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ASME NQA 1 2017

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ASME NQA-1-2017 Quality Assurance Requirements for Nuclear Facility Applications

Published By Publication Date Number of Pages
ASME 2017 235
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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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PDF Pages PDF Title
4 CONTENTS
5 FOREWORD
7 CORRESPONDENCE WITH THE NQA COMMITTEE
9 COMMITTEE ROSTER
11 INTRODUCTION
12 ASME NQA-1-2017 SUMMARY OF CHANGES
14 PART I: REQUIREMENTS FOR QUALITY ASSURANCE PROGRAMS FOR NUCLEAR FACILITIES
CONTENTS
17 PART I INTRODUCTION
100 PURPOSE
200 APPLICABILITY
300 RESPONSIBILITY
400 TERMS AND DEFINITIONS
21 REQUIREMENT 1 Organization
100 GENERAL
200 STRUCTURE AND RESPONSIBILITY
201 General
202 Delegation of Work
300 INTERFACE CONTROL
22 REQUIREMENT 2 Quality Assurance Program
100 GENERAL
200 INDOCTRINATION AND TRAINING
201 Indoctrination
202 Training
300 QUALIFICATION REQUIREMENTS
301 Nondestructive Examination (NDE)
302 Inspection and Test
23 303 Lead Auditor
304 Auditors
24 305 Technical Specialists
400 RECORDS OF QUALIFICATION
401 Inspection and Test Personnel
402 Lead Auditor Personnel
500 RECORDS
25 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
26 500 DESIGN VERIFICATION
501 Methods
600 CHANGE CONTROL
27 601 Configuration Management of Operating Facilities
700 INTERFACE CONTROL
800 SOFTWARE DESIGN CONTROL
900 DOCUMENTATION AND RECORDS
28 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
29 REQUIREMENT 5 Instructions, Procedures, and Drawings
100 GENERAL
30 REQUIREMENT 6 Document Control
100 GENERAL
200 DOCUMENT CONTROL
300 DOCUMENT CHANGES
301 Major Changes
302 Minor Changes
31 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
32 504 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
33 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
34 REQUIREMENT 9 Control of Special Processes
100 GENERAL
200 PROCESS CONTROL
201 Special Processes
202 Acceptance Criteria
203 Special Requirements
300 RESPONSIBILITY
400 RECORDS
35 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
36 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
37 602 Computer Program Test Records
38 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
402 Reports and Certificates
39 REQUIREMENT 13 Handling, Storage, and Shipping
100 GENERAL
200 SPECIAL REQUIREMENTS
300 PROCEDURES
400 TOOLS AND EQUIPMENT
500 OPERATORS
600 MARKING OR LABELING
40 REQUIREMENT 14 Inspection, Test, and Operating Status
100 GENERAL
41 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
42 REQUIREMENT 16 Corrective Action
100 GENERAL
43 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
44 602 Facility Types
603 Temporary Storage
700 RETENTION
800 MAINTENANCE OF RECORDS
45 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
303 Selection of Audit Team
46 400 PERFORMANCE
500 REPORTING
600 RESPONSE
700 FOLLOW-UP ACTION
800 RECORDS
47 PART II: QUALITY ASSURANCE REQUIREMENTS FOR NUCLEAR FACILITY APPLICATIONS
CONTENTS
50 PART II INTRODUCTION
100 PURPOSE
200 APPLICABILITY
300 RESPONSIBILITY
400 PLANNING AND PROCEDURES
401 Planning
402 Procedures
51 500 DEFINITIONS
600 MULTIUNIT FACILITY PROVISIONS
601 Planning and Preparation
602 Documentation
603 Installation
604 Inspection
52 SUBPART 2.1 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components for Nuclear Facilities
100 GENERAL
101 Definitions
53 200 GENERAL REQUIREMENTS
201 Planning
202 Procedures and Instructions
203 Rectification of Unacceptable Cleanness
54 204 Control of Cleaning Solutions
300 CLEANNESS CRITERIA
301 Cleanness Classification
302 Cleanness Class Criteria
55 303 Hydraulic, Instrument Control, and Lubrication Lines and Systems
304 Cleaning and Flushing Fluid Quality Requirements
56 Tables
Table 302.5 Summary Table for Cleanness Classes
57 400 MANUFACTURING PHASE CLEANNESS
Table 304.1 Water Requirements
Table 304.4 Flushing Requirements for Hydraulic, Instrument Control, and Lubrication Systems
