Building Food Defense Plans

Departments - From the Plant Floor

December 10, 2013

Here we are finishing up another year. It is a time when we typically take stock of our accomplishments. We look at what didn’t work out, what has gone well, and any other measurements of success or lack of success. How did things go for you? Did you meet your personal and professional goals? Was your company involved in any recalls or regulatory actions? Are your customers satisfied?

Being avid readers of QA magazine, I trust that you have done all the right things, and nothing bad has happened at any of your companies. That business has grown tremendously, and you met all the new regulatory and customer expectations. You are on top of things, and nothing can stop you from a perfect record—right?

Let’s think again. You may have food safety in hand, but what about food defense? When considering food defense, you have to realize that there is always potential for someone else to have a huge impact on the survival of your company no matter what you do. But there are things you can do to reduce that risk. Before we get to that, though, let’s look at some definitions, so we’re all on the same page. Food defense is different than food security or food safety:

  • Food security is having enough food to feed the population.
  • Food safety is preventing accidental contamination of the food.
  • Food defense is preventing intentional contamination of the food.


Food Defense.

Intentional contamination of food can come from many sources, including disgruntled employees, terrorist groups, product counterfeiting, and diversion of product, as well as economic adulteration of product. There are many ways that an unscrupulous person or group can create grief and wreak havoc in the industry and for the consumer.

The risk to all consumers could rank high in a risk analysis—severity could be “extreme.” Businesses could end up in bankruptcy, and entire industries could suffer. Imagine if a single milk product were to be contaminated in the American southeast, and it was found to be an intentional contamination. Not only would many consumers not purchase that one product, many would cut back or stop purchases of all milk products. Consumers in the American east, north, and west also would be likely to slow their purchases out of fear that it could be happening in these areas as well. The entire dairy industry across the country could fail.

So how do we prevent such attacks? As prudent food manufacturers, we have developed food defense plans. If we used the HACCP model of assessing risk, we used likelihood and severity to determine what needed to be in our plans. However, I found that to be a futile exercise when assessing food defense hazards, because most hazards were found to be extremely low in likelihood, but extremely severe. This would mean that they needed to be controlled with CCPs. So after trying that without much success, I did a bit of research and found that both FDA and USDA have food defense information on their websites that help industry prevent such attacks.

Food Defense Plans.

In 2005, FDA provided CARVER+Shock, and many of us tried to use it. Food industry trade groups published bulleted lists of areas that should be assessed for risk. Based on all that information, I think we all found it easier to develop appropriate and more manageable plans. But it still wasn’t easy.

Now FDA has come out with new tools. Earlier this year, the agency released a software program that makes the task of creating your food defense plan even easier. In its Food Defense Plan Builder, FDA has taken the lists of potential risks, added potential mitigation steps, and put that information into a computer program that walks the user through the creation of an individualized food defense plan. The program is posted on the FDA website and is downloadable to your computer (

One important note: Once you download the program to your computer, everything you do is yours and yours alone—the FDA cannot access your data. You develop a program specific to your plant; it is maintained by your plant; and it is managed by your plant. I highly recommend that you at least check out the Food Defense Plan Builder—not only is it a great tool, your tax dollars paid for it!

The program is a tremendous upgrade from CARVER+Shock. It is built similar to an Excel spreadsheet with several tabs. Starting with the first tab, you create your program. It walks you through identifying risks, assigning mitigation measures, arranging for audits and reviews of those measures. You can assign staff to specific tasks and elements and review times and listing of internal documents. When all is said and done, all the information you put into the program is compiled on the last tab that is your written food defense plan.

You still have to put in the labor to complete it and complete it properly with appropriate depth of thought, but I believe that the finished product is far superior to what we had before. Get to this site and check it out.

So, one more element of our jobs just became easier. I hope that every one of you quality and food safety professionals have had a great 2013. I wish you all the successes you desire in 2014. I’d love to hear what you thought of the program and how it works for you. Feel free to drop me a line at