FMEA (Failure mode and effects analysis) is one of the most popular risk assessment tools which has been used for continuous improvement of product quality. FMEA was formally introduced to cGMP (current Good Manufacturing Practice of China) for the first time in 2010. In order to achieve the requirement of quality risk management under revised 2010 cGMP certification, the in-depth study of FMEA is conducted to evaluate the risk of HVAC in a pharmaceutical plant located in south China. To solve the problems presenting in traditional risk assessment methods such as non-differential evaluation parameters, impossibility of risk evaluation with equal risk priority numbers (RPN) and low accuracy of evaluation results, our research has proposed a modified assessment method based on entropy method and the theory of fuzzy multi-criteria decision-making. On the basis the FMEA of HVAC(Heating, ventilation and air-conditioning), the occurrence, severity and detectability were chosen as the risk evaluating parameters in this method; the values of these three parameters were respectively fuzzed by using triangular fuzzy number; the weights of the parameters indicating their relative importance are obtained by using entropy method; and the fault modes were sorted by means of fuzzy multi-criteria decision-making; finally, the result of risk assessment has be achieved. The assessment results indicated that our method can not only effectively overcome the defects of traditional FMEA methods that are non-differential analysis of evaluation parameters and impossibility of risk evaluation with equal RPN, but also effectively improve the accuracy of the assessment results