58 500 CLEANNESS PRIOR TO INSTALLATION
600 CLEANNESS DURING INSTALLATION
59 700 MAINTENANCE OF INSTALLATION CLEANNESS
800 PREOPERATIONAL CLEANING
801 Preparations
802 Flushing and Cleaning Methods
60 900 LAYUP AND POSTLAYUP CLEANING
1000 POSTOPERATIONAL REPAIRS AND MODIFICATIONS
1100 RECORDS
61 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
62 300 PACKAGING
301 General
302 Levels of Packaging
63 303 Cleaning
64 304 Methods of Preservation
305 Caps, Plugs, Tapes, and Adhesives
65 306 Barrier and Wrap Materials and Desiccants
66 307 Containers, Crating, and Skids
308 Cushioning, Blocking, Bracing, and Anchoring
67 309 Marking
68 400 SHIPPING
401 General
402 Transportation Requirements
403 Precautions During Loading and Transit
404 Identification and Markings
405 Nuclear Material Shipments
500 RECEIVING
501 General
69 502 Receiving Inspection Requirements
70 503 Disposition of Received Items
504 Status-Indicating System
505 Marking
506 Documentation
600 STORAGE
601 General
602 Storage Areas
71 603 Storage Methods
604 Control of Items in Storage
72 605 Removal of Items From Storage
606 Storage Records
700 HANDLING
701 General
800 RECORDS
73 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
74 302 Control of Facilities
303 Material and Equipment
304 Construction Tools, Supplies, and Equipment
305 Surveillance and Inspections
75 400 RECORDS
76 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
77 200 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
78 500 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
600 INSPECTION OF FOUNDATION PILE AND CAISSON CONSTRUCTION
601 Piles
79 Table
Table 506 Required In-Process Tests for Compacted Fill
80 602 Caissons
81 603 Required Qualification Tests
700 INSPECTION OF CONCRETE CONSTRUCTION
701 General
702 Protection of Materials
703 Measuring, Mixing, and Transporting Equipment
704 Preplacement Preparations
82 705 Concrete Placement
706 Finishing and Repairs
707 Curing
708 Stress Transfer of Pretensioned Members
83 709 Post-Tensioning
710 Shipping and Handling of Precast Concrete Members
711 In-Process Tests on Concrete
84 712 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
85 805 Welding
900 DATA ANALYSIS AND EVALUATION
901 General
902 Concrete and Mechanical Splice Test Data Evaluation and Analysis
903 Steel Construction Test Data Evaluation and Analysis
904 Soils Test Data Evaluation and Analysis
86 1000 RECORDS
87 SUBPART 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
100 GENERAL
101 Software Engineering
102 Definitions
88 200 GENERAL REQUIREMENTS
201 Documentation and Records
202 Verification
203 Software Configuration Management
89 204 Problem Reporting and Corrective Action
300 SOFTWARE ACQUISITION
301 Procured Software and Software Services
302 Otherwise Acquired Software
90 400 SOFTWARE ENGINEERING METHOD
401 Software Design Requirements
402 Software Design
403 Implementation
91 404 Acceptance Testing
92 405 Operation
406 Maintenance
407 Retirement
500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES
600 SUPPORT SOFTWARE
601 Software Tools
602 System Software
700 REFERENCES
93 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
94 300 PREINSTALLATION VERIFICATION
301 General
302 Identification
303 Installation Process Control
304 Physical Condition
305 Installation Area Conditions
95 400 INSTALLATION INSPECTIONS
401 General
402 Process and Procedures Control
403 Inspection
404 Installation Checks
96 405 Care of Mechanical Items
500 SYSTEMS TURNOVER INSPECTION AND TESTS
501 General
97 502 Preoperational Testing
503 Cold Functional Tests
98 504 Hot Functional Tests
600 DATA ANALYSIS AND EVALUATION
700 RECORDS
99 SUBPART 2.14 Quality Assurance Requirements for Commercial Grade Items and Services
100 GENERAL
101 Definitions
100 200 CGI DEFINITION APPLICATIONS
300 UTILIZATION
400 TECHNICAL EVALUATION
401 General
101 402 Like-for-Like Items
403 Equivalent Items
500 CRITICAL CHARACTERISTICS
102 600 METHODS OF ACCEPTING COMMERCIAL GRADE ITEMS AND SERVICES
601 Dedication
