Incident report

Dear sir,
The monitor auto-updates while the GC system analysis sequence is running, and the sample is not saved. The problem should be closed with how to write an incident report.

Hi Panja, and welcome!

Loss of CTQ (critical to quality) data can be treated as a deviation, since it has a direct impact on product quality, or its process for release. Either way, the way to approach this event is by evaluating it as loss of data, and how the loss of that data impacts product quality.

There could be actions taken to reduce impact, like doing a re-sample, or re-analysis; but once you identify the root cause of the failure (in this case, automatic update of the system) you can establish controls more effectively (e.g. controlled of pre-authorized updates in the system). These are just examples but you can have a better outcome by following the same steps as you would as if handling it as a deviation; there should not be any obstacle to do so even if your QMS is describing it as an incident instead of a deviation:

  • Asess impact to process or product quality
  • Establish containment actions to reduce impact
  • Investigation of root cause (RCA)
  • Establishing CAPAs to mitigate causes of failures and prevent future failures
  • Implementing and evaluation of CAPA effectiveness

I hope this helps!