Hygro meter quality

Sir how to explain CQA auditor, when the server time and hygrometer time not matched during the audit

Please provide the following information,

  • Which place in the factory, the hygrometer is placed?
  • What is the exact purpose of the hygrometer (to monitor the relative humidity in which area?)
  • Is this hygrometer electronic device? Does it display humidity (electronic display) and is the time also indicated on the display?

If the hygrometer displays the time (Electronic display), then it is required to adjust the time on the hygrometer with server time. There should be an internal procedure (SOP) for the operation, calibration, verification & maintenance of hygrometer.
It will be a deviation if the time does not match with the server timing. Based on the criticality of determination of relative humidity, the acceptance criteria should be set. For example (± 1 min).
If it exceeds the acceptance criteria then a deviation form should be filled according to your internal SOP.