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ASME NQA 1 2019

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ASME NQA-1-2019 Quality Assurance Requirements for Nuclear Facility Applications

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ASME 2019 333
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This Standard provides requirements and guidelines for the establishment and execution of quality assurance programs during siting, design, construction, operation and decommissioning of nuclear facilities. This Standard reflects industry experience and current understanding of the quality assurance requirements necessary to achieve safe, reliable, and efficient utilization of nuclear energy, and management and processing of radioactive materials. The Standard focuses on the achievement of results, emphasizes the role of the individual and line management in the achievement of quality, and fosters the application of these requirements in a manner consistent with the relative importance of the item or activity.

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4 CONTENTS
18 FOREWORD
20 CORRESPONDENCE WITH THE NQA COMMITTEE
22 ASME NQA COMMITTEE ROSTER
25 INTRODUCTION
26 ASME NQA-1–2019 SUMMARY OF CHANGES
28 PART I REQUIREMENTS FOR QUALITY ASSURANCE PROGRAMS FOR NUCLEAR FACILITIES (FROM FORMER NQA-1)
INTRODUCTION
100 PURPOSE
200 APPLICABILITY
300 RESPONSIBILITY
400 TERMS AND DEFINITIONS
32 REQUIREMENT 1 Organization
100 GENERAL
200 STRUCTURE AND RESPONSIBILITY
201 General
202 Delegation of Work
300 INTERFACE CONTROL
33 REQUIREMENT 2 Quality Assurance Program
100 GENERAL
200 INDOCTRINATION AND TRAINING
201 Indoctrination
202 Training
300 QUALIFICATION REQUIREMENTS
301 Nondestructive Examination (NDE)
34 302 Inspection and Test
303 Lead Auditor
304 Auditors
35 305 Technical Specialists
400 RECORDS OF QUALIFICATION
401 Inspection and Test Personnel
402 Lead Auditor Personnel
500 RECORDS
36 REQUIREMENT 3 Design Control
100 GENERAL
200 DESIGN INPUT
300 DESIGN PROCESS
400 DESIGN ANALYSES
401 Use of Computer Programs
402 Documentation of Design Analyses
37 500 DESIGN VERIFICATION
501 Methods
600 CHANGE CONTROL
38 601 Configuration Management of Operating Facilities
700 INTERFACE CONTROL
800 SOFTWARE DESIGN CONTROL
900 DOCUMENTATION AND RECORDS
39 REQUIREMENT 4 Procurement Document Control
100 GENERAL
200 CONTENT OF THE PROCUREMENT DOCUMENTS
201 Scope of Work
202 Technical Requirements
203 Quality Assurance Program Requirements
204 Right of Access
205 Documentation Requirements
206 Nonconformances
207 Spare and Replacement Parts
300 PROCUREMENT DOCUMENT REVIEW
400 PROCUREMENT DOCUMENT CHANGES
40 REQUIREMENT 5 Instructions, Procedures, and Drawings
100 GENERAL
41 REQUIREMENT 6 Document Control
100 GENERAL
200 DOCUMENT CONTROL
300 DOCUMENT CHANGES
301 Major Changes
302 Minor Changes
42 REQUIREMENT 7 Control of Purchased Items and Services
100 GENERAL
200 SUPPLIER EVALUATION AND SELECTION
300 BID EVALUATION
400 CONTROL OF SUPPLIER-GENERATED DOCUMENTS
500 ACCEPTANCE OF ITEM OR SERVICE
501 General
502 Methods of Acceptance
503 Certificate of Conformance
43 504 Source Verification
505 Receiving Inspection
506 Postinstallation Testing
507 Acceptance of Services Only
600 CONTROL OF SUPPLIER NONCONFORMANCES
700 COMMERCIAL GRADE ITEMS AND SERVICES
800 RECORDS
45 REQUIREMENT 8 Identification and Control of Items
100 GENERAL
200 IDENTIFICATION METHODS
201 Item Identification
202 Physical Identification
300 SPECIFIC REQUIREMENTS
301 Identification and Traceability of Items
302 Limited Life Items
303 Maintaining Identification of Stored Items
46 REQUIREMENT 9 Control of Special Processes
100 GENERAL
200 PROCESS CONTROL
201 Special Processes
202 Acceptance Criteria
203 Special Requirements
300 RESPONSIBILITY
400 RECORDS
47 REQUIREMENT 10 Inspection
100 GENERAL
200 INSPECTION REQUIREMENTS
300 INSPECTION HOLD POINTS
400 INSPECTION PLANNING
401 Planning
402 Sampling
500 IN-PROCESS INSPECTION
600 FINAL INSPECTIONS
601 Resolution of Nonconformances
602 Inspection Requirements
603 Modifications, Repairs, or Replacements
604 Acceptance
700 INSPECTIONS DURING OPERATIONS
800 RECORDS
49 REQUIREMENT 11 Test Control
100 GENERAL
200 TEST REQUIREMENTS
300 TEST PROCEDURES (OTHER THAN FOR COMPUTER PROGRAMS)
400 COMPUTER PROGRAM TEST PROCEDURES
500 TEST RESULTS
600 TEST RECORDS
601 Test Records
50 602 Computer Program Test Records
51 REQUIREMENT 12 Control of Measuring and Test Equipment
100 GENERAL
200 SELECTION
300 CALIBRATION AND CONTROL
301 Calibration
302 Reference Standards
303 Control
304 Commercial Devices
400 RECORDS
401 General
52 402 Reports and Certificates
53 REQUIREMENT 13 Handling, Storage, and Shipping
100 GENERAL
200 SPECIAL REQUIREMENTS
300 PROCEDURES
