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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | CONTENTS <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | ASME NQA COMMITTEE ROSTER <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | CORRESPONDENCE WITH THE NQA COMMITTEE <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | ASME NQA-1\u20132022 SUMMARY OF CHANGES <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | REQUIREMENT 1 Organization 100 GENERAL 200 STRUCTURE AND RESPONSIBILITY 201 General 202 Delegation of Work 300 INTERFACE CONTROL <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | REQUIREMENT 2 Quality Assurance Program 100 GENERAL 200 INDOCTRINATION AND TRAINING 201 Indoctrination 202 Training 300 QUALIFICATION REQUIREMENTS 301 Nondestructive Examination (NDE) <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 302 Inspection and Test 303 Lead Auditor 304 Auditors <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 305 Technical Specialists 400 RECORDS OF QUALIFICATION 401 Inspection and Test Personnel 402 Lead Auditor Personnel 500 RECORDS <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 500 DESIGN VERIFICATION 501 Methods 600 CHANGE CONTROL <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 601 Configuration Management of Operating Facilities 700 INTERFACE CONTROL 800 SOFTWARE DESIGN CONTROL 900 DOCUMENTATION AND RECORDS <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | REQUIREMENT 5 Instructions, Procedures, and Drawings 100 GENERAL <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | REQUIREMENT 6 Document Control 100 GENERAL 200 DOCUMENT CONTROL 300 DOCUMENT CHANGES 301 Major Changes 302 Minor Changes <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 800 RECORDS <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | REQUIREMENT 9 Control of Special Processes 100 GENERAL 200 PROCESS CONTROL 201 Special Processes 202 Acceptance Criteria 203 Special Requirements 300 RESPONSIBILITY 400 RECORDS <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 602 Computer Program Test Records <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 402 Reports and Certificates <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | REQUIREMENT 13 Handling, Storage, and Shipping 100 GENERAL 200 SPECIAL REQUIREMENTS 300 PROCEDURES 400 TOOLS AND EQUIPMENT 500 OPERATORS 600 MARKING OR LABELING <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | REQUIREMENT 14 Inspection, Test, and Operating Status 100 GENERAL 200 AUTHORITY 300 STATUS INDICATION <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | REQUIREMENT 16 Corrective Action 100 GENERAL <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | 602 Facility Types 603 Temporary Storage 700 RETENTION 800 MAINTENANCE OF RECORDS <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | REQUIREMENT 18 Audits 100 GENERAL 200 SCHEDULING 201 Internal Audits 202 External Audits 300 PREPARATION 301 Audit Plan 302 Personnel <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | 303 Selection of Audit Team 400 PERFORMANCE 500 REPORTING 600 RESPONSE 700 FOLLOW-UP ACTION 800 RECORDS <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | PART II QUALITY ASSURANCE REQUIREMENTS FOR NUCLEAR FACILITY APPLICATIONS INTRODUCTION 100 PURPOSE 200 APPLICABILITY 300 RESPONSIBILITY 400 PLANNING AND PROCEDURES 401 Planning 402 Procedures <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 500 DEFINITIONS 600 MULTIUNIT FACILITY PROVISIONS 601 Planning and Preparation 602 Documentation 603 Installation 604 Inspection <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | SUBPART 2.1 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components for Nuclear Facilities 100 GENERAL 101 Definitions <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | 200 GENERAL REQUIREMENTS 201 Planning 202 Procedures and Instructions 203 Rectification of Unacceptable Cleanness <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | 204 Control of Cleaning Solutions 300 CLEANNESS CRITERIA 301 Cleanness Classification 302 Cleanness Class Criteria <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | 303 Hydraulic, Instrument Control, and Lubrication Lines and Systems 304 Cleaning and Flushing Fluid Quality Requirements <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | Tables