Upload
alvin-hancock
View
223
Download
0
Tags:
Embed Size (px)
Citation preview
1
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
. 2
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
. 3
Quality Assurance Program Approach
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?
. 4
Quality Assurance Program Approach
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
. 5
Quality Assurance Program Approach
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
. 6
Quality Assurance Program Approach
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
. 7
Quality Assurance Program Approach
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
. 8
Quality Assurance Program Approach
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
. 9
Quality Assurance Program Approach
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
. 10
Quality Assurance Program Approach
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
. 11
Quality Assurance Program Approach
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
. 12
Quality Assurance Program Approach
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
. 13
Quality Assurance Program Approach
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
. 14
Quality Assurance Program Approach
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 Execution
. 15
Quality Assurance Program Approach
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 Execution
. 16
Quality Assurance Program Approach
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 Execution
. 17
Quality Assurance Program Approach
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 Execution
. 18
Quality Assurance Program Approach
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 Development – QDT Project Execution
. 19
Quality Assurance Program Approach
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
. 20
Quality Assurance Program Approach
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