ML25080A304
| ML25080A304 | |
| Person / Time | |
|---|---|
| Site: | Hermes File:Kairos Power icon.png |
| Issue date: | 02/24/2025 |
| From: | Kairos Power |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML25080A302 | List: |
| References | |
| KP-NRC-2503-002 | |
| Download: ML25080A304 (1) | |
Text
KP-NRC-2503-002 Quality Assurance Program for the Kairos Power Hermes Reactor Facility, Revision 2 (Non-Proprietary)
HER-PQ-PRG-000-001 Kairos Power LLC 707 W. Tower Ave Alameda, CA 94501 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 2 of 23 COPYRIGHT NOTICE This document is the property of Kairos Power LLC (Kairos Power) and was prepared in support of the development of the Kairos Power Hermes Reactor Facility. Other than by the NRC and its contractors as part of regulatory reviews of the design, the content herein may not be reproduced, disclosed, or used, without prior written approval of Kairos Power.
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HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 3 of 23 Rev Description of Change Date 0
Initial Issuance 08/2021 1
Changes to Sec 1.2 - definition of term safety related item aligned with Hermes Design.
Changes to Sec 2.4 revised item to read SSC/services Changes to Sec 3.7 revised item to read SSC See Document Date 2
Simplified Sec 2.1 to only include ANS 15.8 requirements for organization, leaving detailed description of organizational responsibilities to internal implementing documents.
See Document Date
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HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 4 of 23 EXECUTIVE
SUMMARY
This document provides a description of the Quality Assurance Program (QAP) for the Kairos Power LLC (Kairos Power) Hermes Reactor Facility (Hermes). The Hermes reactor is a non-power reactor as described in 10 CFR 50.21, Class 104 licenses; for medical therapy and research and development facilities. NRC NUREG-1537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content," directs applicants to ANSI/ANS-15.8-1995, Quality Assurance Program Requirements for Research Reactors, (ANSI/ANS-15.8) when preparing an application for non-power reactors. This standard is endorsed by NRC Regulatory Guide 2.5, Quality Assurance Program Requirements for Research and Test Reactors (RG 2.5).
The Hermes Quality Assurance Program Description (H-QAPD) provides the methods and establishes quality assurance and administrative control requirements that meet 10 CFR 50.34 based on the criteria of ANSI/ANS-15.8-1995 as endorsed by RG 2.5, Revision 1.
The scope of this QAP includes design, construction, and operation activities for Hermes. Consistent with common licensing practice, text is written in the present tense, active voice, including discussions of activities and processes associated with a phased implementation of design, construction, and operation.
The document is divided into three parts:
- 1. Introduction,
- 2. Design, Construction, and Modifications, and
- 3. Facility Operations Kairos Power is implementing this program to satisfy quality assurance requirements for use in the Hermes application submitted in accordance with 10 CFR 50 (as applicable):
Construction Permit (CP) Applications pursuant to 10 CFR 50.34(a)(7)
Operating License (OL) Applications pursuant to 10 CFR 50.34(b)(6)(ii)
Note: The H-QAPD is distinct from the Kairos Power Quality Assurance Program for the Kairos Power Fluoride Salt-Cooled High Temperature Reactor that is the subject of a separate Topical Report which, at this writing, is under review by the NRC staff. That document describes the quality assurance program for the Kairos Power commercial power reactor(s). The H-QAPD is specific and unique to the non-power Hermes reactor facility.
