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:

Designation and Approval

The designation and approval principle focuses on establishing accountability from the outset. An individual or individuals must be designated to review for adequacy and approve all required documents prior to issuance. This approval process, including the date and signature of the approving individual(s), must be documented to create a clear record of oversight and ensure that only vetted materials enter circulation.

Availability

Accessibility is crucial for operational efficiency and regulatory adherence. Documents established to meet Quality System Regulation (QSR) requirements shall be available at all locations for which they are designated, used, or otherwise necessary. This ensures that personnel across various sites or departments can access the right information when needed, preventing delays or non-compliance due to unavailability.

Obsolete Control

Managing outdated materials is essential to avoid risks associated with incorrect usage. 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, which could lead to quality issues, safety hazards, or regulatory violations.

Implementing these document control principles helps manufacturers build robust quality systems that prioritize precision and reliability. For specific implementations, it's wise to reference the full regulatory texts or seek advice from quality management professionals to align with your organization's needs.

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

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

Change Review

The change review principle emphasizes independence and consistency in oversight. Changes must be reviewed and approved by an individual or individuals in the same function or organization that performed the original review and approval, unless specifically designated otherwise. This approach ensures that those with relevant expertise evaluate modifications, preserving the integrity of the documentation.

Communication

Effective communication is key to implementing changes smoothly across an organization. Approved changes shall be communicated to the appropriate personnel in a timely manner. This timely dissemination prevents misunderstandings, reduces downtime, and ensures that everyone involved—from production teams to quality assurance—operates with the most current information.

Change Records

Maintaining thorough documentation of alterations is a cornerstone of regulatory compliance. Manufacturers shall maintain records of changes to documents, which 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. These records serve as an audit trail, facilitating traceability and demonstrating adherence to standards during inspections.

By following these principles, manufacturers can foster a culture of accountability and continuous improvement in their quality management systems. For tailored application, it's recommended to cross-reference with the latest regulatory guidelines or consult compliance experts to address any organization-specific nuances.

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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