NQA AUDITING - .NQA AUDITING National E&E ... REG Guide 1.28, Rev 3 ASME NQA-2-1983 ... ASME NQA-3-1989

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Text of NQA AUDITING - .NQA AUDITING National E&E ... REG Guide 1.28, Rev 3 ASME NQA-2-1983 ... ASME...


    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


  • NQA Chronology


    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

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    NQA 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


  • Underlying NQA-1 Principles


    Senior management:Defines policies and objectivesEstablishes and communicates expectations for quality and continual improvementIdentifies and allocates resources to achieve expectationSpecifies roles, responsibilities and authoritiesEnsures NQA principles are understood, accepted and followed

    Quality of work is:Achieved and maintained by performersVerified by those not directly responsible for performing the work

    Basic RequirementBR 1Organization


  • Underlying NQA-1 Principles


    Management:Ensures proper development and implementation of the organizations QAPEnsures people are competent to perform their assigned quality-affecting workProvides training to achieve and maintain worker proficiency and qualificationsAssesses QAP and management systems to ensure compliancy, adequacy effectiveness and efficiencySeeks and uses relevant experience

    BR 2QA Program


  • Underlying NQA-1 Principles


    Work processes are planned and controlledActivities are performed in accordance with prescribed documentationManagement ensures the right people have the right information at the right time

    BR 5Instructions, procedures and drawings

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

    BR 4 & 7Procurement

    Items are designed and changes controlled using sound engineering practices, analyses and configuration managementDesigns are analyzed and verified

    BR 3Design Control


  • Underlying NQA-1 Principles


    Special processes for achieving quality are performed under controlled conditions to specified requirementsUse of correct materials, tools and processes and control changes is assured

    BR 9Process control

    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

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

    BR 6 & 17Documents and records


  • Underlying NQA-1 Principles


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

    BR 14Inspection, test and operating status

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

    BR 12Measuring and test equipment control

    Items are inspected and tested to verify conformance to specified requirements

    BR 10 & 11Inspection and test control


  • Underlying NQA-1 Principles


    The QAP is assessed using compliance and performance-based methods

    BR 18Audits

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

    BR 16Corrective action

    Items that do not meet specified requirements are identified and controlled

    BR 15Control of non-conforming items


  • 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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    IntroductionApplication of Part I or portions thereof to be invoked

    by written contracts, policies, procedures, specifications or other appropriate documents


    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 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)

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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 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.

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    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

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    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?

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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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