ML26045A157
| ML26045A157 | |
| Person / Time | |
|---|---|
| Site: | 05000614 |
| Issue date: | 12/27/2024 |
| From: | - No Known Affiliation |
| To: | NRC/NRR/DANU |
| References | |
| +reviewed | |
| Download: ML26045A157 (0) | |
Text
From:
ext_Jessica_Maddocks Sent:
Friday, December 27, 2024 10:00 AM To:
Kenny Nguyen Cc:
Adrian Muniz; ext_Yvonne _Mirowski
Subject:
[External_Sender] PUBLIC Long Mott Energy-Revision 0 -
ML24345A045 Replacement File Request Attachments:
Encl 1 - LME QAPD Rev 0 (NONPROP) Public.pdf Hi Kenny, There was an error in the Table of Contents of the Long Mott Energy Quality Assurance Program Description document X-energy submitted December 10th. Adrian requested X-energy do a file replacement for the document. Changes were only made to the Table of Contents and were only editorial in nature.
Attached to this email, you will find the updated Long Mott Energy Quality Assurance Program Description - Revision 0 (50 page pdf - matching originally submitted format) correcting these editorial oversights. We are requesting your assistance in the replacement of the originally posted version with the attached updated version under ML24345A045.
Please let me know if you need any other information from me.
Jessica Maddocks Licensing Project Manager jmaddocks@x-energy.com This message (including any attachments) is intended only for the use of the individual or entity to which it is addressed and may contain information that is non-public, proprietary, privileged, confidential, and exempt from disclosure under applicable law or may constitute attorney work product. If you are not the intended recipient, you are hereby notified that any use, dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, notify us immediately and delete this message immediately. Thank you. X Energy, LLC
Hearing Identifier:
XeDOW_ProjectLongMott_SafPublic Email Number:
158 Mail Envelope Properties (PH3P110MB22477D64ADC632D9099BF834900EA)
Subject:
[External_Sender] PUBLIC Long Mott Energy-Revision 0 - ML24345A045 Replacement File Request Sent Date:
12/27/2024 9:59:47 AM Received Date:
12/27/2024 10:00:02 AM From:
ext_Jessica_Maddocks Created By:
/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=BB0743AD17B046F39958AF4A985C5297-8AC523D3-F8 Recipients:
"Adrian Muniz" <Adrian.Muniz@nrc.gov>
Tracking Status: None "ext_Yvonne _Mirowski" <>
Tracking Status: None "Kenny Nguyen" <Kenny.Nguyen@nrc.gov>
Tracking Status: None Post Office:
PH3P110MB2247.NAMP110.PROD.OUTLOOK.COM Files Size Date & Time MESSAGE 1445 12/27/2024 10:00:02 AM image001.png 3997 Encl 1 - LME QAPD Rev 0 (NONPROP) Public.pdf 576139 Options Priority:
Normal Return Notification:
No Reply Requested:
No Sensitivity:
Normal Expiration Date:
Long Mott Energy, LLC Quality Assurance Program Description General Business Long Mott Energy, LLC Quality Assurance Program Description Revision 0 12/04/2024
Long Mott Energy, LLC 12/04/2024 i
General Business DOCUMENT APPROVAL Role Name Title Signature Date Preparer Randy Eubanks Quality Engineer Reviewer Mark Feltner Technology Principal Approval Edward Stones President
Long Mott Energy, LLC 12/04/2024 ii General Business EXECUTIVE
SUMMARY
This Quality Assurance Program Description (QAPD) identifies the basis of the Long Mott Energy, LLC (LME) Quality Assurance Program (QAP) and its application to the design, construction, and manufacturing of advanced nuclear reactors. The QAPD describes methods and establishes Quality Assurance (QA) and administrative control requirements that meet 10 CFR 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants and ASME NQA-1-2015, Quality Assurance Requirements for Nuclear Facility Applications, as endorsed by Regulatory Guide 1.28 Revision 5, Quality Assurance Requirements (Design and Construction). NUREG-0800 Section 17.5, Quality Assurance Program Description - Design Certification Early Site Permit and New License Applicants and the guidance in Nuclear Energy Institute (NEI)11-04A Rev 0, Nuclear Generation Quality Assurance Program Description template were used to prepare the QAPD.
The QAPD is divided into four parts: I - Introduction; II - Quality Assurance Program Description Details; III - Non-Safety-Related SSC Quality Control; and IV-Regulatory Commitments.
Long Mott Energy, LLC 12/04/2024 iii General Business QUALITY POLICY Long Mott Energy, LLC (LME) shall design, procure, and construct nuclear plants in a manner that will ensure 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 (CFR), the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses and applicable laws and regulations of the state and local governments.
The LME Quality Assurance Program (QAP) is the Quality Assurance Program Description (QAPD) provided in this document and the associated implementing documents. Together they provide for control of LME activities that affect the quality of safety-related nuclear plant structures, systems, and components (SSCs) and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will perform satisfactorily in service. The QAPD may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations.
The QAPD is the top-level policy document that establishes the manner in which quality is to be achieved and presents LMEs overall philosophy regarding achievement and assurance of quality.
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 quality assurance program and is responsible for obtaining the desired result.
Compliance with the QAPD and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the LME QAP.
Edward Stones President, Long Mott Energy, LLC December 5, 2024
Long Mott Energy, LLC 12/04/2024 viii General Business CONFIGURATION CONTROL/CHANGE HISTORY TABLE Rev.
Date Preparer Page/Section Revised Description 0
12/4/2024 Randy Eubanks All Initial release of document.
Long Mott Energy, LLC 12/04/2024 iv General Business Table of Contents Part I - Introduction............................................................................................................................ 1 1.
General........................................................................................................................................ 1 1.1 Scope/Applicability..................................................................................................................... 1 1.2 Responsibilities........................................................................................................................... 2 Part II - QAPD Details......................................................................................................................... 3 2.
Organization................................................................................................................................ 3 2.1 President..................................................................................................................................... 3 2.2 Senior Vice President of Commercial Operations....................................................................... 4 2.3 Quality Assurance Manager........................................................................................................ 4 2.4 Environmental Health & Safety.................................................................................................. 4 2.5 Engineering Design..................................................................................................................... 4 2.6 Procurement & Supply Chain...................................................................................................... 4 2.7 Technology Development........................................................................................................... 4 2.8 Program Director......................................................................................................................... 4 2.9 Authority to Stop Work............................................................................................................... 5 2.10 Quality Assurance Organization.................................................................................................. 5 2.11 NQA-1 Commitment..................................................................................................................... 5 2.12 Quality Assurance Program......................................................................................................... 6 2.13 Responsibilities........................................................................................................................... 7 2.14 Delegation of Work...................................................................................................................... 7 2.15 Site-specific Safety-Related Design Basis Activities..................................................................... 8 2.16 Periodic Review of the Quality Assurance Program................................................................... 8 2.17 Issuance and Revision to Quality Assurance Program................................................................. 8 2.18 Personnel Training and Qualifications......................................................................................... 8 2.19 NQA-1 Commitment / Exceptions............................................................................................... 9 3.
Design Control........................................................................................................................... 10 3.1 Design Verification.................................................................................................................... 10 3.2 Design Records.......................................................................................................................... 11 3.3 Computer Application and Digital Equipment Software........................................................... 11 3.4 Setpoint Control........................................................................................................................ 11 3.5 NQA-1 Commitment.................................................................................................................. 11 4.
Procurement Document Control................................................................................................. 11 4.1 NQA-1 Commitment / Exceptions............................................................................................. 12 5.
Instructions, Procedures, and Drawings...................................................................................... 12 Docusign Envelope ID: E2E7AF6E-D7E5-4464-9C31-9259ECF766F2
Long Mott Energy, LLC 12/04/2024 v
General Business 5.1 Procedure Adherence............................................................................................................... 13 5.2 Procedure Content.................................................................................................................... 13 5.3 NQA-1 Commitment.................................................................................................................. 13 6.
Document Control...................................................................................................................... 14 6.1 Review and Approval of Documents......................................................................................... 14 6.2 Changes to Documents.............................................................................................................. 15 6.3 NQA-1 Commitment.................................................................................................................. 15 7.
Control of Purchased Material, Equipment, and Services.............................................................. 15 7.1 Acceptance of Item or Service................................................................................................... 15 7.2 NQA-1 Commitment / Exceptions............................................................................................. 16 8.
Identification and Control of Materials, Parts, and Components.................................................. 19 8.1 NQA-1 Commitment................................................................................................................. 19 9.