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HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 5 of 23 Abbreviations Term Abbreviation ANS American Nuclear Society ANSI American National Standards Institute CEO Chief Executive Officer CFR Code of Federal Regulations CP Construction Permit FSAR Final Safety Analysis Report H-QAPD Quality Assurance Program Description for the Hermes Reactor Facility KP Kairos Power LLC Limited Liability Company M&TE Measurement & Test Equipment NRC Nuclear Regulatory Commission OL Operating License QA/QC Quality Assurance/Quality Control QAP Quality Assurance Program RG Regulatory Guide SAR Safety Analysis Report SSC Structures, Systems, and Components
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HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 6 of 23 Table of Contents EXECUTIVE
SUMMARY
................................................................................................................................. 4 Abbreviations............................................................................................................................................... 5 Policy Statement.......................................................................................................................................... 8 1
Introduction......................................................................................................................................... 9 1.1 Scope and Applicability............................................................................................................... 9 1.2 Definitions................................................................................................................................. 10 2
Design, Construction, and Modifications........................................................................................... 11 2.1 Organization.............................................................................................................................. 11 2.2 Quality Assurance Program....................................................................................................... 11 2.3 Design Control........................................................................................................................... 13 2.3.1 Design Requirements............................................................................................................ 13 2.3.2 Design Process...................................................................................................................... 13 2.3.3 Design Verification................................................................................................................ 13 2.3.4 Design Documents and Records........................................................................................... 14 2.3.5 Commercial Grade Items...................................................................................................... 14 2.3.6 Change Control..................................................................................................................... 14 2.4 Procurement Document Control.............................................................................................. 14 2.5 Procedures, Instructions, and Drawings................................................................................... 15 2.6 Document Control..................................................................................................................... 15 2.7 Control of Purchased Items and Services.................................................................................. 15 2.7.1 Supplier Selection................................................................................................................. 15 2.7.2 Work Control........................................................................................................................ 15 2.7.3 Verification Activities............................................................................................................ 15 2.7.4 Item or Service Acceptance.................................................................................................. 16 2.8 Identification and Control of Items........................................................................................... 16 2.9 Control of Special Processes..................................................................................................... 16 2.10 Inspections................................................................................................................................ 16 2.11 Test Control............................................................................................................................... 17 2.12 Control of Measuring and Test Equipment............................................................................... 17 2.13 Handling, Storage, and Shipping............................................................................................... 17 2.14 Inspection, Test, and Operating Status..................................................................................... 17 2.15 Control of Non-conforming Items and Services........................................................................ 17 2.16 Corrective Actions..................................................................................................................... 18 2.17 Quality Records......................................................................................................................... 18 2.18 Assessments.............................................................................................................................. 19 3
FACILITY OPERATIONS....................................................................................................................... 20 3.1 Organization.............................................................................................................................. 20 3.2 Quality Assurance Program....................................................................................................... 20 3.3 Performance Monitoring.......................................................................................................... 20 3.4 Operator Experience................................................................................................................. 20 3.5 Operating Conditions................................................................................................................ 20 3.6 Operational Authority............................................................................................................... 21 3.7 Configuration Control............................................................................................................... 21
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© 2025 Kairos Power LLC 7 of 23 3.8 Lockouts and Tagouts............................................................................................................... 21 3.9 Test and Inspection................................................................................................................... 21 3.10 Operating Procedures............................................................................................................... 21 3.11 Operator Aid Postings............................................................................................................... 21 3.12 Equipment Labeling.................................................................................................................. 22 4
References......................................................................................................................................... 23 4.1 American National Standard for Quality Assurance Program Requirements for Research Reactors, ANSI/ANS-15.8-1995.............................................................................................................. 23 4.2 NUREG 1537, Part 1 Guidelines for Preparing and Reviewing Applications for The Licensing of Non-Power Reactors, Format and Content.......................................................................................... 23 4.3 Regulatory Guide 2.5 Rev.1, Quality Assurance Requirements for Research and Test Reactors................................................................................................................................................ 23
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HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 8 of 23 POLICY STATEMENT Kairos Power shall design, procure, deliver, construct, and operate the Hermes Reactor Facility (Hermes) in a manner that ensures the health and safety of the public and workers. These activities shall be performed in compliance with the requirements of the Code of Federal Regulations and applicable laws and regulations of the state and local governments.
The Quality Assurance Program (QAP) for Hermes is described in this document and associated implementing documents. Together they provide for control of Kairos Power activities that affect the quality of safety-related structures, systems, and components (SSCs) and include all planned and systematic activities necessary to provide adequate confidence that such SSCs perform satisfactorily in service. This Quality Assurance Program Description for the Hermes Reactor Facility (H-QAPD) may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations, or where other NRC guidance establishes program requirements.
The H-QAPD is the top-level program document that establishes the manner in which quality is to be achieved and presents Kairos Powers overall philosophy regarding achievement and assurance of quality for Hermes. Implementing documents assign more detailed responsibilities and requirements and define the organizational interfaces involved in conducting activities within the scope of the QAP.
Senior management establishes overall expectations for effective implementation of the QAP and is responsible for obtaining the desired end result. Compliance with the H-QAPD and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the Hermes QAP.
