Planned Deviation

A planned deviation occurs when an expected event is not performed in the way it was written in SOPs/ guidelines or regulations. Planned deviation is used to describe a decision to either defer the performance of an activity or perform it in a different way from what was established in a SOP, method or manufacturing batch record (e.g., a reprocess) due to an unforeseen event. For example, Calibration, preventive maintenance or self-inspection is not performed as per the pre-approved schedule due to some delay for various reasons. All planned deviations must be authorized by QA before they are allowed.

It must be noted that most of the deviations would be unplanned. However, if any planned deviation occurs it must be mentioned in the deviation record and recorded in the log book.

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