No. 10.000 Rev. 3

Quality Assurance

2.0

Effective Date 11/08/2008

1.0 Purpose

The purpose of this policy is to express the fundamental intent and direction for quality assurance at Fermilab.

2.0 Applicability

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.

3.0 Authority

The Director of Fermilab authorizes this policy by signature.

4.0 Policy

4.1

Quality 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.

4.2

At 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.

4.3

Fermilab'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.

4.4

The 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.

4.5

To 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.

4.6

Suspect/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.

5.0 Responsibilities

5.1

The 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

5.2

Division, 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

5.3

The 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

6.0 References

6.1

Department of Energy (DOE) Order 414.1, Quality Assurance

7.0 Definition

7.1

Assessment: A review, evaluation, inspection, test, check, surveillance, or audit to determine and document whether items, processes, systems, or services meet specified requirements and perform effectively. (DOE O 414.1C)

7.2

Graded Approach: The process of ensuring that the levels of analyses, documentation, and actions used to comply with requirements are commensurate with: the relative importance to safety, safeguards, and security; the magnitude of any hazard involved; the life-cycle stage of a facility or item; the programmatic mission of a facility; the particular characteristics of a facility or item; the relative importance to radiological and non-radiological hazards; and any other relevant factors.

7.3

Quality Assurance: All those actions that provide confidence that quality and fitness for intended use is achieved.

7.4

Quality Assurance Program: The overall program or management system established to assign responsibilities and authorities, define policies and requirements, and provide for the performance and assessment of work. Integrated Quality Assurance is the Fermilab Quality Assurance Program that is the vehicle to implement the Fermilab Quality Assurance Policy. It details the implementation of the tenets of the Policy and incorporates the requirements set forth in DOE O 414.1C Section 4.