Does this constitute Nonconformity? Water Testing

J

JodiB

#1
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!
 
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Jim Wynne

Staff member
Admin
#3
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!
I don't know anything about the instrumentation involved, but you say:
  • The "NC" is a common occurrence and
  • It's cured by cleaning the instrument and re-doing the tests.
It seems that there should be some way of anticipating the need for cleaning the instrument. I don't know what's involved with the cleaning, but is it possible just to check the instrument before doing the testing?
 
J

JodiB

#4
Jim,
Thanks for taking the plunge..!

Before running the big tray of samples, we do perform certain maintenance steps so that we're starting with a clean slate. However, during the run (over a hundred samples fed through an autosampler) it could become necessary to do it again, but this isn't something we can automatically anticipate. It just depends on the particular samples that are going through on that day.

The QC failure as an alert mechanism that tells us that somewhere in that last batch of samples , things went a little wonky. So we do what's necesssary to get a clean QC and then re-run the last batch. But perhaps that what all QC failures do...
 

Randy

Super Moderator
#5
NC? Naaaa, it's part of the QC process to determine final conformity to whatever the final result is expected/required to be

Sooooo, how's Houston?
 
K

kaliko81

#7
If I understand correctly, your acceptance systeme is like a go-nogo so the value you get is not statisticaly important, it passes or it fails, you can get a false "fail" but you could never get a false "pass" right? If it is so, I belive your measurment system is acceptable so no NC but not efficient. My 2 cents would be that you determine a cleaning procedure that you could do before taking any measurement or, if it's to long, to expensive or whatever, you determine a preventive maintenance so you need to know when to clen your instrument before getting a false fail.
 
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