Why deviation management is performed — to find and fix problems. Effectively managing deviations in pharmaceutical industry is crucial to ensuring product quality, regulatory compliance and patient safety. Deviation is departure from approved procedure due to unexpected situations, like- breakdown of the equipment/ facility or any other reasons Examples of deviations are- Equipment failure Procedure departure Human failure Material, process and system related failure Deviation can be categorised on basis of severity of impact - 1. Low severity _ Minor deviation- Having no direct or indirect impact on product quality and patient safety 2. Medium severity _ Major deviation - May have indirect impact on product quality and patient safety 3. High severity _ Critical deviation - May have direct impact to the product quality and patient safety DMAIC approach being followed to handling of deviation Investigate the deviation following DMAI...