Table 302.5 Summary Table for Cleanness Classes <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | Table 304.1 Water Requirements Table 304.4 Flushing Requirements for Hydraulic, Instrument Control, and Lubrication Systems <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | 400 MANUFACTURING PHASE CLEANNESS 500 CLEANNESS PRIOR TO INSTALLATION 600 CLEANNESS DURING INSTALLATION <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | 700 MAINTENANCE OF INSTALLATION CLEANNESS 800 PREOPERATIONAL CLEANING 801 Preparations 802 Flushing and Cleaning Methods <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | 900 LAYUP AND POSTLAYUP CLEANING 1000 POSTOPERATIONAL REPAIRS AND MODIFICATIONS <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | 1100 RECORDS <\/td>\n<\/tr>\n | ||||||
| 75<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 76<\/td>\n | 300 PACKAGING 301 General 302 Levels of Packaging <\/td>\n<\/tr>\n | ||||||
| 77<\/td>\n | 303 Cleaning <\/td>\n<\/tr>\n | ||||||
| 78<\/td>\n | 304 Methods of Preservation 305 Caps, Plugs, Tapes, and Adhesives <\/td>\n<\/tr>\n | ||||||
| 79<\/td>\n | 306 Barrier and Wrap Materials and Desiccants <\/td>\n<\/tr>\n | ||||||
| 80<\/td>\n | 307 Containers, Crating, and Skids 308 Cushioning, Blocking, Bracing, and Anchoring <\/td>\n<\/tr>\n | ||||||
| 81<\/td>\n | 309 Marking <\/td>\n<\/tr>\n | ||||||
| 82<\/td>\n | 400 SHIPPING 401 General 402 Transportation Requirements 403 Precautions During Loading and Transit 404 Identification and Markings 405 Nuclear Material Shipments <\/td>\n<\/tr>\n | ||||||
| 83<\/td>\n | 500 RECEIVING 501 General 502 Receiving Inspection Requirements <\/td>\n<\/tr>\n | ||||||
| 84<\/td>\n | 503 Disposition of Received Items 504 Status-Indicating System 505 Marking 506 Documentation 600 STORAGE 601 General 602 Storage Areas <\/td>\n<\/tr>\n | ||||||
| 85<\/td>\n | 603 Storage Methods 604 Control of Items in Storage <\/td>\n<\/tr>\n | ||||||
| 86<\/td>\n | 605 Removal of Items From Storage 606 Storage Records 700 HANDLING 800 RECORDS <\/td>\n<\/tr>\n | ||||||
| 87<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 88<\/td>\n | 302 Control of Facilities 303 Material and Equipment 304 Construction Tools, Supplies, and Equipment 305 Surveillance and Inspections <\/td>\n<\/tr>\n | ||||||
| 89<\/td>\n | 400 RECORDS <\/td>\n<\/tr>\n | ||||||
| 90<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 91<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 92<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 93<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 94<\/td>\n | 602 Caissons <\/td>\n<\/tr>\n | ||||||
| 95<\/td>\n | 603 Required Qualification Tests 700 INSPECTION OF CONCRETE CONSTRUCTION 701 General 702 Protection of Materials 703 Measuring, Mixing, and Transporting Equipment 704 Preplacement Preparations <\/td>\n<\/tr>\n | ||||||
| 96<\/td>\n | 705 Concrete Placement 706 Finishing and Repairs 707 Curing <\/td>\n<\/tr>\n | ||||||
| 97<\/td>\n | 708 Stress Transfer of Pretensioned Members 709 Post-Tensioning 710 Shipping and Handling of Precast Concrete Members 711 In-Process Tests on Concrete <\/td>\n<\/tr>\n | ||||||
| 98<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 99<\/td>\n | 805 Welding 900 DATA ANALYSIS AND EVALUATION 901 General 902 Concrete and Mechanical Splice Test Data Evaluation and Analysis <\/td>\n<\/tr>\n | ||||||
| 100<\/td>\n | 903 Steel Construction Test Data Evaluation and Analysis 904 Soils Test Data Evaluation and Analysis 1000 RECORDS <\/td>\n<\/tr>\n | ||||||
| 101<\/td>\n | SUBPART 2.7 Quality Assurance Requirements for Computer Software for Nuclear Facility Applications 100 GENERAL 101 Software Engineering 102 Definitions <\/td>\n<\/tr>\n | ||||||
| 102<\/td>\n | 200 GENERAL REQUIREMENTS 201 Documentation and Records 202 Verification <\/td>\n<\/tr>\n | ||||||
| 103<\/td>\n | 203 Software Configuration Management 204 Problem Reporting and Corrective Action <\/td>\n<\/tr>\n | ||||||
| 104<\/td>\n | 300 SOFTWARE ACQUISITION 301 Procured Software and Software Services 302 Otherwise Acquired Software 400 SOFTWARE ENGINEERING METHOD 401 Planning <\/td>\n<\/tr>\n | ||||||
| 105<\/td>\n | 402 Software Requirements 403 Software Design 404 Software Design Implementation 405 Computer Program Testing <\/td>\n<\/tr>\n | ||||||