Control of Special Processes....................................................................................................... 20 9.1 NQA-1 Commitment................................................................................................................. 20
- 10. Inspection.................................................................................................................................. 21 10.1 Inspection Program................................................................................................................... 21 10.2 Inspector Qualification.............................................................................................................. 21 10.3 NQA-1 Commitment / Exceptions............................................................................................. 22
- 11. Test Control............................................................................................................................... 23 11.1 NQA-1 Commitment for Computer Program Testing................................................................ 23 11.2 NQA-1 Commitment.................................................................................................................. 24
- 12. Control of Measuring and Test Equipment.................................................................................. 25 12.1 Installed Instrument and Control Devices................................................................................. 25 12.2 NQA-1 Commitment / Exceptions............................................................................................. 25
- 13. Handling, Storage, and Shipping................................................................................................. 26 13.1 Housekeeping........................................................................................................................... 26 13.2 NQA-1 Commitment / Exceptions............................................................................................. 26
- 14. Inspection, Test, and Operating Status........................................................................................ 28 14.1 NQA-1 Commitment................................................................................................................. 28
- 15. Nonconforming Materials, Parts, or Components........................................................................ 29 15.1 Interface with the Reporting Program....................................................................................... 29 Docusign Envelope ID: E2E7AF6E-D7E5-4464-9C31-9259ECF766F2
Long Mott Energy, LLC 12/04/2024 vi General Business 15.2 NQA-1 Commitment.................................................................................................................. 29
- 16. Corrective Action....................................................................................................................... 30 16.1 Interface with the Reporting Program....................................................................................... 30 16.2 NQA-1 Commitment.................................................................................................................. 30
- 17. Quality Assurance Records......................................................................................................... 31 17.1 Record Retention...................................................................................................................... 31 17.2 Electronic Records..................................................................................................................... 31 17.3 NQA-1 Commitment / Exceptions............................................................................................. 31
- 18. Audits........................................................................................................................................ 32 18.1 Performance of Audits.............................................................................................................. 32 18.2 Internal Audits........................................................................................................................... 33 18.3 NQA-1 Commitment................................................................................................................. 33 PART III - Non-Safety-Related SSC Quality Control.............................................................................. 34
- 19. Non-Safety-Related with Special Treatment SSCS........................................................................ 34 19.1 Organization.............................................................................................................................. 34 19.2 QA Program............................................................................................................................... 34 19.3 Design Control........................................................................................................................... 34 19.4 Procurement Document Control.............................................................................................. 34 19.5 Instructions, Procedures, and Drawings................................................................................... 34 19.6 Document Control..................................................................................................................... 35 19.7 Control of Purchased Items and Services................................................................................. 35 19.8 Identification and Control of Purchased Items......................................................................... 35 19.9 Control of Special Processes..................................................................................................... 35 19.10 Inspection.................................................................................................................................. 35 19.11 Test Control............................................................................................................................... 35 19.12 Control of Measuring and Test Equipment (M&TE)................................................................. 35 19.13 Handling, Storage, and Shipping............................................................................................... 35 19.14 Inspection, Test, and Operating Status..................................................................................... 36 19.15 Control of Nonconforming Items.............................................................................................. 36 19.16 Corrective Action...................................................................................................................... 36 19.17 Records..................................................................................................................................... 36 19.18 Audits........................................................................................................................................ 36
- 20. Non-Safety-Related SSCS Credited for Regulatory Events............................................................ 37 PART IV - Regulatory Commitments.................................................................................................. 38 Docusign Envelope ID: E2E7AF6E-D7E5-4464-9C31-9259ECF766F2
Long Mott Energy, LLC 12/04/2024 vii General Business
- 21. NRC Regulatory Guides and Quality Assurance Standards............................................................ 38 21.1 Regulatory Guides..................................................................................................................... 38 21.2 Standards.................................................................................................................................. 39 Docusign Envelope ID: E2E7AF6E-D7E5-4464-9C31-9259ECF766F2
Long Mott Energy, LLC 12/04/2024 ix General Business ABBREVIATIONS This list contains the abbreviations used in this document.
Abbreviation or Acronym Definition ASME American Society of Mechanical Engineers ATWS Anticipated Transients Without Scram BDBE Beyond Design Basis Event CFR Code of Federal Regulations COL Combined License COO Chief Operating Officer CP Construction Permit DBE Design Basis Event DC Design Certification ES&H Environmental, Safety & Health EPRI Electric Power Research Institute ESP Early Site Permit F-C Target Frequency-Consequence Target FSAR Final Safety Analysis Report IEC International Electrotechnical Commission ILAC International Laboratory Accreditation Cooperation IRG Independent Review Group ISO International Organization for Standardization LWA Limited Work Authorization M&TE Measuring and Test Equipment MRA Mutual Recognition Arrangement NEI Nuclear Energy Institute NIRMA Nuclear Information and Records Management Association, Inc.
NQA Nuclear Quality Assurance NRC U.S. Nuclear Regulatory Commission NSRST Non-Safety-Related with Special Treatment NSSS Nuclear Steam Supply System OL Operating License PRA Probabilistic Risk Assessment QA Quality Assurance QAP Quality Assurance Program
Long Mott Energy, LLC 12/04/2024 x
General Business Abbreviation or Acronym Definition QAPD Quality Assurance Program Description QC Quality Control RG Regulatory Guide RIS Regulatory Issue Summary SAR Safety Analysis Report SBO Station Blackout SDA Standard Design Approval SSC Structures, Systems, and Components SSE Safe Shutdown Earthquake
Long Mott Energy, LLC 12/04/2024 1
General Business Part I - Introduction
- 1. General The Long Mott Energy (LME) Quality Assurance Program Description (QAPD) is the top-level policy document that establishes the quality assurance (QA) policy and assigns major functional responsibilities for quality related activities conducted by or for LME. The QAPD describes the methods and establishes QA and administrative control requirements that meet 10 CFR 50, Appendix B. The QAPD is based on the requirements and guidance of ASME NQA-1-2015, "Quality Assurance Requirements for Nuclear Facility Applications," Parts I and II, with specific reference to selected Part III sections, as identified in this document.
The QA Program (QAP) is defined by the NRC-approved regulatory document that describes the QA elements (i.e., the QAPD), along with the associated implementing documents.
Procedures and instructions that control LME quality related activities will be developed prior to commencement of those activities. Policies establish high-level responsibilities and authority for carrying out important administrative functions which are outside the scope of the QAPD. Procedures establish practices for certain activities which are common to all LME organizations performing those activities so that the activity is controlled and carried out in a manner that meets QAPD requirements.
Procedures specific to a site, organization, or group establish detailed implementation requirements and methods, and may be used to implement policies or be unique to particular functions or work activities.
LME may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program.
1.1 Scope/Applicability The QAPD applies to the design-phase and construction-phase, including those in support of Construction Permit (CP) activities affecting the quality and performance of safety-related structures, systems, and components (SSCs), including, but not limited to:
x Designing x Storing x Siting x Constructing x Maintaining x Procuring x Erecting x Repairing x Installing x Modifying x Cleaning x Inspecting x Refueling x Fabricating x Handling x Testing x Training x Shipping x Start-up x Receiving x Pre-operational activities
Long Mott Energy, LLC 12/04/2024 2
General Business Safety-related SSCs, under the control of the QAPD, are identified by design documents. The technical aspects of these items are considered when determining program applicability, including, as appropriate, the item's required safety function. The QAPD may be applied to certain activities where regulations other than 10 CFR 50 establish QA requirements for activities within their scope.
The policy of LME is to assure a high degree of availability and reliability of the nuclear plants while ensuring the health and safety of its workers and the public. To this end, selected elements of the QAPD may also be applied to certain equipment and activities that are not safety-related, but support safe, economic, and reliable plant operations. Implementing documents establish the graded approach to program element applicability.
The definitions provided in ASME NQA-1-2015, Part I, Section 400, apply to select terms as used in this document.
1.2 Responsibilities LME personnel engaged in activities described in this QAPD shall comply with the requirements of the QAP. Contractors, suppliers, or other organizations supporting LME are required to comply with the QAP established by this QAPD, or with their own programs determined by LME to include sufficient controls to meet the applicable requirements of 10 CFR 50, Appendix B.
All facilities shall be designed and constructed in compliance with the applicable Code of Federal Regulations and the applicable laws and regulations of the state and local governments in which the facility is located.
Long Mott Energy, LLC 12/04/2024 3
General Business Part II - QAPD Details
- 2. Organization This section describes the LME organizational structure, functional responsibilities, levels of authority and interfaces for establishing, executing, and verifying QAPD implementation. The organizational structure includes corporate, support, off-site and on-site functions required to support the performance of LME quality-related activities, including interface responsibilities for multiple organizations that perform quality-related functions.
Implementing documents assign more specific responsibilities and duties, and define the organizational interfaces involved in conducting activities and duties within the scope of the QAPD. Management gives careful consideration to the timing, extent, and effects of organizational structure changes based upon project phase requirements.
During design, the LME management senior position responsible for the Quality Assurance organization is responsible to size the Quality Assurance staff commensurate with the duties and responsibilities assigned. During construction, this responsibility transitions to the Program Director.
During the Design Phase, technology development, engineering, procurement and supply chain, and QA/QC services are provided to the LME organization by the Nuclear Steam Supply System (NSSS) supplier, in accordance with their QAPD.
During the Construction Phase, construction and construction testing services will be provided to the LME organization by the Constructor in accordance with their QAPD. Engineering, procurement and supply chain, QA/QC are provided to the LME organization by the NSSS supplier, or other design authority, in accordance with their QAPD.
As the construction of systems (or portions thereof) is completed, control and authority (including oversight, configuration and operations) are transferred from the contractor to the Operator in the operations phase. During the transition, responsibilities will be clearly defined in instructions and procedures to ensure appropriate authority is maintained for each SSC.
The following sections describe the reporting relationships, functional responsibilities, and authorities for organizations implementing and supporting the LME QA Program. The LME organization is shown in Figure 1.
2.1 President The President is responsible for all aspects of design and construction. The President is also responsible for all technical and administrative support activities provided by LME and contractors, including Quality Assurance and EH&S. The President directs the Senior Vice President of Commercial Operations and the Program Director in fulfillment of their responsibilities. The President reports to the LME Board of Directors with respect to all matters.
During all phases, QA management has access to the President as the most senior executive with overall responsibilities for Quality Assurance. QA management shall have the freedom and authority to raise issues, that cannot be resolved at lower levels, to the President for final decision.
