Process validation of rework assembly methods (medical devices)

#1
Hi everyone

According to the FDA: A rework is action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

Said this, in your experience, is common practice in the industry to do process validation for rework procedures?

I ask because I recently had an argument with other colleages about this. They said that there is no "obvius" requirement in the QSR or ISO 13485 suggesting such activities need to be done so reworks shouldn't be validated (as simple as that). I have a conservative approach though. My opinion, process validation is required since basicaly you are stablishing a new process to make the product comply with the specs. I think this is no diferent that doing it right the first time. I recognize that process validation may not be done if we can fully verify the output of the rework.

What do you think?
 
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#3
I think the question becomes a lot clearer when you rephrase it in terms of an individual process step.

Let's say your process is taking a batch of widgets and putting them in an oven for a specified amount of time at a specified temperature. You would do validation activities to show that your equipment was capable of meeting the specifications and that the time and temperature (within a certain range) would consistently give you the outcome you were looking for.

So let's say you validate your process to dry your widgets in a 150 degrees C oven (+/- 10 degrees C) for an hour (+/- 15 minutes). If the oven breaks down after 47 minutes, there's no question that your widgets met specifications for time and temperature per your validation. However, now let's say your oven breaks down after 30 minutes: Can you justify throwing it in for another 30 minutes to get it to an hour?

Maybe, maybe not: It depends on a lot of technical details of your widgets, the drying process, the materials, etc. However, validation activities are one method to expand your body of evidence of how certain process parameters influence the outcomes on the product. So it's not that just "rework activities require validation," it's that all results of a process that cannot be fully verified by subsequent inspection and test need to be validated.

For an example of the other side of things, let's say you've got another process that's taking widgets and putting them in a widget holder. The widgets are then put through a piece of equipment for a verification. The verification equipment reject widgets that aren't loaded correctly into the widget holder. You've got 5 different kinds of widget holders for the 5 different kinds of widgets you have. One day, someone loads a batch of widgets into the wrong kind of widget holder. Your results are already being fully verified by subsequent inspection, so a rework activity to move the widgets into the right kind of widget holder would likely not require validation.
 
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