ML20321A110
| ML20321A110 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/2020 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| AWillis - 301.415.0479 ; SKumar | |
| Shared Package | |
| ML20321A086 | List:
|
| References | |
| NUREG-2215 | |
| Download: ML20321A110 (20) | |
Text
QUALITY ASSURANCE EVALUATION Review Objective The objective of the U.S. Nuclear Regulatory Commissions (NRCs) quality assurance (QA) review is to determine whether the applicant for a dry storage system (DSS) certificate or a specific license for a dry storage facility (DSF) has submitted a quality assurance program description (QAPD) in the applicants safety analysis report (SAR). The QAPD must demonstrate that the applicants QA program complies with the requirements of Subpart G, Quality Assurance, of Title 10 of the Code of Federal Regulations (10 CFR) Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste.
The basis for that determination is developed from an evaluation of the applicant's high-level QAPD against the 18 criteria provided in Section 15.5, Review Procedures, of this standard review plan (SRP) chapter, 10 CFR Part 72, and any associated information found in the Federal Register since the last rulemaking has been completed, as applicable. (Note: The scope of review does not include actual procedures and instructions that implement the QA program, although they may be described in the QAPD.)
The determination that the applicant's QA program is in compliance occurs during the NRC inspection activities that evaluate implementation of the QA plan. (Note: The scope of an inspection does include the actual procedures and instructions that implement the QA program.)
Applicability This chapter applies to the review of applications for specific licenses for an independent spent fuel storage installation (ISFSI) or a monitored retrievable storage installation (MRS), categorized as a DSF. It also applies to the review of applications for a certificate of compliance (CoC) of a DSS for use at a general license facility.
Areas of Review This chapter addresses the following areas of review:
- QA organization
- QA program
- design control
- procurement document control
- instructions, procedures, and drawings
- document control
- control of purchased material, equipment, and services
- identification and control of materials, parts, and components
- control of special processes
- licensee and certificate holder inspection
- test control
- control of measuring and test equipment
- handling, storage, and shipping control
- inspection, test, and operation status
- nonconforming materials, parts, or components 15-1
- corrective action
- quality assurance records
- audits Regulatory Requirements and Acceptance Criteria The NRC staff reviewer should refer to the exact language in 10 CFR Part 72, Subpart G.
The acceptance criteria in Section 15.5, below reflect the 18 quality criteria in 10 CFR Part 72, Subpart G, and describe the information to be included in the applicants QAPD. Examples of measures are provided for each criterion to assist the reviewer in determining whether the QAPD meets the applicable criterion. For each of the activities and items identified as important to safety, the applicant should identify the applicable QA programmatic elements and include, as applicable, provisions for meeting each of the quality criteria listed in Section 15.5.
Review Procedures The purpose of the QA review is to obtain reasonable assurance that the applicant has developed and described a QA program for design, fabrication, construction, testing, operations, modification, and decommissioning activities associated with structures, systems, and components (SSCs) important to safety.
It is important that the applicants QAPD and associated portions of the SAR provide sufficient detail to enable the reviewer to assess whether the applicant has committed to comply with the program and that the QA program complies with the applicable requirements in 10 CFR Part 72, Subpart G. Section 15.6, Evaluation Findings, of this SRP describes the course of action if the reviewer determines that sufficient detail does not exist in the QAPD. If the QAPD indicates a commitment to follow certain standards or codes, then the reviewer should consider the commitments as an integral part of the QA program.
An application for QA program approval may be included as a section of the applicants SAR or it may be separate from the SAR. Because some aspects of the QA program may be described in different portions of the application (the SAR or a submittal separate from the SAR), consider the entire description when evaluating the program against the acceptance criteria. Therefore, if possible, coordinate the QAPD review with other aspects of the review, as shown in Figure 15-1.
Such coordination will allow reviewers to derive a more accurate and complete assessment of the applicant's level of commitment to the overall QA program, the selection of quality criteria and quality levels, and the proposed implementation methods.
The applicant's QA program may be structured to apply QA measures and controls to all activities and items in proportion to their importance to safety, commonly referred to as a graded approach.
