Understanding the Establishment-based Risk Assessment Model

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The Canadian Food Inspection Agency (CFIA) is strongly committed to its mission to safeguard food, animals and plants to enhance the health and well-being of Canada's people, environment and economy.

The risks to food, animal health and plants continue to change rapidly, and Canadian industry is becoming more efficient to compete in a global economy. It is in this context that the CFIA began to change the way we manage risk, support industry's ability to compete globally, and embrace technology to provide more efficient and responsive service. 

The CFIA has worked together with academia, industries and government partners to create a tool to provide a consistent and efficient approach to inspection. The Establishment-based Risk Assessment (ERA) model uses data and a mathematical algorithm to evaluate federally inspected food establishments in terms of the level of risk they represent to Canadian consumers.

How does the ERA model work?

The ERA model will identify areas of higher risk and indicate where inspectors should be spending more or less time.

Using scientific data and establishment-specific information gathered from questionnaires provided to regulated parties, the ERA model evaluates a facility based on three different groups of factors and determines their level of risk (see image below).

This means that higher risk establishments or sectors that require urgent attention can be easily identified and focused on.

Establishment-based Risk Assessment Model. Description follows.
Description for ERA Model

This figure depicts the list of risk factors included in the ERA model. There are three coloured boxes in a row, followed by an arrow in the forward direction, ending with a final box. The boxes are as follows. The first box is yellow. It represents the inherent risk factors which are the risks associated with a specific food commodity, operation or manufacturing process. Listed in the box are: type of operations, commodity, type of products, volume, processing steps, and direct distribution to vulnerable population. The second box is blue. It represents the mitigation factors which are the measures or strategies that a food establishment has implemented to control the inherent risks and reduce the overall risk of a food safety issue. Listed in the box are: additional processes, international scheme certification, 3rd Party audit, control of incoming supplies, QA (Quality Assurance) personnel, and sampling plan. The third box is red. It represents the compliance factors which refer to a food establishment's track record on how well it has complied with its own preventive control plan and with regulatory requirements. Listed in the box are: inspection results and categorization, history of enforcement actions, recalls (Class I, II, III), and food safety confirmed complaints. The arrow in the forward direction leads to the final box, brown, that says ERA results which is the final level of risk of an establishment. Under the first and second box is a text box with the words "Establishment questionnaire" with arrows pointing into the yellow and blue boxes. The establishment questionnaire is used to collect the data for the Inherent risks and Mitigation factors. Under the third box, red, is a text box with the words "Inspection data". Under the final box, brown, at the end of the forward facing arrow, is a text box with the following information: ERA will support: priority setting, work planning, program design, resource allocation, oversight activities, and laboratory capacity mobilization.

What does the ERA model implementation mean for federally regulated establishments?

Establishments will be able to access their individual results and work with the CFIA on strategies to mitigate potential areas of concern.

Once all information pertaining to the different sectors (i.e., commodities) is completed, the ERA model will also provide data to isolate emerging trends and assist in anticipating threats to food safety.

Example of ERA model Results

The ERA model results for two dairy establishments are shown to the right.

Example of ERA model Results

The yellow bar represents the level of risk due to inherent risk factors only (e.g. both establishments manufacture the same type and volume of products).

The blue bar is the level of risk after the mitigation factors have been considered (e.g. compared to establishment 1, establishment 2 is additionally subjected to 3rd party audits).

The last bar expresses the establishment's final level of risk considering all three groups of risk factors (final result).

Efforts made by establishment 2 to mitigate risks are being accounted for, as well as their compliance with regulatory requirements (e.g. inspection results, enforcement actions, recalls, complaints).

Therefore, establishment 2 has a lower risk result than establishment 1.

What is currently happening with the ERA model?

Information is being collected through establishment questionnaires and the inspectors' compliance assessment of establishments. This information is being used to populate the ERA model to produce a risk profile for each establishment within a commodity.

Some sectors, such as dairy, meat/poultry and fish/seafood have already begun the first phase of data collection. By the end of 2017, it is expected that pilots in all remaining food sectors under CFIA jurisdiction will be completed.

How often will the ERA model be updated?

The CFIA will review and update the ERA model on an ongoing basis, using the most up-to-date science, technology, and risk assessment approaches. It is designed to adapt quickly to emerging global and scientific trends, new risks and changes within establishments.

For questions or comments email: RAModel-ModeleER@inspection.gc.ca

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