J
We perform metals analysis of water samples using ICP. The water comes from oilfield production and isn't the cleanest of water even after filtering. We have a QC run after every 10 samples, and sometimes the QC will fail. When that happens we run the QC again, and if it fails again we do a little cleaning / maintenance on the instrument and run the QC again and that passes. Then we re-run the 10 samples that preceded the failed QC. With me so far?
The report is not issued to the customer, because we're still in the middle of our work. There is no impact on the results, because we re-run the samples preceding the failed QC. The QC failure is somewhat of an "expected event" that is typical given the nature of the samples we run. It simply alerts us that we need to interact with the instrument and re-run the samples.
Is the QC failure a nonconformity?
If so, given the minor nature of this common event that requires no root cause analysis, would a simple logging of each event be sufficient, without a full blown Corrective Action process that involves a CAR, investigation, root cause analysis, etc?
Opinions please!
The report is not issued to the customer, because we're still in the middle of our work. There is no impact on the results, because we re-run the samples preceding the failed QC. The QC failure is somewhat of an "expected event" that is typical given the nature of the samples we run. It simply alerts us that we need to interact with the instrument and re-run the samples.
Is the QC failure a nonconformity?
If so, given the minor nature of this common event that requires no root cause analysis, would a simple logging of each event be sufficient, without a full blown Corrective Action process that involves a CAR, investigation, root cause analysis, etc?
Opinions please!