This briefing was presented at the recently complete American Nuclear Society Annual Meeting. The ANS website will also have the briefing (Tech Session, Panel Discussion, Wed. June 27, 1-4 PM)

1. NQA-1-2012
Changes In Support Of
DOE, Industry and
Nuclear Facility Safety
American Nuclear Society Annual Meeting, Chicago, IL June 27, 2012
Gustave (Bud) Danielson
Chief of Nuclear Safety Staff,
Office of the Under Secretary for Nuclear Security
Vice Chair, ASME Committee on Nuclear Quality Assurance
Ron Schrotke
Chief Technical Authority, Quality
Pacific Northwest National Laboratory
Chair, ASME Committee on Nuclear Quality Assurance

2. DOE nuclear facilities regulated under
10 CFR 830 will now have
requirements in NQA-1 that close
the former gaps with DOE Quality
Improvement and Management
Assessment Quality Criteria.
An Implementing Standard for
10 CFR 830, Nuclear Safety
Management

3.  Part I Introduction- clarified requirements
vs guidance expectations
 New Part II for Management Assessment
& Quality Improvement will allow for
common implementation requirements
 Part II updates resolves questions on
“NPP”
 Part III Software CGD Guide provides
clear methods and bridges gaps
 Part III Corrective Action Guide better
aligns with DOE requirements and guide
Part III & IV renumbering simplifies, ties
to Part I
2012 Benefits DOE QA Managers

4. New Part II requirements for quality
improvement & management
assessment
 Consensus implementing methods
 Builds on Part I requirements (gap closure)
 Improves compliance and flow-down
 Transparent to all suppliers using NQA-1
 Flexible and Graded
 Not applicable to NRC-regulated activities
 Bonus – also close gaps w/IAEA GS-R-3
Assessment & Improvement requirements
What Was Added to NQA-1?

5.  Quality Improvement: “Review item
characteristics, process implementation, and
other quality-related information to identify
items, services, and processes needing
improvement.”
 Management Assessment: “Ensure
managers assess their management processes
and identify and correct problems that hinder the
organization from achieving its objectives.”
 Overview of new requirements
 Examples of flexibility & grading
10 CFR 830 Criteria for Quality
Improvement & Management
Assessment

6. Revision to Subpart 4.2 (Application of
NQA-1 in an R&D environment)
 Relationship to other evolutionary
development processes (e.g., Technology
Readiness Levels)
 Enhanced description of software in an
R&D environment (i.e., how does software
efforts “fit” into the R&D evolution
process).
Aid to DOE R&D Operations

7.  Part I Introduction- clarified requirements vs guidance
expectations
 Records, Part I – minor changes
 Packing, Shipping, Receipt, Storing, …, P II, 2.2 update
 Housekeeping , P II, 2.3 update
 Subsurface Investigations, P II, 2.20 - update
 Management Assessment, P II, 2.xx - new
 Quality Improvement, P II, 2.xx - new
 SQA Commercial Grade Dedication Guide, P III,
 Corrective Action Guide, P III, 16A1 – update
 Reorganized Parts III & IV to align with Part I & II
 R&D application guide PIV, 4.2 expanded & clarified
 Inquiries - Many and varied topics!!
Expected Changes for 2012

8. 2.1 Cleaning Fluid Sys 2.8 Mechanical - 2012??
– Pending update 2.14 CGD - Published
2014 2.15 Hoist/Rig - Pending
2.2 Pkg, Ship - 2012 xfr to CNF
2.3 Housekeeping 2012 2.16 M&TE – Removed
2.4 Power/Instr/Control 2010
– pending removal 2.18 Maintenance -
2.5 Concrete/Steel - Pending update 2014
Published 2.20 Subsurface 2012
2.7 SQA - Published
Part II Update Progress!

9. Considerations on requests and
application of Inquiries:
 Requests to the NQA Committee must
meet ASME requirements
 Inquirer interactions with NQA Project
Manager
 QAP implications
 Contract implications
 Regulatory implications
Inquiries

10. Question: For an implementer, is choosing to apply only
paragraph 100 of applicable requirements of Parts I and II
of the standard an appropriate and sufficient method to
implement a NQA-1 based Quality Assurance program?
Response: No. With the exception of the Part I requirement
areas: 5, Instructions, Procedures and Drawings; 14;
Inspection, Test and Operating Status; and 16 Corrective
Action, paragraph 100 is a summary and introductory
paragraph for additional mandatory criteria contained in
the requirement area.
The application of only section 100 by an implementing
organization is insufficient to claim credit for implementing
Part I or Part II of an NQA-1 based Quality Assurance
program. It is also insufficient for an invoking organization
to invoke only section 100 of Part I or Part II and expect
results equivalent to specifying all of Parts I or II. This
response is applicable to NQA-1-2000, NQA-1-2004, NQA-
1-2008 and the NQA-1b-2011 Addenda
Example Inquiry – Section 100

11. Committee is engaging the user community to
enhance the immediacy of the Standard
• Guidance on using NQA-1 beyond 10 CFR 50 Appd B
 Use in a R&D environment
 Relationship to other requirements (e.g., DOE, EPA, IAEA)
 Commercial Grade Dedication, including Software
 Guidance on how CGD activities relate to software
• Looking forward to the next edition - 2014:
• Enhanced considerations on Peer Review
• Comparison of research reactor guidance (e.g., ANS 15.8)
• Consolidation of SQA requirements??
• 2.2 ??
• Part III Comprehensive review and updates??
Chair’s Perspective
Ron Schrotke, ASME Committee on Nuclear Quality Assurance