Research On Project Risk Management Of X Pharmaceutical Company A Product Based On FMEA Method

The pharmaceutical industry is a high-risk industry,most of the projects in pharmaceutical enterprises have a long cycle and significant investment,so they need efficient project management,one of the keys to the success of project management is project risk management.However,due to the complexity of project management,many pharmaceutical enterprises lack systematic project risk management,resulting in a huge workload of project risk management and little effect.FMEA(Failure Mode and Effects Analysis) is a preventive analysis method that uses risk(ie,failure mode)as the evaluation object.Fully consider the risks that may occur in each level in advance,and provide preventive solutions through risk consequence analysis and risk assessment.During the verification of the preventive solutions,improve the program continuously,so that the program continues to be optimal,and finally meet or even exceed the desired expectations.The practice has proved that the FMEA method can play a significant role in risk assessment and analysis of preventive measures.This paper is based on the FMEA method to carry out project risk management of A Product Project in X Pharmaceutical enterprises.Firstly,use the KSF method to extract 21 critical success factors from the 35 primary factors,identify 32 possible risks from them,and analyze the impact and causes of the risks;Secondly,use the FMEA method to build a company that complies with X Medicine The actual situation and the characteristics of the risk assessment indicator system and the principles of risk-taking measures of the A product project,objectively assess the risks,and set the RPN thresholds that require measures,and select 19 risks with RPN values ??greater than 100 from 32 risks;Then,through the enterprise management theory,expert team and enterprise internal comprehensive analysis of the causes of risk and the shortcomings of current risk preset control measures,formulate targeted prevention and response measures,and re-evaluate in the same risk assessment index system to verify the effect of prevention and response measures;Finally,according to the improvement effect after the implementation of the response measures,suggestions are put forward for the risk management in the implementation process of A Product Project of X Pharmaceutical enterprise.Through the system work,realize the risk management of A Product Project in advance,and help X Pharmaceutical enterprises successfully implement A Product Project.