NQA-1 Evolution2008 – 2015Mike Nicol

DOECAP ASP Workshop

Sept. 14,2015

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 WorkshopCharleston, South Carolina

Thursday Morning, September 17, 2015

Break

04/21/23

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