Download pdf - NQA History 1954 2005

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Continuing Evolution of U.S. Nuclear Quality Assurance Principles, Practices and Requirements

1954 - 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


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)


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.


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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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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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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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 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

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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

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NQA Chronology

1990s

NRC Standard Review Plan(NQA-1 & NQA-2)

DOE O 5700.6C

DOE 10CFR Part 830 (sub-part 830-122)

ASME NQA-1-1994

ASME NQA-1-1997

DOE O 414.1A

2000s

DOE O 414.1B

DOE O 414.1C

DOE 10CFR Part 830 (sub-part 830-122)

ASME NQA-1-2000

ASME NQA-1-2004