Approach to Implementing the QA Program Local Effort - Global Expectations

1. Approach to Implementing the QA ProgramLocal Effort - Global Expectations Jed Heyes EG&G QA Manager at Fermilab

2. Fermilab QA; Local Effort - Global Expectations • Local Effort - Implementation of a Formal QA Program • New FRA contract with DOE • New orders including DOE O 414.1C, Quality Assurance and 226.1A, Contractor Assurance • Leverage DOE O 414.1C requirements • Improve laboratory management and operations in support of the mission • Position laboratory for favorable external reviews with a credible QA program • Global Expectations - Support the Fermilab Roadmap to the future • Demonstrate competence to DOE • Implement recommendations from the Root Cause Analysis • Includes establishing a Quality Assurance Program • Design Processes, Procurement, and Fabrication • LHC R&D • SNuMI and Project X .

3. QA – What’s in it for me? • Assists Fermilab community by improving internal processes • Prepares Fermilab for International Projects - ISO 9001 ready • Strong emphasis on best practices and continuous improvement • Better processes means a better reputation and status within the HEP • Improved customer relations – program finds problems and provides methods to self correct • Contractual Compliance – Acceptable to DOE and compliant with DOE O 414.1C and DOE O 226.1A .

4. QA Program Strategy - WHAT • Single Lab-Wide QA Plan and Implementing Procedures • Avoid duplication of effort while allowing activity specific documents • Partner with Divisions, Sections & Centers • solicit input to approach and all QA documents • Build to help Fermilab achieve major goals • Modeled after FESHM • Graded Approach - Tailored to the Lab’s Unique Needs • Only implement controls necessary – not blind compliance to all requirements • Tailored by activity to control risk .

5. QA Program Strategy - WHAT • Graded approach encouraged by DOE O 414.1C • Couples risk (in terms of frequency and consequence) to programmatic requirements in 10 areas: • QA Program • Personnel Training and Qualification • Quality Improvement • Documents and Records • Work Processes • Design • Procurement • Inspection and Acceptance Testing • Management Assessment • Independent Assessment • Suspect/Counterfeit Parts Program .

6. QA Program Strategy - HOW • Establish a Quality Development Team (QDT) • Each Division, Section and Center designate one or more participant(s) • Members approved by the Assurance Council • Must have line or project management experience & access to the D/S/C heads • Authorized to make D/S/C decisions and commitments • Establish direct communication meetings with D/S/C heads • Upon complete implementation, become QA representatives to their organization • DOE member to be requested to augment and partner with Fermilab • Implementation Oversight - OQBP • Guidance & Executive Sponsorship • Fermilab Director, Assurance Council, OQBP • Management, Training, Coaching • EG&G QA Manager with other resources as required .

7. QA Program Development Steps • Refine Project Execution Plan • 2 Distinct phases – Development & Implementation • Establish metrics that demonstrate progress and compliance • Complete baseline documents: • QA Plan • Spend the time to make it work for entire lab • Benchmark existing DOE programs for best practices • ANL, SLAC • Graded Approach Procedure • Agree on gradation, definition of risk, and application of controls • Type of controls and level of rigor .

8. QA Program Development Steps • Assess Fermilab activities using graded approach • Define required implementing documents and begin development • Collect & collate existing QA practices; correlate with identified requirements • Flowchart processes • Identify gaps between existing practice and new requirements • Establish plan to close the gaps .

9. QA Program Implementation Steps • Implement plans and processes to close gaps • Gradual process • Requires training and time to transition • Establish audit/assessment/surveillance program • Create audit/assessment/surveillance schedule • Reviews and their periodicities defined by risk potential and past performance • Make cross-organizational management assessment assignments • Adds a level of independence • Broadens personnel exposure to other laboratory activities and practices .

10. QA Program Implementation Steps • Prepare site to perform assessments and audits • Provide training in assessment & audit techniques to QDT and selected individuals • Perform 1st set of audits/assessments under instruction (with EG&G QA Mgr) • Assess progress toward gap closure, program integration, and compliance • Define corrective & preventive actions as required • Issues tracked to conclusion in Issues Management System (IMS) • Perform follow-on audits per schedule • Reinforce training with coaching and mentoring during subsequent reviews • Disband QDT • Members become Division/Section/Center QA representative .

