Post-Market Surveillance Procedures
Aligned with FSSC 22000 – ISO-Based Food Safety Management System (FSMS)
(Supports ISO/TS 22002-x and ISO 22000:2018 Clause 9.1 Monitoring, Measurement, Analysis and Evaluation)
Requirement Overview
While FSSC 22000 does not prescribe specific post-market surveillance clauses like BRCGS for Consumer Products, it requires organizations to monitor and evaluate performance through Clause 9.1 of ISO 22000:2018. This includes collecting and analyzing relevant information to ensure food safety, detect trends, and continuously improve the Food Safety Management System.
Post-market surveillance is essential for:
• Monitoring product performance after release
• Reacting to customer complaints and feedback
• Detecting potential food safety issues post-distribution
• Informing continuous improvement initiatives
It’s especially important for manufacturers exporting to strict regulatory markets, such as the U.S. and EU.
Key Compliance Objectives
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✓ Monitor and analyze product performance in the marketplace
✓ Capture and respond to consumer feedback, complaints, and returns
✓ Detect emerging issues and non-conformances
✓ Feed post-market data into CAPA and management review processes
✓ Maintain traceable and reviewable records
Step-by-Step Compliance Implementation
1. Define Your Post-Market Surveillance Program
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Include in Scope:
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• Customer complaint handling
• Product performance tracking (e.g., quality, shelf-life)
• Safety alerts or market withdrawals
Evidence to Maintain:
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• Documented post-market surveillance SOP
• Assigned responsibilities within FSMS
• Product categories and indicators being monitored
- • Customer complaint handling • Product performance tracking (e.g., quality, shelf-life) • Safety alerts or market withdrawals
- • Documented post-market surveillance SOP • Assigned responsibilities within FSMS • Product categories and indicators being monitored
2. Monitor and Capture Market Feedback
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Data Sources:
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• Customer service reports and retailer feedback
• Online reviews, warranty claims, or social media mentions
• Regulatory notifications or public recall databases
Evidence to Maintain:
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• Complaint and return logs
• Summaries of third-party or consumer feedback
• Internal or external surveillance trend reports
- • Customer service reports and retailer feedback • Online reviews, warranty claims, or social media mentions • Regulatory notifications or public recall databases
- • Complaint and return logs • Summaries of third-party or consumer feedback • Internal or external surveillance trend reports
3. Analyze, Investigate, and Escalate
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Analysis Process:
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• Categorize and risk-assess complaints (e.g., quality vs. safety)
• Conduct investigations for patterns or recurring issues
• Escalate findings to appropriate FSMS and QA functions
Evidence to Maintain:
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• Root cause analyses (RCA)
• Corrective and preventive action (CAPA) records
• Risk assessments with documented response timelines
- • Categorize and risk-assess complaints (e.g., quality vs. safety) • Conduct investigations for patterns or recurring issues • Escalate findings to appropriate FSMS and QA functions
- • Root cause analyses (RCA) • Corrective and preventive action (CAPA) records • Risk assessments with documented response timelines
4. Implement Corrective and Preventive Actions
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Possible Actions:
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• Product reformulation or process improvement
• Supplier performance review or corrective actions
• Communication with customers or stakeholders
Evidence to Maintain:
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• Change logs and updated specifications
• CAPA documentation linked to surveillance findings
• Notifications to stakeholders or authorities if applicable
- • Product reformulation or process improvement • Supplier performance review or corrective actions • Communication with customers or stakeholders
- • Change logs and updated specifications • CAPA documentation linked to surveillance findings • Notifications to stakeholders or authorities if applicable
5. Review and Report Periodically
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Review Activities:
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• Conduct surveillance effectiveness reviews quarterly or annually
• Discuss findings during FSMS management review (Clause 9.3)
• Adjust programs based on data, trends, and audit findings
Evidence to Maintain:
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• Surveillance review meeting records
• Annual FSMS performance reports including market feedback
• Preventive action logs and improvement initiatives
- • Conduct surveillance effectiveness reviews quarterly or annually • Discuss findings during FSMS management review (Clause 9.3) • Adjust programs based on data, trends, and audit findings
- • Surveillance review meeting records • Annual FSMS performance reports including market feedback • Preventive action logs and improvement initiatives
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No defined post-market process | Develop a formal surveillance SOP aligned with Clause 9.1 |
| Inadequate complaint follow-up | Implement structured investigation and documentation process |
| Missing data analysis | Create monthly or quarterly reporting mechanisms |
| Feedback not integrated into FSMS | Ensure complaints and surveillance trends are reviewed during management review and linked to CAPA |