ML21300A034
| ML21300A034 | |
| Person / Time | |
|---|---|
| Site: | 99902088 |
| Issue date: | 02/14/2022 |
| From: | NRC/NRR/DANU/UARL |
| To: | |
| Rivera R; 301-415-7190 | |
| Shared Package | |
| ML22031A078 | List: |
| References | |
| EPID L-2021-NFO-0006 | |
| Download: ML21300A034 (15) | |
Text
ABILENE CHRISTIAN UNIVERSITY (ACU) - SAFETY EVALUATION OF TOPICAL REPORT ABILENE CHRISTIAN UNIVERSITY NUCLEAR ENERGY EXPERIMENTAL TESTING LABORATORY (NEXT LAB) QUALITY ASSURANCE PROGRAM DESCRIPTION FOR DESIGN, LICENSING, AND CONSTRUCTION OF THE ABILENE CHRISTIAN UNIVERSITY MOLTEN SALT RESEARCH REACTOR (EPID NO. L-2021-NFO-0006)
SPONSOR AND SUBMITTAL INFORMATION Sponsor: Abilene Christian University Sponsor Address: Dr. Rusty Towell, Director of NEXT Lab, Abilene Christian University, ACU Box 28208 Abilene, TX 79699-8208 Docket /Project No(s): 99902088 Submittal Date: March 18, 2021 Submittal Agencywide Documents Access and Management System (ADAMS) Accession No.: ML21099A109 (Reference 1)
Supplement and Request for Additional Information response letters : (Reference 2);
(Reference 7)
Brief Description of the Topical Report:
The Abilene Christian University (ACU), Nuclear Energy eXperimental Testing Laboratory (NEXT Lab), Quality Assurance Program Description (QAPD), is the document that establishes the Quality Assurance Program (QAP) to be applied to the design, fabrication, construction, and testing of the structures, systems, and components (SSCs) of ACUs Molten Salt Research Reactor (MSRR).
For additional details on the submittal, please refer to the documents located at the ADAMS Accession No(s). identified above.
REGULATORY EVALUATION Regulatory Basis: Title 10 of the Code of Federal Regulations (10 CFR) 50.34(a)(7)
The regulations in 10 CFR 50.34, Contents of applications; technical information, paragraph (a)(7), require that a preliminary safety analysis report (PSAR) include A description of the QAP to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. The U.S. Nuclear Regulatory Commission (NRC) Regulatory Guide (RG) 2.5, Revision 1, dated June 2010, Quality Assurance Program Requirements for Research and Test Reactors (Reference 3), states that the general recommendations for establishing and executing a QAP for the design, construction, testing, modification, and maintenance of research reactors in American National Standards Institute/American Nuclear Society (ANSI/ANS) 15.8-1995, Quality Assurance Program Requirements for Research Reactors (Reference 4), provide an acceptable method for complying with the requirements of 10 CFR 50.34, Contents of applications; technical information. Therefore, the NRC staff used ANSI/ANS-15.8-1995 as the basis for evaluating the acceptability of the ACU NEXT Lab QAPD in conformance with the provisions of 10 CFR 50.34(a)(7).
The NRC staff also used the guidance in Section 12.9, Quality Assurance, of NUREG-1537, Parts 1 and 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content and Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria respectively, dated February 1996 (References 5 and 6, respectively). Guidance in NUREG-1537, Part 1, Section 12.9, recommends the applicant consider the guidance in RG 2.5 and ANSI/ANS 15.8 in developing QAPs for non-power reactors.
TECHNICAL EVALUATION 1.0 Introduction QAPD Section 1.1, Scope, states that the QAPD is the top-level policy document that establishes the QAP and assigns major functional responsibilities for all activities associated with the ACU MSRR project conducted by or for NEXT Lab. In the QAPD, Section 1.1 states that the QAPD establishes QA requirements that meet 10 CFR 50.34(a)(7), and that ACU has determined that ANSI/ANS-15.8-1995, following the guidance in RG 2.5, Revision 1, is sufficient for use in developing the QAPD for the MSRR.
