Fermilab | FRA Contractor Assurance System (CAS) | Management Systems

(M8) Quality

Quality Assurance Management System Description
Management System Owner:	Manager, Quality Services, ESH&Q Section (Jed Heyes)
Revision and Date:	Rev. 5, January 14, 2013

1.0 Purpose

The Integrated Quality 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 414.1D will be met via proactive management of processes, tasks, and activities.

2.0 Roles and Responsibilities

Roles	Responsibilities
Manager, Quality Services	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 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. 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 program in accordance with DOE Order 414 and Contract Clause H.13 that entails the ability to understand on-site procedures Managing the QA assessment program Develop and apply a graded approach to the application of quality controls Write program policies and procedures Develop and execute quality 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.
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 Manager of Quality Services 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 QA plans for the customer’s review. The QAE assists the Manager of Quality Services and Fermilab in: Establishing and maintaining the quality program in accordance with DOE Orders 414 and Contract Clause H.13 that entails the ability to understand on-site procedures Conducting assessments Applying a graded approach to the application of quality controls Writing program policies and procedures Developing and executing QA plans Developing and delivering QA training
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 development and updates 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 Manger, Quality Services that are held to discuss institutional and D/S/C QA issues and opportunities for improvement, QA lessons learned, and the application of a graded approach, 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 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 Provides appropriate levels of QA training for home organizations Participates in supplier quality evaluations as required

3.0 Management System Operation

Purpose and Background

Activities necessary to implement the requirements of the FRA Contractor Assurance System (CAS) in accordance with the Director’s Policy # 10, Quality Assurance, and DOE Order 414.1D, Quality Assurance, and and Integrated Quality Assurance (IQA)

Objectives

Ensure that the implementation results in compliance with the DOE QA Order and the FRA Contractor Assurance System (CAS), 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. Independent QA assessments are conducted to determine the compliance, adequacy and effectiveness of QA controls in comparison to the IQA and other specified requirements. These assessments will be conducted using both a process approach or a QA criteria approach or a combination of both.

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 and will be used to identify three things:

Whether Fermilab’s governing documents are in compliance with DOE Orders and Directives and the prime contract
Whether Fermilab is following the requirements written into their implementing plans and procedures
Whether the activities and new, or enhanced, processes are effective

Scope (Work Definition)

Implement the requirements of Fermilab’s Integrated Quality Assurance (IQA) program and participate/lead/consult on the development of program plans, implementing procedures, and implementation plans for the laboratory

Deliverables/End Products

Corrective & Preventive Action Procedure
Root Cause Procedure
Graded Approach Procedure
Suspect/Counterfeit Items Procedure
Consolidated Assessment Program
Assessment Procedures & Forms
Annual assessment schedule (3 year overview & 1 year detailed)
Revisions to the IQA and implementing documents
QA Training
FermiDash QA
iTrack implementation

4.0 References

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 414.1D – Quality Assurance

Integrated Quality Assurance (IQA):
http://www.fnal.gov/directorate/OQBP/index/oqbp_active_procedures/IQA_Rev_001.pdf

Director’s Policy 10 Quality Assurance:
http://www.fnal.gov/directorate/Directors_Policy/quality_assurance.shtml

Director’s Policy 20 Assessments:
http://www.fnal.gov/directorate/Directors_Policy/self_assessments.shtml