ML25343A253
| ML25343A253 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 12/09/2025 |
| From: | Ameren Missouri, Union Electric Co |
| To: | Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML25343A250 | List: |
| References | |
| ULNRC-06972 | |
| Download: ML25343A253 (0) | |
Text
Attachment 2 to ULNRC-06972 OQAM REVISION 37a, 37b, 37c, 37d MARKUPS This attachment provides the markups for Ameren Missouri's Operating Quality Assurance Manual (OQAM) Revisions 37a, 37b, 37c, and 37d which incorporate OQAM Change Notices OQAMCN 23-005,23-004, 24-002,24-003, and 25-001 respectively. New text is depicted in blue underlined text and deleted text is depicted in red strikethrough text.
This attachment includes 26 pages.
OQAM Revision 037a This Interim Update Revision incorporates the changes reflected in OQAMCN 23-005
RIP l
SECTION NO. 18 Ameren REVISION:
037a MISSOURI CALLAWAY ENERGY CENTER OPERATING QUALITY ASSURANCE MANUAL DATE:
07/24 18.5 The Manager, Nuclear Oversight shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Nuclear Oversight has sufficient authority and organizational freedom to schedule and perform both internal and external audits. This individual has the organizational responsibility to measure and assure the overail effectiveness of the OQAP and is independent of the economic pressures of production when opposed to safety or quality. The Manager, Nuclear Oversight has direct access to the Senior Vice President and Chief Nuclear Officer.
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 NOS Department for quality trends and results reported to the appropriate management. The Manager, Nuclear Oversight 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 Manager, Nuclear Oversight shall ensure an independent review of the onsite audit program is conducted periodically, to assure that audits are being performed in accordance with the OQAP. Appropriate levels of management shall be provided copies of internal and external audit reports.
Internal audits shall be conducted by the NOS Department and shall be performed with a frequency commensurate with their safety significance. An audit of safety-related functions shall be completed in accordance with formal audit schedules within a period of two (2) years. A maximum grace period of 99-days25 percent of the audit interval may be applied to performance of internal audits provided the two (2) year frequency for the following audit performance is not set forward. Each element of the OQAP, such as design control and document control, and each area of Plant operations shall be audited.
Supplementary to the biennial requirements to audit safety-related functions:
e
§©Audits of Unit activities (listed below) SHALL be conducted on a performance based frequency by the NOS Department, not to exceed 24 months
- a)
The 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 performance of activities required by the Operating Quality Assurance Program to meet the criteria of Appendix B, 10 CFR Part 50, The Radiological Environmental Monitoring Program and the results thereof; The OFFSITE DOSE CALCULATION MANUAL and implementing procedures; The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wastes; The performance of activities required by the Quality Assurance Program for effluent and environmental monitoring; and Any other area of Unit operation considered appropriate by the Senior Vice President and Chief Nuclear Officer.
A grace period of 90-daysa maximum of 25 percent of the audit interval may be applied to the 24 month frequency for internal audits, provided the 24 month frequency for the following audit performance is not set forward.
[CN 23-005 Page 2 of 5
OQAM Revision 037b This Interim Update Revision incorporates the changes reflected in OQAMCN 23-004 and 24-002.
My SECTION NO.
1 Ameren REVISION:
037b MISSOURI CALLAWAY ENERGY CENTER OPERATING QUALITY ASSURANCE MANUAL DATE:
09/24 1.7.6 The ORC shall be responsible for:
l CN 24-002 a)
BDeleted-Review ofsignificant conditions adverseto quality.
b)
Review of 10 CFR 50.59 and 10 CFR 72.48 evaluations regarding:
¢ procedures, changes to procedures, equipment, systems or facilities, and tests or experiments completed under the provision of 10 CFR 50.59 and 10 CFR 72.48 to verify that such actions did not require prior NRC approval.
Review of proposed procedures and changes to procedures, equipment, systems or facilities which may involve prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48°;
Review of proposed test or experiments which may involve prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48°;
Review of proposed changes to Technical Specifications or Operating License; Investigation of all violations of the Technical Specifications including the forwarding of reports covering evaluation and recommendations to prevent recurrence to the Senior Vice President and Chief Nuclear Officer.
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; Review of all REPORTABLE EVENTS; Review of the plant Security Plan; Review of the Radiological Emergency Response Plan; Review of changes to the PROCESS CONTROL PROGRAM, the OFFSITE DOSE CALCULATION MANUAL, and Radwaste Treatment Systems; 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 Senior Director, Nuclear Operations.
Review of Unit operations to detect potential hazards to nuclear safety; Investigations or analysis of special subjects as requested by the Senior Vice President and Chief Nuclear Officer.
Review of Unit Turbine Overspeed Protection Reliability Program and revisions thereto; Review of the Fire Protection Program.
Consistent with 10 CFR 72.210 and the requirements of 10 CFR 72.212(b)(5) through (b)(8), 10 CFR 72.48 evaluations performed by the CoC holder under their quality program do not require ORC review.
Page 4 of 5
Wy SECTION NO.2 4 Ameren Z
REVISION:
037b CALLAWAY ENERGY CENTER OPERATING QUALITY ASSURANCEMANUAL DATE:
09/24 QUALITY ASSURANCE PROGRAM Ameren Missouri has established an OQAP which controls activities affecting quality. The Program encompasses those quality activities necessary to support the operating phase of the CEC and shall comply with 10 CFR 50, Appendix B
- "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" as described herein and with the Regulatory Position of Regulatory Guide 1.33. This Manual also complies with requirements of 10 CFR 72, Subpart G "Quality Assurance, as applicable to the scope of work being performed and described in Appendix B of this OQAM. 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 ofthe NRC questions applicable to the OQAP, along with the responses, are maintained as a QA Record separate from the OQAM. The Senior Vice President and Chief Nuclear Officer has reviewed the Program and formulated the policy in addition to authorizing Program implementation. This responsibility has been established by the Chairman and Chief Executive Officer of Ameren Missouri for establishing and implementing the Quality Assurance Program requirements.
