No. 13.000 Rev. 001

Document Management and Control

2.0

Effective Date 8/22/11

3.0

Scope

This policy addresses the control of documents at the laboratory.

4.0

Applicability

This policy applies to all employees of Fermilab, Users and Visitors.

5.0

Policy
Fermilab’s document management processes ensure the mechanisms for preserving records sufficient to support technical and regulatory decisions and provide evidence that work was correctly performed.
All policies, program documents, program or project implementation plans, and procedures shall be defined, controlled and maintained by the issuing organization in accordance with the following controls through the entire life cycle:

  • Documents to prescribe processes, specify requirements, or establish design shall:
    • Be approved for adequacy prior to issue by the appropriate level of management.
    • Have authority for approval defined.
    • Allow for review by the affected organizations where documents affect more than one organization.
    • Have a process to review changes and resolve comments.
    • Be reviewed, updated as necessary and re-approved.  The issuing organization shall schedule reviews and updates for each document under its control. The frequency of the reviews will be defined by the document’s type per guidance or requirements from DOE and risk.  Responsible organizations shall perform the reviews with assistance from the other interested parties as applicable.
    • Have a record of the date on which each change is implemented, summary of the change, authorizing party, and reason for change.
    • Ensure designated functions/organizations have access to pertinent background information upon which to base their review and approval.
    • Be identified by a unique descriptor.
    • Be appropriately marked and accessible as defined in DOE O 471.3.
  • The document management process shall:
    • Provide a way to identify the current revision of a document.
    • Ensure implementation includes updates to all appropriate documents, a timely review, and timely distribution of documents including to the subcontractors.
    • Ensure that relevant versions of applicable documents are available for effective reference.
    • Ensure that documents remain legible, readily identifiable, and retrievable.
    • Ensure that documents of external origin that support and/or prescribe processes and procedures, specify requirements, or establish design are identified and their distribution defined.
    • Prevent the unintended use of obsolete documents or uncontrolled documents when a controlled document is required, and to apply suitable identification to any document if they are retained for any purpose.
    • Define provisions for specifying, preparing, reviewing, retaining, disposing, protecting, preserving, changing, traceability, accountability, and retrievability of controlled documents per DOE O 243.1.
    • Require a review of the training plan, if required, to ensure there is adequate time between the issue and effective dates to accomplish training the users.

The requirements, processes, and systems will be documented and conveyed to the appropriate personnel in such a manner to guarantee understanding and proper use.

6.0        

Drivers

    1. DOE O 414.1C, Quality Assurance, dated 6-17-05.
    2. DOE O 243.1, Records Management Program, dated 2-03-06
    3. DOE O 471.3, Indentifying and Protecting Official Use Only Information, dated 4-09-03

7.0         

Responsible Organization

  • The Laboratory Director is responsible for all programs and delegates to the Associate Laboratory Director of Operations the day-to-day management of the Document Control Program required by DOE O 414.1C
  • The Chief Operating Officer has responsibility for ensuring the flowdown of requirements throughout the organization, use of the policies, and review of policies by management in accordance with their prescribed periodicity/expiration date.
  • All Fermilab organizational elements shall conduct their operations in a manner consistent with the above policy and objectives.
  • The responsibility for compliance with requirements starts at the worker level and broadens as it progresses upward through the line organization. The line managers are fully responsible for the work of their personnel, activities and sites assigned to them, and shall take necessary actions to ensure requirements are implemented and performance is monitored and corrected as necessary.
  • The Business Services Section shall prepare, maintain and update the Fermilab Document Control and Management Program (FDCMP) manual to implement this policy; the manual complies with all applicable DOE orders and is for use by all Divisions, Sections and Centers (D/S/Cs).
  • D/S/Cs shall have a Document Coordinator for their respective areas of responsibility in accordance with the FDCMP;
  • Document Coordinators may represent multiple organizations.