400 TOOLS AND EQUIPMENT
500 OPERATORS
600 MARKING OR LABELING
54 REQUIREMENT 14 Inspection, Test, and Operating Status
100 GENERAL
200 AUTHORITY
300 STATUS INDICATION
55 REQUIREMENT 15 Control of Nonconforming Items
100 GENERAL
200 IDENTIFICATION
300 SEGREGATION
400 DISPOSITION
401 Control
402 Responsibility and Authority
403 Personnel
404 Disposition
405 Reexamination
56 REQUIREMENT 16 Corrective Action
100 GENERAL
57 REQUIREMENT 17 Quality Assurance Records
100 GENERAL
200 GENERATION OF RECORDS
300 AUTHENTICATION OF RECORDS
400 CLASSIFICATION
401 Lifetime Records
402 Nonpermanent Records
500 RECEIPT CONTROL OF RECORDS
600 STORAGE
601 General
58 602 Facility Types
603 Temporary Storage
700 RETENTION
800 MAINTENANCE OF RECORDS
59 REQUIREMENT 18 Audits
100 GENERAL
200 SCHEDULING
201 Internal Audits
201.1 Nuclear Facilities Prior to Placing the Facility Into Operation.
201.2 Nuclear Facilities After Placing the Facility Into Operation.
201.3 Suppliers and Other Nuclear Support Organizations.
202 External Audits
300 PREPARATION
301 Audit Plan
302 Personnel
60 303 Selection of Audit Team
400 PERFORMANCE
500 REPORTING
600 RESPONSE
700 FOLLOW-UP ACTION
800 RECORDS
61 PART II QUALITY ASSURANCE REQUIREMENTS FOR NUCLEAR FACILITY APPLICATIONS
INTRODUCTION
100 PURPOSE
200 APPLICABILITY
300 RESPONSIBILITY
400 PLANNING AND PROCEDURES
401 Planning
402 Procedures
62 500 DEFINITIONS
600 MULTIUNIT FACILITY PROVISIONS
601 Planning and Preparation
602 Documentation
603 Installation
604 Inspection
63 SUBPART 2.1 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components for Nuclear Facilities
100 GENERAL
101 Definitions
64 200 GENERAL REQUIREMENTS
201 Planning
202 Procedures and Instructions
203 Rectification of Unacceptable Cleanness
65 204 Control of Cleaning Solutions
300 CLEANNESS CRITERIA
301 Cleanness Classification
302 Cleanness Class Criteria
66 303 Hydraulic, Instrument Control, and Lubrication Lines and Systems
304 Cleaning and Flushing Fluid Quality Requirements
67 400 MANUFACTURING PHASE CLEANNESS
Tables
Table 302.5 Summary Table for Cleanness Classes
Table 304.1 Water Requirements
68 500 CLEANNESS PRIOR TO INSTALLATION
Table 304.4 Flushing Requirements for Hydraulic, Instrument Control, and Lubrication Systems
69 600 CLEANNESS DURING INSTALLATION
700 MAINTENANCE OF INSTALLATION CLEANNESS
800 PREOPERATIONAL CLEANING
801 Preparations
70 802 Flushing and Cleaning Methods
900 LAYUP AND POSTLAYUP CLEANING
1000 POSTOPERATIONAL REPAIRS AND MODIFICATIONS
71 1100 RECORDS
72 SUBPART 2.2 Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Facilities
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
201 Classification of Items
73 300 PACKAGING
301 General
302 Levels of Packaging
74 303 Cleaning
75 304 Methods of Preservation
305 Caps, Plugs, Tapes, and Adhesives
76 306 Barrier and Wrap Materials and Desiccants
77 307 Containers, Crating, and Skids
308 Cushioning, Blocking, Bracing, and Anchoring
78 309 Marking
79 400 SHIPPING
401 General
402 Transportation Requirements
403 Precautions During Loading and Transit
404 Identification and Markings
405 Nuclear Material Shipments
80 500 RECEIVING
501 General
502 Receiving Inspection Requirements
81 503 Disposition of Received Items
504 Status-Indicating System
505 Marking
506 Documentation
600 STORAGE
601 General
602 Storage Areas
82 603 Storage Methods
604 Control of Items in Storage
83 605 Removal of Items From Storage
606 Storage Records
700 HANDLING
800 RECORDS
84 SUBPART 2.3 Quality Assurance Requirements for Housekeeping at Nuclear Facilities
100 GENERAL
200 GENERAL REQUIREMENTS
201 Planning and Procedures
202 Classification of Cleanness
300 REQUIREMENTS
301 Control of Site Area
85 302 Control of Facilities
303 Material and Equipment
304 Construction Tools, Supplies, and Equipment
305 Surveillance and Inspections
86 400 RECORDS
87 SUBPART 2.5 Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete, Structural Steel, Soils, and Foundations for Nuclear Facilities
100 GENERAL
101 Definitions
88 200 GENERAL REQUIREMENTS
300 REQUIREMENTS
301 Planning and Procedures
302 Control of Measuring and Test Equipment
303 Laboratory Testing
400 PRECONSTRUCTION VERIFICATION
401 General
402 Materials Suitability
403 Construction Processes
89 500 INSPECTION OF SOILS AND EARTHWORK
501 General
502 Materials
503 Placing and Compacting Equipment
504 Preplacement Preparations
505 Soil Compaction
506 In-Process Tests on Compacted Fill
90 600 INSPECTION OF FOUNDATION PILE AND CAISSON CONSTRUCTION1 Applicable for nonreactor containment structures only. This section is not applicable to reactor containment structures because piles and caissons are typically not used for U.S. commercial nuclear reactor containment structures.
