Hi,
The medical device we manufacture requires very simple fix if it failure a final inspection, mainly replacing part. e.g. if there is a scratch on the cover the cover will be replaced; if a motor is not working, the motor will be replaced. There is no re-processing required.
Is a rework request, evaluation and approval required for such simple "rework"?
The medical device we manufacture requires very simple fix if it failure a final inspection, mainly replacing part. e.g. if there is a scratch on the cover the cover will be replaced; if a motor is not working, the motor will be replaced. There is no re-processing required.
Is a rework request, evaluation and approval required for such simple "rework"?