The QAP, as described in Section 1.2, Application, of the NEXT Lab QAPD, will be applied to MSRR activities affecting safety and reliability. Such activities will include, at a minimum, those affecting the quality and performance of safety-related SSCs. The NEXT Lab will apply a graded approach to those activities and items which could affect the quality of SSCs of the MSRR and its activities. The NEXT Lab activities affecting quality include, but are not limited to:
designing, receiving, pre-operational activities, siting, storing, maintaining, procuring, constructing, repairing, fabricating, erecting, modifying, cleaning, installing, training, handling, inspecting, shipping, and testing.
In the QAPD, Section 1.2 states that the definitions provided in ANS-15.8-1995, Section 1.3, "Definitions, apply to terms as used in the NEXT Lab QAPD.
The NRC staff finds that the description of the NEXT Labs QAPD in QAPD Section 1 meets the guidance provided in ANSI/ANS-15.8-1995, because it: includes information specified in Section 1 of the ANSI/ANS standard, regarding matters affecting quality of the SSCs in the MSRR, including the design, fabrication, construction, and testing; adds training and pre-operational activities; and states that the terms used are as defined in the ANSI/ANS standard.
The QAPD also applies a graded approach to all activities affecting quality that is consistent with the ANSI/ANS standard and will ensure that controls are applied commensurate with risks associated with controlled items. Therefore, the staff finds the description in QAPD Section 1 acceptable.
2.0 Design, Construction and Modification 2.1 Organization The NEXT Lab QAPD recognizes that for most research reactor facilities, the owner/operator organization is small, and facility personnel perform multiple functions. During the design, construction, or modification of a research reactor, most of the work may be performed by outside organizations or support contractors. The owners/operator's role is then primarily one of specifying requirements and verifying compliance with those requirements. The NEXT Lab organizational structure and assignment of responsibilities are defined and documented such that: (a) quality is achieved and maintained by those who have been assigned responsibility for performing work; and (b) quality achievement is verified by persons not directly performing the work. The NEXT Lab staff responsible for ensuring that appropriate controls have been established, and for verifying that activities have been correctly performed, will have sufficient authority, access to work areas, and freedom to: (a) identify problems; (b) initiate, recommend, or provide corrective actions; and (c) ensure corrective action implementation.
According to the QAPD, the NEXT Lab QA Manager is responsible for the development and verification of implementation of the QAPD. The QA Manager reports to the Director of NEXT Lab, who has overall responsibility for the implementation of the QAPD and laboratory activities, including overall responsibility for the MSRR nuclear safety. The QA Manager also has the ability and responsibility to report directly to the President of ACU, who has overall responsibility for the corporate policy of NEXT Lab and provides executive direction and guidance for the NEXT Lab activities and promulgation of ACU corporate policy through the Director of NEXT Lab.
The QAPD also establishes that the Director of NEXT Lab also reports to the President of ACU, and that coordination of the NEXT Lab research activities are managed with the ACU Vice President of Research.
The QAPD also states that the NEXT Lab QA organization is responsible for independently planning and performing activities to verify the development and effective implementation of the NEXT Lab QAP, including but not limited to the development and verification of implementation of the QAP and oversight of engineering, licensing, document control, the corrective action program and procurement activities that support MSRR activities and projects. Authority for developing and verifying execution of the QAP is delegated to the NEXT Lab QA Manager by the NEXT Lab Director. The QA Manager has sufficient independence from other NEXT Lab priorities to bring forward issues affecting safety and quality and make judgments regarding quality in all areas necessary regarding NEXT Labs nuclear development activities.
The NRC staff determined that NEXT Labs organizational controls described in QAPD Section 2.1 are consistent with the guidance provided in Section 2.1 of ANSI/ANS-15.8-1995, because QAPD Section 2.1 provides an organizational structure, and definitions of roles and responsibilities, that help ensure the achievement and maintenance of quality by those assigned to perform work. Therefore, the staff finds the description in QAPD Section 2.1 acceptable.