Lines of authority and responsibility have been established from the Chairman and Chief Executive Officer to the Senior Vice President and Chief Nuclear Officer 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 job descriptions for key personnel having direct operating, support or audit responsibility. Where specific 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 bya superior.
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), 10 CFR 50.71 and 10 CFR 72.
The pertinent requirements of the OQAP apply to all activities affecting the safety-related functions of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. The safety-related structures, systems and components identified in Table 3.2-1 of the Callaway Final Safety Analysis Report-Standard Plant (FSAR SP). This list includes structures, systems, and components identified during the design and construction phase and may be modified as required during operations consistent with their importance to
safety. Modifications to this list require the approval of the Manager, Nuclear Oversight and the Director; CN 24-002 Engineerine-Design-&-Projects responsiblefor Design Engineering or designee and shall be issued and
controlledin accordance with Section 6. The development, control, and use of computer programs to be usedin safety-related activities are within the scope of the OQAP. The degree of controis applicable to each computer program shall be consistent with the program's importance to safety-related activities.
Consumables which could affect the form, fit or function of safety-related structures, systems, and components, although not listed in Table 3.2-1 of the Callaway FSAR SP, are also under the control of the OQAP.
The OQAP shall be implemented throughout the operating life of the CEC. 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.
Page l of4
Re l
SECTION NO. 2 Ss i
Ameren REVISION:
037b MISSOURI
CALLAWAY ENERGY CENTER OPERATING QUALITY ASSURANCE MANUAL DATE:
09/24 2.9 Preservice (PSI) and Inservice (ISI) inspection, testing, and examination activities may be performed by outside organizations. These inspections and other operating phase "code" activities shall comply with the requirements of the applicable Code Edition and Addenda of the ASME Boiler and Pressure Vessel Code. This compliance includes the independent third-party inspection coverage of code" items by an Authorized Nuclear Inspector.
General indoctrination and training programs shall 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 a
CEC personnel are described in Section 13.2 of the Callaway FSAR Site Addendum (FSAR SA). The CN 24-002 training of permanent Plant personnel is the responsibility of the Director, FrainingeDirector responsible
soto for Training or designee. 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 Ameren Missouri'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.
A retraining and replacement training program for the unit staff shall be maintained under the direction of the Director, Training.
The training programs for Shift Managers, Operating Supervisors, Reactor Operators, and Shift Technical Advisors shall meet or exceed the requirements and recommendations of Section 5 of ANSI/ANS 3.1-1981 as endorsed by Regulatory Guide 1.8, Rev. 2, with the same exceptions as contained in the current revision to the Operator Licensing Examiner Standards, NUREG-1021, ES-202, and 10 CFR Part 55.
All other training programs with the exception of the Radiation Protection program shall meet or exceed the requirements and recommendations of Section 5 of ANSI/ANS 3.1-1978. Radiation Protection program shall meet the requirements of ANSI/ANS 3.1-2014 as endorsed by Regulatory Guide 1.8, Rev.
4 with the exception of the Radiation Protection Manager which shall continue to meet the requirements of Regulatory Guide 1.8, Rev. 1, September, 1975 as clarified by USNRC HPPOS-020.
Training shall include familiarization with relevant industry operational experience identified by the Performance Improvement Department.
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, Nuclear Oversight 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. This individual 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.
Page 3 of 4
- l. OPERATING QUALITY ASSURANCE MANUAL 10.
10.6 CN 24-002 10.7 WW SECTION NO. 10 7
oe Ameren REVISION:
037b CALLAWAY ENERGY CENTER
DATE:
09/24 INSPECTION 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 of individuals who perform the activity.
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.
Inspection of activities at the CEC 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.
Engineering Programs shall be responsible for assuring the development of preservice and inservice (PSI/ISD 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.
Engineering Programs 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, Engineering Programs shall be responsible for administering and performing the PSI/ISI program and implementing the examination and testing plans developed within Nuclear Generation. 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.
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 of inspection personnel. The Director, Fraining Director responsible for Training or designee shall be responsible for providing related technical and quality training appropriate to the certification/qualification of Ameren Missouri personnel.
Quality Control inspection personnel or other personnel 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 N45.2.6-1978. Other personnel performing "inspection activities shall have appropriate experience, training, and retraining to assure competence in accordance with ANSI/ANS-3.1-1978 and applicable codes and standards. 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 N45.2.6-1978, Ameren Missouri shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent competence.
Page l of 2
OPERATING QUALITYASSURANCE MANUAL 11.9 RZ
)
SECTION NO. 11 7 l 4Ameren
/
REVISION:
037b MISSOURI CALLAWAY ENERGY CENTER DATE:
09/24 Review and approval of tests and experiments not described in the FSAR shall be conducted as specified in the OQAM Section 5, 10 CFR 50.59, and 10 CFR 72.48.
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 of individuals not qualified to the program provided they are supervised or overseen by qualified individuals for the activities being performed. The DirecterFrainingDirector responsible for Training or designee shall be responsible for providing related technical and quality training for Ameren Missouri personnel who perform testing.
