FSMA Preventive Controls Verification Checklist [FREE PDF]

FDA's Food Safety Modernization Act (FSMA) requires food facilities to implement a written Food Safety Plan with science-based preventive controls under 21 CFR Part 117. Verification activities must demonstrate that preventive controls are consistently applied and effective at minimizing or preventing identified hazards. This checklist supports Food Safety Managers in conducting structured preventive controls verification in alignment with 21 CFR 117 Subpart C requirements and SQF Code Edition 9

  • Industry: Food Manufacturing
  • Frequency: Monthly
  • Estimated Time: 45-60 minutes
  • Role: Food Safety Manager
  • Total Items: 36
  • Compliance: FDA FSMA 21 CFR 117 Subpart C, FDA FSMA 21 CFR 117.165 - Verification of Preventive Controls, SQF Code Edition 9 Module 2, HACCP Codex Alimentarius CAC/RCP 1-1969, ISO 22000:2018 Section 8.8

Food Safety Plan Documentation Review

Verify that the written Food Safety Plan is current, complete, and accessible to responsible personnel.

  • Is the written Food Safety Plan current and signed by a Preventive Controls Qualified Individual (PCQI)?
  • Does the Food Safety Plan include a written hazard analysis covering all known or reasonably foreseeable hazards?
  • Have all process, allergen, sanitation, and supply-chain preventive controls been identified and documented in the plan?
  • Has the Food Safety Plan been reanalyzed within the past three years or after a significant operational change?
  • Are Food Safety Plan records maintained and accessible for at least two years after creation?

Process Preventive Controls Verification

Confirm that process controls at critical control points are monitored, verified, and documented.

  • Are critical limits established and documented for each process preventive control (e.g., time, temperature, pH, water activity)?
  • Are monitoring procedures being performed at the frequency specified in the Food Safety Plan?
  • Is calibration of monitoring instruments (thermometers, pH meters, water activity meters) current and documented?
  • Have all critical limit deviations been documented with corrective actions taken within the review period?
  • Is product affected by a deviation placed on hold and evaluated before release?
  • Are verification activities (e.g., calibration checks, product testing) performed per the Food Safety Plan schedule?

Allergen Preventive Controls

Verify controls are in place to prevent undeclared allergen cross-contact throughout production.

  • Are all major food allergens used on-site identified and listed in the Food Safety Plan?
  • Are allergen-containing ingredients stored segregated from non-allergen ingredients to prevent cross-contact?
  • Are allergen changeover and line-clearance procedures documented and verified by a second employee?
  • Are finished product labels reviewed and verified to accurately declare all allergens present?
  • Is allergen environmental or product testing conducted to verify effectiveness of allergen controls?

Sanitation Preventive Controls

Assess implementation of sanitation controls that address environmental pathogens and food contact surface cleanliness.

  • Are written sanitation procedures (SSOPs) in place for all food contact surfaces and direct food contact equipment?
  • Are pre-operational sanitation inspections conducted and documented before production begins?
  • Are environmental monitoring results for pathogens (e.g., Listeria spp.) within acceptable limits for the review period?
  • Are chemical sanitizer concentrations verified and recorded at required frequencies?
  • Are corrective actions taken and documented when sanitation deficiencies are identified?

Supply-Chain Preventive Controls

Verify that supply-chain program elements are implemented for raw materials and ingredients with hazards controlled upstream.

  • Is a written supply-chain program in place identifying all raw materials and ingredients requiring supply-chain controls?
  • Are approved supplier lists current and do they include verification of supplier food safety system performance?
  • Are supplier audit records, certificates of analysis, or third-party certification documents maintained on file?
  • Are incoming raw material inspections or testing results documented for the review period?
  • Are non-conforming raw materials quarantined, labeled, and disposition documented?

Monitoring and Recordkeeping Verification

Confirm that all required monitoring records are complete, accurate, and reviewed by qualified personnel.

  • Are all monitoring records completed in real-time (not pre-recorded or back-filled) with the monitor's signature?
  • Are monitoring records reviewed by a PCQI or designated supervisor within seven days of creation?
  • Are records free from unauthorized alterations, erasures, or white-out corrections?
  • Are electronic records, if used, compliant with 21 CFR Part 11 requirements for electronic signatures and audit trails?
  • Are corrective action records clearly linked to the corresponding monitoring deviation or nonconformance?

PCQI Training and Validation Activities

Verify that personnel qualifications and preventive control validation requirements are met.

  • Is at least one PCQI identified on-site who has completed the FSPCA Preventive Controls for Human Food course or equivalent training?
  • Are validation records on file demonstrating that process preventive controls are capable of controlling identified hazards?
  • Have all employees performing monitoring activities received documented training on their specific responsibilities?
  • Are training records current and include training date, topic, trainer name, and employee signature?
  • Have observations of employee practices been conducted to verify adherence to Food Safety Plan procedures?

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Why Use This FSMA Preventive Controls Verification Checklist [FREE PDF]?

This fsma preventive controls verification checklist [free pdf] helps food manufacturing teams maintain compliance and operational excellence. Designed for food safety manager professionals, this checklist covers 36 critical inspection points across 7 sections. Recommended frequency: monthly.

Ensures compliance with FDA FSMA 21 CFR 117 Subpart C, FDA FSMA 21 CFR 117.165 - Verification of Preventive Controls, SQF Code Edition 9 Module 2, HACCP Codex Alimentarius CAC/RCP 1-1969, ISO 22000:2018 Section 8.8. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the FSMA Preventive Controls Verification Checklist [FREE PDF] cover?

This checklist covers 36 inspection items across 7 sections: Food Safety Plan Documentation Review, Process Preventive Controls Verification, Allergen Preventive Controls, Sanitation Preventive Controls, Supply-Chain Preventive Controls, Monitoring and Recordkeeping Verification, PCQI Training and Validation Activities. It is designed for food manufacturing operations and compliance.

How often should this checklist be completed?

This checklist should be completed monthly. Each completion takes approximately 45-60 minutes.

Who should use this FSMA Preventive Controls Verification Checklist [FREE PDF]?

This checklist is designed for Food Safety Manager professionals in the food manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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