The Food and Drug Administration’s Food Safety Modernization Act (FSMA) includes a rule targeting preventive controls in human food. The rule gives the FDA broad powers to enforce key guidelines for food manufacturers, including the ability to manage recalls and lessen the chances of recalls due to contamination.
The rule requires companies to have in place written plans regarding the identification, mitigation, and maintenance of food protections throughout the supply chain. For companies, understanding and responding to this rule requires an ounce of prevention. Here is what you should know about FSMA preventive controls.
Preventive controls 101
The preventive controls rule requires manufacturers to create and implement a wide-ranging food safety plan. The core components include:
- Hazard analysis. The analysis must include known or realistically possible physical, chemical, and biological hazards, whether they are naturally occurring or might be intentionally or unintentionally introduced.
- Preventive controls. This section covers controls in place that will prevent or minimize any identified hazards. These measures include the process, any identified food allergens, sanitation controls, supply chain controls, and a recall plan.
- Oversight and management. The rule spells out a series of remedies that can be used to ensure proper ongoing assessment of the preventive controls, including:
- Monitoring. This step includes procedures designed to ensure preventive controls are done consistently, such as tracking the temperatures recorded in a process to kill pathogens.
- Corrective actions and corrections. Corrections are those steps taken in the case of an isolated, minor issue. Corrective actions are broader measures documented with records that are taken:
- To identify an issue with implementing preventive controls
- To reduce the likelihood of recurrence
- To evaluate affected products
- To prevent those products from entering commerce chains
- Verification. These guidelines cover activities that verify that preventive controls are in place and being used consistently. These activities may include validating the science used to use a preventive control, verifying that instruments are properly calibrated, or that accurate records are created, maintained, and assessed.
With such specific measures in place, companies face increasing scrutiny to ensure they are compliant. Here are a few steps companies can take to be sure they are in good standing:
- Understand the basics. Make sure your employees understand the provisions of each component of the FSMA rules. Construct a flow chart that shows the raw materials, processes, and products, which can form the basis of your hazards analysis work.
- Start with raw materials. Begin your hazards analysis with a focus on raw materials. The act requires companies to demonstrate a thorough evaluation of each ingredient to identify hazards and have a supplier monitoring system in place. If necessary, hire a third party to assess hazards in supplied ingredients.
- Review existing protections. The preventive controls rule requires more specificity than standard programs already in place for food safety, such as HACCP plans. While these practices may be a good place to start, they may not be in keeping with the new rules.
- Leverage technology. Food processing software can play an important role in maintaining compliance. Consider whether an enterprise resource planning (ERP) platform, which integrates operations, production, marketing, warehouse, inventory control, billing, and distribution, will help in creating the process flow, hazards assessments, and preventive controls. A system with inherit traceability features and functionality as well as workflow ability can help automate compliance with peace of mind.
NexTec Group works closely with food and beverage makers to ensure they have the right software in place to meet growing regulatory needs. To learn more about how NexTec and Sage X3 can help you, download our Food Brochure.