NQA-1-2012Changes In Support Of

DOE, Industry and Nuclear Facility Safety

Gustave (Bud) DanielsonChief of Nuclear Safety Staff,

Office of the Under Secretary for Nuclear SecurityVice Chair, ASME Committee on Nuclear Quality Assurance

Ron SchrotkeChief Technical Authority, Quality

Pacific Northwest National Laboratory Chair, ASME Committee on Nuclear Quality Assurance

American Nuclear Society Annual Meeting, Chicago, IL June 27, 2012

An Implementing Standard for 10 CFR 830, Nuclear Safety Management

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.

2012 Benefits DOE QA Managers

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

What Was Added to NQA-1?

New Part II requirements for quality improvement & management assessment

Consensus implementing methods Builds on Part I requirements (gap closure)Improves compliance and flow-downTransparent to all suppliers using NQA-1Flexible and GradedNot applicable to NRC-regulated activitiesBonus – also close gaps w/IAEA GS-R-3

Assessment & Improvement requirements

10 CFR 830 Criteria for Quality Improvement & Management Assessment

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 requirementsExamples of flexibility & grading

Aid to DOE R&D Operations

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).

Expected Changes for 2012

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!!

Part II Update Progress!

2.1 Cleaning Fluid Sys – Pending update 2014

2.2 Pkg, Ship - 20122.3 Housekeeping 20122.4 Power/Instr/Control

– pending removal2.5 Concrete/Steel -

Published2.7 SQA - Published

2.8 Mechanical - 2012?? 2.14 CGD - Published2.15 Hoist/Rig - Pending

xfr to CNF 2.16 M&TE – Removed

20102.18 Maintenance -

Pending update 20142.20 Subsurface 2012

Inquiries

Considerations on requests and application of Inquiries:

Requests to the NQA Committee must meet ASME requirements

Inquirer interactions with NQA Project Manager

QAP implicationsContract implicationsRegulatory implications

Example Inquiry – Section 100

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

Chair’s Perspective Ron Schrotke, ASME Committee on Nuclear Quality Assurance

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??