基于Kano模型的新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)識(shí)別與可控性研究
發(fā)布時(shí)間：2018-10-14 08:22
【摘要】：目的鑒于全面風(fēng)險(xiǎn)管理和內(nèi)部控制一體化發(fā)展的趨勢(shì),結(jié)合新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)管理的必要性及Kano質(zhì)量分類方法在風(fēng)險(xiǎn)管理研究中的可行性,本研究通過(guò)文獻(xiàn)研究構(gòu)建了新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)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(chǔ)上提出Kano風(fēng)險(xiǎn)屬性歸類法進(jìn)行風(fēng)險(xiǎn)因素分類評(píng)價(jià),結(jié)合藥品研發(fā)與風(fēng)險(xiǎn)管理專家對(duì)風(fēng)險(xiǎn)后果嚴(yán)重程度、可控程度的評(píng)分實(shí)現(xiàn)風(fēng)險(xiǎn)嚴(yán)重性、可控性評(píng)價(jià),制定風(fēng)險(xiǎn)應(yīng)對(duì)措施,確保風(fēng)險(xiǎn)內(nèi)控活動(dòng)的順利開展,促進(jìn)研發(fā)項(xiàng)目成功,以最少的管理成本實(shí)現(xiàn)最有效的風(fēng)險(xiǎn)控制。研究結(jié)果對(duì)于增強(qiáng)醫(yī)風(fēng)險(xiǎn)藥企業(yè)新藥研發(fā)能力和風(fēng)險(xiǎn)內(nèi)控能力、實(shí)現(xiàn)風(fēng)險(xiǎn)管理資源優(yōu)化配置、滿足消費(fèi)者藥品需求具有極強(qiáng)的現(xiàn)實(shí)意義和實(shí)用價(jià)值。方法本研究利用文獻(xiàn)分析法對(duì)影響新藥研發(fā)項(xiàng)目的風(fēng)險(xiǎn)因素進(jìn)行分類與篩選,構(gòu)建風(fēng)險(xiǎn)因素集;運(yùn)用問(wèn)卷調(diào)查法了解調(diào)查對(duì)象關(guān)于風(fēng)險(xiǎn)因素對(duì)項(xiàng)目影響程度的認(rèn)知,利用Kano模型雙維度理念實(shí)現(xiàn)新藥研發(fā)工作人員對(duì)風(fēng)險(xiǎn)因素管理認(rèn)知,根據(jù)"風(fēng)險(xiǎn)因素管理與否對(duì)提高患者滿意度是否有促進(jìn)作用"確定風(fēng)險(xiǎn)因素是否需要進(jìn)行有效管理,從風(fēng)險(xiǎn)管理成效角度進(jìn)行風(fēng)險(xiǎn)分類定性評(píng)價(jià)研究;通過(guò)專家咨詢法實(shí)現(xiàn)新藥研發(fā)項(xiàng)目各個(gè)內(nèi)控關(guān)鍵點(diǎn)的后果嚴(yán)重程度、可控程度調(diào)查,按照專家對(duì)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(shè)置權(quán)重,形成風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)嚴(yán)重性、可控性研究;風(fēng)險(xiǎn)屬性分類及排序結(jié)果結(jié)合嚴(yán)重性與可控性分析,進(jìn)行風(fēng)險(xiǎn)管理對(duì)策研究。內(nèi)容本次研究從技術(shù)風(fēng)險(xiǎn)、財(cái)務(wù)風(fēng)險(xiǎn)、管理風(fēng)險(xiǎn)、環(huán)境風(fēng)險(xiǎn)、生產(chǎn)風(fēng)險(xiǎn)、市場(chǎng)風(fēng)險(xiǎn)六個(gè)角度劃分新藥研發(fā)項(xiàng)目中的風(fēng)險(xiǎn)因素,構(gòu)建本次研究的風(fēng)險(xiǎn)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(fēng)險(xiǎn)屬性模型,利用該模型雙維度特性設(shè)計(jì)調(diào)查問(wèn)卷,調(diào)查了解新藥研發(fā)人員對(duì)"項(xiàng)目風(fēng)險(xiǎn)因素管理與否對(duì)提高患者滿意度的影響"的看法,從風(fēng)險(xiǎn)管理成效維度對(duì)各風(fēng)險(xiǎn)因素進(jìn)行Kano風(fēng)險(xiǎn)屬性分類與排序,并從風(fēng)險(xiǎn)因素、風(fēng)險(xiǎn)類別、調(diào)查對(duì)象人口學(xué)差異三個(gè)方面分析比較風(fēng)險(xiǎn)因素對(duì)研發(fā)項(xiàng)目的影響程度;通過(guò)專家咨詢法對(duì)風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)進(jìn)行風(fēng)險(xiǎn)后果嚴(yán)重程度及可控程度的調(diào)查,按照專家對(duì)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(shè)置權(quán)重,完成風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)嚴(yán)重性與可控性研究;最后,根據(jù)識(shí)別出的新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)的關(guān)鍵控制點(diǎn),結(jié)合風(fēng)險(xiǎn)Kano屬性分類及專家評(píng)分,提出新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)應(yīng)對(duì)措施。