Food Safety

Food safety must be a priority from the start to reduce the risk of foodborne illness for consumers and manufacturers. Ingredient sourcing, processing, manufacturing, packaging, storing, delivering, and employee training are crucial for food safety.

The Food Safety Modernization Act (FSMA) was passed to enhance our response to foodborne illnesses. Its regulations have caused a pivot from reactive to proactive foodborne illness prevention. The FSMA also serves a few other purposes.

Food safety plans are required for permitted manufactured food facilities under FDA Title 21 CFR Part 117 Subpart C.

The food safety plan is developed by the permit holder and tailored specifically to the processes used to produce foods. Food Safety Plan Builder is a tool the FDA developed to assist businesses in creating their plans.

A qualified supervisor must be clearly assigned the responsibility of ensuring the safe production of food. This person must complete Preventive Controls Qualified Individual (PCQI) training.

Food Safety Plan Content

• Hazard Analysis
  • Hazard Identification
    • Biological Hazards
    • Chemical Hazards
    • Physical Hazards
  • Determine if those Hazards are:
    • Naturally Occurring
    • Unintentionally Introduced
    • Intentionally Introduced
  • Evaluate Risk of Each Hazard and Need for Preventive Controls

• Preventive Controls
  • Process Controls and Set Critical Control Points
    • Cooking
    • Time/Temperature Controls
    • Acidifying Foods
  • Food Allergen Control
  • Sanitation Control
  • Other Controls

• Supply Chain Program
  • Safe Source or Certificate of Analysis
  • Tracing Raw Ingredients

• Recall Plan
  • Steps Taken
  • Responsible Party
  • Return or Disposal of Food
  • Notify Public
  • Reportable Food Registry (RFR)

• Monitoring Preventive Control
  • Frequency of Monitoring
  • Monitoring Records and Logs

• Corrective Action Plan
  • Procedures when Preventive Controls Faulter
    • Product Testing
    • Environmental Monitoring
  • Steps Taken
    • Identify and Correct
    • Safety of Affected Foods
    • Stop Affected Food from Being Distributed
    • Document Actions Taken

• Verification Procedures
  • Confirm that preventive controls are consistently minimizing and preventing hazards
  • Confirm that critical control points are met
  • Edit hazard analysis when changes in the process are made
    • Confirm those Changes are Working
  • Use an Approved Processing Authority to Validate Your Processes
  • Calibrate thermometers, pH meters, and water activity meters
  • Environmental swabs used to confirm food safety plan is consistently minimizing and preventing hazards
  • Preventive Control Qualified Individual (PCQI) monitors logs and documentation to ensure preventive controls and critical control points are met

• Reevaluate Food Safety Plans Every 3 Years
  • Routinely update when processes and food change
  • Update Food Safety Plan When New Potential Risks and Hazards Develop

• Preventive Control Qualified Individual (PCQI) Role
  • Complete Preventive Controls Training
  • Develop the Food Safety Plan
  • Validate Preventive Controls
  • Review Records
  • Reanalyze Food Safety Plan
  • Maintain Employee Training Records

• Records and Documentation
  • Preventive Control Monitoring
  • Corrective Action Monitoring Logs
  • Validation Records
    • Preventive Control Validation
    • Verification of Monitoring
    • Corrective Action Verification
    • Calibration Logs for Measuring Instruments (e.g., thermometers, pH meters, and water activity meters)
    • Product Testing
    • Environmental Monitoring
    • Record Review
    • Reanalysis/ Reevaluation
  • Supply-Chain Documents (e.g., Invoices and Receipts)
  • Maintain Preventive Control Qualified Individual (PCQI) Training Documentation

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