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Complaint & Foodborne Illness Investigation Checklist
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Investigate consumer complaints and suspected foodborne illness reports systematically, from intake through root cause and corrective action.
21 CFR 117FDA Food Code
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Complaint Intake
- Is every complaint logged with product, lot code, date, complainant details, and nature of the complaint? *
- Is the complaint categorized (foreign material, illness, quality, allergen, packaging)? *
- Is the complaint sample or evidence requested and retained where possible?
- Complaint received date
Illness Escalation
- Are suspected foodborne illness or injury complaints escalated immediately to management and the food safety team? *
- Is there a procedure to notify regulatory authorities and the recall team when illness is credibly linked to product? *
- Are reportable food events assessed against the Reportable Food Registry criteria?
Investigation
- Are production, monitoring, and verification records for the implicated lot reviewed? *
- Are retained samples of the implicated lot examined or tested as appropriate? *
- Is a root-cause analysis conducted to determine how the issue occurred? *
Corrective Action and Trending
- Are corrective and preventive actions defined, assigned, and verified for effectiveness? *
- Is the complainant response documented and closed out?
- Are complaints trended over time to detect systemic issues? *
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