DOE Order O 414.1B, Quality
Assurance, was revised to include Attachment
5 addressing SQA requirements for nuclear
safety applications at DOE nuclear facilities.
The revised Order, DOE
O 414.1C was issued June 17, 2005. 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, are available through the DOE
Directives website at http://www.directives.doe.gov/
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, including
ASME NQA-1-2000. ASME NQA-1-2000, Quality
Assurance Requirements for Nuclear Facility
Applications, or other national or international
consensus standards that provide an equivalent
level of quality assurance requirements as
NQA-1-2000, must be used to develop processes
and implement the 10 software quality work
activities. The standards used must be specified
by the user and approved by DOE.
DOE Guide G 414.1-4 provides
acceptable implementation strategies and appropriate
standards for the 10 software quality work
activities. This new guide incorporates practices
from appropriate existing national/international
standards and processes currently in use at
DOE facilities (ref. site
specific standards and guides). 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 have been updated
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 DOE O 414.1C can
be directed to Colette
Broussard.
