Follow
An unplanned deviation is a deviation that is identified after the procedure has been carried out. In case of unplanned deviation the failure of procedure, utility, material, equipment or any system would have occurred. The unplanned deviation shall be considered as a change from the previous or written procedure. For example, if a process is shifted to a different machine with same principle and mechanism due to a sudden breakdown or unexpected occurrence. Unplanned deviations must be ratified at the earliest opportunity with QA and appropriate action plan must be formalized for conducting additional validation/ stability studies or other actions as deemed fit.
A flowchart to be followed for deviations from its identification to its closure is provided in Annexure-III.
Classification of the deviation shall be determined by conducting an investigation / impact analysis / risk assessment to identify the risk associated with it. Deviations shall be classified as Critical, Major and Minor.
