ND-21-1116, Nuclear Development Quality Assurance Manual Version 22.0
ML22039A055 | |
Person / Time | |
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Site: | Vogtle ![]() |
Issue date: | 02/04/2022 |
From: | Southern Nuclear Operating Co |
To: | Office of Nuclear Reactor Regulation |
Shared Package | |
ML22039A072 | List: |
References | |
ND-21-1116 | |
Download: ML22039A055 (70) | |
Text
Southern Nuclear Operating Company ND-21-1116 Enclosure NDQAM Version 22.0 (This Enclosure consists of 69 pages, not including this cover page)
A Southern Nuclear Quality Assurance Manual
Title:
Nuclear Development Quality Assurance Manual Process/Program Owner: Senior Manager for Quality Assurance Version Number Effective Date 22.0 12/20/2021 Reviewed By/Date: Approved By/Date:
ANTHONY S. PARTON / 12/17/2021 AMY G. AUGHTMAN / 12/20/2021 Senior Manager for Quality Assurance Date Senior Manager for Nuclear Oversight Date GLEN CHICK/ 12/20/2021 Executive Vice President of V3&4 Date Page 1 of 69 Version 22.0
Nuclear Development Quality Assurance Manual Revision Summary: Version 22.0 LDCR 2020-053 This activity incorporates an exception to allow structures with design based on American Concrete Institute (ACI)-349 to be tested and inspected per ACI-349 as identified and supplemented in the Updated Final Safety Analysis Report(UFSAR)Section 3.8 in lieu of NQA-1-1994, Subpart 2.5, paragraph 7.13 requirements. The UFSAR provides appropriate, NRC-accepted testing and inspection requirements for structures with design based on ACI-349. This exception did not get appropriately identified within the NDQAM. This change resolves this discrepancy.
This change is made to the NDQAM, Part II, Section 10, paragraph 4.1.
The 10 CFR 50.54(a)/10 CFR 50.55(f) screening/evaluation confirmed that the change made for this activity did not result in a reduction in Quality Assurance program commitments. No quality functions, control, or activities are being eliminated by these changes.
LDCR 2021-048 This activity updates the Nuclear Development Quality Assurance Manual(NDQAM)to:
(1) Incorporate organizational changes to reporting structure, titles, and responsibilities as described in the NDQAM,Part II, Section 1, Organization:
o Added a Deputy to the Executive Vice President reporting to the Executive Vice President of Vogtle 3&4, moved roles and responsibilities of the Vice President for Site Operations to the Deputy to the Executive Vice President, and removed the Vice President for Site Operations position.
o Added a Senior Manager for Document Closure reporting to the Executive Vice President of Vogtle 3&4 with roles and responsibilities for work package closure.
o Changed the title of the Senior Manager for Project Transltlons to the Senior Manager for Unit 3 Project, and clarified roles and responsibilities, including responsibility for system turnovers from Initial Test Program to Operations jurisdiction.
o Changed the title of the Senior Manager for Project to the Senior Manager for Unit 4 Project, and clarified roles and responsibilities.
o Changed the title of the Plant Manager (Post-Fuel Load Operational Activities) to Unit 3 Plant Manager.
o Changed the reporting relationship of the Vice President Nuclear Plant Site - Vogtle 1&2from the Executive Vice President/Chief Nuclear Officer to the Senior Vice President -
Operations as implemented by the SNC Quality Assurance Topical Report.
o Changed responsibility for staffing under Standard Plant Organization (Operations) description from the Vice President for Site Operations to the Executive Vice President of Vogtle 3&4.
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Nuclear Development Quality Assurance Manual Revision Summary: Version 22.0(continued)
Moved the reporting relationship of the Senior Manager for Site Support, with roles and responsibilities, from the Executive Vice President of Vogtie 3&4 to the Deputy to the Executive Vice President.
Moved the reporting relationship of the Senior Manager for Procurement, with roles and responsibilities, from the Senior Manager for Unit 4 Project to the Senior Manager for Unit 3 Project, and added interfaced relationship between the Senior Manager for Procurement and the Senior Manager for Site Support.
Moved the reporting relationship of the Engineering Director, with roles and responsibilities, from the Unit 3 Plant Manager to the Senior Manager for Engineering, and then changed the title to Site Operations Engineering Director.
Moved roles and responsibilities of the Plant Manager (Construction/ITP/Operational Support Activities)from the Deputy to the Executive Vice President to the Senior Manager for Unit 3 Project, and then removed the Plant Manager (Construction/ITP/Operational Support Activities) position.
Split the Senior Manager for Subcontracts/Site Projects position into the Senior Manager for Subcontracts and the Senior Manager for Site Projects positions, with corresponding roles and responsibilities, and; o Moved reporting relationship of the Senior Manager for Subcontracts, with roles and responsibilities, from the Senior Manager for Unit 4 Project to the Executive Vice President of Vogtie 3&4.
o Moved reporting relationship of the Senior Manager for Site Projects, with roles and responsibilities, from the Senior Manager for Unit 4 Project to the Senior Manager for Site Support, and removed the interfaced relationship between the Senior Manager for Site Projects and the Senior Manager for Site Support.
Moved responsibility for site design engineering from the Site Operations Engineering Director to the Senior Manager for Engineering.
Moved responsibility for digital instrumentation and control (l&C) design and delivery from the Site Operations Engineering Director to the Senior Manager for Initial Test Program.
Moved responsibility for engineering fix-it-now activities from the Senior Manager for Engineering to the Site Operations Engineering Director.
Moved responsibilities for field engineering and scoping from the Senior Manager for Testing and Turnover to the Senior Manager for Engineering.
Moved responsibility for supplier compliance from the Senior Manager for Procurement to the Senior Manager for Supply Chain, and added an interfaced relationship for the responsibility.
Moved interfaced relationship with security from the Senior Manager for Site Support to the Deputy to the Executive Vice President.
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Nuclear Development Quality Assurance Manual Revision Summary: Version 22.0(continued) o Moved responsibility for emergency preparedness from the Senior Manager for Site Support to the Vice President - Regulatory Affairs due to SNC Emergency Preparedness(EP) reorganization that resulted in the Vogtle site EP Manager reporting to the Fleet EP Director, and added an interfaced relationship between the Senior Manager for Site Support and emergency preparedness.
o Moved Corporate engineering function from the manager with responsibilities for Corporate engineering to the manager with responsibilities for Corporate licensing, reporting to the Senior Manager for Offslte Licensing, and then removed the manager with responsibilities for Corporate engineering position.
o Clarified responsibilities of the Senior Manager for initial Test Program.
o Added a block for the Senior Manager for Work Management to Figure 11.1-1. (Condition Report 50074109)
(2) Add selected conditions and limitations described in a Nuclear Regulatory Commission(NRC)Safety Evaluation Report(SER)(Accession No. ML20322A019)to maintain consistency between the NDQAM and regulatory requirements when relying upon the international Laboratory Accreditation Cooperation (ILAC) accreditation process as an alternative source evaluation and selection measure.
This change is made to the NDQAM, Part li. Section 7, paragraph 3.1.1.2 with sub-paragraphs 3.1.1.2.1 to 3.1.1.2.4.
(3) incorporate use of remote assessment techniques during pandemic or exigent conditions though adoption of EPRI Technical Report 3002020796,"Remote Assessment Techniques: Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions," April 2021.
This change is made to the NDQAM, Part II, Section 7, paragraph 3.1.1.5 with sub-paragraphs 3.1.1.5.1 to 3.1.1.5.2, and Part iV, paragraph 1.3.3.
Additionally, the NDQAM revision incorporates global clarifications, grammatical corrections, and formatting changes that are not listed in this summary.
The 10 CFR 50.54(a)/10 CFR 50.55(f) screening/evaluation confirmed that the individual and cumulative changes made during this update to the NDQAM did not result in a reduction in Quality Assurance program commitments. No quality functions, control, or activities are being eliminated by these changes.
Revision Summary: Version 21.0 LDCR 2020-041 This activity incorporates changes regarding criteria for extending internal and supplier audit intervals in the Nuclear Development Quality Assurance Manual(NDQAM)based on a change to the Southern Nuclear Qperating Company Quality Assurance Programs for Farley Nuclear Plant, Hatch Nuclear Plant, and Vogtle Electric Generating Plant as approved by the NRC in Safety Evaluation Report Accession(ADAMS) No. ML051570349.
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Nuclear Development Quality Assurance Manual Revision Summary: Version 21.0(continued)
These changes are made to the NDQAM, Part II, o Section 2, Quality Assurance Program, paragraph 1.7 o Section 18, Audits, paragraph 2.6 The 10 CFR 50.54(a)/10 CFR 50.55(f) screening/evaluation confirmed that the changes made for this activity did not result in a reduction in Quality Assurance program commitments. No quality functions, control, or activities are being eliminated by these changes.
LDCR 2020-100 The primary purpose of this update to the Nuclear Development Quality Assurance Manual(NDQAM)is to incorporate organizational changes noted below and to apply the NDQAM to radioactive material transportation packaging as defined and allowed by 10 CFR 71 Subpart H. Additionally, the NDQAM was revised to incorporate clarifications, grammatical corrections and formatting changes. These administrative type changes were made throughout the NDQAM and are not noted below.
Qrganizational changes were made to reporting structure, titles, and responsibilities as described in the NDQAM, Part II, Section 1, Organization:
o Changed title of the Plant Manager reporting to the Vice President for Site Operations to the Plant Manager (Post-Fuel Load Operational Activities), adding roles and responsibilities for Units 3 and 4 post-fuel load operational activities, commercial operations, and construction support, with senior managers for operations, maintenance, radiation protection, chemistry, and work management still reporting to the position.
o Added an Engineering Director reporting to the Plant Manager (Post-Fuel Load Qperational Activities). Moved following roles and responsibilities from the Senior Manager for Engineering to the Engineering Director: equipment reliability: engineering programs; systems engineering; site design engineering; plant modifications; configuration control; managing receipt and shipping of nuclear fuel; oversight of the probabilistic risk assessment program; standardization, long-term resource planning, and promoting best practices; and SNC Quality Control Inspection program activities performed on plant equipment, systems, components, and structures in support of Vogtle 3&4. Moved roles and responsibilities for technical direction and support of plant activities related to digital l&C systems design/delivery and cyber security from the Senior Manager for Initial Test Program (ITP)to the Engineering Director.
o Added a Plant Manager (Construction/ITP/Qperational Support Activities) reporting to the Vice President for Site Operations, with roles and responsibilities for Units 3 and 4 operational activities associated with construction, integrated test program, and operational support in preparation for initial fuel load, and reporting project managers with responsibilities for operations, maintenance, engineering, and work management project transition.
o Added interfaced relationships between corresponding roles reporting to the Plant Manager (Construction/ITP/Operational Support Activities) and the Plant Manager (Post-Fuel Load Qperational Activities).
