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Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA?

CPhelan

Starting to get Involved
#1
Hello,
Yesterday I opened an NC as it was brought to my attention of a number of received items which had the incorrect expiration date on them. Fortunately we had greatly under reported the shelf life.

Based on our receiving incoming material procedure we stated that material with no listed retest/expiration date should be automatically given a 1 year retest/expiration date. After contacting the manufacturers we were given additional information that material which does not have listed expiration date has a given retest/expiration of 5 years. In the NCR we have captured all of the known items, noted that the receiving SOP needs to be updated, review of all similar items to determine if correct shelf life is needed.

Initially I thought a NC was enough for this but as the workload is growing and the document updates are growing also just want to ask a community of SMEs if a corrective action should be opened or whether this can be resolved as an NC. Basically our documentation did not account for information we didn't have.
 
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William55401

Involved In Discussions
#2
It's your QS and you have visibility to what your procedures state. Following your procedures takes precedence. Always. When I read the thread, I am wondering if each item received resulted in it's own NC for incorrect shelf life. If that's the case, multiple NC on the same issue may trigger a trend in your system and result in escalation to CAPA. When I think about NC's, local correction of issues is an expected outcome. You can process the NCs by correcting the shelf life. By making the local correction, you keep that product moving. When the process that caused the issue is in question, CAPA is a reasonable solution that decouples process improvements from the local issue.
 
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CPhelan

Starting to get Involved
#3
Thank you William. Yes my concern is that the process did not provide enough information for the user to apply the correct information. I have gathered the items as one NC. The issue can be corrected by the NC process. Multiple parts have been affected and this is the first nonconformance we have had related to receiving.
 

Ninja

Looking for Reality
Trusted
#4
You're wondering how to clean up the blood spilt...are you still bleeding?
You found the problem, and multiple cases of the results...did you fix the problem yet?

If no: I would open a CA and fix the problem through it.
If yes, and it was a simple fix...who assigned the NC?
If you launched the NC...just fix it and move on...OFI at best.
If an outside party launched the NC (audit, etc.)...you pretty much have to run it through CA.

Either way...don't get too lost in the paperwork...make sure the problem is fixed and the bleeding has stopped.
 

CPhelan

Starting to get Involved
#5
You're wondering how to clean up the blood spilt...are you still bleeding?
You found the problem, and multiple cases of the results...did you fix the problem yet?

If no: I would open a CA and fix the problem through it.
If yes, and it was a simple fix...who assigned the NC?
If you launched the NC...just fix it and move on...OFI at best.
If an outside party launched the NC (audit, etc.)...you pretty much have to run it through CA.

Either way...don't get too lost in the paperwork...make sure the problem is fixed and the bleeding has stopped.
Thanks Ninja. We are doing an investigation as part of the NC to find affected items but believe this will be resolved solely as an NC.
 
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