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April 4th, the FDA published a Final Rule expanding access to records of Food and Beverage manufacturers (more here and here). Now, instead of requesting records related to a specific suspect food – the FDA can request records on any other food product they believe may be similarly affected.

So let’s say you make a line of chilled pickled beets. Somehow, a case of beets is mistakenly left on the loading dock at a grocery store for a few weeks in 100 degree heat. Then an industrious high-school stock boy finds the errant case and stocks them in the cooler – and suddenly reports of bad pickled beets are coming up everywhere. The FDA shows up to inspect the bad beets still on the shelf, and now they’re headed to your plant to inspect the quality and food safety methodology of your beet bottling. You scramble all hands to pull together all your documentation, the work orders, the purchase orders, the quality testing records, the sales orders, the shipping manifest, the sanitation and maintenance records….there’s files being pulled in a dozen departments, with last minute reviews, scans, root cause analysis – making sure everything was done by the book. (By the way, speaking of book, Where’s the SOP binder? Someone review that to make sure it’s up to date.) It took everyone pulling together over the weekend to get it all in order for the FDA Auditor to see. She walks in and looks at the piles of documents on the meeting room table and says – I’ll also need to see everything on your pickled artichokes, your potted pigs feet, your tinned tuna and candied cucumbers.

Really the only question is, With the blood draining from your face so rapidly, will you pass out right here, or do you think you’ll make it to the hallway before you collapse?


Seriously, this means two things for food producers.

1) Paper documentation records are out – Yes, it’s worked for years with clipboards and paper documents – that era is over. Remember, you also used to hand-slice the bread in the early days and it was a big change bringing in that automated bread slicer – but it eventually turned into the best thing since….well, you know.
Automated documentation processes allow you to pull any records, documents, subsets of information at a moment’s notice. Instead of all-hands-on-deck from a dozen different departments it’s a few clicks of a mouse. So regardless of what the auditor or inspector requests, you can pull it instantly and effortlessly. It shows better control and shows you’re serious about documenting your processes – and it let’s you prove within a few minutes that those beets were fine when they left your loading dock. As well as everything else.
2) You need documentation of the documentation – When you could pull everything to get ready for an inspection, you had the luxury to review all the relevant documents to make sure everything was complete, legible, filled out correctly and so on. Now, with the FDA able to ask for who-knows-what as well as unannounced GFSI audits, you’re going to be pulling records for inspection without having the time to review them beforehand.
With automated documents, you know everything is filled out right, filed properly, within proper specifications. Currently, using paper documents, there’s some review process in place – but do you know every record is checked every time? That’s a huge task. With exception reporting, automated systems can show you instantly if a needed quality control inspection document is missing. You can see last week’s sanitation record wasn’t signed off properly. You can pick that needle out of a haystack of paper – the one record that will get you in trouble with the inspectors – and take corrective actions before the FDA is asking why there’s no temperature check recorded from the refrigerated truck that shipped your beets.

There are dozens of software systems out there to record everything from quality control to sanitation.

I know your first question is “How much is this going to cost me?”
My first question is, “How much is this going to save you?”

Because automation, just like your bread slicer, can make you money. Remember, all those paper documents are taking up space and eating up labor costs – filing, pulling, reviewing. The overtime needed to pull records all weekend for an inspector is costly, disruptive to normal operations and on-going.

Also, let’s not have Frank go down and check if the CIP system is running every day at 11:36 for 17 minutes – let’s integrate to the PLC running that operation and only send Frank an alert if it stops in under 17 minutes. Now Frank has more time to sharpen the blades on the bread slicer.

And the same automated tools that help us document quality can document other operations as well. Now we can do yield management, measure downtime, increase traceability and a whole host of other KPI’s that can help you run the plant more efficiently.

The point is, the right system implemented properly will actually make you money, in the short run and the long run. A bandaid fixit to try and keep your paper system running while delivering everything the inspectors demand will cost you – it may be hidden costs – but it costs you and never quits costing you.
There’s a whole host of software systems available for plants of all sizes and configurations – your answer to the new FDA Final Rule on Expanded Records Access is to get more information from your software consultant on what might work in your plant and start a careful evaluation.

You can reach me at Gene@Genehammons.com