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Nuclear Development Quality Assurance Manual Revision Summary: Version 21.0(continued) o Added a Senior Manager for Project Transitions reporting to the Executive Vice President of Vogtle 3&4(EVP) with responsibilities for EVP-assigned projects including oversight and support of project transition such as construction to initial test program (IIP) and ITP to operations.
o Added a Deputy Senior Manager for Engineering reporting to the Senior Manager for Engineering with support responsibilities.
o Moved roles and responsibilities of the Senior Manager for Site Support from the Vice President for Site Operations to the Executive Vice President of Vogtie 3&4.
o Moved roles and responsibilities of the Senior Manager for Site Regulatory Affairs moved from the Vice President for Site Operations to the Executive Vice President of Vogtie 3&4.
o Moved roles and responsibilities of the Senior Manager for Training from Vice President for Site Operations to Senior Manager for Site Support.
o Moved responsibilities for performance improvement and corrective action program from the Senior Manager for Site Support to the Plant Manager for Operational Activities (Post-Fuel Load).
o Moved responsibilities for site security and access from the Senior Manager for Site Support to the Vice President - Regulatory Affairs due to SNC Security reorganization that resulted in the Vogtie Site Security Director reporting to the Fleet Security Director. Added an interfaced relationship between the Senior Manager for Site Support and site security/access.
o Moved interface responsibilities of Vice President of Nuclear Development Technology to the Senior Manager for Site Regulatory Affairs and removed the vice president position.
o Removed the Testing and Completion Deputy Management position reporting to the Senior Manager of Testing and Turnover since it did not perform NDQA Program-related activities.
o Removed the Vice President - Fleet Governance and Oversight position since it does not perform NDQA Program-related activities.
o Revised Senior Manager for Nuclear Oversight to only describe NDQAP Program-related roles and responsibilities.
o Revised Operating Fleet Organization reporting relationships implemented by the SNC Quality Assurance Topical Report(QATR).
o Revised Figure 11.1-1 to reflect current organizational structure. Removed Figure 11.1-2.
Changes were made to the NDQAM, Part I, Section 2.4 and Part II, Sections 17.1 and 17.2 to apply the NDQAM to radioactive material transportation packaging as defined and allowed by 10 CFR 71 Subpart H.
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Nuclear Development Quality Assurance Manual Revision Summary: Version 21.0(continued)
The 10 CFR 50.54(a)/10 CFR 50.55(f) screening/evaluation confirmed that the individual and cumulative changes made during this update to the NDQAM did not result in a reduction in Quality Assurance program commitments. No quality functions, control, or activities are being eliminated by these changes.
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SOUTHERN NUCLEAR OPERATING COMPANY,INC POLICY STATEMENT Southern Nuclear Operating Company, Inc.(SNC)shall design, procure, construct, and operate the 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 SNC Nuclear Development Quality Assurance Program (NDQAP)Is the SNC Nuclear Development Quality Assurance Manual(NDQAM)and associated Implementing documents. Together they provide for control of SNC activities that affect the quality of safety related nuclear plant structures, systems, and components and Include all planned and systematic activities necessary to provide adequate confidence that such structures, systems, and components will perform satisfactorily In service. The NDQAP may also be applied to certain equipment and activities that are not safety related, but support safe plant operations, or where other NRC guidance establishes program requirements.
The NDQAM Is the top-level policy document that establishes the manner In which quality Is to be achieved and presents SNC's 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 NDQAM. Compliance with the NDQAM and Implementing documents Is mandatory for personnel directly or Indirectly associated with Implementation of the SNC NDQAP.
Signed Original signed by Stephen E. Kuczynski Stephen Kuczynski Chairman, President and Chief Executive Qfflcer Southern Nuclear Qperating Company, Inc.
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TABLE OF CONTENTS POLICY STATEMENT 8 PART 1 INTRODUCTION 10 PART II NDQAM DETAILS 12 SECTION 1 ORGANIZATION 12 SECTION 2 QUALITY ASSURANCE PROGRAM 26 SECTION 3 DESIGN CONTROL 34 SECTION 4 PROCUREMENT DOCUMENT CONTROL 37 SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 39 SECTION 6 DOCUMENT CONTROL 41 SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 44 SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 48 SECTION 9 CONTROL OF SPECIAL PROCESSES 49 SECTION 10 INSPECTION 50 SECTION 11 TEST CONTROL 52 SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT 54 SECTION 13 HANDLING, STORAGE, AND SHIPPING 55 SECTION 14 INSPECTION, TEST, AND OPERATING STATUS 57 SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 58 SECTION 16 CORRECTIVE ACTION 59 SECTION 17 QUALITY ASSURANCE RECORDS 60 SECTION 18 AUDITS 62 PART III NONSAFETY-RELATED 880 QUALITY CONTROL 64 SECTION 1 Non-safety Related SSCs - Significant Contributors to Plant Safety 64 SECTION 2 Non-safety-Related SSCs Credited for Regulatory Events 67 PART IV REGULATORY COMMITMENTS 68 NRC REGULATORY GUIDES AND QUALITY ASSURANCE STANDARDS 68 Page 9 of 69 Version 22.0
PARTI Nuclear Development Quality Assurance Manual PART I INTRODUCTION 1.0 General 1.1 This Southern Nuclear Operating Company, Inc.(SNC) Nuclear Development Quality Assurance Manual(NDQAM)Is the top-level policy document that establishes the quality assurance policy and assigns major functional responsibilities for Nuclear Development activities conducted by or for SNC.
1.2 The NDQAM describes the methods and establishes quality assurance(OA)and administrative control requirements that meet 10 CFR 50, Appendix B and 10 CFR 52.
The NDQAM Is based on the requirements and recommendations of ASME NQA-1-1994, "Quality Assurance Requirements for Nuclear Facility Applications," Parts I, II, and III, herein "NQA-1-1994," as specified In this document.
1.3 The NDQAM Is the Nuclear Regulatory Commission (NRC)approved regulatory document that describes the Nuclear Development Quality Assurance Program (NDQAP)elements, along with the associated Implementing documents.
1.4 Procedures and Instructions that control Nuclear Development(ND)activities will be developed prior to commencement of those activities. Policies establish high level responsibilities and authority for carrying out Important administrative functions that are outside the scope of the NDQAM.
1.5 Procedures establish practices for certain activities that are common to all SNC organizations performing those activities such that the activity Is controlled and carried out In a manner that meets NDQAM requirements.
1.6 Site or organization specific procedures establish detailed Implementation requirements and methods, and may be used to Implement policies or be unique to particular functions or work activities.
1.7 SNC 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.
2.0 Scope I Applicabilltv 2.1 This NDQAM applies to Combined License (CQL), constructlon/pre-operatlon and operations activities affecting the quality and performance of safety-related structures, systems, and components. Including, but not limited to the following; Siting Qperating Modifying Designing Maintaining Inspecting Constructing Receiving Refueling Procuring Storing Shipping Fabricating Erecting Testing Cleaning Installing Startup Handling Repairing Preoperatlonal (Including ITAAC activities)
Licensing Training Decommissioning Page 10 of 69 Version 22.0
PARTI Nuclear Development Quality Assurance Manual 2.2 This manual Is Initiated for the development of COL applications. The NDQAM does not apply to SNC's operating units at Plants Farley, Hatch, and Vogtle.
2.3 Safety-related systems, structures, and components, under the control of the NDQAM, are identified by design documents. The technical aspects of these items are considered when determining program applicability, including, as appropriate, the item's design safety function.
2.4 The NDQAM may be applied to certain activities where regulations other than 10 CFR 50 and 10 CFR 52 establish Quality Assurance Program requirements for activities within their scope. Thus, selected elements of the NDQAM are applied to the "important to safety" activities of radioactive material transportation packages, as defined by 10 CFR 71 Subpart H and allowed by 10 CFR 71.101(f).
2.5 The policy of SNC is to assure a high degree of availability and reliability of its nuclear plants while ensuring the health and safety of its workers and the public. To this end, selected elements of the NDQAP are also applied to certain equipment and activities that are not safety-related or important to safety, but support safe, economic, and reliable plant operations, or where other NRC guidance establishes quality assurance requirements.
These include, but may not be limited to, security and fire protection. Implementing documents establish program element applicability.
2.6 The definitions provided in NQA-1-1994, Part I, Introduction, Section 4 apply to select terms as used in this document.
3.0 Responsibilities 3.1 SNC personnel engaged in activities described in this NDQAM shall comply with the requirements of the NDQAP.
3.2 Contractors, suppliers, or other organizations supporting SNC are required to comply with the NDQAP established by this NDQAM, or with their own programs determined by SNC to include sufficient controls to meet the applicable requirements of 10 CFR 50, Appendix B.
3.3 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.
4.0 Interfaces with Owners Agreements exist between SNC and the nuclear power plant owner organizations(Qwners)to establish responsibilities and authorities for the design, construction, operation, and maintenance of said facilities.
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PART II Nuclear Development Quality Assurance Manual PART II NDQAM DETAILS SECTION 1 ORGANIZATION 1.0 General 1.1 This Section describes the SNC organizationai structure, functionai responsibilities, levels of authority and interfaces for establishing, executing, and verifying NDQAP implementation.
1.2 The organizational structure includes corporate and onsite functions for Nuclear Development including interface responsibilities for multiple organizations performing quality-related functions.
1.3 Implementing documents assign more specific responsibilities and duties, and define the organizationai interfaces involved in conducting activities and duties within the scope of this NDQAM. Management gives careful consideration to the timing, extent, and effects of organizational structure changes.
1.4 The senior manager for nuclear oversight, through the senior manager for quality assurance (QAM), is responsible to size the Quality Assurance organization commensurate with the duties and responsibilities assigned.
1.5 ND is responsible for new nuclear plant licensing, engineering, procurement, construction, startup, and operations development activities.
1.6 There are several organizations within SNC that implement and support the NDQAM. These organizations include, but are not limited to ND, Engineering, Fleet Operations Support, Environmental Affairs, Supply Chain, and Nuclear Oversight.
1.7 During the pre-construction and construction phases, Westinghouse will serve as the Vogtie 3&4 API000 designer and design authority for SNC, subject to SNC approval of changes.
1.8 The following sections describe the reporting relationships, functional responsibilities, and authorities for organizations implementing and supporting the NDQAP.
2.0 Southern Nuclear 2.1 SNC President and Chief Executive Officer (President/CEO)
The President/CEO is responsible for ail aspects of design, construction, and operation of Southern Company's nuclear plants. The President/CEO is also responsible for all technical and administrative support activities provided by SNC and contractors.
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PART II Nuclear Development Quality Assurance Manual The President/CEO directs the Chief Nuclear Officer / Executive Vice President and the Executive Vice President of Vogtle 3&4 in fulfillment of their responsibilities.
The President/CEO reports to the SNC Board of Directors with respect to all matters.
3.0 Nuclear Development The SNC NO organization is responsible for new nuclear plant licensing, engineering, procurement, construction, testing, startup, operational development, operating, and quality assurance activities.
3.1 Executive Vice President of Vogtle 3&4 The Executive Vice President of Vogtle 3&4(EVP)reports to the President/CEO and is responsible for all SNC activities associated with design, construction, and operation of Vogtle Units 3&4 and for Quality Assurance in the areas specified by the NDQAM and ND-ASME Quality Assurance Manual(ND-AQAM).
