Transcript Document 7521871

Energy & Environmental
Conference
Department of Energy
Quality Assurance Updates
Frank Russo
Deputy Assistant Secretary
Office of Corporate Performance Assessment
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 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)
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 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
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 activities
Basic SQA practices
Consistent with consensus standards
Map very closely to most sites institutional SQA program
practices
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
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
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
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
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
[email protected]
http://www.eh.doe.gov/qa/
SQA – Debra Sparkman
301 903-6888
[email protected]
http://www.eh.doe.gov/sqa/
S/CI – Rick Green
301 903-7709
[email protected]
http://www.eh.doe.gov/sci/