# Presentation: 807534

## Continuing Evolution of U.S. Nuclear Quality Assurance Principles, Practices and Requirements1954 - 2005

**PART II - A  Tutorial**
- August 2005
- This document is for information only and is not a part of  the ASME NQA-I-2004 Standard.

## 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**

## 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

## 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

## 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)

## 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)

## 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)

## 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.

## 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**.

## 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

## 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.

## 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)**

## 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”

## 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)

## 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)

## 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
 |
| --- | --- |

## 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 |
| --- | --- |

## 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  |
| --- | --- |

## 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
 |
| --- | --- |

## 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 |
| --- | --- |

## 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
 |
| --- | --- |

## NQA Chronology

| 1950s

AEC SFO QC-1
MIL-Q-1958

 | 1960s

MIL-Q-1958A
10 CFR50 APPENDIX A AEC>DOE RDT F2-2T
 |
| --- | --- |

## NQA Chronology

| 1970s
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) | 1980s
DOE 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 |
| --- | --- |

## 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

 |
| --- | --- |