11. QA Program Development Schedule • Key Dates: • 23 Oct – QDT names approved by Assurance Council • 31 Dec – First draft of Quality Assurance Plan complete • QDT first review complete and comments reconciled Oct07 Jan08 Apr08 Jul08 Oct08 Jan09 Apr09 Jul09 Oct09 Refine Plan and Implementing Documents Perform Assessments (activities vs. graded approach) Perform Gap Analysis – Current to Planned Practices Create Implementation Plan to Close Gaps Create Training Plan Implement Training, Assessments, and QA Program .

12. QA Program Development Status • New QA Policy approved by Fermilab Director • Draft QA documents generated • QA Approach • Quality Assurance Plan with Elements of – • DOE Order and Guides, ISO 9001, Malcolm Baldrige • FRA commitments & initiatives, best practices (benchmarked) • Graded Approach Procedure • Document Control Procedure • Issues Tracking System User Guide • Corrective & Preventive Action Procedure • Ready to engage the site .

13. QA Program Development – QDT Project Execution • Draft documents will be refined by QDT • Graded Approach • QA Plan • Project Execution Plan • Schedule • Continue benchmarking (ANL, SLAC, LBNL, JLAB, BNL) • Canvas division/section/center heads • Understand needs, explain approach, solicit input, concerns .

14. QA Program Development – QDT Project Execution • Assurance Council • Briefed at the conclusion of each major development stage • Review key implementation documents from the QDT • Project Execution Plan • Quality Assurance Plan and metrics • Graded Approach Procedure • Gaps analysis - Draft program and existing practices • Implementation Plan (close gaps) • Assessment Plan • Assessment results • Integration with DOE O 226.1A • Contractor Assurance Program will be developed in parallel • Overlapping requirements addressed by reference to QAP • Use single reviews to suffice for both Order’s requirements when possible .

15. QA Program Development – QDT Project Execution • Communication Plan • Senior management • Briefings at major milestones • QDT representatives report to their Division/Section/Center heads • Division/Section/Center heads invited to ad hoc and milestone meetings • All employees • Fermilab Today - updates from QDT, Director’s corner, EG&G QA Mgr • Staff meetings from division/section/center heads and QDT representatives • EG&G QA Manager and QDT representatives speak at small meetings to explain and solicit feedback, concerns, keep transparent .

16. QA Program Development – QDT Project Execution • Document Control • All QA documents under configuration management • Version control • Changes documented, reviewed and approved • Documents available via website (FESHM model) • Controlled copies at specific locations determined by the QDT • Process Improvement • Anticipate some process improvements during program development phase (QDT sponsored) • Documenting, flowcharting, auditing, gap analysis, and corrective actions • Future improvements via development of a Process Improvement Guide • Part of traditional QA program • Codifies approach; for example: • FMEA, flowcharting, matrices (decision trees), cause and effect diagrams .

17. QA Program Development – QDT Project Execution • Project Kickoff • Introductory remarks - Fermilab Director, OQBP, Assurance Council Chair • Brainstorming and fine tuning the approach • Team building and establishing process • R2A2 • Project Specifics • Budget • Procurement • Integration and Risk Manager • Project Controls • Lessons learned from previous, similar Fermilab projects and other laboratories .

18. QA Program Development – QDT Project Execution • Kickoff, continued • Risk Management • Identify known issues, risks, and associated mitigating actions • Tracked and updated at least quarterly for life of the project • Identification of potential issues that can’t initially be qualified or quantified will be noted for monitoring during the project execution • Project constraints - budget, schedule, manpower, and known issues • Fine tune schedule • Interaction between QDT and site • Documentation and Configuration Control • Communication .

19. QA Program – Communication Themes • Benefits of formal QA • Demonstrated world class science, management, and operations • Using management tools designed to improve the success of current and future projects • Successful SNuMI, NOvA and Project X will put Fermilab in good light for ILC • Readiness for formal, international certification • Increased credibility during external reviews • Less re-work and therefore more time and money available for science .

20. QA Program – Communication Themes • Properly administered QA Program encourages employees to engage in discovering opportunities for improvement • Formal Lessons Learned program allows future projects to learn from past efforts • QA done right is value added rather than a burden • Key is creativity and graded risk based approach .

21. Q & A Questions? .