Best Document Control Procedures for Quality and Compliance

Every document control system, whether manual or automated, should include these elements:

• Document creation and formatting
• Types of controlled documents (policies, SOPs, work instructions, etc.)
• Document identification (naming conventions, numbering)
• Version control to track changes
• Access controls to manage permissions
• Review and approval workflows
• Storage and archiving methods
• Distribution rules
• Document security
• Training and acknowledgment tracking
• External documentation management

How to set up document control procedures

Document control software enables organizations to automate document management procedures in one central repository. Whether you’re starting from scratch or improving your current system, you can follow the steps below to implement effective document control procedures:

Assess your current documentation

Start by listing all the types of documents your company manages—SOPs, reports, equipment logs, customer communications, etc. Include any documentation that reflects on the consistency and quality of your products. Then look for overlaps or gaps.

As you get a better feel for your documentation, consider relationships to processes and hierarchies that can be molded into a system for organizing and naming documents.

Designate document owners

Determine the best possible owners of each type of documentation and designate them as responsible for managing the updating, reviewing, approval and releasing of associated documents. You may want to involve these people in determining document control procedures for their area of responsibility.

How to create a document control policy

Your document control policy acts as a go-to reference for any employee involved with document management. The policy should outline:

1. Document creation 

Your document control procedures should establish who the responsible parties are for creating a document and how the document is to be created. This should include naming and formatting conventions and any other technical specifications. 

2. Types of documents 

Identifying types of documents makes it easier to manage future updates. Typical controlled document types include: policies, procedures, work instructions, forms, drawings, process maps, process flow charts, specifications, internal communications, production schedules, approved supplier lists, test and inspection plans as well as quality plans.  

3. Identification 

Create a system for naming documents that clearly identifies documents and differentiates them, such as unique naming convention or numbering system. 

4. Version control 

A system should be in place to use when changes are made to already approved documents - who reviews the changes, who may edit changes, who approves changes and what is the process to communicate and/or train personnel on the changes.  

This system should include ways to ensure that the most up-to-date version of documentation is in use. Version control procedures should track document revisions and archive or delete outdated versions.   

5. Access control and permissions 

Set up access controls to restrict document access to authorized personnel only. This includes defining who can view, edit, approve and distribute documents within the organization.  

6. Storage and archiving  

Determine a strategy for how to organize, where to store and when to archive documentation. Consider retention periods for archived documents, naming conventions, and storage location for each stage of the document lifecycle. For instance, SOPs might be saved in a shared drive, while customer support ticket templates could be saved in a different application.  

7. Review and approval  

Your document control policy should include instructions for document reviews and approvals, including who, when and how changes and approvals are made. For instance, system documents could be reviewed once per year to ensure they are up to date. Corrective action reports might be reviewed under shorter time periods. 

8. Distribution 

Create procedures for controlling the distribution of documents that identify stakeholders to include in distribution and ways to restrict access, if necessary.  

9. Document training 

Be sure you have guidelines in place for training stakeholders on new or revised documents and a system for recording training completion. 

10. External documentation 

You will also need to develop document control procedures for documentation from external sources. They should be systematically organized and labeled, and there should also be a predetermined method for review, revision and access.