601 Piles
Table 506 Required In-Process Tests for Compacted Fill
91 602 Caissons
92 603 Required Qualification Tests
700 INSPECTION OF CONCRETE CONSTRUCTION
701 General
702 Protection of Materials
703 Measuring, Mixing, and Transporting Equipment
704 Preplacement Preparations
93 705 Concrete Placement
706 Finishing and Repairs
707 Curing
94 708 Stress Transfer of Pretensioned Members
709 Post-Tensioning
710 Shipping and Handling of Precast Concrete Members
711 In-Process Tests on Concrete
95 712 Mechanical Splice Testing
713 Welded Reinforcing Bar Splices
714 Bending of Reinforcement
800 INSPECTION OF STEEL CONSTRUCTION
801 General
802 Supporting Structures
803 Assembly and Erection
804 High-Strength Bolting
96 805 Welding
900 DATA ANALYSIS AND EVALUATION
901 General
902 Concrete and Mechanical Splice Test Data Evaluation and Analysis
97 903 Steel Construction Test Data Evaluation and Analysis
904 Soils Test Data Evaluation and Analysis
1000 RECORDS
98 SUBPART 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
100 GENERAL
101 Software Engineering
102 Definitions
99 200 GENERAL REQUIREMENTS
201 Documentation and Records
202 Verification
100 203 Software Configuration Management
204 Problem Reporting and Corrective Action
101 300 SOFTWARE ACQUISITION
301 Procured Software and Software Services
302 Otherwise Acquired Software
400 SOFTWARE ENGINEERING METHOD
401 Planning
402 Software Requirements
403 Software Design
102 404 Software Design Implementation
405 Computer Program Testing
103 406 Operation
407 Maintenance
408 Retirement
500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES
600 SUPPORT SOFTWARE
601 Software Tools
602 System Software
700 REFERENCES
104 SUBPART 2.8 Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Items for Nuclear Facilities
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
201 Planning and Procedures
202 Prerequisites
105 300 PREINSTALLATION VERIFICATION
301 General
302 Identification
303 Installation Process Control
304 Physical Condition
305 Installation Area Conditions
106 400 INSTALLATION INSPECTIONS
401 General
402 Process and Procedures Control
403 Inspection
404 Installation Checks
107 405 Care of Mechanical Items
500 SYSTEMS TURNOVER INSPECTION AND TESTS
501 General
108 502 Preoperational Testing
503 Cold Functional Tests
503.1 Reactor Coolant System Hydrostatic Tests.
503.2 Functional and Flow Testing.
109 504 Hot Functional Tests
600 DATA ANALYSIS AND EVALUATION
700 RECORDS
110 SUBPART 2.14 Quality Assurance Requirements for Commercial Grade Items and Services
100 GENERAL
101 Definitions1 United States (U.S.) nuclear facilities are regulated and licensed under the Code of Federal Regulation (CFR) based on the facility function or purpose. Regulations can vary based on the type of facility, applicable CFR, and regulatory agency. Regulation 10 CFR Part 21, Reporting of Defects and Noncompliance, establishes criteria for commercial grade item definition and dedication activities that are based on the facility types per 10 CFR Parts 30, 40, 50, 52, 60, 61, 63, 70, 71, and 72, unless specifically provided otherwise in the regulations. United States licensed facilities and other entities supporting the licensed facilities are required to comply with the appropriate regulations. It is the responsibility of the U.S. facility management to determine the applicability of this Subpart to meet the U.S. facility regulatory requirements, including all pertinent definitions.
111 200 CGI DEFINITION APPLICATIONS
300 UTILIZATION
400 TECHNICAL EVALUATION
401 General
112 402 Like-for-Like Items
403 Equivalent Items
500 CRITICAL CHARACTERISTICS
600 METHODS OF ACCEPTING COMMERCIAL GRADE ITEMS AND SERVICES
601 Dedication
113 602 Method 1: Special Test(s), Inspection(s), and/or Analyses
603 Method 2: Commercial Grade Survey of the Supplier
114 604 Method 3: Source Verification
605 Method 4: Acceptable Supplier Item or Service Performance Record
115 606 Supplier Deficiency Correction
700 COMMERCIAL GRADE SERVICES
800 DOCUMENTATION
900 REFERENCES
117 SUBPART 2.15 Quality Assurance Requirements for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants
118 SUBPART 2.17 Quality Assurance Requirements for Electronic Quality Assurance Records Systems
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
300 RECORD RECOVERY
119 301 Record Recovery Plan
400 ACCESS CONTROL AND RETRIEVAL
401 Access Control
402 Retrieval
500 DIGITAL AND PHYSICAL SECURITY
600 ELECTRONIC DATA INTEGRITY
700 DISPOSAL OF RECORDS
800 ACQUISITION, DEVELOPMENT, AND MAINTENANCE OF ELECTRONIC RECORDS SYSTEMS
120 SUBPART 2.18 Quality Assurance Requirements for Maintenance of Nuclear Facilities
100 GENERAL
200 GENERAL REQUIREMENTS
201 Responsibilities
202 Procedures
121 203 Cleanness Control
204 Environmental and Seismic Qualifications
205 Work Authorization
206 Equipment History
207 Verification of Maintenance Work
208 Updating of Maintenance Procedures From Vendor Technical Manuals and Industry Bulletins
300 PREVENTIVE MAINTENANCE
301 General
302 Plans and Procedures
122 400 CORRECTIVE MAINTENANCE
401 General
402 Identification, Reporting, and Documenting of Equipment or Systems Requiring Corrective Maintenance
403 Assessments and Evaluations
404 Implementing Corrective Maintenance
500 RECORDS
123 SUBPART 2.19 Quality Assurance Requirements for the Use of Supplier Accreditation for Calibration or Testing Services
100 GENERAL
200 REQUIREMENTS
201 Calibration Services
202 Testing Services
125 SUBPART 2.20 Quality Assurance Requirements for Subsurface Investigations for Nuclear Facilities
