Software Dedication Using ASME NQA-1 Approach ... (ASME N QA -1a -2009, Part II, Subpart 2.14, Section

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  • Software Dedication Using

    ASME NQA-1 Approach

    EFCOG Las Vegas – May 2012

    Presented by:

    Ronald C. Schrotke

    Chief Technical Authority, Quality

    Pacific Northwest National Laboratory

    ronald.schrotke@pnnl.gov

    http://www.theseuspro.com

    509-375-6803

    Nancy M. Kyle

    Principal Consultant

    Theseus Professional Services, LLC

    nancy5895@gmail.com

    http://www.theseuspro.com

    706-830-3194

    mailto:ronald.schrotke@pnnl.gov http://www.theseuspro.com/ mailto:nancy5895@gmail.com http://www.theseuspro.com/

  • Topics Covered

     Agree on Software Terms and Uses

     ASME NQA-1 Requirements and Guidance

    for Software Dedication

     Sample CGD Plan Form

     Sample CGD Plan Detailed Review

    Theseus Professional Services, LLC Results Through Service Excellence® Slide 2

  • Disclaimer and Thanks

     The views expressed by the speaker do not represent

    the views or positions of the ASME NQA-1 Committee,

    the NRC or EPRI.

     They are the views of the speaker only

     Josh Kolenc, VP Software Engineering Curtiss Wright

    Flow Control Corp. (Farris Engineering Services)

    http://fes.cwfc.com/Solutions/spokes/iPRSM.htm

     Norm Moreau, Principal Consultant

    nmoreau@theseuspro.com

    Theseus Professional Services, LLC Slide 3 Results Through Service Excellence®

    http://fes.cwfc.com/Solutions/spokes/iPRSM.htm mailto:nmoreau@theseuspro.com

  • Theseus Professional Services, LLC Results Through Service Excellence® Slide 4

    CODE COMPUTER

    PROGRAM

    SOFTWARE

    Let Agree on Terms

    http://www.ebay.com/itm/2006-2007-2008-2009-2010-TurboTax-Federal-Deluxe-5-New-CDs-Boxes-/350508610571?pt=LH_DefaultDomain_0&hash=item519bf0f40b http://www.ebay.com/itm/2006-2007-2008-2009-2010-TurboTax-Federal-Deluxe-5-New-CDs-Boxes-/350508610571?pt=LH_DefaultDomain_0&hash=item519bf0f40b http://www.ebay.com/itm/2006-2007-2008-2009-2010-TurboTax-Federal-Deluxe-5-New-CDs-Boxes-/350508610571?pt=LH_DefaultDomain_0&hash=item519bf0f40b http://www.ebay.com/itm/2006-2007-2008-2009-2010-TurboTax-Federal-Deluxe-5-New-CDs-Boxes-/350508610571?pt=LH_DefaultDomain_0&hash=item519bf0f40b http://www.ebay.com/itm/2007-2008-2009-2010-TurboTax-Federal-Deluxe-4-New-CDs-/350510050192?pt=LH_DefaultDomain_0&hash=item519c06eb90

  • Software Used in the Nuclear Industry

    Results Through Service Excellence® Slide 5

    Use: Design Analysis

    (Design & Analysis) Process Control

    (Digital I&C) Operations

    (Mgmt. & Admin)

    Ex:

    FEA, Code Calc, Structural, Geotechnical, Seismic, Dispersion…

    PLC, EPROM, Instrumentation, HMI…

    ERP, MRP, e-P&ID, CMMS, e-Doc/e- Record Control Systems…

    Most software today is very much like an Egyptian pyramid with

    millions of bricks piled on top of each other, with no structural

    integrity, but just done by brute force and thousands of slaves.

    Alan Kay

    Theseus Professional Services, LLC

  • Software Dedication - Requirements

     Changes from NQA-1-2008 to NQA-1a-2009

    Part II, Subpart 2.7 Section 302

     Requires application of Part I, Requirement 7, Control

    of Purchased Items and Services and Part II Subpart

    2.14, Quality Assurance Requirements for Commercial

    Grade Items and Services  For acquisition of software that has not been previously approved

    under a program consistent with NQA-1 for use in its intended

    application.

