Mastering Document Control: A Complete Guide

Chris Nahil
By Chris Nahil on October 31, 2023

Across all industries, document control is one of the most important processes to get right. It ensures documents are updated and revision-controlled, allowing you to effectively route them for review, approval and distribution.

Processes, jobs, specifications—all of your most important documents should be in one place, with consistent procedures for handling them. In this document control guide, we will discuss the most important capabilities of a robust document control system, highlighting how it should integrate with other quality applications to promote process excellence.

What is Document Control?

Document control is the implementation of guidelines that govern the management of documents within a company, ensuring compliance and adherence to ISO regulations.

Its primary objective is to establish a traceable record for both internal and external documents, accompanied by well-defined procedures that outline how these documents should be handled throughout their lifecycle, from creation to disposal.

Document control covers all types of documentation, ranging from crucial files to even the simplest records, guaranteeing a systematic and organized approach to document management.

Why is Document Control Important?

Ensuring compliance with ISO 9001 and ISO 27001 standards is paramount, and having robust document control processes is essential to meet these requirements. If you aspire to obtain or maintain these certifications, it is crucial to have effective document control practices in place.

A document control system will help your organization adhere to the rigorous standards for quality management and information security outlined by ISO, ensuring that your document management processes are up to par.

Top Capabilities of a Document Control System:

Document Creation

Your document control system should standardize the process of document creation. An important point to consider is that not all documents will go through the same set of steps, making flexible workflows essential from a best practices perspective.

For instance, you wouldn’t necessarily have the same team reviewing a policy document as you would a specification, so each one needs its own routing procedure. An effective document control process  will automatically assign each document to the appropriate workflow configured by your team.

Most companies also use Microsoft Office to manage documents, whether in Word, Excel or PowerPoint. You want a document control system integrated with Office so that any changes you make are reflected in the Office file for consistency and accuracy.

Document Routing, Review and Approval

An effective document control system hinges upon its ability to automate workflows for document routing. This ensures the necessary parties have reviewed and approved each document prior to distribution and use.

It’s not just about sending documents to the next phase in the workflow— the system should also use intelligent business rules such as:

  • Conditional routing to send documents to different parties or workflows depending on the business process or document attribute
  • Delegation rules to route documents to an assigned substitute when the primary contact isn’t available
  • Escalation rules to notify responsible parties when documents pending review aren’t reviewed on time, keeping the process moving forward

Ultimately, what you want is a document control process that isn’t just automated, but also intuitive.

Integration with Employee Training

When you distribute new documents such as policies, procedures or work instructions, it’s critical that employees receive training on the updated documents. Integrating document control with employee training creates a seamless transition, making it easy to track who’s received training on key changes.

Capabilities to look for here include:

  • Automatic updates to training requirements after a document revision
  • Training tests built into the document control and training records
  • Employee training records showing complete vs. incomplete training

 

Document Change Requests

Document control is a cyclical process. Even after document approval, you will inevitably need to change the document at some point.

A robust document control system allows you to incorporate a dedicated change request process into your workflow to ensure:

  • All changes go through a consistent set of steps configured according to your unique needs
  • You can request changes to multiple related documents within a single workflow for added efficiency, so other documents affected by the change don’t fall through the cracks
  • The system automatically archives previous versions so you can restore or review them if needed

 

Tips for Maintaining Document Control:

Establish Clear Document Control Procedures:

Develop and communicate well-defined document control procedures within your organization. Clearly outline the steps for document creation, revision, approval, distribution, and disposal.

Implement Version Control Mechanisms:

Utilize version control features to track and manage document revisions effectively. Maintain a clear record of changes made to documents, including the date, author, and purpose of each revision.

Enforce Access Controls:

Control access to documents based on job roles and responsibilities. Implement appropriate permissions and restrictions to ensure that only authorized individuals can view, edit, or distribute sensitive documents. Regularly review and update access privileges as employees change roles or leave the organization.

Regularly Review and Update Documents:

Perform periodic reviews of documents to ensure their accuracy, relevance, and compliance with regulations. Update documents as needed, and retire outdated or obsolete versions. Regularly communicate any changes to relevant stakeholders to maintain transparency and alignment.

Conduct Audits and Quality Checks:

Regularly audit your document control processes to identify any gaps or areas for improvement. Verify the effectiveness of your document control system and address any non-compliance issues promptly. Implement quality checks to ensure that documents adhere to formatting standards and are error-free.

Leverage Document Control Software

Implementing a document control software can significantly enhance your organization’s document management processes. A document control software streamlines document management, provides a centralized platform for creation, organization, and tracking. It enhances collaboration, efficiency, and compliance while reducing errors.

By following these tips, you can establish and maintain effective document control practices, ensuring the accuracy, security, and compliance of your organization’s documents.

Document Control Simplified

Maintaining document control to comply with ISO 9001:2015 or FDA’s GMP requirements is essential, ensuring users have access to the approved version. However, managing document control doesn’t have to be challenging.

With ETQ Reliance document control software, quality management becomes more efficient, simplifying compliance maintenance and enabling effective tracking of regulatory changes.

Request a demo today to see how you can experience streamlined document control processes and ensure seamless compliance.