Food Safety Risk Management News

Focus on Food Safety: The ‘ERA’ of increasing risk management

By Dr. Amy Proulx  November 28, 2022

We all hear the words, “Big Data,” but most businesses, especially small ones are

still wrapping their heads around this concept. Both the Canadian Food

Inspection Agency (CFIA) and United States Food and Drug Administration (FDA)

are jumping into a new era with ERA (establishment-based risk assessment)

programs focused on application of predictive analytics and algorithm-based

food safety analysis. The key outcome for food processors is that federal food

safety authorities will use new ways to understand, quantify and apply risk

within the regulatory space.

The U.S. FDA bases its ERA strategy on the four pillars of tech-enabled traceability; smarter

tools and approaches for prevention and outbreak response; new business models

and retail modernization; and food safety culture. CFIA’s ERA model focuses on

inherent risk, mitigation, inspection, and compliance and defines risk of

activities based on novel algorithms. Let’s break down how to prepare your

organization for the upcoming ERA.

Perform risk analysis

In some companies, risk assessment only gets done when emergencies arise. Risk

assessment should be included in FSQA task rotation and become part of the food

safety culture system—when a risk is identified, there’s a channel to

communicate quickly with decision-makers and respond. We know the classic risk

assessment steps from HACCP-based programs: identify hazards, characterize

them, determine the exposure, and estimate probability of exposure. There are

activities involved in direct food safety risk assessment: performing

site-specific observations of manufacturing, observing, and analyzing quality

control data; interviewing key personnel involved in production; reviewing

certificates of analysis from suppliers; and reviewing customer complaint and

regulatory compliance logs.

There’s a second layer of risk assessment that is not as common but just as important,

and that’s looking for indirect risks that could impact product safety. Are you

monitoring for potential labour disruption or worker shortages? If you don’t

have the workers, food safety, sanitation or quality control tasks could be

neglected or rushed. What about recall information from competitors or other

products in a similar category? Recall information can be found on CFIA and FDA

websites. Trade embargoes, emerging diseases in other regions, or political

upheaval can add to risk, as we’ve seen with the war in Ukraine and export closures

in Indonesia for palm oil. If you must switch suppliers or change lead times on

product inputs, it places considerable pressure on manufacturing systems.

Watching the news, both general and industry specific, can help.

Use traceability tools

Yes, it’s still technically legal to have your traceability program on paper-based

systems. A traceability program for supplier management, process management,

and finished goods management is essential in all modern food safety management

systems. From the ERA program, we’re getting hints that there could be a larger

push toward electronic registration systems. We already know that a lot of this

is linked to GS1-based coding on packaged goods. We may start to see

serialization built into GS1 coding, so that each product can be linked back to

the establishment, the process and the input suppliers in a more automated way.

This rapid traceability scenario will be of great interest to companies using

multiple co-manufacturing steps. Being able to quickly track co-manufacturing

establishments was brought to light in the recent tara flour recalls, which

heavily impacted meal kit manufacturers, who in turn, are heavy users of

co-manufacturing for all the modular food units in their packs.

Build a food safety culture

In the ERA programs, and in fact in all the recent GFSI program updates, a major

emphasis was put on food safety culture. These are the behavioural and

organizational approaches ensuring the success of food safety technical systems

by creating a shared purpose and value across the entire establishment. Have

you done benchmarking tools such as Lone Jespersen’s Cultivate Food Safety

Culture Maturity Model to see the current state of food safety culture in your

organization, and define where you should prioritize growth? Do you have clear

management commitment statements that are shared with all employees? Do you

walk the talk and encourage people to do the right thing?

The future era of food safety is right now. Being prepared is the

hallmark of food risk management, and we can prepare for the future right now. 

Dr. Amy Proulx is professor and academic program

co-ordinator for the Culinary Innovation and Food Technology programs at

Niagara College, Ont.

She can be reached at

This column was originally published in the October 2022 issue of Food in


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