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© 2025 Kairos Power LLC 9 of 23 1
INTRODUCTION This document provides the description of the Kairos Power LLC Quality Assurance Program (QAP) for the site selection, design, construction, and operation of the Kairos Power Hermes Reactor Facility (Hermes).
The Quality Assurance Program Description for the Hermes Reactor Facility (H-QAPD) is the top-level program document that establishes the quality assurance policy and assigns major functional responsibilities for all quality-related activities conducted by or for Hermes.
The Hermes reactor is a non-power reactor as described in 10 CFR 50.21, Class 104 licenses; for medical therapy and research and development facilities. NRC NUREG-1537, "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content," directs applicants to ANSI/ANS-15.8-1995, Quality Assurance Program Requirements for Research Reactors, (ANSI/ANS-15.8) when preparing an application for non-power reactors. This standard is endorsed by NRC Regulatory Guide 2.5, Quality Assurance Program Requirements for Research and Test Reactors (RG 2.5).
The H-QAPD describes the methods and establishes quality assurance (QA) and administrative control requirements that meet 10 CFR 50. 34 based on the criteria of ANSI/ANS-15.8 as endorsed by RG 2.5, Revision 1.
The Hermes QAP comprises the document that describes the QA elements (i.e., the H-QAPD), along with the associated implementing documents. Procedures and instructions that prescribe quality-related activities are developed prior to commencement of those activities. Policies that establish high-level responsibilities and authority for carrying out important administrative functions are outside the scope of the H-QAPD.
1.1 SCOPE AND APPLICABILITY The H-QAPD applies to design, construction, and operations activities, including those in support of Construction Permit (CP) and Operating License (OL) applications affecting the quality and performance of safety-related structures, systems, and components (SSCs), including, but not limited to:
Designing Shipping Inspecting Siting Receiving Testing Procuring Storing Operating Fabricating Constructing Maintaining Cleaning Erecting Repairing Handling Installing Modifying Safety-related SSCs within the scope of the H-QAPD are identified by design documents. The technical aspects of these items are considered when determining program applicability, including, as appropriate, the item's design safety function. The H-QAPD may be applied to certain activities where regulations other than 10 CFR 50 establish QA requirements for activities within their scope.
Implementing documents establish program element applicability.
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© 2025 Kairos Power LLC 10 of 23 1.2 DEFINITIONS The definitions provided in ANSI/ANS-15.8, Section 1.3, apply to this document with the following exception:
The term safety-related items defined in ANSI/ANS-15.8, Section 1.3 will be replaced with the term safety-related SSCs and will be defined as:
Those SSCs that are relied upon to remain functional during normal operating conditions and during and following design basis events to assure:
The integrity of the portions of the reactor coolant boundary relied upon to maintain coolant level above the active core; The capability to shut down the reactor and maintain it in a safe shutdown condition; or The capability to prevent or mitigate the consequences of accidents which could result in potential exposures exceeding the limits set forth in 10 CFR 100.11.
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© 2025 Kairos Power LLC 11 of 23 2
DESIGN, CONSTRUCTION, AND MODIFICATIONS This section provides the requirements for establishing, managing, conducting, and assessing the program of controls over the design, construction, and modification of Hermes. This section is implemented as applicable to the specific scope of work activities.
2.1 ORGANIZATION The organizational structure and assignment of responsibilities is 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. Persons responsible for ensuring that appropriate controls have been established, and for verifying that activities have been correctly performed, have sufficient authority, access to work areas, and independence to: (a) identify problems; (b) initiate, recommend, or provide corrective action; and (c) ensure corrective action implementation. It is recognized that for Hermes, the organization is small, and personnel may perform multiple functions.
2.2 QUALITY ASSURANCE PROGRAM Kairos Power establishes the necessary measures and governing procedures to implement the Hermes QAP as described in the H-QAPD at the earliest time consistent with the schedule for accomplishing quality-related activities. Kairos Power is committed to implementing this QAP in all aspects of work that are important to the safety of the nuclear plants as described and to the extent delineated in the H-QAPD. This QAP shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities important to safety are performed satisfactorily. Further, Kairos Power ensures through the systematic process described herein that its suppliers of safety-related equipment or services meet applicable quality requirements. Senior management is regularly apprised of the adequacy of implementation of the QAP through the assessment functions described in Section 2.18.
