| Objective:The front-end of quality control of Chinese Herbal Slices is Chinese herbal medicines,which can become Chinese Herbal Slices only after cultivation and breeding,primary processing of origin,storage and transportation,processing and processing,and can be used in clinical practice,spanning the first,second and third industries,involving agriculture and forestry,pharmaceutical supervision,industry and commerce,commerce,health,traditional Chinese medicine,hospitals and other government departments,institutions,medical institutions,with a complex system.As a health industry which has existed and developed for hundreds of years,Chinese herbal pieces have been paid more and more attention by regulators and ordinary people.The key to ensure the safe and effective use of Chinese Herbal Slices is to control the risk of the quality of Chinese Herbal Slices.The first thing to control the risk is how to effectively discover and identify the risk.Based on the policies and regulations,the process of industry chain of Chinese herbal medicine and Chinese herbal pieces,this paper identifies the risk indicators of quality control of Chinese herbal pieces by literature research and other methods.Combining with the evaluation of the severity and possibility of the consequences of the risk indicators by experts in the industry,this paper constructs a risk indicator identification framework for quality control of Chinese herbal pieces,and analyses the risk indicators,so as to make the industry better.To control the quality of Chinese herbal pieces can provide a reference basis.It has certain practical significance and practical value for relevant farmers,production enterprises and medical units to improve the quality control ability and risk management ability of traditional Chinese medicine decoction pieces.Method:This paper classifies and screens the risk factors of quality control of Chinese Herbal Slices by literature research method,and preliminarily establishes the risk identification framework of the influencing factors of quality control;demonstrates the risk identification framework of quality control of Chinese Herbal Slices by Delphi expert consultation method,and collects opinions on the possibility of occurrence of each risk index P and the severity of consequences C.According to the proportion of experts'authoritative degree to the total authoritative coefficient,the weighted calculation is carried out.According to the risk grade R,the key risk points for the quality control of Chinese Herbal Slices are identified.The risk index framework identified by the risk matrix method is evaluated simply;and the Countermeasures for the quality control of Chinese Herbal Slices are studied through interviews.Content:This paper collects the development of risk management and quality control,including risk events,important policies,regulations and theories.Secondly,through collecting and sorting out the factors affecting the quality of Chinese herbal pieces,including the unique risk items,key points,risk analysis and control methods of Chinese herbal pieces industry,the factors affecting the quality control of Chinese herbal pieces and the establishment of an index system are determined.Thirdly,through communication with relevant experts,the risk factors of quality control of traditional Chinese medicine pieces were initially determined,and the risk identification index system of quality control of traditional Chinese medicine pieces was determined by Delphi expert consultation method.Through the risk matrix method to analyze and evaluate the key risk factors,through the output of the risk map,the practitioners in the industry of traditional Chinese medicine decoction pieces can understand the key control points of quality control of traditional Chinese medicine decoction pieces.Finally,from different angles of government,related enterprises and medical institutions,this paper puts forward valuable countermeasures and suggestions for various risks,which can help the development of traditional Chinese medicine.Result:According to the industrial chain of Chinese herbal medicine and Chinese herbal decoction pieces,the risk of quality control is divided into six categories:cultivation and breeding base construction,primary processing of origin,storage and transportation,processing of Chinese herbal decoction pieces and clinical selection and use of Chinese herbal decoction pieces.43 secondary risk indicators are identified.The severity C value and probability P value of each indicator are scored by experts,and Kendall coordination system is used.The consistency of evaluation results by several W-response experts was analyzed.Five risk indicators with coefficient of variation>0.3 were eliminated.Four risk indicators were added through interviews,and 42 risk indicators identification frameworks were finally determined.According to the proportion of experts'authoritative degree to the total authoritative coefficient,the C value and P value of each risk index are calculated by weighting.Through the risk grade formula R=C*P,the risk grade value of each secondary risk index is obtained,and a major risk control point is output to analyze the coping strategies of high,middle and low risk zones.Through the semi-quantitative risk matrix,all secondary risk indicators are expressed,and the Countermeasures of risk management are studied,which can provide reference for relevant enterprises and units in the industry.Conclusion:To ensure strict implementation of the existing standards for Chinese medicinal materials and pieces of Chinese medicinal herbs;to improve the access threshold of Chinese medicinal materials and pieces of Chinese medicinal herbs as medicines;to optimize laws and regulations;to improve and improve the pharmaceutical standards;to focus on the optimization of technical specifications for each link of the production of Chinese medicinal herbs and the construction of traceability system in the whole process,and to promote the promotion and assessment of traceability system in medical institutions. |
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