| 106<\/td>\n | 406 Operation 407 Maintenance 408 Retirement 500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES <\/td>\n<\/tr>\n | ||||||
| 107<\/td>\n | 600 SUPPORT SOFTWARE 601 Software Tools 602 System Software 700 REFERENCE <\/td>\n<\/tr>\n | ||||||
| 108<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 109<\/td>\n | 300 PREINSTALLATION VERIFICATION 301 General 302 Identification 303 Installation Process Control 304 Physical Condition 305 Installation Area Conditions <\/td>\n<\/tr>\n | ||||||
| 110<\/td>\n | 400 INSTALLATION INSPECTIONS 401 General 402 Process and Procedures Control 403 Inspection 404 Installation Checks <\/td>\n<\/tr>\n | ||||||
| 111<\/td>\n | 405 Care of Mechanical Items 500 SYSTEMS TURNOVER INSPECTION AND TESTS 501 General <\/td>\n<\/tr>\n | ||||||
| 112<\/td>\n | 502 Preoperational Testing 503 Cold Functional Tests <\/td>\n<\/tr>\n | ||||||
| 113<\/td>\n | 504 Hot Functional Tests 600 DATA ANALYSIS AND EVALUATION 700 RECORDS <\/td>\n<\/tr>\n | ||||||
| 114<\/td>\n | SUBPART 2.14 Quality Assurance Requirements for Commercial Grade Items and Services 100 GENERAL 101 Definitions <\/td>\n<\/tr>\n | ||||||
| 115<\/td>\n | 200 CGI DEFINITION APPLICATIONS 300 UTILIZATION 400 TECHNICAL EVALUATION 401 General <\/td>\n<\/tr>\n | ||||||
| 116<\/td>\n | 402 Like-for-Like Items 403 Equivalent Items 500 CRITICAL CHARACTERISTICS 600 METHODS OF ACCEPTING COMMERCIAL GRADE ITEMS AND SERVICES 601 Dedication <\/td>\n<\/tr>\n | ||||||
| 117<\/td>\n | 602 Method 1: Special Test(s), Inspection(s), and\/or Analyses 603 Method 2: Commercial Grade Survey of the Supplier <\/td>\n<\/tr>\n | ||||||
| 118<\/td>\n | 604 Method 3: Source Verification 605 Method 4: Acceptable Supplier Item or Service Performance Record <\/td>\n<\/tr>\n | ||||||
| 119<\/td>\n | 606 Supplier Deficiency Correction 700 COMMERCIAL GRADE SERVICES 800 DOCUMENTATION 900 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 121<\/td>\n | SUBPART 2.15 Quality Assurance Requirements for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants <\/td>\n<\/tr>\n | ||||||
| 122<\/td>\n | SUBPART 2.17 Quality Assurance Requirements for Electronic Quality Assurance Records Systems 100 GENERAL 101 Definitions 200 GENERAL REQUIREMENTS 300 RECORD RECOVERY <\/td>\n<\/tr>\n | ||||||
| 123<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 124<\/td>\n | SUBPART 2.18 Quality Assurance Requirements for Maintenance of Nuclear Facilities 100 GENERAL 200 GENERAL REQUIREMENTS 201 Responsibilities 202 Procedures <\/td>\n<\/tr>\n | ||||||
| 125<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 126<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 127<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 129<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 130<\/td>\n | 203 Results 204 Personnel Qualifications 300 VERIFICATION 301 General 302 Preinvestigation 303 Field Investigation <\/td>\n<\/tr>\n | ||||||
| 131<\/td>\n | 304 Laboratory Testing 305 Engineering Evaluation and Analysis 400 FIELD INVESTIGATION 401 General 402 Field Operations <\/td>\n<\/tr>\n | ||||||
| 132<\/td>\n | 403 Field Equipment 404 Surveying 405 Boring and Excavating 406 Sampling and Testing 407 Classification and Reporting <\/td>\n<\/tr>\n | ||||||
| 133<\/td>\n | 500 LABORATORY TESTING 501 General 502 Scope <\/td>\n<\/tr>\n | ||||||
| 134<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 135<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 136<\/td>\n | 200 MANAGEMENT ASSESSMENT REQUIREMENTS 201 General 202 Assessment Planning and Scheduling 203 Assessment Process <\/td>\n<\/tr>\n | ||||||
| 137<\/td>\n | 204 Evaluation of Assessment Results 300 QUALITY IMPROVEMENT 301 General 302 Evaluation of Work 303 Quality Improvement Tools <\/td>\n<\/tr>\n | ||||||
| 138<\/td>\n | 304 Improvement Identification and Implementation 305 Improvement Evaluation 400 RECORDS 500 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 139<\/td>\n | SUBPART 2.25 Quality Assurance Requirements for High-Level Waste Custodians 100 GENERAL 101 Definitions 200 REQUIREMENTS 201 Organization: Interface Control 202 Program <\/td>\n<\/tr>\n | ||||||
| 140<\/td>\n | 203 Design Control 204 Procurement Document Control 205 Instructions, Procedures, and Drawings 206 Document Control <\/td>\n<\/tr>\n | ||||||
