1. Department of Energy Quality Assurance Updates Frank Russo Deputy Assistant Secretary Office of Corporate Performance Assessment Energy & Environmental Conference

2. Topics DOE O 414.1C, Quality Assurance Application to NQA-1-2000 New Guidance in DOE G 414.1- 4 DOE wide rollout conducted HEPA Filter Test Facility Relocation

3. DOE O 414.1C, Quality Assurance Revised QA Order issued in June 2005 SQA 2002-1 Implementation Plan Commitment Now supported by 4 Guides DOE G 414.1-1A, Management Assessment and Independent Assessment DOE G 414.1-2A, Quality Assurance Management System Guide for use with 10 CFR 830.120 and DOE O 414.1C, Quality Assurance (Revision issued with DOE O 414.1C) DOE G 414.1-3, Suspect/Counterfeit Items Guide for use with 10 CFR 830.120 and DOE O 414.1C, Quality Assurance DOE G 414.1-4, Safety Software Guide for use with 10 CFR 830.120 and DOE O 414.1C, Quality Assurance New guide issued with DOE O 414.1C)

4. DOE O 414.1C, Quality Assurance (continued) Invokes ASME NQA-1-2000,supplemented by other consensus standards or other consensus standards that provide an equivalent level of SQA requirements The definition of Safety Software was revised to clarify Safety Management and Administrative Controls Software Ten Software Quality Assurance work activities identified

5. DOE O 414.1C, Quality Assurance (continued) Sites define grading levels and consensus standards in DOE approved QAP or other appropriate DOE approved document Using the grading levels, select and implement the applicable software quality assurance work activities defined in the Order Identification, documentation, and maintenance of safety software inventory Definitions added from 10 CFR 830

6. Application of 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 implement these 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 these work activities.”

7. New Safety Software Definition Safety System Software: Software for a nuclear facility that performs a safety function as part of a structure, system, or component and is cited in either (a) a DOE approved documented safety analysis or (b) an approved hazard analysis per DOE P 450.4, Safety Management System Policy, dated 10 ‑ 15 ‑ 96, and the DEAR clause.

8. New Safety Software Definition (continued) Safety and Hazard Analysis Software and Design Software: Software that is used to classify, design, or analyze nuclear facilities. This software is not part of a structure, system, or component (SSC) but helps to ensure the proper accident or hazards analysis of nuclear facilities or an SSC that performs a safety function.

9. New Safety Software Definition (continued) Safety Management and Administrative Controls Software: Software that performs a hazard control function in support of nuclear facility or radiological safety management programs or technical safety requirements or other software that performs a control function necessary to provide adequate protection from nuclear facility or radiological hazards. This software supports eliminating, limiting, or mitigating nuclear hazards to workers, the public, or the environment as addressed in 10 CFR 830, 10 CFR 835, and the DEAR ISMS clause.

10. SQA Work Activities DOE O 414.1C Identifies 10 SQA Work Activities Software project management Software risk management Software configuration management Procurement and supplier management Software requirements identification and management Software design and implementation Software safety Verification and validation Problem reporting and corrective action Training of personnel in the design, development, use and evaluation of safety software

11. New Guidance in DOE G 414.1-4 Safety Software Facilitates implementation of SQA responsibilities and requirements Detail guidance for each of the10 SQA work activities for safety software Procedures for updating, adding and removing tool box codes from Central Registry Cross references from ASME NQA-1-2000 to 10 CFR 830 and DOE O 414.1C Sample Criteria Review and Approach Document for DOE O 414.1C

12. Impact of DOE O 414.1C, Quality Assurance Update and maintain an inventory of safety software NA and EM have initial lists Grade safety software Many sites institutional SQA programs include graded approach Implement 10 SQA work activities Basic SQA practices Consistent with consensus standards Map very closely to most sites institutional SQA program practices

13. Cooperative Efforts with other Standards Organizations ANS 10.4, Guidelines for the Verification and Validation of Scientific and Engineering Computer Programs for the Nuclear Industry DOE G 414.1-4 being reviewed for partial inclusion into ANS 10.4 revision ASME NQA-1, Quality Assurance Requirements for Nuclear Facility Applications Update may include components of DOE G 414.1-4

14. DOE O 414.1C Rollout Activities Rollout Activities conducted Video conferences conducted - July 25 & August 4, 2005 SQA Orientation Activities: ASME NQA-1 Committee Meeting Oct 11-13, 2005 Southwest Regional with EFCOG meeting Oct 31-Nov 4, 2005 Southeast Regional (EM) meeting Nov/Dec 2005 Working with other DOE Program Offices to define needs Ongoing Communication using: FAQs posted on SQA Knowledge Portal Discussion Forum updated to include SQA implementation DOE QA Newsletters – July, September

15. HEPA Filter Test Facility New Facility relocated from Oak Ridge to Baltimore Air Techniques International (ATI) owns and operates facility under contract with DOE to provide testing services Required to have a nuclear QA program NQA-1 Audit conducted prior to startup QA Program including implementation Test procedures and equipment operation Audit Plan based on NQA-1 Audit Team Members from across the Complex including an NQA-1 certified auditor and HEPA filter SMEs Testing Operations Started end of August 2005

16. Revision of DOE HEPA Filter Standards First of four DOE HEPA Standards in RevCom – to be issued Dec 2005 Revised to comply with ASME AG-1 Incorporates results from previous assessments and advances in HEPA filter technology Developed by a DOE and industry SME working team Reviewed by individuals drawn from ASME AG-1 Committee, NRC, filter manufactures, and users

17. Upcoming Activities Revise DOE G 414.1-1A, Management Assessment and Independent Assessment Develop and implement QAPs as required by DOE 414.1C, Quality Assurance DOE HQ and Field QAPs New DOE Oversight Manual Next Generation Nuclear Power QA

18. Contacts QA – Bud Danielson 301 903-2954 Bud.Danielson@eh.doe.gov http://www.eh.doe.gov/qa/ SQA – Debra Sparkman 301 903-6888 Debra.Sparkman@eh.doe.gov http://www.eh.doe.gov/sqa/ S/CI – Rick Green 301 903-7709 Rick.Green@eh.doe.gov http://www.eh.doe.gov/sci/