Identification, Evaluation and Ranking of Manufacturing Risks in the Pharmaceutical Industry using the FMEA Method (Case study: Sobhan Darou Company)

The important role of risk and its challenges in organizations is one of the reasons for the importance of examining the risks of production. Considering the classification of the pharmaceutical industry as one of the most important industries, the investment risks in this industry have been analyzed using the Failure mode and effects analysis (FMEA) method. This method is one of the risk management techniques to identify, analyze, and ranking risk factors in order to increase the efficiency of the industry. This descriptive study suggests FMEA as a quantitative method for identifying production risks and, by computing risk priority numbers (RPNs), represents the probability of their risks and effects in the pharmaceutical industry. In this research, after identifying the risks of drug production through literature review and interviewing experts, a questionnaire was designed that out of 66 identified risks, 19 risks were identified and ranked by experts as important risks. Good manufacturing practices (GMP), exchange rate fluctuation, no marketing strategy and lack of proper estimation of market trends, inventories of raw materials and inventory of supplies was identified as the most important risks of drug production.