基于Kano模型的新藥研發(fā)項目風險識別與可控性研究
發(fā)布時間：2018-10-14 08:22
【摘要】：目的鑒于全面風險管理和內(nèi)部控制一體化發(fā)展的趨勢,結(jié)合新藥研發(fā)項目風險管理的必要性及Kano質(zhì)量分類方法在風險管理研究中的可行性,本研究通過文獻研究構(gòu)建了新藥研發(fā)項目風險因素集,在系統(tǒng)研究Kano質(zhì)量模型的定義、結(jié)構(gòu)的基礎上提出Kano風險屬性歸類法進行風險因素分類評價,結(jié)合藥品研發(fā)與風險管理專家對風險后果嚴重程度、可控程度的評分實現(xiàn)風險嚴重性、可控性評價,制定風險應對措施,確保風險內(nèi)控活動的順利開展,促進研發(fā)項目成功,以最少的管理成本實現(xiàn)最有效的風險控制。研究結(jié)果對于增強醫(yī)風險藥企業(yè)新藥研發(fā)能力和風險內(nèi)控能力、實現(xiàn)風險管理資源優(yōu)化配置、滿足消費者藥品需求具有極強的現(xiàn)實意義和實用價值。方法本研究利用文獻分析法對影響新藥研發(fā)項目的風險因素進行分類與篩選,構(gòu)建風險因素集;運用問卷調(diào)查法了解調(diào)查對象關于風險因素對項目影響程度的認知,利用Kano模型雙維度理念實現(xiàn)新藥研發(fā)工作人員對風險因素管理認知,根據(jù)"風險因素管理與否對提高患者滿意度是否有促進作用"確定風險因素是否需要進行有效管理,從風險管理成效角度進行風險分類定性評價研究;通過專家咨詢法實現(xiàn)新藥研發(fā)項目各個內(nèi)控關鍵點的后果嚴重程度、可控程度調(diào)查,按照專家對各板塊熟悉程度及判斷依據(jù)的分值占總權(quán)威系數(shù)的比例設置權(quán)重,形成風險內(nèi)控關鍵點嚴重性、可控性研究;風險屬性分類及排序結(jié)果結(jié)合嚴重性與可控性分析,進行風險管理對策研究。內(nèi)容本次研究從技術風險、財務風險、管理風險、環(huán)境風險、生產(chǎn)風險、市場風險六個角度劃分新藥研發(fā)項目中的風險因素,構(gòu)建本次研究的風險因素集;研究Kano質(zhì)量模型的定義及分類方法,轉(zhuǎn)換為Kano二維風險屬性模型,利用該模型雙維度特性設計調(diào)查問卷,調(diào)查了解新藥研發(fā)人員對"項目風險因素管理與否對提高患者滿意度的影響"的看法,從風險管理成效維度對各風險因素進行Kano風險屬性分類與排序,并從風險因素、風險類別、調(diào)查對象人口學差異三個方面分析比較風險因素對研發(fā)項目的影響程度;通過專家咨詢法對風險內(nèi)控關鍵點進行風險后果嚴重程度及可控程度的調(diào)查,按照專家對各板塊熟悉程度及判斷依據(jù)的分值占總權(quán)威系數(shù)的比例設置權(quán)重,完成風險內(nèi)控關鍵點嚴重性與可控性研究;最后,根據(jù)識別出的新藥研發(fā)項目風險的關鍵控制點,結(jié)合風險Kano屬性分類及專家評分,提出新藥研發(fā)項目風險應對措施。結(jié)果本研究將新藥研發(fā)項目風險劃分為技術風險、財務風險、管理風險、環(huán)境風險、生產(chǎn)風險和市場風險六大類,下設20項細分風險,形成新藥研發(fā)項目風險因素集;基于Kano模型的問卷調(diào)查共計收集98份有效問卷,通過分析了解到,不同性別、職務級別的調(diào)查對象對20個風險因素影響度的認知均不具有統(tǒng)計學差異,P0.05,而在年齡、教育程度、工作年限三種分類情況下,對部分風險因素影響度的認知略有不同。利用Kano模型雙維度理念進行藥品研發(fā)人員對于項目風險管理的認知調(diào)查,將20項內(nèi)控評價指標劃分為5類Kano風險屬性,其中必備屬性風險9項,魅力屬性風險9項,一維屬性風險和逆反屬性風險各1項,根據(jù)"必備屬性魅力屬性一維屬性逆反屬性"的風險應對優(yōu)先順序制定風險應對措施;邀請8位專家從風險后果嚴重程度和可控程度評價風險內(nèi)控關鍵點的嚴重性及可控性,按照五級量化評分將風險內(nèi)控關鍵點可控性劃分為高可控性風險、中可控性風險、低可控性風險、極低可控性風險4個等級,并在風險對策研究中予以應用。結(jié)論本研究嘗試將Kano質(zhì)量模型引入風險管理研究領域,利用Kano模型屬性特點進行新藥研發(fā)項目風險分類,結(jié)合專家評分確定的風險后果嚴重度及風險可控性等級,實現(xiàn)了新藥研發(fā)項目風險內(nèi)控關鍵點管理對策研究。研究方法具有科學性、創(chuàng)新性和可行性,研究結(jié)果對于增強醫(yī)風險藥企業(yè)新藥研發(fā)能力和風險內(nèi)控能力、實現(xiàn)風險管理資源優(yōu)化配置、滿足消費者藥品需求具有極強的現(xiàn)實意義和實用價值。在設計問卷條目時,應按照風險因素篩選原則保證調(diào)查內(nèi)容的全面、精簡和可操作;在選擇調(diào)查對象時,基于本次研究的內(nèi)容和目的,邀請權(quán)威程度高的專家進行嚴格打分,選擇專業(yè)性強的藥品研發(fā)專職人員開展Kano雙維度問卷調(diào)查,以求提升研究結(jié)果的嚴謹性和專業(yè)性;此外,還需科學地選擇適用的統(tǒng)計學方法進行數(shù)據(jù)處理和分析。
[Abstract]:Objective In view of the trend of overall risk management and internal control integration development, combining the necessity of new drug R & D project risk management and the feasibility of Kano's quality classification method in risk management research, this paper constructs a new drug R & D project risk factor set through literature research. Based on the definition and structure of the Kano quality model of the system, the classification and evaluation of risk factors based on the Kano risk attribute classification method are put forward, and the risk severity and controllable evaluation are realized by combining the drug R & D and risk management experts on the severity and controllable degree of the risk. Develop risk response measures to ensure the smooth development of risk control activities, promote the success of R & D projects, and realize the most effective risk control with the minimum management cost. The research results are of great practical significance and practical value to enhance the R & D ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. Methods The risk factors influencing the R & D project of new drugs were classified and screened by the literature analysis method, and the risk factor set was constructed. Using the Kano model's double dimension idea to realize the cognition of risk factor management in new drug R & D staff, the risk factors need to be effectively managed according to the "Whether risk factor management plays a role in improving patient's satisfaction", and qualitative evaluation of risk classification is carried out from the perspective of risk management effectiveness. By means of expert consultation, the severity and controllability of the key points of risk control are formed according to the degree of familiarity of each plate and the proportion of the total authority coefficient according to the degree of familiarity and the judgment basis of the experts. Risk attribute classification and sequencing result combined severity and controllability analysis, carry on the risk