602 Method 1: Special Tests, Inspections, and/or Analyses
603 Method 2: Commercial Grade Survey of the Supplier
103 604 Method 3: Source Verification
605 Method 4: Acceptable Supplier Item or Service Performance Record
104 606 Supplier Deficiency Correction
700 COMMERCIAL GRADE SERVICES
800 DOCUMENTATION
105 900 REFERENCES
106 SUBPART 2.15 Quality Assurance Requirements for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
107 201 Planning and Procedures
202 Classification of Items Handled
300 TYPES OF HANDLING EQUIPMENT
301 Standard Manufactured Component
302 Commercial Standard Design Equipment
108 303 Special Design Equipment
304 Permanent Plant Handling Equipment
400 DESIGN REQUIREMENTS
401 Standard Manufactured Components
402 Commercial Standard Design
403 Special Design Equipment
110 500 ACCEPTANCE CRITERIA FOR MANUFACTURED HANDLING EQUIPMENT
501 Standard Manufactured Components
502 Commercial Standard Design
503 Special Design Equipment
600 TESTING, INSPECTION, AND MAINTENANCE
601 Testing
111 602 Inspection
112 603 Maintenance
700 CONTROL OF THE USE OF HANDLING EQUIPMENT
701 Handling Category A Items
113 702 Handling Category B Items
703 Handling Category C Items
800 QUALIFICATIONS OF PERSONNEL
801 Person-in-Charge PIC
802 Engineer
803 Inspector
900 RECORDS
114 SUBPART 2.17 Quality Assurance Requirements for Electronic Quality Assurance Records Systems
100 GENERAL
101 Definitions
200 GENERAL REQUIREMENTS
300 RECORD RECOVERY
115 301 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
116 SUBPART 2.18 Quality Assurance Requirements for Maintenance of Nuclear Facilities
100 GENERAL
200 GENERAL REQUIREMENTS
201 Responsibilities
202 Procedures
117 203 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
118 400 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
119 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
121 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
122 203 Results
204 Personnel Qualifications
300 VERIFICATION
301 General
302 Preinvestigation
303 Field Investigation
123 304 Laboratory Testing
305 Engineering Evaluation and Analysis
400 FIELD INVESTIGATION
401 General
402 Field Operations
124 403 Field Equipment
404 Surveying
405 Boring and Excavating
406 Sampling and Testing
125 407 Classification and Reporting
500 LABORATORY TESTING
501 General
502 Scope
126 503 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
127 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
128 200 MANAGEMENT ASSESSMENT REQUIREMENTS
201 General
202 Assessment Planning and Scheduling
203 Assessment Process
129 204 Evaluation of Assessment Results
300 QUALITY IMPROVEMENT
301 General
302 Evaluation of Work
303 Quality Improvement Tools
130 304 Improvement Identification and Implementation
305 Improvement Evaluation
400 RECORDS
500 REFERENCES
131 PART III: GUIDANCE FOR IMPLEMENTING PARTS I AND II REQUIREMENTS
CONTENTS
133 PART III INTRODUCTION
100 PURPOSE
200 APPLICABILITY
134 SUBPART 3.1 Guidance for Implementing Part I Requirements
135 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
136 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
137 400 WORK REQUIREMENTS AND PERFORMANCE
401 Basis and Structure
402 Planning
500 WORK PROCESSES
501 Process Management
502 Graded Approach
600 TRAINING AND QUALIFICATION
138 700 ASSESSMENT OF PERFORMANCE
139 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
140 Figures
Fig. 300 Sample Form for Record of Lead Auditor Qualification
142 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
303 Level III
143 400 USE OF INSPECTION AND TEST PERSONNEL
144 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
145 400 PERFORMANCE
401 Notification
402 Conduct of Surveillance
146 500 REPORTING AND COMMUNICATION
600 RESOLUTION OF ISSUES
601 Response to Surveillance Reports
602 Follow-Up
147 SUBPART 3.1-3.1 Implementing Guidance for Part I, Requirement 3: Design Control
100 GENERAL
200 DESIGN INPUT
148 300 DESIGN PROCESS
149 400 DESIGN ANALYSIS
401 Use of Computer Programs
150 500 DESIGN VERIFICATION
151 600 CHANGE CONTROL
Table
