SQA Directives and Guidance

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 Web site 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 Software Quality Assurance Requirements & Guidance can be directed to Subir Sen.

Questions on Quality Assurance Directives & Guidance can be directed to Colette Broussard.