I've been trying to wrap my head around the traceability aspect of hazards to harms to risk controls, residual risk assessments, etc as well as the design related tracing of user needs, inputs, outputs, verification evidence etc. While these things seem to go somewhat hand in hand, I am envisioning it to be pretty clunky to combine these into a single document. I've also digested quite a bit of information related to these two topics over the past couple weeks, so my brain is a little fried, and I'm hoping someone could provide a comment that will click for me!
We currently rely on our FMEAs for essentially all risk documentation. I understand this is insufficient in the typical form of an FMEA. In trying to remedy this, I am thinking there should be (minimally) a master trace matrix or something similar that would list all potential hazards, hazardous situations, harms, etc, and then continue on to further columns that show any controls were verified as implemented/effective, a residual risk assessment, etc. In my mind, the FMEA can relate to this, or essentially provide a partial subset of the line items in this overall trace matrix. I'm sure there are other ways to skin the cat as well, but something like this seems like a reasonable way to satisfy 14971 without having to create a laundry list of new risk docs. Does anyone have a good example of this, or can anyone provide an alternative option for someone who is looking to expand from an FMEA to cover the remaining requirements of 14971?
My question on DI/DO traceability I assume is a separate one that would typically be covered in a separate document, but wanted to throw this in as well since this is a separate item I am looking into, and wanted to see if anyone had other relevant comments that bridges these two things together.
Thanks!!!!
We currently rely on our FMEAs for essentially all risk documentation. I understand this is insufficient in the typical form of an FMEA. In trying to remedy this, I am thinking there should be (minimally) a master trace matrix or something similar that would list all potential hazards, hazardous situations, harms, etc, and then continue on to further columns that show any controls were verified as implemented/effective, a residual risk assessment, etc. In my mind, the FMEA can relate to this, or essentially provide a partial subset of the line items in this overall trace matrix. I'm sure there are other ways to skin the cat as well, but something like this seems like a reasonable way to satisfy 14971 without having to create a laundry list of new risk docs. Does anyone have a good example of this, or can anyone provide an alternative option for someone who is looking to expand from an FMEA to cover the remaining requirements of 14971?
My question on DI/DO traceability I assume is a separate one that would typically be covered in a separate document, but wanted to throw this in as well since this is a separate item I am looking into, and wanted to see if anyone had other relevant comments that bridges these two things together.
Thanks!!!!