Introduction to Risk Analysis

Risk analysis is used to develop an estimate of the risks to human health and safety. It is used to solve complex food processing problems and make decisions about food safety hazards.

Risk Versus Hazard

Risk is a measure of the likelihood of a hazard occurring. Most food production and handling processes involve some risk. How you do tasks in light of the potential hazards in your plant affects your risk levels. Knowing how to eliminate or reduce safety hazards with proper controls, helps reduce your food safety risks.

A food safety hazard is a biological, chemical or physical problem with food that can potentially cause a health problem. Many of the factors that can cause health problems are found in specific ingredients and/or the process used.

Not all food safety hazards are serious and not all of them create an immediate risk. Some hazards are higher risk, depending on the levels, sizes, quantities or doses of unwanted substances or processing conditions. While some conditions may not be hazardous for the general population, they may be hazardous for more vulnerable consumers (ex: elderly, pregnant, infants).

Risk Analysis Components

Risk analysis has three components:

  • Risk assessment is the scientific information that describes the likelihood and magnitude of specific hazards.
  • Risk management applies to processes used to control the potential hazards.
  • Risk communication is the exchange of information about the hazards between the people connected to the processes involved.
Diagram of Risk Analysis

How Risk Analysis Works

The first step in analysis is to do a risk assessment. It defines the level or severity for each possible hazard. Proper risk assessments include complete information so the risk management team has all the facts they need to make the best possible decisions to eliminate or reduce the hazards. Risk assessment is the scientific foundation of risk analysis and has four components:

  1. hazard analysis — which includes identification and evaluation
  2. hazard characterization — what the hazard actually is
  3. exposure assessment — how much exposure the food has to the risk
  4. risk characterization — the potential degree of risk

Risk assessment is very important in developing a Hazard Analysis Critical Control Point (HACCP) (PDF 363 KB) system, because the first principle of HACCP is hazard analysis. Hazard analysis looks at hazards that might affect raw ingredients, packaging and process. This is an ongoing process and must be done every time, especially when substitutions, changes or reformulations are made.

The second step in risk analysis is risk management. In arriving at decisions about how to manage potential risks, protecting human health must be the primary factor. Other factors include costs, benefits, technical feasibility and risk perceptions (internal or public).

Effective risk management uses the best options to reduce public health risks, by controlling the risks as much as possible. Management decisions should be monitored for the effectiveness of the control measure and its impact on risk to the exposed consumer. Risk assessment results help management choose the best way to manage their own unique risks.

Main components of risk management:

  • evaluating the risk
  • selecting the best course of action
  • making management decisions on final processes
  • monitoring and reviewing effectiveness of risk management measures
  • documenting all processes and keep detailed records

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The third step risk analysis is risk communication. (See Figure 1) Clear communication is necessary throughout the whole risk analysis process, and includes communication with the public consumers. Proper communication requires specific plans for every aspect of risk management. The goal is to ensure the business maintains clear, positive public awareness and planning is especially important if there is a food safety emergency. When risk management decisions are made, it is important to clearly communicate it to everyone involved.

Main components of risk communication include:

  • promoting awareness
  • promoting consistency and clarity
  • providing background information
  • explaining risk management decisions to stakeholders
  • promoting appropriate involvement from all stakeholders
  • exchanging information, perceptions and knowledge

Effective communications plans include:

  • a clearly defined communications goal
  • a clearly defined audience (usually the public, but also internal)
  • clearly defined messaging
  • identified spokespeople
  • communications scheduling
  • process for measuring and documenting effectiveness

Risk Management Team

A team is essential to assess, identify risks and set priorities for managing them. An effective risk management team has broad representation to ensure balanced, objective decisions and eliminate bias and conflicts of interests. In many cases, members of your hazard analysis critical control points (HACCP) team can be part of this team.

In smaller food processing plants, risk assessment can be done internally with a small team or an individual. The team or individual should be able to gather the necessary scientific data that can be adapted to do a complete risk assessment.

In large food processing plants, risk assessment is best done by a team of people who have a variety of technical backgrounds. Where appropriate, the team should include experts with biological, statistical and chemical skills and any others required for the specific needs of your facility. A broader pool of expertise greatly increases the efficiency of your risk assessment and management.

Risk Analysis and Hazard Analysis Critical Control Point (HACCP)

Risk analysis provides the information that activates and technically supports your HACCP plan. Risk assessments can help identify critical control points (CCP) and establish the limits that are part of HACCP development.

Evaluating Risk

Risk management includes the ability to understand the identified risks in your facility and processes. When analyzing risks, it is essential to look at the existing control measures you're using. Risk is measured in terms of likelihood and severity — a combination of the likelihood of an event happening and the impact or consequences.

A risk evaluation matrix is a common tool used in risk analysis because it helps visualize risks by prioritizing the likelihood and severity. A matrix plots the ranges and the likelihood and severity on each of the axis lines.

An effective risk matrix should:

  • be simple to use and interpret
  • have clear directions on how to use it
  • have consistent likelihood and severity ranges that cover all potential scenarios
  • have detailed descriptions of the consequences of concern for each scenario
  • have clearly defined tolerable and intolerable risk levels

Sample Risk Evaluation Matrix



Thorough record keeping is key to effective risk analysis and includes details on assessing the risks and the reasons for decisions on managing the risks. Risk analysis documents are required for food safety audits and provide the evidence that supports your food safety program.

Related Links

For more information, email the Food Safety and Inspection Branch or call 204-795-8418 in Winnipeg.