Personnel within the various Ameren 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 under the direction and control of the Senior Vice President and ChiefNuclear Officer. The qualification of QC testing personnel shall be defined in three levels of capability as described in ANSI N45.2.6-1978. Other personnel performing "testing" activities shall have appropriate experience, training, and retraining to assure competence in accordance with ANSI/ANS-3.1-1978 and applicable codes and standards. 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 N45.2.6-1978, Ameren Missouri shall demonstrate by documented results of written examinations and evaluations of actual work proficiency that individuals possess comparable or equivalent competence.
Personnel from outside organizations or Ameren personnel who are not Nuclear Generation personnel selected to perform other testing activities associated with safety-related items at the CEC shall meet one or more of the following for the activities which they are performing:
e be certified as required by ANSI N45.2.6-1978, meet the education and experience requirements applicable to the position, e
be qualified through Ameren Missouris systematic approach to training, e
be qualified through a vendors training and qualification program, which has been approved by Ameren Missouri.
When contractors or vendors are retained to perform work activities or to provide services associated with safety-related items at the CEC, 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 CEC, then the persons performing the testing/valve settings would be qualified as required by the vendor's quality assurance program unless otherwise specified in the applicable procurement documents.
Page 2 of 2
OPERATING QUALITY ASSURANCE MANUAL _
[ cn 24-002 l 12.5 MW 7
"SECTION NO. 12 Ss4 Ameren REVISION:
037b MISSOURI CALLAWAY ENERGY CENTER DATE:
09/24 CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test equipment utilized in activities affecting quality shall be controlled in accordance with written procedures or instructions. The procedures or work instructions for calibration and control shall address the identification of test equipment, calibration techniques, calibration frequencies, maintenance control, and storage requirements. The equipment subject to these controls includes:
(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) when it is used to provide quantitative calibration and test data (i-e., in lieu of using M&TE).
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.
Permanently installed process instrumentation shall be afforded the control measures described herein consistent with the surveillance testing program and preventive maintenance program.
The calibration and control program established at the CEC shall assure that M&TE, reference standards, and PI maintain their required accuracy. The Direeter;Senior Manager or above responsible for Maintenance or designee is responsible for assuring the program establishment. Program implementation is the responsibility of the appropriate Department Heads.
M&TE, reference standards, and PI shall be utilized by various 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 CEC in activities affecting quality shall be required to implement calibration and control measures consistent with the applicable requirements of this section. Vendors activities performed offsite, other than calibration services for CEC M&TE or PI, do not need to meet the requirements of item 8 and 9 of OQAM Section 12.6 unless specified in procurement documents. Vendor-provided calibration services for CEC M&TE or PI are required to be consistent with the requirements of item 8 and 9 of OQAM Section 12.6. Other Ameren organizations (e.g. relay testing, battery testing) using M&TE or reference standards at the CEC 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 CEC calibration and control program.
Page 1 of 2
OPERATING QUALITYASSURANCEMANUAL 13.5 CN 24-002 MW SECTION NO. 13 Ameren REVISION:
037b MISSOURI CALLAWAY ENERGY CENTER DATE:
09/24 HANDLING, STORAGE, AND SHIPPING 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 of items is preserved from fabrication until incorporation in the CEC. The procedures shall also establish responsibilities for determining applicable requirements for packaging, shipping, receiving, storage, and handling activities.
Generic procedures or instructions shall be prepared 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.
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.
The requirements for activities described in this Section shall be divided into levels with respect to protective measures to prevent damage, deterioration, or contamination of items. These levels are based upon the important physical characteristics and not the important functional characteristics of the item with respect to safety, reliability, and operation. The specific environmental, special measures or other conditions applicable to each level shall be described in implementing procedures.
The Direeter;SeniorManager or above responsible for Maintenance or designee 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.
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, which 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.
Procurement documents or procedures shali address packaging requirements which afford protection from the possible degradation of quality during shipping, handling, or storing. The packaging protection specified may vary in degree consistent with the item's protection classification. Similarly, the mode of transportation employed shall be consistent with the protection classification of items.
Measures shall also be established to control the shipping of licensed radioactive materials in accordance with 10 CFR 71.
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 ina storage level commensurate with the protection level of items. The various levels of storage shall correspond to prescribed environmental conditions which are procedurally defined.
Pagel of 1
SECTION NO.
16 Ne 4 Ameren REVISION:
037b MISSOURI CALLAWAY ENERGY CENTER OPERATING QUALITYASSURANCE MANUAL DATE:
09/24 CORRECTIVE ACTION 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:
1)
Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.
Define responsibility for verifying that remedial action was taken for conditions adverse to quality.
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 recurrence.
Define responsibility for performing root cause evaluation, determining necessary actions to prevent recurrence, implementing those actions and verifying completion of those actions for significant conditions adverse to quality.
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.
Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct address, distribution of copies, electronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.
Provide methods for submitting reports required by external agencies concerning conditions adverse to quality.
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.
Conditions adverse to quality which are classified as nonconformances shall be controlled in accordance with the additional requirements described in OQAM, Section 15.
A significant condition adverse to quality is a condition adverse to quality that, if uncorrected, could have a serious effect on safety or operability. 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.
Conditions adverse to quality which involve defects in basic components shall be reviewed for reporting applicability under 10 CFR 21 and other Federal reporting requirements.
The nature of the condition adverse to quality may be such that remedial actions must be taken immediately, whereas development and implementation of corrective action to preclude recurrence may take substantially longer.
