GTSTRUDL Software QAQC Conformance to the U.S.A. Nuclear Regulatory Commissions Rigorous Quality Ass

1
GTSTRUDL Software QA/QC Conformance to the
U.S.A. Nuclear Regulatory Commissions Rigorous
Quality Assurance and Quality Control
RequirementsforSafety Critical Structural
Engineering Software(Beginning in 1983) Leroy
Z. Emkin , Ph.D., P.E., F.ASCEFounder and
Co-DirectorComputer Aided Structural Engineering
CenterGeorgia Institute of TechnologyAtlanta,
Georgia 30332-0355 U.S.A.Tel
1-404-8942260Fax [phone]email
casec_at_ce.gatech.eduWeb Page www.gtstrudl.gatech
.edu
2
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• GTSTRUDL is the ONLY Civil/Structural software
  system that has fully conformed to the NRC
  quality regulations since 1983, and it continues
  to be the highest quality civil/structural
  software system available in the world today

3
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable provisions of the
• United States Nuclear Regulatory Commission (U.S.
  NRC) Rules and Regulations, Volume 10, Code of
  Federal Regulations, Part 50, Appendix B, Quality
  Assurance Criteria for Nuclear Power Plants and
  Fuel Reprocessing Plants (NRC 10CFR50, Appendix
  B).
• United States Nuclear Regulatory Commission
  ("U.S. NRC") Rules and Regulations, Volume 10,
  Chapter 1, Code of Federal Regulations - Energy,
  Part 21, Reporting of Defects and Noncompliance
  (NRC 10CFR21).
• American Society of Mechanical Engineers for the
  American National Standards Institute "Quality
  Assurance Requirements for Nuclear Facility
  Applications (ASME NQA-1-2000).
• International Standards Organization (ISO)
  "Guidelines for the Application of ISO 9001 to
  the Development, Supply and Maintenance of
  Software, ISO 9000-31991 (ISO 9000-3).

4
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume
• Set)

5
GTSTRUDL User Reference Manual16 Volume
Set(over 11,000 pages)
6
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)

7
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Education
• Experience
• Knowledge and areas of specialization
• Programming skills
• Awareness of, and commitment to, QA/QC procedures

8
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Approximately 2.0 Million Lines of Code 10,000
  Subprograms
• Why was the change made
• Who made the change
• When was the change made
• Where in the program was the change made
• Who developed the test problems
• When were the test problems run
• What was the result of the test problems
• What Manager signed and verified that the change
  process was
• conducted in accordance with NRC quality
  regulations and the
• GTSTRUDL QA/QC Procedures Manual

9
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Base Verification Manual published for each new
  version of software (3 Volumes, 2,150 pages, 324
  test problems)

10
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Base Verification Manual published for each new
  version of software (3 Volumes, 2,150 pages, 324
  test problems)
• General QA/Verification Test Problems
• (3,792 test problems)

11
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Base Verification Manual published for each new
  version of software (3 Volumes, 2,150 pages, 324
  test problems)
• General QA (more than 3,792 test problems)
• Archive each new version of software (40 Years)

12
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Base Verification Manual published for each new
  version of software (3 Volumes, 2,150 pages, 324
  test problems)
• General QA (more than 3,792 test problems)
• 40 Year Archive for each new version of software
• Audits by end-users regulated by the NRC

13
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Audits by end-users regulated by the NRC
• It is the responsibility of the design company
  that is regulated by the U.S. NRC to pass the
  responsibility for conformance to NRC's quality
  standards to the vendor (i.e., supplier) of the
  structural analysis and design software. Each
  such regulated company must perform all necessary
  audits of the structural software vendor and
  report the results of such audit to both the
  software vendor and the U.S. NRC.
• The audit report identifies any deficiencies
  found, and requires that all deficiencies be
  corrected. If any identified deficiencies are not
  corrected within the required period of time,
  then the software which is the subject of the
  audit is removed from the list of approved safety
  related software products.

14
GTSTRUDL QA/QC Requirements of the U.S.A.
Nuclear Regulatory Commissions Safety Critical
Structural Engineering Software

• Conformance to applicable NRC requirements
• Comprehensive User Documentation (16 Volume Set)
• QA/QC Procedures Manual (118 page document)
• Proof of developer qualifications
• Detailed records of changes to software
• Base Verification Manual published for each new
  version of software (3 Volumes, 2,150 pages, 324
  test problems)
• General QA (more than 3,792 test problems)
• 40 Year Archive for each new version of software
• Audits by end-users regulated by the NRC
• (4 to 6 times per year!)

15
GTSTRUDL Quality Assurance Agreement

• QA Agreement Between an NRC Regulated End-
• User Company and the Georgia Tech Research
• Corporation
• US12,000 for the first year of the QA Agreement
• US6,600 per year thereafter