The QAPD should address the use of a graded approach for the application of QA by adequately assigning appropriate grading classifications and providing an associated justification. However, an applicant may instead choose to apply the highest level of QA and control to all activities and items. The QA program should identify the items and attributes that are important to safety and the degree or category, as applicable, of their importance. For application of a graded approach, the highly important-to-safety activities and items must have a high level of quality control, whereas those less important may have a lower level of quality control. If the QA program is graded, the staff should be able to conclude that the structure of the graded program is acceptable and that the highest levels of QA are applied to those SSCs that are most important to safety. In making determinations about the application of QA to those SSCs important to safety, 15-2
coordinate with the appropriate NRC project manager and associated technical staff to possibly evaluate other chapters or portions of the applicants submittal. In evaluating the QA program, the QA reviewer may also use NUREG/CR-6314, Quality Assurance Inspections for Shipping and Storage Containers, as an additional source of information in determining the programs compliance with regulatory requirements.
If the reviewer finds the QAPD submitted as part of a SAR to be acceptable, this should be documented in the safety evaluation report (SER). If the applicants QAPD was submitted before submittal of the SAR, the acceptance of the QAPD should be documented in a letter to the applicant and, if possible, appended to the SER at a later time. In either case, the documentation of the review should include the basis for acceptance as noted in Section 15.6 of this SRP.
Section 15.6 also describes the process for making any recommendations (requests for additional information process) for modifications to the application that are required before the application can be accepted.
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Chapter 1 - General Chapter 3 - Principal Chapter 11 -
Chapter 12 - Conduct of Information Design Criteria Operation Procedures Operations Evaluation Evaluation Evaluation and Systems Evaluation
- Site Description (SL)
- Classification of SSCs
- Storage Container Handling
- Organizational Structure (SL)
- DSF Description and
- Design Bases for SSCs and Storage Operations
- Preoperational Testing and Operational Features Important to Safety
- Operation Support Systems Startup Operations (SL)
- Engineering Drawings
- Design Criteria for Safety (SL)
- Normal Operations (SL)
- Contents Protection Systems
- Control Room and Control
- Maintenance Program
- Quality Assurance Program Area (SL)
- Personnel Selection, Training, (SL)
- Repair and Maintenance (SL)
- Emergency Planning (SL)
- Fire and Explosion Protection
- Physical Security and (SL) Safeguards Contingency Plans (SL)
Chapter 15 - Quality Assurance Evaluation Quality Assurance Organization Licensee and Certificate Holder Inspection Quality Assurance Program Test Control Design Control Control of Measuring and Test Equipment Procurement Control Handling, Storage, and Shipping Control Instructions, Procedures, and Drawings Inspection, Test, and Operation Status Document Control Nonconforming Materials, Parts, or Components Control of Purchased Material, Equipment, and Services Corrective Action Identification and Control of Materials, Parts, Components Quality Assurance Records Control of Special Processes Audits Chapter 4 - Structural Chapter 11 - Operation Chapter 12 - Conduct Chapter 14 -
Evaluation Procedures and of Operations Decommissioning Systems Evaluation Evaluation Evaluation (SL)
- Description of the SSCs
- Storage Container Handling
- Organizational Structure (SL)
- Proposed Decommissioning
- Design Criteria and Storage Operations
- Preoperational Testing and Plan
- Loads
- Operation Support Systems Startup (SL)
- Design Features
- Normal and Off-Normal (SL)
- Maintenance Program
- Operational Features Conditions
- Control Room and Control Area
- Normal Operations (SL)
- Accident Conditions (SL)
- Personnel Selection, Training,
- Repair and Maintenance
- Emergency Planning (SL)
- Fire and Explosion Protection
- Physical Security and (SL) Safeguards Contingency Plans (SL)
Figure 15-1 Overview of QA Evaluation 15.5.1 Quality Assurance Organization Ensure that the QAPD describes the structure, interrelationships, and areas of functional responsibility and authority for all organizational elements that will perform activities related to quality and safety. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to retain and exercise responsibility for the QA program; the assignment of responsibility for the overall QA program in no degree relieves line management of its responsibility for the achievement of quality 15-4
- measures to identify and describe the QA functions performed by the applicant's QA organization or delegated to other organizations that will provide controls to ensure implementation of the applicable elements of the QA criteria
- measures to provide clear management controls and effective lines of communication between the applicants QA organizations and suppliers to ensure proper direction of the QA program and resolution of QA-related problems
- measures to identify onsite and offsite organizational elements that will function under the purview of the QA program and the lines of responsibility
- measures to designate a position that retains overall authority and responsibility for the QA program (e.g., manager or director of QA) and independently reports to at least the same organizational level authority as the highest line manager directly responsible for performing activities affecting quality
- measures to ensure that high-level management is responsible for documenting and promulgating the applicants QA policies, goals, and objectives, and that this management level maintains a continuing involvement in QA matters; the application should also describe the lines of communication between intermediate levels of management and between high-level management and the manager (or director) of QA