Engineering Design or Projects personnel shall review conditions adverse to quality which involve design deficiencies or which involve recommending design/configuration changes as corrective action.
Fuel Cycle Management should review conditions adverse to quality for fuel related issues. Fhe-ORG
- CN 24-002 shall-review-significant conditions-adverse to quality.
mn Page l of 2
OPERATING QUALITY ASSURANCE MANUAL 18.5 CN 23-004 MW
)
SECTION NO. 18 lAmeren REVISION:
037b MISSOURI rn CALLAWAY ENERGY CENTER DATE:
09/24 The Manager, Nuclear Oversight shall be responsible for assuring the implementation of a comprehensive system of planned audits to verify compliance with the OQAP. The Manager, Nuclear Oversight has sufficient authority and organizational freedom to schedule and perform both internal and external audits. This individual 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, Nuclear Oversight has direct access to the Senior Vice President and Chief Nuclear Officer.
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 NOS Department for quality trends and results reported to the appropriate management. The Manager, Nuclear Oversight 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 Manager, Nuclear Oversight shall ensure an independent review of the onsite audit program is conducted periodically, to assure that audits are being performed in accordance with the OQAP. Appropriate levels of management shall be provided copies of internal and external audit reports.
Internal audits shall be conducted by the NOS Department and shall be performed with a frequency commensurate with their safety significance. An-auditAudits of safety-related functions shall be completed in accordance with formal audit schedules-within a-period oftwo-2)}years which are separated into three cycles covering a period of 36 months. Each cycle includes a set of audits and 24-month reviews. Results of the completed audits will be reviewed to determine if additional audit activities are necessary prior to their next scheduled performance. Each functional area will receive an additional performance analysis (24-month review) within two years of the last performed audit based on internal and external data; functional area changes in responsibility, resources, or management; and consideration_of the impacts, as applicable, to determine if additional audit activities are necessary prior to the 36-month scheduled performance.. A maximum grace period of 25 percent of the audit interval may be applied to performance of internal audits provided the two @}-year36 month frequency for the following audit performance is not set forward. Each element of the OQAP, such as design control and document control, and each area of Plant operations shall be audited.
Page 2 of S a
Wy l
SECTION NO. 18 Ameren REVISION:
037b MISSOURI
CALLAWAY ENERGY CENTER OPERATING QUALITYASSURANCE MANUAL l DATE:
09/24 18.8 Supplementary to the biennial requirements to audit safety-related functions:
e Audits of Unit activities (listed below) SHALL be conducted on a performance based frequency by CN 23-004 the NOS Department, not to exceed 24-36months
- a)
The 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 performance of activities required by the Operating Quality Assurance Program to meet the criteria of Appendix B, 10 CFR Part 50, The Radiological Environmental Monitoring Program and the results thereof; The OFFSITE DOSE CALCULATION MANUAL and implementing procedures; The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wastes; The performance of activities required by the Quality Assurance Program for effluent and environmental monitoring; and Any other area of Unit operation considered appropriate by the Senior Vice President and Chief Nuclear Officer.
A grace period of a maximum of 25 percent of the audit interval may be applied to the 24 month frequency for internal audits, provided the 24 month frequency for the following audit performance is not set forward.
The following areas shall be reviewed or audited per the frequency specified in applicable regulations:
Radiological Protection program Security program Access Authorization Fitness-For-Duty program Radiological Emergency Response Plan In addition to the audits conducted under 18.8.a) i) and 18.8.1, a triennial Fire Protection Program audit shall be conducted with an audit scope that includes the following:
FP Program as defined in FSAR SP, Section 9.5.1; Fire Protection Quality Assurance Program (FSAR-SP, Section 9.5.1.6.2);
NFPA 805 Fire Protection Monitoring Program (FSAR-SP, Section 9.5,1.4.2);
This triennial audit utilizes a qualified outside independent Fire Protection Consultant (non-Ameren).
During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements are properly implemented.
Page 3 of 5
OQAM Revision 037c This Interim Update Revision incorporates the changes reflected in OQAMCN 24-003.
NZ LL,Ameren MISSOURI REVISION:
037¢ CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITY ASSURANCE MANUAL OQAP POLICY / INTRODUCTION It is the policy of Union Electric Company (Ameren Missouri) to develop, implement, and maintain an Operating Quality Assurance Program (OQAP) for Callaway Energy Center as required by provisions of the 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 CN 04.003 3)
The capability to prevent or mitigate the consequences of accidents which could result in off-site aT 3
CN 24-003 exposures comparable to the guideline exposures of NRC Regulation 10 CFR Part-+00 10 CFR 50.67 and Regulatory Guide L.183.
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.
Callaway Energy Center has been licensed to use 10CFR50-6650.69 "Risk-Informed Categorization and Treatment of Structures, Systems, and Components for Nuclear Power Reactors." Within the provisions of this voluntary regulation, alternative approaches for establishing the requirements for treatment of a structure, system, or component using a risk-informed method of categorization according to safety significance are allowed. Applicability and scope of structures, systems, and components will be in accordance with approved processes and detailed in site licensing documents. Structures, systems, and components categorized as Safety-Related, Low Safety Significant (RISC-3) in accordance with 10CFR50.69 and the site license will continue to be governed by the OQAM until an alternative treatment is developed.
Ameren Missouri 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.
