Introduction
What is a document control procedure?
Core elements of document control procedures
How to implement document control procedures
Document control procedures and ISO 9001
Document control procedures for ISO 13485
Document control procedures and FDA and GMP standards
How do documentation procedures contribute to good internal controls?
Manual document control versus electronic document control
Summary
How to Create the Best Document Control Procedures
January 18, 2024
Document control procedures enable organizations to manage documentation in a way that is compliant with government and industry regulations. Document control is a key component for U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) compliance with quality management standards, environmental management standards, and health and safety standards.
Document control is an essential preventive measure that ensures that only approved, current documents are used throughout your organization. Inadvertent use of out-of-date or unapproved documents can have significant negative consequences on audits, quality, costs and customer satisfaction.
Whether you’re creating document control procedures from scratch or fine-tuning an existing system, familiarizing yourself with document control procedure best practices is a great place to start.
Core elements of document control procedures
Core elements of document control procedures include:
- Document creation
- Types of documents
- Document identification
- Document version control
- Document access control and permissions
- Document review and approval
- Document storage and archiving
- Document distribution
- Document security
- Document training
- External documentation
We delve into these in more detail below.
How to implement document control procedures
Document management software, or document control software, enables organizations to automate document control procedures in one central repository. Below are steps for implementing effective document control procedures.
Assess
The first step in creating effective document control procedures is to assess the current types and amount of documentation your company manages. This includes items such as SOPs, reports, customer communications, equipment logs, etc. Include any documentation that reflects on the consistency and quality of your products.
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 Process 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.
Create a Policy
Outline your document control procedures in a clear document control policy. Establish rules for document creation, organizing, sharing, access and storage. This policy should define roles and responsibilities, the document lifecycle, and the procedures for creating, reviewing, approving and updating documents.
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.
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.
Document Identification
Create a system for naming documents that clearly identifies documents and differentiates them, such as unique naming convention or numbering system.
Document 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.
Document 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.
Document 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.
Document 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.
Document Distribution
Create procedures for controlling the distribution of documents that identify stakeholders to include in distribution and ways to restrict access, if necessary.
Document Training
Be sure you have guidelines in place for training stakeholders on new or revised documents and a system for recording training completion.
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.
Document control procedures and ISO 9001
If you’re creating document control procedures to satisfy ISO 9001 quality standards, keep in mind that the ultimate goal is to demonstrate the effective planning, operation and control of your business processes.
Primary elements of ISO 9001 document control:
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Maintaining documentation that supports work processes and ensures those processes are undertaken accordingly. Examples include SOPs, policies, training records, and validation documents.
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Establishing a method for creating and updating documented information that ensures the accuracy of the documented information. For example:
Document identification and description (e.g., a title, date, author or reference number)
Format (e.g., language, software version, graphics)
Media (e.g., paper or electronic)
Document review and approval processes
- Ensuring the availability of information where and when it is needed and that the information is adequately protected.
- Having a system for the control of documented information including:
Distribution, access, retrieval and use
Storage and preservation, including preservation of legibility
Version control
Retention and disposition
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Determining and implementing the controls needed for documented information from external parties.
- Establishing a system to prevent the unintended use of obsolete documented information. If it is retained, there must be a method to ensure that it is suitably identified to prevent its unintended use.
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Document control procedures for ISO 13485
Medical device companies must comply with ISO 13485:2016. The standards reflect many of the same elements of ISO 9001. They include:
- A system for document review and approval
- Records of revisions history and status
- Document availability at points of use
- Document legibility
- Document identification
- Control of external documentation
- Preventing deterioration or loss
- Preventing unintended use of obsolete documents
Document control procedures and FDA and GMP standards
In recent years, FDA warning letters have largely been issued in instances where there were found to be lack of written procedures as reflected in FDA 21 CFR Part 820. These standards are drawn from GMP guidance and require that procedures be in place for:
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Document approval – Documents must have a designated reviewer/approver, and approvals must be signed and dated.
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Document distribution – Documents must be available at all locations where necessary, and there must be a system to prevent unintended use.
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Document changes – Changes require review and approval by appropriate individuals and must be communicated in a timely manner.
How do documentation procedures contribute to good internal controls?
Good document control procedures play a crucial role in maintaining effective internal control within an organization. They provide:
Accuracy and Consistency: Document control procedures ensure that the information in documents, such as specifications, procedures and requirements, is accurate and consistent. This helps prevent errors and discrepancies in the development and production processes, contributing to better internal control.
Audit Trail: Robust document control procedures create an audit trail, allowing you to track the history of changes made to documents. This transparency provides a window into the evolution of documents and lets you track changes. This is especially helpful during the auditing process to demonstrate document and quality control to regulators.
Compliance with Standards: Quality control often involves adherence to industry standards and regulations. Document control ensures that documents are aligned with these standards, contributing to compliance and reducing the risk of non-conformities.
Risk Management: Document control procedures help identify, assess and manage risks associated with the development and operational processes. By having a clear record of specifications, requirements and procedures, you can proactively address potential issues, contributing to better internal control over project outcomes.
Training and Onboarding: Well-maintained documents aid in training and onboarding new team members. Having standardized and controlled documentation ensures that new employees receive accurate and consistent information, helping them integrate into the team and contribute effectively.
Additional benefits of effective document control procedures include:
- Easier access to documents
- Less risk of errors
- Less time spent looking for and delivering documents
- Improved data security
- Positive impact on bottom line
Manual document control versus electronic document control
Manual document control procedures generally refer to document management procedures that are set up and utilized via word processing or spreadsheet applications, perhaps even printed and distributed. While manual document control procedures often come into existence because of initial ease and accessibility, these systems are generally more time consuming and less accessible in the long run.
The most cost-effective and efficient document control procedures are automated to better streamline and centralize important documentation. This improves proper use of documents and prevents improper access and use of outdated versions. Cloud-based systems make documentation available anytime from anywhere.
Summary
Good document control procedures are a hallmark of any quality management system. They ensure the accuracy, consistency and integrity of information, and ensure your business is operating at its most efficient.
Peak performance can be achieved when you automate your document control procedures. Automating eliminates cumbersome manual processes that suck up time and leave more room for error, ultimately affecting your bottom line.
QT9 QMS is an affordable, easy-to-use quality management system loved by customers. Schedule a demo or get a free trial today.
