Temperature Control Measures
Aligned with BRCGS for Storage & Distribution – Issue 4, Section 4.6
Requirement Overview
BRCGS for Storage & Distribution requires that all temperature-sensitive products are maintained within specified temperature ranges throughout receipt, storage, handling, and dispatch. These controls must be monitored, recorded, and verified to ensure product safety and quality
Clause 4.6.1: “The company shall have procedures in place to ensure that all products are stored and transported at temperatures appropriate to the product.”
Failure to control temperatures may result in microbial growth, product spoilage, or non-compliance with regulatory and customer requirements.
Key Compliance Objectives
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✓ Maintain storage and transport temperatures within acceptable ranges
✓ Use calibrated equipment for continuous or manual monitoring
✓ Document and review all temperature logs and deviations
✓ Protect product integrity and safety throughout the supply chain
Step-by-Step Compliance Implementation
1.Define Temperature Requirements by Product Type
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Key Actions Include:
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• Identify and list products requiring temperature control
• Establish acceptable temperature ranges (e.g., frozen ≤ –18°C, chilled 0–5°C)
• Ensure product-specific requirements are clearly documented
Evidence to Maintain:
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• Product storage requirement matrix
• Supplier or customer specifications
• Regulatory temperature standards
- • Identify and list products requiring temperature control • Establish acceptable temperature ranges (e.g., frozen ≤ –18°C, chilled 0–5°C) • Ensure product-specific requirements are clearly documented
- • Product storage requirement matrix • Supplier or customer specifications • Regulatory temperature standards
2. Equip and Calibrate Temperature Monitoring Devices
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Monitoring Options:
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• Continuous digital monitoring systems (data loggers, sensors)
• Manual temperature checks using calibrated thermometers
• Alarms for out-of-range events
Evidence to Maintain:
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• Equipment calibration records
• Maintenance logs for temperature devices
• Sensor location validation records
- • Continuous digital monitoring systems (data loggers, sensors) • Manual temperature checks using calibrated thermometers • Alarms for out-of-range events
- • Equipment calibration records • Maintenance logs for temperature devices • Sensor location validation records
3. Monitor and Record Temperatures
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Monitoring Frequencies:
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• Continuous (automated) or scheduled (manual) based on product sensitivity
• Temperature checks during receiving, storage, picking, and dispatch
• Immediate response for temperature deviations
Evidence to Maintain:
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• Completed temperature logs (manual or electronic)
• Records of receiving temperature checks
• Out-of-specification alerts and corrective actions
- • Continuous (automated) or scheduled (manual) based on product sensitivity • Temperature checks during receiving, storage, picking, and dispatch • Immediate response for temperature deviations
- • Completed temperature logs (manual or electronic) • Records of receiving temperature checks • Out-of-specification alerts and corrective actions
4. Respond to Temperature Deviations
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Response Protocols Include:
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• Quarantine affected product
• Root cause analysis and equipment checks
• Notification to QA or supervisor for disposition
Evidence to Maintain:
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• Deviation log with root cause and corrective actions
• IProduct disposition records
• Preventive action reports
- • Quarantine affected product • Root cause analysis and equipment checks • Notification to QA or supervisor for disposition
- • Deviation log with root cause and corrective actions • IProduct disposition records • Preventive action reports
5. Conduct Internal Reviews and Verification
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Ongoing Verification Activities:
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• Monthly review of logs and deviation reports
• Random spot checks by QA team
• Random spot checks by QA team
Evidence to Maintain:
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• Internal audit reports
• Verification checklists
• Meeting minutes from cold chain reviews
- • Monthly review of logs and deviation reports • Random spot checks by QA team • Random spot checks by QA team
- • Internal audit reports • Verification checklists • Meeting minutes from cold chain reviews
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented temperature specs | Create product-specific storage requirement sheets |
| Incomplete or missing logs | Standardize monitoring forms and enforce timely completion |
| Uncalibrated equipment | Implement scheduled calibration and verification process |
| No corrective action for deviations | Require documented CAPA and review during management meetings |