' Effective December 31, 1997, Union Electric (UE) and Central Illinois Public Services Company (CIPSCO) completed a merger into a new operating company
- Ameren Corporation. With this merger, some reorganization occurred with several of the functions and divisions previously within Union Electric being redistributed either to AmerenUE (new operating company for the power generation portion of the company previously within UE) or Ameren Services (new operating company for the non-power generation side of the newly created Ameren Corporation). As of October 1, 2010 the name of AmerenUE was changed to Ameren Missouri. Although the Docket still refers to Callaway Plant Unit 1, Ameren Missouri refers to the facility as Callaway Energy Center.
Me SECTION NO.
1 Ameren REVISION:
037c MISSOURI CALLAWAY ENERGY CENTER OPERATING QUALITY ASSURANCE MANUAL DATE:
02/25 1.7.6 The ORC shall be responsible for:
a)
Review of significant conditions adverse to quality to ensure causes of the condition have been determined and adequate corrective action has been taken.
CN 24-003 b)
Review of 10 CFR 50.59 and 10 CFR 72.48 evaluations regarding the following and to verify that such actions did not require prior NRC approval:
¢ procedures,
¢ changes to procedures, equipment, systems or facilities, and e
tests or experiments completed under the provision of 10 CFR 50.59 and 10 CFR 72.48 te-verify that such-aetiens did not require-prier NRC approval.
CN 24-003
Review of proposed procedures and changes to procedures, equipment, systems or facilities which may involve prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48°; or involves a change in Technical Specifications.
Review of proposed test or experiments which may involve prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48°;
Review of proposed changes to Technical Specifications or Operating License; Investigation of all violations of the Technical Specifications including the forwarding of reports covering evaluation and recommendations to prevent recurrence to the Senior Vice President and Chief Nuclear Officer.
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; Review of all REPORTABLE EVENTS;
i)
Review of the plant Security Plan and the Cyber Security Plan and revisions thereto; CN 24-003 j)
Review of the Radiological Emergency Response Plan and revisions thereto; Review of changes to the PROCESS CONTROL PROGRAM, the OFFSITE DOSE CALCULATION MANUAL, and Radwaste Treatment Systems and revisions thereto; 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 Senior Director, Nuclear Operations.
Review of Unit operations to detect potential hazards to nuclear safety; Investigations or analysis of special subjects as requested by the Senior Vice President and Chief Nuclear Officer.
CN 24-003 Review of Unit Turbine Overspeed Protection Reliability Program and revisions thereto; Review of the Fire Protection Program and revisions thereto.
Consistent with 10 CFR 72.210 and the requirements of 10 CFR 72.212(b)(5) through (b)(8), 10 CFR 72.48 evaluations performed by the CoC holder under their quality program do not require ORC review.
Page 4 of 5
CN OPERATING QUALITY ASSURANCE MANUAL 3.18 24-003 l
My SECTIONNO.3 a Ameren nen.
MISSOURI REVISION:
037¢ CALLAWAY ENERGY CENTER DATE:
02/25 Independent of the responsibilities of the design organization, the requirements of the Onsite Review Committee (ORC) as defined in OQAM Section 1.0 shall be satisfied.
Safety Retated-Desien evaluations for design changes shall be reviewed by the ORC and approved by the Senior Director, Nuclear Operations.
When design is performed by an outside organization, Ameren Missouri shall perform or coordinate a review of the design for operability, maintainability, inspectability, FSAR commitment compatibility, test and inspection acceptance criteria acceptability, and design requirements imposed by Plant generating equipment.
10 CFR 50.59 and 10 CFR 72.48 evaluations, which consider the effect of the design as described in the design documents, shall be performed by the responsible Ameren Missouri engineering organization or outside organization(s). These evaluations shall include the basis for the determination that the design/configuration change does not involve prior NRC approval via a License Amendment or CoC Amendment. As deemed necessary by the evaluating organization, detailed analyses shall be performed to support the bases of 10 CFR 50.59 and 10 CFR 72.48 evaluations. Changes involving the substitution of equivalent hardware require the 10 CFR 50.59 and 10 CFR 72.48 process (in addition to the appropriate requirements of this OQAM) to assure that the design requirement changes are consistent with and do not alter the design criteria specified in existing design documents. When an outside organization prepares design documents under its QA program, review and approval per ANSI N45.2.11 will be included.
Design/configuration changes which require an amendment of the license shall be submitted on an application to the Nuclear Regulatory Commission for approval in accordance with 10 CFR 50.90.
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 performance of their duties through procedure revisions, or specific training in the operation of modified equipment or systems, or other appropriate means.
Records of design and configuration control activities are maintained in accordance with Section 17.
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.
Page 4 of 4
OPERATING QUALITYASSURANCE MANUAL Jen 24-003 l 18.8.1 AD SECTION NO. 18 Ameren REVISION:
037c c
MISSOURI ALLAWAY ENERGY CENTER DATE:
02/25 A grace period ofamaximum of 25 percent ofthe audit interval may be applied to the 24 36 month frequency for internal audits, provided the 24 36 month frequency for the following audit performance is not set forward.
The following areas shall be reviewed or audited per the frequency specified in applicable regulations:
Radiological Protection program Security program Access Authorization Fitness-For-Duty program Radiological Emergency Response Plan In addition to the audits conducted under 18.8.a) i) and 18.8.1, a triennial Fire Protection Program audit shall be conducted with an audit scope that includes the following:
FP Program as defined in FSAR SP, Section 9.5.1; Fire Protection Quality Assurance Program (FSAR-SP, Section 9.5.1.6.2);
NFPA 805 Fire Protection Monitoring Program (FSAR-SP, Section 9.5.1.4.2);
This triennial audit utilizes a qualified outside independent Fire Protection Consultant (non-Ameren).
During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements are properly implemented.