Long Mott Energy, LLC 12/04/2024 4
General Business 2.2 Senior Vice President of Commercial Operations The Senior Vice President of Commercial Operations reports to the President and is responsible for ensuring LME programs, products, and processes deliver the highest technical quality and nuclear safety for the safe, reliable, and efficient operation of nuclear plants. The Senior Vice President directs Technology Development, Engineering, Procurement and Supply Chain in fulfilment of their responsibilities during the design phase, and the Site Executive during the construction phase. The Senior Vice President is responsible for the administration of reactor development, nuclear licensing, and support activities for LME under the QAPD.
2.3 Quality Assurance Manager The Quality Assurance Manager reports to the President and is responsible for quality assurance, quality control, and the implementation of the LME QAPD. The Quality Assurance Manager and is responsible for planning and performing activities to verify development and effective implementation of the QAPD.
Effective implementation includes, but is not limited to, developing and maintaining the QAPD, evaluating compliance to QA Program requirements through audits and technical reviews, independent oversight of the implementation of quality activities, and ensuring that vendors providing quality services, parts, and materials to LME are meeting the requirements of 10 CFR 50, Appendix B through LME vendor audits.
The Quality Assurance Manager is responsible for ensuring the Quality Assurance organization is sized appropriately commensurate with the duties and responsibilities assigned.
2.4 Environmental Health & Safety Environmental, Health & Safety reports to the President and is responsible for nuclear safety assurance.
2.5 Engineering Design Engineering Design reports to the Senior Vice President, Commercial Operations and is responsible for design, development, and licensing associated with the reactor plant design.
2.6 Procurement & Supply Chain Procurement and Supply Chain reports to the Senior Vice President, Commercial Operations and is responsible for supply chain management (including supplier evaluation) and procurement.
2.7 Technology Development Technology Development reports to the Senior Vice President, Commercial Operations and is responsible for associated design analysis, including modelling of coolant; materials qualification and testing; and support services (including training, document control and records management).
2.8 Program Director During the construction phase, the Program Director reports to the President and is responsible for site-related construction activities. Transition from design phase to the construction phase occurs such that those positions required to support quality-related activities will retain their responsibilities until deemed they are no longer necessary.
Long Mott Energy, LLC 12/04/2024 5
General Business 2.8.1 Construction Program Management Construction Program Management reports to the Program Director and is responsible for construction activities, including construction, fabrication, engineering, supply chain, construction testing, document control, and other support services, and QA/QC.
Construction Program Management is staffed and has the appropriate authority required to perform quality-related construction activities. Interfaces between site/construction phase management and corporate support is defined in implementing procedures.
2.9 Authority to Stop Work Quality Assurance and Quality Control Inspection personnel have the authority, and the responsibility, to stop work in progress which is not being done in accordance with approved procedures or where safety or SSC integrity may be jeopardized. This authority extends to off-site work performed by suppliers that furnish safety-related materials and services to LME.
2.10 Quality Assurance Organization The LME Quality Assurance organization is responsible for independent oversight of the implementation of activities including but not limited to construction, engineering, procurement, and construction testing. QA is responsible for assuring compliance with regulatory requirements and procedures through audits and technical reviews, monitoring organizational processes to ensure conformance to commitments and licensing document requirements, and ensuring that vendors providing quality services, parts, and materials to LME are meeting the requirements of 10 CFR 50, Appendix B through NUPIC or LME vendor audits.
QA has sufficient independence from other LME construction priorities to bring forward issues affecting safety and quality and makes judgments regarding quality in all areas regarding LME construction activities as appropriate. QA may make recommendations to management regarding improving the quality of work processes. If QA disagrees with any actions taken by the organization and is unable to obtain resolution, QA shall inform Construction Program Management and bring the matter to the attention of the President, who will determine the final disposition.
2.11 NQA-1 Commitment In establishing its organizational structure, LME commits to compliance with NQA-1-2015, Requirement 1.
Long Mott Energy, LLC 12/04/2024 6
General Business Figure 1: LME Organization 2.12 Quality Assurance Program LME has established the necessary measures and governing procedures to implement the QAP as described in the QAPD. LME is committed to implementing the QAP in all aspects of work that are significant to the safety of the nuclear plants as described and to the extent delineated in the QAPD. The QAP shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities relevant to safety are performed satisfactorily. Further, LME ensures through the systematic process described herein that its suppliers of safety-related equipment or services meet the applicable requirements of 10 CFR 50, Appendix B. Senior management is regularly apprised of the adequacy of implementation of the QAP through the audit functions described in Part II, Section 18.
The objective of the QAP is to assure that LMEs nuclear generating plants are designed, constructed, and operated in accordance with governing regulations and license requirements. The program is based on the requirements of ASME NQA-1-2015, "Quality Assurance Requirements for Nuclear Facility Applications," as further described in this document. The QAP applies to those quality-related activities that involve the required safety 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. A list or system that identifies SSCs and activities to which this program applies is maintained at the appropriate facility.
Specific program controls are applied to non-safety-related SSCs that are significant contributors to plant safety, for which 10 CFR 50, Appendix B, is not applicable. The specific program controls, consistent with applicable sections of the QAPD, are applied to those items in a select manner, targeted at those characteristics or critical attributes that qualifies the SSC as a significant contributor to plant safety.
Long Mott Energy, LLC 12/04/2024 7
General Business Delegated responsibilities may be performed under a supplier's or principal contractor's QAP, provided that the supplier or principal contractor has been approved as a supplier in accordance with the LME QAP. Periodic audits and assessments of supplier QA programs are performed to assure compliance with the supplier's or principal contractor's QAPD and implementing procedures. In addition, routine interfaces with the suppliers personnel provide added assurance that quality expectations are met.
New nuclear plant construction will be performed by the Construction organization under the responsibility of LME's Program Director. Detailed engineering specifications and construction procedures will be developed to implement the QAPD and the Construction organization QA programs prior to commencement of construction activities. Examples of Limited Work Authorization (LWA) activities that could impact safety-related SSCs include impacts of construction to existing facilities and, for construction of new plants, the interface between non-safety-related and safety-related SSCs and the placement of seismically-designed backfill.
In general, the program requirements specified herein are detailed in implementing procedures that are either LME implementing procedures, or supplier implementing procedures governed by a supplier quality assurance program.
A grace period of 90 days may be applied to provisions that are required to be performed on a periodic basis, unless otherwise noted. Annual evaluations and audits that must be performed on a triennial basis are examples where the 90-day general period could be applied. The grace period does not allow the "clock" for a particular activity to be reset forward. The "clock" for an activity is reset backwards by performing the activity early. Audit schedules are based on the month in which the audit starts.
2.13 Responsibilities Personnel who work directly or indirectly for LME are responsible for achieving acceptable quality in the work covered by the QAPD. This includes the activities delineated in Part I, Section 1.1. LME personnel performing verification activities are responsible for verifying the achievement of acceptable quality.
Activities governed by the QAPD are performed as directed by documented instructions, procedures, and drawings that are of a detail appropriate for the activity's complexity and effect on safety.
Instructions, procedures and drawings specify quantitative or qualitative acceptance criteria as applicable or appropriate for the activity, and verification is against these criteria. Provisions are established to designate or identify the proper documents to be used in an activity, and to ascertain that such documents are being used. The Quality Assurance Manager is responsible to verify that processes and procedures comply with QAPD and other applicable requirements, that such processes or procedures are implemented, and that management appropriately ensures compliance.
2.14 Delegation of Work LME retains and exercises the responsibility for the scope and implementation of an effective QAP.
Positions identified in Part II, Section 1, may delegate all or part of the activities of planning, establishing, and implementing the program for which they are responsible to others, but retain the responsibility for the program's effectiveness.
Decisions affecting safety are made at the level appropriate based upon their nature and effect, with technical advice or review as appropriate.
Long Mott Energy, LLC 12/04/2024 8
General Business 2.15 Site-specific Safety-Related Design Basis Activities Site-specific safety-related design basis activities are defined as those activities, including sampling, testing, data collection, and supporting engineering calculations and reports, that will be used to determine the bounding physical parameters of the site. Appropriate quality assurance measures are applied.
2.16 Periodic Review of the Quality Assurance Program Management of those organizations implementing the QA program, or portions thereof, shall assess the adequacy of that part of the program for which they are responsible to assure its effective implementation at least once each year or at least once during the life of the activity, whichever is shorter.
2.17 Issuance and Revision to Quality Assurance Program Administrative control of the QAPD will be in accordance with 10 CFR 50.55(f) and 10 CFR 50.54(a).
Changes to the QAPD are evaluated by the Quality Assurance Manager to ensure that such changes do not degrade safety for previously approved quality assurance controls specified in the QAPD. This document shall be revised as appropriate to incorporate additional QA commitments that may be established during application development processes. New revisions to the document will be reviewed, at a minimum, by the LME Quality Assurance Manager and approved by the Senior Vice President of Commercial Operations.
Regulations 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 requirements of 10 CFR 50, Appendix B will be satisfied. In order to comply with this requirement, the FSAR references the QAPD and, as a result, the requirements of 10 CFR 50.54(a) are satisfied by and apply to the QAPD.
2.18 Personnel Training and Qualifications Personnel assigned to implement elements of the QAPD shall be capable of performing their assigned tasks. To this end, LME establishes and maintains formal indoctrination, training, and qualification as necessary for personnel performing, verifying, or managing activities within the scope of the QAPD to achieve initial proficiency, maintain proficiency, and adapt to technology changes, method, or job responsibilities. The indoctrination, training, and qualification programs are commensurate with scope, complexity, and importance of the activities; and include or address the following, as appropriate:
x Education, experience, and proficiency of the personnel receiving training x General criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements x On-the-job training, if direct hands-on applications or experience is needed to achieve and maintain proficiency.
