ANSI N45.2.23 - 1978 titled Ornanizational 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 Auurance; Supervising Engineer, QA; or Lead Auditor spall, prior to commencing the audit, assign personnel who collectively have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.
With respect to Section 5.3 of ANSI N45.2.23 - 1978 titled Updatine of1.ead Aud; tor's Records: UE shall substitute the following sentence for this Section: (CTSN 3001)
Records for each Lead Auditor shall be maintained and updated during the period of the annual management assessment as denned in Section 3.2 (as clari6ed).
With respect to Section 5.4 of ANSI N45.2.23 - 1978 titled Records Retention: UE shall substitute the following sentence for this Section: (CTSN 3002)
Quali0 cation records shall be generated and maintained as required by OQAM Section 17 and by commitment ta Regulatory Guide 1.88 (ANSI N45.2.9) as clarined in this Appendix.
In every case either identical or equivalent coritrols are provided in the sections of the referenced Standards and documents.
A-25