| Based on the low awareness rate and low survival rate under the high incidence trend of cancer in China,this paper considers and compares the early screening methods of cancer.Among the many screening methods,liquid biopsy has irreplaceable advantages and development space.Liquid biopsy is not only a noninvasive detection method,but also its main detection technology can meet the simultaneous detection of multiple cancers and improve the detection rate of highrisk cancers.Based on the concept of early diagnosis and early treatment,it can greatly improve the five-year survival rate of cancer patients.The pan cancer early screening products produced by Burning Rock medicine are used to screen patients for multiple types of cancer by liquid biopsy.However,due to the huge investment in product research and development,it is particularly important to identify the risks in the research and development projects and implement effective control measures previously.In this paper,after searching literatures,the interview method is used to identify risks,and the FMEA model is used to analyze risks,formulate risk prevention and control measures and evaluate the effectiveness of prevention and control measures.First of all,in the risk identification stage,this paper identifies five major types of risks in the project progress by using the interview method,then theses five major types of risks are classified and into 12 risk factors.Secondly,in the risk assessment stage,the FMEA model is used to score the severity(S),occurrence probability(O)and risk detectability(D)of the 12 risk factors,so as to quantify the risk characteristics.Then,the risk priority number of all risk factors is calculated by using RPN = S ~* O~* D,and the risk level is divided according to RPN value.Finally,the FMEA model is still used to put forward the risk prevention and control measures,and after the implementation of the prevention and control measures,the severity(S),probability of occurrence(O)and risk detectability(D)of each risk should be scored once more.Then it’s necessary to calculate the RPN value of each risk factor after the implementation of the prevention and control measures.The effectiveness of FMEA method for risk prevention and control will be proven if the RPN value of the later period is lower than that which before the prevention and control measures are implemented.This paper has practical guiding significance for the risk management of the research and development project of Pan cancer early screening products of Burning Rock medicine.For the 22 types of cancer early screening project of Burning Rock medicine,the identification of risks in advance and risk prevention and control can effectively reduce the irreversible impact of risk occurrence during the development of the project. |