2.2 Quality Assurance Program The NEXT Lab QAPD documents the requirement for establishing the QAP at the earliest time consistent with the schedule for accomplishing quality-affecting activities. The QAPD Section 2.2 states that the QAPD identifies the items and activities to which it applies and the extent of QAP application for each item and activity. The QAPD states that the QAP provides for the appropriate and necessary indoctrination and training of NEXT Lab staff who perform activities that affect quality to ensure that suitable proficiency is achieved and maintained.
The NRC staff determined that the general QAP requirements in QAPD Section 2.2 are consistent with the guidance provided in Section 2.2 of ANSI/ANS-15.8-1995, because QAPD Section 2.2 states that the QAPD identifies the items and activities to which the QAP applies, and the extent of its application. As recommended by the ANSI/ANS standard, QAPD Section 2.2 requires that the QAP be established in accordance with the QAPD requirements and be established at the earliest time consistent with NEXT Labs schedule for accomplishing quality-affecting activities, and indicates the QAP provides for the training necessary for NEXT Lab staff to perform quality-affecting activities. Therefore, the staff finds the description in QAPD Section 2.2 acceptable.
2.3 Design Control The NEXT Lab QAPD establishes a design control process to prescribe, develop, document, and preserve the design of the SSCs of the MSRR facility subject to the QAP.
Based on the information in the QAPD, described in the subsections below, the NRC staff finds that NEXT Labs design controls in QAPD Section 2.3 are consistent with the guidance provided in Section 2.3 of ANSI/ANS-15.8-1995, because QAPD Section 2.3 adequately addresses ANSI/ANS standard recommendations for design requirements, processes, verification, documents and records, verification of commercial grade items, and change control necessary to maintain design control. The NRC staff also finds that the QAPD Section 2.3 statement that design efforts interfaces will be coordinated among NEXT Lab participating organizations is consistent with the ANSI/ANS standard, and will help ensure appropriate coordination among all organizations participating in the design of the MSRR. Therefore, the staff finds the description in QAPD Section 2.3 and its subsections, acceptable.
2.3.1 Design Requirements The NEXT Lab QAPD states that applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes, and standards are to be identified and documented.
2.3.2 Design Process The NEXT Lab QAPD states that design interfaces will be identified and controlled, and that design efforts interfaces will be coordinated among the NEXT Lab participating organizations.
The applicability of standardized or previously proven designs, with respect to meeting pertinent design inputs, will be verified for each application. Deviations from the established design inputs will be documented and controlled.
The QAPD also states that the final design will be relatable to the design input by documentation in sufficient detail to permit design traceability and verification, and will identify assemblies and/or components that are part of the item being designed. Computer design programs used to develop portions of the facility design or to analyze the design will be controlled. When a design program must be developed, the program will be controlled to ensure that it is fully documented and validated. When changes to previously validated computer programs are made, documented revalidation will be required for the change and include appropriate benchmark testing.
2.3.3 Design Verification The NEXT Lab QAPD describes how the NEXT Lab independent design reviews will be performed to verify the adequacy of design. Design verification will be performed by competent persons other than those who designed the item. Design verification will be completed prior to reliance upon an SSC, or computer program to perform its function in operations. Qualification testing will be defined in formal test plans and will include appropriate acceptance criteria.
Testing will demonstrate the adequacy of performance that simulates the most adverse design conditions. Test results will be documented and verified to have met the test requirements.
2.3.4 Design Document and Records The NEXT Lab QAPD states that design documents and records, which provide evidence that the design and design verification processes are performed, will be collected, stored, and maintained for the life of the safety-related item.
2.3.5 Commercial Grade Items The NEXT Lab QAPD states the use of commercial grade items (CGIs) in safety-related applications will be reviewed to ensure that this equipment can adequately perform its intended function. When a CGI, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than the suppliers published product description, the component or part will be represented as different from the CGI in a manner traceable to a documented definition of the difference.
2.3.6 Change Control The NEXT Lab QAPD describes how modifications to the MSRR facility SSCs or computer codes will be procedurally controlled. Design changes will be documented, justified, and subject to control measures commensurate with those applied to the original design. These measures shall include assurance that the design analyses for SSCs or computer codes are still valid.