The objective of the Hermes QAP is to assure that Hermes Reactor Facility is designed, constructed, and operated in accordance with governing regulations and license requirements. The program is based on the criteria of ANSI/ANS-15.8, as further described in this document. This QAP applies to those quality-related activities that involve the functions of safety-related structures, systems, and components (SSCs) associated with the design, fabrication, construction, and testing of the SSCs of the facility and to the managerial and administrative controls to be used to assure safe operations. Examples of CP/OL program safety-related activities include, but are not limited to, engineering related to safety-related SSCs, site geotechnical investigations, site engineering analysis, seismic analysis, and meteorological analysis. A list or system that identifies SSCs and activities to which this program applies is maintained at the appropriate facility. Design documents are used as the basis for this list. Cost and scheduling challenges must be addressed; however, they do not prevent proper implementation of the QAP. This includes the managerial and administrative aspects of internal and external activities that affect quality of Hermes and programs.
This QAP provides for the use of a graded approach to quality. The measures applied to a particular engineered or administrative control or control system may be graded commensurate with the
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© 2025 Kairos Power LLC 12 of 23 reduction of the risk attributable to that control or control system. This approach to achieving levels of quality is described in the H-QAPD and related implementing documents.
In general, the program requirements specified herein are detailed in implementing procedures that are either Kairos Power implementing procedures, or supplier implementing procedures governed by a supplier quality assurance program.
Delegated responsibilities may be performed under a suppliers quality program, provided that it has been approved in accordance with the H-QAPD. Periodic assessments are conducted to assure compliance with the supplier's or principal contractor's quality program and implementing procedures.
In addition, routine interfaces with their personnel provide added assurance that quality expectations are met. Assessments may be planned and performed by Kairos Power qualified assessors or independent contractors or consultants as determined by Quality Management.
Personnel assigned to implement elements of the H-QAPD shall be capable of performing their assigned tasks. Kairos Power establishes and maintains formal indoctrination and training programs for personnel performing, verifying, or managing activities within the scope of the H-QAPD to ensure that suitable proficiency is achieved and maintained. Sufficient managerial depth is provided to cover absences of incumbents. When required by code, regulation, or standard, specific qualification and selection of personnel is conducted in accordance with those requirements as established in applicable Kairos Power procedures. Indoctrination includes the administrative and technical objectives and requirements of the applicable codes and standards and QAP requirements as necessary. Records of personnel training and qualification are maintained.
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© 2025 Kairos Power LLC 13 of 23 2.3 DESIGN CONTROL Kairos Power has established and implements a process to control the design, design changes, and temporary modifications of items that are subject to the provisions of the QAP. The design process includes provisions for the development, verification, approval, release, status, distribution, and revision of design inputs and outputs.
2.3.1 Design Requirements Applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes, and standards shall be identified and documented.
2.3.2 Design Process Design interfaces shall be identified and controlled, and the design efforts shall be coordinated among the participating organizations.
The applicability of standardized or previously proven designs, with respect to meeting pertinent design inputs, shall be verified for each application. Known problems affecting the standardized or previously proven designs, and their effects on other features, shall be considered. Deviations from the established and documented design inputs, including the reasons for the changes, shall be documented and controlled.
The design organization is responsible to ensure that the final design shall:
- 1.
be relatable to design input by documentation in sufficient detail to permit design traceability and verification, and
- 2.
identify assemblies and/or components that are part of the item being designed When a computer design program is used to develop portions of the facility design or to analyze a design for acceptability, that program shall be fully documented, validated, and controlled to ensure the correctness of its output. When a design program must be developed, the program shall be controlled to ensure that it is fully documented and validated. Where changes to previously valid computer programs are made, documented revalidation shall be required for the change. Verification of design-unique computer programs shall include appropriate benchmark testing.
2.3.3 Design Verification Independent design verifications shall be used to verify the adequacy of design by one or more of the following:
- 1.
performance of design reviews,
- 2.
use of alternate calculations,
- 3.
performance of qualification tests, or
- 4.
comparison of similar proven systems.
The responsible design organization shall identify and document the design verification method or methods used. Design verification is performed by competent individuals or groups other than those who performed the design, but who may be from the same organization. In all cases the design
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© 2025 Kairos Power LLC 14 of 23 verification shall be completed prior to reliance upon the component, system, structure, or computer program to perform its function in operations.
