Document Control

‍Document Control is the quality system process that ensures that every employee working on a device has access to the correct, current, and approved instructions needed to perform their job, and that old, incorrect instructions are immediately removed from use.

The Document Controls section of the U.S. FDA’s Quality System Regulation (QSR), found in 21 CFR 820.40 (Subpart D), mandates the procedures manufacturers must follow to manage all quality-related documentation.

1. Regulatory Basis and Core Requirement

The goal of document control is to maintain the integrity of the Quality Management System (QMS). Manufacturers must establish and maintain procedures to control all documents that are required by the QSR (Part 820).

Documents required by the QSR, such as the Device Master Record (DMR) (the manufacturing instructions) and the Quality System Record (QSR) (the general system procedures), must be prepared and approved in accordance with $\S 820.40$.

2. Key Principles of Document Control (21 CFR 820.40)

The required procedures must address the control of both document issuance and document changes:

A. Document Approval and Distribution ($\S 820.40(a)$)

This section focuses on ensuring that only approved, current documentation is being used:

Document Control Principles

Principle	Requirement
Designation and Approval	An individual(s) must be designated to review for adequacy and approve all required documents prior to issuance. The approval, including the date and signature of the approving individual(s), must be documented.
Availability	Documents established to meet QSR requirements shall be available at all locations for which they are designated, used, or otherwise necessary.
Obsolete Control	All obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. This is critical to prevent personnel from mistakenly using older, incorrect information.

B. Document Changes ($\S 820.40(b)$)

Procedures must strictly control how and by whom documents are revised:

Document Change Principles

Principle	Requirement
Change Review	Changes must 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.
Communication	Approved changes shall be communicated to the appropriate personnel in a timely manner.
Change Records	Manufacturers shall maintain records of changes to documents. These change records must include: a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

3. Integration Across the Quality System

Document control procedures are the backbone for controlling all specific records and processes throughout the QMS:

Production Changes: Procedures regarding changes to specifications, methods, processes, or procedures for Production and Process Controls must be approved in accordance with $\S 820.40$.
Purchasing Controls: Documentation related to purchasing data must be approved in accordance with $\S 820.40$.
Design Controls: The requirements for Design Changes (21 CFR 820.30(i)) are specifically intended to be documented, reviewed, and approved before implementation. Changes to the resulting design documentation (like drawings or parts lists) must then follow the established Document Control procedures for review and approval.
Quality System Documentation: The QMS relies on a hierarchy of documents (like the Quality Manual, procedures, work instructions, and records). All quality system documentation must be controlled and maintained.
Auditing: Auditors look for compliance with documented quality system procedures and check if personnel know where to find their controlled procedures. They verify that documents are available and that obsolete documents are promptly removed.

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