Incident Management & Product Withdrawal/Recall Procedures
Aligned with FSSC 22000 – ISO 22000:2018 Clauses 8.4.2 & 8.9
Also Relevant: ISO/TS 22002-1:2009 Clauses 13 & 14
Requirement Overview
FSSC 22000 requires certified sites to establish documented procedures for managing potential emergency situations, including product withdrawal and recall events. These systems must ensure quick, controlled responses to incidents that may impact food safety, legality, or quality.
Key Standard References:
•ISO 22000:2018 Clause 8.4.2 – Handling of potential emergency situations and incidents
•Clause 8.9 – Withdrawal/recall
•ISO/TS 22002-1:2009 Clause 13 – Withdrawal procedures
•Clause 14 – Crisis management
Effective incident and recall procedures ensure traceability, rapid containment, and transparent communication with all stakeholders—while maintaining records to support root cause analysis and corrective actions.
Step-by-Step Compliance Implementation
1. Establish an Incident & Recall Management Team
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Team Should Include:
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• Incident/Recall Coordinator
• Food Safety or QA Lead
• Regulatory Compliance Officer
• Communications or Customer Service Lead
Evidence to Maintain:
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• Team contact list with alternates
• Role descriptions and authority matrix
• Training and mock recall participation records
- • Incident/Recall Coordinator • Food Safety or QA Lead • Regulatory Compliance Officer • Communications or Customer Service Lead
- • Team contact list with alternates • Role descriptions and authority matrix • Training and mock recall participation records
2. Develop Documented Procedures for Incident Management
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Your Procedures Must Include:
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• Risk-based classification of incidents (e.g., food safety vs quality issue)
• Escalation and decision-making framework
• External notification protocols for regulators and customers
Evidence to Maintain:
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• Incident Management SOP
• Emergency contact list (internal and external)
• Escalation matrix and flowchart
- • Risk-based classification of incidents (e.g., food safety vs quality issue) • Escalation and decision-making framework • External notification protocols for regulators and customers
- • Incident Management SOP • Emergency contact list (internal and external) • Escalation matrix and flowchart
3. Implement a Product Withdrawal & Recall Procedure
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Withdrawal/Recall Activities Should Cover:
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• Identification and location of affected products
• Internal hold or quarantine instructions
• Communication to affected parties
• Recordkeeping of all actions and feedback
Evidence to Maintain:
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• Product traceability records
• Recall notification templates and call/email logs
• Completed recall or withdrawal forms
- • Identification and location of affected products • Internal hold or quarantine instructions • Communication to affected parties • Recordkeeping of all actions and feedback
- • Product traceability records • Recall notification templates and call/email logs • Completed recall or withdrawal forms
4. Test the System Annually with a Mock Recall
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Mock Recall Requirements:
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• Conduct at least once per year
• Simulate traceability to final point of sale/distribution
• Evaluate response time, accuracy, and team performance
Evidence to Maintain:
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• Signed-off mock recall report
• Performance evaluation and improvement actions
• Updated procedures and retraining logs
- • Conduct at least once per year • Simulate traceability to final point of sale/distribution • Evaluate response time, accuracy, and team performance
- • Signed-off mock recall report • Performance evaluation and improvement actions • Updated procedures and retraining logs
5. Close the Incident with CAPA and Final Review
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Post-Incident Actions:
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• Conduct root cause analysis
• Develop corrective and preventive actions (CAPA)
• Report to senior management for review and approval
Evidence to Maintain:
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• Final incident report and impact assessment
• CAPA forms with due dates and assigned responsibilities
• Management review meeting minutes
- • Conduct root cause analysis • Develop corrective and preventive actions (CAPA) • Report to senior management for review and approval
- • Final incident report and impact assessment • CAPA forms with due dates and assigned responsibilities • Management review meeting minutes
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No mock recall performed in 12 months | Schedule and document annual tests with full traceability verification |
| Incomplete recall procedures | Revise SOP to include notification, CAPA, and closure protocols |
| Missing stakeholder contact records | Maintain a log of all communications during real or mock recalls |
| Disconnected traceability and recall | Integrate traceability outputs into recall workflows and validation tests |