Management System Owner: Head, Quality Assurance
The Quality 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:
Aligned DOE Orders, Standards, and Guidelines
FRA Contract Clause Mapping to Management Systems
The Quality management system contains the activities necessary to implement the requirements of the FRA Contractor Assurance System (CAS), in accordance with the Fermilab policy on Quality, through Fermilab's Quality Assurance (QA) program. The Quality management system provides input to the FRA Contractor Assurance System and improves Fermilab's ability to meet or exceed customer expectations.
The Quality management system consists of the overarching Quality Assurance 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 Fermilab and its resources.
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 (Batavia, IL and Lead, South Dakota), 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. The QA Program provides guidance and tools which enable the Management
Systems to ensure Fermilab’s compliance with the DOE contract provisions and
enable line management to ensure that products and services meet established
standards, criteria or expectations. The Quality Assurance Manual consists of the key quality procedures that are applicable across Fermilab:
Documents the overarching QA program requirements appliable to Fermilab in Batavia, IL and Lead, South Dakota.
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 ESH&Q 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 formally generated on a periodic basis:
· Dashboard metrics
· Suspect/Counterfeit Items Investigations
· Lessons Learned Reports
· Issues Management Status Reports
The Fermilab Quality Assurance program is reviewed by the Department of Energy as improvements are made.
In lieu of formal status report meetings, the Department of Energy - Fermi Site Office has representation on the Quality Assurance Subcommittee to stay current on the Fermilab Quality Assurance Program and the Quality Management System.
The Quality management system is monitored by a series of reviews and assessments that occur throughout the year, both scheduled and ad hoc, including, but not limited to:
All issues identified during these activities are recorded in and tracked via the Issues Management Tracking System (iTrack).
Department of Energy
The Fermilab Contractor Assurance System applies to all Fermilab activities in South Dakota to ensure compliance with Fermilab’s contract with DOE. The Fermilab Quality Assurance (QA) Policy applies to all work performed in the leased space in South Dakota. Assurance is provided in accordance with the Fermilab Quality Assurance (QA) Program outlined in FESHM 12002. The Fermilab QA team provides additional assurance functions such as independent assessments or documentation reviews. SURF Services work processes and activities performed by SDSTA are expected to adhere to the SDSTA QA Policy and Plan. The Fermilab QA team provides quality subject matter expertise to SDSD for program or process development/improvement where needed. The appropriate functional manager is responsible for an assurance system sufficient to ensure safety, compliance and success. Additionally, the QA Team provides assurance that subcontractor QA Programs are sufficient and adequately implemented.