Post-Market Surveillance Procedures
Aligned with BRCGS for Consumer Products – Issue 4, Clause 4.5
Requirement Overview
BRCGS for Consumer Products Issue 4 emphasizes the importance of post-market surveillance to ensure continued product safety, legality, and quality once a product is available to the end user.
Clause 4.5.1:
“Procedures shall be in place to monitor and assess product performance once the product has been released into the marketplace. This shall include a process for reviewing customer complaints, returns, and feedback to identify product failures or risks.”
Post-market surveillance protects consumers, strengthens brand integrity, and ensures that non-conforming products are identified and addressed quickly—even after distribution.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Monitor product performance after market release
✓ Identify and respond to customer complaints and safety issues
✓ Detect patterns of product failure or non-conformance
✓ Maintain traceable documentation and escalation records
Step-by-Step Compliance Implementation
1. Define Your Post-Market Surveillance Program
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Program Scope Should Include:
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• Customer complaints and return analysis
• Product reviews, third-party testing, or consumer feedback
• Safety alerts, injury reports, and regulatory notices
Evidence to Maintain:
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• Documented surveillance SOP
• Designated roles and responsibilities
• List of monitored product categories and metrics
- • Customer complaints and return analysis • Product reviews, third-party testing, or consumer feedback • Safety alerts, injury reports, and regulatory notices
- • Documented surveillance SOP • Designated roles and responsibilities • List of monitored product categories and metrics
2. Monitor and Capture Market Feedback
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Sources of Surveillance Data:
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• Customer service reports, reviews, and warranty claims
• Distributor or retail partner feedback
• Regulatory body notifications or public recall databases
Evidence to Maintain:
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• Complaint log or ticketing system
• Monthly or quarterly product trend reports
• Screenshots or summaries from online reviews or feedback
- • Customer service reports, reviews, and warranty claims • Distributor or retail partner feedback • Regulatory body notifications or public recall databases
- • Complaint log or ticketing system • Monthly or quarterly product trend reports • Screenshots or summaries from online reviews or feedback
3. Analyze, Investigate, and Escalate
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Analysis Steps:
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• Categorize and prioritize complaints (e.g., safety risk, functional failure)
• Conduct root cause investigations for frequent or critical issues
• Escalate findings to internal quality, compliance, and design teams
Evidence to Maintain:
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• CAPA records linked to post-market data
• Investigation reports and response timelines
• Root cause analysis and risk assessment documentation
- • Categorize and prioritize complaints (e.g., safety risk, functional failure) • Conduct root cause investigations for frequent or critical issues • Escalate findings to internal quality, compliance, and design teams
- • CAPA records linked to post-market data • Investigation reports and response timelines • Root cause analysis and risk assessment documentation
4. Take Corrective and Preventive Actions
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Actions May Include:
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• Product redesign, labeling changes, or material substitutions
• Customer communication or recall (if risk is high)
• Supplier notification and review
Evidence to Maintain:
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• Change request forms and engineering logs
• Updated specifications or instructions for use (IFUs)
• Corrective action closure reports
- • Product redesign, labeling changes, or material substitutions • Customer communication or recall (if risk is high) • Supplier notification and review
- • Change request forms and engineering logs • Updated specifications or instructions for use (IFUs) • Corrective action closure reports
5. Review and Report Periodically
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Review Activities:
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• Evaluate effectiveness of post-market processes quarterly or annually
• Share findings with senior management and product development
• Use data to drive product improvements and reduce liability
Evidence to Maintain:
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• Surveillance review meeting minutes
• Annual surveillance program effectiveness reports
• Management review input
- • Evaluate effectiveness of post-market processes quarterly or annually • Share findings with senior management and product development • Use data to drive product improvements and reduce liability
- • Surveillance review meeting minutes • Annual surveillance program effectiveness reports • Management review input
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No defined post-market process | Create and document a formal surveillance SOP |
| Poor complaint follow-up | Implement investigation and escalation workflows |
| No trend analysis | Introduce regular complaint data reviews and reporting |
| Lack of feedback loop to product team | Build procedures that tie findings to product or supplier updates |