What is supposed to happen when a CA cannot be closed out or the root cause...




Customer Complaint: Contamination is found in the product we provide to them. (chemical, liquid petroleum based, processed and shipped out of our facility in 55g drums)

Investigation phase: It was determined and agreed upon by all parties (this was a lengthy RCA process involving multiple parties including (1) our organization (2) supplier of drums (3) customer and (4) supplier of raw the material.
During this investigation it is determined by all (and agreed upon) that the most likely source of contamination was coming from the drums. Chemical analysis of the contamination was also performed and backed up the theory that the source was indeed the drums.

Corrective Actions: Corrective actions were put in place to (1) check the drums, (2) clean the drums out (if necessary) and (3) filter the product before being transferred to the drums (as a precaution.)

Implementation: Revisions to SOPs and Work INstructions are made and implemented and process is audited to verify the effectiveness of the changes made. All is good.
Then, the contamination is back. Furthermore, it is revealed that it was probably there all along but it was just smaller particles that they prior observed. So what actions do we ,\should we, take from here? Re-open that CAR, or issue a new one? What if its revealed that the contamination has always been there and the customer just did not have the necessary equipment in place to find it? Could the CAR be redacted in this case?

Thanks for all suggestions and opinions here folks!!

Big Jim

I would open a new one and reference the old one.

Sometimes even with due diligence problems are not resolved on the first go around. You now have another opportunity to resolve it. That doesn't mean that you didn't learn from the effort so far. At minimum you have learned that what was already done either wasn't right or wasn't sufficient.

When a problem repeats, there is ALWAYS something about it that can help with the resolution. The circumstances were different. The conditions were different. Someone else observed it. Etc.

When you have a repeat it may be necessary to bring more resources to the resolution. Keep an open mind and brainstorm with the best individuals in the collective organizations.

In this case, having been through something like this, I suspect that the drum supplier is still having trouble with his coating process. That said, keep an open mind and see what turns up this time around.

The smaller particles could also be due to your own filtering process. You might see if the particles are smaller than your filter mesh and check the filters to see if they caught anything.

Run with what you have learned that is different and keep an open mind about other possibilities.
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