Audit Food Safety Plans Against FSMA Standards

FDA Food Safety Auditor is a skill for reviewing food facility records and preventive controls. Its scope includes Food Safety Plans, HARPC documentation, HACCP plans, Supply Chain Program records, and corrective actions. The review is framed around Food Safety Modernization Act standards and preparation for FDA facility inspections.

The workflow activates through @fda-food-safety-auditor with the document or record to review. It examines HACCP, preventive-control, or supplier-verification records, identifies gaps, and provides specific correction guidance. Gap types include missing Critical Control Points, inadequate monitoring parameters, and incomplete corrective-action records. The practical outcome is an actionable review of the submitted documentation before an actual inspection.

A worked example examines a pasteurizer dropping below a critical temperature limit of 161 degrees Fahrenheit for 30 seconds. The operator restores the temperature and logs that it was fixed, but no product is quarantined. The example classifies the finding as major or critical and connects it to corrective actions and corrections under 21 CFR 117.150. Its analysis identifies an inadequate deviation log, potentially unsafe affected product, failure to quarantine, and an undocumented root-cause evaluation.

The example's required-action excerpt is:

1. Place all product produced during the deviation window on hold.
2. Conduct a risk assessment to determine product disposition.
3. Document a formal Corrective Action identifying the root cause
   (e.g., valve failure, calibration drift).
4. Verify the corrective action is effective before resuming production.

This example illustrates how the review connects a monitoring event, the operator's record, product handling, root cause, and verification of correction. It is a document-review scenario for the skill rather than a substitute for facility-specific validation or expert judgment.

Use it when auditing a manufacturing or processing facility's Food Safety Plan, reviewing supply-chain documentation for FSMA compliance, preparing for a routine FDA inspection, or evaluating corrective actions for a CCP deviation. It also supports practicing mock inspections.

Do not assume Sanitation Standard Operating Procedures satisfy the same requirements as process preventive controls. A CCP deviation should not be treated as closed before a full product disposition is completed. Keep environment-specific validation, testing, and expert review in the process. If required inputs, permissions, safety boundaries, or success criteria are missing, stop to clarify them.

Inputs are the documents or records selected for review, including exact monitoring logs with temperatures, pH values, or times. The relevant records may be a HACCP plan, preventive-control record, supplier-verification record, or deviation log. Outputs identify the documentation gap and provide concrete correction guidance; the example presents severity, citation, analysis, and required actions in an audit finding.

The workflow applies to manufacturing and processing facilities reviewing food safety documentation and preparing for inspection.