External audits shall be conducted by or for the NOS 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 Ameren Missouri performed audits and may not necessarily audit specific items furnished to Ameren Missouri. These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted in accordance with this OQAM and NOS 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.
When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC)
Mutual Recognition Arrangement (MRA), commercial grade surveys need not be performed provided all of the following conditions are met:
1.
A documented review of the supplier's accreditation is performed and includes a verification of the following:
a.
The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, "General Requirements for the Competence of Testing and Calibration Laboratories."
For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.
The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.
It is validated, at receipt inspection, that the laboratory's documentation certifies that:
Page 3 of 5
CN 24-003 CN 24-003 CN 24-003 l
CN 24-003 l
CN 24-003 NSI APPENDIX A FiAmeren REVISION:
037c MISSOURI CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITYASSURANCE MANUAL With regard to Section 3.4.2 of ANSI N18.7-1976/ANS 3.2 titled Requirements for the Onsite Operating Organization:
Some of Ameren Missouri's technical support organizations are physically located at the Callaway site. Therefore, the second sentence of this Section shall be implemented as follows:
"Initial incumbents or replacements for members of the onsite or offsite technical support organizations shall have appropriate experience, training and retraining to assure that necessary competence is maintained in accordance with the provisions of ANSI/ANS 3.1
- 1978Property "ANSI code" (as page type) with input value "ANSI/ANS 3.1</br></br>- 1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. as committed to in the OQAM."
In the third sentence, Ameren Missouri interprets "QA" to be "QC", consistent with the intent of Regulatory Guide 1.58 (ANSI N45.2.6-1978) and the OQAM.
Training standards referenced in this Section are implemented as described in this Appendix's commitments to Regulatory Guide 1.8 (ANSI/ANS 3.1) and Regulatory Guide 1.58 (ANSI N45.2.6-1978) or as otherwise included as part ofthe Callaway Operating License. Ameren Missouri's methods of documenting and otherwise meeting the remainder of the requirements of this Section are set forth in OQAM Section 2, in the Callaway Plant Technical Specifications, and in other licensing commitments.
With regard to Section 4.1 of ANSI N18.7-1976/ANS 3.2 titled General: The Ameren Missouri 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 4.2 of ANSI N18.7-1976/ANS 3.2 titled Program
Description:
Two aspects are addressed in this Section: audits and independent reviews. The independent review program shall be implemented as required by the OQAM. The Ameren Missouri 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/ANS 3.2 titled Independent Review Process: The requirements of this Section, including of its subparts, shall be met by compliance with the OQAM.
With regard to audit frequency specified in Section 4.5 of ANSI N18.7 1976 titled Audit Program: The Ameren Missouri audit program shall be implemented in accordance with the frequencies specified in OQAM Sections 18.7 and 18.8.
With regard to Section 4.5 of ANSI N18.7-1976/ANS 3.2 titled Audit Program: The Ameren Missouri 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/ANS 3.2 titled Program
Description:
The fourth sentence in this Section requires a "summary document." Ameren Missouri's OQAM is organized in accordance with the 18 criteria of 10 CFR 50, Appendix B. Ameren Missouri 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/ANS 3.2 titled Procedure Adherence: The temporary change requirements of this Section are delineated in the OQAM for activities occurring after the Operating License (OL) is issued; the requirements of the OQAM shail be used to control temporary changes.
Page 6 of 30
APPENDIXA Me ne A Amenen REVISION:
037¢ MISSOURI
CALLAWAY ENERGY CENTER DATE:
= 02/25 OPERATING QUALITYASSURANCE MANUAL With respect to Section 5.2.6 of ANSI N18.7-1976/ANS 3.2 titled Equipment Control: Ameren Missouri shall comply with l
CN 24-003 l 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 Ameren Missouri sometimes uses descriptive names to designate equipment, the sixth paragraph, second sentence is replaced with:
"Suitable means include identification numbers or other descriptions which are traceable to records of the status of inspections and tests."
The first sentence in the seventh paragraph shall be met after clarifying "operating personnel" to mean trained employees assigned to, or under the control of, Plant management at Callaway.
CN 24-903 l With regard to Section 5.2.7 of ANSI N18.7-1976/ANS 3.2 titled Maintenance and Modification: Ameren Missouri shall interpret the word "original" in the first sentence of this Section to modify ONLY the words "design bases." This interpretation is to assure that original inspection requirements are not imposed, without appropriate review, on modifications or maintenance activities which are similar in nature to original construction activities. In 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, Ameren Missouri 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 health and safety of the public, to protect equipment or personnel, or to prevent the deterioration of Plant conditions to a possibly unsafe or unstable level, maintenance or modification of equipment shall be preplanned and performed in accordance with written procedures. Where written procedures would be required and are not used, the activities that were accomplished shall be documented after-the-fact and receive the same degree of review as if they had been preplanned.
With regard to Section 5.2.7.1 of ANSI N18.7-1976/ANS 3.2 titled Maintenance Programs: Ameren Missouri shall comply ae with the requirements of the first sentence of the fifth paragraph, where practical. This clarification is needed since it is not
_ EN 24-003 always possible to promptly determine the cause of the malfunction. Ameren Missouri shall initiate proceedings to determine the cause, and shall make such determinations promptly, where practical. NOS is involved via both audits and surveillances, and QC is involved in inspection of maintenance inspection activities. Ameren Missouri shall comply with the commitment to Regulatory Guide 1.160 (10 CFR50.65) as described in FSAR Appendix 3A.