In the event that qualification testing is needed to verify design, the use of qualification tests is defined in a formal test plan that shall include appropriate acceptance criteria and shall demonstrate the adequacy of performance under conditions that simulate the most adverse design conditions. Test results are documented and evaluated by the responsible design organization to ensure that test requirements have been met.
2.3.4 Design Documents and Records Design documents and records, which provide evidence that the design and design verification process were performed, shall be collected, stored, and maintained for the life of the safety-related item.
2.3.5 Commercial Grade Items The use of commercial-grade equipment in safety-related applications shall be reviewed to ensure that it can adequately perform its intended function. When a commercial grade item, 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 part shall be represented as different from the commercial grade item in a manner traceable to a documented definition of the difference.
2.3.6 Change Control Modifications to safety-related structures, systems, and components, or computer codes shall be based on a defined as-exists design. Changes to verified designs shall be documented, justified, and subject to design control measures commensurate with those applied to the original design. The control measures shall include assurance that the design analyses for the structure, system, component, or computer code are still valid. Where a significant design change is necessary because of an incorrect design, the design process and verification procedure should be reviewed and modified as necessary.
2.4 PROCUREMENT DOCUMENT CONTROL Procedures shall be established to ensure that procurement documents contain sufficient technical and quality requirements to ensure that the items or services satisfy the needs of Kairos Power.
Procurement documents at all procurement levels shall identify the documentation required to be submitted for information, review, or approval by Kairos Power. At each level of procurement, the procurement documents shall provide for access to the suppliers plant facilities and records, for inspection or audit by Kairos Power, a designated representative, or other parties authorized by Kairos Power.
Hermes procurement documents shall include Kairos Powers requirements for reporting and approving disposition of suppliers non-conformances associated with the items or services being procured. The procurement documents for safety-related SSCs/services should prohibit the supply/use of sub-standard or counterfeit parts or materials.
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© 2025 Kairos Power LLC 15 of 23 2.5 PROCEDURES, INSTRUCTIONS, AND DRAWINGS Activities affecting quality shall be performed in accordance with documented instructions, procedures, or drawings appropriate to the circumstances. These documents shall include or reference appropriate quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished.
2.6 DOCUMENT CONTROL The preparation, issue, and change of documents which specify requirements that affect quality or prescribe activities affecting quality shall be controlled to ensure that correct documents are used. The document control system shall be documented and provide for:
- 1.
identification of documents to be controlled and their specified distribution;
- 2.
identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents; and
- 3.
review of documents for adequacy, completeness, and correctness prior to approval and issuance.
Major changes to controlled documents shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.
2.7 CONTROL OF PURCHASED ITEMS AND SERVICES The procurement of items and services shall be controlled to ensure appropriate procurement planning, source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services for acceptance upon delivery or completion.
2.7.1 Supplier Selection The selection of suppliers shall be based on evaluation of their capability to provide items or services in accordance with requirements of the procurement documents.
2.7.2 Work Control Kairos Power shall establish measures to control the suppliers performance to ensure that purchased items and services meet Hermes quality requirements. Controls may include test plans, review of suppliers submitted documents, arrangements for source surveillance or inspection, and other technical and administrative interfaces with the supplier in accordance with procurement documents.
2.7.3 Verification Activities The supplier shall be responsible for the quality of its product and shall verify and provide evidence of that quality. Supplier-generated documents shall be controlled, handled, and approved in accordance with established methods. Means shall be implemented to provide for the acquisition, processing, and recorded evaluation of technical, inspection, and test data against acceptance criteria. Based on complexity of the product and importance to safety, Kairos Power should independently verify the quality of a suppliers product through source surveillances, inspections, audits, or review of the suppliers non-conformances, dispositions, waivers, and corrective actions.
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© 2025 Kairos Power LLC 16 of 23 2.7.4 Item or Service Acceptance Kairos Power shall establish a system to provide assurances that purchased items and services conform to procurement specifications. Methods used to accept an item or related service from a supplier shall be a supplier Certificate of Conformance, source verification, receiving inspection, post-installation test, or a combination thereof. Receiving inspection shall be performed in accordance with established procedures and instructions, to verify by objective evidence such features as proper configuration, identification, and cleanliness, and to determine any shipping damage, fraud, or counterfeit.
