View source for CP-202100550, Quality Assurance Program Internal Audit Frequency

{{Adams
| number = ML21236A291
| issue date = 08/24/2021
| title = Quality Assurance Program Internal Audit Frequency
| author name = Sewell S
| author affiliation = Luminant, Vistra Operating Co., LLC (VistraOpCo)
| addressee name = 
| addressee affiliation = NRC/Document Control Desk, NRC/NMSS, NRC/NRR
| docket = 05000445, 05000446, 07200074
| license number = 
| contact person = 
| case reference number = CP-202100550, TXX-21104
| document type = Letter type:CP, Quality Assurance Program
| page count = 14
}}

=Text=
{{#Wiki_filter:Steven K. Sewell Comanche Peak a Senior Director, Nuclear Power Plant Engineering & Regulatory Affairs (Vlstra Operations Company LLC)
Luminant P.O. Box 1002 6322 North FM 56 Glen Rose, TX 76043

T 254.897.6113

CP-202100550 TXX-21104 August 24, 2021

ATTN: Document Control Desk Ref 10 CFR 50.54(a)(4)
U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

==Subject:==
Comanche Peak Nuclear Power Plant (CPNPP)
DocketNos.50-445,50-446,72-74 Quality Assurance Program Internal Audit Frequency

==Dear Sir or Madam:==
In accordance with the requirements of 10 CFR 50.54(a)(4), Vistra Operations Company LLC (Vistra OpCo) requests approval of a proposed change to the Quality Assurance Program (QAP) as described in Chapter 17 of the Comanche Peak Nuclear Power Plant (CPNPP) Final Safety Analysis Report (FSAR).

The proposed change modifies the internal audit frequency from 24 months to 36 months as described in Attachment 1. The increased period between audits will be supplemented by an interim analysis of functional area performance. The change is applicable to audits implemented to meet the requirements of 10 CFR 50 11 Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power plants and Fuel Reprocessing Plants," non-safety programs, and programs that do not have a defined audit interval, as described in the QAP.

Since this change is considered a reduction in quality assurance commitment, NRC approval is required prior to implementation of the change. Vistra OpCo believes the change does not reduce the effectiveness of the Quality Assurance Program.

Attachment 1 provides a mark-up of the affected FSAR pages. Attachment 2 provides a description of the change, the reason for the change, and the basis for concluding that the revised program continues to satisfy the criteria of 10 CFR 50 11 Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants."

In accordance with 10 CFR 50.54(a)(4)(iv), CPNPP plans to implement the change following receipt of an NRC letter indicating acceptance or 60 days after the date of the submittal.

This communication contains no new commitments regarding CPNPP Units 1 and 2.
TXX-21104 Page2 of2

Should you have any questions, please contact Carl B. Corbin at (254) 897-0121 or carl.corbin@luminant.com.

Sincerely, s:z_ &#xa3;".G~
Steven K. Sewell FSAR marked up pages Description and Basis for Change - Quality Assurance Program Internal Audit Frequency

c (email)- Scott Morris, Region IV [Scott.Morris@nrc.gov]
Dennis Galvin, NRR [Dennis.Galvin@nrc.gov]
John Ellegood, Senior Resident Inspector, CPNPP Uohn.Ellegood@nrc.gov]
Neil Day, Resident Inspector, CPNPP [Neil.Day@nrc.gov] to TXX-21104 Page 1 of 8 CPNPP/FSAR
: 2. The recommendations of Revision 1 (6/73) or Revision 2 (5/77) of this regulatory guide are used.
: 3. The exception described in Subsection 6.1 B.1.1.4.

Also refer to Appendix 1A(N).

Regulatory Guide 1.32

Criteria for Safety-Related Electric Power Systems for Nuclear Power Plants

Discussion

The CPNPP design complies with the requirements of Revision 2 (2/77) of this regulatory guide.
For details see Section 8.3.

