Deviation Handling Model in Highly Regulated Industry (Study case: PT XYZ)

This study aims to develop an effective and efficient deviation handling model that used in the pharmaceutical industry (case study at PT XYZ). The AHP method is used to analyze the priority of deviation categories, which is used as the pilot for modelling. The period of data analyzed is data deviation of 2015 and 2016. Analysis of important factors in handling deviations is analyzed through in-depth interviews with stakeholders (Production manager, QA Manager and Head Quality). The AHP analysis identifies eight categories of deviations that are prioritized in construct a deviation handling model. The deviation handling model has been verified to provide more effective and efficient results in addressing the risks involved in an aberration.