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(M8) Quality
Contractor Assurance

​​​Management System Owner: Chief Safety Officer

​​Revision and Date: Revision 2.1, 2016-11-16

1.0            Pu​​rpose

The 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 and assurance that customer expectations for quality are met or exceeded via proactive management of processes, tasks, and activities.

2.0            Roles and Respo​​nsibilities

Title Responsibilities
Chief Safety Officer
  • Owns the Quality Assurance management system
  • Establishes and maintains Quality policies and procedures
  • Assesses line organizations for compliance
  • Seeks and implements improvements
Quality Assurance Subcommittee
  • Monitor, update (with management system owner concurrence), review, and improve the Quality Assurance management system policies and processes in their area of expertise.
Quality Assurance Manager
  • Designated Fermilab management representative responsible for the development, implementation, assessment and improvement of the Quality Assurance management system.
  • To implement and oversee the operation of Fermilab's Quality Assurance Program by leading the day-to-day effort to define and support the framework of processes and procedures used to ensure that an organization can fulfill their QA requirements, including:
  • Establish and maintain the Fermilab Quality Assurance Program in accordance with Contract Clause H.13
  • Coordinate all changes to the Quality Assurance Program and advise and assist the laboratory in implementing and maintaining the overall program.
  • Managing the QA assessment program
  • Develop and apply a graded approach to the application of quality controls
  • Develop and execute quality plans, policies, and procedures
  • Implement and oversee formal quality initiatives as they develop
  • To facilitate continuous improvement of the Laboratory's management processes.
  • To research emerging best practices in programs found at other National Laboratories, industry and other research organizations
  • Establishes quality assurance program metrics to measure performance and evaluate the effectiveness of the program
  • Monitors Fermilab's progress towards completion of agreed performance milestones and measures to notify Laboratory management of possible performance shortfalls and to work with Division/Section Heads and Project Managers to remedy such shortfalls
Quality Assurance Specialist
  • Supports Fermilab in the areas of business management and quality assurance capabilities and resources
  • Serves as the Subject Matter Expert and assists the QA Manager in establishing and maintaining the Quality Assurance Program for Fermilab
  • Assist Fermilab in identifying opportunities for improvement and documentation development
  • Assists the QA Manager and Fermilab in:
  • Establishing and maintaining the QA Program in accordance with Contract Clause H.13
  • Conducting assessments
  • Applying a graded approach to quality controls
  • Writing Quality Assurance Program policies and procedures
  • Developing and executing QA plans
  • Developing and delivering QA training
Quality Assurance Representative
  • Attends monthly Quality Assurance Subcommittee meetings representing their organization
  • Serves as the point of contact for QA implementation in their organization
  • Serves as the point of contact for disseminating QA information to their organization, and for gathering QA information from their organization
  • Communicates QA program requirements, and revisions to their organization's management
  • Coordinates and assists in the execution of quality related self-assessments for their organization
  • Ensures iTrack items assigned to their organization are addressed by the responsible parties prior to assigned due dates
  • Works with the Division Safety Officer (DSO) to address items from ES&H inspections, audits, and reviews
  • Participates in reviewing revisions to the Quality Assurance manual and other QA procedures that have been prepared/proposed

The following responsibilities are only required on an as-needed basis

  • Assists with lessons learned and Suspect/Counterfeit Item (S/CI) investigations.  Depending on the nature of the situation, this responsibility may fall to the D/S S/CI Coordinator and/or the DSO
  • Assists in identifying and communicating opportunities for quality improvement
  • Assists in verifying the effectiveness of completed corrective and preventive actions
  • Coordinates QA training for their organizations (QA training then provided by the ESH&Q Section)
  • Participates in general quality investigations 
  • Participates in DOE or 3rd party assessments representing the organization
All Employees
  • Ensure compliance to Fermilab's Quality Assurance Program and Contract Clause H.13 by developing and following processes and procedures relevant to their organizations and the work they perform

3.0            Primary Requireme​nts

M&O Contract

    • DOE Prime Contract No. DE-AC02-07CH11359 for the Management and Operation of the Fermi National Accelerator Laboratory (Fermilab)
    • Fermilab Performance Evaluation and Measurement Plan (PEMP) Objective 6.4 – Provide Efficient, Effective, and Responsive Contractor Assurance System, including Internal Audit and Quality

Other DOE Orders and Instructions

    • DOE Order 227.1 Independent Oversight Program
    • ANSI/ASQ Z1.13-1999 Quality Guidelines for Research

FRA Contract Clause Mapping to Management Systems

https://fermipoint.fnal.gov/organization/ood/cas/

4.0            Management System Description Overview

The Quality Assurance management system contains the activities necessary to implement the requirements of the FRA Contractor Assurance System (CAS), in accordance with the Director's Policy on Quality Assurance, through Fermilab's Quality Assurance (QA) program.  The QA management system provides input to the FRA Contractor Assurance System and improves Fermilab's ability to meet or exceed customer expectations.

