(M8) Quality
The IntegratedQuality Assurance Management System is a set of interrelated or interacting elements that Fermilab uses to plan, direct, control, coordinate, assure and improve how quality policies, objectives, processes, and procedures are established, implemented monitored, and achieved. The system is intended to establish confidence that requirements of DOE O 414.1C will be met via proactive management of processes, tasks, and activities.
| Roles |
Responsibilities |
| Head, Office of Quality and Best Practices |
- The designated Fermilab senior management representative responsible for the development, implementation, assessment and improvement of the Quality Assurance Management System (QAMS).
- Ensures continuous improvement of the Laboratory’s management processes in compliance with DOE Orders and good management practices so supporting the Laboratory’s plans and objectives.
- To implement and oversee the operation of DOE’s Quality Assurance Program, Contractor Assurance Program, Fermilab’s Self-Assessment/Continuous Improvement Program, Performance Evaluation Management Plan (PEMP) and other formal quality initiatives as may develop. This responsibility includes policymaking, planning, reporting, oversight, establishing program metrics to measure performance, evaluating the effectiveness of actions and other activities required to achieve an integrated and effective programs.
- To research emerging best practices in programs found at other National Laboratories, industry and other research organizations.
- To develop proposals and implementation plans for introduction of new management approaches, procedures and tools shown to have resulted in productivity improvements and/or cost savings in environments similar to that of the Laboratory.
- To monitor the Laboratory’s progress towards completion of agreed performance milestones/measures, to notify Laboratory management of possible performance shortfalls and to work with D/S/C Heads to remedy such shortfalls.
- To engage, manage the efforts and oversee the work of subcontractors engaged to provide services in the area of quality assurance and Independent Verification and Validation of Laboratory programs.
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| Quality Manager |
- Leads the day-to-day effort to define and support the framework of processes and procedures used to ensure that an organization can fulfill the requirements in the QAMS, including:
- Establish and maintain the quality and contractor assurance programs in accordance with DOE Orders 414 and Contract Section H.13 that entails the ability to understand on-site procedures
- Conduct assessments
- Develop and apply a graded approach to the application of quality controls
- Write program policies and procedures
- Develop and execute plans
- Develop and deliver QA training
- Coordinates all substantive changes to the Integrated Quality Assurance Program, advises and assists the laboratory in providing continuity, completeness, and appropriate standardization in the overall program.
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| Quality Assurance Engineer (QAE) |
- Supports the Fermi site in the areas of business management and quality assurance capabilities and resources. This position serves as the Quality Assurance Engineer (subject matter expert) and assists the QA Manager in establishing and maintaining quality and assurance programs for Fermilab. The QAE also assists the Fermilab in identifying areas for improvement, in development of documentation and project plans for the customer’s review and approval.
- The QAE assists the Quality Manager and Fermilab in:
- Establishing and maintaining the quality and contractor assurance programs in accordance with DOE Orders 414 and Contract Section H.13 that entails the ability to understand on-site procedures
- Conducting assessments
- Applying graded approach to the application of quality controls
- Writing program policies and procedures
- Developing and executing plans
- Developing and delivering QA training
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| Quality Assurance Representative (QAR) |
- Supports the framework of processes and procedures used to ensure that an organization can fulfill the requirements in the quality management system. This person’s perspective focuses on division/section/center implementation.
- Works with Division/Section/Center management to implement the quality program in their organizations:
- Interprets Laboratory quality assurance standards, practices and requirements and ensures their incorporation into Division/Section/Center quality assurance programs
- Represents the Division/Section/Center in laboratory-wide QA activities
- Coordinates review of revisions to the IQA and other institutional QA implementing documents for their organizations
- Participates in the writing of the QA implementing documents for the laboratory
- Communicates QA program requirements to Division/Section/Center management
- Serves as the point of contact for QA implementation in the Division/Section/Center
- Attends periodic meetings with other QARs and the OQBP that are held to discuss institutional QA issues, lessons learned, and graded approach documentation, and passes that information on to the appropriate people in their organization, to ensure consistent implementation throughout the laboratory
- Participates in the graded approach risk evaluation and reviews the output, and ensures that the QA controls and topics identified in the graded approach tables are adequately addressed
- Performs QA-related duties as assigned by their Division/Section/Center head
- Assesses organizational compliance with and effectiveness of IQA implementation
- Assesses that work controls are in place and effective
- Investigates and analyzes quality issues
- Identifies opportunities for quality improvement
- Verifies effectiveness of corrective and preventive actions
- Manages organization-specific QA implementation, processes and procedures as applicable
- Provides appropriate levels of QA training for home organizations
- Participates in supplier quality evaluations as required
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Purpose and Background
Activities necessary to implement the requirements of the Fermilab Integrated Quality Management Program (FIQMP) in accordance with the Director’s Policy # 10, Quality Assurance, and DOE Order 414.1C, Quality Assurance.
