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

2. ASME NQA-1 Updates and Revisions
NQA 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 (Continued)
Part II Introduction significantly revised to clarify applicability
Subpart 4.6, Application Guidance on the Use of NQA 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 to Meet NQA , updated to ISO-9001:2008 and NQA /2009

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

10. NQA
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 , Corrective Action, substantially revised
Subpart , Audits, minor subparagraph revisions

12. NQA (Continued)
Added Subpart , 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
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 (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

15. NQA (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 , Guidance for Design Control
401, Use of Computer Programs for Design Analysis added
Additional enhancements added
Subpart , 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
Subpart , Guidance on Classification and Handling of Audit Issues added
Subpart , Guidance on Parts I and II Requirements for Software added

17. NQA (Continued)
Subpart 4.1.5, Guidance to Modify an ANSI/ANS-15.8 Program (Research Reactors) to meet NQA
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 Workshop Charleston, South Carolina Thursday Morning, September 17, 2015
Break
4/24/2017