2.8 IDENTIFICATION AND CONTROL OF ITEMS When specified by codes, standards, or specifications that include identification or traceability requirements, the item identification and control process shall be capable of providing identification and traceability control. Items identification shall be maintained from the initial receipt or fabrication of the items 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 shall be employed. Identification markings shall be applied using materials and methods which provide clear and legible identification and do not detrimentally affect the function or service life of the item. Markings shall be transferred to each part of an identified item when the item is subdivided and shall not be obliterated or hidden by surface treatment or coatings unless substitute means are provided. Where specified, items having limited calendar or operating life shall be identified and controlled to preclude use of items whose shelf life or operating life is expired.
2.9 CONTROL OF SPECIAL PROCESSES Special processes include those in which the results are highly dependent on the control of the process or skill of the personnel. These are also those processes in which the specified quality cannot be readily determined by inspection or non-destructive testing of the product. Kairos Power implements the necessary measures and governing procedures to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, and nondestructive examination, are controlled. These processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means. Kairos Power and its suppliers are responsible to adhere to the approved procedures and processes when performing special processes for Hermes. The requirements of applicable codes and standards, including acceptance criteria for each process, shall be specified or referenced in the procedures or instructions that control the process. Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment associated with special processes.
2.10 INSPECTIONS Inspections to verify conformance of an item or activity to requirements shall be planned, documented, and performed. The inspection program shall apply to procurement, construction, modification, and maintenance. Inspection of items in-process or under construction shall be performed for work activities where product quality cannot be determined by inspection of the completed product. The final inspection shall be planned to arrive at a conclusion regarding conformance of the item to specified requirements. Completed items shall be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and conformance of the item to specified requirements. Associated quality records shall be examined for adequacy and completeness. Only items that have passed the required inspections and tests shall be used, installed, or
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© 2025 Kairos Power LLC 17 of 23 operated. Measuring and Test Equipment (M&TE) used to perform inspections shall be identified in inspection documentation for traceability of inspection results.
Inspection results shall be documented. Acceptance of items shall be documented and approved by authorized personnel. Inspection shall be performed by persons other than those who performed the work being inspected but they may be from the same organization. Each person who verifies conformance of work activities for purposes of acceptance shall be qualified to perform the assigned inspection task. The need for formal training shall be determined and training activities conducted as required to qualify personnel who perform inspections and tests. On-the-job training shall be included, with emphasis on firsthand experience gained through actual performance of inspections. Records of inspection personnels qualification shall be established and maintained by their employer.
2.11 TEST CONTROL Formal testing shall be required to verify conformance of designated structures, systems, or components to specified requirements and demonstrate satisfactory performance for service or to collect data in support of design or fabrication. Testing shall include prototype qualification tests, proof tests prior to installation, and functional tests. Test results shall be documented and evaluated by a responsible authority to ensure that test requirements have been satisfied.
Computer programs used for operational control shall be tested in accordance with an approved verification and validation plan and shall demonstrate required performance over the range of operation of the controlled function or process.
2.12 CONTROL OF MEASURING AND TEST EQUIPMENT Tools, gauges, instruments, and other M&TE used for activities affecting quality shall be controlled and calibrated or adjusted, at specified periods to maintain accuracy within specified limits. Out-of-calibration devices shall be tagged or segregated, and not used until they have been recalibrated.
Records shall be maintained of calibration data traceable to the individual piece of M&TE. Calibration and control measures are not required when normal commercial equipment provides adequate accuracy.
2.13 HANDLING, STORAGE, AND SHIPPING Handling, storage, and shipping of items shall be in accordance with work and inspection instructions, drawings, specifications, shipping instructions, or other pertinent documents or procedures for conducting the activity.
2.14 INSPECTION, TEST, AND OPERATING STATUS The status of inspection and test activities shall be identified on the items or in documents traceable to the items in order to ensure that required inspections and tests are performed and to ensure that items which have not passed the required inspections and tests are not inadvertently installed or operated.
2.15 CONTROL OF NON-CONFORMING ITEMS AND SERVICES Items that do not conform to requirements shall be controlled to prevent inadvertent installation or use.
Controls on non-conforming items shall provide for identification, documentation, evaluation, segregation from like conforming items when practical, and disposition of non-conforming items. Non-
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© 2025 Kairos Power LLC 18 of 23 conforming conditions shall be evaluated for further reporting to appropriate regulatory agencies. Non-conforming characteristics shall be reviewed, and recommended dispositions of non-conforming items proposed and approved, in accordance with documented procedures.