The EVP directs the planning and development of the NO staff and organization resources.
The EVP's direct reports are:
Deputy to the EVP Senior Manager for Unit 3 Project Senior Manager for Unit 4 Project Senior Manager for Engineering Senior Manager for Testing and Turnover Senior Manager for Site Regulatory Affairs Senior Manager for Subcontracts Senior Manager for Document Closure The EVP interfaces with the QAM on quality related activities associated with Vogtle 3&4.
Figure 11.1-1 identifies the specific quality functions, direct reports and other matrixed functions reporting to the EVP. The following management positions with specific responsibilities under the NDQAM either directly report to, or are matrixed to, the EVP.
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PART II Nuclear Development Quality Assurance Manual 3.1.1 Deputy to the Executive Vice President The deputy to the executive vice president(EVP) is responsible for operational activities associated with construction, integrated test program, and operational support in preparation for initial fuel load, and post-initial fuel load activities through commercial operations.
Managers reporting to this position have line responsibility for effective implementation of the NDQAP per approved procedures for the operational activities. This position also interfaces with security.
3.1.1.1 Unit 3 Plant Manager The Unit 3 plant manager reports to the deputy to the EVP and is responsible for Vogtle Unit 3 post-fuel load operational activities, commercial operations, and construction support. Activities include initial staffing, operational program development, maintenance, engineering, radiation protection, chemistry, and work management in preparation for startup activities and commercial operations. The management position is also responsible for the performance improvement and corrective action program for the Vogtle 3&4 project.
The following managers reporting to the Unit 3 Plant Manager have responsibilities for activities associated with the efficient, safe, and reliable operation of the nuclear plant.
3.1.1.1.1 Senior Manager for Operations The senior manager for operations is responsible for the safe and reliable operation of the plant, including;
- Unit operations
- Day-to-day planning
- Technical support
- Preparation for and conduct of outage related activities
- Overseeing outage work activities, surveillances, and tests In addition, operating personnel responsibilities include the following:
- The reactor operator's authority and responsibility for shutting down the reactor when it is determined that the safety of the reactor is in jeopardy or when operating parameters exceed any of the reactor protection system set-points and automatic shutdown does not occur.
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PART II Nuclear Development Quality Assurance Manual The responsibility to determine the circumstances, analyze the cause, and determine that operations can proceed safely before the reactor is returned to power after a trip or an unexplained or unscheduled power reduction.
The senior reactor operator's responsibility to be present at the plant and to provide direction for returning the reactor to power following a trip or an unscheduled or unexplained power reduction.
The responsibility to believe and respond conservatively to instrument indications unless they are proved to be incorrect.
- The responsibility to adhere to the plant's Technical Specifications.
- The responsibility to review routine operating data to assure safe operation.
- The responsibility to take action to minimize personnel injury or damage to the facility and to protect the health and safety of the public in the event of conditions not covered by approved procedures.
3.1.1.1.2 Senior Manager for Maintenance The senior manager for maintenance directs maintenance personnel in performance of preventive maintenance, repair of plant equipment, and maintenance support utilizing contractor craft personnel. Managers reporting to this position include support/preservation preventive maintenance, instrument and control (l&C), mechanical, and electrical.
3.1.1.1.3 Senior Manager for Radiation Protection The senior manager for radiation protection is responsible for the maintenance of all required radiation exposure records of plant support and visiting personnel; provides radiation surveys and minimization of occupational radiation exposure(ALARA program); manages the shipping and receiving of all byproduct, source, and special nuclear material except fuel; manages the radwaste management program including radwaste cleaning/processing performed by operations; and manages the personnel dosimetry and respiratory protection programs.
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PART II Nuclear Development Quality Assurance Manual 3.1.1.1.4 Senior Manager for Chemistry The senior manager for chemistry is responsible for chemical and radiochemical activities at the plant; chemistry related activities including filter/ demineralizer control and water chemistry; administrative control of effluent releases from the plant to ensure that the releases are maintained ALARA and within the required limits; and implementing primary, secondary, and component cooling water chemistry programs.
3.1.1.1.5 Senior Manager for Work Management The senior manager for work management is responsible for ensuring maximum advantage is taken of forced outages and load reductions to do needed repair, replacement, modification, and inspection work; working with Maintenance to ensure management control of work is accomplished through the use of an effective priority system; preparing Outage Safety Assessments in support of scheduled refueling outages; conducting ongoing outage risk assessments; and implementation of the startup schedule from fuel load through 100-percent sustained operation. The management position interfaces with the Operations organization for testing and startup activities.
Managers reporting to this position have line responsibility for effective implementation of the NDQAP per approved procedures and include testing/work controls and start-up testing/scheduling.
3.1.1.2 Senior Manager for Site Support The senior management position for site support functions is responsible for effective implementation of the NDQAP associated with the development and management of training and site projects. This position also interfaces with procurement, emergency preparedness, access, fitness for duty (FFD), and medical services. Managers reporting to this position have line responsibility for effective implementation of the NDQAP per approved procedures and NRC regulations per approved procedures.
3.1.1.2.1 Senior Manager for Training The senior manager for training is responsible for training support, nuclear operations training, construction training, simulator performance, and maintenance and technical training. This senior manager is also responsible for developing and maintaining a training/retraining program for plant personnel that meets requirements for National Academy for Nuclear Training accreditation and the security plan and emergency response plans. Additionally, this position is responsible for maintaining the training simulators.
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PART II Nuclear Development Quality Assurance Manual 3.1.1.2.2 Senior Manager for Site Projects The senior manager for site projects is responsible for the development and management of site projects, providing oversight of project activities by ensuring testing/outage activities are integrated and supported, and schedules and objectives are met including severe accident management related projects.
3.1.2 Senior Manager for Unit 3 Project The senior management position for the Unit 3 project is responsible for effective implementation of the NDQAP associated with readiness of Unit 3for fuel load. This position is also responsible for oversight of Bechtel's Unit 3 construction activities. This position sets direction for construction completion of systems/areas for turnover and inspections, tests, analyses, and acceptance criteria (ITAAC) requirements for submittal. This position interfaces with initial test program (ITP), engineering, and work management for support, and is responsible for system turnovers from ITP to Operations.
A manager reporting to the senior manager for Unit 3 project has line responsibility for effective implementation of the NDQAP per approved procedures for project procurement.
3.1.2.1 Senior Manager for Procurement The senior manager for procurement is responsible for all site procurement to support construction, procurement document control, development of sources of supply including the selection of suppliers to be awarded purchase orders or contracts, and materials management activities. Managers reporting to this management position have line responsibility for effective implementation of the NDQAP per approved procedures and include management positions for site procurement, materials management, and procurement engineering. This position interfaces with the Southern Company Services senior manager for supply chain for project supplier compliance. This position also interfaces with the Senior Manager for Site Support.
While in construction, this senior manager is responsible for oversight of the receipt, storage, handling, and transport(RSH&T), maintenance, and product identification and traceability activities performed on the Vogtle 3&4 construction project. RSH&T staff is also responsible for oversight of material transport logistics from supplier shops to Vogtle 3&4 storage facilities.
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PART II Nuclear Development Quality Assurance Manual 3.1.3 Senior Manager for Unit 4 Project The senior management position for the Unit 4 project is responsible for effective implementation of the NDQAP associated with delivery of Unit 4 for fuel load and Balance of Plant, including construction completion, subcontractor completion, and construction testing. This position is also responsible for oversight of Bechtel's Unit 4 construction activities. This position sets direction for engineering, procurement, and maintenance support of Unit 4 activities, and also interfaces with ITP for support.
3.1.4 Senior Manager for Engineering The senior management position for engineering is responsible for effective implementation of the NDQAP associated with engineering to support construction and operations. In this regard, this position is responsible for the preparation of design changes and provides oversight for the creation and management of design, including calculations and design criteria. This also includes the design aspects of severe accident management. This position interfaces with the design authority to assure plant design and modifications are consistent with the design basis. As part of this responsibility, this position provides oversight of the contractor's ASME programs as it relates to owner responsibility. Other responsibilities include engineering design projects controls, resident engineering, field engineering, and scoping.
Managers reporting to the senior manager for engineering have line responsibility for effective implementation of the NDQAP per approved procedures and include management positions for design engineering and operational engineering. Additionally, a deputy position is responsible for providing support to the senior manager.
3.1.4.1 Site Operations Engineering Director The site operations engineering director is responsible for equipment reliability, engineering programs, systems engineering, site design engineering, plant modifications, configuration control, managing the receipt and shipping of nuclear fuel, oversight of the probabilistic risk assessment(PRA) program, engineering fix-it-now activities, standardization, long-term resource planning, and promoting best practices. The management position is also responsible for the SNC Quality Control(QC)Inspection program activities performed on plant equipment, systems, components, and structures in support of Vogtle 3&4.
Managers reporting to this position have line responsibility for effective implementation of the NDQAP per approved procedures and include management positions for plant support, site systems, reactor engineering, and cyber security.
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PART II Nuclear Development Quality Assurance Manual 3.1.5 Senior Manager for Testing and Turnover The senior management position for testing and turnover is responsible for effective implementation of the NDQAP associated with the initial test program (ITP) and turnover, including:
- Performance of component and pre-operational testing.
- Preparation, approval, and closure of testing-related work packages.
3.1.5.1 Senior Manager for Initial Test Program The senior management position for ITP is responsible for the effective implementation of the NDQAP related to the component and systems testing for Vogtle 3&4 activities. The managers reporting to this position have the line responsibility for the effective implementation of the NDQAP for assigned activities per approved conduct of operations and departmental procedures associated with implementation of construction activities. These management positions have the functional responsibility for work controls, test support, balance of plant, nuclear island, and digital testing related to startup and operations. These management positions are also responsible for the management of the staff, creation of procedures, and processes necessary for the testing phase.
The managers reporting to this senior manager have the line responsibility for the effective implementation of the NDQAP per approved procedures for activities associated with the following:
- Onsite component, preoperational, and support of startup testing activities.
- Coordinating turnover efforts of systems, structures, and components (SSCs)from construction to ITP.
- Initial energization and operation of plant equipment as well as functional performance tests at the component or sub-system level.
- Testing of plant systems to support the plant hot functional test program.
- API000 digital l&C systems design, delivery, and testing.
3.1.6 Senior Manager for Site Regulatory Affairs The senior management position for site regulatory affairs functions is responsible for effective implementation of the NDQAP associated with site licensing and regulatory compliance direction including the Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) program, and document control and procedures. This position interfaces with the senior manager for off-site licensing.
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PART II Nuclear Development Quality Assurance Manual The managers reporting to the management position responsible for regulatory affairs have line responsibility for effective implementation of the NDQAP per approved procedures for activities associated with the following;
- Licensing and regulatory compliance direction to onsite personnel.
- 10 CFR 21, 10 CFR 50.55(e), and safeguards reportability evaluations.
- ITAAC completion activities.
- Document control and procedures, including the development and management of the required administrative controls to ensure the successful receipt, preservation, retention, storage, final disposition of quality assurance(QA) and non-QA records and plant procedures.