Objectives
Ensure that the implementation results in compliance with the DOE Order and the FIQMP, and improves Fermilab’s ability to meet or exceed customer expectations.
Approach
In order to ensure the QA program is “right-sized,” Fermilab will use a graded approach to determine the application of QA controls. Graded approach will be done in two phases; the first is a site-wide “as-is” baseline effort to contrast current practices against the programs required by the FIQMP and to develop a picture as to the depth and breadth of those programs. This phase is primarily a data acquisition phase with a small assessment of whether there is any, some, or a complete program. This valuation will help focus the second phase which entails an in-depth assessment of the efficacy of current controls and whether additional, or changed, controls are necessary. The second phase will be performed on programmatic processes such as engineering, procurement, etc., and processes unique to individual D/S/Cs.
Fermilab will use a combination of project management, audit and assessment, process improvement, and corrective and preventative actions to manage the implementation of Quality Assurance. Assessments and audits will be performed after the graded approach effort is complete and the D/S/Cs have had time to implement programs, or changes to programs, and will be used to identify three things:
- Whether Fermilab’s governing documents are in compliance with DOE Orders and Directives and the FRA contract
- Whether Fermilab is following the requirements written into their implementing plans and procedures
- Whether the activities and new, or enhanced, processes are effective
In an effort to reduce workload and improve effectiveness, the graded approach and subsequent process improvements will replace the current self-assessment program.
Scope (Work Definition)
Implement the requirements of the Fermilab Integrated Quality Management Program (FIQMP) which OQBP controls and to participate/lead the development of program plans, implementing procedures, and implementation plans for the laboratory
Deliverables/End Products
- Document Control Procedure
- Corrective & Preventive Action Procedure
- Non-Conformance Reporting Procedure
- Root Cause Procedure
- Graded Approach Procedure
- Suspect/Counterfeit Procedure
- Consolidated Assessment Program Plan (QA & CA)
- Audit Procedures & Forms
- Annual assessment schedule (3 year overview & 1 year detailed)
- Process Improvement Procedures
- Inspection & Acceptance Test Program Document
- Inspection & Test Procedures
- Revisions to the FIQMP
- Training Plan
- This Project Management Plan (PMP)
- QA Metrics
FNAL Contract Requirements:
- C.3.2.1.a. Mission Accomplishment (Quality and Productivity of R&D)
- C.3.1.2. Program Development and Mission Accomplishment
- C.4.3.vi.j. Self-Assessment Program
- DOE Order 414.1C – Quality Assurance
Integrated Quality Assurance (IQA) manual:
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/IQA_Rev_001.pdf
Director’s Policy 10 Quality Assurance
Director’s Policy 20 Assessments
Assessment (Independent & Management)
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/FAM_Chapter_4_Independent_QA_Assessment_Procedure_Rev001.2.pdf
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/Fermilab_Management_Assessment_Procedure_Rev001.2.pdf
Benchmarking
Planned for 2012
Continuous Improvement
Planned for 2012
Corrective Action
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/Fermilab%20Corrective%20%20Preventive%20Action%20Procedure%20Rev001.pdf
Inspection – Measurement & Test Equipment (M&TE)
Need management decision on approach
Suspect – Counterfeit Items (S/CI)
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/Suspect%20Counterfeit%20Items%20Program%20Rev001.pdf
Quarterly FSO-OQBP Review Meetings
On-going; access to documents is in a restricted location.
Mid–year and Annual Performance Reviews
On-going; access to documents is in a restricted location.
FRA BoD Meetings
On-going; access to documents is in a restricted location.
Weekly OQBP Staff/Status Meetings
On-going; access to documents is in a restricted location.
QA Self-Assessment
Planned for 2012
AC Briefings
http://www.fnal.gov/directorate/AC/AC_minutes.html