Plant and support staff minimum qualification requirements are as delineated in the unit Technical Specifications. Other qualification requirements may be established but will not reduce those required by Technical Specifications.
Long Mott Energy, LLC 12/04/2024 9
General Business 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 the applicable LME procedures. Indoctrination includes the administrative and technical objectives, requirements of the applicable codes and standards, and the QAPD elements to be employed. Training for positions identified in 10 CFR 50.120 is accomplished according to programs developed to be in compliance with the facility license, including all technical specifications and applicable regulations. Records of personnel training and qualification are maintained.
The minimum qualifications of the Quality Assurance Manager require that the individual holds an engineering or related science degree and a minimum of four years of related experience including two years of nuclear power plant experience, one year of supervisory or management experience, and one year of the experience is in performing quality verification activities. Special requirements shall include management and supervisory skills and experience or training in leadership, interpersonal communication, management responsibilities, motivation of personnel, problem analysis and decision making, and administrative policies and procedures. Individuals who do not possess these formal education and minimum experience requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.
The minimum qualifications for the individuals responsible for supervising QA or QC personnel is that each has a high school diploma or equivalent and has a minimum of one year of experience performing quality verification activities. Individuals who do not possess these formal education and experience requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.
The minimum qualifications of individuals that are part of the Quality Assurance function responsible for planning, implementing, and maintaining the programs for the QAPD are that each has a high school diploma or equivalent and has a minimum of one year of related experience. Individuals who do not possess these formal education and minimum experience requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.
2.19 NQA-1 Commitment / Exceptions In establishing qualification and training programs, LME commits to compliance with NQA-1-2015, Requirement 2 with the following clarifications and exceptions:
x Section 302, Inspection and Test, LME commits to the use of Subpart 3.1-2.3 guidance.
x LME follows Section 301 for qualification of non-destructive examination personnel, except that LME will follow the applicable standard cited in the version(s) of Section III and Section XI of the ASME Boiler and Pressure Vessel Code approved by the NRC for use at LME sites for the scope of activities governed by these cited standards.
x Section 401 (g) requires the date of certification expiration be included on the qualification record. LME considers the certification expiration date to be the date from the certification or recertification date plus the certification interval time, and its inclusion on the qualification record is optional.
Long Mott Energy, LLC 12/04/2024 10 General Business
- 3. Design Control LME has established and implements a process to control the design, design changes, and temporary modifications (e.g., temporary bypass lines, electrical jumpers and lifted wires, and temporary setpoints) of items that are subject to the provisions of the QAPD. The design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within LME and with suppliers. These provisions assure that design inputs (such as design bases and the performance, regulatory, quality, and quality verification requirements) are correctly translated into design outputs (such as analyses, specifications, drawings, procedures, and instructions) so that the final design output contains or references appropriate acceptance criteria that can be related to the design input in sufficient detail to permit verification by inspection and test, as required.
Design change processes and the division of responsibilities for design-related activities are detailed in LME and supplier procedures. Changes to design inputs, final designs, field changes, and temporary and permanent modifications to operating facilities are justified and subject to design control measures commensurate with those applied to the original design. The design control program includes interface controls necessary to control the development, verification, approval, release, status, distribution, and revision of design inputs and outputs. Design changes and disposition of nonconforming items as "use as is" or "repair" are reviewed and approved by the LME design organization or by other organizations so authorized by LME.
Design documents are reviewed by individuals knowledgeable in QA to ensure the documents contain the necessary QA requirements.
3.1 Design Verification LME design processes provide for design verification to ensure that items, computer programs, and activities subject to the provisions of the QAPD are suitable for their intended application, consistent with their effect on safety. Design changes are subjected to these controls, which include verification measures commensurate with those applied to original plant design.
Design verifications are performed by competent individuals or groups other than those who performed the original design but who may be from the same organization. The verifier shall not have taken part in the selection of design inputs, the selection of design considerations, or the selection of a singular design approach, as applicable. This verification may be performed by the originator's supervisor provided the supervisor did not specify a singular design approach, rule out certain design considerations, and did not establish the design inputs used in the design, or if the supervisor is the only individual in the organization competent to perform the verification. If the verification is performed by the originator's supervisor, the justification of the need is documented and approved in advance by management.
The extent of the design verification required is a function of the importance to safety of the item or computer program under consideration, the complexity of the design, the degree of standardization, the state-of-the-art, and the similarity with previously proven designs. This includes design inputs, design outputs, and design changes. Design verification procedures are established and implemented to assure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance criteria are identified, and the verification is satisfactorily accomplished and documented. Verification methods may include, but are not limited to, design reviews, alternative
Long Mott Energy, LLC 12/04/2024 11 General Business calculations, and qualification testing. Testing used to verify the acceptability of a specific design feature demonstrates acceptable performance under conditions that simulate the most adverse design conditions expected for the item's intended use.
LME normally completes design verification activities before the design outputs are used by other organizations for design work, and before they are used to support other activities such as procurement, manufacture, or construction. When such timing cannot be achieved, the design verification is completed before relying on the item to perform its intended design or required safety function.
3.2 Design Records LME maintains records sufficient to provide evidence that the design was properly accomplished. These records include the final design output and any revisions thereto, as well as record of the important design steps (e.g., calculations, analyses and computer programs) and the sources of input that support the final output.
Plant design drawings reflect the properly reviewed and approved configuration of the plant.
3.3 Computer Application and Digital Equipment Software The NSSS supplier is responsible for the development, procurement, testing, maintenance, control, and use of computer applications and digital equipment software when used in safety-related applications and designated non-safety-related applications. Computer applications and digital equipment software services are provided to the LME organization by the NSSS supplier in accordance with their QAPD.
3.4 Setpoint Control Instrument and equipment setpoints that could affect nuclear safety shall be controlled in accordance with written instructions. As a minimum, these written instructions shall:
x Identify responsibilities and processes for reviewing, approving, and revising setpoints and setpoint changes originally supplied by the NSSS supplier and the plant's technical staff.
x Ensure that setpoints and setpoint changes are consistent with design and accident analysis requirements and assumptions.
x Provide for documentation of setpoints, including those determined operationally.
x Provide for access to necessary setpoint information for personnel who write or revise plant procedures, operate or maintain plant equipment, develop or revise design documents, or develop or revise accident analyses.
3.5 NQA-1 Commitment In establishing its program for design control and verification, LME commits to compliance with NQA 2015, Requirement 3 for Design Control, Subpart 2.7 for Computer Software, Subpart 2.14 for Commercial Grade Items and Services, and Subpart 2.20 for Subsurface Investigation.
- 4. Procurement Document Control LME has established the necessary measures and governing procedures to assure that purchased items, computer programs, and services are subject to appropriate quality and technical requirements.
Long Mott Energy, LLC 12/04/2024 12 General Business Procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents. These controls include provisions such that:
x Where original technical or quality assurance requirements cannot be determined, an engineering evaluation is conducted and documented by qualified staff to establish appropriate requirements and controls to assure that interfaces, interchangeability, safety, fit, and function, as applicable, are not adversely affected or contrary to applicable regulatory requirements.
x Applicable technical, regulatory, administrative, quality, and reporting requirements (such as specifications, codes, standards, tests, inspections, special processes, and 10 CFR 21) are invoked for procurement of items and services. 10 CFR 21 requirements for posting, evaluating, and reporting will be followed and imposed on suppliers when applicable. Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and services. To the extent necessary, procurement documents shall require suppliers to have a documented QA program that is determined to meet the applicable requirements of 10 CFR 50, Appendix B, as appropriate to the circumstances of procurements (or the supplier may work under LMEs approved QA program).
Reviews of procurement documents shall be performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.
4.1 NQA-1 Commitment / Exceptions In establishing controls for procurement, LME commits to compliance with NQA-1-2015, Requirement 4, with the following clarifications and exceptions:
x With regard to service performed by a supplier, LME procurement documents may allow the supplier to work under the LME QAP, including implementing procedures, in lieu of the supplier having its own QAP.
x Section 300 and 400 of Requirement 4 require the review of technical and Quality Assurance Program requirements of procurement documents prior to award of a contract and for procurement document changes. LME may satisfy this requirement through the review of the procurement specification, when the specification contains the technical and quality assurance requirements of the procurement.
Procurement documents for Commercial Grade Items that will be procured by LME for use as safety-related items shall contain technical and quality requirements such that the procured item can be appropriately dedicated in accordance with the LME QAPD, Section 7, Control of Purchased Material, Equipment and Services.
- 5. Instructions, Procedures, and Drawings LME has established the necessary measures and governing procedures to ensure that activities affecting quality are prescribed by and performed in accordance with instructions, procedures, or drawings of a type appropriate to the circumstances and which, where applicable, include quantitative or qualitative acceptance criteria to implement the QAP as described in the QAPD. Such documents are
Long Mott Energy, LLC 12/04/2024 13 General Business prepared and controlled according to Part II, Section 6. In addition, means are provided to disseminate to the staff instructions of both general and continuing applicability, as well as those of short-term applicability. Provisions are included for reviewing, updating, and canceling such procedures.
5.1 Procedure Adherence LMEs policy is that procedures are followed, and the requirements for use of procedures have been established in administrative procedures. Where procedures cannot be followed as written, provisions are established for making changes in accordance with Part II, Section 6. Requirements are established to identify the manner in which procedures are to be implemented, including identification of those tasks that require:
x the written procedure to be present and followed step-by-step while the task is being performed, x the user to have committed the procedure steps to memory, and/or x verification of completion of significant steps, by initials or signatures or use of check-off lists.
