The Food Safety Modernization Act (FSMA) requires a unique food safety plan for every production line. That includes the process and the products made.
Have you read the 1,500 or so pages that the Food and Drug Administration has written about preventive controls for human food? It’s not so overwhelming if you understand that it defines a single concept: preventive controls. F.D.A. deserves credit for keeping the concept of preventive controls simple and logical. These are the next steps in the evolution of food safety. Bakers need to understand, embrace and implement preventive controls in an effective manner. It is possible.
Here is the basic concept: Develop a food safety plan that identifies potential food safety risks, provides control to prevent failures, assigns corrective actions to take in the event of a failure, verifies and validates the controls’ effectiveness, documents that the proper steps have been taken, and lastly, creates a training program for your employees to ensure that they are aware of the risks, controls and corrective actions.
This sounds like a lot, but when it’s broken down, bakers are already doing most of it. What’s new is that the steps and process are integrated and connected in a holistic manner and linked to vendors and consumers. FDA loves to create new acronyms, so HACCP (Hazard Analysis and Critical Control Points) is now being replaced by HARPC (Hazard Analysis and Risk-based Preventive Controls). The difference involves more than mere semantics. Let’s break it down into bite-sized pieces.
The first step is to perform a comprehensive risk assessment of the production process. The best way to do this is to assemble a multi-functional team who knows the process intimately. Have this team go through the process step by step to consider the potential food safety risks, including physical, biological, chemical and radiological. The process should include the ingredients purchased and the risks inherited from suppliers as well as the products shipped to customers and the risks passed on to them. These are the same risks typically considered while preparing an HACCP plan, except that the scope and depth are greater. Under HACCP, prerequisite programs managed risks considered to be important but not critical. These programs can be integrated into HARPC as preventive controls and corrective actions.
Next, identify the controls in place to prevent failures due to the risks. Some failures can be eliminated by a control step. Other risks can only be managed, meaning that the risk is reduced but still exists. In these cases, the control step must include the ability to detect when a failure occurs and the corrective actions needed to prevent the risk from causing harm to a consumer.
Metal detection is a good example. Bakers do everything possible to prevent metal parts from entering products, but some risk remains. Oftentimes, they will install a metal detector to detect and mitigate the risk. They can verify that the unit is operating properly with checks that are performed and documented every hour and validate that the unit is capable of detection by having the manufacturer test the unit once a year. They also can train employees about risk, controls and corrective actions.
The heart of a preventive control is to perform a comprehensive risk assessment. Document the controls, the validation process, the verification activities, the failures, the corrective actions taken and the training given to employees to complete the package. Keep in mind, however, to keep it simple.
The purpose of performing a risk assessment is not actually to perform a risk assessment. The purpose of performing a risk assessment is to identify what can go wrong, implement controls to prevent failure and establish corrective actions to manage, mitigate or eliminate loss if a failure occurs. Use the process to develop and educate your team about the potential risks. Use it to control, manage, mitigate or eliminate them. This is the way to implement HARPC in an effective and simple manner.