| 141<\/td>\n | 207 Control of Purchased Items and Services 208 Inspection <\/td>\n<\/tr>\n | ||||||
| 142<\/td>\n | 209 Test Control 210 Control of Measuring and Test Equipment (M&TE) 211 Control of Nonconforming Items 212 Corrective Action 213 Records <\/td>\n<\/tr>\n | ||||||
| 143<\/td>\n | 214 Audits 215 Scientific Investigations and Data Qualification <\/td>\n<\/tr>\n | ||||||
| 144<\/td>\n | PART III GUIDANCE FOR IMPLEMENTING PARTS I AND II REQUIREMENTS INTRODUCTION 100 PURPOSE 200 APPLICABILITY <\/td>\n<\/tr>\n | ||||||
| 145<\/td>\n | SUBPART 3.1 Guidance for Implementing Part I Requirements <\/td>\n<\/tr>\n | ||||||
| 146<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 147<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 148<\/td>\n | 302 Timing 400 WORK REQUIREMENTS AND PERFORMANCE 401 Basis and Structure 402 Planning 500 WORK PROCESSES 501 Process Management 502 Graded Approach <\/td>\n<\/tr>\n | ||||||
| 149<\/td>\n | 600 TRAINING AND QUALIFICATION 700 ASSESSMENT OF PERFORMANCE <\/td>\n<\/tr>\n | ||||||
| 150<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 151<\/td>\n | Figures Figure 300 Sample Form for Record of Lead Auditor Qualification <\/td>\n<\/tr>\n | ||||||
| 153<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 154<\/td>\n | 303 Level III 400 USE OF INSPECTION AND TEST PERSONNEL <\/td>\n<\/tr>\n | ||||||
| 155<\/td>\n | SUBPART 3.1-2.4 Implementing Guidance for Part I, Requirement 2: Quality Assurance Programs, Management Assessment of the QA Program 100 GENERAL 200 TYPES OF MANAGEMENT ASSESSMENT 201 QA Program Management Assessment 202 Supplemental Management Assessments 300 SCHEDULING AND PLANNING 301 Scheduling <\/td>\n<\/tr>\n | ||||||
| 156<\/td>\n | 302 Planning Assessments 400 ASSESSMENT PERFORMANCE 401 Assessment Team Responsibilities Table 301 <\/td>\n<\/tr>\n | ||||||
| 157<\/td>\n | 402 Assessment Methodologies 500 REPORTING <\/td>\n<\/tr>\n | ||||||
| 158<\/td>\n | SUBPART 3.1-2.5 Risk-Informed Approach for the Treatment of Structures, Systems, and Components for Nuclear Facilities Not Subject to NRC Regulation11NRC licensed users should consult NEI 00-04, 10 CFR 50.69 SSC Categorization Guideline 100 GENERAL 101 Definitions 102 RISC Descriptions <\/td>\n<\/tr>\n | ||||||
| 159<\/td>\n | 200 SSC CATEGORIZATION 201 SSC Categorization References 202 SSC Categorization Direction 203 SSC Categorization Regulator Approval 204 SSC Categorization Records 300 ADAPTATION Figure 102-1 \u00a750.69 RISC Categories <\/td>\n<\/tr>\n | ||||||
| 160<\/td>\n | 301 Adaptation Application 400 IMPLEMENTATION GUIDANCE 401 RISC-1 SSCs Figure 200-1 Summary of NEI 00-04 Categorization Process <\/td>\n<\/tr>\n | ||||||
| 161<\/td>\n | 402 RISC-2 SSCs 403 RISC-3 SSCs <\/td>\n<\/tr>\n | ||||||
| 163<\/td>\n | 404 RISC-4 SSCs 500 COMPUTER SOFTWARE 600 FEEDBACK AND PROGRESS ADJUSTMENT 601 Monitor RISC-1 and RISC-2 Item Performance 602 Evaluate RISC-3 Related Inspections 700 10 CFR 50.69 IMPLEMENTATION REFERENCES FROM EPRI <\/td>\n<\/tr>\n | ||||||
| 164<\/td>\n | SUBPART 3.1-3.1 Implementing Guidance for Part I, Requirement 3: Design Control 100 GENERAL 200 DESIGN INPUT <\/td>\n<\/tr>\n | ||||||
| 165<\/td>\n | 300 DESIGN PROCESS <\/td>\n<\/tr>\n | ||||||
| 166<\/td>\n | 400 DESIGN ANALYSIS 401 Use of Computer Programs <\/td>\n<\/tr>\n | ||||||
| 167<\/td>\n | 500 DESIGN VERIFICATION 600 CHANGE CONTROL <\/td>\n<\/tr>\n | ||||||
| 168<\/td>\n | 700 USE OF REVERSE-ENGINEERING TECHNIQUES Table 401.4 Scenarios for Use of Computer Programs in Design Analysis <\/td>\n<\/tr>\n | ||||||
| 169<\/td>\n | 800 INTERFACE CONTROL 900 DOCUMENTATION AND RECORDS 1000 REFERENCE <\/td>\n<\/tr>\n | ||||||
| 170<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 171<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 172<\/td>\n | 600 LOGIC CHART 700 METHODS OF SPECIFYING QUALITY ASSURANCE PROGRAM REQUIREMENTS 701 Example of Specifying the Overall Method 702 Example of Specifying the Unique Order Method <\/td>\n<\/tr>\n | ||||||
| 173<\/td>\n | Figure 600 Logic Chart for Determining Appropriate Quality Requirements <\/td>\n<\/tr>\n | ||||||
| 175<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 176<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 177<\/td>\n | 702 Receiving Inspection 703 Certificate of Conformance 704 Postinstallation Testing 705 Determining Authenticity <\/td>\n<\/tr>\n | ||||||