The QAPD requires that, when a significant design change is necessary because of an incorrect design, the design organization review and modify the design process and verification procedure, as necessary.
2.4 Procurement Document Control The NEXT Lab QAPD describes a process to ensure that procurement documents contain sufficient technical and quality requirements to ensure that the items and services satisfy the needs prescribed in NEXT Labs procurement documents or specifications. The QAPD states that procurement documents at all procurement levels shall identify the documentation required to be submitted for information, review, or approval by the NEXT Lab QA Manager and Procurement Manager. The procurement documents will provide for access to the suppliers facility and records for inspection or audit by the NEXT Lab assigned QA Lead Auditor, the designated representative, or other Lead Auditor, authorized and qualified by the NEXT Lab QA Manager. Procurement documents will include NEXT Lab requirements for reporting and approving disposition of supplier nonconformances associated with the items or services being procured.
The NRC staff determined that NEXT Labs procurement document controls in QAPD Section 2.4 are consistent with the guidance provided in Section 2.4 of ANSI/ANS-15.8-1995, because the controls reflect the actions recommended to maintain sufficient technical and quality requirements throughout the procurement process, ensuring that the items and services satisfy the labs needs as prescribed in its procurement processes or specifications. Therefore, the staff finds the description in QAPD Section 2.4, acceptable.
2.5 Procedures, Instructions, and Drawings The NEXT Lab QAPD describes the measures to ensure that activities affecting quality are based on documented instructions, quality procedures, or drawings, as appropriate. The QAPD also states that these documents shall include or reference appropriate quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished.
The NRC staff determined that NEXT Labs controls for instructions, procedures, and drawings in QAPD Section 2.5 are consistent with the guidance provided in Section 2.5 of ANSI/ANS-15.8-1995, because they contain the measures recommended to ensure that activities affecting quality are based on the appropriate documented instructions, quality procedures, or drawings, and are therefore, acceptable.
2.6 Document Control The NEXT Lab QAPD describes the NEXT Lab process to control the preparation, issuance, and changes to documents which specify requirements that affect quality. The implementing procedures will establish the requirements for identification, assignment of responsibility, and review, approval, and issuance of documents. Major changes to controlled documents must be reviewed and approved by the same organizations that performed the review of the original issue.
The NRC staff determined that NEXT Labs document controls in QAPD Section 2.6 are consistent with the guidance provided in Section 2.6 of ANSI/ANS-15.8-1995, because they include, as recommended, processes to identify documents to be controlled and how they will be distributed; identify, as recommended, assignment of responsibilities for preparing, reviewing, approving and issuing documents; and require, as recommended, review of documents for adequacy, completeness and correctness prior to issuance and approval.
Therefore, the staff finds the description in QAPD Section 2.6, acceptable.
2.7 Control of Purchased Items and Services The NEXT Lab QAPD describes the NEXT Lab measures to ensure that purchased items and services conform to procurement documents. These measures include controls to ensure appropriate procurement planning, source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examinations of items and services for acceptance upon delivery, or completion.
Based on the information in the QAPD, described in the subsections below, the NRC staff determined that NEXT Labs controls for purchased items and services in QAPD Section 2.7 are consistent with the guidance provided in Section 2.7 of ANSI/ANS-15.8-1995, because Section 2.7 includes the information recommended to ensure that suppliers are selected based on evaluation of their capabilities to provide the required items or services. Also, as recommended, Section 2.7 has measures to control the suppliers performance; establishes the responsibility of the supplier for the quality of their products and requires documented evidence of that quality in accordance with established methods; and establishes a system to ensure that purchased items and services conform to procurement specifications. Therefore, the staff finds the description in QAPD Section 2.7 and its subsections, acceptable.
2.7.1 Supplier Selection The NEXT Lab QAPD requires that the selection of suppliers be based on evaluation of their capabilities to provide items or services consistent with the requirements of the procurement documents.
2.7.2 Work Control The NEXT Lab QAPD requires that measures be established to control the suppliers performance.
2.7.3 Verification Activities The NEXT Lab QAPD requires that suppliers verify and provide evidence of the quality of their products. The NEXT Lab will establish methods to control and approve supplier-generated documents. Based on the complexity of the product and importance to safety, NEXT Lab will independently verify the quality of the suppliers product using source surveillances, inspections, audits, or review of suppliers non-conformances, dispositions, waivers, and corrective actions.