Procedures that are required to be present and referred to directly are those developed for extensive or complex jobs where reliance on memory cannot be trusted, tasks that are infrequently performed, and tasks where steps must be performed in a specified sequence.
In cases of emergency, personnel are authorized to depart from approved procedures when necessary to prevent injury to personnel or damage to the plant. Such departures are recorded describing the prevailing conditions and reasons for the action taken.
5.2 Procedure Content The established measures address the applicable content of procedures as described in the Introduction to Part II of NQA-1-2015. In addition, procedures governing tests and inspections will include, as applicable, initial conditions and prerequisites for the performance of the activity.
5.3 NQA-1 Commitment In establishing procedural controls, LME commits to compliance with NQA-1-2015, Requirement 5.
Long Mott Energy, LLC 12/04/2024 14 General Business
- 6. Document Control LME has established the necessary measures and governing procedures to control the preparation, issuance, and revision of documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, to ensure that correct documents are employed.
The following controls, including electronic systems used to make documents available, are applied to documents and changes thereto:
x Identification of controlled documents, x Specified distribution of controlled documents for use at the appropriate location, x A method to identify the correct document (including revision) to be used and control of superseded documents, x Identification of individuals responsible for controlled document preparation, review, approval, and distribution, x Review of controlled documents for adequacy, completeness, and approval prior to distribution, x A method to ensure the correct documents are being used, x A method to provide feedback from users to improve procedures and work instructions, and x Coordinating and controlling interface documents and procedures.
The types of documents to be controlled include:
x Drawings such as design, construction, installation, and as-built drawings, x Engineering calculations, x Design specifications, x Purchase orders and related documents, x Vendor-supplied documents, x Audit, surveillance, and quality verification/inspection procedures, x Inspection and test reports, x Instructions and procedures for activities covered by the QAPD including design, construction, installation, calibration, and routine testing, x Technical specifications, and x Nonconformance reports and corrective action reports.
6.1 Review and Approval of Documents Documents are reviewed for adequacy by qualified persons other than the preparer. During the design or construction phase, procedures for design, construction, and installation are also reviewed by the organization to ensure quality assurance measures have been appropriately applied.
Prior to issuance or use, documents including revisions thereto, are approved by the designated authority. A listing of all controlled documents identifying the current approved revision, or date, is maintained so personnel can readily determine the appropriate document for use.
Long Mott Energy, LLC 12/04/2024 15 General Business 6.2 Changes to Documents Changes to documents, other than those defined in implementing procedures as minor changes, are reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated. The reviewing organization has access to pertinent background data or information upon which to base their approval.
Minor changes to documents, such as inconsequential editorial corrections, do not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a classification shall be clearly delineated in implementing procedures.
6.3 NQA-1 Commitment In establishing provisions for document control, LME commits to compliance with NQA 2015, Requirement 6.
- 7. Control of Purchased Material, Equipment, and Services LME has established the necessary measures and governing procedures to control purchased items and services to assure conformance with specified requirements. Such control provides for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services.
7.1 Acceptance of Item or Service LME establishes and implements measures to assess the quality of purchased items and services, whether purchased directly or through contractors, at intervals and to a depth consistent with the item or service importance to safety, complexity, quantity, and the frequency of procurement. Verification actions include inspection and testing during design, fabrication, and construction activities.
Verifications occur at the appropriate phases of the procurement process, including, as necessary, verification of activities of suppliers below the first tier.
Measures to assure the quality of purchased items and services include the following, as applicable:
x Items are inspected, identified, and stored to protect against damage, deterioration, or misuse.
x Prospective safety-related items and service suppliers are evaluated to assure only qualified suppliers are used. Qualified suppliers are audited on a triennial basis. In addition, if a subsequent contract or a contract modification significantly changes the scope, methods, or controls performed by a supplier, an audit of the changes is performed, thus starting a new triennial period.
x LME may utilize audits conducted by outside organizations for supplier qualification provided that the scope and adequacy of the audits meet LME requirements. Industry programs applied as input or the basis for supplier qualification may include ASME NQA-1 and ISO/IEC 17025. By way of example, irradiation testing will be performed by LME suppliers. Irrespective of what QA program a supplier is using, LME will review and supplement a suppliers programs where required to make them compliant with 10CFR 50 Appendix B, in addition to ASME NQA-1
Long Mott Energy, LLC 12/04/2024 16 General Business requirements. Furthermore, 10 CFR 21 requirements will be included as well. Documented annual evaluations are performed for qualified suppliers to ensure they continue to provide acceptable products and services. Industry programs, such as those applied by ASME during the construction phase, or other established utility groups, are used as input or the basis for supplier qualification whenever appropriate. The results of the reviews are promptly considered for effect on a suppliers continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third-party auditing entities). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
x Controls (subjected to quality and technical requirements, such as the LME QA program requirements) are imposed for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and acceptance of commercial-grade services or items to ensure they will perform satisfactorily in service in safety-related applications.
x If there is insufficient evidence of implementation of a QA program, the initial evaluation is of the existence of a QA program addressing the scope of services to be provided. The initial audit is performed after the supplier has completed sufficient work to demonstrate that its organization is implementing a QA program.
x Provisions are made for accepting purchased items and services, such as source verification, receipt inspection, pre-and post-installation tests, certificates of conformance, and document reviews (including Certified Material Test Report/Certificate). Acceptance actions/documents should be established by the Purchaser with appropriate input from the Supplier and be completed to ensure that procurement, inspection, and test requirements, have been satisfied before relying on the item to perform its intended required safety function.
7.2 NQA-1 Commitment / Exceptions In establishing controls for purchased items and services, LME commits to compliance with NQA 2015, Requirement 7, and regulatory positions stated in Regulatory Guide 1.28, Rev 5 with the following clarifications and exceptions:
- a. LME considers that 10 CFR Part 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to the LME plants are not required to be evaluated or audited.
- b. LME will implement the NRC endorsed guidance from NEI 14-05A, Rev. 1-A, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys in Procurement of Laboratory Calibration and Test Services.
- c. For Section 501, LME considers documents that may be stored in approved electronic media under LME or supplier control, not physically located on the plant site, but accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site. Following completion of the construction period, sufficient as-built
Long Mott Energy, LLC 12/04/2024 17 General Business documentation will be turned over to LME to support operations. The LME records management system will provide for timely retrieval of necessary records.
- d. In establishing commercial-grade item requirements, LME commits to compliance with NQA 2015, Section 700, Subpart 2.14, with the following clarification:
- 1. For commercial-grade items, quality verification requirements are established and described in LME documents to provide the necessary assurance an item will perform satisfactorily in service. The LME documents address determining the critical characteristics that ensure an item is suitable for its intended use, technical evaluation of the item, receipt requirements, and quality evaluation of the item.
- 2. LME will assume 10 CFR 21 reporting responsibility for items that LME dedicates as safety-related.
- e. When purchasing commercial-grade calibration or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), procurement source evaluation and selection measures need not be performed, provided each of the following conditions are met:
- 1. The purchase documents impose any additional technical and administrative requirements to comply with the LME QA program and technical provisions. The purchase documents require:
(i) The laboratory must provide the service in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.
(ii) Reporting as-found calibration data when calibrated items are found to be out-of-tolerance (for calibration services only).
(iii) Identifying in the certificate of calibration, the equipment/standards used to perform the calibration (for calibration services only).
(iv) The testing or calibration service supplier shall not subcontract the service to any other supplier.
(v) Notifying the customer of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.
(vi) Performance of the services listed on this order is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the Accreditation Body within the past 48 months.
(vii) Additional technical and quality requirements based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.
- f.
A documented review of the suppliers accreditation will be performed and will include a verification of the following:
Long Mott Energy, LLC 12/04/2024 18 General Business
- 1. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.
(i) For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.
(ii) The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.
- 2. It is validated, at receipt inspection, that the laboratorys documentation certifies that:
(i) The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program and has been performed within their scope of accreditation.
(ii) The purchase orders requirements are met.
Long Mott Energy, LLC 12/04/2024 19 General Business
- 8. Identification and Control of Materials, Parts, and Components LME has established the necessary measures and governing procedures to identify and control items to prevent the use of incorrect or defective items. This includes controls for consumable materials and items with limited shelf life. The identification of items is maintained throughout fabrication, erection, installation, and use so that the item can be traced to its documentation, consistent with the item's effect on safety. Identification locations and methods are selected so as not to affect the function or quality of the item.
8.1 NQA-1 Commitment In establishing provisions for identification and control of items, LME commits to compliance with NQA 2015, Requirement 8.
Long Mott Energy, LLC 12/04/2024 20 General Business
- 9. Control of Special Processes LME has established 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 provisions include assuring that special processes are accomplished by qualified personnel using qualified procedures and equipment. Personnel are qualified and special processes are performed in accordance with applicable codes, standards, specifications, criteria or other specially established requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product.
9.1 NQA-1 Commitment In establishing measures for the control of special processes, LME commits to compliance with NQA 2015, Requirement 9.
Long Mott Energy, LLC 12/04/2024 21 General Business
- 10. Inspection LME has established the necessary measures and governing procedures to implement inspections that assure items, services, and activities affecting safety meet established requirements and conform to applicable documented specifications, instructions, procedures, and design documents. Inspection may also be applied to items, services, and activities affecting plant reliability and integrity. Types of inspections may include those verifications related to procurement, such as source, in-process, final, and receipt inspection, as well as construction, installation, modification, and in-service activities.
Inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work. Inspection results are documented.
10.1 Inspection Program The inspection program establishes inspections (including surveillance of processes), as necessary to verify quality:
x At the source of supplied items or services, x In-process during fabrication at a supplier's facility or at an LME facility, x For final acceptance of fabricated and/or installed items during construction, x Upon receipt of items for a facility, and x During maintenance, modification, in-service, and operating activities.