- Interface between the design authority (Westinghouse), site engineering, regulatory affairs, and the NRC to manage and address key project regulatory challenges.
3.1.6.1 Senior Manager for Offsite Licensing The senior management position for offsite licensing reports to the SNC Regulatory Affairs Vice President and interfaces with the senior manager for site regulatory affairs.
This manager and staff are the primary interface with the NRC staff for all license-related activities and is responsible for ensuring compliance with the Licensing Basis of the plant. During construction, this manager will oversee and support the following corporate and site activities: Updated Final Safety Analysis Report(UFSAR) maintenance, performance of design change regulatory and environmental reviews, Office of New Reactors(NRG)interface, NRC submittals, and environmental permits.
The managers reporting to the senior manager for offsite licensing have the line responsibility for effective implementation of the NDQAP per approved conduct of operations and/or departmental procedures for activities associated with the following;
- Corporate Licensing (including Corporate Engineering function)
- New Nuclear Plant Development 3.1.7 Senior Manager for Subcontracts The senior management position for subcontracts is responsible for effective implementation of the NDQAP associated with management of scope, schedule, cost, and performance of Vogtle 3&4 site contractors to ensure execution and delivery of services and deliverables.
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PART II Nuclear Development Quality Assurance Manual 3.1.8 Senior Manager for Document Closure The senior management position for document closure is responsible for effective implementation of the NDQAP associated with oversight of the work package closure process. This position interfaces with ITP, ITAAC, maintenance, and Bechtel construction for setting priority and providing guidance on work package closures.
3.2 Senior Manager for Quality Assurance The senior management position for quality assurance(QAM)is responsible for the performance of OA organization activities that includes the development and verification of implementation of the NDQAP, evaluating compliance to the programs, and managing the QA organization's resources. The QAM reports to the senior manager for nuclear oversight and interfaces with the EVP on activities associated with the construction and start-up and operation of Vogtle 3&4.
The QAM is responsible for independently planning and performing activities to verify effective implementation of this manual including oversight of delegated QA requirements.
The QAM is sufficiently independent from other nuclear development priorities to bring fon/vard issues affecting safety and quality, and makes judgments regarding quality in all areas necessary regarding SNC's ND activities. Quality issues that are not addressed in a timely or effective manner will be directed to the appropriate level of management for resolution.
3.3 Standard Plant Organization (Operations)
At the appropriate time. Southern Nuclear will implement an operating organization consistent with the Standard Plant Organization described in the SNC Quality Assurance Topical Report(QATR).
Staffing plans are developed under the direction and guidance of the EVP and the Chief Nuclear Officer. Sufficient numbers of personnel are assigned to perform preoperational and startup testing to facilitate safe and efficient implementation of the testing program.
The onsite operating organization shall provide, as part of the normal duties of plant supervisory personnel, timely and continuing monitoring of operating activities to assist the EVP in keeping abreast of general plant conditions and to verify that the day-to-day operating activities are conducted safely and in accordance with applicable administrative controls. The onsite Operating organization shall include one or more individuals knowledgeable in the following nuclear power plant fields:
- Operation
- Mechanical
- Electrical and Electronic Systems Page 21 of 69 Version 22.0
PART II Nuclear Development Quality Assurance Manual
- Nuclear Engineering
- Chemistry and Radiochemistry
- Radiation Protection
- Quality Assurance 4.0 Operating Fleet Organization The SNC operating fleet is composed of the Joseph M. Farley Nuclear Plant Units 1&2, the Edwin I. Hatch Nuclear Plant Units 1&2 and the Vogtle Electric Generating Plant Units 1&2. The SNC operating fleet and support activities are performed to the SNC QATR, which is based on NQA-1-1994. The operating fleet organization is described in the QATR, and with the following additional information.
4.1 Vice President Nuclear Plant Site - Vogtie 1&2 The Vice President Nuclear Plant Site - Vogtle 1&2 reports to the Senior Vice President - Operations and is responsible for the safe and efficient operation of Vogtle Units 1&2, and for the implementation of quality assurance requirements in the areas specified by the SNC QATR.
For the purposes of this program, the description of the duties of the Vice President Nuclear Plant Site - Vogtle 1&2 and staff is limited to those site activities that support Nuclear Development.
Along with the Executive Vice President Vogtle 3&4, the Vice President Nuclear Plant Site - Vogtle 1&2 is responsible for controlling interfaces between the operating units and any preconstruction or construction activities.
4.2 Vice President - Regulatory Affairs The Vice President - Regulatory Affairs reports to the Executive Vice President/Chief Nuclear Officer and is responsible for the oversight of licensing and interface activities with the NRC for the fleet, including Vogtle 3&4. The Vice President -
Regulatory Affairs provides organizational support and management oversight of the plants to ensure prompt and proper disposition of regulatory issues, develops regulatory positions and advises senior management on priorities and activities affecting regulatory issues at the nuclear sites. Other responsibilities include developing policies and standardized processes and procedures for the maintenance of the licensing basis, the preparation of submittals to the NRC and other regulatory organizations, the dissemination of regulatory and operational experience information, security, access, and emergency preparedness.
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PART II Nuclear Development Quality Assurance Manual 4.3 Senior Manager for Nuclear Oversight The responsibilities of the senior manager for nuclear oversight are described in the SNC QATR. The Nuclear Development senior manager for quality assurance reports to the senior manager for nuclear oversight. The senior manager for nuclear oversight will have the authority to escalate matters directly to higher levels of management including the Executive Vice President/Chief Nuclear Officer, if needed, to ensure that nuclear safety considerations are addressed.
5.0 Southern Companv Services Southern Company Services, Inc.(SOS)is a wholly owned subsidiary of Southern Company that provides multiple support functions for the operating companies. Among the services provided are supply chain, human resources, and information technology.
5.1 Senior Manager for Supply Chain The senior manager for supply chain reports directly to the SCS Vice President -
Supply Chain Management Operations and provides matrix accountability to the Vice President - Engineering in the areas of procurement, procurement document control, development of sources of supply including the selection of suppliers to be awarded purchase orders or contracts, and materials management activities.
The Vogtle 3&4 senior manager for procurement has a matrixed reporting relationship to the SCS senior manager for supply chain for the scope of shared SNC processes and procedures. The senior manager for supply chain is responsible for supporting the Vogtle 3&4 procurement process during construction and operations, and assuring that the regulatory and business requirements for procurement are met.
5.2 Vice President - Human Resources The Vice President - Human Resources provides matrix accountability to the SNC President/CEO for matters related to communications, human resources and medical and FFD issues. The Vice President - Human Resources is responsible for ensuring the delivery of communications, human resources, and medical and FFD services to the nuclear operating company.
5.3 Senior Manager for Information Technology The senior manager for information technology reports to the SCS Vice President -
Technology and is responsible for SNC information technology (IT) activities.
This manager also provides support to Engineering or Corporate Services under this NDQAP and associated SNC procedures for software control, electronic document storage disaster prevention/recovery, and emergency planning.
This manager is also responsible for maintaining controls for SNC software applications which are not required to be maintained under the SNC program described herein.
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PART II Nuclear Development Quality Assurance Manual 6.0 Authorltv to Stop Work SNC Executive Management, Quality Assurance, and Oversight personnel have the authority, and the responsibility, to stop work in progress that is not being done in accordance with approved procedures or where safety or SSC integrity may be jeopardized.
This extends to off-site work performed by suppliers furnishing safety-related materials and services to SNC.
7.0 Qualitv Assurance Organizational Independence For the COL and construction, independence shall be maintained between the organization or organizations performing the checking (quality assurance and control) functions and the organizations performing the functions.
8.0 NQA-1-1994 Commitment In establishing its organizational structure, SNC commits to compliance with NOA 1994, Basic Requirement 1 and Supplement 1S-1.
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PART II Nuclear Development Quality Assurance Manual Figure 11.1-1 SNC Vogtle 3&4 Functional Organization Executive Vice President(EVP)
Vogtle3&4 Deputy ID EVP Testing & Turn over Document Oasure Regulatory Affairs Site Licensing :
Site Operations Engineering Units Plant Manager Site Support 1 Inidal Test Program (ITP)
ITAAC Chemistry r Maintenance I I
' Offsite Licensing I Work Management Work Management l-I Emergency Operations I Preparedness Radiation protection-Support Oreanizations SCSSupply Chain Business Operations SCS Information Technology Employee Concerns SCS Human Resources Communications NDQuality Assurance Page 25 of 69 Version 22.0l
PART II Nuclear Development Quality Assurance Manual SECTION 2 QUALITY ASSURANCE PROGRAM 1.0 General 1.1 SNC has established the necessary measures and governing procedures to implement the NDQAP as described in the NDQAM. SNC is committed to implementing the Quality Assurance Program in all aspects of work that are important to the safety of the nuclear plants as described and to the extent delineated in this NDQAM. Further, SNC 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 NDQAP through the audit functions described in Part II, Section 18.
1.2 The objective of the NDQAP is to assure that SNC's nuclear generating plants are designed, constructed and operated in accordance with governing regulations and license requirements. The program is based on the requirements of NQA-1-1994, "Quality Assurance Requirements for Nuclear Facility Applications," as further described in this document. The NDQAP applies to those quality-related activities that involve the functions of safety-related structures, systems, and components (SSCs) associated with the design (excluding Design Certification activities),
fabrication, licensing, construction, testing, and operation of new nuclear power plants and managerial and administrative controls as described in the COL Final Safety Analysis Report. Examples of COL program safety-related activities include, but are not limited to, site specific engineering related to safety-related SSCs, site geotechnical investigations, site engineering analysis, seismic analysis, and meteorological analysis. A list of systems identifying SSCs and activities to which this program applies is maintained at the appropriate facility. The Design Certification Document is used as the basis for this list. Cost and scheduling functions do not prevent proper implementation of the NDQAP.
1.3 As described in Part III, 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 NDQAM are applied to those items in a selected manner, targeted at those characteristics or critical attributes that render the SSC a significant contributor to plant safety.
1.4 Delegated responsibilities may be performed under a supplier's or principal contractor's QAPD, provided that the supplier or principle contractor has been approved as a supplier in accordance with the NDQAP. Periodic audits and assessments of supplier QA programs are performed to assure compliance with the supplier's or principle contractor's QAPD and implementing procedures.
1.5 New nuclear plant construction will be the responsibility of SNC's Nuclear Development organization. Detailed engineering specifications and construction procedures will be developed to implement the NDQAP, and Westinghouse QA programs prior to commencement of construction (CQL) activities.
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PART II Nuclear Development Quality Assurance Manual 1.6 In general, the program requirements specified herein are detailed In implementing procedures that are either SNC implementing procedures, or supplier Implementing procedures governed by a supplier quality assurance program.
1.7 A grace period of 90 days may be applied to provisions that are required to be performed on a periodic basis unless otherwise noted. Audits of facility activities shall be performed within the specified time interval with the following allowances (allowances do not apply to audits of the emergency plan and security plan):
1.7.1 Audits will be performed at required intervals for each audit area. Schedules shall be based on the month in which the audit starts.