management countermeasure research. In this study, the risk factors of the new drug R & D project are divided into six aspects: technical risk, financial risk, management risk, environmental risk, production risk and market risk, and the risk factor set of this study is constructed. The definition and classification method of the Kano quality model is studied. The method is converted into a Kano two-dimensional risk attribute model, and a questionnaire is designed by utilizing the two-dimensional characteristic design questionnaire of the model, the view of the new drug R & D personnel to the "The Influence of Risk Factors Management on Improving Patient Satisfaction" is investigated, the Kano risk attribute classification and the sorting are performed on the risk factors from the risk management effectiveness dimension, and the risk factors and the risk categories are selected. The influence degree of risk factors on R & D project is analyzed in three aspects of demographic difference of respondents, and the degree and degree of control of risk control key points are investigated by expert consultation method. according to the proportion setting weight of the experts on the familiarity degree and the judgment basis of each plate, and completing the research on the severity and controllability of the risk internal control key points; and finally, according to the identified key control points of the new drug R & D project risk, According to the classification of the risk Kano attribute and the expert's score, a new drug R & D project risk response measure is proposed. Results This study divided the R & D project risk into technical risk, financial risk, management risk, environmental risk, production risk and market risk. Based on the Kano model, a total of 98 effective questionnaires were collected. Through the analysis, it was found that there were no statistical differences in the influence degree of 20 risk factors among the subjects with different gender and job level, but in the case of age, education degree and service life, The cognition of the degree of influence of some risk factors is slightly different. According to the knowledge survey of the project risk management by the drug R & D personnel using the Kano model double dimension concept, 20 internal control evaluation indexes are classified into 5 Kano risk attributes, including 9 mandatory attribute risk, 9 charm attribute risk 9 items, one-dimensional attribute risk and one-dimensional attribute risk each item. The risk response measures shall be formulated according to the risk response of the "One-dimensional attribute inverse attribute of mandatory attribute charm attribute"; 8 experts shall be invited to evaluate the severity and controllability of risk control key points from the degree of severity and controllability of risk, and divide the controllability of risk internal control key points into high controllability risk according to the five-level quantitative score. Medium-controllable risk, low controllability risk, extremely low controllability risk 4 levels, and application in risk countermeasure research. Conclusion This study attempts to introduce the Kano quality model into the research field of risk management, make use of the characteristics of Kano model to carry on the classification of new drug R & D project risk, combine the risk degree and the degree of risk controllability determined by the expert's score, The research on management countermeasures of key points in the project risk control of new drug R & D project is realized. The research method is scientific, innovative and feasible, and the research results are of great practical significance and practical value to enhance the research and development ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. When designing questionnaire items, the comprehensive, thin and operable survey contents shall be ensured according to the principle of risk factor screening; when selecting survey objects, experts with high authority shall be invited to carry out strict scoring based on the content and purpose of this study. Select professional drug R & D professionals to carry out the Kano double dimension questionnaire to improve the strictness and professionalism of the research results; besides, it is necessary to select the applicable statistical methods scientifically to carry out data processing and analysis.
