K
Currently I am having issue trying to get everyone (Quality, Regulatory, Engineering) on the same page regarding the risk analysis. We basically use a FMEA approach for our risk analysis then list mitigation, risk acceptability, risk benefit analysis, you get the point.
We have it set up so the hazard is identified, then the sequence of events (Failure mode),, the hazardous situation and then we list the harm. We will break it out if multiple harms are possible.
Currently, when quality receives a complaint in which there is no patient harm, they wants us to update the risk file for a new line item in which there was a device non conformance but it was noticed prior to use and no harm occurred. To me, adding in line items in the risk analysis in which the sequence of events did not lead to the hazardous situation and thus no harm occurred does not make sense to me. They insist they need a specific bucket to place the complaint into.
For example:
if you are operating and a device were to fracture and thus fall into the open patient, creating an unintended laceration of maximum severity - Minor.
Vs
You receive a device and it is already broken. It is noticed and so the device is discarded, and a complaint is filed.
Do we need to include product non conformancies that occur prior to the involvement of the user in the risk analysis?
When answering the complaint I would think the correct thing to do would be to evaluate what would happen if the device failure were to recur and if it would be likely to cause or contribute to a death or serious injury for a recurrence, then you would report it to the FDA.
I would not create an additional line item in the risk analysis of negligible severity for the user to notice the defect prior to use and discard it. Tis seems as though then when the complaint is being analyzed, they are not considering the maximum harm if the failure to recur. TO me this would actually just be a mitigation for the scenario, saying to inspect devices prior to use for any damage or wear.
I hope some of this makes sense!
We have it set up so the hazard is identified, then the sequence of events (Failure mode),, the hazardous situation and then we list the harm. We will break it out if multiple harms are possible.
Currently, when quality receives a complaint in which there is no patient harm, they wants us to update the risk file for a new line item in which there was a device non conformance but it was noticed prior to use and no harm occurred. To me, adding in line items in the risk analysis in which the sequence of events did not lead to the hazardous situation and thus no harm occurred does not make sense to me. They insist they need a specific bucket to place the complaint into.
For example:
if you are operating and a device were to fracture and thus fall into the open patient, creating an unintended laceration of maximum severity - Minor.
Vs
You receive a device and it is already broken. It is noticed and so the device is discarded, and a complaint is filed.
Do we need to include product non conformancies that occur prior to the involvement of the user in the risk analysis?
When answering the complaint I would think the correct thing to do would be to evaluate what would happen if the device failure were to recur and if it would be likely to cause or contribute to a death or serious injury for a recurrence, then you would report it to the FDA.
I would not create an additional line item in the risk analysis of negligible severity for the user to notice the defect prior to use and discard it. Tis seems as though then when the complaint is being analyzed, they are not considering the maximum harm if the failure to recur. TO me this would actually just be a mitigation for the scenario, saying to inspect devices prior to use for any damage or wear.
I hope some of this makes sense!