Problem & answerI-07
Room Conditions Out of Specification
Likely causes
- HVAC failure
- Door left open
- High external humidity
- Monitoring sensor malfunction
How to fix it
- 1Stop production if limits are exceeded.
- 2Notify QA and Maintenance.
- 3Check HVAC operation and close all doors.
- 4Verify temperature and RH with a calibrated instrument.
- 5Resume only when conditions return to specification.
It is fixed when
Temperature and RH stay within validated limits.
Stop it coming back
- Record room conditions at the required frequency and respond immediately to excursions.
Did this solve the problem?