2.7.4 Item or Service Acceptance The NEXT Lab QAPD states that implementing procedures will establish requirements to ensure that purchased items and services conform to procurement specifications. The NEXT Lab will use one or more of the following methods to accept an item or service: supplier certificate of conformance, source verification, receiving inspection, post-installation test, or a combination thereof. Receiving inspection will be performed in accordance with the established procedures to verify by objective evidence such features as proper configuration, identification, marking, and cleanliness, and to determine any shipping damage, fraud, or evidence of counterfeiting.
2.8 Identification and Control of Items The QAPD states that, when specified by codes, standards, or specifications that include specific identification of traceability requirements, NEXT Labs measures for item identification and control process will be capable of providing identification traceability control. The NEXT Lab procedures will ensure that an item identification is maintained from the initial receipt or fabrication of the item up to and including installation and use. Where physical identification on the item is either impractical or insufficient, physical separation, procedural control, or other appropriate means will be used. Items having a limited shelf and service life will be identified and controlled.
The NRC staff determined that NEXT Labs controls for identification and control of items in QAPD Section 2.8 are consistent with the guidance provided in Section 2.8 of ANSI/ANS-15.8-1995, because Section 2.8 provides the recommended measures for item identification and identification traceability control, and means to employ physical separation, procedural control, or other appropriate means, when physical identification of items is either impractical or insufficient, as well as means to identify and control items that have limited calendar or operating life. Therefore, the staff finds the description in QAPD Section 2.8, acceptable.
2.9 Control of Special Processes The QAPD states that special processes include any in which the results are highly dependent on the control of the process or the skill of the personnel. Special processes also include activities in which the specified quality cannot be readily determined by inspection or non-destructive testing of the product. Special processes at NEXT Lab will be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means. Records for qualified personnel, processes, and equipment associated with special processes shall be maintained, as appropriate.
The NRC staff determined that NEXT Labs controls for special processes in QAPD Section 2.9 are consistent with the guidance provided in Section 2.9 of ANSI/ANS-15.8-1995, because Section 2.9 includes the recommended means to control these processes by instructions, drawings, checklists, travelers, or other appropriate means. As recommended, QAPD Section 2.9 also states that responsibility for the special process will be assigned to the organization performing the special process; states that the procedures or instructions for the special process will include the requirements of applicable codes and standards, and acceptance criteria; and specifies appropriate record maintenance. Therefore, the staff finds the description in QAPD Section 2.9, acceptable.
2.10 Inspections The NEXT Lab QAPD describes the inspection process to verify conformance of an item or activity to requirements. The inspection process will be planned, documented, and performed, as necessary. The inspection process will be applicable to procurement, construction, modification, maintenance, and experiment fabrication. Inspections will be performed by persons other than those who performed the work being inspected, but may be from the same organization. Completed items will be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and performance of the item to specified requirements. Associated quality records shall be examined for adequacy and completeness.
Only items that have passed required inspections and tests shall be used, installed, or operated.
Measuring and test equipment (M&TE) used to perform inspections will be identified in inspection documentation, for traceability of inspection results.
Acceptance of inspected items will be documented and approved by authorized personnel.
Verification of conformance of work activities for the purpose of acceptance will be performed by qualified personnel.
The NEXT Lab will determine the need for formal training and training activities to qualify inspection and test personnel. The NEXT Lab will provide on-the-job training with emphasis on firsthand experience gained through actual performance of inspections. Records of inspection personnels qualification will be established and maintained by the NEXT Lab QA Manager.
The NRC staff determined that NEXT Labs controls for inspection in QAPD Section 2.10 are consistent with the guidance provided in Section 2.10 of ANSI/ANS-15.8-1995, because Section 2.10 describes the recommended requirements to plan, document and perform inspections required to verify conformance of quality affecting items or activities, including items in-process or under construction, to specified requirements. Section 2.10 also requires the recommended examination of the associated quality records for adequacy and completeness, requires that measuring and test equipment used to perform inspections be identified in the inspection documentation, and describes the qualification and training requirements, including on-the-job training, for the lab personnel performing the inspection activities. Therefore, the staff finds the description in QAPD Section 2.10, acceptable.
