In the fourth episode of Kellerman Consulting’s Risk Assessments in Food Businesses series, we look at risk assessments as part of a food safety program, including what government regulators are looking for and how to conduct annual reviews of the completed risk assessments with the safety team .
As a part of this review, we will be looking at how risk assessments are used in Food and Drug Administration (FDA) regulated facilities versus U.S. Department of Agriculture (USDA) – Food Safety & Inspection Service (FSIS) regulated facilities, and here the use of risk assessments are quite different.
For facilities manufacturing food packaging, and are not under food regulations or oversight, risk assessments required by BRC, SQF and FSSC 22000 covered in our GFSI video would be the only potential risk assessments that apply to the facility, as a food safety or food packaging plan is only required if you voluntarily participate in those certification schemes.
For facilities that process meat or poultry products under FSIS inspection and operate HACCP programs, the frequency at which the inspector is onsite determines how important performing risk assessments is in those facilities. Regardless of what the FSIS inspector needs for regulatory purposes, the facility can always create a risk assessment to assist in the evaluation of their operations.
This is in contrast to FDA inspection which does not occur constantly, and where the regulator needs a written record to understand how the facility has been operating in between their last and current regulatory inspection . This is the same issue that occurs during certification audits, where auditors only see a snap shot in time for the facility during the day or two they are onsite, and need those risk assessments to judge how things work during the course of the year.
It is the responsibility of the food safety team to review all risk assessments associated with the food safety program at least annually as part of the overall assessment of the food safety system.
In our previous episode we talked about leadership review, and we suggest that these remain separate reviews from the review conducted by the food safety team, unless leadership heads the food safety team in operations.
Additionally, risk assessment reviews must include evidence that food was produced safely in accordance with those risk assessments. Non-conformance reports, GMP walkthroughs, customer complaints and pre-shipment reviews can be part of proof in these reviews, as well as any product testing or sensory evaluations performed on finished product
In our final episode of the Risk Assessment series, we’ll take a detailed look at the risk assessment requirements for each GFSI program, and how those are reviewed as part of certification audits.
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