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NQA-1 Evolution 2008 – 2015 Mike Nicol DOECAP ASP Workshop Sept. 14,2015

NQA-1 Evolution 2008 – 2015 Mike Nicol DOECAP ASP Workshop Sept. 14,2015. ASME NQA-1 Updates and Revisions. NQA-1-1979 was 1 st Edition Updated Editions published ~ every 3 years (1983, 1986, 1989, 1994, 1997, 2000, 2004, 2008, 2012, 2015) Addenda published every year

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NQA-1 Evolution 2008 – 2015 Mike Nicol DOECAP ASP Workshop Sept. 14,2015

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  1. NQA-1 Evolution2008 – 2015Mike NicolDOECAP ASP WorkshopSept. 14,2015

  2. ASME NQA-1 Updates and Revisions NQA-1-1979 was 1st Edition Updated Editions published ~ every 3 years (1983, 1986, 1989, 1994, 1997, 2000, 2004, 2008, 2012, 2015) Addenda published every year Starting in 2012 Editions published every 2 years with no addenda publication

  3. NQA-1-2008 Issued 3/19/2008 as 9th Edition Performance based requirements deleted in 2004 Edition added back in (e.g. QA staff responsibilities) Appendix 7A-2, Guidance on Commercial Grade Items and Services, revised and designated in Subpart 2.14 as requirements

  4. NQA-1-2008 (Continued) • Part II Introduction significantly revised to clarify applicability • Subpart 4.6, Application Guidance on the Use of NQA-1-2000 for Compliance With 10 CFR 71 and/or 10 CFR 72 Requirements

  5. NQA-1a-2009 • Endorsed by DOE and NRC • Three Commercial Grade Item definitions • Requirements 3 and 7 specify Subpart 2.14 for CGD • Expansion on Requirement 11 for computer program testing; Appendix 11A-1 folded in • Minor technical changes to Subpart 2.1, Cleaning of Fluid Systems

  6. NQA-1a-2009 (Continued) Minor technical changes to Subpart 2.2, Packaging, Shipping, Receiving, Storage, and Handling plus scope expansion from power plants to nuclear facilities Subpart 2.7, Computer Software QA, requires Subpart 2.14 for software CGD Security features added to software design requirements (vulnerability protections)

  7. NQA-1a-2009 (Continued) Subpart 2.14 revised in its entirety (combining prior Subpart 2.14 and Requirement 7 CGD) Appendix 17A-1 List of Typical Lifetime Records expanded Subpart 4.2, Graded Application of NQA to R&D versus QA for Nuclear R&D

  8. NQA-1b-2011 • Requirements 1 – 18, Article 100 titles revised from Basic to General • Subpart 2.5, Installation, Inspection and Testing of Structural Concrete, Steel, Soils, and Foundations • Title changed from power plants to nuclear facilities • Substantial update (32 locations changed) • Subpart 4.3, Use of ISO-9001-2000 to Meet NQA-1-2000, updated to ISO-9001:2008 and NQA-1-2008/2009

  9. NQA-1b-2011(continued) • Subpart 4.5, Use of NQA-1-2000 for Compliance with 10 CFR 830 Subpart A and DOE O 414.1, updated to NQA-1-2008/2009 • Added Subpart 4.7, Comparison of NQA-1-2008/2009 and IAEA GS-R-3, 2006-STI/PUB/1252

  10. NQA-1-2012 • Minor technical changes to Subpart 2.2, Packaging, Shipping, Receiving, Storage, and Handling plus, 405, Shipments From Countries Outside the US added • Subpart 2.3, Housekeeping, scope expanded from power plants to nuclear facilities • Subpart 2.8, Installation, Inspection, and Testing of Mechanical Systems • Scope expanded from power plants to nuclear facilities • Substantially rewritten

  11. NQA-1-2012 (Continued) • Subpart 2.20, Subsurface Investigations • Scope expanded from power plants to nuclear facilities • Substantially updated • Added Subpart 2.22, Management Assessment and Quality Improvement for 10 CFR 830 and DOE O 414.1 • Nonmandatory Appendices changed to Subparts • Subpart 3.1-16.1, Corrective Action, substantially revised • Subpart 3.1-18.1, Audits, minor subparagraph revisions

  12. NQA-1-2012 (Continued) • Added Subpart 3.2-2.14, Guidance on CGD of Computer Programs and Computer Services • Subpart 4.2.1, Guidance on Graded Application of QA to Nuclear R&D, revised and enhanced

  13. NQA-1-2015 • Parts I, II, III and IV Introduction; clarified Purpose, Applicability, Responsibility • Requirement 2, QA Program, 400 Records of Qualification, corrected for Lead Auditors and Inspection and Test personnel • Requirement 3, Design Control • 401 Use of Computer Programs for Design Analysis, clarified • 800 Software Design Control, 801 – 802 replaced by Subpart 2.7

  14. NQA-1-2015 (Continued) • Requirement 11, Test Control, Computer Program Test Control elements replaced by Subpart 2.7 • Requirement 18, Audits, grace period of 90 days allowed for scheduled audits and evaluations • Subpart 2.1, Cleaning of Fluid Systems • Expanded from power plants to nuclear facilities • Technical content updated • Subpart 2.4, Installation, Inspection, Testingof PI&C Equipment deleted

  15. NQA-1-2015 (Continued) • Subpart 2.7, Computer Software, substantially revised including elements of software design control and testing • Subpart 2.16, Calibration and Control of M&TE deleted • Subpart 3.1-3.1, Guidance for Design Control • 401, Use of Computer Programs for Design Analysis added • Additional enhancements added • Subpart 3.1-7.1, Guidance on Control of Purchased Items and Services, 705 Determining Authenticity added

  16. NQA-1-2015 (Continued) • Subpart 3.1-18.1, Guidance on Audits • 204 Shared External Audits added • Audit scheduling guidance deleted (moved into Requirement 18) • 600 Response and 700 Follow-up Action revised and refer to new Subpart 3.1-18.2 • Subpart 3.1-18.2, Guidance on Classification and Handling of Audit Issues added • Subpart 3.1-2.7.2, Guidance on Parts I and II Requirements for Software added

  17. NQA-1-2015 (Continued) Subpart 4.1.5, Guidance to Modify an ANSI/ANS-15.8 Program (Research Reactors) to meet NQA-1-2012 Subpart 4.2.7, Guidance on Peer Review added

  18. NQA-1-2017 • Vision 2017 • Revise Requirements 4 & 7 for S/CI • Revise Requirements 4, 7, 18 for NQA Certification Program • New Subpart on Graded QA • New Subpart on Calibration and Testing Facilities • New Subpart to replace OCRWM QARD • New Part 5 Requirements and Guidance on QMS

  19. NQA-1-2008 through 2015 Evolution Questions?

  20. 2015 Analytical Services Program WorkshopCharleston, South CarolinaThursday Morning, September 17, 2015 Break

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