2.11 Test Control The QAPD states formal testing shall be required to verify conformance of designated SSCs to specified requirements, and demonstrate satisfactory performance for service, or to collect data in support of design or fabrication. Testing will include prototype qualification tests, proof tests prior to installation, and functional tests. Test results will be documented and evaluated by a responsible authority to ensure that test requirements have been satisfied. Computer programs to be used for operational control will be tested consistent with an approved verification and validation plan and will demonstrate required performance over the range of operation of the controlled function or process.
The NRC staff determined that NEXT Labs controls for testing in QAPD Section 2.11 are consistent with the guidance provided in Section 2.11 of ANSI/ANS-15.8-1995, because Section 2.11 describes the recommended formal testing requirements to verify conformance of designated SSCs to specified requirements and demonstrate satisfactory performance for service, or to collect data to support design or fabrication. Section 2.11 also requires, as recommended, the documentation and evaluation of test results by NEXT Lab Design Engineering, and that verification and validation of computer programs be performed.
Therefore, the staff finds the description in QAPD Section 2.11, acceptable.
2.12 Control of Measuring and Test Equipment The QAPD states that NEXT Lab will implement measures to ensure that tools, gauges, instruments, and other M&TE used for activities affecting quality are controlled, calibrated, or adjusted at specified periods, to maintain accuracy within specified limits. Out-of-calibration devices will be tagged and segregated, until calibration has been restored. Records of calibration traceable to an individual piece of M&TE will be maintained. Calibration and control measures will not be required when normal commercial equipment provides adequate accuracy.
The NRC staff determined that NEXT Labs controls for M&TE in QAPD Section 2.12 are consistent with the guidance provided in Section 2.12 of ANSI/ANS-15.8-1995, because Section 2.12 includes recommended requirements for control, calibration, and adjustment that need to be performed for tools, gauges, instruments and other M&TE equipment used for activities affecting quality, as well as the measures that will be taken for out-of-calibration devices, and the requirements to maintain records of calibration data for each M&TE. Therefore, the staff finds QAPD Section 2.12, acceptable.
2.13 Handling, Storage, and Shipping The NEXT Lab QAPD states implementing procedures will establish requirements that handling, storage, and shipping of items be performed consistent with work and inspection instructions, drawings, specifications, shipping instructions, or other pertinent documents for conducting the activity. The NRC staff determined that NEXT Labs QAPD Section 2.13 is consistent with the guidance provided in Section 2.13 of ANSI/ANS-15.8-1995, because it includes the controls for handling, storage, and shipping recommended in the ANSI/ANS standard, and is therefore, acceptable.
2.14 Inspection, Test, and Operating Status The QAPD requires that the status of inspection and test activities be identified either on the items or in documents traceable to the items. Identification of inspection and test status will ensure that required inspection and tests were performed and prevent inadvertent installation or operation of items that have not passed the required inspections or tests.
The NRC staff determined that NEXT Labs controls for inspection, test, and operating status in QAPD Section 2.14 are consistent with the guidance provided in ANSI/ANS-15.8-1995, because Section 2.14 includes ANSI/ANS standard recommended actions that allow the traceability of the status of inspection and test activities of items, and avoid the installation or operation of items that have not passed the required inspections and tests. Therefore, the staff finds QAPD Section 2.14 acceptable.
2.15 Control of Nonconforming Items and Services The QAPD describes the necessary measures to control nonconforming items to prevent their inadvertent use or installation. These controls include measures for identification, documentation, evaluation, segregation from like conforming items when practical, and disposition of nonconforming items. Dispositions, such as use-as-is, reject, repair, or rework, will be identified and documented.