| 178<\/td>\n | SUBPART 3.1-10.1 Implementing Guidance for Part I, Requirement 10: Inspection 100 GENERAL 200 INSPECTION AND PROCESS MONITORING 300 IN-SERVICE INSPECTION <\/td>\n<\/tr>\n | ||||||
| 179<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 180<\/td>\n | Figure 100 Nonconforming Item Process Chart <\/td>\n<\/tr>\n | ||||||
| 181<\/td>\n | 402 Disposition Control, Documentation, and Closure <\/td>\n<\/tr>\n | ||||||
| 182<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 183<\/td>\n | 303 Report to Management 304 Cause Determination 305 Corrective Action Plan 306 Verification of Implementation 307 Effectiveness Review 308 Closure 309 Trend Analysis <\/td>\n<\/tr>\n | ||||||
| 184<\/td>\n | Figure 300 Corrective Action Process Chart 400 MANAGEMENT INVOLVEMENT 500 PROCESS CHART Figure 300 Corrective Action Process Chart <\/td>\n<\/tr>\n | ||||||
| 185<\/td>\n | SUBPART 3.1-16.2 Implementing Guidance for Part I, Requirement 16: Trend Analysis 100 GENERAL 200 DEFINITIONS 300 TRENDING PROGRAM <\/td>\n<\/tr>\n | ||||||
| 186<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 187<\/td>\n | 504 Trend Significance Analysis 600 TREND REPORTING 601 Report Content 602 Reporting Frequency <\/td>\n<\/tr>\n | ||||||
| 188<\/td>\n | 700 RECORDS 800 REFERENCES AND RECOMMENDED READING <\/td>\n<\/tr>\n | ||||||
| 189<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 190<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 191<\/td>\n | 203 Manufacturing Records 204 Installation Construction Records 205 Preoperational and Start-Up Test Records 206 Operation Records <\/td>\n<\/tr>\n | ||||||
| 192<\/td>\n | 207 Decommissioning and Destruction <\/td>\n<\/tr>\n | ||||||
| 193<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 194<\/td>\n | 300 GENERATION OF RECORDS 301 Electronic Records Systems 302 Conversion of Media 303 Indexing Records 400 RECEIPT CONTROL OF RECORDS <\/td>\n<\/tr>\n | ||||||
| 195<\/td>\n | 500 STORAGE 501 Environmental Considerations 502 Facility and System Access 503 Temporary Storage 504 Portable Electronic Media 600 ACCESS CONTROL AND RETRIEVAL <\/td>\n<\/tr>\n | ||||||
| 196<\/td>\n | 700 DISPOSAL OF RECORDS 701 Guidance Factors <\/td>\n<\/tr>\n | ||||||
| 197<\/td>\n | 800 MAINTENANCE OF RECORDS SYSTEM 900 SYSTEM INTEGRITY AND RECORD RECOVERY <\/td>\n<\/tr>\n | ||||||
| 198<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 199<\/td>\n | 205 Supplemental Audits 206 Audit Equivalents 300 PREPARATION FOR AUDITING 301 Team Selection and Assignment <\/td>\n<\/tr>\n | ||||||
| 200<\/td>\n | 302 Planning the Audit 303 Audit Notification 400 AUDIT PERFORMANCE 401 Pre-Audit Conference 402 Methods <\/td>\n<\/tr>\n | ||||||
| 201<\/td>\n | 403 Audit Implementation 404 Post-Audit Conference 500 REPORTING 600 RESPONSE 700 FOLLOW-UP ACTION <\/td>\n<\/tr>\n | ||||||
| 202<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 203<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 204<\/td>\n | SUBPART 3.1-18.3 Implementing Guidance for Part I, Requirement 18: Audits, Use of Surveillance 100 GENERAL 200 PLANNING AND SCHEDULING 201 Planning 202 Scheduling 300 PREPARATION <\/td>\n<\/tr>\n | ||||||
| 205<\/td>\n | 400 PERFORMANCE 401 Notification 402 Conduct of Surveillance <\/td>\n<\/tr>\n | ||||||
| 206<\/td>\n | 500 REPORTING AND COMMUNICATION 600 RESOLUTION OF ISSUES 601 Response to Surveillance Reports 602 Follow-Up <\/td>\n<\/tr>\n | ||||||
| 207<\/td>\n | SUBPART 3.2 Guidance for Implementing Part II Requirements <\/td>\n<\/tr>\n | ||||||
| 208<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 209<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 210<\/td>\n | 102 Definitions <\/td>\n<\/tr>\n | ||||||
| 211<\/td>\n | 200 GENERAL REQUIREMENTS 201 Documentation and Records 202 Verification 203 Software Configuration Management <\/td>\n<\/tr>\n | ||||||
| 212<\/td>\n | 204 Problem Reporting and Corrective Action 300 SOFTWARE ACQUISITION 301 Procured Software and Software Services 302 Otherwise Acquired Software <\/td>\n<\/tr>\n | ||||||
| 213<\/td>\n | 400 SOFTWARE ENGINEERING METHOD 401 Planning 402 Software Requirements 403 Software Design <\/td>\n<\/tr>\n | ||||||