The inspection program establishes requirements for planning inspections, such as the group or discipline responsible for performing the inspection, where inspection hold points are to be applied, determining applicable acceptance criteria, the frequency of inspection to be applied, and identification of special tools needed to perform the inspection. Inspection planning is performed by personnel qualified in the discipline related to the inspection and includes qualified inspectors or engineers.
Inspection plans are based on, as a minimum, the importance of the item to the safety of the facility, the complexity of the item, technical requirements to be met, and design specifications. Where significant changes in inspection activities for the facilities are to occur, management responsible for the inspection programs evaluate the resource and planning requirements to ensure effective implementation of the inspection program.
Inspection program documents establish requirements for performing the planned inspections, and documenting required inspection information such as rejection, acceptance, and re-inspection results, and the person(s) performing the inspection.
Inspection results are documented by the inspector, reviewed by authorized personnel qualified to evaluate the technical adequacy of the inspection results, and controlled by instructions, procedures, and drawings.
10.2 Inspector Qualification LME has established qualification programs for personnel performing quality inspections. The qualification program requirements are described in Part II, Section 2. These qualification programs are applied to individuals performing quality inspections regardless of the functional group where they are assigned.
Long Mott Energy, LLC 12/04/2024 22 General Business 10.3 NQA-1 Commitment / Exceptions In establishing inspection requirements, LME commits to compliance with NQA-1-2015, Requirement 10 and Subparts 2.5 and 2.8 for establishing appropriate inspection requirements.
Long Mott Energy, LLC 12/04/2024 23 General Business
- 11. Test Control LME has established the necessary measures and governing procedures to demonstrate that items subject to the provisions of the QAPD will perform satisfactorily in service, that the plant can be operated safely and as designed, and that the coordinated operation of the plant as a whole is satisfactory. These programs include criteria for determining when testing is required, such as proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, and in-service tests to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions to establish and adjust test schedules, and to maintain status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety:
x Instructions and prerequisites to perform the tests, x Use of proper test equipment, x Acceptance criteria, x Mandatory verification points as necessary to confirm satisfactory test completion, and x Suitable environmental conditions.
Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, re-testing is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.
The initial start-up test program is planned and scheduled to permit safe fuel loading and start-up; to increase power in safe increments; and to perform major testing at specified power levels. If tests require the variation of operating parameters outside of their normal range, the limits within which such variation is permitted will be prescribed. The scope of the testing demonstrates, insofar as practicable, that the plant is capable of withstanding the design transients and accidents. For new facility construction, the suitability of facility operating procedures is checked to the maximum extent possible during the pre-operational and initial start-up test programs.
Except for computer program testing, which is addressed in Part II, Section 11.1, tests are performed, and results documented in accordance with applicable technical and regulatory requirements, including those described in the Technical Specifications and Final Safety Analysis Report (FSAR). Test programs ensure appropriate retention of test data in accordance with the records requirements of the QAPD. Personnel that perform or evaluate tests are qualified in accordance with the requirements established in Part II, Section 2.
11.1 NQA-1 Commitment for Computer Program Testing LME establishes and implements provisions to assure that computer software used in applications affecting safety is prepared, documented, verified and tested, and used such that the expected output is obtained, and configuration control maintained. To this end LME commits to compliance with the requirements of NQA-1-2015, Requirement 11 Section 400 and Subpart 2.7 to establish the appropriate provisions, in addition to the commitment to NQA-1-2015, Requirement 3.
Long Mott Energy, LLC 12/04/2024 24 General Business 11.2 NQA-1 Commitment In establishing provisions for testing, LME commits to compliance with NQA-1-2015, Requirement 11.
Long Mott Energy, LLC 12/04/2024 25 General Business
- 12. Control of Measuring and Test Equipment LME has established the necessary measures and governing procedures to control the calibration, maintenance, and use of measuring and test equipment (M&TE) that provides data to verify acceptance criteria are met or information important to safe plant operation. The provisions of such procedures cover equipment such as indicating and actuating instruments and gages, tools, reference and transfer standards, and nondestructive examination equipment. The suppliers of commercial-grade calibration services are controlled as described in Part II, Section 7. LME applies the following controls with regard to measuring and test equipment:
x The types of equipment covered by the program (e.g., instruments, tools, gauges, reference and transfer standards, and non-destructive examination equipment) are defined.
x M&TE is labeled, tagged, or otherwise controlled to indicate its calibration status and to ensure its traceability to calibration test data.
x M&TE is calibrated, adjusted, and maintained at prescribed intervals, or prior to use, against certified equipment having known valid relationships to nationally recognized standards. If no nationally recognized standards exist, the bases for calibration are documented.
x M&TE found to be out of calibration is tagged or segregated and not used until it is recalibrated.
When measuring and test equipment is found to be out of calibration, an evaluation is made and documented of the validity of previous inspection or test results and of the acceptability of items previously inspected or tested. If any measuring or test equipment is consistently found to be out of calibration, it is repaired or replaced. A calibration is performed when the accuracy of the equipment is suspect.
12.1 Installed Instrument and Control Devices LME has established and implements procedures for the calibration and adjustment of instrument and control devices installed in the facility. The calibration and adjustment of these devices is accomplished through the facility maintenance programs to ensure the facility is operated within design and technical requirements. Appropriate documentation will be maintained for these devices to indicate the control status, when the next calibration is due, and identify any limitations on use of the device.
12.2 NQA-1 Commitment / Exceptions In establishing provisions for control of measuring and test equipment, LME commits to compliance with NQA-1-2015, Requirement 12.
Long Mott Energy, LLC 12/04/2024 26 General Business
- 13. Handling, Storage, and Shipping LME has established the necessary measures and governing procedures to control the handling, storage, packaging, shipping, cleaning, and preservation of items to prevent inadvertent damage or loss, and to minimize deterioration. These provisions include specific procedures, when required to maintain acceptable quality of the items important to the safe operations of the plant. Items are appropriately marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the item's integrity and indicate the need for special controls. Special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels) are provided when required to maintain acceptable quality.
Special or additional handling, storage, shipping, cleaning, and preservation requirements are identified and implemented as specified in procurement documents and applicable procedures. Where special requirements are specified, the items and containers (where used) are suitably marked.
Special handling tools and equipment are used and controlled as necessary to ensure safe and adequate handling. Special handling tools and equipment are inspected and tested in accordance with procedures at specified time intervals or prior to use.
Operators of special handling and lifting equipment are experienced or trained in the use the equipment. Controls will be established and implemented over hoisting, rigging, and transport activities to the extent necessary to protect the integrity of the items involved, as well as potentially affected nearby structures and components. Where required, LME complies with applicable hoisting, rigging and transportation regulations and codes.
13.1 Housekeeping Housekeeping practices are established to account for conditions or environments that could affect the quality of structures, systems, and components within the plant. This includes control of cleanliness of facilities and materials, fire prevention and protection, disposal of combustible material and debris, control of access to work areas, and protection of equipment (as well as, radioactive contamination control, and storage of solid radioactive waste). Housekeeping practices help assure that only proper materials, equipment, processes, and procedures are used, and that the quality of items is not degraded.
Necessary procedures or work instructions, such as for electrical bus and control center cleaning, and cleaning of control consoles, and radioactive decontamination, are developed and used.
13.2 NQA-1 Commitment / Exceptions In establishing provisions for handling, storage, and shipping, LME commits to compliance with NQA 2015, Requirement 13. LME also commits, during the construction phase of the plant, to compliance with the requirements of NQA-1-2015, Subpart 2.1, Subpart 2.2, Subpart 2.3, and Subpart 3.2-2.1, with the following clarifications and exceptions:
x NQA-1-2015, Subpart 2.1 Subpart 2.1, Section 301 and 302 establish criteria for classifying items into cleanness classes and requirements for each class. Instead of using the cleanness level system of Subpart 2.1, LME may establish cleanness requirements on a case-by-case basis, consistent with the other provisions of Subpart 2.1. LME establishes appropriate cleanliness controls for work on safety-
Long Mott Energy, LLC 12/04/2024 27 General Business related equipment to minimize introduction of foreign material and maintain system/component cleanliness throughout maintenance or modification activities, including documented verification of absence of foreign material prior to system closure.
x NQA-1-2015, Subpart 2.2 Subpart 2.2, Section 202 establishes criteria for classifying items into protection levels.
Instead of classifying items into protection levels during the operational phase, LME may establish controls for the packaging, shipping, handling, and storage of such items on a case-by-case basis with due regard for the items complexity, use, and sensitivity to damage. Prior to installation or use, the items are inspected and serviced as necessary to assure that no damage or deterioration exists which could affect their function.
Subpart 2.2, Section 606 requires written records be prepared containing information on personnel access. As an alternative to this requirement, LME documents establish controls for storage areas that describe those authorized to access areas and the requirements for recording access of personnel. However, these records of access are not considered quality records and will be retained in accordance with the administrative controls of the applicable plant.
x NQA-1-2015, Subpart 2.3 Subpart 2.3, Section 202 requires the establishment of five zone designations for housekeeping cleanliness controls. Instead of the five-level zone designation, LME bases its control over housekeeping activities on a consideration of what is necessary and appropriate for the activity involved. The controls are implemented through procedures or instructions which, in the case of maintenance or modification work, are developed on a case-by-case basis. Factors considered in developing the procedures and instructions include cleanliness control, personnel safety, fire prevention and protection, radiation control, and security. The procedures and instructions make use of standard janitorial and work practices to the extent possible.
