Quality Assurance Management System

1. Quality Assurance Management System Martha Michels Management System Review April 18, 2014

2. Fermilab Quality Assurance Program • The QA program has been developed to address the requirements outlined in DOE O 414.1D Quality Assurance • The management system “owns” 19 clauses in our contract • The Integrated Quality Assurance (IQA) Program describes how we implement QA at Fermilab • The QA program consists of: • The QA Subcommittee • QA Self-Assessment Program • Software Quality Assurance Program • Issues Management Program • Suspect/Counterfeit Item and Lessons Learned Programs • QA Support for Projects Martha Michels| QA Management System Review

3. QA Subcommittee • The QA Subcommittee consists of members from all divisions, sections, and centers and has been opened up to include membership from projects • The subcommittee is no longer its own stand alone committee and has been incorporated into FESHCom • Some organizations have developed a more advanced QA infrastructure than others based on their specific needs and the Quality Assurance Representative (QAR) responsibilities have been revised to be flexible enough to meet the needs of each unique organization Martha Michels| QA Management System Review

4. QA Subcommittee Membership Name Organization Term Kathy Zappia ESH&Q – Chair Indefinite T.J. Sarlina ESH&Q – Deputy 7/31/16 Berline Short FSO – Observer 7/31/16 Adam Bracero TD 8/19/16 Margie Bruce APC 7/31/16 JB Dawson ESH&Q, Directorate, WDRS 7/31/16 Tony Metz CD, CCD, SCD 7/31/16 JJ Schmidt Jr. PPD 7/31/16 Rod Walton FESS 7/31/16 Jim Wollwert Finance 7/31/16 Jeff Dolph LBNE 7/31/16 OPEN AD --- Martha Michels| QA Management System Review

5. QA Self-Assessment Program • The QA self-assessment program has been revised to focus on smaller, high value assessments instead of large labor intensive assessments • For FY14, the program is in place with input from each QAR • Minimum of 2 have been identified per organization • On-track for conducting FY14 self-assessments • Identified 2 internal assessments to be conducted by QA across the entire laboratory • On-The-Job Training Requirements (TRAIN) • Review cycle for controlled documents Martha Michels| QA Management System Review

6. ISO Certifications • Currently coordinate the certification for • ISO 14001, Environmental Management Standard • OHSAS 18001, Occupational Health & Safety Standard • Computing Sector coordinates the certification for • ISO 20000, Information Technology Service Management Standard Martha Michels| QA Management System Review

7. Software Quality Assurance Program • The Fermilab Software Quality Assurance (SQA) Program defines the minimum quality assurance requirements for applications used by Fermilab • Through a graded approach, this program ensures development, management, and delivery of reliable software applications that meet or exceed established requirements and expectations • D/S/C’s are in the process of inventorying and grading their software applications • Implementation of the program will continue over the next year Martha Michels| QA Management System Review

8. Quality Assurance Manual • The Quality Assurance Manual is now linked to FESHM via the 12000 series and mirrors the Fermilab Radiation Control Manual 10000 series • We have collected the various QA procedures that had been written by the contractors, reformatted them to be consistent with the FESHM format, and updated the content to better represent current practices • The Software Quality Assurance Program will be added as a QAM chapter in the near future Martha Michels| QA Management System Review

9. Issues Management • A cross-organizational task force has been created and is in the process of defining issues management for the laboratory • The task force is also focusing on improving the tracking tool used to manage issues (currently iTrack) • QA is now cataloging assessments, reviews, audits, and inspections conducted at the laboratory and ensuring proper entry into iTrack • In partnership with each organization’s QAR’s and SSO’s, we are monitoring the status of issues in the tracking system and following up on items that are overdue Martha Michels| QA Management System Review

10. Suspect/Counterfeit Items (S/CI) & Lessons Learned • Through various communication channels, including through Quality Assurance Representatives, S/CI Coordinators, and Senior Safety Officers, we are now tracking S/CI and Lessons Learned found at the laboratory • We are transmitting DOE issued S/CI and Lessons Learned notices requiring communication to the field organizations • Tracking notifications from other sources (UL, National Safety Council, etc.) and informing field personnel as necessary Martha Michels| QA Management System Review

11. QA Training Program • QAs training program includes: • Introduction to QA for new hires • Suspect/Counterfeit Item Program • Lessons Learned Program • Software Quality Assurance Program • A future training program might be: • Basic Internal Assessor Training Martha Michels| QA Management System Review

12. QA Support for Projects • QA is providing support to projects by: • Assisting with project QA Plan development • Participating in project reviews • Assisting with project QA audits, including vendor and collaborator audits • Assisting the Office of Project Support Services (OPSS) with developing QA policies for projects Martha Michels| QA Management System Review

13. Current QA Dashboard Metrics Martha Michels| QA Management System Review

14. Planned QA Dashboard Metrics • iTrack issues with no assigned due date • QA Self-Assessments • Planned vs. Complete • Certification Status • ISO 14001 (Environmental) • OHSAS 18001 (Health & Safety) • ISO 20000 (IT) • # of Assessments/Reviews/Inspections per FY • Fermilab Initiated vs. DOE Initiated Martha Michels| QA Management System Review

15. Summary • TBD Martha Michels| QA Management System Review