| 214<\/td>\n | 404 Software Design Implementation 405 Computer Program Testing <\/td>\n<\/tr>\n | ||||||
| 216<\/td>\n | 406 Operation <\/td>\n<\/tr>\n | ||||||
| 217<\/td>\n | 407 Maintenance 408 Retirement 500 STANDARDS, CONVENTIONS, AND OTHER WORK PRACTICES 600 SUPPORT SOFTWARE 601 Software Tools 602 System Software 700 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 218<\/td>\n | SUBPART 3.2-2.7.2 Implementation Guidance on the Requirements of ASME 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 <\/td>\n<\/tr>\n | ||||||
| 219<\/td>\n | 202 Legend <\/td>\n<\/tr>\n | ||||||
| 220<\/td>\n | Figure 201-1 Software Engineering <\/td>\n<\/tr>\n | ||||||
| 225<\/td>\n | Figure 201-2 Software Design Requirements <\/td>\n<\/tr>\n | ||||||
| 226<\/td>\n | Figure 201-3 Software Configuration Management <\/td>\n<\/tr>\n | ||||||
| 227<\/td>\n | Figure 201-4 Support Software and Tools <\/td>\n<\/tr>\n | ||||||
| 228<\/td>\n | Figure 201-5 Problem Reporting and Corrective Action <\/td>\n<\/tr>\n | ||||||
| 230<\/td>\n | Figure 201-6 Software Design <\/td>\n<\/tr>\n | ||||||
| 231<\/td>\n | Figure 201-7 Software Reviews <\/td>\n<\/tr>\n | ||||||
| 232<\/td>\n | Figure 201-8 Software Design Implementation <\/td>\n<\/tr>\n | ||||||
| 233<\/td>\n | Figure 201-9 Computer Program Testing <\/td>\n<\/tr>\n | ||||||
| 236<\/td>\n | Figure 201-10 Software Operation, Maintenance, and Retirement <\/td>\n<\/tr>\n | ||||||
| 237<\/td>\n | Figure 201-11 Software Acquisition <\/td>\n<\/tr>\n | ||||||
| 239<\/td>\n | Figure 201-12 Computer Program Use in Design Analysis <\/td>\n<\/tr>\n | ||||||
| 240<\/td>\n | Figure 202-1 Legend for Flowcharts <\/td>\n<\/tr>\n | ||||||
| 241<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 242<\/td>\n | 200 DEFINITION APPLICATIONS 300 UTILIZATION 400 TECHNICAL EVALUATION 401 Technical Evaluation Considerations <\/td>\n<\/tr>\n | ||||||
| 243<\/td>\n | 402 Technical Evaluation Documentation Review 500 CRITICAL CHARACTERISTICS 501 Computer Program Critical Characteristics <\/td>\n<\/tr>\n | ||||||
| 244<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 245<\/td>\n | Table 501 Typical Critical Characteristics to Consider for Computer Programs <\/td>\n<\/tr>\n | ||||||
| 249<\/td>\n | 603 Method 2: Commercial Grade Survey of the Supplier <\/td>\n<\/tr>\n | ||||||
| 250<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 251<\/td>\n | 802 Dedication Documentation 803 User Documentation 900 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 252<\/td>\n | SUBPART 3.2-2.15 Implementing Guidance for Part II, Requirement 2.15: Hoisting, Rigging, and Transportation 100 GENERAL <\/td>\n<\/tr>\n | ||||||
| 253<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 254<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 255<\/td>\n | 203 Using Engineering Evaluation Results <\/td>\n<\/tr>\n | ||||||
| 256<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 257<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 258<\/td>\n | PART IV GUIDANCE ON THE APPLICATION AND USE OF ASME NQA-1 INTRODUCTION 100 PURPOSE 200 APPLICABILITY <\/td>\n<\/tr>\n | ||||||
| 259<\/td>\n | 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, Part I 100 PURPOSE AND SCOPE 200 BACKGROUND 300 TERMS AND DEFINITIONS 400 COMPARISON TABLES <\/td>\n<\/tr>\n | ||||||
| 260<\/td>\n | Table 400-1 NQA-1, Part I, Requirement 1 (Organization) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 261<\/td>\n | Table 400-2 NQA-1, Part I, Requirement 2 (Quality Assurance Program) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 262<\/td>\n | Table 400-3 NQA-1, Part I, Requirement 3 (Design Control) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 263<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 264<\/td>\n | Table 400-6 NQA-1, Part I, Requirement 6 (Document Control) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 265<\/td>\n | Table 400-7 NQA-1, Part I, Requirement 7 (Control of Purchased Items and Services) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 266<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 267<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 268<\/td>\n | Table 400-12 NQA-1, Part I, Requirement 12 (Control of Measuring and Test Equipment) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 269<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 270<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 271<\/td>\n | Table 400-17 NQA-1, Part I, Requirement 17 (Quality Assurance Records) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 272<\/td>\n | Table 400-18 NQA-1, Part I, Requirement 18 (Audits) and Corresponding ISO 9001 Clauses <\/td>\n<\/tr>\n | ||||||
