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 firstname.lastname@example.org.
This column was originally published in the October 2022 issue of Food in
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