1 Continuing Evolution of U.S. Nuclear Quality Assurance Principles, Practices and Requirements PART II - A Tutorial August 2005 This document is for information only and is not a part of the ASME NQA-I-2004 Standard.

2 NQA Historical and Tutorial Purposes PART I describes how nuclear quality assurance (NQA) has evolved in the U.S. over 50 years from 1954 as reactions and responses to:  public concerns  government regulations  program needs  experiences  quality failures  external events PART II (this part) is intended to acquaint the next generation of management, technical and quality professionals with NQA):  terms and definitions  paradigm shifts from ineffectual concepts  principles underlying NQA-1 requirements  program lessons

3 PART II - NQA Tutorial Outline Acronyms NQA Evolutionary Paths Terms and Definitions NQA Paradigm Shifts from ineffectual concepts Underlying NQA-1 Principles NQA Program Lessons NQA Chronology Specificity

4 Acronyms AEC Atomic Energy Commission ANSI American National Standards Institute ASLB Atomic Safety and Licensing Board ASME American Society of Mechanical Engineers 10 CFR Title 10 Code of Federal Regulations DOE U.S. Department of Energy NRC U.S. Nuclear Regulatory Commission NQA Nuclear Quality Assurance NUREGNuclear Regulations QA Quality Assurance QAP Quality Assurance Program QC Quality Control

5 NQA Evolutionary Paths AEC>DOE Standards and Directives AEC>NRC Regulations, Regulatory Guides, Standard Review Plans ANSI>ASME N45.2> NQA-1/2/3 Standards Other related NQA Standard (ANS, IEEE, etc)

6 Terms and Definitions Quality: The condition achieved (or existing) when an item, service or process meets or exceeds the users’ requirements or expectations (Source:DOE) Quality assurance : All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. (Source: 10 CFR 50 Appendix B) All those actions that provide confidence that quality is achieved (or exists) (Source:ASME NQA-1)

7 Terms and Definitions QAP - An overall plan, program or management system established to: Define quality policies, purpose, objectives, requirements, standards, practices and procedures Scope applicable items and activities Assign organizational responsibilities and authorities for management, achievement and assurance of quality Designate need for training and qualification of personnel Provide for performance, assessment and continual improvement of work processes ( Source: ASME NQA-1, DOE)

8 NQA Paradigm Shift Ineffective Concept Quality is “inspected into” an item. Present NQA-1 Culture Quality is achieved by people possessing the competence, skills, knowledge, experience, training, resources and work ethic and motivation to do the job right.

9 NQA Paradigm Shift Ineffective Concepts NQA-1 was written by and for QA professionals NQA applied only to safety structures, systems and components NQA program required strict compliance with inflexible requirements and procedures Present NQA-1 Culture NQA-1 is written by and for managers, performers and verifiers. NQA-1 requires a quality management system that applies to safe and reliable operation across the nuclear facility. NQA-1 program applies a sensible graded approach that is both compliance and performance oriented.

10 NQA Paradigm Shift Ineffective Concept Quality professionals are primarily responsible for planning, documenting and implementing the organization’s quality assurance program (quality management system) Present NQA-1 Culture Persons who manage, perform and verify work all contribute to planning, documenting and implementing an integrated, cost effective and efficient quality management system to produce a quality product

11 NQA Paradigm Shift Ineffective Concept A QAP generates excessive amounts of paper. Present NQA-1 Culture QAP documentation is readily available to provide sufficient objective evidence and a defensible record that NQA requirements and commitments have been met.