1.7.2 A maximum extension not to exceed 25 percent of the audit Interval shall be allowed. That is to say that, for audits on a 24-month frequency, the maximum time between specific audits shall not exceed 30 months. Likewise, audits on an annual(12 month)frequency shall not be extended beyond 15 months.
1.7.3 When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.
1.7.4 For supplier related audits and evaluations, the total combined time interval for any three consecutive inspection or audit intervals should not exceed 3.25 times the specified inspection or audit interval. 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.
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PART II Nuclear Development Quality Assurance Manual 2.0 Responsibilities 2.1 Personnel who work directly or indirectly for SNC are responsible for achieving acceptable quality in the work covered by this NDQAM. This includes the activities delineated in Part I, Section 2.1.
2.2 SNC personnel performing verification activities are responsible for verifying the achievement of acceptable quality. Activities governed by the NDQAP 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.
2.3 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.
2.4 The senior manager for quality assurance is responsible to verify that processes and procedures comply with NDQAM and other applicable requirements, that such processes or procedures are implemented, and that management appropriately ensures compliance.
3.0 Delegation of Work 3.1 SNC retains and exercises the responsibility for the scope and implementation of an effective NDQAP.
3.2 Positions identified in the Organization section of this NDQAM 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.
3.3 Decisions affecting safety are made at the level appropriate for its nature and effect, and with any necessary technical advice or review.
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PART II Nuclear Development Quality Assurance Manual 4.0 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.
5.0 Periodic Review of the Quaiitv Assurance Program Management of those organizations implementing the OA program or portions thereof, 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.
6.0 issuance and Revision to Quaiitv Assurance Proaram Description 6.1 Administrative control of the NDQAM will be in accordance with 10 CFR 50.55(f) and 10 CFR 50.54(a), as appropriate. New revisions to the document will be reviewed, at a minimum, by the senior manager for quality assurance and approved by the Executive Vice President of Vogtle 3&4 and the senior manager for nuclear oversight.
6.2 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 Appendix B will be satisfied. In order to comply with this requirement, the FSAR references this NDQAM and, as a result, the requirements of 10 CFR 50.54(a) are satisfied by and apply to the NDQAM.
7.0 Personnel Qualifications 7.1 Personnel assigned to implement elements of the NDQAP shall be capable of performing their assigned tasks. To this end, SNC establishes and maintains formal indoctrination and training programs for personnel performing, verifying, or managing activities within the scope of the NDQAP to assure that suitable proficiency is achieved and maintained.
7.2 Plant and support staff minimum qualification requirements are as delineated in each site's Technical Specifications. Other qualification requirements may be established but will not reduce those required by Technical Specifications. Sufficient managerial depth is provided to cover absences of incumbents.
7.3 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 SNC procedures. Indoctrination includes the administrative and technical objectives, requirements of the applicable codes and standards, and the NDQAP elements to be employed.
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PART II Nuclear Development Quality Assurance Manual 7.4 Training for positions identified in 10 CFR 50.120 is accomplished according to programs accredited by the National Nuclear Accrediting Board of the National Academy of Nuclear Training that implement a systematic approach to training.
Records of personnel training and qualification are maintained.
7.5 The minimum qualifications of the senior manager for quality assurance are an engineering or related science degree and a minimum of four years of related experience including 2 years of nuclear power plant experience, 1 year of supervisory or management experience and one year of experience performing quality verification activities.
7.6 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.
7.7 The minimum qualifications of the individuals responsible for planning, implementing, and maintaining the programs for the NDQAP 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.
8.0 Independent Review 8.1 Activities occurring during the operational phase shall be independently reviewed on a periodic basis. The independent review program shall be functional prior to initial core loading. The independent review function performs the following:
8.1.1 Reviews proposed changes to the facility as described in the safety analysis report(SAR)through the Plant Review Board (PRB). The PRB also verifies that changes do not adversely affect safety and if a technical specification change or NRC review is required.
8.1.2 Reviews proposed tests and experiments not described in the SAR. Changes to proposed tests and experiments not described in the SAR that do require a technical specification change must be reviewed by the PRB prior to NRC submittal and implementation.
8.1.3 Reviews proposed technical specification changes and license amendments relating to nuclear safety prior to NRC submittal and implementation, except in those cases where the change is identical to a previously approved change.
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PART II Nuclear Development Quality Assurance Manual 8.1.4 Reviews violations, deviations, and reportabie events that are required to be reported to the NRC. This review includes the results of investigations and recommendations resulting from such investigations to prevent or reduce the probability of recurrence of the event.
8.1.5 Reviews any matter related to nuclear safety that is requested by executive management, or any PRB member.
8.1.6 Reviews corrective actions for significant conditions adverse to quality.
8.1.7 Reviews the adequacy of the audit program every 24 months.
8.2 In discharging its review responsibilities, the PRB keeps safety considerations paramount when opposed to cost or schedule considerations.
8.3 Additionally, a separate Safety Review Board provides for the following:
8.3.1 An independent review committee is assigned independent review responsibilities.
8.3.2 The independent review committee reports to the Executive Vice President of Vogtie 3&4.
8.3.3 The independent review committee is composed of no less than 5 persons and no more than a minority of members are from the on-site operating organization.
8.3.4 For example, at least 3 of the 5 members must be from off-site if there are 5 members on the committee. A minimum of the chairman or alternative chairman and 2 members must be present for all meetings.
8.3.5 During the period of initial operation, meetings are conducted no less frequently than once per calendar quarter. Afterwards meetings are conduced no less than twice a year.
8.3.6 Results of the meeting are documented and recorded.
8.3.7 Consultants and contractors are used for the review of complex problems beyond the expertise of the off-site/on-site independent review committee.
8.3.8 Persons on the independent review committee are qualified as follows:
8.3.8.1 Supervisor or Chairman of the Independent Review Committee
- Education: baccalaureate in engineering or related science
- Minimum experience: 6 years combined managerial and technical support 8.3.8.2 independent Review Committee members education:
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PART II Nuclear Development Quality Assurance Manual 8.3.8.2.1 Baccalaureate in engineering or related science for those independent review personnel who are required to review problems in:
nuclear power plant operations, nuclear engineering, chemistry and radiochemistry, metallurgy, nondestructive testing, instrumentation and control, radiological safety, mechanical engineering and electrical engineering.
8.3.8.2.2 High school diploma for those independent review personnel who are required to review problems in administrative control and quality assurance practices, training, and emergency plans and related procedures and equipment.
8.3.8.2.3 Minimum experience: 5 years of experience in their own area of responsibility (nuclear power plant operations, nuclear engineering, chemistry and radiochemistry, metallurgy, nondestructive testing, instrumentation and control, radiological safety, mechanical engineering, and electrical engineering, administrative control and quality assurance practices, training, and emergency plans and related procedures and equipment).
9.0 NQA-1-1994 Commitment / Exceptions In establishing qualification and training programs, SNC commits to compliance with NQA-1-1994, Basic Requirement 2 and Supplements 28-1, 28-2, 28-3, and 28-4, with the following clarifications and exceptions:
9.1 NQA-1-1994, Supplement 28-1 Supplement 28-1 will include use of the guidance provided in Appendix 2A-1 the same as if it were part of the Supplement. The following two alternatives may be applied to the implementation of this Supplement and Appendix:
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PART II Nuclear Development Quality Assurance Manual 9.1.1 In lieu of being certified as Level 1, 11, or ill in accordance with NQA-1-1994, personnel performing independent quality verification inspections, examinations, measurements, or tests of material, products, or activities will be required to possess qualifications equal to or better than those required for performing the task being verified; and the verification is within the skills of these personnel and/or is addressed by procedures. These individuals will not be responsible for the planning of quality verification inspections and tests (i.e., establishing hold points and acceptance criteria in procedures, and determining who will be responsible for performing the inspections), evaluating inspection training programs, nor certifying inspection personnel.
9.1.2 A qualified engineer may be used to plan inspections, evaluate the capabilities of an inspector, or evaluate the training program for inspectors. For the purpose of these functions, a qualified engineer is one who has a baccalaureate in engineering in a discipline related to the inspection activity (such as electrical, mechanical, civil) and has a minimum of five years engineering work experience with at least two years of this experience related to nuclear facilities.
9.2 NQA-1-1994, Supplement 28-2 In lieu of Supplement 2S-2, for qualification of nondestructive examination personnel, SNC 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 NRG for use at SNC sites.
9.3 NQA-1-1994, Supplement 2S-3 The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three(3) years is replaced by the following,"The prospective lead auditor shall demonstrate his/her ability to properly implement the audit process, as implemented by SNC,to effectively lead an audit team, and to effectively organize and report results, including participation in at least one nuclear audit within the year preceding the date of qualification."
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PART II Nuclear Development Quality Assurance Manual SECTION 3 DESIGN CONTROL 1.0 General 1.1 SNC 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 this NDQAM.
1.2 The design process includes provisions to control design inputs, outputs, changes, interfaces, records, and organizational interfaces within SNC 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 can be related to the design input in sufficient detail to permit verification.
1.3 Design change processes and the division of responsibilities for design-related activities are detailed in SNC and supplier procedures. 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 SNC design organization or by other organizations so authorized by SNC.
1.4 Design documents are reviewed by individuals knowledgeable in OA to ensure the documents contain the necessary OA requirements.
2.0 Design Verification 2.1 SNC design processes provide for design verification to ensure that items and activities subject to the provisions of this NDQAM 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.
2.2 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.
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PART II Nuclear Development Quality Assurance Manual 2.3 The extent of the design verification required is a function of the importance to safety of the item 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 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 item's intended use.
2.4 SNC 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 safety function.
3.0 Design Records 3.1 SNC 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.
3.2 Plant design drawings reflect the properly reviewed and approved configuration of the plant.
4.0 Computer Application and Digital Eaulpment Software 4.1 The NDQAP governs the development, procurement, testing, maintenance, and use of computer application and digital equipment software when used in safety-related applications and designated non safety-related applications.
4.2 SNC and suppliers are responsible for developing, approving, and issuing procedures, as necessary, to control the use of such computer application and digital equipment software. The procedures require that the application software be assigned a proper quality classification and that the associated quality requirements be consistent with this classification.
4.3 Each application software and revision there to is documented and approved by designated SNC and supplier management and listed in a software register for identifying active quality related applications. This NDQAP is also applicable to the administrative functions associated with the maintenance and security of computer hardware where such functions are considered essential in order to comply with other NDQAP requirements such as QA records.
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PART II Nuclear Development Quality Assurance Manual 5.0 Setpoint Control Instrument and equipment setpolnts that could affect nuclear safety shall be controlled In accordance with written Instructions. As a minimum, these written Instructions shall; 5.1 Identify responsibilities and processes for reviewing, approving, and revising setpolnts and setpoint changes originally supplied by the Design Certification holder, the A/E, and the plant's technical staff.
5.2 Ensure that setpolnts and setpoint changes are consistent with design and accident analysis requirements and assumptions.
5.3 Provide for documentation of setpolnts. Including those determined operationally.
5.4 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.
