Imagine the following situation: The U.S. Food and Drug Administration (FDA) is inspecting your facility, and regulators ask to see documentation for your Hazard Analysis and Critical Control Points (HACCP) plan.
You spend 20 minutes trying to pick out the most recent documents, only to get hammered by regulators because only a few are actually dated. What’s more, most references to related documents are broken. After this impressive start, how well do you think the rest of the inspection will go?
Food manufacturers must keep track of numerous documents in order to ensure compliance and mitigate risks. This post looks at 7 of the most common document control gaps that companies should address to avoid regulatory citations and food safety issues.1. Spotty Information
One of the most common document control gaps is not including the proper information on documents, including dates, authors, permissions and revision history. The main problem this causes is lack of control over document versions.
What’s less obvious is the cost of versioning mistakes. But think for a moment what might happen if you sent the wrong specification to a supplier, or produced multiple batches from an old recipe. It’s clear these mistakes can get expensive very quickly.2. Server Folders
Using binders and paper forms to track food safety is becoming a thing of the past. Today, nearly half of companies store documents in a shared network drive, which isn’t actually much better in terms of efficiency.
Consider, for example, that the average employee spends an entire day every week looking for information (like in the example at the beginning of the post). It’s also harder to keep a handle on versioning and reviews, calling into question whether you’re effectively controlling documents at all.3. Email Chains
Sending documents to internal teams and even third parties via email is a corollary strategy to managing documents on shared drives. Again, this makes documents hard to find, particularly those buried deep in an email chain. This can also lead to sending the wrong version, like when someone pulls a document from the wrong conversation thread altogether.
The next step up from server folders and email chains is an electronic Document Control system. This type of system allows you to centralize your documents and define processes for who can review specific documents and what edits they can make.4. Uncontrolled Forms and Reference Materials
All information needs to be documented in the Food Safety Management System (FSMS), including paper forms. The use of untracked forms, notebooks and reference materials is a common inspection failure. You can’t have documents floating around outside the system, even if it’s just a setup sheet taped up next to a piece of equipment.
Your best bet is to convert all forms and reference materials to electronic versions so they can be tracked closely. You’ll want to periodically check that you don’t have unsanctioned documents, whether through an informal walkthrough or formal audit.5. Reviewing Hard Copies
Some organizations still print out paper copies of documents for reviewing drafts and making changes. If you miss an edit, you might never know it once you’ve thrown away the markup. It also adds one more step in the process that drains productivity and creates room for errors.6. Document Procedures
You should have formalized processes for tracking, reviewing and updating your documents. Just as important, you need to make sure you’re not ignoring those processes—a common complaint of FDA regulators. A robust food safety process is one where you do what you say you’re going to, and if you don’t it calls everything else into question.7. Disconnected Documents
When Document Control tools aren’t connected to related documents, it often means changes don’t get rolled out appropriately. You need to consider whether changes you make to documents require changes in other areas such as:
- Employee training requirements.
- Change management.
- HACCP plan.
- Supplier management.
Maintaining control over your documents can be tedious and time-consuming, but there’s no way to ensure food safety when policies, procedures and specifications are all over the place. Taking a proactive approach to automating document control and integrating documents with related processes is vastly more effective. And who knows, it just might win you some brownie points with the FDA as well.