Table 401.4 Scenarios for Use of Computer Programs in Design Analysis
152 700 INTERFACE CONTROL
800 DOCUMENTATION AND RECORDS
153 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
154 400 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
155 505 Quality History and Degree of Standardization of the Item
600 LOGIC CHART
700 METHODS OF SPECIFYING QUALITY ASSURANCE PROGRAM REQUIREMENTS
701 Example of Specifying the Overall Method
156 Fig. 600 Logic Chart for Determining Appropriate Quality Requirements
157 702 Example of Specifying the Unique Order Method
158 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
159 303 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
702 Receiving Inspection
160 703 Certificate of Conformance
704 Postinstallation Testing
705 Determining Authenticity
161 SUBPART 3.1-10.1 Implementing Guidance for Part I, Requirement 10: Inspection
100 GENERAL
200 INSPECTION AND PROCESS MONITORING
300 IN-SERVICE INSPECTION
162 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
163 Fig. 100 Nonconforming Item Process Chart
164 402 Disposition Control, Documentation, and Closure
165 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
303 Cause Determination
166 Fig. 300 Corrective Action Process Chart
167 304 Corrections
305 Follow-Up
306 Effectiveness Review
307 Trend Analysis
400 MANAGEMENT INVOLVEMENT
500 PROCESS CHART
168 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
106 Preservation and Safekeeping
169 107 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
203 Manufacturing Records
170 204 Installation Construction Records
205 Preoperational and Start-Up Test Records
206 Operation Records
171 207 Decommissioning and Destruction
172 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
173 300 GENERATION OF RECORDS
301 Electronic Records Systems
302 Conversion of Media
303 Indexing Records
400 RECEIPT CONTROL OF RECORDS
174 500 STORAGE
501 Environmental Considerations
502 Facility and System Access
503 Temporary Storage
504 Portable Electronic Media
600 ACCESS CONTROL AND RETRIEVAL
175 700 DISPOSAL OF RECORDS
701 Guidance Factors
800 MAINTENANCE OF RECORDS SYSTEM
176 900 SYSTEM INTEGRITY AND RECORD RECOVERY
177 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
178 205 Supplemental Audits
206 Audit Equivalents
300 PREPARATION FOR AUDITING
301 Team Selection
302 Planning the Audit
179 303 Audit Notification
400 AUDIT PERFORMANCE
401 Pre-Audit Conference
402 Methods
403 Audit Implementation
404 Post-Audit Conference
500 REPORTING
600 RESPONSE
180 700 FOLLOW-UP ACTION
181 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
400 RESPONSES TO ISSUES
182 401 Findings
402 Observations
403 Opportunities for Improvement
404 Strengths
500 FOLLOW-UP
501 Evaluate the Written Response
502 Monitor Corrective Actions
503 Reaudit
183 SUBPART 3.2 Guidance for Implementing Part II Requirements
184 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
185 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
186 102 Terms and Definitions
200 GENERAL REQUIREMENTS
201 Documentation
187 202 Review
203 Software Configuration Management
204 Problem Reporting and Corrective Action
300 SOFTWARE ACQUISITION
301 Procured Software and Software Services
302 Otherwise Acquired Software
400 SOFTWARE ENGINEERING METHOD
188 401 Software Design Requirements
402 Software Design
403 Implementation
404 Acceptance Testing
405 Operation
406 Maintenance
407 Retirement
189 500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES
600 SUPPORT SOFTWARE
601 Software Tools
602 System Software
190 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
191 202 Legend
192 Figures
Fig. 201-1 Software Engineering
197 Fig. 201-2 Software Design Requirements
198 Fig. 201-3 Software Configuration Management
199 Fig. 201-4 Support Software and Tools
200 Fig. 201-5 Problem Reporting and Corrective Action
201 Fig. 201-6 Software Design
202 Fig. 201-7 Software Reviews
203 Fig. 201-8 Software Design Implementation
204 Fig. 201-9 Computer Program Testing
