OBJECTIVE： To reduce quality risk of the solid preparation production process， and to ensure the quality of the product. METHODS： On the basis of analysis of solid preparation production process， the quality risk management tool（failure mode and effect analysis， FMEA） was used to take risk assessment， risk control and risk review in the basic production unit of solid preparation. Then suggestions were put forward for the improvement of solid preparation production process. RESULTS & CONCLUSIONS： In solid preparation production process， the mixing time of mixing operation unit， the mount of adhesives and adhesives joining speed of soft material preparation unit， and drying temperature of drying operation unit are high risk factors. It’s suggested that the production process of solid preparation can be improved by establishing standard operational procedures， controlling parameters and intermediates， taking production process validation and carrying out regular risk assessment.