K
kbishop94
determined?
Example:
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!!
Example:
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!!