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How to Conduct a Food Safety Risk Assessment
David Hatch

By: David Hatch on April 10th, 2019

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How to Conduct a Food Safety Risk Assessment

Food Safety Testing  |  Food Safety  |  Food Safety Audit

“Risk” is a word that’s used pretty frequently in the world of food safety. For manufacturers, it’s a word of caution, one that often engenders fear. Why? Because the greater your food safety risk, the higher your probability of experiencing production-halting, brand-damaging and even job-defining repercussions.

When applied more broadly to food safety, the term “risk” has implications for retailers, consumers and the food industry at large. Even the U.S. Food and Drug Administration (FDA) uses risk analysis, “a concept and framework fostered by the World Health Organization, to ensure that regulatory decisions about foods are science-based and transparent.”

To help you unravel the complex concept of food safety risk and develop a comprehensive program around it, we’re breaking down the basic elements of a food risk assessment and laying out some key insights on how to conduct one at your organization.


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The 4 Basic Steps of Risk Assessment

All along the food chain, safety risks exist. Food is susceptible to contamination, mislabeling and mismanagement at many points in its journey. For food processing plants, the path to reducing these risks begins with risk assessment, which can be boiled down to four fundamental components:


1. Hazard Identification

Identifying hazards is actually one of the first activities involved in implementing a food safety program based on the widely recognized Hazard Analysis Critical Control Points (HACCP) system. It will be necessary to develop the framework for your hazard identification by fleshing out a flow diagram.

Provide a clear, simple outline of the steps involved in the process that are directly under the control of your establishment, as well as steps in the food chain that come before and after your processing. A flow diagram is a pictorial representation of all the steps that raw materials go through to become a finished product, which may include receiving raw materials, storing ingredients, preparation, cooking, cooling, packing, labeling, bulk storage and distribution.

In each of these stages, determine and detail the potential for any food safety hazards (biological, chemical or physical contaminants or conditions) that may cause harm to the public. Identifying and articulating the nature of a food safety hazard is an essential first task for risk managers. Food safety teams can uncover hazards in a variety of ways, including:

  • Inspection

  • Environmental monitoring

  • Laboratory, epidemiological, clinical and toxicological studies

  • Outbreak investigations

  • Review of compliance standards

2. Exposure Assessment

Exposure assessment is the qualitative and/or quantitative evaluation of the likely intake of a food hazard with the potential to cause an adverse health effect. It may identify the frequency and amount of food consumed in a given period for a given population or consumer base.

This assessment can be used to both gauge the effectiveness of your current hazard prevention measures and identify potential Critical Control Points (CCPs). A CCP is a step or procedure in a food process, from its raw state through processing, at which controls can be applied to eliminate biological, physical or chemical hazards or minimize their likelihood of occurrence. The ability to determine and validate CCPs is crucial to the task of defining critical limits in your monitoring procedures.

3. Hazard Characterization

The World Health Organization (WHO) defines hazard characterization as “the qualitative and/or quantitative evaluation of the nature of the adverse effects associated with biological, chemical and physical agents which may be present in food.” In other words, it describes the relationship between levels of contamination and the probability that an illness or adverse health outcome will develop as a result.

The WHO provides guidelines for the characterization of hazards using a structured, six-step approach, which encompasses:

  1. Description of the process of hazard characterization

  2. Process initiation

  3. Data collection and evaluation

  4. Descriptive characterization

  5. Dose-response modeling

  6. Review of results

When approaching the task of hazard characterization, it is important to keep the following insights in mind:

  • Hazard characterization is an iterative process, as the lessons learned often lead to further refinement of the initial issue, which results in further analysis.

  • Probability calculations and other relevant decisions may require consultation with
    experienced statisticians, mathematicians or experts in other scientific disciplines.

  • Transparency requires full documentation of the process, including sources of data and their evaluation, and any assumptions made.

4. Risk Characterization

Finally, the risk characterization estimates the probability of occurrence and severity of known or
potential adverse health effects in a given population
based on all three of the aforementioned risk assessment steps (hazard identification, hazard characterization and exposure assessment). This is basically the conclusion of the risk assessment, with data to support the findings.

The Food and Agriculture Organization of the United Nations (FAO) explains:

“During risk characterization, all the evidence from the previous three steps is combined in
order to obtain a risk estimate (i.e. an estimate of the likelihood and severity of the adverse
health effects that would occur in a given population with associated uncertainties) and
respond to the questions posed by the risk managers. In general, the risk characterization
includes a summary description of the consequences of exposure to the hazard, as well as an
estimate of the likelihood of the adverse consequences of interest in a risk estimate.

The outputs of a risk characterization should clearly identify important data gaps, assumptions
and uncertainties in order to help risk managers judge how close the characterization might
come to describing reality.”

To get an even more detailed look into the process of conducting a food safety risk assessment, be sure to leverage the FDA’s Web-based tool, FDA-iRISK®. It’s a food-safety modeling tool that enables users to compare and rank risks from multiple microbial and chemical hazards, and then predict the effectiveness of prevention and control measures. It supports your efforts to conduct fully quantitative, probabilistic risk assessments in a relatively rapid and efficient manner by building scenarios that mathematically simulate food-safety issues at any points in the food chain. You can assess the impact of interventions, for example, by varying your data to explore how changes in various practices would be likely to affect public-health outcomes.

When to Perform a Risk Assessment

Armed with the information and support you need to conduct risk assessments that complement your overall food safety program, you may be wondering when all of this should be carried out in your organization. The answer can vary depending on the ingredients, processes, consumers and other factors relevant to your operation. But, as a general rule, it is advised to conduct a risk assessment for any product, process or activity that could increase public health risks or directly impact food safety.

Examples include:

  • The use of new additives in your facility’s food products

  • Facility changes that affect exposure and product safety

  • Environmental changes that could affect product safety

  • Changes to a process or facility that might affect the microbiological or chemical safety of food supplies or the food supply chain

  • Efforts to improve current risk-prevention practices by assessing existing facilities, procedures, processes and policies

In essence, carrying out well-managed risk assessments is a means to an end, the end being a strong food safety program that effectively protects consumers and maintains compliance with governing authorities in the industry. It works in tandem with your audit preparation and performance processes to form a solid foundation for safeguarding your brand, preserving your bottom line and sustaining the long-term success of your business.

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Use this free, comprehensive template to get your audit processes and information in order.


About David Hatch

Dave Hatch has spent over 30 years solving data management, information security and analytics challenges across multiple industries, including food/beverage, healthcare, publishing, manufacturing and financial services. As Chief Strategy Officer at Corvium, Dave focuses on the emerging digital transformation occurring in the food industry, and its impact on the advancement of food safety programs across the food supply chain.