As part of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration has issued several rules to clarify regulatory requirements. One of these relates to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.
In general, the requirements apply to companies that manufacture, process, pack, or hold human food for consumption in the United States, whether your facility is domestic or foreign.
A few examples of facilities that are exempt from the rule include those that process, pack, or hold seafood, juice, low-acid canned foods, dietary supplements, alcoholic beverages, or cosmetics.
Preventive controls are actions a company takes to ensure the products it produces are safe. The FDA recognizes five types of preventive controls in the Preventive Controls for Human Food rule. They include process, allergen, sanitation, supply chain, and other preventive controls.
Facilities must have a written food safety plan that identifies “known or reasonably foreseeable hazards.” Covered facilities must have a written food safety plan that identifies “known or reasonably foreseeable hazards.”
Known or Reasonably Foreseeable Hazard Examples:
Chemical (including radiological) hazards.
Physical hazards are specific to each food at the facility.
Other hazards that may occur intentionally for economic gain.
Some hazards are obvious, but many are not. And it’s hard to weed out bad actors who are constantly devising new ways to commit food fraud or economically-motivated adulteration.
How can Preventive Controls Qualified Individuals (PCQIs) capture all of the known and reasonably foreseeable risks when writing and implementing their food safety plan? Simply put, it takes a lot of education, research, and ongoing monitoring.
Automated Risk Management
What if there was a solution that could provide notifications when there are food hazards or other potential problems with the ingredients, raw materials, packaging, or vendors within your supply chain?
Now there is. We built Smart Alerts to gather business intelligence and monitor incidents. We’ve made the labor-intensive task of identifying known or reasonably foreseeable hazards a lot easier by providing the best source for industry-related regulatory, safety, incident, and fraud information. You can research by commodity, country of origin, type of threat, supplier, date of event, and more.
Staying up to date is easy with automatic alerts for key ingredients and formulas, and daily system updates on new and emerging issues. Smart Alerts is integrated with other TraceGains solutions so companies can continuously monitor and manage supply chain risk in one system.