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
201 Planning
202 Procedures and Instructions
126 203 Results
204 Personnel Qualifications
300 VERIFICATION
301 General
302 Preinvestigation
303 Field Investigation
127 304 Laboratory Testing
305 Engineering Evaluation and Analysis
400 FIELD INVESTIGATION
401 General
402 Field Operations
128 403 Field Equipment
404 Surveying
405 Boring and Excavating
406 Sampling and Testing
129 407 Classification and Reporting
500 LABORATORY TESTING
501 General
502 Scope
130 503 Test Methods
504 Report of Laboratory Tests
600 ENGINEERING EVALUATION AND ANALYSIS
601 General
602 Analysis of Subsurface Conditions
603 Report of Evaluation and Analysis
700 RECORDS
131 SUBPART 2.22 Quality Assurance Requirements for Management Assessment and Quality Improvement for Compliance With 10 CFR 830 and Department of Energy (DOE) Order 414.1 for DOE Nuclear Facilities
100 GENERAL
101 Definitions
132 200 MANAGEMENT ASSESSMENT REQUIREMENTS
201 General
202 Assessment Planning and Scheduling
203 Assessment Process
133 204 Evaluation of Assessment Results
300 QUALITY IMPROVEMENT
301 General
302 Evaluation of Work
303 Quality Improvement Tools
134 304 Improvement Identification and Implementation
305 Improvement Evaluation
400 RECORDS
500 REFERENCES
135 SUBPART 2.25 Quality Assurance Requirements for High-Level Waste Custodians
100 GENERAL
101 Definitions
200 REQUIREMENTS
201 Organization: Interface Control
202 Program
136 203 Design Control
204 Procurement Document Control
205 Instructions, Procedures, and Drawings
206 Document Control
137 207 Control of Purchased Items and Services
208 Inspection
138 209 Test Control
210 Control of Measuring and Test Equipment (M&TE)
211 Control of Nonconforming Items
212 Corrective Action
213 Records
139 214 Audits
215 Scientific Investigations and Data Qualification
140 PART III GUIDANCE FOR IMPLEMENTING PARTS I AND II REQUIREMENTS
INTRODUCTION
100 PURPOSE
200 APPLICABILITY
141 SUBPART 3.1 Guidance for Implementing Part I Requirements
142 SUBPART 3.1-1.1 Implementing Guidance for Part I, Requirement 1: Organization
100 GENERAL
200 ORGANIZATIONAL STRUCTURE
300 BASIC PRINCIPLES
301 Management Functions
302 Quality Achievement Functions
143 SUBPART 3.1-2.1 Implementing Guidance for Part I, Requirement 2: Quality Assurance Programs
100 GENERAL
200 PROGRAM FORMAT
300 PROGRAM DEVELOPMENT
301 Purpose and Scope
302 Timing
144 400 WORK REQUIREMENTS AND PERFORMANCE
401 Basis and Structure
402 Planning
500 WORK PROCESSES
501 Process Management
502 Graded Approach
600 TRAINING AND QUALIFICATION
145 700 ASSESSMENT OF PERFORMANCE
146 SUBPART 3.1-2.2 Implementing Guidance for Part I, Requirement 2: Quality Assurance Programs, Lead Auditor Qualification
100 GENERAL
200 EDUCATION AND EXPERIENCE
201 Education (4 Credits Maximum)
202 Experience (9 Credits Maximum)
203 Other Credentials of Professional Competence (2 Credits Maximum)
204 Rights of Management (2 Credits Maximum)
300 RECORDS
147 Figure 300 Sample Form for Record of Lead Auditor Qualification
Figures
Figure 300 Sample Form for Record of Lead Auditor Qualification
149 SUBPART 3.1-2.3 Implementing Guidance for Part I, Requirement 2: Quality Assurance Programs, Inspection and Test Personnel Qualification
100 GENERAL
200 FUNCTIONAL QUALIFICATIONS
201 Level I Personnel Capabilities
202 Level II Personnel Capabilities
203 Level III Personnel Capabilities
300 EDUCATION AND EXPERIENCE QUALIFICATIONS
301 Level I
302 Level II
150 303 Level III
400 USE OF INSPECTION AND TEST PERSONNEL
151 SUBPART 3.1-2.4 Implementing Guidance for Part I, Requirement 2: Quality Assurance Programs, Management Assessment of the QA Program Using Surveillance
100 GENERAL
200 PLANNING AND SCHEDULING
201 Planning
202 Scheduling
300 PREPARATION
152 400 PERFORMANCE
401 Notification
402 Conduct of Surveillance
153 500 REPORTING AND COMMUNICATION
600 RESOLUTION OF ISSUES
601 Response to Surveillance Reports
602 Follow-Up
154 SUBPART 3.1-3.1 Implementing Guidance for Part I, Requirement 3: Design Control
100 GENERAL
200 DESIGN INPUT
155 300 DESIGN PROCESS
156 400 DESIGN ANALYSIS
401 Use of Computer Programs
157 500 DESIGN VERIFICATION
600 CHANGE CONTROL
158 700 USE OF REVERSE-ENGINEERING TECHNIQUES
Table 401.4 Scenarios for Use of Computer Programs in Design Analysis
159 800 INTERFACE CONTROL
900 DOCUMENTATION AND RECORDS
1000 REFERENCE
160 SUBPART 3.1-4.1 Implementing Guidance for Part I, Requirement 4: Procurement Document Control
100 GENERAL
200 PROCUREMENT DOCUMENT REVIEW
300 TYPICAL SCOPE OF PROCUREMENT EFFORT
301 Design, Construction, and Testing Phases
302 Operational Phase
161 400 CATEGORIZATION OF PROCUREMENT ACTIONS
500 GENERAL LOGIC CONSIDERATIONS
501 Importance of Malfunction or Failure of the Item to Plant Safety
502 Complexity or Uniqueness of the Item
503 Need for Special Controls and Surveillance Over Processes and Equipment
504 Degree to Which Functional Compliance Can Be Demonstrated by Inspection and Test
505 Quality History and Degree of Standardization of the Item
162 600 LOGIC CHART
700 METHODS OF SPECIFYING QUALITY ASSURANCE PROGRAM REQUIREMENTS
701 Example of Specifying the Overall Method
163 Figure 600 Logic Chart for Determining Appropriate Quality Requirements
164 702 Example of Specifying the Unique Order Method
165 SUBPART 3.1-7.1 Implementing Guidance for Part I, Requirement 7: Control of Purchased Items and Services
100 GENERAL
200 PROCUREMENT PLANNING
300 SUPPLIER SELECTION
301 Performance History
302 Quality Records