結(jié)果本研究將新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)劃分為技術(shù)風(fēng)險(xiǎn)、財(cái)務(wù)風(fēng)險(xiǎn)、管理風(fēng)險(xiǎn)、環(huán)境風(fēng)險(xiǎn)、生產(chǎn)風(fēng)險(xiǎn)和市場(chǎng)風(fēng)險(xiǎn)六大類,下設(shè)20項(xiàng)細(xì)分風(fēng)險(xiǎn),形成新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)因素集;基于Kano模型的問(wèn)卷調(diào)查共計(jì)收集98份有效問(wèn)卷,通過(guò)分析了解到,不同性別、職務(wù)級(jí)別的調(diào)查對(duì)象對(duì)20個(gè)風(fēng)險(xiǎn)因素影響度的認(rèn)知均不具有統(tǒng)計(jì)學(xué)差異,P0.05,而在年齡、教育程度、工作年限三種分類情況下,對(duì)部分風(fēng)險(xiǎn)因素影響度的認(rèn)知略有不同。利用Kano模型雙維度理念進(jìn)行藥品研發(fā)人員對(duì)于項(xiàng)目風(fēng)險(xiǎn)管理的認(rèn)知調(diào)查,將20項(xiàng)內(nèi)控評(píng)價(jià)指標(biāo)劃分為5類Kano風(fēng)險(xiǎn)屬性,其中必備屬性風(fēng)險(xiǎn)9項(xiàng),魅力屬性風(fēng)險(xiǎn)9項(xiàng),一維屬性風(fēng)險(xiǎn)和逆反屬性風(fēng)險(xiǎn)各1項(xiàng),根據(jù)"必備屬性魅力屬性一維屬性逆反屬性"的風(fēng)險(xiǎn)應(yīng)對(duì)優(yōu)先順序制定風(fēng)險(xiǎn)應(yīng)對(duì)措施;邀請(qǐng)8位專家從風(fēng)險(xiǎn)后果嚴(yán)重程度和可控程度評(píng)價(jià)風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)的嚴(yán)重性及可控性,按照五級(jí)量化評(píng)分將風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)可控性劃分為高可控性風(fēng)險(xiǎn)、中可控性風(fēng)險(xiǎn)、低可控性風(fēng)險(xiǎn)、極低可控性風(fēng)險(xiǎn)4個(gè)等級(jí),并在風(fēng)險(xiǎn)對(duì)策研究中予以應(yīng)用。結(jié)論本研究嘗試將Kano質(zhì)量模型引入風(fēng)險(xiǎn)管理研究領(lǐng)域,利用Kano模型屬性特點(diǎn)進(jìn)行新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)分類,結(jié)合專家評(píng)分確定的風(fēng)險(xiǎn)后果嚴(yán)重度及風(fēng)險(xiǎn)可控性等級(jí),實(shí)現(xiàn)了新藥研發(fā)項(xiàng)目風(fēng)險(xiǎn)內(nèi)控關(guān)鍵點(diǎn)管理對(duì)策研究。研究方法具有科學(xué)性、創(chuàng)新性和可行性,研究結(jié)果對(duì)于增強(qiáng)醫(yī)風(fēng)險(xiǎn)藥企業(yè)新藥研發(fā)能力和風(fēng)險(xiǎn)內(nèi)控能力、實(shí)現(xiàn)風(fēng)險(xiǎn)管理資源優(yōu)化配置、滿足消費(fèi)者藥品需求具有極強(qiáng)的現(xiàn)實(shí)意義和實(shí)用價(jià)值。在設(shè)計(jì)問(wèn)卷?xiàng)l目時(shí),應(yīng)按照風(fēng)險(xiǎn)因素篩選原則保證調(diào)查內(nèi)容的全面、精簡(jiǎn)和可操作;在選擇調(diào)查對(duì)象時(shí),基于本次研究的內(nèi)容和目的,邀請(qǐng)權(quán)威程度高的專家進(jìn)行嚴(yán)格打分,選擇專業(yè)性強(qiáng)的藥品研發(fā)專職人員開展Kano雙維度問(wèn)卷調(diào)查,以求提升研究結(jié)果的嚴(yán)謹(jǐn)性和專業(yè)性;此外,還需科學(xué)地選擇適用的統(tǒng)計(jì)學(xué)方法進(jìn)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(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R95
本文編號(hào)：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(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R95
【參考文獻(xiàn)】
相關(guān)期刊論文 前10條
1 孔祥芬;張凱奇;陳鵬;;基于Kano模型視角的民航服務(wù)質(zhì)量動(dòng)態(tài)預(yù)測(cè)研究[J];科技和產(chǎn)業(yè);2016年09期
2 許廣林;;論石油企業(yè)的風(fēng)險(xiǎn)管理[J];經(jīng)營(yíng)管理者;2016年20期
3 于奇;;中央企業(yè)全面風(fēng)險(xiǎn)管理評(píng)價(jià)指標(biāo)體系構(gòu)建研究[J];企業(yè)改革與管理;2016年06期
4 張洪秀;鄒西贏;;制藥行業(yè)實(shí)施風(fēng)險(xiǎn)管理的做法與實(shí)踐意義探尋[J];化工管理;2015年34期
5 包鈺婷;;基于KANO模型的杭州文化紀(jì)念品滿意度設(shè)計(jì)研究[J];中國(guó)包裝工業(yè);2015年21期
6 鄧亞昊;張濤;;國(guó)內(nèi)外對(duì)風(fēng)險(xiǎn)管理的綜述研究[J];經(jīng)貿(mào)實(shí)踐;2015年11期
7 馮蔚蔚;李宇晟;辛向陽(yáng);;基于Kano模型的家庭健身車改良設(shè)計(jì)研究[J];機(jī)械設(shè)計(jì);2015年08期
8 何月雯;周豐;;基于KJ法及KANO模型的產(chǎn)品功能設(shè)計(jì)方法研究[J];輕工機(jī)械;2015年03期
9 涂海麗;唐曉波;;微信功能需求的KANO模型分析[J];情報(bào)雜志;2015年05期
10 龔啟民;;企業(yè)風(fēng)險(xiǎn)管理和保險(xiǎn)籌劃實(shí)務(wù)[J];經(jīng)營(yíng)管理者;2015年08期
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