S
Hello-
Can anyone provide me some insight as to whether it makes sense and is common to exclude latent failures (failures that occur past the point of final manufacturing) as part of a manufacturing PFMEA for a medical device? And why or why not?
It seems to me that while this is drawing a clear line in the sand, it may not address all the risks that the product could experience that we'd want to assess and possibly mitigate.
Other options would be:
1. to exclude latent failures that occur after a short time past the point of sale (to include any shipping and handling related causes past manufacturing).
2. to include latent failures
Thanks!
Can anyone provide me some insight as to whether it makes sense and is common to exclude latent failures (failures that occur past the point of final manufacturing) as part of a manufacturing PFMEA for a medical device? And why or why not?
It seems to me that while this is drawing a clear line in the sand, it may not address all the risks that the product could experience that we'd want to assess and possibly mitigate.
Other options would be:
1. to exclude latent failures that occur after a short time past the point of sale (to include any shipping and handling related causes past manufacturing).
2. to include latent failures
Thanks!