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

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

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

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

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

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)

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

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

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

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

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

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

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

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, Testing of PI&C Equipment deleted

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

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

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

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

NQA-1-2008 through 2015 Evolution Questions?

2015 Analytical Services Program Workshop Charleston, South Carolina Thursday Morning, September 17, 2015 Break 4/24/2017