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(M8) Quality
Contractor Assurance

​​​Management System Owner: Quality Section Head

Revision Number:     2.0                        Date:     April 22, 2019

1.0   Pu​​rpose

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.

2.0   Roles and Respo​​nsibilities

Title

Responsibilities
Head, Quality Assurance
  • Owns the Quality management system

  • Establishes and maintains Quality policies and procedures

  • Assesses line organizations for compliance

  • Seeks and implements improvements

  • Designated Fermilab management representative responsible for the development, implementation, assessment and improvement of the Quality management system.

  • Implements and oversees 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:

      1. Establish and maintain the Fermilab Quality Assurance Program in accordance with Prime Contract Clauses;  I.87 and H.13.

      2. Coordinate all changes to the Quality Assurance Program and advise and assist the laboratory in implementing and maintaining the overall program.

      3. Managing the QA assessment program.

      4. Develop and apply a graded approach to the application of quality controls.

      5. Develop and execute quality plans, policies, and procedures.

      6. Implement and oversee formal quality initiatives as they develop.

      7. Manage the Suspect/Counterfeit Items identification program.

      8. To facilitate continuous improvement of the Laboratory's management processes.

      9. To research emerging best practices in programs found at other National Laboratories, industry and other research organizations.

      10. Establishes quality assurance program metrics to measure performance and evaluate the effectiveness of the program.

      11. 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.

  • Delegates aspects of these responsiblities to Quality Assurance Specialists and ESH&Q Subject Matter Experts in the group.

Quality Assurance Specialist / ESH&Q Subject Matter Experts

  • Supports Fermilab in the areas of business management and quality assurance capabilities and resources.

  • Serves as the Subject Matter Expert and assists the QA Section Head in establishing and maintaining the Quality Assurance Program for Fermilab.

  • Assist Fermilab in identifying opportunities for improvement and process and documentation development.

  • Assists the QA Section Head and Fermilab in:

      1. Establishing and maintaining the QA Program in accordance with Prime Contract Clauses I.87 and H.13

      2. Conducting / Facilitating asessment activities 

      3. Applying a graded approach to quality controls

      4. Developing Quality Assurance Program policies and procedures

      5. Developing and executing QA Plans

      6. Developing and delivering QA Training

      7. Facilitating/Participating in Human Performance Improvement (HPI) Investigations

      8. Facilitating or Advising S/CI investigations

All Laboratory Staff
  • Ensure compliance to Fermilab's Quality Assurance Program and Contract Clauses I.87 and H.13 by developing and following processes and procedures relevant to their organizations and the work they perform.

3.0   Primary Requireme​nts

3.1  M&O Contract

  • DOE Prime Contract No. DE-AC02-07CH11359 for the Management and Operation of the Fermi National Accelerator Laboratory (Fermilab)

3.2   Fermilab Performance Evaluation and Measurement Plan (PEMP)

  • Goal 6.0: Deliver Efficient, Effective, and Responsive Business Systems and Resources that Enable the Successful Achievement of the Laboratory Missions(s).
    •  Objective 6.4 - Provide Efficient, Effective, and Responsive Contractor Assurance System, including Internal Audit and Quality

3.3  Other Required DOE Orders and Instructions (Not required by the Prime Contract*)

  • DOE O 413.3B - Program and Project Management for the Acquisition of Capital Assets
  • ISO 9001:2015 Quality Management Systems Requirements*
  • DOE O 414.1D - Quality Assurance*
  • ANSI/ASQ Z1.13-1999 Quality Guidelines for Research*

4.0   Management System Description

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.

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 lab'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.

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 sites (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 and guidance for quality control implementation that are applicable across Fermilab.

 4.2.1   Quality Assurance Program

Documents the overarching QA program requirements applicable to Fermilab sites in Batavia, IL and Lead, South Dakota.

4.2.2   Software Quality Assurance (SQA) 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. The SQA Program is owned and managed by the Fermilab Core Computing Division. The QA groups supports the implementation and assessment of the progam, as well as develops supplemental guidance documentation for the laboratory.

 

4.2.3   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 and Risk Assessment

Describes the issues management procedure and tool used to document and resolve issues found at the laboratory and also the process for determining risk for Quality and ESH-based issues found.