Regulatory Guide 1.33

Quality Assurance Program (Operation)

Discussion

The quality assurance requirements for the operations phase of CPNPP are in compliance with Revision 2 (2/78) of this regulatory guide as implemented by ANSI N18.7-1976, "Administrative Controls and Quality Assurance for Operational Phase of Nuclear Power Plants", with the following exceptions:
: 1. Audit Intervals (Section 17.2.18)

Audits shall be performed at the intervals designated herein for each audit area. Schedules shall be based on the month in which the audit starts. For audits, other than those audit areas with maximum frequency specified by regulation (Security and Emergency Plan), an interval extension grace period of up to 25% may be used for the scheduled commencement date when conditions, such as plant operational considerations or to accommodate performance based observations of activities related to the audit area, make meeting the specified schedule date impractical. When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.
: 2. Regulatory Position C.4

The quality assurance program has specified alternatives to the program area audit frequencies stated in Regulatory Position C.4. The quality assurance program schedules the audits provided for in Regulatory Position C.4 at ~month frequencies. The audit schedule is performance-based and additional audits may scheduled based upon program or functional area performance or other factors that in ate the need for increased assessment.
36

1A(B)-9 Amendment No. 110 to TXX-21104 Page2 of8 CPNPP/FSAR No changes to this page For Information Only
: 3. Biennial Reviews of Plant Procedures

The intent of the biennial review is accomplished by CPNPP programmatic controls already in place. The following controls assure that procedures are appropriately reviewed and revised to incorporate information based on plant operations, design changes, regulatory requirements, industry experience and other conditions that may impact plant procedures.
* Site Modification Process
* Corrective Action Program
* Off-Normal Occurrence
* User Feedback and Procedure Compliance
* Operating Experience Review
* Vendor Technical Information
* Licensed Document Change/50.59 Evaluation
* Commitment Tracking System (CTS)
* Trending Activities
* Infrequently Performed Evolutions Control
* Requalification Training
* Quality Assurance Activities

Note: 1 0CFRS0.59 has been revised and the terminology in Section 4.3.4 of ANSI N 18.7-1976 is no longer current. Section 17.2 has been updated to reflect the revision to 1 0CFRS0.59.
: 4. Identification of QA Program Requirements in Procurement Documents

Quality Assurance program requirements consistent with 1 0CFRS0 Appendix B or ANSI N45.2 are not imposed in procurement documents for commercial grade calibration services from a National Voluntary Laboratory Accreditation Program (NVLAP) or American Association for Laboratory Accreditation (A2LA) accredited calibration laboratory evaluated in accordance with Section 17.2. 7.

Regulatory Guide 1.34

Control of Electroslag Weld Properties

Discussion

Refer to Appendix 1A(N).

1A(B)-10 Amendment No. 110 to TXX-21104 Page 3 of 8 CPNPP/FSAR No change to this page For Information Only
: 6. Each review shall include a determination of whether or not an amendment to the operating license is required. For items requiring an amendment to the operating license, NRG approval shall be obtained prior to the Plant Manager approval for implementation.

Records of the activities described above shall be provided to the Plant Manager, SORG, and/or ORC as necessary for the required reviews.

17.2.1.6.1 Reportable Events

The following action shall be taken for all events submitted pursuant to 1 0CFR50. 73:

Each event shall be reviewed by the SORG, and the results of this review shall be submitted to the ORC and the Senior Vice President & Chief Nuclear Officer.

Written procedures shall be established, implemented and maintained covering the Process Control Program implementation.

Changes to the PCP:
: 1. Shall be documented and records of reviews performed shall be retained as required by FSAR Section 17.2.17.1. This documentation shall contain:
: a. Sufficient information to support the change together with the appropriate analyses or evaluations justifying the change(s) and
: b. A determination that the change will maintain the overall conformance of the solidified waste product to existing requirements of Federal, State, or other applicable regulations.
: 2. Shall become effective after review and acceptance by the SORG and the approval of the Plant Manager.

Each procedure and administrative policy of Technical Specification 5.4.1 and changes thereto, shall be reviewed and approved prior to implementation as set forth above.

