Temperature Control Measures
Aligned with FSSC 22000 – ISO 22000:2018 & ISO/TS 22002-1/5 Requirements
Requirement Overview
FSSC 22000-certified organizations are required to maintain proper storage and transport conditions for temperature-sensitive products to prevent contamination, spoilage, and quality degradation. According to ISO 22000:2018 Clause 8.5.4 and ISO/TS 22002-1/5, temperature control must be based on product-specific requirements and risk analysis and must be monitored and verified.
Failure to control temperatures may lead to microbiological growth, loss of product integrity, regulatory non-compliance, and failure to meet customer expectations.
Key Compliance Objectives
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✓ Identify and apply temperature control measures based on hazard and risk analysis
✓ Use validated, calibrated monitoring equipment
✓ Maintain complete records of temperature monitoring and corrective actions
✓ Ensure product safety across all stages: receiving, storage, handling, and dispatch
Step-by-Step Compliance Implementation
1. Define Temperature Requirements by Product Type
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Key Actions Include:
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• Identify all products requiring environmental control
• Establish critical limits for temperature ranges (e.g., frozen ≤ –18°C, chilled 0–5°C)
• Base limits on hazard analysis, product characteristics, and regulatory guidelines
Evidence to Maintain:
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• Product temperature specification sheets
• Regulatory references (e.g., Codex, FDA, EU)
• HACCP or risk assessment documentation
- • Identify all products requiring environmental control • Establish critical limits for temperature ranges (e.g., frozen ≤ –18°C, chilled 0–5°C) • Base limits on hazard analysis, product characteristics, and regulatory guidelines
- • Product temperature specification sheets • Regulatory references (e.g., Codex, FDA, EU) • HACCP or risk assessment documentation
2. Equip and Calibrate Monitoring Devices
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Monitoring Options:
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• Continuous monitoring systems (e.g., data loggers, IoT sensors)
• Manual checks using traceable calibrated thermometers
• Alerts or alarms for excursions
Evidence to Maintain:
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• Calibration certificates and schedules
• Maintenance and validation logs
• Mapping studies for cold rooms or transport units
- • Continuous monitoring systems (e.g., data loggers, IoT sensors) • Manual checks using traceable calibrated thermometers • Alerts or alarms for excursions
- • Calibration certificates and schedules • Maintenance and validation logs • Mapping studies for cold rooms or transport units
3. Monitor and Record Temperatures
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Monitoring Frequencies:
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• Based on risk and product sensitivity (e.g., continuous or scheduled checks)
• Include all temperature-controlled steps: receiving, storage, transport
• Immediate action required on deviations
Evidence to Maintain:
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• Electronic or manual temperature records
• Receiving inspection logs
• Alerts and incident response documentation
- • Based on risk and product sensitivity (e.g., continuous or scheduled checks) • Include all temperature-controlled steps: receiving, storage, transport • Immediate action required on deviations
- • Electronic or manual temperature records • Receiving inspection logs • Alerts and incident response documentation
4. Respond to Temperature Deviations
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Response Protocols Include:
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• Quarantine affected batches
• Conduct root cause analysis (RCA)
• Implement corrective and preventive actions (CAPA)
• Notify relevant parties for disposition
Evidence to Maintain:
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• Nonconformance and deviation logs
• Disposition and investigation reports
• CAPA documentation linked to deviation events
- • Quarantine affected batches • Conduct root cause analysis (RCA) • Implement corrective and preventive actions (CAPA) • Notify relevant parties for disposition
- • Nonconformance and deviation logs • Disposition and investigation reports • CAPA documentation linked to deviation events
5. Conduct Internal Reviews and Verification
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Ongoing Verification Activities:
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• Review temperature logs monthly or as defined in FSMS
• Conduct internal audits on cold chain and monitoring process
• Include temperature control in management review
Evidence to Maintain:
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• Internal audit checklists and reports
• Verification records
• Review meeting minutes
- • Review temperature logs monthly or as defined in FSMS • Conduct internal audits on cold chain and monitoring process • Include temperature control in management review
- • Internal audit checklists and reports • Verification records • Review meeting minutes
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented temperature specifications | Create product-specific control limit sheets based on hazard analysis |
| Incomplete or missing temperature logs | Standardize and digitize monitoring forms |
| Uncalibrated or expired equipment | Establish and follow calibration program |
| No corrective actions for temperature excursions | Require RCA and CAPA; include review in FSMS |