- measures to provide authority and independence of the individual responsible for managing the QA program such that he or she can direct and control the organizations QA program, effectively ensure conformance to quality requirements, and remain sufficiently independent of undue influences and responsibilities of schedules and costs
- measures for individuals or groups responsible for defining and controlling the content of the QA program and related manuals to have appropriate organizational position and authority, as should the management level responsible for final review and approval
- measures describing the qualification requirements for the principal QA management positions so as to demonstrate management and technical competence commensurate with the responsibilities of these positions
- measures to ensure that conformance to established requirements will be verified by individuals or groups who do not have direct responsibility for performing the work being verified; the quality control function may be part of the line organization, provided the QA organization performs periodic surveillance to confirm sufficient independence from the individuals who performed the activities
- measures to ensure that persons and organizations performing QA functions have direct access to management levels that will ensure accomplishment of quality-affecting activities; these individuals should have sufficient authority and organizational freedom to perform their QA functions effectively and without reservation and should be able to identify quality problems; initiate, recommend, or provide solutions through designated channels; and verify implementation of solutions
- measures to ensure that designated QA individuals or organizations have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control 15-5
further processing, delivery, or installation of nonconforming material; the application should describe how stop-work requests will be initiated and completed
- measures to determine the extent of QA controls to be identified by the QA staff in combination with the line staff and to depend on the specific activity or item complexity and level of importance to safety 15.5.2 Quality Assurance Program Ensure that the QAPD provides acceptable evidence that the applicant's proposed QA program will be well documented, planned, implemented, and maintained to provide the appropriate level of control over activities and SSCs consistent with their relative importance to safety. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures used to ensure that the QA program meets applicable acceptance criteria
- measures for management to regularly assess the effectiveness of the QA program; measures for management (above and beyond the QA organization) to regularly assess the scope, status, adequacy, and compliance of the QA program to the requirements of 10 CFR Part 72; measures to provide for managements frequent appraisal of program status through reports, meetings, and audits as well as performance of a periodic assessment that is planned and documented with corrective actions identified and tracked
- measures to ensure that activities important to safety are accomplished using appropriate production and test equipment, suitable environmental conditions, applicable codes and standards, and proper work instructions
- measures used to ensure that trained, qualified personnel within the organization will be assigned to determine that functions delegated to contractors are properly accomplished
- summaries of the corporate QA policies, goals, and objectives and establishment of a meaningful channel for transmittal of these policies, goals, and objectives down through the levels of management
- measures to designate responsibilities for implementing the major activities addressed in the QA manuals
- measures to control the distribution of the QA manuals and revisions
- measures for communicating to all responsible organizations and individuals that policies, QA manuals, and procedures are mandatory requirements
- measures to provide a comprehensive listing of QA procedures, as well as a matrix of these procedures cross-referenced to each of the QA criteria, to demonstrate that the QA program will be fully implemented by documented procedures
- identification of SSCs, items, and attributes important to safety and how the QA program will control them 15-6
- measures for the applicant to review supplier documents for agreement with QA program provisions and ensure implementation of a program meeting the QA criteria
- measures for the resolution of disputes involving quality arising from a difference of opinion between QA personnel and personnel from other departments (e.g., engineering, procurement, manufacturing)
- measures for indoctrination, training, and qualification programs that fulfill the following criteria:
- instruction of personnel responsible for performing activities affecting quality as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures
- training and qualification in the principles and techniques of the activities being performed for personnel performing activities affecting quality
- maintenance of the proficiency of personnel performing quality-affecting activities by retraining, reexamining, and recertifying
- preparation and maintenance of documentation of completed training and qualification
- qualification of personnel in accordance with accepted codes and standards 15.5.3 Design Control Ensure that the QAPD describes the approach the applicant will use to define, control, and verify the design and development of the DSS or DSF. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to carry out design activities in a planned, controlled, and orderly manner
- measures to correctly translate the applicable regulatory requirements and design bases into specifications, drawings, written procedures, and instructions
- measures to describe how the applicant will specify quality standards in the design documents and control deviations and changes from these quality standards
