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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/
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