6.0 NQA-1-1994 Commitment In establishing Its program for design control and verification, SNC commits to compliance with NQA-1-1994, Basic Requirement 3, and Supplement 38-1, the subsurface Investigations requirements contained In Subpart 2.20 and the standards for computer software contained In Subpart 2.7.
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PART II Nuclear Development Quality Assurance Manual SECTION 4 PROCUREMENT DOCUMENT CONTROL 1.0 General 1.1 SNC has established the necessary measures and governing procedures to assure that purchased items and services are subject to appropriate quality and technical requirements. 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:
1.1.1 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, interchangeabillty, safety, fit and function, as applicable, are not adversely affected or contrary to applicable regulatory requirements.
1.1.2 Applicable technical, regulatory, administrative, quality and reporting requirements(such as specifications, codes, standards, tests, inspections, special processes, 10 CFR 21, and 10 CFR 50.55(e)) 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.
1.1.3 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 OA 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 SNC's approved OA program).
1.2 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.
2.0 NQA-1-1994 Commitment / Exceptions In establishing controls for procurement, SNC commits to compliance with NQA-1-1994, Basic Requirement 4 and Supplement 4S-1, with the following clarifications and exceptions:
NQA-1-1994, Supplement 4S-1
- Section 2.3 of this Supplement 4S-1 includes a requirement that procurement documents require suppliers to have a documented QAP that implements NQA 1994, Part 1. In lieu of this requirement, SNC may require suppliers to have a documented supplier QAP that is determined to meet the applicable requirements of 10 CFR 50, Appendix B, as appropriate to the circumstances of the procurement.
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PART II Nuclear Development Quality Assurance Manual With regard to service performed by a supplier, SNC procurement documents may allow the supplier to work under the SNC QAP, including implementing procedures, in lieu of the supplier having its own QAP.
Section 3 of this supplement 4S-1 requires procurement documents to be reviewed prior to bid or award of contract. The quality assurance review of procurement documents is satisfied through review of the applicable procurement specification, including the technical and quality procurement requirements, prior to bid or award of contract. Procurement document changes will also receive the quality assurance review; e.g., scope, technical, or quality requirements.
Procurement documents for Commercial Grade Items that will be procured by SNC for use as safety-related items shall contain technical and quality requirements such that the procured item can be appropriately dedicated.
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PART II Nuclear Development Quality Assurance Manual SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 1.0 General SNC 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 NDQAM as described in the NDQAM. Such documents are prepared and controlled according to Part II, Section 6. In addition, means are provided for dissemination to the staff of 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.
2.0 Procedure Adherence 2.1 The SNC policy is that procedures are followed, and the requirements for use of procedures have been established in administrative procedures.
2.2 Where procedures cannot be followed as written, provisions are established for making changes in accordance with Part II, Section 6.
2.3 Requirements are established to identify the manner in which procedures are to be implemented, including identification of those tasks that require:
2.3.1 The written procedure to be present and followed step-by-step while the task is being performed; 2.3.2 The user to have committed the procedure steps to memory; and 2.3.3 Verification of completion of significant steps, by initials or signatures or use of check-off lists.
2.4 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.
2.5 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.
3.0 Procedure Content The established measures address the applicable content of procedures as described in the introduction to Part II of NQA-1-1994. In addition, procedures governing tests, inspections, operational activities, and maintenance will include, as applicable, initial conditions and prerequisites for the performance of the activity.
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PART II Nuclear Development Quality Assurance Manual 4.0 NQA-1-1994 Commitment In establishing procedural controls, SNC commits to compliance with NQA-1-1994, Basic Requirement 5.
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PART II Nuclear Development Quality Assurance Manual SECTION 6 DOCUMENT CONTROL 1.0 General 1.1 SNC has established the necessary measures and governing procedures to control the preparation of, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality, including organizational interfaces, are controlled to assure that correct documents are being employed. The control systems, including electronic systems used to make documents available, are documented and provide for the following:
1.1.1 identification of documents to be controlled and their specified distribution; 1.1.2 a method to identify the correct document(including revision) to be used and control of superseded documents; 1.1.3 identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents; 1.1.4 review of documents for adequacy, completeness, and correctness prior to approval and issuance; 1.1.5 a method for providing feedback from users to continually improve procedures and work instructions; and, 1.1.6 coordinating and controlling interface documents and procedures.
1.2 The types of documents to be controlled include:
1.2.1 drawings such as design, construction, installation, and as-built drawings; 1.2.2 engineering calculations; 1.2.3 design specifications; 1.2.4 purchase orders and related documents; 1.2.5 vendor-supplied documents; 1.2.6 audit, surveillance, and quality verification/inspection procedures; 1.2.7 inspection and test reports; 1.2.8 instructions and procedures for activities covered by this NDQAM including design, construction, installation, operating (including normal and emergency operations), maintenance, calibration, and routine testing; 1.2.9 technical specifications; and, 1.2.10 nonconformance reports and corrective action reports.
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PART II Nuclear Development Quality Assurance Manual 1.3 During the operational phase, where temporary procedures are used, they shall include a designation of the period of time during which it is acceptable to use them.
2.0 Review and Approval of Documents 2.1 Documents shall be reviewed for adequacy by qualified persons other than the preparer. During the construction phase, procedures for design, construction, and installation are also reviewed by the organization responsible for quality verification to ensure quality assurance measures have been appropriately applied. The documented review signifies concurrence.
2.2 During the operations phase, documents affecting the configuration or operation of the station as described in the SAR are screened to identify those that require review by the PRB prior to implementation as described in Part II, Section 2.
2.3 To ensure effective and accurate procedures during the operational phase, applicable procedures are reviewed, and updated as necessary, based on the following conditions:
2.3.1 following any modification to a system; 2.3.2 following an unusual incident, such as an accident, significant operator error, or equipment malfunction; 2.3.3 when procedure discrepancies are found; 2.3.4 prior to use if not used in the previous two years; or 2.3.5 results of OA audits that are conducted in accordance with Part II, Section 18.1.
2.4 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.
3.0 Changes to Documents 3.1 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.
3.2 The reviewing organization has access to pertinent background data or information upon which to base their approval.
3.3 Where temporary procedure changes are necessary during the operations phase, changes that clearly do not change the intent of the approved procedure may be implemented provided they are approved by two members of the staff knowledgeable in the areas affected by the procedures.
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PART II Nuclear Development Quality Assurance Manual 3.4 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.
3.5 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.
4.0 NQA-1-1994 Commitment In establishing provisions for document control, SNC commits to compliance with NQA 1994, Basic Requirement6 and Supplement 68-1.
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PART II Nuclear Development Quality Assurance Manual SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 1.0 General SNC has established the necessary measures and governing procedures to control the procurement of 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.
2.0 Acceptance of Item or Service 2.1 SNC 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's or service's importance to safety, complexity, quantity and the frequency of procurement. Verification actions include testing, as appropriate, 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.
2.2 Measures to assure the quality of purchased items and services include the following, as applicable:
2.2.1 Items are inspected, identified, and stored to protect against damage, deterioration, or misuse.
2.2.2 Prospective suppliers of safety-related items and services are evaluated to assure that only qualified suppliers are used. Qualified suppliers are audited on a triennial basis. In addition, if a subsequent contract or a contract modification significantly enlarges the scope of or changes the methods or controls for activities performed by the same supplier, an audit of the modified requirements is conducted, thus starting a new triennial period. SNC may utilize audits conducted by outside organizations for supplier qualification provided that the scope and adequacy of the audits meet SNC requirements. Documented evaluations are performed for qualified suppliers to assure they continue to provide acceptable products and services. Industry programs, such as those applied by ASME, Nuclear Procurement Issues Committee (NUPIC), 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 supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
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PART II Nuclear Development Quality Assurance Manual 2.2.3 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 (inciuding Certified Materiai Test Report/Certificate). Acceptance actions/documents shouid be estabiished by the Purchaser with appropriate input from the Supplier and be completed to ensure that procurement, inspection, and test requirements, as applicable, have been satisfied before relying on the item to perform its intended safety function.
2.2.4 Controls are imposed for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and acceptance of commercial-grade services or items to assure they will perform satisfactorily in service in safety-related applications.
2.2.5 If there is insufficient evidence of implementation of a OA program, the initial evaluation is of the existence of a OA 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 OA program.
3.0 NQA-1-1994 Commitment / Exceptions 3.1 in establishing procurement verification controls, SNC commits to compliance with NQA-1-1994, Basic Requirement 7 and Supplement 78-1, with the following clarifications and exceptions; 3.1.1 NQA-1-1994, Supplement 7S-1 3.1.1.1 SNC considers that other 10 CFR 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 SNC plants are not required to be evaluated or audited.
3.1.1.2 When purchasing commercial grade calibration services from a calibration or test laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met:
3.1.1.2.1 A documented review of the supplier's accreditation is performed and includes a verification of the following:
- The calibration or test laboratory holds accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement(MRA). The accreditation encompasses ISO/IEC-17025:2017,"General Requirements for the Competence of Testing and Calibration Laboratories."
- For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
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PART II Nuclear Development Quality Assurance Manual
- For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.
- The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected Accreditation Body(AB)within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.
3.1.1.2.2 The purchase documents require that:
- The service must be provided in accordance with their accredited iSO/IEC-l7025:2017 program and scope of accreditation.
- As found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-toierance. (for calibration services only)
- The equipment/standards used to perform the calibration must be identified in the certificate of calibration, (for calibration services only)
- Subcontracting of these accredited services is prohibited.
- The customer must be notified of any condition that adversely impacts the laboratory's ability to maintain the scope of accreditation.
- 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 AB within the past 48 months.
- Any additional technical and quality requirements, as necessary, 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.
3.1.1.2.3 It is validated, at receipt inspection, that the laboratory's documentation certifies that:
- 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, and
- The purchase order's requirements are met.
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PART II Nuclear Development Quality Assurance Manual 3.1.1.2.4 There are specific personnel qualification and certification requirements for personnel performing safety-related non destructive evaluation (NDE)activities for the nuclear industry that are not addressed by the I LAC accreditation process. Therefore, the ILAC accreditation process cannot be used as part of the commercial-grade dedication process of NDE services in lieu of performing procurement source evaluation and selection.
3.1.1.3 For Section 8.1, SMC considers documents that may be stored in approved electronic media under SNC or vendor control and not physically located on the plant site but which are accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site. Documents needed for construction will be accessible to SNC during construction. Following completion of the construction period, sufficient as-built documentation will be turned over from the architect engineer to SNC to support operations. The SNC records management system will provide for timely retrieval of necessary records.
In lieu of the Requirements of 7S-1, section 10, Commercial Grade Items, controls for commercial grade items and services are established in SNC documents using 10 CFR 21 and the guidance of EPRI NP-5652 as discussed in Generic Letter 89-02 and Generic Letter 91-05.
3.1.1.4.1 For commercial grade items, special quality verification requirements are established and described in SNC documents to provide the necessary assurance an item will perform satisfactorily in service. The SNC 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.
3.1.1.4.2 SNC will also use other appropriate approved regulatory means and controls to support SNC commercial grade dedication activities.
SNC will assume 10 CFR 21 reporting responsibility for all items that SNC dedicates as safety-related.
