Avoid These Common Mistakes When Preparing a FSMA-Compliant Food Safety Plan

Kevin Byrne, senior consultant at Essential Food Safety Consulting, says most companies don’t do enough research. “Especially if you’re a smaller company with little time to look at what’s out there, you may not be aware that other hazards exist, so you can’t complete a thorough assessment of your ingredients, process steps or finished products. For example, something that a lot of people don’t even realize is that the FDA put out an appendix to the draft guidance on the food safety plan, which covers all of the biological and chemical hazards that you would expect to encounter with different ingredients based on their category. It’s a huge reference, but not a lot of people are aware that it even exists.”

Make Your Food Safety Plan Crisis Ready

Managing a food safety emergency requires a lot of intense decision making, including knowing when to issue a recall or not. “There are a lot of layers involved, but if there’s even a chance that misbranding or adulteration occurred and you can’t prove that it didn’t, you still have to initiate a recall,” Scharlach says.

According to Byrne, the first step is obviously to assess the impact by identifying which customers the product was sold to and then to take care of the regulatory aspects by contacting the appropriate people.

The part of the food safety plan about crisis management should be a tool that helps quality and safety teams make the right decisions quickly. Unpredictability is an objective limit here: When prevention fails, there are an infinite number of things that can go wrong, and it would be impossible to include all of them in the recall plan—in fact, this isn’t what the FDA expects. “What the FDA wants to see in your recall plan isn’t necessarily the hundred different scenarios that could happen. What they want to see is that you have a list of key contacts, both internal and external, and a step-by-step protocol that the recall team will follow in order to decide on, initiate, and follow through with the recall process,” Scharlach says.

Do Mock Recalls, but Do Them Right

A good way to bridge this gap as much as possible is by conducting mock recalls, but they need to be done the right way.

“A lot of businesses do mock recalls, but once they know which customers are being affected and they can account for everything, they stop the exercise,” Byrne says. He suggests companies add more specific steps to their mock recalls, such as root cause analysis and the drafting of a press release.

“You may think you’re doing a mock recall, but all you’re really doing is a traceability exercise,” adds Suri. “That’s only one aspect of a mock recall, though. There are several other things that have to be done, sometimes concurrently,” says Suri.

Mock recalls aren’t just for rehearsing for an emergency, but also to find out if there are any gaps in your recall plan. “[Businesses] put a plan together that looks like it should hold up procedurally, but practically they’ve missed steps because they’ve never really mocked the process the whole way through. So when an actual recall shows up, they’re lost,” Suri says. “You might not be able to role play every potential situation, but we encourage our clients to pick a different scenario each time and role play it out fully twice a year. That way, you wind up gaining experience with a wide gamut of issues.”

Byrne also warns food companies away from taking a superficial approach toward corrective action through a lack of monitoring. “We see a lot of companies identify the problem and what the corrective action is or should be, and document that it’s being done. But then they don’t monitor it to make sure that the corrective action is continuing to prevent the problem from reoccurring. I think the main challenge is in making sure that corrective actions go far enough and that you’re not looking at them just as a Band Aid.”

Company Culture Is Key

For Perry, the effort that FSMA has required from food manufacturers has definitely improved food safety standards. “It’s been like a tide that raises the waterline for all boats. The focus on prevention brought a clear improvement and probably helped to weed out some bad actors,” he says.