Long Mott Energy, LLC 12/04/2024 28 General Business
- 14. Inspection, Test, and Operating Status LME has established the necessary measures and governing procedures to identify the inspection, test, and operating status of items and components subject to the provisions of the QAPD, in order to maintain personnel and reactor safety and avoid inadvertent operation of equipment. Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test, or operating status be verified before release, fabrication, receipt, installation, test or use. These measures also establish the necessary authorities and controls for the application and removal of status indicators or labels.
In addition, temporary design changes (temporary modifications), such as temporary bypass lines, electrical jumpers and lifted wires, and temporary trip-point settings, are controlled by procedures that include requirements for appropriate installation and removal, independent/concurrent verifications, and status tracking.
Administrative procedures also describe the measures taken to control altering the sequence of required tests, inspections, and other operations. Review and approval for these actions is subject to the same control as taken during the original review and approval of tests, inspections, and other operations.
14.1 NQA-1 Commitment In establishing measures for control of inspection, test and operating status, LME commits to compliance with NQA-1-2015, Requirement 14.
Long Mott Energy, LLC 12/04/2024 29 General Business
- 15. Nonconforming Materials, Parts, or Components LME has established the necessary measures and governing procedures to control items, including services that do not conform to specified requirements to prevent inadvertent installation or use.
Instructions require that the individual discovering a nonconformance identify, describe, and document the nonconformance in accordance with the requirements of Part II, Section 16. Personnel performing evaluations to determine a disposition have demonstrated competence in the specific area they are evaluating, have an adequate understanding of the requirements, and have access to pertinent background information.
Controls provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations. Controls are provided to address conditional release of nonconforming items for use on an at-risk basis prior to resolution and disposition of the nonconformance, including maintaining identification of the item and documenting the basis for such release. Conditional release of nonconforming items for installation requires the approval of the designated management. Nonconformances are corrected or resolved prior to depending on the item to perform its intended required safety function. Nonconformances are evaluated for impact on operability of quality structures, systems, and components to assure that the final condition does not adversely affect safety, operation, or maintenance of the item or service.
Nonconformances to design requirements, dispositioned repair, or use-as-is are subject to design control measures commensurate with those applied to the original design. Nonconformance dispositions are reviewed for adequacy, analysis of quality trends, and reports provided to the designated management. Significant trends are reported to management in accordance with LME procedures, regulatory requirements, and industry standards.
15.1 Interface with the Reporting Program LME has appropriate interfaces between the QAP for identification and control of nonconforming materials, parts, or components and the non-QA Reporting Program to satisfy the requirements of 10 CFR 50.55 and/or 10 CFR 21 during Construction Permit design and construction.
15.2 NQA-1 Commitment In establishing measures for nonconforming materials, parts, or components, LME commits to compliance with NQA-1-2015, Requirement 15.
Long Mott Energy, LLC 12/04/2024 30 General Business
- 16. Corrective Action LME has established the necessary measures and governing procedures to promptly identify, control, document, classify, and correct conditions adverse to quality. LME procedures assure that corrective actions are documented and initiated following the determination of conditions adverse to quality in accordance with regulatory requirements and applicable quality standards. LME procedures require personnel to identify known conditions adverse to quality. When complex issues arise where it cannot be readily determined if a condition adverse to quality exists, LME documents establish the requirements for documentation and timely evaluation of the issue. Reports of conditions adverse to quality are analyzed to identify trends. Significant conditions adverse to quality and significant adverse trends are documented and reported to responsible management. In the case of a significant condition adverse to quality, the cause is determined and actions to preclude recurrence are taken.
In the case of suppliers working on safety-related activities, or other similar situations, LME may delegate specific responsibilities for corrective actions, but LME maintains responsibility for the effectiveness of corrective action measures.
16.1 Interface with the Reporting Program LME has appropriate interfaces between the QAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR 50.55 and/or 10 CFR 21 during Construction Permit design and construction.
16.2 NQA-1 Commitment In establishing provisions for corrective action, LME commits to compliance with NQA 2015, Requirement 16.
Long Mott Energy, LLC 12/04/2024 31 General Business
- 17. Quality Assurance Records LME has the necessary measures and governing procedures to ensure that sufficient records of items and activities affecting quality are developed, reviewed, approved, issued, used, and revised to reflect completed work. The provisions of such procedures establish the scope of the records retention program for LME and include requirements for records administration, including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user privileges, and final disposition.
17.1 Record Retention Measures are established that ensure that sufficient records of completed items and activities affecting quality are appropriately stored. Records of activities for design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, modification, and audits and their retention times are defined in appropriate procedures. The records and retention times are based on Regulatory Position C.3.a of Regulatory Guide 1.28, Revision 5 for design, construction, and initial start-up. Retention times for records are based on construction records that are similar in nature.
In all cases where state, local, or other agencies have more restrictive requirements for record retention, those requirements will be met.
17.2 Electronic Records LME will manage the storage of QA Records in electronic media consistent with Regulatory Guide 1.28, Revision 5, and NIRMA Guidelines TG 11-2011, TG15-2011, TG16-2011, and TG21-2011.
17.3 NQA-1 Commitment / Exceptions In establishing provisions for records, LME commits to compliance with NQA-1-2015, Requirement 17, and regulatory positions stated in Regulatory Guide 1.28, Rev 5.
Long Mott Energy, LLC 12/04/2024 32 General Business
- 18. Audits LME has established the necessary measures and governing procedures to implement audits to verify that activities covered by the QAPD are performed in conformance with the established requirements and performance criteria are met. The audit programs are themselves reviewed for effectiveness as a part of the overall audit process.
18.1 Performance of Audits Internal audits of selected aspects of the licensing, design, construction, and operating phase activities are performed with a frequency commensurate with the safety significance of the activity and in a manner which ensures that audits of safety-related activities are completed. During early activities, audits will focus on areas including, but not limited to, design, site investigation, document control, procurement, and corrective action. Functional areas of an organizations QA program for auditing include, at a minimum, verification of compliance and effectiveness of implementation of internal rules and procedures (e.g., operating, design, procurement, maintenance, modification, refueling, surveillance, test, security, radiation control procedures, and the emergency plan), Technical Specifications, regulations and license conditions, programs for training, retraining, qualification and performance of the operating staff, observation of performance of operating, refueling, maintenance, and modification activities, and corrective actions, including associated record keeping.
The audits are scheduled on a formal preplanned audit schedule and in a manner to provide coverage and coordination with ongoing activities, based on the status and importance of the activity. Scheduled audits are supplemented by additional audits of specific subjects when necessary to provide adequate coverage. The scope of the audit is determined by the quality status and safety importance of the activities being performed. These audits are conducted by trained personnel not having direct responsibilities in the area being audited and in accordance with preplanned and approved audit plans or checklists, under the direction of a qualified Lead Auditor and the cognizance of the LME Quality Assurance management responsible for the day-to-day program, as documented in Part II, Section 1.
LME is responsible for conducting periodic internal and external audits. Internal audits are conducted to determine the adequacy of programs and procedures (by representative sampling), and to determine if they are meaningful and comply with the overall QAPD. External audits determine the adequacy of a supplier or contractor quality assurance program and are issued to the management of the audited organization and applicable LME management.
The results of each audit are reported in writing to the Senior Executive responsible for the Quality Assurance Program, or designee, as appropriate. Additional internal distribution is made to other concerned management levels and to management of the internal audited organizations or activities, in accordance with approved procedures.
Management responds to all audit findings and initiates corrective action where indicated. Where corrective action measures are indicated, documented follow-up of applicable areas, through inspections, review, re-audits, or other appropriate means, is conducted to verify implementation and effectiveness of assigned corrective action.
Audits of suppliers of safety-related components and/or services are conducted as described in Part II, Section 7.
Long Mott Energy, LLC 12/04/2024 33 General Business 18.2 Internal Audits Internal audits of organization and facility activities, conducted prior to placing the facility in operation, should be performed in such a manner as to assure that an audit of all applicable QA program elements is completed for each functional area at least once each year or at least once during the life of the activity, whichever is shorter.
Internal audits of activities, conducted after placing the facility in operation, should be performed in such a manner as to assure that an audit of all applicable QA program elements is completed for each functional area within a period of two years. Internal audit frequencies of well-established activities, conducted after placing the facility in operation, may be extended one year at a time beyond the above two-year interval based on the results of an annual evaluation of the applicable functional area and objective evidence that the functional area activities are being satisfactorily accomplished. The evaluation should include a detailed performance analysis of the functional area based upon applicable internal and external source data and due consideration of the impact of any functional area changes in responsibility, resources, or management. However, the internal audit frequency interval should not exceed a maximum of four years. If an adverse trend is identified in the applicable functional area, the extension of the internal audit frequency interval should be rescinded, and an audit scheduled as soon as practicable.
Audits may also be used to meet the periodic review requirements of the code for the Security, Emergency Preparedness, and Radiological Protection programs within the provisions of the applicable code.
Internal audits include verification of compliance and effectiveness of the administrative controls established for implementing the requirements of the QAPD; regulations and license provisions; provisions for training, retraining, qualification, and performance of personnel performing activities covered by the QAPD; corrective actions taken following abnormal occurrences; and, observation of the performance of construction, fabrication, operating, refueling, maintenance, and modification activities including associated record keeping.
18.3 NQA-1 Commitment In establishing the independent audit program, LME commits to compliance with NQA 2015, Requirement 18 and the regulatory positions stated in Regulatory Guide 1.28, Rev 5.