- measures to describe how the applicant will review designs to ensure that design characteristics can be controlled, inspected, and tested and that inspection and test criteria are identified
- measures to describe how the applicant will establish both internal and external design interface controls; these controls should include review, approval, release, distribution, and revision of documents involving design interfaces with participating design organizations
- measures to describe how the applicant will properly select and perform design verification processes such as design reviews, alternative calculations, or qualification 15-7
testing; when a test program is to be used to verify the adequacy of a design, measures to describe how the applicant will use a qualification test of a prototype unit under adverse design conditions
- measures to ensure that design verifications (i.e., confirmation that the design of the SSC is suitable for its intended purpose) are completed by an individual with a level of skill at least equal to that of the original designer; measures to ensure design checking is also performed, recognizing design checking can be performed by a less experienced person (as an example, confirmation that the correct computer code has been used is part of design verification. Design checking includes confirmation of the numerical accuracy of computations and the accuracy of data input to computer codes); measures to describe how design verification will be performed by persons other than those performing design checking; measures to include how individuals or groups responsible for design verification will not include the original designer and normally not include the designers immediate supervisor
- measures to ensure that design and specification changes are subject to the same design controls and the same or equivalent approvals that were applicable to the original design
- measures to ensure the documentation of all errors and deficiencies in the design or the design process that could adversely affect SSCs, items, and attributes important to safety; measures for adequate corrective action, including root cause evaluation of significant errors and deficiencies, to preclude repetition
- measures to review the suitability of any materials, parts, and equipment for the intended application before selecting such items that are standard, commercial (off-the-shelf), or have been previously approved for a different application
- measures to provide written procedures to identify and control the authority and responsibilities of all individuals or groups responsible for design reviews and other design verification activities
- measures that include the use of valid industry standards and specifications for the selection of suitable materials, parts, equipment, and processes for SSCs important to safety 15.5.4 Procurement Document Control Ensure that documents used to procure SSCs or services include or reference applicable design bases and other requirements necessary to ensure adequate quality. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish procedures that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents
- measures to ensure that qualified personnel review and concur with the adequacy of quality requirements stated in procurement documents and ensure that the quality requirements are correctly stated, inspectable, and controllable; there are adequate 15-8
acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements
- measures to document the review and approval of procurement documents before they are released, with the documentation available for verification
- measures to ensure that procurement documents identify the applicable QA requirements that should be compiled and described in the suppliers QA program and to ensure that the applicant reviews and concurs with the supplier's QA program; if subtier suppliers are also used, measures to ensure that the suppliers QA program applies to the subtier suppliers
- measures to ensure that procurement documents contain or reference the regulatory requirements, design bases, and other technical requirements
- measures to ensure that procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval
- measures to ensure that procurement documents identify records to be retained, controlled, and maintained by the supplier and those records to be delivered to the purchaser before use or installation of the hardware
- measures to ensure that procurement documents specify the procuring agencys right of access to the suppliers facilities and records for source inspection and audit
- measures to ensure that changes and revisions to procurement documents are subject to the same or equivalent review and approval as the original documents 15.5.5 Instructions, Procedures, and Drawings Ensure that the QAPD defines the applicants proposed procedures for ensuring that activities affecting quality will be prescribed by, and performed in accordance with, documented instructions, procedures, or drawings of a type appropriate for the circumstances. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to ensure that activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or drawings
- measures to establish provisions that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings
- measures to ensure that instructions, procedures, and drawings specify the methods for complying with each of the applicable QA criteria
- measures to ensure that instructions, procedures, and drawings include quantitative acceptance criteria (such as dimensions, tolerances, and operating limits) as well as 15-9
qualitative acceptance criteria (such as workmanship samples) as verification that activities important to safety have been satisfactorily accomplished
- measures to ensure that the QA organization reviews and concurs with the procedures, drawings, and specifications related to inspection plans, tests, calibrations, and special processes, as well as any subsequent changes to these documents 15.5.6 Document Control Ensure that the QAPD defines the applicants proposed procedures for preparing, issuing, and revising documents that specify quality requirements or prescribe activities affecting quality. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- identification of all documents to be controlled under this subsection, including, as a minimum, design specifications; design and fabrication drawings; procurement documents; QA manuals; design criteria documents; fabrication, inspection, and testing instructions; and test procedures
