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Conformance to applicable provisions of the:

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Conformance to applicable provisions of the:

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  1. GTSTRUDL Software QA/QC as anExample ofConformance to the U.S.A. Nuclear Regulatory Commission’s 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: +1-404-8948014email: casec@ce.gatech.eduWeb Page: www.gtstrudl.gatech.edu Civil/Structural Engineering

  2. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s 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).

  3. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set)

  4. GTSTRUDL User Reference Manual16 Volume Set(over 8,000 pages)

  5. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 page document)

  6. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 page document) • Proof of developer qualifications Education Experience Knowledge and areas of specialization Programming skills Awareness of, and commitment to, QA/QC procedures

  7. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 page document) • Proof of developer qualifications • Detailed records of changes to software: (Approximately 1.8 Million Lines of Code & 9,000 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

  8. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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) Civil/Structural Engineering

  9. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) Civil/Structural Engineering

  10. GTSTRUDL Base Verification ManualVolumes 1, 2, & 3(2,150 pages)

  11. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA/Validation Test Problems

  12. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA/Validation Test Problems (more than 3,100 test problems) Civil/Structural Engineering

  13. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA (more than 3,100 test problems) • Archive each new version of software

  14. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA (more than 3,100 test problems) • Archive each new version of software (40 Years) Civil/Structural Engineering

  15. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA (more than 3,100 test problems) • 40 Year Archive for each new version of software • Audits by end-users regulated by the NRC

  16. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s 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. Civil/Structural Engineering

  17. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA (more than 3,100 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!) Civil/Structural Engineering

  18. GTSTRUDL QA/QC Requirements of the U.S.A. Nuclear Regulatory Commission’s Safety Critical Structural Engineering Software • Conformance to applicable NRC requirements • Comprehensive User Documentation (16 Volume Set) • QA/QC Procedures Manual (123 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, 303 test problems) • General QA (more than 3,100 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!)

  19. GTSTRUDL Quality Assurance Agreement • QA Agreement Between an NRC Regulated End-User Company and the Georgia Tech Research Corporation • US$12,000 for the first year of the QA Agreement • US$6,600 per year thereafter Civil/Structural Engineering

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