Definition: An event where product temperature moves outside the specified acceptable range. Must be documented and investigated per R638 and GDP requirements.
Classification::
- **Minor excursion**: Brief (< 30 minutes), small deviation (1-3°C above limit)
- **Major excursion**: Extended duration or significant deviation (>5°C above limit)
- **Critical excursion**: Product safety compromised, may require destruction
Required Actions:
1. Document: Time, duration, temperature range, cause
2. Investigate: Root cause analysis
3. Assess: Product safety and quality impact
4. Correct: Implement corrective actions
5. Report: To relevant parties (customer, regulator if required)
Related Terms: Temperature Monitoring, R638 Compliance, GDP, Temperature Log
Resources: Temperature Excursion Investigation Report Template