Long Mott Energy, LLC 12/04/2024 34 General Business PART III - Non-Safety-Related SSC Quality Control
- 19. Non-Safety-Related with Special Treatment SSCS Specific program controls are applied to non-safety-related SSCs, for which 10 CFR 50, Appendix B is not applicable, that are significant contributors to plant safety. The specific program controls consistent with applicable sections of the QAPD are applied to those items in a selected manner, targeted at those characteristics or critical attributes that render the SSC non-safety-related with special treatment (NSRST).
The following clarify the applicability of the QA Program to the non-safety-related SSCs and related activities, including the identification of exceptions to the QA Program described in Part II, Sections 1 through 18 taken for non-safety-related SSCs.
19.1 Organization The verification activities described in this part may be performed by the LME line organization. The QA organization described in Part II is not required to perform these functions.
19.2 QA Program LME QA requirements for non-safety-related NSRST SSCs are established in the QAPD and appropriate procedures. Suppliers of these SSCs or related services describe the quality controls applied in appropriate procedures. A new or separate QA program is not required.
19.3 Design Control LME has design control measures to ensure that the contractually established design requirements are included in the design. These measures ensure that applicable design inputs are included or correctly translated into the design documents, and deviations from those requirements are controlled. Design verification is provided through the normal supervisory review of the designer's work.
19.4 Procurement Document Control Procurement documents for items and services obtained by or for LME include or reference documents describing applicable design bases, design requirements, and other requirements necessary to ensure component performance. The procurement documents are controlled to address deviations from the specified requirements.
19.5 Instructions, Procedures, and Drawings LME provides documents such as, but not limited to, written instructions, plant procedures, drawings, vendor technical manuals, and special instructions in work orders, to direct the performance of activities affecting quality. The method of instruction employed provides an appropriate degree of guidance to the personnel performing the activity to achieve acceptable functional performance of the SSC.
Long Mott Energy, LLC 12/04/2024 35 General Business 19.6 Document Control LME controls the issuance and change of documents that specify quality requirements or prescribe activities affecting quality to ensure that correct documents are used. These controls include review and approval of documents, identification of the appropriate revision for use, and measures to preclude the use of superseded or obsolete documents.
19.7 Control of Purchased Items and Services LME employs measures, such as inspection of items or documents upon receipt or acceptance testing, to ensure that all purchased items and services conform to appropriate procurement documents.
19.8 Identification and Control of Purchased Items LME employs measures where necessary, to identify purchased items and preserve their functional performance capability. Storage controls consider appropriate environmental, maintenance, or shelf-life restrictions for the items.
19.9 Control of Special Processes LME employs process and procedure controls for special processes, including welding, heat treating, and nondestructive testing. These controls are based on applicable codes, standards, specifications, criteria, or other special requirements for the special process.
19.10 Inspection LME uses documented instructions to ensure necessary inspections are performed to verify conformance of an item or activity to specified requirements or to verify that activities are satisfactorily accomplished. These inspections may be performed by knowledgeable personnel in the line organization. Knowledgeable personnel are from the same discipline and have experience related to the work being inspected.
19.11 Test Control LME employs measures to identify required testing that demonstrates that equipment conforms to design requirements. These tests are performed in accordance with test instructions or procedures. The test results are recorded, and authorized individuals evaluate the results to ensure that test requirements are met.
19.12 Control of Measuring and Test Equipment (M&TE)
LME employs measures to control M&TE use, and calibration and adjustment at specific intervals or prior to use.
19.13 Handling, Storage, and Shipping LME employs measures to control the handling, storage, cleaning, packaging, shipping, and preservation of items to prevent damage or loss and to minimize deterioration. These measures include appropriate marking or labels, and identification of any special storage or handling requirements.
Long Mott Energy, LLC 12/04/2024 36 General Business 19.14 Inspection, Test, and Operating Status LME employs measures to identify items that have satisfactorily passed required tests and inspections and to indicate the status of inspection, test, and operability as appropriate.
19.15 Control of Nonconforming Items LME employs measures to identify and control items that do not conform to specified requirements to prevent their inadvertent installation or use.
19.16 Corrective Action LME employs measures to ensure that failures, malfunctions, deficiencies, deviations, defective components, and nonconformances are properly identified, reported, and corrected.
19.17 Records LME employs measures to ensure records are prepared and maintained to furnish evidence that the above requirements for design, procurement, document control, inspection, and test activities have been met.
19.18 Audits LME employs measures for line management to periodically review and document the adequacy of the process, including taking any necessary corrective action. Audits independent of line management are not required. Line management is responsible for determining whether reviews conducted by line management or audits conducted by any organization independent of line management are appropriate.
If performed, audits are conducted and documented to verify compliance with design and procurement documents, instructions, procedures, drawings, and inspection and test activities. Where the measures of this part (Part III) are implemented by the same programs, processes, or procedures as the comparable activities of Part II, the audits performed under the provisions of Part II may be used to satisfy the review requirements of this Section (Part III, Section 1.18).
Long Mott Energy, LLC 12/04/2024 37 General Business
- 20. Non-Safety-Related SSCS Credited for Regulatory Events The following criteria apply to fire protection (10 CFR 50.48), anticipated transients without scram (ATWS) (10 CFR 50.62), the station blackout (SBO) (10 CFR 50.63) SSCs that are not safety-related:
x LME implements quality requirements for the fire protection system in accordance with Regulatory Position 1.7, "Quality Assurance," in Regulatory Guide 1.189, "Fire Protection for Nuclear Power Plants," Revision 4.
x LME implements the quality requirements for non-safety-related, safety significant ATWS equipment in accordance with Part III, Section1.
x LME implements quality requirements for non-safety-related, safety significant SBO equipment in accordance with Part III, Section1.
Long Mott Energy, LLC 12/04/2024 38 General Business PART IV - Regulatory Commitments
- 21. NRC Regulatory Guides and Quality Assurance Standards This section identifies the NRC Regulatory Guides (RG) and the other quality assurance standards which have been selected to supplement and support the LME QAPD. LME identifies the extent of conformance with these RGs and quality assurance standards as described below or within applicable license application documents submitted in accordance with 10 CFR 50 (e.g., LWA, CP, OL), as applicable.
Commitment to a particular RG or standard does not constitute a commitment to other RGs or standards that may be referenced therein.
21.1 Regulatory Guides x Regulatory Guide 1.8, [Rev. 4, June 2019], Qualification and Training of Personnel for Nuclear Power Plants Regulatory Guide 1.8 provides guidance that is acceptable to the NRC staff regarding qualifications and training for nuclear power plant personnel.
x Regulatory Guide 1.28, [Rev. 5, October 2017], Quality Assurance Program Criteria (Design and Construction)
Regulatory Guide 1.28 describes a method acceptable to the NRC staff for complying with the provisions of Appendix B with regard to establishing and implementing the requisite quality assurance program for the design and construction of nuclear power plants.
LME will implement this guidance and will identify exceptions to the applicable regulatory position guidance provided in this regulatory guide in applicable license applications (e.g., safety analysis reports).
x Regulatory Guide 1.29, [Revision 6, July 2021] - Seismic Design Classification Regulatory Guide 1.29 defines systems required to withstand a safe shutdown earthquake (SSE).
LME will identify conformance with the applicable regulatory position guidance provided in this regulatory guide in applicable license applications (e.g., safety analysis reports).
x Regulatory Guide 1.87, Appendix A [Rev 2, January 2023], High Temperature Reactor Quality Group Classification Regulatory Guide 1.87, Appendix A provides guidance on establishing quality group assignments of mechanical systems and components of non-light-water reactors acceptable to the U.S.
Nuclear Regulatory Commission (NRC) staff for all the safety classification methods. LME also follows the Risk-informed classification method described in RG 1.233, Guidance for a Technology-Inclusive, Risk-Informed, and Performance-Based Methodology to Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light-Water Reactors, Revision 0, dated June 2020 and as clarified in LMEs accepted Xe-100 Licensing Topical Report Risk-Informed Performance-Based Licensing Basis Development, Revision 2-A, dated November 4, 2022.
Long Mott Energy, LLC 12/04/2024 39 General Business x Regulatory Guide 1.164, [Revision 0, June 2017], Dedication of Commercial-Grade Items for Use in Nuclear Power Plants.
Regulatory Guide 1.164 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable in meeting regulatory requirements for dedication of commercial-grade items and services used in nuclear power plants.
LME identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications (e.g., safety analysis reports).
x Regulatory Guide 1.231, [Revision 0, January 2017], Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants.
Regulatory Guide 1.231 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable in meeting regulatory requirements for acceptance and dedication of commercial-grade design and analysis computer programs used in safety-related applications for nuclear power plants.
LME identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications (e.g., safety analysis reports).
x Regulatory Guide 1.233, [Revision 0, June 2020], Guidance for a Technology-Inclusive, Risk-Informed, and Performance-Based Methodology to Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light-Water-Reactors.
x Regulatory Guide 1.234, [Revision 0, April 2018], Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21.
Regulatory Guide 1.234 describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for complying with the provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting of Defects and Noncompliance.
LME identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in applicable license applications (e.g., safety analysis reports).
21.2 Standards x ASME NQA-1-2015 - Quality Assurance Requirements for Nuclear Facility Applications LME commits to NQA-1-2015 Parts I and II, as described in Parts II and V of this document with specific identification of exceptions or clarification. LME commits to NQA-1-2015 Parts III and IV only as specifically noted in Parts II and V of this document.
x ISO 9001:2015 - Quality management systems - Requirements LME commits to the implementation of ISO 9001:2015 in a graded approach for the planning and conduct of specific NSRST work activities.
x Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guides (TGs)
LME commits to NIRMA TGs as described in Part II, Section 17 of this document.