- measures to ensure the establishment of procedures to control the review, approval, and issuance of documents, and any subsequent changes, before release to ensure that the documents are adequate and applicable quality requirements are stated
- measures to ensure the establishment of provisions to identify individuals or groups responsible for reviewing, approving, and issuing documents and subsequent revisions to the documents
- measures to ensure that document revisions receive review and approval by the same organizations that performed the original review and approval or by other qualified responsible organizations designated by the applicant
- measures to ensure that approved changes are included in instructions, procedures, drawings, and other documents before the change is implemented
- measures to ensure the control of obsolete or superseded documents to prevent inadvertent use
- measures to ensure that documents are available at the location where the activity is performed
- measures to ensure the establishment of a master list (or equivalent) to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents; measures to ensure the updating and distribution of the list to predetermined, responsible personnel to avoid the use of superseded documents 15.5.7 Control of Purchased Material, Equipment, and Services Ensure that the QAPD defines the applicants proposed procedures for controlling purchased material, equipment, and services to ensure conformance with specified requirements. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
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- measures to ensure that qualified personnel evaluate the suppliers capability to provide services and products of acceptable quality before the award of the procurement order or contract; measures to ensure that QA and engineering groups participate in the evaluation of those suppliers providing critical items and services important to safety, including a definition of the responsibilities for each participating group
- measures to ensure the evaluation of suppliers should consider establishing the following provisions (if applicable)
- the suppliers capability to comply with the elements of the QA criteria that are applicable to the type of material, equipment, or service being procured
- review of previous records and performance of suppliers that have provided similar articles or services of the type being procured
- a survey of the suppliers facilities and QA program to assess the capability to supply a product that meets applicable design, manufacturing, and quality requirements
- measures to ensure the documentation and filing of the results of supplier evaluations
- measures to ensure the planning and performance of adequate surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components in accordance with written procedures to ensure conformance to the purchase order requirements; the measures should ensure that the procedures provide the following information:
- instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation required; and those responsible for implementing these instructions
- procedures for audits and surveillance to ensure that the supplier complies with the quality requirements (surveillance should be performed for SSCs for which verification of procurement requirements cannot be determined upon receipt)
- measures to ensure that the supplier furnishes the following records to the purchaser:
- documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items
- documentation that identifies any procurement requirements that have not been met and a description of any nonconformances designated accept as is or repair
- measures to describe the proposed procedures for reviewing and accepting these documents and, as a minimum, to ensure that this review and acceptance will be undertaken by a responsible QA individual 15-11
- measures to ensure the performance of periodic audits, independent inspections, or tests to ensure the validity of the suppliers certificates of conformance
- measures to ensure the performance of a receiving inspection of supplier-furnished material, equipment, and services to ensure fulfillment of the following criteria:
- proper identification of the material, component, or equipment in a manner that corresponds with the identification on the purchasing and receiving documentation
- inspection of material, components, equipment, and acceptance records and judgment of their acceptability in accordance with predetermined inspection instructions before installation or use
- availability of inspection records or certificates of conformance attesting to the acceptance of material, components, and equipment before installation or use
- identification of the inspection status for accepted items and ensuring associated markings are attached before the accepted items are forwarded to a controlled storage area or released for installation or further work
- measures to assess the effectiveness of suppliers quality controls at intervals consistent with the importance to safety, complexity, and quantity of the SSCs procured 15.5.8 Identification and Control of Materials, Parts, and Components Ensure that the QAPD defines the applicants proposed provisions for identifying and controlling materials, parts, and components to ensure that incorrect or defective SSCs are not used. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish procedures to identify and control materials, parts, and components (including partially fabricated subassemblies)
- measures to determine identification requirements during the generation of specifications and design drawings
- measures to ensure that identification will be maintained either on the item or on records traceable to the item to preclude the use of incorrect or defective items
