The Five Most Common FDA Audit Tip-Offs
What will FDA auditors be looking for when they arrive at your facility? We sat down with Roberto Bellavia, Principal, Senior Food Safety Consultant at Kestrel Management Group, to talk about the five most common tip-offs FDA inspectors may recognize while visiting your plant.
Are You Sticking to the Plan? From the moment the inspection team arrives at your facility, they will be evaluating your Food Safety Plan. “Without a comprehensive food safety plan, you cannot have a wholesome product that leaves your facility,” Roberto tells us.
The plan must be thorough. “Make sure that you have conducted an hazard analysis for every step in the production process,” Roberto says, “and be sure to keep records. We see so many facilities that develop a good food safety plan, but when the inspectors arrive, they can’t verify it’s being implemented.” An auditor may ask to review records from the past two years, so it is critical to maintain legible records that verify every step of implementation from day one.
Inspectors are also going to look into whether your safety program is adequately staffed and supported. Roberto says that FDA investigators could ask: “Who is your Qualified Individual, and what makes them qualified?” And while the qualified individual serves as the point person for implementing the food safety plan, inspectors will also be checking for a supporting team. “Food safety is not a one man show,” Roberto tells us. “It takes a multidisciplinary team to implement a comprehensive Food Safety Plan, and the auditor will want to see your team is getting all the resources they need from management.”
A good plan will be reflected in every aspect of production. “The best companies build a culture of safety that is embedded within the employees at every level,” Roberto says. “The more involved and knowledgeable your workers are, the more successful the program will be.” If employees aren't familiar with the plan, the FDA may start to doubt its implementation.
Commit to Sanitation: Inspectors know when things aren’t clean. “Probably the biggest visual tip-off for inspectors is when corners are being cut in sanitation,” Roberto says. “The way you’re performing your sanitation process says so much about your commitment to food safety.”
Inspectors will be looking for red flags like employees entering the production floor without scrubbing in, or maintenance workers moving between areas of production without taking measures to prevent cross-contamination. “When an inspector sees an issue with sanitation, they know the problem goes deeper.”
Know Your Suppliers: The Food Safety Modernization Act makes producers responsible for ensuring the safety of their raw ingredients. “You need to have a perfect understanding and knowledge of your supply chain,” Roberto tells us. “Auditors will be checking that you can account for the history of every ingredient, from harvest to the loading dock.”
The FDA will need to review your program for qualifying suppliers. “They want to see that you are taking steps to ensure the safety of your raw ingredients,” he says. “That means not only having a written program in place for verifying your suppliers, but also keeping thorough records at the receiving dock—if an inspector discovers that you cannot validate the origin and chain of custody for every shipment, that is a huge safety issue for your facility.”
Total Recall: Inspectors will also be taking a close look at what happens to your products once they leave the facility. “Your recall plan needs to be flawless. If something goes wrong, you need to be able to trace products forward and completely remove any potentially tainted food product from the supply chain.”
They will expect to see robust record keeping. “You need to keep track of each lot’s characteristics—what exactly is in it, where it’s headed, and how it’s packaged—and you also need to know what it will be used for,” Roberto says. The auditors will be checking for a recall program, ensuring that you have practiced and verified your procedures for tracing goods after they have left the plant.
Justify and Validate Your Preventive Controls: It’s not enough to show that you’re implementing a set of preventive controls. “Your qualified individual needs to be able to justify the program,” Roberto says. “You need to show that you're taking a scientific approach. Too many producers are complacent—they think that because they’ve never had an issue, they must be at low risk. But you need to proactively look for hidden risk factors.”
Ultimately, Roberto says, “You can’t maintain the status quo. You want to develop and maintain a program that is continuously fit for your operation, and you need to address the risks that are specific to your facility and your finished product.” If you can’t explain and justify why the preventive controls you have in place are appropriate and sufficient for your plant, the FDA will surely begin to wonder, too.