When a major food production outbreak or food safety failure occurs, what would does management do?
What is a proper investigation?
What can be done to prevent future failures?
A properly executed accident/incident investigation drives to the root causes of the food production failure to prevent a repeat occurrence. A valid incident investigation process includes identifying the investigation team, establishing/reviewing written procedures, identifying root causes, and tracking of all hazards found to the generation of a completion report and corrective actions and new SOPs.
What is all of the above worth an organization?
EVERYTHING or cease to exist also known as an existential threat.
A root cause analysis (RCA) is a method of problem solving engaged to identify the root causes of faults or causation of production problems. Root case analysis is widely used in food production operations to determine the underlying causes of the variance from designed performance standards in order to identify appropriate solutions to the issues. Ideally, the RCA team should have extensive experience gained from prior, similar situations combined with immediate and economic solutions.
The RCA team should also consider that there can be, and often are, multiple root causes contributing to the failure(s).
Investigative focus should also be on HOW and WHY the events occurred, rather than WHO was responsible for the causation.
Evidence gleaned from methodical and concrete data points should be used to back up root cause claims.
Sufficient, valid information must be presented to decision-makers to allow them to engage the best corrective course(s) of action.
Comprehensive and holistic approach(es) are the most supportable to prevent future occurrences.
Ultimately, timely, accurate, and economically implementable actionable analysis is the need of every decision-maker faced with an incident or food safety failure.
FDA initiated traceback and testing investigations are initiated when food is the subject harm to the public. The government investigation examines where the food was grown, processed, transported, and stored prior to the humans ingesting the suspect products. Additionally, the government's traceback, sample collection and onsite inspection(s) should be mirrored by the inspected food production organization. Mirroring refers to the suspect organization's double-testing all government sites.
The goal for the government and the food production organization is that no human will ever become sick or die from consuming food products. All food safety efforts should focus on this goal.
A "Market Withdrawal" is an action taken by a supplier to hold a food product for inspection, dumping or return.
A Market Withdrawal is not a recall and does not necessarily require a trace-back.
A supplier may engage a Market Withdrawal for product quality issues, or while checking other quality issues. If it becomes a food safety issue then the Market Recall becomes a Food Recall.
A supplier may request that a buyer "Hold" the product until disposition can be determined. Alternatively, a client may be asked to dispose of the product. The client may request to be reimbursed for the disposal action.
The supplier may issue a credit and normally ships replacement product.
Buyers have choices with a "Market Withdrawal" that are not available in a Recall situation.
Andy Moreno, PhD
Bacterial Surveillance Systems Engineer
AME Certified Laboratories
650-445-4115
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