Research On FEMA Model Of Risk Assessment Of Chinese Herbal Medicine Production Process

Objective:In view of the Chinese medicine decoction pieces as the main raw material for the production of Chinese patent medicine and the clinical treatment of traditional Chinese medicine,the processing of Chinese medicine decoction pieces should be carried out in accordance with strict procedures and the quality inspection and control links should be set up.At present,the monitoring of its processing and production and the quality assurance are not comprehensive and systematic so that the all aspects of the production of APIs and the overall quality situation cannot be comprehensively judged and supervised.For this purpose,through the analysis of the risk management of Chinese medicine decoction pieces processing,this paper will make reasonable,comprehensive and strict supervision on the production and processing of Chinese medicine raw materials to ensure the good quality and quality control of the raw material for the production of the follow-up patent medicine.Methods:Based on the Failure Mode Effects Analysis(FMEA),combined with the quality elements and quality link characteristics of the decoction pieces and the decoction pieces enterprise,the standard is set respectively on the severity(S),occurrence(O)and detectability(D)of the key points of the process and the corresponding risk index is determined.The severity,occurrence and detectability of the key points of the process are scored according to the standard.The values of each process key point are obtained by the fuzzy comprehensive evaluation method.The risk is sorted according to the number of the values to draw the risk assessment conclusion.A high score shows that this key point of the process has greater impact on the product quality and vice versa.A representative Chinese medicine decoction pieces enterprise is selected,from which two kinds of decoction pieces are selected for orthogonal test.The result of the “orthogonal test” is compared with that of the combination of the “FMEA and fuzzy comprehensive evaluation method” to obtain the risk ranking.Results:The risk degrees of severity(S),occurrence(O)and detectability(D)are divided into five levels by fuzzy language and assigned to a score of 1-5.The assessment scores of severity(S),occurrence(O)and detectability(D)of the relevant staff in the decoction pieces production enterprise are collected and the risk ranking of the key points is calculated by the “FMEA and fuzzy comprehensive evaluation method”.The production processes of Scutellaria baicalensis and Forsythia suspensa are selected for the risk assessment.The combination of the “FMEA and fuzzy comprehensive evaluation” is used for the two Chinese patent medicines to make the risk ranking.The result is consistent with that of the factor range ranking in the “orthogonal test”,indicating that the risk assessment method of the combination of the “FMEA” and “fuzzy comprehensive evaluation method” is feasible.Conclusion: This paper for the first time uses the “FMEA” in the risk management of the production of Chinese medicine decoction pieces,establishes the risk evaluation mechanism for all aspects of the production of Chinese medicine decoction pieces and broadens the application field of fuzzy comprehensive evaluation method.By combining the “Failure Mode Effects Analysis(FEMA)” with the “fuzzy comprehensive evaluation method”,a risk assessment method suitable for the production process of Chinese medicine decoction pieces is obtained.This method can be used to accurately calculate the risk coefficient of the key point and each key point can be sorted according to the risk coefficient,which has a guiding role in improving the quality management in the production of Chinese medicine decoction pieces.