Document Changes (CFR 820.40(b))

Document Changes (21 CFR 820.40(b)) is the required procedure to ensure that when any official quality or manufacturing document (like a procedure, specification, or drawing) needs to be updated, the change is properly reviewed, approved by the right people, and communicated quickly throughout the facility before the new version is put into use.

The requirements for Document Changes (sometimes referred to as revision control or change control for documents) in the U.S. FDA's Quality System Regulation (QSR) are specifically detailed under 21 CFR 820.40(b), which falls under the broader mandate of Document Controls (Subpart D).

Here is a simplified definition and detailed breakdown of the principles required for managing document changes:

Core Requirements for Document Changes

The procedures established for document control must specifically provide for the control of changes to documents, requiring four key steps:

1. Review and Approval by the Same Function

Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise.

• This ensures that the technical expertise and organizational responsibility that established the original document are applied to evaluating the proposed change.
• For quality requirements documentation, the review and approval should typically be performed by individuals in the same function or organization that performed the original approval.

2. Timely Communication

Approved changes shall be communicated to the appropriate personnel in a timely manner.

• This principle ensures that personnel who rely on the document for their work (such as production staff or inspectors) immediately become aware of and start using the correct, updated version.

3. Record Keeping (Change Records)

Manufacturers shall maintain records of changes to documents.

• These records are crucial for tracking the history of the quality system and proving compliance.
• The manufacturer must use these records to show that requirements have been met.

4. Required Content of Change Records

The required Change records must include specific, documented details:

• A description of the change.
• Identification of the affected documents.
• The signature of the approving individual(s).
• The approval date.
• When the change becomes effective (the implementation date).

Context in the Quality System

Document Change Control is intrinsically linked to other quality system elements:

• Relationship to Approval and Distribution (820.40(a)): The entire Document Control system (Subpart D) requires documents to be approved prior to issuance and must ensure that obsolete documents are promptly removed from all points of use or prevented from unintended use. Proper change control supports this by verifying and documenting that the change is correct before the new document is issued.
• Widespread Application: The requirement to approve changes is incorporated into various other QSR requirements, such as Production and Process Changes ($\S 820.70(b)$) which must be approved in accordance with $\S 820.40$. Similarly, changes to documents and data related to Purchasing must also be approved in accordance with $\S 820.40$.
• Design Changes: Changes to design documentation (like drawings or parts lists) must follow the Document Controls procedures after the design changes have been made and approved by authorized personnel. The Design Changes requirement ($\S 820.30(i)$) is specifically focused on controlling the changes to the device design itself, including their necessary verification/validation, before implementation.
• Corrective Action and Prevention (CAPA): Any procedural changes addressing quality problems must be recorded, implemented, and communicated to responsible personnel and management as part of the CAPA system.
• Supplier Agreements: In supplier quality agreements, the supplier is often required to provide written notification of any changes in their quality system and specific documents using a change notification template, allowing the Purchaser (manufacturer) to evaluate the impact of the change to the finished product. Changes to documentation are also generally addressed under the supplier's Change Notification procedures.

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