- measures to ensure that the identification of materials and parts for items important to safety is traceable to the appropriate documentation (such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports)
- measures to ensure that the location and method of identification do not affect the fit, function, or quality of the item being identified
- measures to verify and document the correct identification of all materials, parts, and components before releasing them for fabrication, assembly, shipping, and installation 15-12
15.5.9 Control of Special Processes Ensure that the QAPD describes the controls the applicant will establish to ensure the acceptability of special processes (such as welding, heat treatment, nondestructive testing, and chemical cleaning) and that the proposed controls are performed by qualified personnel using qualified procedures and equipment. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish procedures to control special processes (such as welding, heat treating, nondestructive testing, and cleaning) for which direct inspection is generally impossible or disadvantageous, as well as a providing listing of these special processes
- measures to qualify procedures, equipment, and personnel connected with special processes in accordance with applicable codes, standards, and specifications
- measures to ensure that qualified personnel perform special processes in accordance with written process sheets (or the equivalent) with recorded evidence of verification
- measures to establish, file, and keep current qualification records of procedures, equipment, and personnel associated with special processes 15.5.10 Licensee and Certificate Holder Inspection Ensure that the QAPD defines the applicants proposed provisions for the inspection of activities affecting quality to verify conformance with instructions, procedures, and drawings. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish, document, and conduct an inspection program that effectively verifies the conformance of quality-affecting activities with requirements in accordance with written, controlled procedures
- measures to ensure that inspection personnel are sufficiently independent from the individuals performing the activities being inspected
- measures to ensure that inspection procedures, instructions, and checklists provide the following details:
- identification of characteristics and activities to be inspected
- identification of the individuals or groups responsible for performing the inspection operation
- acceptance and rejection criteria
- a description of the method of inspection
- procedures for recording evidence of completing and verifying a manufacturing, inspection, or test operation 15-13
- identification of the recording inspector or data recorder and the results of the inspection operation
- measures to ensure the use of inspection procedures or instructions with the necessary drawings and specifications when performing inspection operations
- measures to qualify inspectors in accordance with applicable codes, standards, and company training programs and to keep inspector qualifications and certifications current
- measures to inspect modifications, repairs, and replacements in accordance with the original design and inspection requirements or acceptable alternatives
- measures to establish provisions that identify mandatory inspection hold points for witnessing by a designated inspector
- measures to identify the individuals or groups who will perform receiving and process verification inspections, demonstrating that these individuals or groups have sufficient independence and qualifications
- measures to establish provisions for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible 15.5.11 Test Control Ensure that the QAPD defines the applicants proposed provisions for tests to verify that SSCs conform to specified requirements and will perform satisfactorily in service. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish, document, and conduct a test program to demonstrate that the item will perform satisfactorily in service in accordance with written, controlled procedures
- measures to ensure that written test procedures incorporate or reference the following information:
- requirements and acceptance limits contained in applicable design and procurement documents
- instructions for performing the test
- test prerequisites
- mandatory inspection hold points
- acceptance and rejection criteria
- methods of documenting or recording test data results 15-14
- measures to ensure a qualified, responsible individual or group documents test results and evaluates their acceptability; when practicable, the measures should ensure that testing of the SSC occurs under conditions that will be present during normal and anticipated off-normal operations 15.5.12 Control of Measuring and Test Equipment Ensure that the QAPD defines the applicants proposed provisions to ensure that tools, gauges, instruments, and other measuring and testing devices are properly identified, controlled, calibrated, and adjusted at specified intervals. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to ensure that documented procedures describe the calibration technique and frequency, maintenance, and control of all measuring and test equipment (instruments, tools, gauges, fixtures, reference and transfer standards, and nondestructive test equipment) that will be used in the measurement, inspection, and monitoring of SSCs important to safety
- measures to ensure that measuring and test equipment are identified and traceable to the calibration test data
- measures to ensure the use of labels, tags, or documents for measuring and test equipment to indicate the date of the next scheduled calibration and to provide traceability to calibration test data
- measures to calibrate measuring and test instruments at specified intervals on the basis of the required accuracy, precision, purpose, degree of usage, stability characteristics, and other conditions that could affect the accuracy of the measurements
- measures to assess the validity of previous inspections when measuring and test equipment is found to be out of calibration, and measures to document the assessment and to take control of the equipment that is out of calibration
