Medical Device manufacturing processes are now heading towards full automation which is a way used by manufacturers to reduce the risk due to human errors. These automated machines and equipment are fairly costly, large and complicated. During process validation, the manufacturer always include a maintenance schedule as well as a calibration schedule to ensure that the equipment is properly maintained throughout its lifecycle. The question here is that assuming that one of the critical equipment on the manufacturing floor have severely failed and required to be fixed. Does this trigger new validation? Do the manufacturer have to repeat IQ, OQ and PQ after the maintenance was performed?