207 Fig. 201-10 Software Operation, Maintenance, and Retirement
208 Fig. 201-11 Software Acquisition
210 Fig. 201-12 Computer Program Use in Design Analysis
211 Fig. 202-1 Legend for Flowcharts
212 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
213 200 DEFINITION APPLICATIONS
300 UTILIZATION
400 TECHNICAL EVALUATION
401 Technical Evaluation Considerations
214 402 Technical Evaluation Documentation Review
500 CRITICAL CHARACTERISTICS
501 Computer Program Critical Characteristics
215 Table
Table 501 Typical Critical Characteristics to Consider for Computer Programs
222 502 Computer Program Acceptance Criteria
600 METHODS FOR ACCEPTING COMMERCIAL GRADE ITEMS AND SERVICES
601 Dedication
602 Method 1: Special Tests, Inspections, and/or Analyses
223 603 Method 2: Commercial Grade Survey of the Supplier
604 Method 3: Source Verification
224 605 Method 4: Acceptable Supplier Item or Service Performance Record
700 COMMERCIAL GRADE SOFTWARE SERVICES
800 DOCUMENTATION
801 Computer Program Procurement Documents
802 Dedication Documentation
225 803 User Documentation
900 REFERENCES
226 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
227 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
228 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
229 203 Using Engineering Evaluation Results
230 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
231 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
232 PART IV: GUIDANCE ON THE APPLICATION AND USE OF NQA-1
CONTENTS
236 PART IV INTRODUCTION
100 PURPOSE
200 APPLICABILITY
237 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
238 Tables
Table 400-1 NQA-1, Part I, Requirement 1 (Organization) and Corresponding ISO 9001 Clauses
239 Table 400-2 NQA-1, Part I, Requirement 2 (Quality Assurance Program) and Corresponding ISO 9001 Clauses
240 Table 400-3 NQA-1, Part I, Requirement 3 (Design Control) and Corresponding ISO 9001 Clauses
241 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
242 Table 400-6 NQA-1, Part I, Requirement 6 (Document Control) and Corresponding ISO 9001 Clauses
243 Table 400-7 NQA-1, Part I, Requirement 7 (Control of Purchased Items and Services) and Corresponding ISO 9001 Clauses
244 Table 400-8 NQA-1, Part I, Requirement 8 (Identification and Control of Items) and Corresponding ISO 9001 Clauses
245 Table 400-9 NQA-1, Part I, Requirement 9 (Control of Special Processes) and Corresponding ISO 9001 Clauses
246 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
247 Table 400-12 NQA-1, Part I, Requirement 12 (Control of Measuring and Test Equipment) and Corresponding ISO 9001 Clauses
248 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
249 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
250 Table 400-17 NQA-1, Part I, Requirement 17 (Quality Assurance Records) and Corresponding ISO 9001 Clauses
251 Table 400-18 NQA-1, Part I, Requirement 18 (Audits) and Corresponding ISO 9001 Clauses
252 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
253 Table 300 10 CFR 830 Subpart A, Dated January 10, 2001 §830.121, Quality Assurance Program; DOE O 414.1C, Dated June 17, 2005
254 Table 400 10 CFR 830 Subpart A, Dated January 10, 2001 §830.122, Quality Assurance Criteria
257 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
258 Table 300 10 CFR 71 and 10 CFR 72 Criteria Addressed by NQA-1
264 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 GS-R-3
265 400 HOW TO USE THIS GUIDE TO ACHIEVE COMPLIANCE WITH GS-R-3 OR NQA-1
401 Two Perspectives and Two Tables
402 How to Use Tables I and II
266 Table I The Extent to Which GS-R-3 Addresses NQA-1 Requirements
276 Table II The Extent to Which NQA-1 Addresses GS-R-3 Requirements
285 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/ANSÃ15.8 QUALITY PROGRAM
286 Table 200-1 Corresponding NQA Sections(Introduction) to ANSI/ANS-15.8
Table 200-2 Corresponding NQA Sections (Requirement 1) to ANSI/ANS-15.8
287 Table 200-3 Corresponding NQA Sections (Requirement 2) to ANSI/ANS-15.8
288 Table 200-4 Corresponding NQA Sections (Requirement 3) to ANSI/ANS-15.8