4.2.6   Corrective and Preventive Actions

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

4.2.7   Root Cause Analysis

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 Research

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

4.2.9   Graded Approach

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 Clauses I.87 and H.13.

5.0    Policies

6.0    Key Processes, Procedures, and Manuals

7.0   Approach to Collaboration and Communication

The Quality management system details expectations of D/S/P in the Quality Assurance Manual. Quality Liaison roles have been established that serve as the direct points of contact per each D/S/P. The liaisons serve as one of the main conduits for collaboration and communication between Quality and the D/S/P. Despite assigned liaison, Quality has established an open approach for D/S/P support with QA Program implementation, documentation, monitoring, measuring, improvement opportunities, and feedback.

8.0    Contractor Assurance Requirements

8.1   Metrics and Key Performance Indicators (KPIs)

Current Quality management system metrics and KPIs on FermiDash are:

  • Average Days to Close – Average number of elapsed business days to close iTrack items, segregated by item type.
  • Continuous Improvement – Number of continuous improvements by organizations per fiscal year.
  • Effectiveness Review Findings – Results of effectiveness reviews by organization per fiscal year.
  • HPI/Dashboard – Number of Latent Organizational Weaknesses.
  • HPI/Error Precursors – Number of error precursors for the entire Lab and number of error precursors by organization.
  • HPI/Incident Types – Number of Incident types by Division.
  • Items by Category/Management System – Number of iTrack items by category for each Management System.
  • Items by Category/Organization – Number of iTrack items by category for each Organization.
  • Items by Category/ Project – Number of iTrack items by category for each Project.
  • Items by Management System - Number of iTrack items by Management System, year, item type, and status.
  • Items by Organization – Number of iTrack items by Organization, year, item type, and status.
  • Items by Project – Number of iTrack items by Project, year, item type, and status.
  • Lessons Learned – Number of Lessons Learned by organization and fiscal year.
  • Fermilab Manuals – Number of Chapter Manual Reviews past due or coming due by Manual.
  • Open High-Risk Items – Number of open high-risk items by review number.
  • Open Management System Items – Number of open iTrack items by Management System by month.
  • Open Organization Items – Number of open iTrack items by Organization by month.
  • Open Project Items – Number of open iTrack items by project by month.

8.2   Assessments

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 Assurance Council 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:

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

8.3    Approach to Issues Management

Issues are identified via events such as formalized assessments, but also from informally from events such as walkthrough but also program/process updates or management concerns. Issues identified during these activities are recorded in the Issues Management Tracking System (iTrack) and tracked through resolution.

8.4   Lessons Learned

Identify, capture, and track Lessons Learned in iTrack system. Lessons Learned are communicated via the subject matter experts via a link to iTrack.

8.5   Risk Management

Risks are mainly identified and monitored via formal and informal assessment activities.

  • Self-Assessment Program
  • iTrack Procedures and Risk Assignment
  • Corrective Action Plans – in iTrack
  • Effectiveness Reviews – in iTrack

 9.0   Reports and Records

9.1   Records

  • Records of Assessments (DOE Reviews, Director's Reviews, External Assessments, etc.)
  • QA Assessments
  • QA Self-Assessments
  • HPI Review Reports (database)
  • Issues Management Tracking System (iTrack)
  • Suspect/Counterfeit Item Investigations
  • Lessons Learned Reports
  • Configuration Management Database (CMBD) of inventoried software

       Other records including:    

  • Training Records 

9.2   Reports

  • Dashboard
  • Assessment Reports
  • HPI Review Reports

10.0    Extension of Management System to SDSTA (SURF)

The Fermilab Contractor Assurance System applies to all Fermilab activities to ensure compliance with FRA's Prime Contract with DOE. The Fermilab Quality Assurance (QA) Policy applies to all work performed in Batavia, IL and leased spaces in Lead, South Dakota.  Assurance is provided in accordance with the  Fermilab Quality Assurance (QA) Program outlined in FESHM 12002. The Fermilab QS 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.

11.0   Additional References

12.0   Acronyms and Terms​​

Acronym Definition
DOE

Department of Energy

D/S/PDivisions/Sections/Projects
​FSO​Fermilab Site Office
MSOManagement System Owner
PEMPPerformance Evaluation and Measurement Plan
QAQuality Assurance
S/CISuspect/Counterfeit Item