I work for a Medical Device Startup, and we are in the process of identifying our Process Validation Requirements.
I know that the FDA identified soldering as a "special process", but I wanted to see if anyone knows if this applies to PCBs assembly? If so, do we need to validate the assembly process for each of our PCBAs, or is it sufficient that the process at the Contract Manufacturer (who uses standard equipment for PCB assembly)?
Well, I was hoping someone would jump in but since nobody has yet, I'll give it a go.
Processes whose outputs are not 100% verified are expected to be validated. Is anything done to give assurance that each PCBA meets spec? Any scanning systems? Electrical tests? What about even later in the process where you might test the installed PCBA?
Stepping back a bit, how do you know the assembly process is set up correctly (e.g., maybe oven temperatures)? Just because you use standard equipment doesn't necessarily imply you're using it correctly!
I work for a PCB assembly CM. Your PCB design and layout makes a big difference in how easily your finished PCB can be tested. A dedicated tester is best. A general purpose electrical tester is limited by the ability of its probes to touch the test points. The test probes we have are a bit smaller in diameter than a pencil and taper to a rounded point. Tall components can block access a lot of general purpose test equipment can't probe both sides at the same time. Of our three general purpose testers, only one has double side capability.
PCB design also impacts how difficult your board is to build. See the IPC-22xx Series for design guidelines. In a few cases, the IPC acceptance standards 600 and 610 apply different requirements to boards designed to 22xx series vs boards that are not.