Follow
Planned deviation
*** Planned deviation is the preapproved deviation.
*** Planned deviation shall be approved before execution.
*** No Route cause analysis or corrective action preventive action (CAPA) is required for planned deviation as parameters are intentionally deviated.
*** Example of planned Deviation: Use raw material for unapproved vendor, Change in batch size, Change in equipment, release of material with limited test etc.
Unplanned Deviation
*** Unplanned deviation is that deviation which occurs during the execution of the plan.
*** Unplanned deviation is never approved before the execution.
*** Example of unplanned Deviation: Human error e.g: wrong batch number, Dilution error, wrong solution preparation, Material is not charged properly.
*** Route cause analysis and corrective action preventive action (CAPA) required.
