SQA Directives and Guidance
- DOE O 414.1D, Quality Assurance
- DOE G 414.1-4, Software Guide for use with 10 CFR 830 Subpart A, Quality Assurance Requirements, and DOE O 414.1C, Quality Assurance
DOE Order O 414.1D, Quality
Assurance, includes Attachment 4
addressing SQA requirements for nuclear
safety applications at DOE nuclear
facilities. The DOE O 414.1D was issued April 25, 2011.
This Order and its associated Guide for
safety software,
DOE G 414.1-4, Safety Software Guide for
use with 10 CFR 830 Subpart A, Quality
Assurance Requirements.
The Order identifies 10
software quality work activities that are to
be performed using the graded approach
specified in the Order. These 10 work
activities are: (1) software project
management, (2) software risk management,
(3) software configuration management, (4)
procurement and vendor management, (5)
software requirements identification and
management, (6) software design and
implementation, (7) software safety design,
(8) verification and validation, (9) problem
reporting and corrective action, and (10)
training of personnel in the design,
development, use and evaluation of safety
software. These 10 work activities were
consolidated from practices and activities
identified in several well known consensus
standards and federal requirements. Safety software
must be acquired, developed and implemented using ASME
NQA-1-2008 with the NQA-1a-2009 addenda (or later
edition), Quality Assurance Requirements for Nuclear
Facility Applications, Part 1 and Subpart 2.7, or
other national or international consensus standards that
provide an equivalent level of quailty assurance
requirements as NQA-1-2008.
DOE Guide G 414.1-4 provides
acceptable implementation strategies and
appropriate standards for the 10 software
quality work activities. This Guide incorporates
practices from appropriate existing
national/international standards and processes
currently in use at DOE facilities. The Guide describes
how the quality work activities may be implemented using
a graded approach to satisfy the Order requirements. The
grading guidance identifies subactivities that can be
implemented at varying levels of rigor to align with the
grading level (Level A, B or C) for the specific safety
software application. The grading level is based upon
the impact on safety and the safety software type
(e.g., custom developed, configurable, or acquired).
The Guide contains two key
appendices: Appendix B, Procedure for Adding
or Revising Software to, or Deleting from
the DOE Safety Software Central Registry and
Appendix F, DOE O 414.1C Criteria Review and
Approach Document. These appendices to reflect the 10
work activities in the Order. The
assessment/evaluation criteria and
information collected during evaluations of
proposed Central Registry codes or during
assessments of safety software are based
upon the 10 work activities and their
sub-activities in the Guide.
Questions on Software Quality
Assurance Requirements & Guidance can be
directed to
Subir
Sen.
Questions on Quality
Assurance Directives & Guidance can
be directed to
Colette Broussard.
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