Department of Energy Quality Assurance Updates

Frank RussoDeputy Assistant Secretary

Office of Corporate Performance Assessment

Energy & Environmental

Conference

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

DOE O 414.1C, Quality Assurance

Revised QA Order issued in June 2005SQA 2002-1 Implementation Plan CommitmentNow 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)

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

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

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.”

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.

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.

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.

SQA Work Activities

DOE O 414.1C Identifies 10 SQA Work Activities

Software project managementSoftware risk managementSoftware configuration managementProcurement and supplier managementSoftware requirements identification and managementSoftware design and implementationSoftware safetyVerification and validationProblem reporting and corrective actionTraining of personnel in the design, development, use and evaluation of safety software

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

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 activitiesBasic SQA practices

Consistent with consensus standards

Map very closely to most sites institutional SQA program practices

Cooperative Efforts with other Standards

OrganizationsANS 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

DOE O 414.1C Rollout Activities

Rollout Activities conductedVideo conferences conducted - July 25 & August 4, 2005

SQA Orientation Activities:ASME NQA-1 Committee Meeting Oct 11-13, 2005Southwest Regional with EFCOG meeting Oct 31-Nov 4, 2005Southeast Regional (EM) meeting Nov/Dec 2005Working with other DOE Program Offices to define needs

Ongoing Communication using:FAQs posted on SQA Knowledge PortalDiscussion Forum updated to include SQA implementationDOE QA Newsletters – July, September

HEPA Filter Test Facility

New Facility relocated from Oak Ridge to BaltimoreAir Techniques International (ATI) owns and operates facility under contract with DOE to provide testing servicesRequired to have a nuclear QA program

NQA-1 Audit conducted prior to startupQA Program including implementationTest procedures and equipment operationAudit Plan based on NQA-1

Audit TeamMembers from across the Complex including an NQA-1 certified auditor and HEPA filter SMEs

Testing Operations Started end of August 2005

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-1Incorporates results from previous assessments and advances in HEPA filter technology

Developed by a DOE and industry SME working teamReviewed by individuals drawn from ASME AG-1 Committee, NRC, filter manufactures, and users

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

Contacts

QA – Bud Danielson 301 903-2954

Bud.Danielson@eh.doe.gov

http://www.eh.doe.gov/qa/

SQA – Debra Sparkman301 903-6888

Debra.Sparkman@eh.doe.gov

http://www.eh.doe.gov/sqa/

S/CI – Rick Green301 903-7709

Rick.Green@eh.doe.gov

http://www.eh.doe.gov/sci/