17.2.2 QUALITY ASSURANCE PROGRAM

The Quality Assurance Program requires a Quality Assurance manual be developed for each nuclear power plant, which prescribe specific measures to assure the quality of safety-related activities, structures, systems and components of that facility. The quality assurance requirements and controls implemented during operations of CPNPP are established by the portion of the CPNPP Quality Assurance Program in this section (17.2) of the FSAR. Quality assurance requirements and controls established by the CPNPP Quality Assurance Program for the Dry Cask Storage System shall be implemented throughout the period during which the ISFSI is licensed or the spent fuel storage cask is certified.

Quality assurance requirements and controls are established and implemented throughout the testing and operation phases at CPNPP. This program shall be implemented at least 90 days prior to fuel loading. Responsibilities and authority, and measures for the control and accomplishment of activities affecting the quality and operation of safety-related structures,

17.2-10 Amendment No. 110 to TXX-21104 Page4 of 8 CPNPP/FSAR

systems, and components of CPNPP are defined. The structures, systems, and components covered by the quality assurance program are discussed in Appendix 17 A. These provisions apply to all activities, such as operating, maintaining, repairing, modifying, and refueling which affect the safety-related functions of those structures, systems, and components. These provisions, as necessary, shall ensure conformance with the approved design of the ISFSI or spent fuel storage cask.

A Quality Assurance Program shall be developed and implemented to attain high levels of quality assurance during the operation of CPNPP. This program shall comply with the requirements of Title 10, Code of Federal Regulations, Part 50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Processing Plants," and certain NRC Regulatory Guides and ANSI standards as identified in the Final Safety Analysis Report (FSAR).

The Quality Assurance Program also complies with 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". Appendix 17 A addresses the applicability of the quality assurance program requirements and procedural controls for the Dry Cask Storage System shall be based on the following considerations concerning the complexity and proposed use of the structures, systems, or components:
: 1. The impact of malfunction or failure of the item on safety;
: 2. The design and fabrication complexity or uniqueness of the item;
: 3. The need for special controls and surveillance over processes and equipment;
: 4. The degree to which functional compliance can be demonstrated by inspection or test; and triennial
: 5. The quality history and de ree of standardization of the item.

Vistra OpCo may delegate to thers such as contractors, agents, or consultants the work of establishing and executing e quality assurance program, or any part thereof, but the overall responsibility for the Quar Assurance (QA) Program lies with the Senior Vice President & Chief Nuclear Officer. Specifi responsibility for development and administration of the program rests with the Director, Nu ar Oversight. The Senior Vice President & Chief Nuclear Officer will assure that a *
* independent assessment of the evaluation program is performed.

These independent assessments will be conducted in accordance with predetermined schedules, with results documented, and a follow-up system utilized to assure that corrective action is taken and evaluated when it is considered necessary to verify implementation requirements of 1 0CFR50, Appendix B and 1 0CFR72 Subpart G, as applicable. The Vice-Presidents shall meet periodically to assess the status and adequacy of the quality assurance program.

The quality assurance requirements and controls applicable to the operations phase, comply with

the requirements of 10 CFR Part 50, Appendix B. Table 17.2-1 provides a matrix showing those sections of the QA Manual which satisfy the requirements of each criterion of 10 CFR Part 50, Appendix B. The quality assurance requirements and controls shall 17.2-11 Amendment No. 110 be consistent with the to TXX-21104 Page 5 of8 CPNPP/FSAR No change to this page For Information Only
: 12. Records of the service lives of all hydraulic and mechanical snubbers required by the Technical Requirements Manual including the date at which the service life commences and associated installation and maintenance records;
: 13. Records of secondary water sampling and water quality;
: 14. Records of analyses required by the Radiological Environmental Monitoring Program that would permit evaluation of the accuracy of the analysis at a later date. This should include procedures effective at specified times and QA records showing that these procedures were followed; and
: 15. Records of reviews performed for changes made to the OFFSITE DOSE CALCULATION MANUAL and the PROCESS CONTROL PROGRAM.
: 16. Records of radioactive shipments.