With regard to Section 5.2.8 of ANSI N18.7-1976/ANS 3.2 titled Surveillance Testing and Inspection Schedule:
In lieu of a "master surveillance schedule, the following requirement shall be met: "Schedules shall be established reflecting the l
CN 24-003 l status of in-plant surveillance tests and scheduled inspections."
With regard to Section 5.2.9 of ANSI N18.7-1976/ANS 3.2 titled Plant Security and Visitor Control: The requirements of the Security Plan shall be implemented in lieu of these general requirements. When compliance with an NRC accepted l
CN 24-003 l program (e.g., Callaway Security Plan) is referenced, Ameren Missouri has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance program standards.
Page 7 of 30
l CN 24-003 l CN 24-003 l ov 24-003 l
l CN 24-003 l
lBD APPENDIX A Fi4Ameren MISSOURI CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITYASSURANCE MANUAL REVISION:
037¢ With regard to Section 5.2.10 of ANSI N18.7-1976/ANS 3.2 titled Housekeeping andCleanliness Control: The requirements of this Section, beginning with the last sentence of the first paragraph and continuing through the end of the Section, shall be implemented as described in Ameren Missouri'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/ANS 3.2 titled Procurement Document Control: Ameren Missouri shall comply with the following sentences in lieu of the last sentence of the referenced Section.
When procuring commercial-grade items (products or services), the procurement documents are not required to impose a quality assurance program consistent with ANSI N45.2. Alternative requirements described in Ameren Missouris commitment to Regulatory Guide 1.123 as set forth in this Appendix may be implemented in lieu of imposing a quality assurance program consistent with ANSI N45.2. 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/ANS 3.2 titled Review, Approval and Control of Procedures; in lieu of the wording starting with the second sentence in the third paragraph of this section beginning with "The frequency of...,"
through the end of the fourth paragraph, which ends "... a procedure review.", Ameren Missouri 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 ofprocedure changes necessary to implement License, Technical Specification, FSAR or OQAM revisions as well as evaluations of changes necessary to resolve 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/ANS 3.2 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.
The following is a clarification to the sixth paragraph:
Inspections may not require generation of a separate inspection report. Inspection requirements may be integrated into appropriate procedures or other documents with the procedure or document serving as the record. However, records of inspections shall be identifiable and retrievable.
With regard to Section 5.2.18 of ANSI N18.7-1976/ANS 3.2 titled Control ofSpecial Processes: Ameren Missouri shall comply with the following sentence in lieu of the last sentence of the referenced Section:
Page 8 of 30
lD APPENDIX A A Amerien REVISION:
_037¢ MISSOURI CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITYASSURANCE MANUAL For special processes not covered by existing codes or standards, or where item quality requirements exceed the requirements of established codes or standards, personnel, equipment and procedure qualification shall be defined by engineering.
With regard to Section 5.3.5(4) of ANSI N18.7-1976/ANS 3.2 titled Supporting Maintenance Documents: Ameren l
CN24-003 Missouri 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 specific section; the manual may then be used in conjunction with the procedure for performing the activity.
(3) The material, either as originally written or as modified by the procedure's author, may be reproduced within the body of the procedure.
In options (1) and (2) above, the material shall be considered as having received "the same 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, Ameren Missouri is NOT reviewing and accepting the entire manual. Ameren Missouri reviews and accepts that portion of each vendor manual that is used by Ameren Missouri.
With regard to Section 5.3.9 of ANSI N18.7-1976/ANS 3.2 titled Emergency Procedures: Ameren Missouri's Emergency Procedures are in the format specified by the NRC in the Callaway Safety Evaluation Report, as required for issuance of the Operating License, in lieu of the requirements given here.
l CN 24-003 With regard to Section 5.3.9.2 of ANSI N18.7-1976/ANS 3.2 titled Events of Potential Emergency: The licensing FSAR l
CN 24-003 l identified natural occurrences which affect the Callaway Plant. Therefore, Ameren Missouri shall interpret item (11) to mean the natural occurrences which were evaluated in the licensing FSAR.
With regard to Section 5.3.9.3 of ANSI N18.7-1976/ANS 3.2 titled Procedures for Implementing Emergency Plan:
l &N 24-003 l Ameren Missouri'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, Ameren Missouri has substituted the NRC accepted program for applicable regulatory requirements in lieu of the general requirements of the Quality Assurance Program standards.
Page 9 of 30
l CN 24-003 lD APPENDIX A Ameren REVISION:
_037¢ MISSOURI CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITYASSURANCE MANUAL Guide 1.8 (ANSI/ANS 3.1-1978). This position is consistent with Regulatory Guide 1.33 (ANSI N18.7-1976/ANS 3.2, Section 3.4.2).
In instances where the education and experience recommendations of ANSI N45.2.6-1978 are not met by QC personnel, Ameren Missouri 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 HI 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 Ameren Missouri is committed at the time the NDE is performed.
However, when qualifying personnel to perform visual examinations in accordance with IWA-2300 of Section XI, Division 1, ANSI/ASME N45.2.6-1978 may be used instead of ANSI N45.2.6-1973 (Code Case N-424). Persons certified to perform NDE for Code work shall also be considered as qualified to perform non-Code NDE (e.g. crane hook inspection) unless more rigorous qualification or certification requirements are imposed by Ameren Missouri's commitments or government regulations.
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; Ameren Missouri 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 Ameren employees; the applicability of the Standard to suppliers shali be documented and applied, as appropriate, in the procurement documents for such suppliers.