166 303 Facility Survey
400 BID EVALUATION
500 PURCHASER/SUPPLIER COMMUNICATIONS
600 CONTROL OF CHANGES IN ITEMS OR SERVICES
601 Bid Evaluation Changes
602 Control of Changes
603 In Process Control of Deviations
700 PRODUCT ACCEPTANCE
701 Source Verification
167 702 Receiving Inspection
703 Certificate of Conformance
704 Postinstallation Testing
705 Determining Authenticity
168 SUBPART 3.1-10.1 Implementing Guidance for Part I, Requirement 10: Inspection
100 GENERAL
200 INSPECTION AND PROCESS MONITORING
300 IN-SERVICE INSPECTION
169 SUBPART 3.1-15.1 Implementing Guidance for Part I, Requirement 15: Control of Nonconforming Items
100 GENERAL
200 IDENTIFICATION
201 Validation
202 Evaluation
300 SEGREGATION
400 DISPOSITION
401 Allowable Use and Documentation of Preapproved Reject or Rework Process
170 402 Disposition Control, Documentation, and Closure
171 Figure 100 Nonconforming Item Process Chart
172 SUBPART 3.1-16.1 Implementing Guidance for Part I, Requirement 16: Corrective Action
100 GENERAL
200 CORRECTIVE ACTION
300 BASIC CORRECTIVE ACTION ELEMENTS
301 Identification and Documentation
302 Classification
173 303 Report to Management
304 Cause Determination
Figure 300 Corrective Action Process Chart
174 305 Corrective Action Plan
306 Verification of Implementation
307 Effectiveness Review
308 Closure
309 Trend Analysis
400 MANAGEMENT INVOLVEMENT
500 PROCESS CHART
175 SUBPART 3.1-16.2 Implementing Guidance for Part I, Requirement 16: Trend Analysis
100 GENERAL
200 DEFINITIONS
300 TRENDING PROGRAM
176 400 DATA COLLECTION
401 Program and Preparation for Effective Trending
402 Data Collection Sources and Methods
500 TREND ANALYSIS PROCESS
502 Trend Analysis Staff and Teams
503 Data Sorting and Categorization
177 504 Trend Significance Analysis
600 TREND REPORTING
601 Report Content
602 Reporting Frequency
178 700 RECORDS
800 REFERENCES AND RECOMMENDED READING
179 SUBPART 3.1-17.1 Implementing Guidance for Part I, Requirement 17: Quality Assurance Records
100 GENERAL
101 Generation of Records
102 Authentication of Records
103 Indexing
104 Corrected Information in Records
105 Storage
180 106 Preservation and Safekeeping
107 Facilities and Containers
108 Retrieval
109 Records Transfer to Owner or Purchaser
110 Record Destruction
200 LIST OF TYPICAL LIFETIME RECORDS
201 Design and Safety Basis Records
202 Procurement Records
181 203 Manufacturing Records
204 Installation Construction Records
205 Preoperational and Start-Up Test Records
206 Operation Records
182 207 Decommissioning and Destruction
183 SUBPART 3.1-17.2 Implementing Guidance for Part I, Requirement 17: Quality Assurance Records, Electronic Records
100 GENERAL
101 Definitions
200 AUTHENTICATION OF RECORDS
201 Electronic Signatures
184 300 GENERATION OF RECORDS
301 Electronic Records Systems
302 Conversion of Media
303 Indexing Records
400 RECEIPT CONTROL OF RECORDS
185 500 STORAGE
501 Environmental Considerations
502 Facility and System Access
503 Temporary Storage
504 Portable Electronic Media
600 ACCESS CONTROL AND RETRIEVAL
186 700 DISPOSAL OF RECORDS
701 Guidance Factors
800 MAINTENANCE OF RECORDS SYSTEM
187 900 SYSTEM INTEGRITY AND RECORD RECOVERY
188 SUBPART 3.1-18.1 Implementing Guidance for Part I, Requirement 18: Audits
100 GENERAL
200 AUDIT ADMINISTRATION
201 Purpose
202 Elements
203 Frequency of Audits
204 Shared External Audits
189 205 Supplemental Audits
206 Audit Equivalents
300 PREPARATION FOR AUDITING
301 Team Selection and Assignment
190 302 Planning the Audit
303 Audit Notification
400 AUDIT PERFORMANCE
401 Pre-Audit Conference
402 Methods
191 403 Audit Implementation
404 Post-Audit Conference
500 REPORTING
600 RESPONSE
700 FOLLOW-UP ACTION
192 SUBPART 3.1-18.2 Implementing Guidance on Classification and Handling Audit Issues
100 GENERAL
200 INTRODUCTION
300 CLASSIFICATION OF ISSUES
301 Finding
302 Observation
303 Opportunity for Improvement
304 Strength
193 400 RESPONSES TO ISSUES
401 Finding Responses
402 Observation Responses
403 Opportunities for Improvement
404 Strengths
500 FOLLOW-UP
501 Evaluate the Written Response
502 Monitor Corrective Actions
503 Reaudit
194 SUBPART 3.2 Guidance for Implementing Part II Requirements
195 SUBPART 3.2-2.1 Implementing Guidance for Part II, Requirement 2.1: Cleaning of Fluid Systems
100 GENERAL
200 APPLICABILITY
300 CLEANING RECOMMENDATIONS AND PRECAUTIONS
400 GUIDELINES FOR ASSIGNING CLEANNESS CLASSIFICATIONS
401 Normal Fluid Systems and Components
402 Hydraulic, Instrument Control, and Lubrication Lines and Systems
196 SUBPART 3.2-2.7.1 Implementing Guidance for Part II, Requirement 2.7: Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
INTRODUCTION
100 GENERAL
101 Software Engineering
101.1
101.2
197 101.3
101.4
101.5
101.6
101.7
102 Definitions
102.1 Software Characteristics.
102.2 Hardware Characteristics.
102.3 Firmware Characteristics.
198 200 GENERAL REQUIREMENTS
201 Documentation and Records
202 Verification
202.1 Reviews.
203 Software Configuration Management
203.1 Configuration Identification.
203.2 Configuration Change Control.
203.3 Configuration Status Control.
203.4 Configuration Audits.
199 204 Problem Reporting and Corrective Action
300 SOFTWARE ACQUISITION
301 Procured Software and Software Services
302 Otherwise Acquired Software
400 SOFTWARE ENGINEERING METHOD
401 Planning
402 Software Requirements
403 Software Design
200 404 Software Design Implementation
405 Computer Program Testing
405.1 Testing Process.
405.1.1 Unit Testing.
405.1.2 Integration Testing.
201 405.1.3 Regression Testing.