17.2.17.3 The following additional record retention requirements apply to the Dry Cask Storage System structures, systems, and components that are classified as important to safety in accordance with 1 0CFR72 and NUREG/CR-6407, "Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety":
: 1. Documentary evidence that material and equipment conform to procurement specifications shall be retained for the life of the ISFSI or spent fuel storage cask as defined in the applicable appendix to the CPNPP QA Manual.
: 2. Records pertaining to the design, fabrication, erection, testing, maintenance, and use of structures, systems, and components important to safety shall be retained until the NRC terminates the license or Certificate of Compliance (CoC).
: 3. Records showing the receipt, inventory (including location), disposal, acquisition, and transfer of special nuclear material including spent fuel must be retained for as long as the material is stored and for a period of 5 years after the material is disposed of or transferred out of the ISFSI. These records must include, as a minimum, the name of the shipper of the material to the ISFSI, the estimated quantity of radioactive material per item (including special nuclear material in spent fuel), item identification and seal number, storage location, onsite movements of each fuel assembly or storage canister, and ultimate disposal. These records must be kept in duplicate at separate locations sufficiently remote from the original records that a single event would not destroy both sets of records.

17.2.18 AUDITS

Requirements are established for an Audit program. The Audit program is consistent with the applicable portions of Regulatory Guides 1.33, 1.144, and 1.146 as discussed in Appendix 1A(B).

Planned and periodic audits are performed in accordance with written procedures to verify compliance with all aspects of the quality assurance program. Audits shall be performed at the intervals designated herein for each audit area. Schedules shall be based on the month in which

17.2-29 Amendment No. 110 to TXX-21104 Page6 of 8 CPNPP/FSAR

the audit starts. Audit reports shall be forwarded to the Senior Vice President & Chief Nuclear Officer and to the management positions responsible for the areas audited within 30 days after completion of the audit by the auditing organization. Responsibility for the evaluation program has been assigned to the Director, Nuclear Oversight. Audits are conducted or coordinated by Nuclear Oversight personnel and shall include evaluation and examination of the following quality-related activities: 36
: 1. The conformance of unit operation to provisions contained within th echnical Specifications and applicable license conditions at least once per 24-months; ~
: 2. The performance, training and qualifications of the entire unit staff at least once per ~
months; r{367
: 3. The results of actions taken to correct deficiencies occurring in unit equipment, '-b L___J structures, systems or method of operation that affect nuclear safety, at least once per 24-months; 36
: 4. The performance of activities required by the Operational Qua
* Assurance Program to meet the criteria of Appendix B, 1 0CFRS0, at least once per~ months; ~
: 5. The fire protection programmatic controls, including the implementing proct6'ures, program implementation, and fire protection equipment at least once per~ months by qualified licensee Nuclear Oversight personnel and qualified offsite fire protection engineers;
: 6. The fire protection equipment and program implementation at least once per 36 months utilizing an outside independent fire protection consultant.
36
: 7. The nvironmental Monitoring Program and the results thereof ~t least once per 36
: 8. The OFFSlli DOSE CALCULATION MANUAL and implementing procedures at least once per~ months; 36
: 9. The PROCESS CONTROL PROGRAM and implem ting procedures for processing and packaging of radioactive wastes at least once per ~ months; 36
: 10. The performance of activities required by the lity ssurance Program for effluent and environmental monitoring at least once per~ months.
: 11. Any other area of unit operation considered appropriate by the ORC or the Senior Vice President & Chief Nuclear Officer; and
: 12. The perfomtat,ce oracavrlies required ~ by the Technical Requirements Manual at least

once per~ months. 36
: 13. The performance of activities required by the Operational Q ity Assurance Program to meet the criteria of subpart G, 1 0CFR72, at least once per~ months.