3.1.1.5 Pandemic or Exigent Conditions 3.1.1.5.1 Within Requirement 7S-1, the terms "direct evaluation" and "audit" may be satisfied using remote assessment techniques in pandemic or exigent conditions.
3.1.1.5.2 In the case of pandemic or exigent conditions, SNC has adopted EPRI Technical Report 3002020796,"Remote Assessment Techniques: Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions," April 2021.
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PART II Nuclear Development Quality Assurance Manual SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 1.0 General 1.1 SNC has established the necessary measures and governing procedures to identify and control items to prevent the use of incorrect or defective items.
1.2 This includes controls for consumable materials and items with limited shelf life to preclude use of items whose shelf life has expired.
1.3 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.
2.0 NQA-1-1994 Commitment In establishing provisions for identification and control of items, SNC commits to compliance with NQA-1-1994, Basic Requirement 8 and Supplement 8S-1.
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PART II Nuclear Development Quality Assurance Manual SECTION 9 CONTROL OF SPECIAL PROCESSES 1.0 General 1.1 SNC 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.
1.2 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.
1.3 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.
2.0 NQA-1-1994 Commitment In establishing measures for the control of special processes, SNC commits to compliance with NQA-1-1994, Basic Requirement 9 and Supplement 9S-1.
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PART II Nuclear Development Quality Assurance Manual SECTION 10 INSPECTION 1.0 General 1.1 SNC 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.
1.2 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, and operations activities.
1.3 Inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work. Inspection results shall be documented.
2.0 Inspection Program 2.1 The inspection program establishes inspections (including surveillance of processes), as necessary to verify quality:(1) at the source of supplied items or services,(2) in-process during fabrication at a Supplier's facility or at a Company facility,(3)for final acceptance of fabricated and/or installed items during construction,(4) upon receipt of items for a facility, as well as(5) during maintenance, modification, in-service, and operating activities.
2.2 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.
2.3 Inspection program documents establish requirements for performing the planned inspections, and documenting required inspection information such as: reject acceptance, and re-inspection results; and the person performing the inspection.
2.4 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.
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PART II Nuclear Development Quality Assurance Manual 3.0 Inspector Qualification SNC has estabiished 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.
4.0 NQA-1-1994 Commitment I Exceptions 4.1 In establishing inspection requirements, SNC commits to compliance with NQA 1994, Basic Requirement 10, Supplement 10S-1 and Subpart 2.4, with the following clarification. In addition, SNC commits to compliance with the requirements of Subparts 2.5 and 2.8 for establishing appropriate inspection requirements.
4.1.1 Subpart 2.4 commits SNC to IEEE 336-1985. IEEE 336-1985 refers to IEEE 498-1985. Both IEEE 336 -1985 and IEEE 498-1985 use the definition of "Safety Systems"from IEEE 603-1980. SNC commits to the definition of Safety Systems in IEEE 603-1980, but does not commit to the balance of that standard.
This definition is only applicable to equipment in the context of Subpart 2.4.
4.1.2 An additional exception to Subpart 2.4 is contained in Part II, Section 12.
4.1.3 Where inspections at the operating facility are performed by persons within the same organization (e.g.. Maintenance group), SNC takes exception to the requirements of NQA-1-1994, Supplement 10S-1, Section 3.1. The inspectors report to the engineering organization responsible for quality control while performing those inspections.
4.1.4 For structures with design based on American Concrete Institute (ACI)-349, the testing and inspection requirements of ACI-349, as identified and supplemented in Updated Final Safety Analysis Report Section 3.8, may be applied in lieu of NQA-1-1994 Subpart 2.5, paragraph 7.13.
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PART II Nuclear Development Quality Assurance Manual SECTION 11 TEST CONTROL 1.0 General 1.1 SNC has established the necessary measures and governing procedures to demonstrate that items subject to the provisions of this NDQAM 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.
1.2 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, in-service tests, and operational tests (such as surveillance tests required by Plant Technical Specifications), 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.
1.3 Tests are performed according to applicable procedures that include, consistent with the effect on safety; 1.3.1 instructions and prerequisites to perform the test; 1.3.2 use of proper test equipment; 1.3.3 acceptance criteria; and 1.3.4 mandatory verification points as necessary to confirm satisfactory test completion.
1.4 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, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.
1.5 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 preoperational and initial start-up test programs.
1.6 Tests are performed and results documented in accordance with applicable technical and regulatory requirements including those described in the Technical Specifications and SAR. Test programs ensure appropriate retention of test data in accordance with the records requirements of this NDQAM. Personnel that perform or evaluate tests are qualified in accordance with the requirements established in Part II, Section 2.
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PART II Nuclear Development Quality Assurance Manual 2.0 NQA-1-1994 Commitment In establishing provisions for testing, SNC commits to compliance with NQA-1-1994, Basic Requirement 11 and Supplement 118-1.
3.0 NQA-1-1994 Commitment for Computer Program Testing SNC 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 SNC commits to compliance with the requirements of NQA-1-1994, Supplement 11S-2 and Subpart 2.7 to establish the appropriate provisions.
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PART II Nuclear Development Quality Assurance Manual SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT 1.0 General SNC has established the necessary measures and governing procedures to control the calibration, maintenance, and use of measuring and test equipment(M&TE)that provides 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 shall be controlled as described in Part II, Section 7.
2.0 Installed Instrument and Control Devices For the operations phase of the facilities, SNC 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.
3.0 NQA-1-1994 Commitment/ Exceptions 3.1 In establishing provisions for control of measuring and test equipment, SNC commits to compliance with NQA-1-1994, Basic Requirement 12 and Supplement 12S-1 with the following clarification and exception:
3.1.1 The out of calibration conditions described in paragraph 3.2 of Supplement 12S-1 refers to when the M&TE is found out of the required accuracy limits during calibration: i e-, out of tolerance.
3.1.2 Measuring and test equipment are not required to be marked with the calibration status where it is impossible or impractical due to equipment size or configuration (such as the label will interfere with operation of the device) provided the required information is maintained in suitable documentation traceable to the device. This exception also applies to the calibration labeling requirement stated in NQA-1-1994, Subpart 2.4, Section 7.2.1 (ANSI/IEEE Std. 336-1985).
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PART II Nuclear Development Quality Assurance Manual SECTION 13 HANDLING,STORAGE,AND SHIPPING 1.0 General 1.1 SNC 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.
1.2 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.
1.3 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.
1.4 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.
1.5 Special handling tools and equipment shall be used and controlled as necessary to ensure safe and adequate handling. Special handling tools and equipment shall be inspected and tested at specified time intervals and in accordance with procedures to verify that the tools and equipment are adequately maintained.
1.6 Operators of special handling and lifting equipment shall be experienced or trained in the use of the equipment. SNC establishes and implements controls 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, SNC complies with applicable hoisting, rigging and transportation regulations and codes.
2.0 Housekeeping 2.1 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 cleanness of facilities and materials, fire prevention and protection, disposal of combustible material and debris, control of access to work areas, protection of equipment, radioactive contamination control, and storage of solid radioactive waste.
2.2 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, cleaning of control consoles, and radioactive decontamination are developed and used.
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PART II Nuclear Development Quality Assurance Manual 3.0 NQA-1-1994 Commitment / Exceptions 3.1 In establishing provisions for handling, storage and shipping, SNC commits to compliance with NQA-1-1994, Basic Requirement 13 and Supplement 138-1. SNC also commits, during the construction and pre-operational phase of the plant, to compliance with the requirements of NQA-1-1994, Subpart 2.1, Subpart 2.2 and Subpart 3.2, Appendix 2.1, with the following clarifications and exceptions; 3.1.1 NQA-1-1994, Subpart2.2 3.1.1.1 Subpart 2.2, section 6.6,"Storage Records:" This section requires written records be prepared containing information on personnel access. As an alternative to this requirement, SNC 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.
3.1.1.2 Subpart 2.2, section 7.1 refers to Subpart 2.15 for requirements related to handling of items. The scope of Subpart 2.15 includes hoisting, rigging and transporting of items for nuclear power plants during construction.
3.1.2 NQA-1-1994, Subpart 3.2 Subpart 3.2, Appendix 2.1: Only Section 3 precautions are being committed to in accordance with Regulatory Guide 1.37. In addition, a suitable chloride stress-cracking inhibitor should be added to the fresh water used to flush systems containing austenitic stainless steels.
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PART II Nuclear Development Quality Assurance Manual SECTION 14 INSPECTION, TEST, AND OPERATING STATUS 1.0 General 1.1 SNC 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 this NDQAM in order to maintain personnel and reactor safety and avoid inadvertent operation of equipment.
1.2 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.
1.3 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.
1.4 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.
2.0 NQA-1-1994 Commitment In establishing measures for control of inspection, test, and operating status, SNC commits to compliance with NQA-1-1994, Basic Requirement 14.
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PART II Nuclear Development Quality Assurance Manual SECTION 15 NONCONFORMING MATERIALS,PARTS,OR COMPONENTS 1.0 General 1.1 SNC 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.
1.2 Controls provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations.
1.3 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.
1.4 Conditional release of nonconforming items for installation requires the approval of the designated management. Non-conformances are corrected or resolved prior to depending on the item to perform its intended safety function.
1.5 Non-conformances 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.
1.6 Non-conformances to design requirements dispositioned repair or use-as-is are subject to design control measures commensurate with those applied to the original design.
1.7 Nonconformance dispositions are reviewed for adequacy, analysis of quality trends, and reports provided to the designated management.
1.8 Significant trends are reported to management in accordance with SNC procedures, regulatory requirements, and industry standards.
2.0 Reporting Program SNC has appropriate interfaces between the NDQAP for identification and control of nonconforming materials, parts, or components and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55(e) and/or 10 CFR 21 during COL and construction and 10 CFR 21 during operations.
3.0 NQA-1-1994 Commitment In establishing measures for nonconforming materials, parts, or components, SNC commits to compliance with NQA-1-1994, Basic Requirement 15, and Supplement 15S-1.
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PART II Nuclear Development Quality Assurance Manual SECTION 16 CORRECTIVE ACTION 1.0 General 1.1 SNC has established the necessary measures and governing procedures to promptly identify, control, document, classify and correct conditions adverse to quality.
1.2 SNC 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.
1.3 SNC procedures require personnel to identify known conditions adverse to quality.
1.4 When complex issues arise where it cannot be readily determined if a condition adverse to quality exists, SNC documents establish the requirements for documentation and timely evaluation of the issue.
1.5 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.
1.6 In the case of a significant condition adverse to quality, the cause is determined and actions to preclude recurrence are taken.
1.7 In the case of suppliers working on safety-related activities, or other similar situations, SNC may delegate specific responsibilities for corrective actions but SNC maintains responsibility for the effectiveness of corrective action measures.
2.0 Interface with the Reporting Program SNC has appropriate interfaces between the NDQAP for corrective actions and the non-QA Reporting Program to satisfy the requirements of 10 CFR 52, 10 CFR 50.55(e) and 10 CFR Part 21 during COL design and construction, and 10 CFR 21 during operations.