| 273<\/td>\n | SUBPART 4.1.2 Guidance on the Use of NQA-1\u20132008\/1a\u20132009 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 <\/td>\n<\/tr>\n | ||||||
| 274<\/td>\n | Table 300 10CFR830 Subpart A, Dated January 10, 2001 \u00a7830.121, Quality Assurance Program;DOEO414.1C, Dated June 17, 2005 <\/td>\n<\/tr>\n | ||||||
| 275<\/td>\n | Table 400 10 CFR 830 Subpart A, Dated January 10, 2001 \u00a7830.122, Quality Assurance Criteria <\/td>\n<\/tr>\n | ||||||
| 278<\/td>\n | SUBPART 4.1.3 Guidance on the Use of NQA-1\u20132015 for Compliance With 10 CFR 71 and\/or 10 CFR 72 Requirements 100 PURPOSE 200 INTRODUCTION 300 SUMMARY RESULTS <\/td>\n<\/tr>\n | ||||||
| 279<\/td>\n | Table 300 10 CFR 71 and 10 CFR 72 Criteria Addressed by ASME NQA-1 <\/td>\n<\/tr>\n | ||||||
| 284<\/td>\n | SUBPART 4.1.4 Guidance to Modification of an IAEA GS-R-3 Quality Program to Meet ASME NQA-1a\u20132009 Requirements and Modification of an NQA-1a\u20132009 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 <\/td>\n<\/tr>\n | ||||||
| 285<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 286<\/td>\n | Table I The Extent to Which GS-R-3 Addresses NQA-1 Requirements <\/td>\n<\/tr>\n | ||||||
| 295<\/td>\n | Table II The Extent to Which NQA-1 Addresses GS-R-3 Requirements <\/td>\n<\/tr>\n | ||||||
| 303<\/td>\n | SUBPART 4.1.5 Guidance to Modification of an ANSI\/ANS-15.8-1995 (R2005; R2013) Quality Program to Meet NQA-1\u20132012 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 <\/td>\n<\/tr>\n | ||||||
| 304<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 305<\/td>\n | Table 200-3 Corresponding NQA Sections (Requirement 2) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 306<\/td>\n | Table 200-4 Corresponding NQA Sections (Requirement 3) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 307<\/td>\n | Table 200-5 Corresponding NQA Sections (Requirement 4) to ANSI\/ANS-15.8 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 <\/td>\n<\/tr>\n | ||||||
| 308<\/td>\n | Table 200-8 Corresponding NQA Sections (Requirement 7) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 309<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 310<\/td>\n | Table 200-11 Corresponding NQA Sections (Requirement 10) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 311<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 312<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 313<\/td>\n | Table 200-17 Corresponding NQA Section (Requirement 16) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 314<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 315<\/td>\n | Table 200-20 Corresponding NQA Sections (Parts I and II) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 316<\/td>\n | Table 200-21 Corresponding NQA Sections (Part II) to ANSI\/ANS-15.8 <\/td>\n<\/tr>\n | ||||||
| 317<\/td>\n | SUBPART 4.1.6 Guidance to Modification of an NQA-1\u20132019 Quality Program to Meet IAEA GSR Part 2 (2016) Management System Requirements 100 PURPOSE AND SCOPE 200 APPLICABILITY 300 BACKGROUND 301 Global Uses of NQA-1 and GSR Part 2 302 Conceptual Approaches to the Development of NQA-1 and GSR Part 2 400 HOW TO USE THIS GUIDE TO ACHIEVE COMPLIANCE WITH NQA-1 <\/td>\n<\/tr>\n | ||||||
| 318<\/td>\n | Table 400-1 The Extent to Which NQA-1 Addresses GSR Part 2 Requirements <\/td>\n<\/tr>\n | ||||||
| 324<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 325<\/td>\n | 104 Research and Development Process Interfaces and Continuity Figure 103 Technology Life Cycle <\/td>\n<\/tr>\n | ||||||
| 326<\/td>\n | 200 RESEARCH AND DEVELOPMENT QUALITY ASSURANCE THROUGH PEER REVIEW 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 <\/td>\n<\/tr>\n | ||||||
| 327<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 328<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 329<\/td>\n | 603 NQA-1, Requirement 3: Design Control 604 NQA-1, Requirement 4: Procurement Document Control 605 NQA-1, Requirement 5: Instructions, Procedures, and Drawings <\/td>\n<\/tr>\n | ||||||