289 Table 200-5 Corresponding NQA Sections (Requirement 4) to ANSI/ANS-15.8
290 Table 200-6 Corresponding NQA Section (Requirement 5) to ANSI/ANS-15.8
Table 200-7 Corresponding NQA Sections (Requirement 6) to ANSI/ANS-15.8
291 Table 200-8 Corresponding NQA Sections (Requirement 7) to ANSI/ANS-15.8
Table 200-9 Corresponding NQA Sections (Requirement 8) to ANSI/ANS-15.8
292 Table 200-10 Corresponding NQA Sections (Requirement 9) to ANSI/ANS-15.8
Table 200-11 Corresponding NQA Sections (Requirement 10) to ANSI/ANS-15.8
293 Table 200-12 Corresponding NQA Sections (Requirement 11) to ANSI/ANS-15.8
Table 200-13 Corresponding NQA Sections (Requirement 12) to ANSI/ANS-15.8
294 Table 200-14 Corresponding NQA Sections (Requirement 13) to ANSI/ANS-15.8
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
295 Table 200-17 Corresponding NQA Section(Requirement 16) to ANSI/ANS-15.8
Table 200-18 Corresponding NQA Sections (Requirement 17) to ANSI/ANS-15.8
296 Table 200-19 Corresponding NQA Sections(Requirement 18) to ANSI/ANS-15.8
Table 200-20 Corresponding NQA Sections (Parts I and II) to ANSI/ANS-15.8
297 Table 200-21 Corresponding NQA Sections (Part II) to ANSI/ANS-15.8
298 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
299 104 Research and Development Process Interfaces and Continuity
200 RESEARCH AND DEVELOPMENT QUALITY ASSURANCE THROUGH PEER REVIEW
300 300 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
301 500 RESEARCH AND DEVELOPMENT QUALITY ASSURANCE GLOSSARY OF TERMS
600 APPLICATION OF NQA-1 TO RESEARCH AND DEVELOPMENT ACTIVITIES
601 NQA-1, Requirement 1: Organization
602 NQA-1, Requirement 2: Quality Assurance Program
302 Tables
Table 600-1 Guidance on Graded Application of the NQA Standard for Research and Development
Table 600-2 Software Within Research and Development
303 603 NQA-1, Requirement 3: Design Control
604 NQA-1, Requirement 4: Procurement Document Control
304 605 NQA-1, Requirement 5: Instructions, Procedures, and Drawings
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
610.1 General.
610.2 Basic Research.
610.3 Applied Research.
610.4 Development and Support.
611 NQA-1, Requirement 11: Test Control
611.1 General.
305 611.2 Basic Research.
611.3 Applied Research.
611.4 Development and Support.
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
306 617 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
307 Table 700 Comparison of Subpart 4.2.1 Technology Life Cycle and Technology Readiness Levels
308 SUBPART 4.2.2 Guidance for Managing Electronic Information
309 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
310 402 Data Corroboration Method
403 Confirmatory Testing Method
404 Peer Review Method
500 DOCUMENTATION OF RESULTS
311 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
300 TECHNICAL DATA
301 Data Identification
312 302 Data Validation, Verification, and Qualification
303 Data Usage
304 Model Validation
400 SAMPLE CONTROL
500 PEER REVIEW
501 General Guidance for Peer Review
313 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
314 302 Testing of Plant Systems and Components
303 Turnover to Operations
315 304 Preparation for Operation
305 Start-Up Test Program
400 RECORDS
316 SUBPART 4.2.6 Guidance on Quality Assurance for Decommissioning of Nuclear Facilities
100 GENERAL
101 Definitions
200 PREREQUISITES
317 300 PREDECOMMISSIONING CHECKS
301 General
302 Plans, Specifications, and Procedures
318 303 Identification
304 Physical Condition
319 305 System Protection
400 CONTROL DURING DECOMMISSIONING
401 General
402 Processes and Procedures Control
320 403 Checks of Systems, Components, and Equipment Required for Decommissioning
404 Checks During Decommissioning
500 POSTDECOMMISSIONING CHECKS
600 RECORDS
321 SUBPART 4.2.7 Guidance on Peer Review
100 GENERAL
200 TERMS AND DEFINITIONS
300 PERFORMANCE
301 General
322 302 Planning
323 303 Methods
400 REVIEWER SELECTION
401 Competence/Technical Expertise
402 Independence/Conflict of Interest
403 Balance
404 Training
500 COMMENT RESOLUTION
324 600 PEER REVIEW REPORT
700 RECORDS
ASME NQA 1 2017
$98.04