The QAPD states that NEXT Lab will document the technical justification for the acceptability of a non-conforming item dispositioned as repair or use-as-is. Non-conformances to design requirements of items dispositioned as repair or use-as-is will be subject to design control measures commensurate with those applied to the original design. The as-built records will reflect the accepted deviation. Repaired or reworked items will be reexamined consistent with evaluation requirements in the corrective action program as implemented in the NEXT Lab quality procedures.
The NRC staff determined that NEXT Labs controls for nonconforming items and services in QAPD Section 2.15 are consistent with the guidance provided in Section 2.15 of ANSI/ANS-15.8-1995, because Section 2.15 includes the measures recommended to prevent inadvertent installation or use of non-conforming items, and to allow identification, documentation, evaluation, and segregation of these items. In addition, as recommended, Section 2.15 includes requirements for documenting the technical justification for the acceptability of non-conforming items, and includes requirements for the reexamination of repaired or reworked items, consistent with the implemented corrective action program. Therefore, the staff finds QAPD Section 2.15, acceptable.
2.16 Corrective Actions The QAPD requires that conditions adverse to quality be identified promptly and corrected as soon as practical. The corrective actions will be consistent with the design requirements unless those requirements were faulty. In the case of a significant condition adverse to quality, the cause of the condition will be investigated and corrective action to prevent recurrence will be taken.
The NRC staff determined that NEXT Labs controls for corrective actions in QAPD Section 2.16 are consistent with the guidance provided in Section 2.16 of ANSI/ANS-15.8-1995, because, as recommended, Section 2.16 requires the prompt identification and correction of conditions adverse to quality in accordance with the labs corrective action plan, and requires that investigation and corrective actions be performed for conditions that are significantly adverse to quality to preclude recurrence. Therefore, the staff finds QAPD Section 2.16, acceptable.
2.17 Quality Records The QAPD describes the necessary measures to ensure that, at minimum, records of the following activities be maintained and appropriately stored: inspection and test results, results of quality assurance reviews, quality assurance procedures, and engineering reviews and analyses for design or changes and modifications.
Some records will be maintained by NEXT Lab for the life of the item while it is installed in the facility or stored for future use. Such records will be classified consistent with applicable documented classification criteria. Other records will be retained for a shorter period, as determined by NEXT Lab.
Records will be stored in a location that prevent damage from moisture, temperature, and pestilence. Provisions will be specified for special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media, to prevent damage. Records maintained by suppliers will be accessible to NEXT Lab personnel.
The NRC staff determined that NEXT Labs controls for quality records in QAPD Section 2.17 are consistent with the guidance provided in Section 2.17 of ANSI/ANS-15.8-1995, because, as recommended, Section 2.17 includes requirements to store records applicable to quality for specified periods and under appropriate conditions. Therefore, the staff finds QAPD Section 2.17, acceptable.
2.18 Assessments/Audits The QAPD describes the necessary measures for conducting periodic assessments of quality-affecting activities during design, construction, or modification to evaluate the effectiveness of the as-implemented QAP. Assessments will be performed consistent with written procedures or checklists. Assessment results will be documented and reviewed by the management personnel responsible for the area assessed. Management of the assessed organization will investigate adverse findings and schedule corrective actions. The adequacy of the responses will be evaluated by the assessing organization.
Assessment records will include plans, reports, written replies, and records of completion of corrective actions. The QAPD requires that personnel conducting assessments have the requisite training and experience.
The NRC staff determined that NEXT Labs controls for assessments in QAPD Section 2.18 are consistent with the guidance provided in Section 2.18 of ANSI/ANS-15.8-1995, because, as recommended, Section 2.18 requires the lab staff, representatives, or both to conduct and document periodic assessments of quality-affecting activities during design, construction, or modification to evaluate the effectiveness of the as-implemented QAP, requires the review of such documents by the QA Manager, and requires the prompt implementation of corrective actions in the CAP. Section 2.18, also requires NEXT Lab management to investigate adverse findings, schedule corrective actions, and notify the appropriate assessing organization of any actions taken or planned. Section 2.18, also as recommended, further requires the maintenance of assessment records, and requires that the personnel selected for assessment assignments have the requisite experience and training. Therefore, the staff finds QAPD Section 2.18, acceptable.
