Fermilab QA; Local Effort - Global Expectations

1. Fermilab QA; Local Effort - Global Expectations • Local Effort - Implementation of a Formal QA Program • New FRA contract with DOE • Leverage DOE O 414.1C requirements • Global Expectations - Support the Fermilab Roadmap to the future • Demonstrate competence to DOE • LHC R&D • SNuMI and Project X .

2. 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 .

3. QA Program Strategy - WHAT • Single Lab-Wide QA Plan and Implementing Procedures • Graded Approach - Tailored to the Lab’s Unique Needs .

4. 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 .

5. QA Program Strategy - HOW • Establish a Quality Development Team (QDT) • Implementation Oversight - OQBP • Guidance & Executive Sponsorship • Fermilab Director, Assurance Council, OQBP • Management, Training, Coaching • EG&G QA Manager with other resources as required .

6. 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 • Graded Approach Procedure .

7. 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 .

8. 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 .

9. 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) • Perform follow-on audits per schedule • Reinforce training with coaching and mentoring during subsequent reviews • Disband QDT • Members become Division/Section/Center QA representative .

10. 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 .

11. QA Program Development Status • New QA Policy approved by Fermilab Director • Draft QA documents generated • QA Approach • Quality Assurance Plan with Elements of – • Graded Approach Procedure • Document Control Procedure • Issues Tracking System User Guide • Corrective & Preventive Action Procedure • Ready to engage the site .

12. 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 .

13. QA Program Development – QDT Project Execution • Assurance Council • Briefed at the conclusion of each major development stage • Review key implementation documents from the QDT • 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 .

14. QA Program Development – QDT Project Execution • Communication Plan • Document Control • Process Improvement .

15. Q & A Questions? .