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

2. Quality Assurance Program Approach. 2  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 Fermilab QA; Local Effort - Global Expectations

3. Quality Assurance Program Approach. 3  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 QA – What’s in it for me?

4. Quality Assurance Program Approach. 4  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 QA Program Strategy - WHAT

5. Quality Assurance Program Approach. 5  Graded approach encouraged by DOE O 414.1C  Couples risk (in terms of frequency and consequence) to programmatic requirements in 10 areas: 1) QA Program 2) Personnel Training and Qualification 3) Quality Improvement 4) Documents and Records 5) Work Processes 6) Design 7) Procurement 8) Inspection and Acceptance Testing 9) Management Assessment 10) Independent Assessment  Suspect/Counterfeit Parts Program QA Program Strategy - WHAT

6. Quality Assurance Program Approach. 6  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 QA Program Strategy - HOW

7. Quality Assurance Program Approach. 7  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 QA Program Development Steps

8. Quality Assurance Program Approach. 8  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 QA Program Development Steps

9. Quality Assurance Program Approach. 9  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 QA Program Implementation Steps

10. Quality Assurance Program Approach. 10  Prepare site to perform assessments and audits  Provide training in assessment & audit techniques to QDT and selected individuals  Perform 1 st 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 QA Program Implementation Steps

11. Quality Assurance Program Approach. 11  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 QA Program Development Schedule 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 Oct07 Jan08 Apr08 Jul08 Oct08 Jan09 Apr09 Jul09 Oct09

12. Quality Assurance Program Approach. 12  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 QA Program Development Status

13. Quality Assurance Program Approach. 13  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 QA Program Development – QDT Project Execution

14. Quality Assurance Program Approach. 14  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 QA Program Development – QDT Project Execution

15. Quality Assurance Program Approach. 15  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 QA Program Development – QDT Project Execution

16. Quality Assurance Program Approach. 16  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 QA Program Development – QDT Project Execution

17. Quality Assurance Program Approach. 17  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 QA Program Development – QDT Project Execution

18. Quality Assurance Program Approach. 18  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 QA Program Development – QDT Project Execution

19. Quality Assurance Program Approach. 19  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 QA Program – Communication Themes

20. Quality Assurance Program Approach. 20  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 QA Program – Communication Themes

21. Quality Assurance Program Approach. 21 Questions? Q & A