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Approach to Implementing the QA Program Local Effort - Global Expectations. Jed Heyes EG&G QA Manager at Fermilab. Fermilab QA; Local Effort - Global Expectations. Local Effort - Implementation of a Formal QA Program New FRA contract with DOE

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Approach to implementing the qa program local effort global expectations

Approach to Implementing the QA ProgramLocal Effort - Global Expectations

Jed Heyes

EG&G QA Manager at Fermilab


Fermilab qa local effort global expectations
Fermilab QA; Local Effort - Global Expectations

  • 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

.


Qa what s in it for me
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

.


Qa program strategy what
QA Program Strategy - WHAT

  • 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 what1
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

.


Qa program strategy how
QA Program Strategy - HOW

  • 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 development steps
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

      • 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 steps1
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

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Qa program implementation steps
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

      • Adds a level of independence

      • Broadens personnel exposure to other laboratory activities and practices

.


Qa program implementation steps1
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)

      • 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 development schedule
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

.


Qa program development status
QA Program Development Status

  • 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 qdt project execution
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

.


Qa program development qdt project execution1
QA Program Development – QDT Project Execution

  • 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 execution2
QA Program Development – QDT Project Execution

  • 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 execution3
QA Program Development – QDT Project Execution

  • 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 execution4
QA Program Development – QDT Project Execution

  • 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 execution5
QA Program Development – QDT Project Execution

  • 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 communication themes
QA Program – Communication Themes

  • 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

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Qa program communication themes1
QA Program – Communication Themes

  • 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

.


Approach to implementing the qa program local effort global expectations
Q & A

Questions?

.