1 approach to implementing the qa program local effort - global expectations approach to...

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Approach to Implementing the QA ProgramApproach to Implementing the QA Program

Local Effort - Global ExpectationsLocal Effort - Global Expectations

Jed Heyes Jed Heyes

EG&G QA Manager at FermilabEG&G QA Manager at Fermilab

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Quality Assurance Program Approach

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

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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?

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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

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Graded approach encouraged by DOE O 414.1C Couples risk (in terms of frequency and consequence) to

programmatic requirements in 10 areas:1) QA Program2) Personnel Training and Qualification3) Quality Improvement4) Documents and Records5) Work Processes6) Design7) Procurement8) Inspection and Acceptance Testing9) Management Assessment10) Independent Assessment

Suspect/Counterfeit Parts Program

QA Program Strategy - WHAT

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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

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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

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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

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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

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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

QA Program Implementation Steps

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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

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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

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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

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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


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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


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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


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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


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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


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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

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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

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Questions?

Q & A

1 approach to implementing the qa program local effort - global expectations approach to...

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