GoSpeedRacer
Registered
We are a small contract manufacturer and have been building a medical device system (class II) for one of our customers for more than 10 years. They have now decided that it would be good to evaluate our special processes, ensuring that we have validations for all processes where "the resulting output cannot be verified by subsequent monitoring or measurement. I understand this requirement in theory, however in practice we are working on things like the welds on the corners of the sheet metal control box that are purely cosmetic. The weld could fail completely and the control box would continue to function perfectly.
I looked throughout the standard trying to find an out. I don't want to go to our sheet metal fabricator and develop a validation for this process. Could a risk assessment show that there are no hazards associated with this weld and therefor give us relief from 7.5.6?
Any help appreciated.
I looked throughout the standard trying to find an out. I don't want to go to our sheet metal fabricator and develop a validation for this process. Could a risk assessment show that there are no hazards associated with this weld and therefor give us relief from 7.5.6?
Any help appreciated.