17.2-30 Amendment No. 110 to TXX-21104 Page 7 of8 CPNPP/FSAR

17.2.18.1 Audit Organizations

Organizations performing activities affecting quality that are subject to evaluation include the following:
: 1. The nuclear engineering, operations, regulatory affairs and Nuclear Oversight organizations for CPNPP.
: 2. Contractors, consultants, and suppliers of quality related items or service. NVLAP and A2LA accredited commercial grade calibration suppliers do not require audit when evaluated in accordance with -------------------------, Section 17.2. 7.
An evaluation is performed once per calendar year to determine the need for 17.2.18.2 Nuclear Oversight additional audit activities. When determined necessary, an additional audit activity will be performed within a time frame established by the evaluation.
: 1. Utilizes an audit planning document which defines the organization and activities to be evaluated and the frequency of the audits. The audit schedule is p ormance-based and additional audits may be scheduled based upon program or func i nal area performance or other factors that indicate the need for increased assessment. or audits, other than those audit areas with a maximum frequency specified by regulation (Security and Emergency Plan), an interval extension grace period of up to 25% may be used for the scheduled commencement date when conditions, such as plant operational considerations or to accommodate performance-based observations of activities related to the audit area, make meeting the specified schedule date impractical. When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.
: 2. Requires auditors to be familiar with the type of activities to be evaluated and have no direct responsibilities in the area being evaluated.
: 3. Provide audit checklists or other objective guidelines to identify those activities which affect quality.
: 4. Requires examination of the essential characteristics of the quality activity examined.
: 5. Requires an audit report be prepared that notes the extent of examination and deficiencies found.
: 6. Requires the audit report be sent to management responsible for the area evaluated for review and corrective action for deficiencies.
: 7. Requires corrective action taken as result of the audit be reported.
: 8. Requires re-audit of deficient areas when it is considered necessary to verify implementation of required corrective actions.
: 9. Requires vendors/subcontractors to comply with items 1-8 above to the extent necessary.

17.2-31 Amendment No. 110 to TXX-21104 Page 8 of 8 CPNPP/FSAR No change to this page For Information Only

Documentation of audits performed by participating contractors is made available to Nuclear Generation for evaluation.

17.2.18.2.1 Nuclear Generation Verification

In summary, Nuclear Generation verifies conformance of the regulatory audit requirements by three methods:
: 1. Review of contractor's/vendors' quality assurance methods for auditing.
: 2. Review of documentation of the audit report performed by these contractors/vendors.
: 3. Internal and external evaluations performed by Nuclear Oversight personnel.

17.2-32 Amendment No. 110 to TXX-21104 Page 1 of4

Description and Basis for Change-Quality Assurance Program (OAP) Internal Audit Frequency

Description of Change:

Summary of changes (see Attachment 1 for FSAR marked up pages)

FSAR Appendix 1A(B). "Discussion of Regulatory Guides/ Regulatory Guide 1.33 Quality Assurance Program (Operation)"
* The discussion of regulatory position C.4 of NRC Regulatory Guide 1.33, Revision 2 (Reference 3) is updated to reflect the audit interval change from 24 months to 36 months.

FSAR Section 17.2.2. "Quality Assurance Program"
* updates performance of the independent assessment of the evaluation program from biennial to triennial.

FSAR Section 17.2.18. "Audits" The specific audit topics proposed for the interval change (from 24 to 36 months) are:
* The conformance of unit operation to provisions contained within the Technical Specifications and applicable license conditions
* The performance, training and qualifications of the entire unit staff
* The results of actions taken to correct deficiencies occurring in unit equipment, structures, systems or method of operation that affect nuclear safety
* The performance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B, 10CFRS0
* The fire protection programmatic controls, including the implementing procedures, program implementation, and fire protection equipment by qualified licensee Nuclear Oversight personnel and qualified offsite fire protection engineers
* 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
* The performance of activities required by the Technical Requirements Manual
* The performance of activities required by the Operational Quality Assurance Program to meet the criteria of subpart G, 10CFR72

FSAR Section 17.2.18.2. "Nuclear Oversight"
* Adds requirement to perform an evaluation once per calendar year to determine the need for additional audit activities. When determined necessary, an additional audit activity will be performed within a time frame established by the evaluation. to TXX-21104 Page 2 of4

Reason for Change:

Extending the interval between formal audits provides a more strategic and efficient use of resources. The extended interval between audits is offset by the annual evaluation being added as described in the basis for conclusion section below.

