Application and Control of FMEA in the Risk Management of Instruments and Equipments of Drug Inspection Organizations / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the application and control of failure mode and effect analysis (FMEA) in the risk management of food and drug inspection institutions. METHODS: A 25-people team was set up and the factors related to equipments in the management review report and external review were analyzed through brainstorming and expert consultation. Thirty-four large risk factors were idendified. RESULTS: The top five risk factors in respect to risk priority number(RPN) value were as follows equipment not undergoing period verification, lack of experience, communication risk between inspection department and equipment management department, daily use and maintenance not meeting the requirements, inadequate consciousness of equipment management. CONCLUSION: The application of FMEA can identify and deal with the failure mode in the process of equipment management and timely detect high risk projects in the equipment management to achieve better control of quality of laboratories.