No. 10.000 Rev. 3
Effective Date 11/08/2008
The purpose of this policy is to express the fundamental intent and direction for quality assurance at Fermilab.
This policy applies to Fermilab Research Alliance, LLC (including all legal entities under its exclusive control) and all its employees, contractors, subcontractors, and Fermilab users.
The Director of Fermilab authorizes this policy by signature.
4.1Quality assurance programs are intended to improve and sustain a facility's ability to consistently, dependably, and cost-effectively meet or exceed programmatic and operational customer requirements. Implemented properly, an effective quality assurance program is transparent among business processes and creates a culture of continuous improvement.
4.2At Fermilab, quality assurance is used to maintain a high state of readiness, reliability, and sustainability of programs that support the Nation's efforts of using high-energy physics to advance our understanding of the fundamental nature of matter and energy. Fermilab uses a graded approach to define and integrate the appropriate level of quality controls based upon risk of the subject initiative or operation. Using a graded approach is paramount to an effective quality program to ensure that effort expended to maintain it provides value to the organization.
4.3Fermilab's Integrated Quality Assurance program is composed of the Integrated Quality Assurance (IQA) program document, programmatic implementing procedures such as the Fermilab graded approach, and Divisions/Sections/Centers implementing procedures. The IQA provides a single, integrated approach for assuring quality throughout Fermilab. The IQA implements the tenets of this policy, and those set forth in the current revisions of the referenced documents.
4.4The IQA and programmatic procedures implement this policy; set expectations for Divisions/Sections/Centers to develop implementing procedures; establish and maintain a graded approach; perform audits and self-assessments; provide tools for continuous/process improvement and adoption of best practices; and provide guidelines for levels of inspection, documentation, and recordkeeping.
4.5To the extent reasonable and appropriate, quality assurance activities at all levels should systematically aim to:
- build enduring customer relationships;
- earn customer and stakeholder trust;
- keep activities relevant with current research directions and customer expectations;
- choose partners and suppliers that share Fermilab's enthusiasm and commitment to safety and quality;
- reduce process complexity, variation and cost, and encourage organizational flexibility;
- focus on preventive versus corrective actions;
- embed organizational and personal learning, and improvement in our processes;
- seek and accept complaints as opportunities to strengthen customer relationships; and
- utilize national and international consensus standards where practical, consistent with contractual or regulatory requirements, or where a competitive advantage is achieved.
4.6Suspect/Counterfeit Items Program
It is Fermilab's policy to make every reasonable effort to prevent the use of suspect/counterfeit items (S/CI) in keeping with our policy of ensuring personnel and public safety, and environmental integrity, while safeguarding investments that affect the Laboratory's mission.
Each individual is expected to be vigilant to detect and report suspect/counterfeit items according to Fermilab suspect/counterfeit procedures. It is the responsibility of each individual to be aware of the consequences of incorporating suspect/counterfeit material into the operations of the laboratory. As appropriate for their job duties, all individuals shall make themselves aware of the various items that are likely to be suspect/counterfeit.
5.1The Fermilab Director
- Holds senior leaders accountable for implementation of, and compliance with, this policy
- Provides financial support to senior leaders for pertinent quality assurance activities
- Ensures the use of graded levels of documentation, recordkeeping, and assessment
- Regularly reviews a system of metrics indicating the effectiveness of quality assurance activities
5.2Division, Section and Center Heads
- Comply with this policy and implement the IQA for their areas of responsibility
- Continue to minimize E,S,&H and other risk while improving consistency and reliability in the performance of Fermilab work
- Financially support pertinent quality assurance activities such as employee training, process documentation, document and records control, inspection and acceptance testing, and independent assessments
- Work closely with the Office of Quality and Best Practices to develop and maintain a graded approach for their areas of responsibility
- Make quality assurance the responsibility of every Fermilab employee and contractor
5.3The Office of Quality and Best Practices
- Manages, improves and administers the Fermilab Quality Assurance Program
- Maintains and improves the strategy for implementing graded quality assurance plans
- Works with Division and Section Heads to build and implement graded quality assurance plans and procedures
- Embeds personnel into programs and operations to assist in quality assurance implementation