- measures to document and maintain the complete status of all items under the calibration system
- measures to ensure that reference and transfer standards are traceable to nationally recognized standards, or to document the basis for calibration where national standards do not exist 15.5.13 Handling, Storage, and Shipping Control Ensure that the QAPD defines the applicants proposed provisions to control the handling, storage, shipping, cleaning, and preservation of SSCs in accordance with work and inspection instructions to prevent damage, loss, and deterioration. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish and accomplish special handling, preservation, storage, cleaning, packaging, and shipping requirements in accordance with predetermined work and inspection instructions 15-15
- measures to control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration by environmental conditions (such as temperature or humidity) 15.5.14 Inspection, Test, and Operating Status Ensure that the QAPD defines the applicants proposed provisions to control the inspection, test, and operating status of SSCs to prevent the inadvertent use of SSCs or bypassing of inspections and tests. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to know the inspection and test status of items throughout fabrication
- measures to establish procedures to control the application and removal of inspection and welding stamps and operating status indicators (such as tags, markings, labels, and stamps)
- measures to ensure that procedures under the cognizance of the QA organization control the bypassing of required inspections, tests, and other critical operations
- measures to specify the organization responsible for documenting the status of nonconforming, inoperative, or malfunctioning SSCs and for identifying the item to prevent inadvertent use 15.5.15 Nonconforming Materials, Parts, or Components Ensure that the QAPD defines the applicants proposed provisions to control the use or disposition of nonconforming materials, parts, or components. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to establish procedures to control the identification, documentation, tracking, segregation, review, disposition, and notification of affected organizations regarding nonconforming materials, parts, components, services, or activities
- measures to provide for adequate documentation to identify nonconforming items and describe the nonconformance, its disposition, and the related inspection requirements; such measures should also provide for adequate documentation and include signature approval of the disposition
- measures to establish provisions to identify those individuals or groups with the responsibility and authority for the disposition and closeout of nonconformance
- measures to ensure that nonconforming items are segregated from acceptable items and identified as discrepant until properly dispositioned and closed out
- measures to verify the acceptability of reworked or repaired materials, parts, and SSCs by reinspecting and retesting the item as originally inspected and tested or by using a method that is at least equal to the original inspection and testing method; the measures should provide for documentation of the relevant inspection, testing, rework, and repair procedures 15-16
- measures to ensure that nonconformance reports designated accept as is or repair are made part of the inspection records and forwarded with the hardware to the customer for review and assessment
- measures to periodically analyze nonconformance reports to show quality trends and help identify root causes of nonconformance. Significant results should be reported to responsible management for review and assessment 15.5.16 Corrective Action Ensure that the QAPD defines the applicants proposed provisions to ensure that conditions adverse to quality are promptly identified and corrected, and that measures are taken to preclude recurrence. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to evaluate conditions adverse to quality (such as nonconformance, failures, malfunctions, deficiencies, deviations, and defective material and equipment) in accordance with established procedures to assess the need for corrective action
- measures to initiate corrective action to preclude the recurrence of a condition identified as adverse to quality
- measures to conduct follow-up activities to verify proper implementation of corrective actions and close out the corrective action documentation in a timely manner
- measures to document significant conditions adverse to quality, as well as the root causes of the conditions, and the corrective actions taken to remedy and preclude recurrence of the conditions; this information should be reported to cognizant levels of management for review and assessment 15.5.17 Quality Assurance Records Ensure that the QAPD in the SAR defines the applicants proposed provisions for identifying, retaining, retrieving, and maintaining records that document evidence of the control of quality for activities and SSCs important to safety. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to define the scope of the records program such that sufficient records will be maintained to provide documentary evidence of the quality of items and activities affecting quality; to minimize the retention of unnecessary records, the records program should list records to be retained by type of data rather than by record title
- measures to ensure that QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports, design review and peer review reports, nonconformance reports, and corrective action reports
- measures to ensure that records are identified and retrievable 15-17
- Measures to ensure that requirements and responsibilities for record creation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents
- measures to ensure that inspection and test records contain the following information, where applicable:
- a description of the type of observation
- the date and results of the inspection or test
- information related to conditions adverse to quality
- identification of the inspector or data recorder
