Risk-based Preventive Controls

Acceptable Level of Risk

If you are new to the food manufacturing industry or at least new to food safety, you may not know that the food industry heavily relied on finished product testing to determine safety. It wasn’t until the US manned space program was developed in the 1960s that industry looked at building safety in to the process. Now we look more at farm-to-fork and identify preventive controls outside of processing, as well as within processing. Because of this all-inclusive trip down the food highway, some managers have a difficult time choosing the controls most important to food safety.

One analogy I use is my frightening drive from Green Bay to Chicago one January. I worked until 6:30 pm and left Green Bay in the dark. As I drove out of Green Bay and into the darker countryside, it started to rain. The rain mixed with buckets of snow that alternated between rain and snow for the first hour of my drive. I was in a hurry, driving fast, and actually hydroplaned at least once. As fast as I was going, I was still being passed by semis and other trucks. By the time I reached Milwaukee, the rubber of the driver’s side wiper was flapping around and giving me a marginal view.

In this scenario, what were the most important controls for a safe drive? I stopped in Milwaukee to install a new wiper. My tire tread kept me on the road. The lights were working, as was the engine. I used my seatbelt. The air bags were assumed to be in working condition. The brakes worked. The gasoline is analogous to utilities. My cell phone was charged, if needed as a communication tool.

It was not important how much trunk space I had for my bags. It was not important that the radio worked. Optional features like automatic windows or adjustable mirrors were not important.

Similarly, much of your process is not related to safety. In the hazard analysis for our food safety plans, we are asked to identify hazards and their preventive controls. When you are deciding if a preventive control is needed, imagine taking it away. In my driving scenario, my safety would be compromised without working wipers, lights, tires, engine, seatbelt, air bags, and brakes. These parts of driving received my utmost focus that night. What, if taken away, will compromise safety?

I cannot take credit for the following analogy to define risk vs. severity, but it is a good one. When we are out walking in the world, there is a risk of getting hit and hurt by a car. It is a hazard we all experience. When I leave a building and walk through the parking lot to my car, the probability or severity of getting hit and hurt is small. It hasn’t happened yet! If I do get bumped by car, my injuries might not even be treatable. Now let’s say I walk across an LA highway-six lanes going each way. The risk of getting hit is high, and the injuries will be severe. Think about it; it is the same hazard!

Since I scored high in Harmony on the StrengthsFinder survey, I like my team to be happy and get along. If you have food safety teammates who want to list every hazard in the world in your hazard analysis, keep the peace, and go ahead and list them! Then, your team will debate the risk vs. the severity. By the way, at the end of Chapter 1 in the book for Preventive Controls for Human Food, there is a nice definition for your team of both risk and severity. If loss of control results in a class I recall due to an allergen or pathogen, then the hazard is automatically severe and must have a preventive control. Other hazards, while theoretically possible, may be concluded to be of low risk and low severity. These hazards to not require a preventive control.

As a team:

  • Identify hazards.
  • Define risk vs. severity.
  • Debate and assign risk and severity to each hazard.
  • Identify hazards requiring a preventive control.

The folks at ConnectFood are here to walk across the farm-to-fork path together, hand-in-hand.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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