J
Jason3312003
I am looking for some information and guidance on how to properly analyze a need to update an FMEA POC based on the rate of complaints received.
My specific situation at the moment is that I have a complaint lodged that relates to an identified risk. The risk was assigned a severity of 2 with a POC of 2. A 2 POC equates to a failure rate >.01% but <=.1%. With this complaint we now have 2 related complaints our of 695 recorded uses of our device. This equates to a 0.29% rate of failure(POC of 3).
I am currently debating internally whether 695 uses is a significant sample size and a change to our FMEA should be implemented. The 695 uses are single use devices, and the lowest out of 4 total product lines. The arguement against an update has been that even 1 complaint for this product line is over many of our POCs as most are a 2 or 1 estimation.
Is there enough evidence and trend to justify revising the FMEA and ultimately generating a CAPA for Risk mitigation based on 2 complaints?
My specific situation at the moment is that I have a complaint lodged that relates to an identified risk. The risk was assigned a severity of 2 with a POC of 2. A 2 POC equates to a failure rate >.01% but <=.1%. With this complaint we now have 2 related complaints our of 695 recorded uses of our device. This equates to a 0.29% rate of failure(POC of 3).
I am currently debating internally whether 695 uses is a significant sample size and a change to our FMEA should be implemented. The 695 uses are single use devices, and the lowest out of 4 total product lines. The arguement against an update has been that even 1 complaint for this product line is over many of our POCs as most are a 2 or 1 estimation.
Is there enough evidence and trend to justify revising the FMEA and ultimately generating a CAPA for Risk mitigation based on 2 complaints?