3.0 NQA-1-1994 Commitment In establishing provisions for corrective action, SNC commits to compliance with NQA 1994, Basic Requirement 16.
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PART II Nuclear Development Quality Assurance Manual SECTION 17 QUALITY ASSURANCE RECORDS 1.0 General SNC shall establish 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 SNC and include requirements for records administration, including receipt, preservation, retention, storage, safekeeping, retrieval, access controls, user privileges, and final disposition. For activities governed by 10 CFR 71, these provisions address the specific requirements of Section 71.135.
2.0 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, startup, operations, maintenance, modification, decommissioning, and audits and their retention times are defined in appropriate procedures. The records and retention times are based on Regulatory Position C.2 and Table 1, of Regulatory Guide 1.28, Revision 3 for design, construction, and initial start-up. Retention times for operations phase records are based on construction records that are similar in nature. In addition, SNC uses 10 CFR 71.135 to establish the types of records that will be created and retained in support of transportation operations governed by 10 CFR 71. In all cases where state, local, or other agencies have more restrictive requirements for record retention, those requirements will be met.
3.0 Electronic Records When using optical disks for electronic records storage and retrieval systems, SNC complies with NRC guidance Generic Letter 88-18,"Plant Record Storage on Optical Disks." SNC will manage the storage of QA Records in electronic media consistent with the intent of RIS 2000-18 and associated NIRMA Guidelines TG 11-1998, TG15-1998, TG16-1998, and TG21-1998. Periodic inspections of systems, software applications, and media are performed to ensure the retrievability, integrity and retention period of electronic records.
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PART II Nuclear Development Quality Assurance Manual 4.1 NQA-1-1994, Supplement 178-1 Supplement 17S-1, section 4.2(b) requires records to be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets or on shelving in containers. For hard-copy records maintained by SNC,the records are suitably stored in steel file cabinets or on shelving in containers, except that methods other than binders, folders, or envelopes may be used to organize the records for storage.
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PART II Nuclear Development Quality Assurance Manual SECTION 18 AUDITS 1.0 General SNC has established the necessary measures and governing procedures to implement audits to verify that activities covered by this NDQAM are performed in conformance with the requirements established. The audit programs are themselves reviewed for effectiveness as a part of the overall audit process.
2.0 Performance of Audits 2.1 Internal audits of selected aspects of licensing, design, construction phase and operating activities are performed with a frequency commensurate with safety significance and in a manner which assures that audits of safety-related activities are completed. During the early portions of Nuclear Development activities, audits will focus on areas including, but not limited to, site investigation, procurement, and corrective action. Functional areas of an organization's OA program for auditing include at a minimum verification of compliance and effectiveness of implementation of internal rules, procedures f^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 operating staff, corrective actions, and observation of performance of operating, refueling, maintenance and modification activities, including associated record keeping.
2.2 The audits are scheduled on a formal preplanned audit schedule. The audit system is reviewed periodically and revised as necessary to assure coverage commensurate with current and planned activities. Additional audits may be performed as deemed necessary by management. 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 senior manager for quality assurance.
2.3 SNC 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 NDQAM. External audits determine the adequacy of supplier and contractor quality assurance program. Audits conducted by the SNC Nuclear Oversight group to satisfy the operating fleet's Quality Assurance Topical Report(QATR)are conducted at frequencies defined in Section 18.1 of the QATR. Where applicable.
Nuclear Development Quality Assurance personnel participate and Nuclear Development may take credit for such audits to satisfy the requirements of the NDQAM.
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PART II Nuclear Development Quality Assurance Manual 2.4 The results of each audit are reported in writing to the applicable manager of the area or program being audited. The Executive Vice President of Vogtie 3&4 and the senior manager for nuclear oversight will be copied on the report. Additional internal distribution is made to other concerned management levels in accordance with approved procedures.
2.5 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 of assigned corrective action.
2.6 Audits of suppliers of safety-related components and/or services are conducted as described in Part II, Section 7.
3.0 Internal Audits 3.1 Internal audits of organization and facility activities new or unique to construction, 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.
3.2 Audits of Fleet organizations established prior to new construction will be conducted at the frequency indicated in the SNC QATR. Nuclear Development will evaluate the results of the audits of Fleet organizations performed by the SNC Fleet quality organization and take credit for those with satisfactory results. NDQA will perform more frequent audits of Fleet organizations if their performance degrades significantly or if requested by management.
3.3 Internal audits include verification of compliance and effectiveness of the administrative controls established for implementing the requirements of this NDQAM; regulations and license provisions; provisions for training, retraining, qualification, and performance of personnel performing activities covered by this NDQAM; corrective actions taken following abnormal occurrences; and, observation of the performance of construction, fabrication, operating, refueling, maintenance and modification activities including associated record keeping.
4.0 NQA-1-1994 Commitment In establishing the independent audit program, SNC commits to compliance with NQA 1994, Basic Requirement 18 and Supplement 18S-1.
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PART III Nuclear Development Quality Assurance Manual PART III NONSAFETY-RELATED SSC QUALITY CONTROL SECTION 1 Non-safety Related SSCs - Significant Contributors to Plant Safety 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 NDQAM are applied to those items in a selected manner, targeted at those characteristics or critical attributes that render the SSC a significant contributor to plant safety.
The following clarify the applicability of the OA Program to the nonsafety-related SSCs and related activities, including the identification of exceptions to the OA Program described in Part II, Sections 1 through 18 taken for non-safety-related SSCs.
1.0 Organization The verification activities described in this part may be performed by the SNC line organization. The OA organization described in Part II is not required to perform these functions.
2.0 OA Program SNC OA requirements for non-safety-related SSCs are established in the NDQAM and appropriate procedures. Suppliers of these SSCs or related services describe the quality controls applied in appropriate procedures. A new or separate OA program is not required.
3.0 Design Control SNC 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.
4.0 Procurement Document Control Procurement documents for items and services obtained by or for SNC 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.
5.0 Instructions. Procedures, and Drawings SNC 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 shall provide an appropriate degree of guidance to the personnel performing the activity to achieve acceptable functional performance of the SSC.
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PART III Nuclear Development Quality Assurance Manual 6.0 Document Control SNC 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.
7.0 Control of Purchased Items and Services SNC 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.
8.0 Identification and Control of Purchased Items SNC employs measures where necessary, to identify purchased items and preserve their functional performance capability. Storage controls take into account appropriate environmental, maintenance, or shelf life restrictions for the items.
9.0 Control of Special Processes SNC 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.
10.0 Inspection SNC 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 personnel in the line organization. Knowledgeable personnel are from the same discipline and have experience related to the work being inspected.
11.0 Test Control SNC 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.
12.0 Control of Measuring and Test Equipment(M&TE)
SNC employs measures to control M&TE use, and calibration and adjustment at specific intervals or prior to use.
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PART III Nuclear Development Quality Assurance Manual 13.0 Handling. Storage, and Shipping SNC 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.
14.0 inspection. Test, and Operating Status SNC 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.
15.0 Control of Nonconforming items SNC employs measures to identify and control items that do not conform to specified requirements to prevent their inadvertent installation or use.
16.0 Corrective Action SNC employs measures to ensure that failures, malfunctions, deficiencies, deviations, defective components, and non-conformances are properly identified, reported, and corrected.
17.0 Records SNC 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.
18.0 Audits SNC employs measures for line management to periodically review and document the adequacy of the process, including 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).
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PART Nuclear Development Quality Assurance Manual SECTION 2 Non-safety-Related SSCs Credited for Regulatory Events 1.0 General 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.
1.1 SNC 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 Operating Nuclear Power Plants" as identified in FSAR Chapter 1.
1.2 SNC implements the quality requirements for ATWS equipment in accordance with Part III, Section 1.
1.3 SNC implements the quality requirements for SBO equipment in accordance with Part III, Section 1. Regulatory Guide 1.155 is not applicable forthe AP1000 design in accordance with the certified design as shown in DCD Appendix 1 A. Regulatory Guide 1.155 relates to the availability of safety related functions supported by AC power. Since AC power is not required to support the availability of safety-related functions, the guidance is not applicable.
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PART IV Nuclear Development Quality Assurance Manual PART IV REGULATORY COMMITMENTS NRC REGULATORY GUIDES AND QUALITY ASSURANCE STANDARDS This section identifies the NRC Regulatory Guides and the other quality assurance standards which have been selected to supplement and support the SNC NDQAM. SMC complies with these standards to the extent described or referenced. Commitment to a particular Regulatory Guide or standard does not constitute a commitment to Regulatory Guides or standards that may be referenced therein.
1.0 Reoulatorv Guides 1.1 Reoulatorv Guide 1.8. Rev. 3, May 2000, Qualification and Training of Personnel for Nuclear Power Plants 1.1.1 Regulatory Guide 1.8 provides guidance that is acceptable to the NRC staff regarding qualifications and training for nuclear power plant personnel.
1.1.2 SNC identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in FSAR Chapter 1, Appendix 1A.
1.2 Reoulatorv Guide 1.26. Revision 4, March 2007- Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants 1.2.1 Regulatory Guide 1.26 defines classification of systems and components.
1.2.2 SNC identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in FSAR Chapter 1, Appendix 1A.
1.3 Reaulatorv Guide 1.28. Rev. 3, August 1985, Quality Assurance Program Requirements(Design and Construction) 1.3.1 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.
1.3.2 SNC identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in FSAR Chapter 1, Appendix 1A.
1.3.3 Within Regulatory Guide 1.28, the terms "direct evaluation" and "audit" may be satisfied using remote assessment techniques in pandemic or exigent conditions.
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PART IV Nuclear Development Quality Assurance Manual 1.4 Reoulatorv Guide 1.29. Revision 4, March 2007- Seismic Design Classification 1.4.1 Regulatory Guide 1.29 defines systems required to withstand a safe shutdown earthquake (SSE).
1.4.2 SNC identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in FSAR Chapter 1, Appendix 1A.
1.5 Reoulatorv Guide 1.33. Rev. 2, February 1978, Quality Assurance Program Requirements (Operations) 1.5.1 Regulatory Guide 1.33 describes a method acceptable to the NRC staff for complying with the Commission's regulations with regard to overall quality assurance program requirements for the operation phase of nuclear power plants.
1.5.2 SNC commits to this guidance and identifies conformance with it in FSAR Chapter 1, Appendix 1A.
1.6 Reoulatorv Guide 1.37. Revision 1, March 2007- Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants 1.6.1 Regulatory Guide 1.37 provides guidance on specifying water quality and precautions related to the use of alkaline cleaning solutions and chelating agents.
1.6.2 SNC identifies conformance and exceptions for the applicable regulatory position guidance provided in this regulatory guide in FSAR Chapter 1, Appendix 1A.
2.0 Standards
2.1 ASME NQA-1-1994 Edition - Quality Assurance Requirements for Nuclear Facility Applications SNC commits to NQA-1-1994, Parts I, II, and III as described in the foregoing sections of this document.
2.2 Nuclear Information and Records Management Association, Inc.(NIRMA)
Technical Guides(TGs)
SNC commits to NIRMA TGs as described in Part II, Section 17.
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