Hazard Analysis and Risk-Based Preventative Controls Program Development and Validation
The FDA’s Food Safety Modernization Act (FSMA), which became a final rule in 2015, requires domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic (FD&C) Act to enact risk-based preventive controls. As such, food facilities are now required to have a written food safety plan (FSP) that includes an analysis of hazards and risk-based preventive controls to minimize or prevent identified hazards.
Essential to meeting the FDA’s new requirements for food safety are several updates to the requirements for prerequisite programs, such as current good manufacturing practices (CGMPs), including: requirements for management to provide essential education and training for all employees to perform their job, addressing allergen cross-contact, and a provision for holding and distributing human food by-products that are used in animal food.
Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies biological, chemical, and physical hazards that may occur during the procurement, handling, manufacturing, and distribution process of a food’s raw materials and applies rigid preventive control measures to eliminate the hazard’s risk to the consumer.
A HACCP plan is required by the Food Safety and Inspection Services (FSIS) for processing meat and poultry, and by the FDA for processing juice and seafood. There are seven guiding principles of HACCP, including:
- Principle 1: Conduct a Hazard Analysis
- Principle 2: Determine the Critical Control Points (CCPs)
- Principle 3: Establish Critical Limits
- Principle 4: Establish Monitoring Procedures
- Principle 5: Establish Corrective Actions
- Principle 6: Establish Verification Procedures
- Principle 7: Establish Record Keeping and Documentation Procedures
Most facilities required to register with the FDA covered under section 415 of the FD&C Act are required to have and implement a written FSP. The preventive controls approach to controlling hazards used in a FSP incorporates the seven guiding principles of HACCP in its development, as well as additional elements. Covered facilities are required to have the following written and implemented programs in their Food Safety Plan:
- Hazard Analysis: A system that must consider biological, chemical, and physical hazards that are known or likely to occur. If the hazard analysis identifies one or more hazards that require a preventive control, the facility must implement written preventive controls to address each hazard.
- Preventive Controls: Including the following:
- Process Controls
- Food Allergen Controls
- Sanitation Controls
- Other Controls
- Measures to Assess and Manage Preventive Controls: The facility must ensure the preventive controls are working as intended and perform and document the following activities:
- Monitoring
- Corrections
- Corrective Actions
- Verification
- Supply Chain Program: Manufacturers are required to apply a supply chain preventive control program for hazards that require a preventive control and if the control will be applied in the facility’s supply chain.
- Recall Plan: If the hazard analysis identifies a hazard that requires a preventive control then the facility must have a written recall plan.
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