NQA AUDITING

National E&E Division ConferenceSeptember 17, 2008

C. H. Moseley, Jr.Senior Executive Consultant

Chronology of Nuclear Standards Development

Structure of ASME NQA-1

Auditing using ASME NQA-1

2

NQA Chronology

3

1980sDOE O 5700.6, 6A, 6BANS 3.2-1982ASME NQA-1-1983(N45.2.1, 2.2, 2.3, 2.5, 2.8, 2.15, 2.20)

REG Guide 1.28, Rev 3ASME NQA-2-1983ASME NQA-1-1986ANS 3.2-1988ASME NQA-1-1989ASME NQA-3-1989

1970s10 CFR50 Appendix A10 CFR50 Appendix BANSI N45-2-1971AEC Safety Guide 28ANSI N18.7(ANS 3.2)ANSI/ASME N45.2-1977ASME N45.2.9 2.23NRC Rainbow seriesANSI N46.2-1978ASME NQA-1-1979(N45.2.6, 2.9, 2.10, 2.11, 2.12, 2.13, 2.23)

1960sMIL-Q-1958A10 CFR50 APPENDIX AAEC>DOE RDT F2-2T

1950sAEC SFO QC-1MIL-Q-1958

4NQA Chronology2000s

DOE O 414.1BDOE O 414.1CDOE 10CFR Part 830

(sub-part 830-122)

ASME NQA-1-2000ASME NQA-1-2004ANS 3.2-2006ASME NQA-1-2008

1990sNRC Standard Review Plan

(NQA-1 & NQA-2)

DOE O 5700.6CDOE 10CFR Part 830

(sub-part 830-122)

ASME NQA-1-1994ANS 3.2-1994ASME NQA-1-1997DOE 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

6

Underlying NQA-1 Principles

7

Senior management:9 Defines policies and objectives9 Establishes and communicates expectations for

quality and continual improvement9 Identifies and allocates resources to achieve

expectation9 Specifies roles, responsibilities and authorities9 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

Basic RequirementBR 1Organization

NQA-1

Underlying NQA-1 Principles

7

Management:9 Ensures proper development and implementation

of the organizations QAP9 Ensures people are competent to perform their

assigned quality-affecting work9 Provides training to achieve and maintain worker

proficiency and qualifications9 Assesses QAP and management systems to

ensure compliancy, adequacy effectiveness and efficiency

9 Seeks and uses relevant experience

BR 2QA Program

NQA-1

Underlying NQA-1 Principles

7

9 Work processes are planned and controlled9 Activities are performed in accordance with

prescribed documentation9 Management ensures the right people have the

right information at the right time

BR 5Instructions, procedures and drawings

9 Items and services are purchased, accepted and controlled to specified requirements

BR 4 & 7Procurement

9 Items are designed and changes controlled using sound engineering practices, analyses and configuration management

9 Designs are analyzed and verifiedBR 3Design Control

NQA-1

Underlying NQA-1 Principles

7

9 Special processes for achieving quality are performed under controlled conditions to specified requirements

9 Use of correct materials, tools and processes and control changes is assured

BR 9Process control

9 Items are identified and controlled during shipping, handling, installation or use to assure their quality and prevent damage, loss or deterioration

BR 8 & 13Item identification and control

9 Quality documents and records are developed, identified and controlled in accordance with specified requirements

BR 6 & 17Documents and records

NQA-1

Underlying NQA-1 Principles

7

9 Item inspection, test and operating status are identified to ensure required activities have been performed successfully

BR 14Inspection, test and operating status

9 M&TE used for activities affecting quality are controlled to specified accuracy requirements

BR 12Measuring and test equipment control

9 Items are inspected and tested to verify conformance to specified requirements

BR 10 & 11Inspection and test control

NQA-1

Underlying NQA-1 Principles

7

9 The QAP is assessed using compliance and performance-based methods

BR 18Audits

9 Conditions adverse to quality are identified, controlled and corrected to prevent recurrence, and reviewed for lessons learned

BR 16Corrective action

9 Items that do not meet specified requirements are identified and controlled

BR 15Control of non-conforming items

NQA-1

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

10

11

IntroductionApplication 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

11

NQA-1 Part IIQA 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)

11

Requirement 18 Audits

11

Types of QA Audits Adequacy Audit

Implementation Audit

Effectiveness Audit (Performance-Based)

Full Scope

Partial Scope

11

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

11

Audit PreparationAudit 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.

11

Requirement 18 AuditsAudit 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

11

Requirement 18 AuditsAuditor Qualifications (Requirement 2, Training) Technical Specialists Auditors Lead Auditor

Background Communication Examination Certification

Why Do We Perform Audits?

Why is It Required that Auditor Independence be Maintained?

11

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

11

Questions?????