Document Control Simplified: Keeping Your QMS Organized
Tom Radachy
Quality Control Manager specializing in Lean Six Sigma at Compco Quaker Manufacturing
Ever searched for a critical document only to find three outdated versions, conflicting instructions, and no idea which one is correct?
Yeah, me too.
Poor document control is a silent killer of quality management systems (QMS). It leads to: ? Employees following outdated procedures ? Confusion over which version is correct ? Nonconformities in audits due to missing records ? Wasted time hunting down information instead of fixing problems
And yet, many companies treat document control like a low-priority task, until it blows up in their face.
Here’s how I simplify document control, eliminate version chaos, and make audits painless.
Why Document Control Matters in Quality Management
A strong Document Control System ensures that: ? The right people have the right documents at the right time. ? Outdated or incorrect documents don’t cause process failures. ? Every change is tracked, reviewed, and approved.
?? Example: A manufacturer failed an audit because production was following an outdated work instruction that missed a critical process update. The result? Nonconforming parts, rework costs, and a major headache for leadership.
?? Lesson: Document control isn’t just paperwork—it’s the backbone of a well-run QMS.
How I Simplify Document Control for a QMS
1. Standardize Document Naming and Storage
If employees waste time searching for documents, your system is already broken.
?? What I Do: ? Create a standard naming convention for all documents (e.g., SOP-001 for procedures, WI-002 for work instructions). ? Store documents in a centralized, controlled location (not on random desktops or emails). ? Use role-based access control to prevent unauthorized changes.
?? Example: A company had multiple versions of the same work instruction floating around. By centralizing documents in a secure, controlled repository, confusion dropped immediately.
?? Lesson: If people can’t find the latest document in seconds, your system needs fixing.
2. Establish Version Control and Approval Workflows
Outdated documents floating around = recipe for disaster.
?? What I Do: ? Assign clear version numbers (e.g., Rev 1, Rev 2) to every document. ? Implement an approval workflow so no changes go live without proper review. ? Require change tracking—who made updates, when, and why.
?? Example: An audit revealed two conflicting versions of a calibration procedure. A proper version control system ensured only one approved version was accessible, eliminating confusion.
?? Lesson: If you don’t control document versions, expect problems in audits and production.
3. Set Expiration Dates and Periodic Reviews
Documents shouldn’t gather dust—they need regular reviews to stay relevant.
?? How I Fix This: ? Set review intervals (e.g., annual reviews for SOPs). ? Assign document owners responsible for updates. ? Flag outdated documents for revision or removal.
?? Example: A company found that 15% of their quality procedures were outdated when they finally did a review. Now, they have a system in place to prevent outdated documents from lingering.
?? Lesson: If no one is reviewing your documents, you’re running on outdated information.
4. Automate Document Control Where Possible
Manual document control = slow, painful, and full of human error.
?? What I Use: ? Cloud-based QMS software to store, track, and distribute documents. ? Automated approval workflows to eliminate email chains. ? Document change notifications so employees always know when something updates.
?? Example: A company relied on paper-based work instructions—resulting in missed updates and nonconformities. Switching to digital document control cut update time by 50% and improved compliance.
?? Lesson: If document control is painful, automation can make your life easier.
5. Train Employees on Document Use & Access
A perfect document control system means nothing if employees don’t know how to use it.
?? How I Ensure Compliance: ? Train employees on where to find and how to use controlled documents. ? Enforce document change notifications so people stay updated. ? Audit document usage—if employees aren’t using controlled documents, something is wrong.
?? Example: A company struggled with production employees using old printed SOPs. Training them to always check the digital system fixed the issue overnight.
?? Lesson: If employees don’t know where to find documents, your system is failing.
Common Document Control Mistakes (and How to Avoid Them)
?? Mistake: Allowing uncontrolled copies of documents to circulate. ? Fix: Only allow access to the most recent, approved version in a centralized system.
?? Mistake: Making document updates without notifying employees. ? Fix: Set up automatic change notifications when a document is revised.
?? Mistake: Ignoring document control until an audit forces you to fix it. ? Fix: Conduct regular reviews to ensure all documents are up to date.
?? Mistake: Keeping document control manual when digital tools exist. ? Fix: Use QMS software or cloud-based storage to streamline access and tracking.
Final Thoughts: Why Document Control is the Heart of a QMS
?? A well-organized QMS runs on strong document control.
? If employees can’t find the latest procedures, expect nonconformities. ? If version control is a mess, expect failed audits and rework. ? If employees don’t know where to access documents, quality will suffer.
?? Want an easier, more reliable way to manage your QMS? Fix document control, and everything else gets easier.
If your document control is still a mess, the best time to fix it was yesterday. The second-best time is right now.