Management System Owner: Chief Safety Officer
Revision and Date: Revision 2.1, 2016-11-16
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.
The following responsibilities are only required on an as-needed basis
Other DOE Orders and Instructions
FRA Contract Clause Mapping to Management Systems
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.
The 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.
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.
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:
Documents the overarching QA program implemented at Fermilab.
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.
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.
Documents the responsibilities and actions required to identify and control the use of Suspect/Counterfeit Items.
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.
Describes the process for handling issues and implementing corrective and preventive actions when necessary.
The activities required to perform root cause analysis, and provides tools to assist in identifying the root cause.
Implementation guide for quality of scientific research per ANSI/ASQ Z1.13-1999, Quality Guidelines for Research.
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.
Instructions for performing and documenting self-assessments by organizations internal to Fermilab.
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.
The following reports are required on a periodic basis:
· Dashboard metrics
· Suspect/Counterfeit Items Investigations
· Lessons Learned Reports
· Issues Management Status Reports
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):
All issues identified during these activities are tracked through iTrack.
Department of Energy