Fermilab

1
Fermilabs 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

• EGG 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_at_fnal.gov)
• She will coordinate division response which is
  due to Bob Grant by Tuesday next week