Risky Business: Conducting A Food Safety Risk Assessment in 4 Steps

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With high-profile food recalls in the news, it’s easy to forget that food safety regulations are not primarily aimed at punishing infractions. Rather, their intent is to prevent food safety incidences from happening in the first place.  

Preventing food safety incidences can only be realized by anticipating or predicting what threats may be coming. Once threats are identified, a plan can be formulated for protection against such threats. Although this logic is intuitive in our daily lives, predicting a microbial risk or food safety can be quite challenging. 

The good news is, there are many tools you can use to help in identifying and preparing for microbial risks. One tool is the Risk Analysis model which is an effective model for many industries including food manufacturing. The model consists of Risk Assessment, Risk Management, and Risk Communication as pillars for Risk Analysis.

Below are the four essential components for conducting a Microbial Risk Assessment, the first phase of any Risk Analysis that will protect your product line.

The 4 Steps of Food Safety Risk Assessment

1.      Hazard Identification

In a Microbial Risk Assessment exercise, quality professionals are tasked with identifying hazards that are reasonably likely to cause foodborne illness. Pathogenic microorgansims and viruses are the primary focus of this type of exercise. 

A great starting point for gathering information is to visit the FDA website.  On the FDA homepage, links are available for access to information on “Recalls and Alerts” and “Outbreaks – Food”. From the information provided, food manufacturers can ascertain if food safety incidences have occurred with products they manufacture or raw materials used in their facility. Evaluating this data along with multiple resources relating microbial hazards to food categories can aid in making a list of potential risks.

Another reputable resource is the Journal of Food Protection. Scientific research often follows a need to understand a problem and the Journal of Food Protection is devoted to issues related to food. Articles can provide valuable information on microorganisms and their interaction with raw materials and finished food products similar to yours. This information can assist in identifying what pathogens may be a risk for your products.

2.      Hazard Characterization

With a list of identified microbial hazards in-hand, move on to step two: Hazard Characterization. In this step, define the nature, severity, and duration of potential adverse effects that may result from hazards. For microbial risks, this would include the symptoms of various foodborne illnesses within each type of host.  

A good resource for this type of information is the Centers for Disease Control (CDC) website and FDA Bad Bug Book. These resources will provide the above necessary information to characterize your hazard and will be useful to rank risks during risk characterization.

3.      Hazard (Exposure) Assessment

During step three, you’ll need to take the data gathered and run a forecast for anticipated exposures when the public consumes contaminated foods. Again, good resources for this are the FDA and CDC, but your will also want to review your sales volumes, end consumer, and manufacturing processes. What is the potential level of contamination in your product?  How severe are the illnesses associated with the pathogen? What are your higher volume products and are these associated with pathogens?  How many hospitalizations and deaths are associated with the identified pathogens? Are children, the elderly, and the immune compromised groups consuming your product?  These are valuable questions to answer during the exposure assessment phase.

The likelihood of exposure to pathogens is also influenced by formulations and processing. All processes and all levels of the production chain from “farm to fork” should be considered. Factors such as thermal inactivation of pathogens, the pH and water activity of the formulation, and processing steps such as harvesting, cutting, mixing, etc. can result in the increase or reduction of the public’s exposure to the hazard.  

4.      Risk Characterization

This is where you get to leverage identification, characterization and assessment to fully understand the risks. The products with the highest volumes, highest potential of contamination with the most severe pathogens, and the highest hospitalization and death rates should be ranked the highest. These are the situations in which a food has a high risk for contamination at levels that can be life threatening and would result in severe injury to a customer. These situations are considered the highest risk. 

Use the same information and criteria to rank the remaining products and pathogens you have identified in your hazard identification, hazard characterization, and exposure assessment. This process will result in the identification of high, medium, and low priority hazards that threaten your products.

Staying true to this process for Risk Assessment can help keep your organization on the side of prevention, rather than the side of crisis, recall and other punitive measures from regulatory agencies. This overview can provide a starting point toward this goal.

Bryce Wilks