Basis for Conclusion that revised program incorporating this Change continues to satisfy the criteria of Appendix B of this part [i.e., 10 CFR 50) and the Safety Analysis Report quality assurance program:

This change request is written specifically for the Vistra Operations Company LLC (Vistra OpCo)
Quality Assurance Program (OAP), which is based on ANSI N18.7-1976/ANS 3.2, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants (Reference
: 2) and NRC RG 1.33, Revision 2, "Quality Assurance Program Requirements (Operation)"
(Reference 3) as described in the OAP (i.e., Final Safety Analysis Report (FSAR) Section 17).

The details of the proposed change were developed with industry input through the Nuclear Quality Management Leadership (NQML) forum and is consistent with the Quality Assurance Program changes submitted by Exelon Generation Company, LLC and approved by the NRC (References 4, 5, and 6).

It should be noted that Vistra OpCo is not adopting other standards discussed below (e.g., NOA-1-2015 or ANSI/ANS 3.2-2012) as part of this proposed change but is only citing those standards to show that the proposed intervals are similar to other NRC endorsed standards.

The Vistra OpCo OAP ensures conformance to 10 CFR 50 Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." In accordance with 10 CFR 50.54(a)(4)(ii), Vistra OpCo requests approval of a proposed change to the OAP. The proposed change described below is a reduction in commitment and, therefore, NRC approval is required prior to implementation. In accordance with 10 CFR 50.54(a)(4)(iv), CPNPP plans to implement the change following receipt of an NRC letter indicating acceptance or 60 days after the date of the submittal.

FSAR Appendix lA(B)

Appendix lA(B) is not part of the OAP (i.e., FSAR Section 17) but is updated to reflect the changes to FSAR Section 17.

FSAR Section 17.2.2

Section 4.1 of Reference 2 states that "These programs for reviews and audits shall, themselves, be periodically reviewed for effectiveness by management of the owner organization," The independent assessment of the evaluation program is changed from biennial to triennial for consistency with the change of internal audits frequency from 24 months to 36 months as discussed for FSAR Sections 17.2.18 and 17.2.18.2. to TXX-21104 Page 3 of4

FSAR Sections 17.2.18 and 17.2.18.2

The Vistra OpCo QAP currently complies with administrative controls and quality assurance requirements for performance of internal audits established by ANSI N18.7-1976/ANS 3.2, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants" (Reference 2). Reference 2 states "Audits of selected aspects of operational phase activities shall be performed with a frequency commensurate with their safety significance and in such a manner as to assure that an audit of all safety-related functions is completed within a period of two years".

Vistra OPCO is requesting NRC approval to change the internal audit interval from 24 months to 36 months. Currently FSAR Section 17.2.18, "Audits," requires audits related to the performance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B, 10CFR50, at least once per 24 months. This proposed change replaces the 24-month interval requirement with a 36-month interval requirement. The 25% grace period is maintained ensuring that the period between audit performance will not exceed 45 months.

Section 17.2.18.2 is also revised to require an evaluation once per calendar year to determine the need for additional audit activities. Results of the evaluation will be assessed and, when necessary, a review of the identified areas of performance weakness will be planned at the earliest possible opportunity.

The proposed interval change supplemented by evaluation is similar to audit requirements outlined in ASME NQA-1-2015, "Quality Assurance for Nuclear Facility Applications," that was endorsed by Regulatory Guide 1.28, "Quality Assurance Program Criteria (Design and Construction)," Revision 5. This revision of NQA-1, Requirement 18, "Audits," Section 201.2, "Nuclear Facilities After Placing the Facility into Operation," references extending the 2-year internal audit interval to 3 years, not to exceed 4 years with performance of an annual evaluation.

