Warehouse Audit Survival Guide: Food Warehouses and the FDA

FDA Inspectors can cause a bit of anxiety. No one wants their company’s name in the papers for a salmonella or listeria outbreak. We get that. In order to help you foodies out a bit, we wrote our very own “Warehouse Survival Guide for Food Storage.” This is by no means an end all be all list, and you should always consult your on-site auditor or local FDA auditor before implementing any changes, but these few rules will help you out by showing you the essentials of what you will need to survive the next audit of your warehouse.

Rule 1: Validate everything, document more than everything.

Whether you are a storage warehouse that receives multiple kinds of food from multiple vendors, or a warehouse that is constructed right next to the production floor, only holding items for a few days before they are shipped out to various vendors, you must must must must validate as much of your equipment and processes that you can. Everything should be proven to work, and then documented specifically that it is working. That means temperature mapping your facility, validating your HVAC system, validating your inventory management system, implementing and documenting GMP's, providing power failure plans, developing backup procedures, and much more. Also, all of that should be documented.

Rule 2: Know the agenda like the back of your hand.

After receiving your notice for your routine audit inspection, you will usually receive, or communicate with the inspector(s) on what they will be investigating. Know exactly what they are going to be looking at and looking for. Don’t put away the agenda for two weeks, only to remember it as they are ringing your doorbell. If it all possible, set up an internal audit that follows that agenda, and make any small changes that you feel need to be made (large scale changes shouldn't be necessary, because you have been doing everything right this entire time).

Rule 3: Specifically highlight and mention all changes to your warehouse.

It may have been months since you've last been audited. In that time, things can change. You could be using a different temperature monitoring system, your HVAC system could have been updated, or you could have moved products around to keep them better organized or safe. Let your auditor know about those changes, show him/her the validation plans, the procedures that took place, and the procedures that are in place right now that account for the change.

Rule 4: Zip those lips.

We know you have a bubbly personality, and that you don’t like awkward silences. But you do not have to fill the silence. Answer questions to the best of your ability, but don’t meander around topics while the inspector isn't looking for an answer to anything. Answer questions, but nothing more. Way too often, food warehouse supervisors will stumble over their own words, and get themselves in trouble by talking too much, saying something not true, or contradicting something they, or someone else said earlier. If your goal is to pass the audit, it’s time to zip those lips. The best way to get around this rule? Do everything so correctly and so completely, that you can talk about anything, and it’s all right. That’s what we recommend.

Rule 5: Do NOT think, “We've just got to pass.”

If you take anything away from this survival guide, we would ask for it to be Rule 5. This is an awful mantra to have! We have seen this kind of mindset affect food storage warehouses everywhere, either do to the perceived cost of going the extra mile, or the complications of changing up validation, protocols, and processes. Doing the bare minimum sets yourself up for long-term failure. You may pass your routine audit when you first apply for marketing, but the bare minimum line will change. Will you be prepared for it? We think not. Also, if you ever falter from the bare minimum, you are going to risk your product safety. When it comes to food storage safety, there are no such things as over-achievers.