- evidence as to the acceptability of the results
- action taken to resolve any noted discrepancies
- Measures to ensure that record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flood, theft, and deterioration by environmental conditions (such as temperature or humidity); measures to ensure that the facilities are maintained by, or under the control of, the licensee throughout the life of the DSS or DSF or the individual product 15.5.18 Audits Ensure that the QAPD defines the applicants proposed provisions for planning and scheduling audits to verify compliance with all aspects of the QA program and to determine the effectiveness of the overall program. The following are examples of areas and items that may be addressed to support implementation of the quality criteria:
- measures to perform audits in accordance with written procedures or checklists such that qualified personnel tasked with performing these audits do not have direct responsibility for the achievement of quality in the areas being audited
- measures to ensure that audit results are documented and reviewed by management with responsibility in the area audited
- measures to establish provisions for responsible management to undertake appropriate corrective action as a follow up to audit reports; the measures should ensure that auditing organizations schedule and conduct appropriate follow up to ensure that the corrective action is effectively accomplished
- measures to perform both technical and QA programmatic audits to achieve the following objectives:
- comprehensive, independent verification and evaluation of procedures and activities affecting quality
- verification and evaluation of the suppliers QA programs, procedures, and activities 15-18
- measures to ensure that audits are led by appropriately qualified and certified audit personnel from the QA organization; measures to ensure that the audit team membership includes personnel (not necessarily QA organization personnel) with technical expertise in the areas being audited
- measures to schedule regular audits on the basis of the status and importance to safety of the activities being audited; measures to provide that audits are initiated early enough to ensure effective QA during design, procurement, and contracting activities
- measures to analyze and trend audit deficiency data as well as ensure that the resulting reports, indicating quality trends and the effectiveness of the QA program, are given to management for review, assessment, corrective action, and follow up
- measures to ensure that audits objectively assess the effectiveness and proper implementation of the QA program and address the technical adequacy of the activities being conducted
- measures to establish provisions requiring the performance of audits in all areas to which the requirements of the QA program apply Evaluation Findings The NRC reviewer should prepare evaluation findings upon satisfaction of the regulatory requirements in Section 15.4 of this SRP. If the reviewer determines that the applicants QAPD does not adequately address the requirements in 10 CFR Part 72, a request for additional information must be prepared and submitted to the NRC project manager to be forwarded to the applicant for resolution and response to the NRC. If the reviewer concludes that information provided with the application, along with additional information provided in response to the NRCs request for additional information, shows that the QAPD meets the requirements, statements of finding similar to the following should be included in the staffs SER or in a letter to the applicant, if the applicants QAPD was submitted separately from the SAR:
F15.1 The applicants description of the QA program indicates that the requirements, procedures, and controls that, when properly implemented, should comply with the requirements of 10 CFR Part 72, Subpart G.
F15.2 The applicants description of the QA program covers activities affecting SSCs, items, and attributes important to safety, as identified in the SAR.
F15.3 The applicants description of the QA program covers activities affecting other SSCs, items, and attributes with consideration to their relative importance to safety, as identified in the SAR.
F15.4 The applicants description of the QA program describes organizations and persons performing QA functions, indicating that sufficient independence and authority should exist to perform their functions without undue influence from those directly responsible for costs and schedules.
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F15.5 The applicants description of the QA program is in compliance with applicable NRC regulations and industry standards, and the acceptance of the QA program description by NRC allows implementation of the associated QA program for the [specify: design, fabrication and construction, operation, decommissioning] phase[s] of the installations life cycle.
The reviewer should provide a summary statement similar to the following:
The staff finds, with reasonable assurance, that the QA program for the
[DSS/DSF] installation meets the requirements in 10 CFR Part 72 and addresses all 18 criteria as required in Subpart G to 10 CFR Part 72. The staff also finds, with reasonable assurance, that the QA program encompasses facility design controls, materials and services procurement controls, records and document controls, fabrication controls, nonconformance and corrective actions controls, an audit program, and operations or programs controls, as appropriate, adequate to ensure that the [DSS/DSF] installation will allow safe storage of spent nuclear fuel, high-level radioactive waste [applies to MRS only], and reactor-related greater than Class C waste. The staff reached this finding based on a review that considered applicable NRC regulations and regulatory guides and the statements and representations contained in the SAR.
References 10 CFR Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste.
NUREG/CR-6314, Quality Assurance Inspections for Shipping and Storage Containers, INEL95-0061, Idaho National Engineering Laboratory, April 1996.
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