405.1.4 System Testing.
405.1.5 Factory Acceptance Testing.
405.1.6 Installation Testing.
405.1.7 Site Acceptance Testing.
405.2 Test Plans and Test Cases
202 405.3 Test Results and Test Reports.
406 Operation
406.1 Use of Software.
406.2 Access Control.
406.3 In-Use Testing.
203 406.4 User Documentation.
407 Maintenance
408 Retirement
500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES
600 SUPPORT SOFTWARE
601 Software Tools
602 System Software
700 REFERENCES
205 SUBPART 3.2-2.7.2 Implementation Guidance on the Requirements of NQA-1, Parts I and II for Software Used for Nuclear Facility Applications
INTRODUCTION
100 GENERAL
101 Terms and Definitions
200 FLOWCHART APPROACH
201 Flowcharts
206 202 Legend
207 Figure 201-1 Software Engineering
Figure 201-1 Software Engineering
212 Figure 201-2 Software Design Requirements
Figure 201-2 Software Design Requirements
213 Figure 201-3 Software Configuration Management
Figure 201-3 Software Configuration Management
214 Figure 201-4 Support Software and Tools
Figure 201-4 Support Software and Tools
215 Figure 201-5 Problem Reporting and Corrective Action
Figure 201-5 Problem Reporting and Corrective Action
216 Figure 201-6 Software Design
Figure 201-6 Software Design
217 Figure 201-7 Software Reviews
Figure 201-7 Software Reviews
218 Figure 201-8 Software Design Implementation
Figure 201-8 Software Design Implementation
219 Figure 201-9 Computer Program Testing
Figure 201-9 Computer Program Testing
222 Figure 201-10 Software Operation, Maintenance, and Retirement
Figure 201-10 Software Operation, Maintenance, and Retirement
223 Figure 201-11 Software Acquisition
Figure 201-11 Software Acquisition
225 Figure 201-12 Computer Program Use in Design Analysis
Figure 201-12 Computer Program Use in Design Analysis
226 Figure 202-1 Legend for Flowcharts
Figure 202-1 Legend for Flowcharts
227 SUBPART 3.2-2.14 Implementing Guidance for Part II, Requirement 2.14: Quality Assurance Requirements for Commercial Grade Items and Services, Commercial Grade Computer Programs, and Software Services
100 GENERAL
101 Definitions
228 200 DEFINITION APPLICATIONS
300 UTILIZATION
400 TECHNICAL EVALUATION
401 Technical Evaluation Considerations
229 402 Technical Evaluation Documentation Review
500 CRITICAL CHARACTERISTICS
501 Computer Program Critical Characteristics
230 502 Computer Program Acceptance Criteria
600 METHODS FOR ACCEPTING COMMERCIAL GRADE ITEMS AND SERVICES
601 Dedication
602 Method 1: Special Test(s), Inspection(s), and/or Analyses
602.1 Special Tests.
231 Table 501 Typical Critical Characteristics to Consider for Computer Programs
Table 501 Typical Critical Characteristics to Consider for Computer Programs
235 602.2 Inspections.
602.3 Analyses.
603 Method 2: Commercial Grade Survey of the Supplier
236 604 Method 3: Source Verification
605 Method 4: Acceptable Supplier Item or Service Performance Record
700 COMMERCIAL GRADE SOFTWARE SERVICES
800 DOCUMENTATION
801 Computer Program Procurement Documents
237 802 Dedication Documentation
803 User Documentation
900 REFERENCES
238 SUBPART 3.2-2.15 Implementing Guidance for Part II, Requirement 2.15: Hoisting, Rigging, and Transportation
100 GENERAL
200 RECOMMENDED DESIGN CRITERIA
201 Structural
202 Mechanical
300 RECOMMENDED CONTROL OF THE USE OF HANDLING EQUIPMENT
239 SUBPART 3.2-2.18.1 Implementing Guidance for Part II, Requirement 2.18: Maintenance of Nuclear Facilities, Establishing and Maintaining Equipment Histories
100 GENERAL
200 DEVELOPING AN EQUIPMENT HISTORY
300 MAINTAINING HISTORICAL DATA
400 USING MAINTENANCE HISTORY
240 SUBPART 3.2-2.18.2 Implementing Guidance for Part II, Requirement 2.18: Maintenance of Nuclear Facilities, Engineering Evaluations of Equipment Failures
100 INTRODUCTION
200 ENGINEERING EVALUATIONS
201 Initiating Engineering Evaluations
202 Performing Engineering Evaluations
241 203 Using Engineering Evaluation Results
242 SUBPART 3.2-2.20 Implementing Guidance for Part II, Requirement 2.20: Subsurface Investigations for Nuclear Power Plants, Sample Control and Identification
100 GENERAL
200 CONTROL OF SUBSURFACE INVESTIGATIONS
300 IDENTIFICATION OF SAMPLES
400 CONTROL OF SAMPLES
243 SUBPART 3.3 Nonmandatory Guidance on Quality Assurance Program Requirements for Collection of Scientific and Technical Information for Site Characterization of High-Level Nuclear Waste Repositories
244 PART IV GUIDANCE ON THE APPLICATION AND USE OF NQA-1
INTRODUCTION
100 PURPOSE
200 APPLICABILITY
245 SUBPART 4.1 Guides on Use and Comparison of NQA-1 With Other Quality Requirements
SUBPART 4.1.1 Guidance to Modification of an ISO 9001:2015 Quality Management System for Compliance With NQA-1–2015, Part I
100 PURPOSE AND SCOPE
200 BACKGROUND
300 TERMS AND DEFINITIONS
400 COMPARISON TABLES
246 Table 400-1 NQA-1, Part I, Requirement 1 (Organization) and Corresponding ISO 9001 Clauses
247 Table 400-2 NQA-1, Part I, Requirement 2 (Quality Assurance Program) and Corresponding ISO 9001 Clauses
