Good morning everybody, I have a quick question regarding the best way to handle transferring a medical product (board assembly, not a finished device), from one SMT line to another SMT line. We are a contract manufacturer and we need to move a pcb assembly from SMT line 1 to line 2 in order to free up manufacturing resources. Both lines have had IQ OQ PQ performed and both lines are currently in use.
Would performing only a FAI be sufficient to validate that the line change is able to produce products that meet requirements?
Wanted other opinions before I make a decision. Thanks!
Would performing only a FAI be sufficient to validate that the line change is able to produce products that meet requirements?
Wanted other opinions before I make a decision. Thanks!