The disposition (use-as-is, reject, repair, or rework) of non-conforming items shall be identified and documented. Technical justification for the acceptability of a non-conforming item disposition repair or use-as-is shall be documented. Non-conformance to design requirements of items dispositioned use-as-is or repair shall be subject to design control measures commensurate with those applied to the original design. The as-built records shall reflect the accepted deviation. Repaired or reworked items shall be re-examined in accordance with applicable procedures and with the original acceptance criteria unless the non-conforming item disposition has established alternate acceptance criteria.
2.16 CORRECTIVE ACTIONS Conditions adverse to quality shall be identified promptly and corrected as soon as practical. The corrective actions shall be in accordance with the design requirements unless those requirements were faulty. In the case of a significant condition adverse to quality, the cause of the condition shall be investigated, and corrective action taken to preclude recurrence.
2.17 QUALITY RECORDS A records system or systems shall be established at the earliest practical time consistent with the schedule for accomplishing work activities. The records system or systems shall be defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation. The records shall include as a minimum: inspection and test results, results of quality assurance reviews, quality assurance procedures, and engineering reviews and analyses in support of designs or changes and modifications.
Some records shall be maintained by or for the plant owner for the life of the particular item while it is installed in the plant or stored for future use. Such records shall include those meeting the following criteria:
- 1.
those that are of value in demonstrating capability for safe operation;
- 2.
those that are of value in maintaining, reworking, repairing, replacing, or modifying an item;
- 3.
those that are of value in determining the cause or results of an accident or malfunction of a safety-related item;
- 4.
those that provide required baseline data for in-service inspections; or
- 5.
those that are of value in planning for facility decommissioning.
Other records shall be retained for a shorter period as determined by Kairos Power. The records shall be stored in a location or locations that prevent damage from moisture, temperature, and pestilence.
Additional provisions shall be made for special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media, to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity. Records maintained by a supplier shall be accessible to Kairos Power.
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 19 of 23 2.18 ASSESSMENTS Kairos Power conducts periodic assessments of quality-related activities during design, construction, modification, and operations to evaluate the effectiveness of the as-implemented quality program.
Assessments shall be performed in accordance with written procedures or checklists. Assessment results shall be documented and should be reviewed by management personnel who have responsibility for the area assessed. Conditions requiring prompt corrective action shall be reported immediately to the appropriate management of the assessed organization.
Management of the assessed organization or activity shall investigate adverse findings, schedule corrective action (including measures to prevent recurrence) and notify the appropriate assessing organization in writing of action taken or planned. The adequacy of the responses shall be evaluated by the assessing organization. Assessment records include assessment plans, reports, written replies, and the record of completion of corrective action. Personnel selected for assessment assignments shall have experience or training commensurate with the scope, complexity, or special nature of the activities to be assessed. The assessor shall have the capability to communicate effectively, both in writing and orally.
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 20 of 23 3
FACILITY OPERATIONS This section provides the elements of a quality assurance program for conduct of operation at Hermes.
The requirements shall be applied to equipment or operations as appropriate and consistent with its potential safety impact or program goals. Many of the program requirements are satisfied by existing documentation, or by procedures and activities required by other standards and requirements of the applicable permit(s) or license(s). Some requirements of the quality assurance program for operations may also be found in other documents, such as the Training Program, Emergency Plan, Security Plan, Technical Specifications, and the Radiation Protection Program. Such requirements do not need to be duplicated in the quality assurance program.
3.1 ORGANIZATION Kairos Power shall provide sufficient resources in personnel and materials to safely conduct operations at Hermes. Planning should anticipate needs as appropriate for associated tasks. The organization structure shall be defined as required by Technical Specifications.
3.2 QUALITY ASSURANCE PROGRAM Kairos Power shall establish a quality assurance program for Hermes by implementing a policy for the conduct of operations. The policy should assign personnel to implement the policy and identify the goals for operating Hermes. Personnel assignments and progress toward achieving goals should be documented.
3.3 PERFORMANCE MONITORING Kairos Power shall monitor facility performance relative to the goals used as performance indicators for Hermes. Kairos Power shall document periodic observations of operations and identify deficiencies.