     Changes from an evaluation (IAW Subpart 2.7) to a

    dedication process

     Eliminates exceptions from the process

     Includes the identification of Critical Characteristics

    Slide 6 Results Through Service Excellence® Theseus Professional Services, LLC

  • 302 Otherwise Acquired Software [NQA-1a-2009] Part I, Requirement 7, and Part II, Subpart 2.14, Quality Assurance Requirements for Commercial Grade Items and

    Services, shall be applied to the acquisition software that has not been previously approved under a program consistent with this Standard for use in its intended application (e.g., freeware, shareware, procured commercial off-the-shelf, or otherwise acquired software). The acquired software shall be identified and controlled during the dedication process.

    The dedication process shall be documented and include the following: (a) identification of the capabilities and limitations for intended use as critical characteristics (b) utilization of test plans and test cases as the method of acceptance to demonstrate the capabilities within the limitations (c) instructions for use (e.g., user manual) within the limits of the dedicated capabilities The dedication process shall be documented and the performance of the actions necessary to accept the software shall

    be reviewed and approved. The resulting documentation and associated computer program(s) shall establish the current baseline.

    Subsequent revisions of accepted software received from organizations not required to follow this Subpart shall be dedicated in accordance with this section.

    302 Otherwise Acquired Software [NQA-1-2008] Software that has not been previously approved under a program consistent with this Standard for use in its intended

    application (e.g., freeware, shareware, procured commercial off-the-shelf, or otherwise acquired software), shall be evaluated in accordance with the requirements of this Subpart. The software shall be identified and controlled prior to evaluation. The evaluation, specified by this section, shall be performed and documented to determine adequacy to support operation and maintenance and identify the activities to be performed and the documentation that is needed.

    This determination shall be documented and shall identify as a minimum: (a) capabilities and limitations for intended use (b) test plans and test cases required to demonstrate the capabilities within the limitations (c) instructions for use within the limits of the capabilities

    Exceptions from the documentation requirements of this Subpart and the justification for acceptance shall be documented.

    The results of the above evaluation and the performance of the actions necessary to accept the software, shall be reviewed and approved. The resulting documentation and associated computer program(s) shall establish the current baseline.

    Revisions to previously baseline software received from organizations not required to follow this Subpart shall be evaluated in accordance with this section.

    Results Through Service Excellence® Slide 7 Theseus Professional Services, LLC

  • Software Dedication - Requirements

     NQA-1a-2009 Part II, Subpart 2.14

     Provides amplified requirements to provide

    reasonable assurance that a commercial grade item or

    service will perform its safety function.

     Commercial Grade Item (3 definitions)

     Nuclear Power Plants

     Nuclear Facilities Other than Nuclear Power Plants

     DOE Nuclear Facilities:

     A structure, system, or component or part thereof, that affects its

    safety function, that was not designed and manufactured in

    accordance with the requirements of this Standard.

     Includes Process Control Systems

     Application in the context of SP 2.7 includes ALL software

    (e.g. Operational Control, Design and Analysis, Databases)

    Slide 8 Results Through Service Excellence® Theseus Professional Services, LLC

  • Software Dedication - Requirements

     NQA-1a-2009 Part II, Subpart 2.14

     Technical Evaluation

     Determine Safety Function

     Identify Performance Requirements

     Identify Critical Characteristics

     Identify Dedication Method

    1. Special Tests, Inspections, and/or Analyses

    2. Commercial Grade Survey of the Supplier

    3. Source Verification

    4. Acceptable Supplier Item or Service Performance Record

     Determine if replacement is like-for-like or equivalent

    Slide 9 Results Through Service Excellence® Theseus Professional Services, LLC

  • Guidance for Dedication of Software

     NQA-1-2012 Non-Mandatory Appendix (NMA)

     Focused on dedication of Design/Analysis Computer

    Programs

     Aligns with each of the Sections of SP 2.14 and

    provides information where the SP cannot be clearly

    interpreted as it applies to computer programs

     Unique Definitions that apply to computer programs

     Limits application of Like-for-Like

     Omits Equivalency unless complete evaluation is possible.

     EM Guidance suggests Equivalency is possible under limited conditions

     Critical Characteristics derived from EM Guidance document

     Also adopted, in part, by the current draft of the EPRI CGD Guidance

    Slide 10 Results Through Service Excellence® Theseus Professional Services, LLC

  • Guidance for Dedication of Software  4 Categories of Critical Characteristics

     Identification

     i.e., version, build date, release name, or part or catalog number

     Physical

     physical media (e.g., CD, tapes, downlo