We are currently in the process of pilot runs for our medical device. We perform 100% testing on each device. We perform testing and troubleshooting for each unit until obtaining a passing result. What, if anything, is validatable and if the procedures do not give instructions for troubleshooting during test failure, how is that validatable?
Please advise, I do not see how this can be validated if we are testing until pass.
I am not familiar with device manufacturing, in Pharma, we would not be validating at this point and if testing until pass it would not a validation either.
IMO, that is not a process that can be validated. It’s not a manufacturing process, either. I guess you could seed a device with defects to ensure the testing catches them. That might give you some level of assurance that the testing is effective. You could perform some risk analysis (e.g., FTA) to identify defects that would result in product quality issues.
Are all test results, changes, etc. during the testing process at least captured in the Device History Record? Personally, I would not be comfortable defending this to a regulatory agency.
Is it possible to back up a few steps to understand why you have to do so much troubleshooting with each device? Maybe those processes could be evaluated, refined, and validated (and then you wouldn’t have the issues you see in test)? The goal for manufacturing is repeatability and clearly you have some issues.
Not sure if I understand where you are at, but you should have certain aspects of your process and testing validated. You should have a FMEA for the product which drives into a plan of some kind for the validation strategy and what kind of validation is required. Aside from equipment, instrument, etc. related stuff, you would most definitely want to validate any testing methods used for your 100% inspections (or any other accept/reject/rework type inspections even if only done on an AQL basis or what have you) and finally, you need to have some type of PPQ on your product as documented evidence that your production process is effective. Hope that helps, Keeks.