Th​​e Quality Assurance management system consists of the overarching QA Program and is supported by the procedures in the Quality Assurance Manual, and supporting Division/Section/Project (D/S/P) processes and procedures.

4.1               Quality Assurance Program

The purpose of the QA program is to define a methodology which ensures that Fermilab's products and services meet or exceed customer expectations; provide the lab with requirements for the purpose of implementing and maintaining a QA program throughout the lab; and to provide a QA system capable of monitoring, controlling, and continually improving the program's activities, processes, and systems.

The scope of the QA program applies to Fermi Research Alliance, LLC (including all legal entities under its exclusive control) and all employees, contractors, subcontractors, and Fermilab users when performing work that affects the laboratory.

4.2               Quality Assura​nce Manual

The Quality Assurance Manual is a living document that contains Fermilab's requirements and procedures designed to manage the quality program. Quality Assurance applies to all work conducted at Fermilab, and we have worked diligently to establish an overarching institutional approach to QA at the laboratory. This approach applies program controls using a graded approach based on an analysis of identified risks where work is to be performed. It also outlines requirements necessary to consistently meet the contract obligations throughout the laboratory. The Quality Assurance Manual consists of the key quality procedures that are applicable lab-wide:

4.2.1    Quality Assurance Program​​

Documents the overarching QA program implemented at Fermilab.

4.2.2    Software Quality Assurance Program​​

Documents the overarching Software QA program implemented at the laboratory including the SQA grading process and quality controls required by all software utilized at the laboratory.

4.2.3    Contractor Assurance/Lessons Learned​

Documents the responsibilities and actions required to process and communicate lessons learned within Fermilab and to the Department of Energy as required by DOE O 210.2A, The DOE Corporate Experience Program.

4.2.4    Suspect/Counterfeit Item (S/CI) Program

Documents the responsibilities and actions required to identify and control the use of Suspect/Counterfeit Items.

4.2.5    iTrack Procedures & Risk Assignment

Describes the issues management procedure and tool used to document and resolve issues found at the laboratory, and also describes the process for determining risk for ES&H based issues found.

4.2.6    Corrective & Preventive Actions

Describes the process for handling issues and implementing corrective and preventive actions when necessary.

4.2.7​    Root Cause Analysis: Documents

The activities required to perform root cause analysis, and provides tools to assist in identifying the root cause.

4.2.8    QA Guidelines for Scientific Res​​​​earch

Implementation guide for quality of scientific research per ANSI/ASQ Z1.13-1999, Quality Guidelines for Research.

4.2.9    Graded Approach Proced​​ure

Guide to aid in the selection of the level of controls to be applied to activities which pose the greatest risk for significant negative impact on operations and/or reputation.

4.2.10  Self-Assessments​​

Instructions for performing and documenting self-assessments by organizations internal to Fermilab.

4.3               Supporting D/S/P Processes & Procedures​​

The D/S/P processes and procedures support the implementation of the Fermilab Quality Assurance program within their respective organization and demonstrate how the organization is compliant with Contract Clause H.13.

5.0            Reports, Audits, Assessments and Required Re​​cords

5.1               Reports​​

The following reports are required on a periodic basis:

·       Dashboard metrics

·       Suspect/Counterfeit Items Investigations

·       Lessons Learned Reports

·       Issues Management Status Reports

5.2               Reviews and Audits​​​

The Fermilab Quality Assurance Program is reviewed and approved by the Department of Energy as improvements are made.

In lieu of formal status report meetings, the Department of Energy has representation on the Quality Assurance Subcommittee to stay current on the Fermilab Quality Assurance Program and the Quality Assurance management system.

The Quality Assurance management system is monitored by a series of reviews and audits that occur throughout the year, both scheduled and ad hoc, including (but not limited to):

  • DOE Reviews
  • Tripartites
  • QA Self-Assessments
  • QA Assessments
  • Director's Reviews

All issues identified during these activities are tracked through iTrack.

5.3               Records​​​

  • Monthly QA Subcommittee Minutes & Actions
  • Semi-Annual QA Subcommittee FESHComm Reports
  • Annual QA Subcommittee FESHComm Self-Assessments
  • Records of Assessments (DOE Reviews, Director's Reviews, External Assessments, etc.)
  • QA Assessments
  • QA Self-Assessments
  • Issues Management Tracking System (iTrack)
  • Suspect/Counterfeit Item Investigations
  • Lessons Learned Reports
  • Configuration Management Database (CMBD) of inventoried software

6.0            Additional References​​

7.0            Definitions of Acronyms and Terms​​

Acronym Definition
DOE

Department of Energy

D/S/PDivisions, Sections, and Projects
ESH&QEnvironment, Safety, Health, and Quality
MSOManagement System Owner
PEMPPerformance Evaluation and Measurement Plan
QAQuality Assurance
S/CISuspect/Counterfeit Item