12 NQA Program Lesson “No quality assurance program is self- executing. Thus, irrespective of how comprehensive it may appear on paper, the program will be essentially without value unless it is timely, improved and properly implemented.” ( Source: ASLB at Consumer Power Midland Station public licensing hearings, March 1973)

13 NQA Program Lesson “Top-down management commitment to quality is a primary project objective. Top management must understand the magnitude, complexity and difficulties in designing and constructing nuclear power plants compared to conventional steam plants, and the importance of applying exacting engineering and quality standards. Prior nuclear facility design and construction experience of key project personnel is essential.” ( Source NRC NUREG-1055) “Improving Quality and the Assurance of Quality in the Design and Construction of Nuclear Power Plants”

14 NQA Program Lesson “There is a level of change actions – technical, regulatory and procedural – beyond which any project management structure can no longer effectively implement its quality assurance program.” (Source: NRC NUREG-1055)

15 NQA Program Lesson The QAP is implemented as an integral part of a comprehensive management system. The QAP supports prompt detection, communication and correction of quality problems in design, effective management system oversight of the design process, and the ability to control plant configuration and manage change. ( Source: NRC NUREG-1055, as modified)

16 Underlying NQA-1 Principles NQA-1 Basic Requirement BR 1 Organization Senior management: Defines policies and objectives Establishes and communicates expectations for quality and continual improvement Identifies and allocates resources to achieve expectation Specifies roles, responsibilities and authorities Ensures NQA principles are understood, accepted and followed Quality of work is:  Achieved and maintained by performers  Verified by those not directly responsible for performing the work

17 Underlying NQA-1 Principles NQA-1 BR 2 QA Program Management: Ensures proper development and implementation of the organization’s QAP Ensures people are competent to perform their assigned quality-affecting work Provides training to achieve and maintain worker proficiency and qualifications Assesses QAP and management systems to ensure compliancy, adequacy effectiveness and efficiency Seeks and uses relevant experience

18 Underlying NQA-1 Principles NQA-1 BR 3 Design Control BR 4 & 7 Procurement BR 5 Instructions, procedures and drawings Items are designed and changes controlled using sound engineering practices, analyses and configuration management Designs are analyzed and verified Items and services are purchased, accepted and controlled to specified requirements Work processes are planned and controlled Activities are performed in accordance with prescribed documentation Management ensures the right people have the right information at the right time

19 Underlying NQA-1 Principles NQA-1 BR 6 & 17 Documents and records BR 8 & 13 Item identification and control BR 9 Process control  Quality documents and records are developed, identified and controlled in accordance with specified requirements  Items are identified and controlled during shipping, handling, installation or use to assure their quality and prevent damage, loss or deterioration  Special processes for achieving quality are performed under controlled conditions to specified requirements  Use of correct materials, tools and processes and control changes is assured

20 Underlying NQA-1 Principles NQA-1 BR 10 & 11 Inspection and test control BR 12 Measuring and test equipment control BR 14 Inspection, test and operating status Items are inspected and tested to verify conformance to specified requirements M&TE used for activities affecting quality are controlled to specified accuracy requirements Item inspection, test and operating status are identified to ensure required activities have been performed successfully

21 Underlying NQA-1 Principles NQA-1 BR 15 Control of nonconforming items BR 16 Corrective action BR 18 Audits Items that do not meet specified requirements are identified and controlled Conditions adverse to quality are identified, controlled and corrected to prevent recurrence, and reviewed for lessons learned The QAP is assessed using compliance and performance-based methods

22 NQA Chronology 1950s AEC SFO QC-1 MIL-Q s MIL-Q-1958A 10 CFR50 APPENDIX A AEC>DOE RDT F2-2T

23 NQA Chronology 1970s 10 CFR50 Appendix A 10 CFR50 Appendix B ANSI N AEC Safety Guide 28 ANSI N18.7(ANS 3.2) ANSI/ASME N ASME N – 2.23 NRC Rainbow series ANSI N ASME NQA (N45.2.6, 2.9, 2.10, 2.11, 2.12, 2.13, 2.23) 1980s DOE O , 6A, 6B ASME NQA (N45.2.1, 2.2, 2.3, 2.5, 2.8, 2.15, 2.20) REG Guide 1.28, Rev 3 ASME NQA ASME NQA ASME NQA ASME NQA

24 NQA Chronology 1990s NRC Standard Review Plan ( NQA-1 & NQA-2) DOE O C DOE 10CFR Part 830 (sub-part ) ASME NQA ASME NQA DOE O 414.1A 2000s DOE O 414.1B DOE O 414.1C DOE 10CFR Part 830 (sub-part ) ASME NQA ASME NQA