Practice of Quality Risk Management Mode Based on FMEA in Collinear Production of External Solution Preparations
OBJECTIVE To establish the quality risk management mode based on failure mode and effect analysis(FMEA),and explore the application effect in the collinear production of external solution preparations.METHODS FMEA was performed on each link during the whole process of collinear production of external solution preparations.The high and medium risk failure modes were identified according to risk priority number(RPN),and failure causes were analyzed for formulating and implementing improvement measures.The risk level and the continuous verification effect of cleaning verification were evaluated before and after the implementa-tion of control measures,the incidence of equipment failure,the qualified rate of first clearance,the rate of quality control compliance and the frequency of deviation treatment before and after the application of quality risk management mode were compared,and the improvement effect was examined.RESULTS A total of 21 failure modes were identified in the whole process of collinear production,of which 4 were high-risk,11 were medium-risk and 6 were low-risk.The 15 items of medium and high risk failure modes were down-graded to low risk,and all cleaning verification indicators are controlled within the limits by continuous improvement of pollution and cross-contamination control measures,continuous supervision and research of collinear production risk control measures,continuous confirmation of equipment cleaning effect and other measures.Moreover,after the implementation of quality risk management mode,the incidence of equipment failure and the frequency of deviation treatment were reduced markedly,and the qualified rate of the first clearance and the quality control compliance rate were significantly increased,and the differences were statistically significant(P＜0.05).CONCLUSION Applying the quality risk management model in the whole process of collinear preparation production can effectively reduce the risk of confusion,contamination and cross contamination,ensure the quality of collinear preparation products,and improve the operation level of the quality management system.
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