| 330<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 331<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 332<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 333<\/td>\n | Table 700 Comparison of Subpart 4.2.1 Technology Life Cycle and Technology Readiness Levels <\/td>\n<\/tr>\n | ||||||
| 334<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 335<\/td>\n | 402 Data Corroboration Method 403 Confirmatory Testing Method 404 Peer Review Method 500 DOCUMENTATION OF RESULTS <\/td>\n<\/tr>\n | ||||||
| 336<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 337<\/td>\n | 300 TECHNICAL DATA 301 Data Identification 302 Data Validation, Verification, and Qualification 303 Data Usage 304 Model Validation 400 SAMPLE CONTROL <\/td>\n<\/tr>\n | ||||||
| 338<\/td>\n | 500 PEER REVIEW 501 General Guidance for Peer Review <\/td>\n<\/tr>\n | ||||||
| 339<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 340<\/td>\n | 302 Testing of Facility Systems and Components <\/td>\n<\/tr>\n | ||||||
| 341<\/td>\n | 303 Turnover to Operations 304 Preparation for Operation 305 Start-Up Test Program <\/td>\n<\/tr>\n | ||||||
| 342<\/td>\n | 400 RECORDS <\/td>\n<\/tr>\n | ||||||
| 343<\/td>\n | SUBPART 4.2.6 Guidance on Quality Assurance for Decommissioning of Nuclear Facilities 100 GENERAL 101 Definitions 200 PREREQUISITES <\/td>\n<\/tr>\n | ||||||
| 344<\/td>\n | 300 PREDECOMMISSIONING CHECKS 301 General 302 Plans, Specifications, and Procedures <\/td>\n<\/tr>\n | ||||||
| 345<\/td>\n | 303 Identification 304 Physical Condition <\/td>\n<\/tr>\n | ||||||
| 346<\/td>\n | 305 System Protection 400 CONTROL DURING DECOMMISSIONING 401 General 402 Processes and Procedures Control <\/td>\n<\/tr>\n | ||||||
| 347<\/td>\n | 403 Checks of Systems, Components, and Equipment Required for Decommissioning 404 Checks During Decommissioning 500 POSTDECOMMISSIONING CHECKS 600 RECORDS <\/td>\n<\/tr>\n | ||||||
| 348<\/td>\n | SUBPART 4.2.7 Guidance on Peer Review 100 GENERAL 200 TERMS AND DEFINITIONS 300 PERFORMANCE 301 General <\/td>\n<\/tr>\n | ||||||
| 349<\/td>\n | 302 Planning <\/td>\n<\/tr>\n | ||||||
| 350<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 351<\/td>\n | 700 RECORDS <\/td>\n<\/tr>\n | ||||||
| 352<\/td>\n | SUBPART 4.2.8 Guidance for Prevention, Detection, and Control of Counterfeit, Fraudulent, or Suspect Items (CFSI) 100 GENERAL 101 Definitions 102 Identification Of Potential CFSI <\/td>\n<\/tr>\n | ||||||
| 353<\/td>\n | 103 Situations Increasing the Risk Of CFSI 200 PREVENTION 201 Quality Assurance Program 202 Procurement Document Control 203 Control of Purchased Items and Services 300 DETECTION 301 Organization <\/td>\n<\/tr>\n | ||||||
| 354<\/td>\n | 302 Quality Assurance Program 303 Control Of Purchased Items And Services 304 Inspection 305 Audits 400 CONTROL 401 Organization 402 Control Of Nonconforming Items 403 Corrective Action <\/td>\n<\/tr>\n | ||||||
| 355<\/td>\n | 500 RECORDS 600 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 356<\/td>\n | SUBPART 4.2.9 Guidance on Quality Assurance for Low-Level Waste Shipping from Nuclear Facilities 100 GENERAL 101 Definitions <\/td>\n<\/tr>\n | ||||||
| 357<\/td>\n | Table 100-1Regulation and Other References <\/td>\n<\/tr>\n | ||||||
| 361<\/td>\n | 102 Application of Requirements to LLW Shipping Activities 200 PREREQUISITES 201 Planning and Procedures 202 Requirement Implementation and Quality Maintenance 300 PRESHIPPING CHECKS 301 Personnel Qualifications and Training <\/td>\n<\/tr>\n | ||||||
| 362<\/td>\n | 302 Characterization <\/td>\n<\/tr>\n | ||||||
| 363<\/td>\n | 400 PROCUREMENT OF ITEMS AND SERVICES 500 CONTAINERS\/PACKAGING 600 EQUIPMENT AND CALIBRATION 601 Control of Measuring and Test Equipment 700 DISPOSITION 701 DOE Disposal 702 Non-DOE Disposal <\/td>\n<\/tr>\n | ||||||
| 364<\/td>\n | 703 Shipping and Transport Paperwork 800 SHIPPING VEHICLE INSPECTION 801 Vehicles 900 AUDITS 901 Internal Audits 902 External Audits 903 Audits by External Entities 1000 POST-SHIPPING CHECKS 1100 RECORDS <\/td>\n<\/tr>\n | ||||||
| 366<\/td>\n | Figure 100-1Low-Level Water Shipper Guidance <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ASME NQA-1-2022 Quality Assurance Requirements for Nuclear Facility Applications<\/b><\/p>\n |