1. Fermilab’s New Quality Assurance Program Irwin Gaines 23-Jan-2008

2. Fermilab needs a QA Program FRA promised one in their bid for the management contract DOE order 414.1C requires one We have been cited in recent audits for lack of a lab wide QA program The Director wants one Note that a Quality Assurance program is at least as much about A (assurance) as it is about Q (quality)

3. Creating the new QA Program EG&G wrote an initial draft of the QA plan It was presented to a newly constituted QDT (QA Plan development team) for approval before being sent to DOE at end of December Plan was for team to have 3 4-hour meetings to review and modify plan

4. But in real life…. Team was violently opposed to many of provisions in draft plan (overly prescriptive, insufficiently flexible, unaware of costs associated with proposed QA controls) Team met 3 full days/wk for 5 weeks and made substantial revisions in plan New draft (still considered a draft) is much improved and is now being shared with division/sections for comment

5. Basic structure of plan Take credit for all that we already do to assure quality, but strive for more uniformity across lab (especially in documentation and procedures) Graded approach: activity owners will determine what additional QA controls (chosen from standard menu) are appropriate Many “to-be” documents describing lab standard procedures will be developed at appropriate future dates

6. Sample text from plan This QAP describes the overarching institutional Quality Assurance Program for Fermilab. It is implemented using a graded approach to the application of controls, based on the analysis of risks identified in areas where work is to be performed. This QAP refers to laboratory-wide manuals, policies, and procedures that detail the activities which execute the Fermilab QA requirements. In many cases, these activities are decentralized among the divisions/sections. Centralized implementations will leverage current activities and capture best practices. In cases where the documents do not yet exist, full laboratory-wide implementations will be developed according to a schedule based on availability of resources and perceived benefits. While the ultimate responsibility for ensuring an effective Quality Assurance Program lies with the laboratory director, the responsibility for full and effective implementation of the QA Program is delegated to every employee, user, and subcontractor while conducting work for Fermilab or its customers. (Integrated Quality Management)

7. To Be Documents contractor assurance plan graded approach procedures managing qualification and training Project mgmt procedure issues tracking procedure process improvement procedure mgmt review procedure document control procedures material control property inventory control policy and procedures FEMP (Fermilab Engineering Manual) corrective action preventive action assessments manual suspect/counterfeit items procedure control of measuring and test equip (?)

8. Examples of additional QA controls Task specific training Corrective and preventive action plans when defect are discovered Document control with versioning, approval tracking, history Written procedures Monitoring and assessing performance Design authorities for engineering projects Design baselines and design reviews Documented inspection and test plans Formal assessment plans to identify deficiencies and opportunities for improvement

9. Next Steps Plan will be put into DocDB at conclusion of this meeting Irwin, Bill and Bakul are doing careful read If you have time look it over and send comments to Bakul by close of business Friday (bakulb@fnal.gov)bakulb@fnal.gov She will coordinate division response which is due to Bob Grant by Tuesday next week