Also, the proposed change is similar to ANSI/ANS 3.2-2012, "Managerial, Administrative and Quality Assurance Controls for the Operational Phase of Nuclear Power Plants," that was endorsed by Regulatory Guide 1.33, "Quality Assurance Program Requirements (Operation),"
Revision 3. This quality standard also, provides guidance in section 3.18.1.1, "Regularly Scheduled Audits," for extending the 2-year interval not to exceed 4 years with performance of an annual evaluation. In addition, the proposed 36-month audit interval is consistent with external audit requirements for audit of suppliers and with NRC triennial inspections.

The variations between the proposed change and NRC endorsed quality standards include setting the audit interval to 36 months with 25% grace versus the 2-year interval with a 1-year extension(s) not to exceed 4 years described in NQA-1-2015 and ANSI/ANS 3.2-2012 standards.
The proposed evaluation in FSAR Section 17.2.18.2 will focus on identifying areas that require audit activity prior to the next scheduled audit, rather than justifying extension.

Functional area audits and evaluations would be separated into three cycles covering a period of 36 months. Each cycle includes a set of audits and an evaluation (the once per calendar year to TXX-21104 Page4 of4

evaluation added in FSAR Section 17.2.18.2). Results of the completed audits will be reviewed to determine if additional audit activities are necessary prior to their next scheduled performance. Additionally, each functional audit area will be evaluated 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. These evaluations will meet the intent of the annual evaluation described in NRC endorsed quality standards by ensuring action by the audit organization upon evaluation of adverse performance trends should they exist prior to the next scheduled audit activity. The resulting action will be based on the problem identified and may include one or more of a variety of audit tools, such as simple observations, follow-up reviews, limited scope audits up to a full audit of the functional area.

The proposed change does not represent a reduction in effectiveness or compliance with 10 CFR 50 Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." A comprehensive system of planned and periodic audits will continue to be performed by independent trained personnel using written procedures to verify compliance with all aspects of the QAP. The internal audit program will continue to be conducted on a performance driven interval that is commensurate with the status and importance of the activity to be completed. Performance of functional area and vendor audits will continue to determine effectiveness of the program.

In aggregate, the change will continue to meet the fundamental requirements of an internal audit program as described in quality standards endorsed by the NRC and will continue to provide proper coverage of QAP activities. Evaluations of performance (once per calendar year) will be used to effectively focus audit resources in areas indicating gaps in QAP implementation.

==References:==
: 1. Comanche Peak Nuclear Power Plant Final Safety Analysis Report (FSAR)
: a. Appendix lA(B), "Discussion of Regulatory Guides/ Regulatory Guide 1.33 Quality Assurance Program (Operation)"
: b. Section 17.2.2, "Quality Assurance Program"
: c. Section 17.2.18, "Audits"
: d. Section 17.2.18.2, "Nuclear Oversight"
: 2. ANSI N18. 7-February 1976 ANS-3.2 Administrative Controls and QA for Operational Phase of Nuclear Power Plants
: 3. NRC RG 1.33 Rev 2, Quality Assurance Program Requirements (Operation)
: 4. Letter from Exelon Generation Company, LLC to the NRC regarding "Request for Approval of Change to Exelon Generation Company, LLC, Quality Assurance Topical Report," dated December 5, 2019 (ADAMS No. ML19339E544)
: 5. Letter from Exelon Generation Company, LLC to the NRC regarding "Additional Information Regarding Request for Approval of Change to Exelon Generation Company, LLC, Quality Assurance Topical Report," dated February 24, 2020 (ADAMS No. ML20055G249)
: 6. Letter from NRC to Exelon Generation Company, LLC regarding, "Review of Quality Assurance Program Changes (EPID L-2019-LLQ-0003)," dated November 5, 2020 (ADAMS No. ML20287A130)}}