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This is a great discussion. I have to agree with Macelo based on 21CFR820. Before it's relased for distribution it is rework.
After release if the customer identifies an issue (on a limited scale) it is a repair regardless of repeat calls for the same unit.
Now to add a little more..............
After release if the manufacturer identifies a problem it is a correction or removal, based on their knowledge and/or the analysis the repair frequency.
After release if the FDA identifies a problem its a recall.
After release if the customer identifies an issue (on a limited scale) it is a repair regardless of repeat calls for the same unit.
Now to add a little more..............
After release if the manufacturer identifies a problem it is a correction or removal, based on their knowledge and/or the analysis the repair frequency.
After release if the FDA identifies a problem its a recall.