With regard to Section 1.4 of ANSI N45.2.6
- 1978Property "ANSI code" (as page type) with input value "ANSI N45.2.6</br></br>- 1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. 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 Ameren Missouri's commitment to Regulatory Guide 1.74.
With regard to Section 2.5 of ANSI N45.2.6
- 1978Property "ANSI code" (as page type) with input value "ANSI N45.2.6</br></br>- 1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. titled Physical: Ameren Missouri shall implement the requirements of this Section with the stipulation that, where no special physical characteristics are required, none shall be specified. The converse is also true: if no special physical requirements are stipulated by Ameren Missouri, none shall be considered necessary.
REGULATORY GUIDE 1.64 REVISION 2 DATED 6/76 Quality Assurance Requirements for the Design of Nuclear Power Plants (Endorses ANSI N45.2.1 11-1974)
DISCUSSION:
Ameren Missouri 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 Page 16 of 30
l CN 24-003 RD APPENDIX A 4Ameren REVISION:
_037c MISSOURI CALLAWAY ENERGY CENTER DATE:
02/25 OPERATING QUALITYASSURANCE MANUAL "Bids"
- Supplier quotation submitted in response to specified technical and quality requirements for which price and delivery are primary considerations.
"Proposals"
- Supplier offerings that define the scope of supply as well as specific technical and quality requirements for a product or service. Such offerings usually require negotiation prior to acceptance as either a purchase order, contract, or Engineering Service Agreement.
"Program Deficiencies" (Not defined in ANSI N45.2.10, but used and defined differently in Regulatory Guide 1.144 (ANSI N45.2.12))
- Failure to develop, document or implement effectively 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 Ameren Missouri's suppliers.
"Independent Verification
- Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed. Such 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
- 1977Property "ANSI code" (as page type) with input value "ANSI N45.2.12</br></br>- 1977" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. (Regulatory Guide 1.144) and Section 1.4.3 of ANSI N45.2.23
- 1978Property "ANSI code" (as page type) with input value "ANSI N45.2.23</br></br>- 1978" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. (Regulatory Guide 1.146) as opposed to the definition given in ANSI N45.2.10
- 1973Property "ANSI code" (as page type) with input value "ANSI N45.2.10</br></br>- 1973" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.)
- 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 not be confused with surveillance or inspection for the sole purpose of process control or product acceptance.
"Must"
- (Not defined in any ANSI Standard)
- An internally auditable requirement imposed by Ameren Missouri management upon its employees, contractors, and agents
- above and in excess ofthe 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 theOQAM.)
"Unit staff"
- (Not defined in any ANSI standard)
- Means those personnel who report to the Senior Director, Nuclear Operations. This term shall also be synonymous with the onsite operating organization" described (but not defined) in ANSI N18.7-1976/ANS 3.2, Section 3.4.2; the unit staff" as used in the OQAM and in Callaway Plant Technical Specifications Section 5.2 and its subparts; including operating staff and unit organization as described in the Callaway Plant Technical Specifications Section 5.2.1 and 5.2.2, respectively; and personnel having line responsibility for operation of the unit as used in the OQAM.
Page 18 of 30
OQAM Interim Revision 037d This interim revision incorporates the change notices listed below:
OQAMCN 25-001 All changes are annotated with the change notice number in the margin and reflect the original information (lined-through) and the change notice information.
Re APPENDIX B Ss a
4 Ameren REVISION:
037d MISSOURI CALLAWAY ENERGY CENTER OPERATING QUALITYASSURANCE MANUAL DATE:
04/25 Category C (ITS C)
Minor impact on safety ITS C items include structures, systems and components whose failure or malfunction would not significantly reduce the packaging effectiveness and would not be likely to create a situation adversely affecting public health and safety.
1.0.
ORGANIZATION 1.1.
The Senior Vice President & Chief Nuclear Officer has overall responsibility and authority for the DCSS quality program.
CN 35-001 2 Overall implementation of the quality program requirements for the Dry Cask Storage System and spent fuel dry 1
cask loading operation resides with each Callaway Energy Center Director and above for their area of responsibility.
The Manager, Nuclear Oversight, has the responsibility for verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.
QUALITY ASSURANCE PROGRAM The Quality Assurance Program for DCSS complies with the applicable sections of the Callaway Energy Center OQAM, the requirements of Title 10, Code of Federal Regulations, Part 72, Subpart G, Quality Assurance Requirements for the Independent Storage of Spent Nuclear Fuel, High Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste, and applicable industry codes and standards as identified in the DCSS Final Safety Analysis Report.
The Ameren Missouri Quality Assurance Program controls established in this manual to meet 10 CFR 50 Appendix B shall be applied to those portions of the Dry Cask Storage System that are classified as ITS A with additional requirements for record retention specified in section 17 of this Appendix.
29 66 References throughout this document to Callaway Plant, Callaway Energy Center, station, or plant, includes the Dry Cask Storage System structures, systems, and components, unless indicated otherwise. The Dry Cask Storage System includes the Independent Spent Fuel Storage Installation (ISFSI) facility, activities supporting spent fuel dry cask loading, and the associated dry cask storage equipment.
The NRC Certificate of Compliance (CoC) holder is responsible for the quality assurance requirements as applied to the design, fabrication, and testing of a spent fuel storage cask unti! possession of the spent fuel storage cask is transferred to the general licensee. The general licensee and the certificate holder are also simultaneously responsible for these quality assurance requirements through the oversight of contractors and subcontractors.
The quality assurance program shall be documented by written procedures or instructions and the program shall be carried out in accordance with these procedures throughout the period during which the DCSS is licensed or the spent fuel storage cask is certified.
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