NQA AUDITING

National E&E Division Conference

September 17, 2008
C. H. Moseley, Jr.
Senior Executive Consultant

 Chronology of Nuclear Standards Development

Structure of ASME NQA-1
Auditing using ASME NQA-1

NQA Chronology
1950s
AEC SFO QC-1
MIL-Q-1958

1960s
MIL-Q-1958A
10 CFR50 APPENDIX A
AEC>DOE RDT F2-2T

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

1980s
DOE O 5700.6, 6A, 6B
ANS 3.2-1982
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
ANS 3.2-1988
ASME NQA-1-1989
ASME NQA-3-1989

(N45.2.6, 2.9, 2.10, 2.11, 2.12, 2.13, 2.23)

NQA Chronology
1990s
2000s
NRC Standard Review Plan DOE O 414.1B
(NQA-1 & NQA-2)
DOE O 414.1C
DOE O 5700.6C
DOE 10CFR Part 830
DOE 10CFR Part 830
(sub-part 830-122)
(sub-part 830-122)
ASME NQA-1-2000
ASME NQA-1-1994
ASME NQA-1-2004
ANS 3.2-1994
ANS 3.2-2006
ASME NQA-1-1997
ASME NQA-1-2008
DOE O 414.1A

Layout of NQA-1
Part I - Requirements for QA Programs for
Nuclear Facilities (Formerly NQA-1)
Part II - QA requirements for Nuclear Facility
Applications
Part III Non-mandatory Appendices (From
former NQA-1 and NQA-2)
Part IV Non-mandatory Appendices Positions
and Application Matrices

Underlying NQA-1 Principles

NQA-1
Basic
Requirement
BR 1
Organization

Senior management:
9
9
9
9
9

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:
9
9
9
9

Ensures proper development and implementation

of the organizations 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

9
9

Items are designed and changes controlled

using sound engineering practices, analyses
and configuration management
Designs are analyzed and verified

BR 4 & 7
Procurement

Items and services are purchased, accepted

and controlled to specified requirements

BR 5
Instructions,
procedures
and drawings

9
9

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

Quality documents and records are developed,

identified and controlled in accordance with
specified requirements

BR 8 & 13
Item
identification
and control

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

BR 9
Process
control

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
9
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

Part I Introduction
Purpose - QA Requirements for Nuclear facilities
Applicability - Part I Applies to activities that
could affect quality of nuclear material
applications, structures, systems and
components of nuclear facilities
Activities to which it applies listed

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Introduction
Application of Part I or portions thereof to be invoked
by written contracts, policies, procedures,
specifications or other appropriate documents
Responsibility
Organization invoking shall specify which requirements
or portions related to specific items and services
Organization implementing responsible to comply with
requirements to achieve results

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NQA-1 Part II
QA requirements for planning and conducting of
fabrication, construction, modification, repair,
maintenance and testing of systems components or
activities for nuclear facilities (i.e., requirements for
work practices)

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Requirement 18 Audits

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Types of QA Audits
Adequacy Audit
Implementation Audit
Effectiveness Audit (Performance-Based)
Full Scope
Partial Scope

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Requirement 18 Audits
Audits Shall be Planned and Scheduled to Verify Compliance
and Effectiveness with all Aspects of the QA Program
Performed per Procedures by Personnel Independent of the
Activities being Audited
Audit Results are Documented and Reported
Objective:
To determine by Independent Investigation Examination, or
Evaluation of Objective Evidence the Adequacy,
Implementation and Effectiveness of a Process

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Audit Preparation
Audit Preparation shall include:

A review of background information, procedures and

technical documents so that audit team members
are familiar with the work being audited.
A review of past audit results to determine the
nature of corrective action that have been taken and
determine whether the corrective actions were
effective in preventing recurrence.

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Requirement 18 Audits
Audit Elements:
Scheduling
Preparation (Audit Plan, Personnel Selection,
Checklists, Logistics, etc.)
Performance (Interviews, Observations and Records
Review)
Reporting
Response to Corrective Actions
Follow-Up Actions
Records
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Requirement 18 Audits
Auditor Qualifications (Requirement 2, Training)
Technical Specialists
Auditors
Lead Auditor
Background
Examination

Communication
Certification

Why Do We Perform Audits?

Why is It Required that Auditor Independence be
Maintained?

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Summary Audits
The Auditee, responsible for the performance of
activities, implements a program of surveillances and
audits using Qualified Personnel.
The Assessment program shall be planned, documented
and include both routine surveillance of activities and
audits to verify compliance with all aspects of the QA
program and to determine adequacy and effectiveness.
Assessment Results shall be Documented.
Audit QA Records shall be Retained and Maintained

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Questions
?????

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