What is FSMA?

The Food Safety Modernization Act (FSMA) is a set of food safety regulations in the United States that aims to shift the focus from responding to contamination to preventing it. FSMA was signed into law in 2011 and gave the FDA new authorities to regulate the way foods are grown, harvested, and processed.

For example, FSMA regulations require food facilities to have a food safety plan that includes:

• Hazard analysis to identify and control risks
• Preventive controls like process controls and food allergen controls
• Oversight of suppliers and raw material sourcing
• Recall procedures
• Monitoring and verification of safety systems

Why FSMA is Important

FSMA represents a fundamental change in the FDA's approach to food safety, with the goal of preventing problems before they occur.

For example, previous regulations focused on reacting to contamination by requiring recalls. FSMA requires proactive prevention through steps like supplier verification and environmental monitoring.

Having robust FSMA compliance is crucial for food businesses to avoid issues like foodborne illness outbreaks and costly product recalls.

Getting Ready for Your First FSMA Inspection

If your food business is covered by FSMA, you can expect the FDA to inspect within the next few years. Use this time to get your food safety plan ready.

Review FSMA Requirements

Carefully review which FSMA rules apply to your facility and products. For example:

• A cheesemaking operation must comply with preventive controls requirements for hazard analysis, preventive controls, monitoring, corrective actions, verification, and associated recordkeeping.
• A fruit jam kitchen should reference the produce safety rule covering worker health and hygiene, agricultural water management, biological soil amendments, equipment and buildings, and wildlife/domesticated animal controls.

Read the exact regulatory text in 21 CFR Part 117 or 112 to understand expectations.

Assess Gaps

Conduct a gap assessment comparing existing programs to FSMA requirements. For example:

• If your hazard analysis only covers microbial hazards, assess how to expand it to cover chemical, physical, and radiological hazards per FSMA.
• If you lack documented supplier verification procedures, identify how to implement a supplier approval and verification program meeting FSMA expectations.

Be detailed in examining FSMA regulations line-by-line to pinpoint gaps.

Update Food Safety Plan

Revise your food safety plan to address gaps and comply with FSMA. For example:

• Designate a Preventive Controls Qualified Individual to oversee FSMA compliance.
• Expand hazard analysis to assess and control all known or reasonably foreseeable hazards.
• Describe validation for each preventive control, like scientific support that heat treatment eliminates pathogens.

Provide enough details to demonstrate how your updated plan satisfies FSMA requirements.

Train Staff

Educate employees on FSMA and the updated food safety plan. For example:

• Train maintenance staff on hygiene and allergen controls when entering processing areas.
• Review sampling procedures for QA technicians tasked with product testing.
• Ensure sanitation employees understand daily cleaning and sanitizing procedures.

Keep training records like sign-in sheets listing topics covered, trainer qualifications, and employee signatures. Employees should demonstrate FSMA knowledge.

What to Expect During the FSMA Inspection

Inspectors will verify your food safety plan is robust, implemented properly, and controlling hazards through:

Facility Tour

Inspectors will walk through the facility to observe operations. For example, they may inspect:

• Processing lines for food residue buildup
• Refrigerator and freezer temperatures
• Worker hygiene and protective garments
• Pest control measures

Ensure the facility is well-organized and sanitary. Address any issues immediately.

Document Review

Inspectors will review documents like:

• Hazard analyses listing each identified hazard and associated preventive control
• Validation records proving preventive control effectiveness
• Monitoring logs showing compliance with temperature requirements
• Non-conformance reports detailing deviations from safety plan

Have all documentation up-to-date, organized, and accessible.

Staff Interviews

Inspectors will interview employees on their FSMA responsibilities. For example:

• Processing operators should describe monitoring procedures at key steps.
• Sanitation staff should be able to explain daily cleaning protocols.
• Managers should be able to retrieve records and describe food safety oversight.

Brief staff on proper interview etiquette and how to accurately describe their role.

After the Inspection

Promptly address any issues noted on Form 483. For example:

• Provide a written response within 15 days detailing proposed corrections.
• Update procedures and immediately correct any problems with preventive controls implementation.
• Conduct refresher employee training on identified gaps.
• Use the inspection as a learning experience to continue enhancing your FSMA program.

Conclusion

Thorough preparation is key to passing your first FSMA inspection. This demonstrates your strong commitment to food safety. Follow the steps outlined here to have a compliant program ready for the auditor's review.