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Continuing Evolution of U.S. Nuclear Quality Assurance Principles, Practices
and Requirements1954 - 2005
PART II - A TutorialAugust 2005
This document is for information only and is not a part of the ASME NQA-I-2004 Standard.
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NQA Historical and Tutorial PurposesPART 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
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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
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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 NUREG Nuclear Regulations QA Quality Assurance QAP Quality Assurance Program QC Quality Control
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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)
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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)
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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)
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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.
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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.
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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
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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.
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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)
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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”
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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)
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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)
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Underlying NQA-1 PrinciplesNQA-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
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Underlying NQA-1 PrinciplesNQA-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
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Underlying NQA-1 PrinciplesNQA-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
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Underlying NQA-1 PrinciplesNQA-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
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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
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Underlying NQA-1 PrinciplesNQA-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
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NQA Chronology1950s
AEC SFO QC-1
MIL-Q-1958
1960s
MIL-Q-1958A
10 CFR50 APPENDIX A AEC>DOE RDT F2-2T
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NQA Chronology1970s
10 CFR50 Appendix A
10 CFR50 Appendix B
ANSI N45-2-1971
AEC Safety Guide 28
ANSI N18.7(ANS 3.2)
ANSI/ASME N45.2-1977
ASME N45.2.9 – 2.23
NRC Rainbow series
ANSI N46.2-1978
ASME NQA-1-1979(N45.2.6, 2.9, 2.10, 2.11, 2.12, 2.13, 2.23)
1980sDOE O 5700.6, 6A, 6B
ASME NQA-1-1983(N45.2.1, 2.2, 2.3, 2.5, 2.8, 2.15, 2.20)
REG Guide 1.28, Rev 3
ASME NQA-2-1983
ASME NQA-1-1986
ASME NQA-1-1989
ASME NQA-3-1989