【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R95
本文編號：2269893
[Abstract]:Objective In view of the trend of overall risk management and internal control integration development, combining the necessity of new drug R & D project risk management and the feasibility of Kano's quality classification method in risk management research, this paper constructs a new drug R & D project risk factor set through literature research. Based on the definition and structure of the Kano quality model of the system, the classification and evaluation of risk factors based on the Kano risk attribute classification method are put forward, and the risk severity and controllable evaluation are realized by combining the drug R & D and risk management experts on the severity and controllable degree of the risk. Develop risk response measures to ensure the smooth development of risk control activities, promote the success of R & D projects, and realize the most effective risk control with the minimum management cost. The research results are of great practical significance and practical value to enhance the R & D ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. Methods The risk factors influencing the R & D project of new drugs were classified and screened by the literature analysis method, and the risk factor set was constructed. Using the Kano model's double dimension idea to realize the cognition of risk factor management in new drug R & D staff, the risk factors need to be effectively managed according to the "Whether risk factor management plays a role in improving patient's satisfaction", and qualitative evaluation of risk classification is carried out from the perspective of risk management effectiveness. By means of expert consultation, the severity and controllability of the key points of risk control are formed according to the degree of familiarity of each plate and the proportion of the total authority coefficient according to the degree of familiarity and the judgment basis of the experts. Risk attribute classification and sequencing result combined severity and controllability analysis, carry on the risk management countermeasure research. In this study, the risk factors of the new drug R & D project are divided into six aspects: technical risk, financial risk, management risk, environmental risk, production risk and market risk, and the risk factor set of this study is constructed. The definition and classification method of the Kano quality model is studied. The method is converted into a Kano two-dimensional risk attribute model, and a questionnaire is designed by utilizing the two-dimensional characteristic design questionnaire of the model, the view of the new drug R & D personnel to the "The Influence of Risk Factors Management on Improving Patient Satisfaction" is investigated, the Kano risk attribute classification and the sorting are performed on the risk factors from the risk management effectiveness dimension, and the risk factors and the risk categories are selected. The influence degree of risk factors on R & D project is analyzed in three aspects of demographic difference of respondents, and the degree and degree of control of risk control key points are investigated by expert consultation method. according to the proportion setting weight of the experts on the familiarity degree and the judgment basis of each plate, and completing the research on the severity and controllability of the risk internal control key points; and finally, according to the identified key control points of the new drug R & D project risk, According to the classification of the risk Kano attribute and the expert's score, a new drug R & D project risk response measure is proposed. Results This study divided the R & D project risk into technical risk, financial risk, management risk, environmental risk, production risk and market risk. Based on the Kano model, a total of 98 effective questionnaires were collected. Through the analysis, it was found that there were no statistical differences in the influence degree of 20 risk factors among the subjects with different gender and job level, but in the case of age, education degree and service life, The cognition of the degree of influence of some risk factors is slightly different. According to the knowledge survey of the project risk management by the drug R & D personnel using the Kano model double dimension concept, 20 internal control evaluation indexes are classified into 5 Kano risk attributes, including 9 mandatory attribute risk, 9 charm attribute risk 9 items, one-dimensional attribute risk and one-dimensional attribute risk each item. The risk response measures shall be formulated according to the risk response of the "One-dimensional attribute inverse attribute of mandatory attribute charm attribute"; 8 experts shall be invited to evaluate the severity and controllability of risk control key points from the degree of severity and controllability of risk, and divide the controllability of risk internal control key points into high controllability risk according to the five-level quantitative score. Medium-controllable risk, low controllability risk, extremely low controllability risk 4 levels, and application in risk countermeasure research. Conclusion This study attempts to introduce the Kano quality model into the research field of risk management, make use of the characteristics of Kano model to carry on the classification of new drug R & D project risk, combine the risk degree and the degree of risk controllability determined by the expert's score, The research on management countermeasures of key points in the project risk control of new drug R & D project is realized. The research method is scientific, innovative and feasible, and the research results are of great practical significance and practical value to enhance the research and development ability and risk control ability of medical risk drug enterprises, to realize the optimal allocation of risk management resources and to meet the needs of consumers. When designing questionnaire items, the comprehensive, thin and operable survey contents shall be ensured according to the principle of risk factor screening; when selecting survey objects, experts with high authority shall be invited to carry out strict scoring based on the content and purpose of this study. Select professional drug R & D professionals to carry out the Kano double dimension questionnaire to improve the strictness and professionalism of the research results; besides, it is necessary to select the applicable statistical methods scientifically to carry out data processing and analysis.
【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R95
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