248 Table 400-3 NQA-1, Part I, Requirement 3 (Design Control) and Corresponding ISO 9001 Clauses
249 Table 400-4 NQA-1, Part I, Requirement 4 (Procurement Document Control) and Corresponding ISO 9001 Clauses
Table 400-5 NQA-1, Part I, Requirement 5 (Instructions, Procedures, and Drawings) and Corresponding ISO 9001 Clauses
250 Table 400-6 NQA-1, Part I, Requirement 6 (Document Control) and Corresponding ISO 9001 Clauses
251 Table 400-7 NQA-1, Part I, Requirement 7 (Control of Purchased Items and Services) and Corresponding ISO 9001 Clauses
252 Table 400-8 NQA-1, Part I, Requirement 8 (Identification and Control of Items) and Corresponding ISO 9001 Clauses
Table 400-9 NQA-1, Part I, Requirement 9 (Control of Special Processes) and Corresponding ISO 9001 Clauses
253 Table 400-10 NQA-1, Part I, Requirement 10 (Inspection) and Corresponding ISO 9001 Clauses
Table 400-11 NQA-1, Part I, Requirement 11 (Test Control) and Corresponding ISO 9001 Clauses
254 Table 400-12 NQA-1, Part I, Requirement 12 (Control of Measuring and Test Equipment) and Corresponding ISO 9001 Clauses
255 Table 400-13 NQA-1, Part I, Requirement 13 (Handling, Storage, and Shipping) and Corresponding ISO 9001 Clauses
Table 400-14 NQA-1, Part I, Requirement 14 (Inspection, Test, and Operating Status) and Corresponding ISO 9001 Clauses
256 Table 400-15 NQA-1, Part I, Requirement 15 (Control of Nonconforming Items) and Corresponding ISO 9001 Clauses
Table 400-16 NQA-1, Part I, Requirement 16 (Corrective Action) and Corresponding ISO 9001 Clauses
257 Table 400-17 NQA-1, Part I, Requirement 17 (Quality Assurance Records) and Corresponding ISO 9001 Clauses
258 Table 400-18 NQA-1, Part I, Requirement 18 (Audits) and Corresponding ISO 9001 Clauses
259 SUBPART 4.1.2 Guidance on the Use of NQA-1–2008/1a–2009 for Compliance With Department of Energy Quality Assurance Requirements 10 CFR 830, Subpart A and DOE O 414.1
100 PURPOSE
200 INTRODUCTION
300 DOE RULE AND ORDER GENERAL QAP REQUIREMENTS
400 DOE RULE AND ORDER QA CRITERIA
260 Table 300 10 CFR 830 Subpart A, Dated January 10, 2001 §830.121, Quality Assurance Program; DOE O 414.1C, Dated June 17, 2005
261 Table 400 10 CFR 830 Subpart A, Dated January 10, 2001 §830.122, Quality Assurance Criteria
264 SUBPART 4.1.3 Guidance on the Use of NQA-1–2015 for Compliance With 10 CFR 71 and/or 10 CFR 72 Requirements
100 PURPOSE
200 INTRODUCTION
300 SUMMARY RESULTS
265 Table 300 10 CFR 71 and 10 CFR 72 Criteria Addressed by NQA-1
270 SUBPART 4.1.4 Guidance to Modification of an IAEA GS-R-3 Quality Program to Meet NQA-1a-2009 Requirements and Modification of an NQA-1a–2009 Quality Program to Meet IAEA GS-R-3 Requirements
100 PURPOSE AND SCOPE
200 APPLICABILITY
300 BACKGROUND
301 Global Uses of NQA-1 and IAEA GS-R-3
302 Conceptual Approaches to the Development of NQA-1 and IAEA GS-R-3
271 400 HOW TO USE THIS GUIDE TO ACHIEVE COMPLIANCE WITH IAEA GS-R-3 OR NQA-1
401 Two Perspectives and Two Tables
402 How to Use Tables I and II
272 Table I The Extent to Which GS-R-3 Addresses NQA-1 Requirements
289 SUBPART 4.1.5 Guidance to Modification of an ANSI/ANS-15.8-1995 (R2005; R2013) Quality Program to Meet NQA-1–2012 Requirements
100 INTRODUCTION
200 APPLICABILITY
300 BACKGROUND
400 TERMS AND DEFINITIONS
500 HOW TO USE THE GUIDE TO ACHIEVE COMPLIANCE WITH NQA-1 OR AN ANSI/ANS-15.8 QUALITY PROGRAM
290 Table 200-1 Corresponding NQA Sections (Introduction) to ANSI/ANS-15.8
291 Table 200-2 Corresponding NQA Sections (Requirement 1) to ANSI/ANS-15.8
292 Table 200-3 Corresponding NQA Sections (Requirement 2) to ANSI/ANS-15.8
293 Table 200-4 Corresponding NQA Sections (Requirement 3) to ANSI/ANS-15.8
294 Table 200-6 CorrespondingNQASection (Requirement 5) to ANSI/ANS-15.8
Table 200-7 Corresponding NQA Sections (Requirement 6) to ANSI/ANS-15.8
295 Table 200-8 Corresponding NQA Sections (Requirement 7) to ANSI/ANS-15.8
296 Table 200-9 Corresponding NQA Sections (Requirement 8) to ANSI/ANS-15.8
Table 200-10 Corresponding NQA Sections (Requirement 9) to ANSI/ANS-15.8
297 Table 200-11 Corresponding NQA Sections (Requirement 10) to ANSI/ANS-15.8
Table 200-12 Corresponding NQA Sections (Requirement 11) to ANSI/ANS-15.8
298 Table 200-13 Corresponding NQA Sections (Requirement 12) to ANSI/ANS-15.8
Table 200-14 Corresponding NQA Sections (Requirement 13) to ANSI/ANS-15.8
299 Table 200-15 Corresponding NQA Section (Requirement 14) to ANSI/ANS-15.8
Table 200-16 Corresponding NQA Sections (Requirement 15) to ANSI/ANS-15.8
Table 200-17 Corresponding NQA Section (Requirement 16) to ANSI/ANS-15.8
300 Table 200-18 Corresponding NQA Sections (Requirement 17) to ANSI/ANS-15.8
Table 200-19 Corresponding NQA Sections (Requirement 18) to ANSI/ANS-15.8
301 Table 200-20 Corresponding NQA Sections (Parts I and II) to ANSI/ANS-15.8
302 Table 200-21 Corresponding NQA Sections (Part II) to ANSI/ANS-15.8
303 SUBPART 4.2 Guides on Application of NQA-1 to Work Processes and Activities
SUBPART 4.2.1 Guidance on Graded Application of Nuclear Quality Assurance (NQA) Standard for Research and Development