2.19 Experimental Equipment The NEXT Lab QAPD states that the QAP and implementing procedures will provide controls over the design, fabrication, installation, and modification of experimental equipment to the extent that these impact safety-related items.
The NRC staff determined that NEXT Labs controls for experimental equipment in QAPD Section 2.19 are consistent with the guidance provided in ANSI/ANS-15.8-1995, because, as recommended, Section 2.19 requires controls of experimental equipment to the extent that it impacts safety-related items. Therefore, the staff finds QAPD Section 2.19, acceptable.
3.0 Facility Operations The QAPD states that the regulations in 10 CFR 50.34(b) require that the Final Safety Analysis Report (FSAR) include, among other things, the managerial and administrative controls to be used to assure safe operation, including a discussion of how the applicable quality requirements will be satisfied. ACU submitted its QAPD pursuant to 10 CFR 50.34(a)(7). The NEXT Lab QAPD Section 3 pertains to the facility operations phase of the NEXT Lab facility, and states that the MSRR FSAR submitted in the operating license application will describe how ACU intends to comply with 10 CFR 50.34(b). Therefore, the NRC staff will defer its review of how ACU intends to comply with 10 CFR 50.34(b) for facility operations until the receipt of a FSAR included in an operating license application.
4.0 Applicability to Existing Facilities The QAPD Section 4 states that because the MSRR construction permit application will be an application for a new facility, there are no existing facilities. The NRC staff finds this section of the QAPD does not apply to the ACU MSRR facility.
5.0 Decommissioning The QAPD Section 5 indicates that the QAPD references decommissioning activities where applicable (e.g., records retention). However, the QAPD states that QA for decommissioning activities will be included as part of a decommissioning plan submission in accordance with 10 CFR 50.82(b)(4)(v). Because submission of a decommissioning plan and associated quality assurance provisions are not required until a licensee applies for license termination after the permanent cessation of operations, the NRC staff will defer a detailed evaluation of QA for decommissioning until the receipt of a proposed decommissioning plan.
LIMITATIONS AND CONDITIONS The NRC staff did not identify any areas in the QAPD that would require the use of limitations or conditions on the application of the QAPD for the design, fabrication, construction, and testing of ACUs MSRR facility or for referencing the QAPD in a future ACU license application.
CONCLUSION Based on its evaluation of the ACU NEXT Labs QAPD, Revision B, the NRC staff finds that the QAPD is consistent with the guidance contained within Section 12.9 of NUREG-1537, Parts 1 and 2, and ANSI/ANS-15.8-1995, which the NRC endorsed in RG 2.5, Revision 1. Therefore, the NRC staff concludes that the ACU NEXT Lab QAPD, Revision B, complies with the applicable requirements of 10 CFR 50.34(a)(7), and is approved for use by ACU for the QAP implemented for the design, fabrication, construction, and testing of the ACU MSRR facility.
REFERENCES
- 1. Letter from ACU to NRC, Submittal of the Abilene Christian University Quality Assurance Program Description, dated March 18, 2021(ADAMS Accession No. ML21099A109)
- 2. Letter from ACU to NRC, Response to the Abilene Christian University Quality Assurance Program Description Request for Additional Information, dated July 27, 2021 (ADAMS Accession No. ML21230A307)
- 3. Regulatory Guide 2.5, Quality Assurance Requirements for Research and Test Reactors, Revision 1, dated June 2010 (ADAMS Accession No. ML093520099)
- 4. ANSI/ANS-15.8-1995, American National Standard for Quality Assurance Program Requirements for Research Reactors, dated May 10, 2013.
- 5. NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, dated February 1996 (ADAMS Accession No. ML042430055)
- 6. NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, dated February 1996 (ADAMS Accession No. ML042430048)
- 7. Letter from ACU to NRC, Response to the NRC phone request to affirm a typographical error in the Abilene Christian University QAPD Rev B, dated December 9, 2021 (ADAMS Accession No. ML21362A408)
Principal Contributors: Dong Park Paul Prescott Edward Helvenston Richard Rivera Project Managers: Edward Helvenston Richard Rivera Date: February 14, 2022