Kairos Power should assess deficiencies to ensure the execution of corrective actions that prevent recurrence. If appropriate, trend analysis should be performed to indicate where improvements or lessons learned could be implemented. Violations of operating practices should be addressed and documented as appropriate.
3.4 OPERATOR EXPERIENCE Kairos Power shall document the methods for maintaining operator experience for Hermes. Operators should be responsible for maintaining experience in operating Hermes. This may be achieved by routine operation of Hermes and documentation of the activity. A method should be provided to make operators aware of important current information that is related to facility operations and individual job assignments. Operator training is addressed by the Kairos Power training program.
3.5 OPERATING CONDITIONS Pre-operations checklists shall be used to determine or verify required pre-operational conditions and readiness to operate. Operating equipment shall be periodically monitored to detect abnormal conditions or adverse trends. Operating conditions should be documented in an operations logbook or other record. The operator should notify the appropriate level of management of abnormal situations.
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 21 of 23 3.6 OPERATIONAL AUTHORITY Kairos Power shall establish the method for conducting operations and the responsibility for each shift for Hermes. Operating personnel shall conduct a comprehensive review of appropriate records and equipment before assuming responsibility for the facility. Operational authority may be transferred through a documented turnover briefing and facility walk-through procedures. These procedures should include checklists to record items important to facility status.
3.7 CONFIGURATION CONTROL Equipment shall be identified that requires configuration control. Kairos Power is responsible for establishing and maintaining proper configuration for Hermes and should authorize any changes to safety-related SSCs. Configuration changes to safety-related SSCs should be documented. Before placing equipment into operation, the system shall be properly calibrated or checked, as appropriate, and any deficiencies in the equipment or the current configuration of the system documented. This should also address methods for temporary modifications. Maintenance that requires a change in the system shall be documented.
3.8 LOCKOUTS AND TAGOUTS Locks and tags shall be placed on equipment when, for safety or other special administrative reasons, controls must be established. If there is potential for equipment damage or personnel injury during equipment operation, maintenance, inspection, or modification activities, or from inadvertent activation of equipment, a facility lockout/tagout procedure shall be implemented.
3.9 TEST AND INSPECTION Tests shall be performed following system maintenance, design changes, or inspection that involves dismantlement of components or systems. A documented test plan shall be used to demonstrate that the component or system is capable of performing its intended function. The results of the test should be documented and retained in facility records as appropriate.
3.10 OPERATING PROCEDURES Operating procedures shall provide appropriate direction to ensure that the facility is operated normally within its design basis, and in compliance with technical specifications. Operating procedures shall be written, reviewed, approved by appropriate management, controlled, and monitored to ensure that the content is technically correct and the wording and format are clear and concise. The facility policy on use of procedures should be documented and clearly understood by all operators. The extent of detail in a procedure should depend on the complexity of the task; the experience, education, and training of the users; and the potential significance of the consequences of error. The process for making changes and revisions to procedures should be documented. A controlled copy of all operations procedures should be maintained in the control room or equivalent area.
3.11 OPERATOR AID POSTINGS Posted information that aids operators in performing their duties should be current and correct.
Management should review operator aids to determine that they are necessary and correct before approving their posting. Postings should be checked periodically for continued applicability.
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 22 of 23 3.12 EQUIPMENT LABELING Equipment shall be labeled to help facility personnel positively identify equipment they operate and maintain. Information on labels should be consistent with information found in facility procedures, valve lineup sheets, piping and instrument diagrams, or other documents. Labels should be permanent, securely attached, readable, and have appropriate information.
[Released - 02/24/2025 - KP-1000005908 - rev.2]
HER-PQ-PRG-000-001 Quality Assurance Program for the Kairos Power Hermes Reactor Facility Non-Proprietary
© 2025 Kairos Power LLC 23 of 23 4
REFERENCES 4.1 American National Standard for Quality Assurance Program Requirements for Research Reactors, ANSI/ANS-15.8-1995.
4Property "ANSI code" (as page type) with input value "ANSI/ANS-15.8-1995.</br></br>4" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..2 NUREG 1537, Part 1 Guidelines for Preparing and Reviewing Applications for The Licensing of Non-Power Reactors, Format and Content.
4.3 Regulatory Guide 2.5 Rev.1, Quality Assurance Requirements for Research and Test Reactors.
[Released - 02/24/2025 - KP-1000005908 - rev.2]