100 INTRODUCTION
101 Research and Development and Conventional NQA Applications
102 The Quality and Nature of Research and Development Work
103 Research and Development in the Technology Life Cycle
103.1 Basic Research.
304 103.2 Applied Research.
103.3 Developmental Work.
103.4 Research and Development Support Activities.
104 Research and Development Process Interfaces and Continuity
200 RESEARCH AND DEVELOPMENT QUALITY ASSURANCE THROUGH PEER REVIEW
Figure 103 Technology Life Cycle
305 300 A GRADED APPROACH
301 Basic Research
302 Applied Research
303 Development Work and Research and Development Support Activities
400 QUALITY ASSURANCE RESEARCH AND DEVELOPMENT APPLICATIONS
306 500 RESEARCH AND DEVELOPMENT QUALITY ASSURANCE GLOSSARY OF TERMS
600 APPLICATION OF NQA-1 TO RESEARCH AND DEVELOPMENT ACTIVITIES
601 NQA-1, Requirement 1: Organization
307 602 NQA-1, Requirement 2: Quality Assurance Program
Table 600-1 Guidance on Graded Application of the NQA Standard for Research and Development
Table 600-2 Software Within Research and Development
308 603 NQA-1, Requirement 3: Design Control
604 NQA-1, Requirement 4: Procurement Document Control
605 NQA-1, Requirement 5: Instructions, Procedures, and Drawings
309 606 NQA-1, Requirement 6: Document Control
607 NQA-1, Requirement 7: Control of Purchased Materials, Items, and Services
608 NQA-1, Requirement 8: Identification of Control Items
609 NQA-1, Requirement 9: Control of Processes
610 NQA-1, Requirement 10: Inspection
611 NQA-1, Requirement 11: Test Control
310 612 NQA-1, Requirement 12: Control of Measuring and Test Equipment
613 NQA-1, Requirement 13: Handling, Storage, and Shipping
614 NQA-1, Requirement 14: Inspection, Test, and Operating Status
615 NQA-1, Requirement 15: Control of Nonconforming Items
616 NQA-1, Requirement 16: Corrective Action
311 617 NQA-1, Requirement 17: Quality Assurance Records
618 NQA-1, Requirement 18: Audits
700 TECHNOLOGY LIFE CYCLE (SUBPART 4.2.1) AND TECHNOLOGY READINESS LEVELS
Table 700 Comparison of Subpart 4.2.1 Technology Life Cycle and Technology Readiness Levels
313 SUBPART 4.2.3 Guidance on Qualification of Existing Data
100 GENERAL
200 SELECTING DATA SETS FOR QUALIFICATION
300 DATA QUALIFICATION PROCESS
301 Data Qualification Planning
302 Data Qualification Preparation
303 Data Qualification Attributes
400 QUALIFICATION METHODS
401 Quality Assurance Program Equivalency Method
314 402 Data Corroboration Method
403 Confirmatory Testing Method
404 Peer Review Method
500 DOCUMENTATION OF RESULTS
315 SUBPART 4.2.4 Guidance on the Control of Scientific Investigations
100 GENERAL
101 Definitions
200 PLANNING AND PERFORMING SCIENTIFIC INVESTIGATIONS
201 Scientific Investigation Planning
202 Performing Scientific Investigations
316 300 TECHNICAL DATA
301 Data Identification
302 Data Validation, Verification, and Qualification
303 Data Usage
304 Model Validation
400 SAMPLE CONTROL
317 500 PEER REVIEW
501 General Guidance for Peer Review
318 SUBPART 4.2.5 Guidance on the Transition From Construction to Operation for Nuclear Facilities
100 GENERAL
200 APPLICABILITY
201 Regulatory
300 TRANSITION RECOMMENDATIONS
301 Turnover From Construction to Testing
319 302 Testing of Plant Systems and Components
303 Turnover to Operations
320 304 Preparation for Operation
305 Start-Up Test Program
400 RECORDS
322 SUBPART 4.2.6 Guidance on Quality Assurance for Decommissioning of Nuclear Facilities
100 GENERAL
101 Definitions
200 PREREQUISITES
323 300 PREDECOMMISSIONING CHECKS
301 General
302 Plans, Specifications, and Procedures
324 303 Identification
304 Physical Condition
325 305 System Protection
400 CONTROL DURING DECOMMISSIONING
401 General
402 Processes and Procedures Control
326 403 Checks of Systems, Components, and Equipment Required for Decommissioning
404 Checks During Decommissioning
500 POSTDECOMMISSIONING CHECKS
600 RECORDS
327 SUBPART 4.2.7 Guidance on Peer Review
100 GENERAL
200 TERMS AND DEFINITIONS
300 PERFORMANCE
301 General
328 302 Planning
329 303 Methods
400 REVIEWER SELECTION
401 Competence/Technical Expertise
402 Independence/Conflict of Interest
403 Balance
404 Training
500 COMMENT RESOLUTION
600 PEER REVIEW REPORT
330 700 RECORDS
ASME NQA 1 2019
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