医药行业属于高风险行业，医药企业项目大多周期长、投入大，需要进行高效的项 目管理，项目管理成功的关键之一是项目风险管理。但是，由于项目管理工作的复杂性， 许多医药企业开展项目风险管理缺乏系统性，导致项目风险管理工作量巨大却收效甚微。 FMEA（Failure Mode and Effects Analysis，失效模式与影响分析）是一种以 风险（即失效模式）为评估对象的预防性分析方法。预先充分考虑各个环节可能出现的 风险，通过风险后果分析与风险评估给出预防方案与解决措施，在验证预防方案与解决 措施的过程中不断改进方案，使方案不断趋于最优，最终得到符合期望或超出期望的预 防方案。实践证明，FMEA方法在风险评估与预防应对措施分析中可以发挥强大的作用。 本文基于FMEA方法开展X医药企业A产品项目的项目风险管理。首先，运用关键 因素法从35个主要因素中提取出21个关键成功因素，从中识别出32项可能存在的风 险，并分析风险发生的影响与形成原因；其次，借鉴FMEA方法构建符合X医药企业实 际情况与A产品项目特点的风险评估指标体系，对风险进行客观评估，并设置需要采取 措施的RPN阈值，从32项风险中筛选出RPN值大于100的19项风险；然后，通过企业 管理理论、专家组与企业内部综合剖析风险产生的原因与现行风险预设控制措施的不足， 制定具有针对性的预防应对措施，并在同一风险评估指标体系中进行再次评估，验证预 防应对措施的效果；最后，根据实施应对措施后的改进效果，为X医药企业A产品项目 实施过程中的风险管理工作提出建议。通过系统工作，实现对A产品项目的风险事前管 理，帮助X医药企业成功实施A产品项目。 关键词：医药企业；项目风险管理；FMEA；关键成功因素；风险评估 I Abstract The pharmaceutical industry is a high-risk industry, most of the projects in pharmaceutical enterprises have a long cycle and significant investment, so they need efficient project management, one of the keys to the success of project management is project risk management. However, due to the complexity of project management, many pharmaceutical enterprises lack systematic project risk management, resulting in a huge workload of project risk management and little effect. FMEA (Failure Mode and Effects Analysis) is a preventive analysis method that uses risk (ie, failure mode) as the evaluation object. Fully consider the risks that may occur in each level in advance, and provide preventive solutions through risk consequence analysis and risk assessment. During the verification of the preventive solutions, improve the program continuously, so that the program continues to be optimal, and finally meet or even exceed the desired expectations. The practice has proved that the FMEA method can play a significant role in risk assessment and analysis of preventive measures. This paper is based on the FMEA method to carry out project risk management of A Product Project in X Pharmaceutical enterprises. Firstly, use the KSF method to extract 21 critical success factors from the 35 primary factors, identify 32 possible risks from them, and analyze the impact and causes of the risks; Secondly, use the FMEA method to build a company that complies with X Medicine The actual situation and the characteristics of the risk assessment indicator system and the principles of risk-taking measures of the A product project, objectively assess the risks, and set the RPN thresholds that require measures, and select 19 risks with RPN values greater than 100 from 32 risks; Then, through the enterprise management theory, expert team and enterprise internal comprehensive analysis of the causes of risk and the shortcomings of current risk preset control measures, formulate targeted prevention and response measures, and re-evaluate in the same risk assessment index system to verify the effect of prevention and response measures；Finally, according to the improvement effect after the implementation of the response measures, suggestions are put forward for the risk management in the implementation process of A Product Project of X Pharmaceutical enterprise. Through the system work, realize the risk management of A Product Project in advance, and help X Pharmaceutical enterprises successfully implement A Product Project. Key words：Pharmaceutical enterprises; Project risk management; FMEA; KSF; Risk assessment II 目录 摘要 ............................................... I Abstract ............................................ II 第一章 绪论 .......................................... 1 1.1 研究背景 ..................................................... 1 1.2 研究目的 ..................................................... 2 1.3 研究意义 ..................................................... 2 1.3 研究方法和研究路线 ........................................... 3 1.3.1 研究方法 .................................................. 3 1.3.2 研究路线 .................................................. 4 第二章 相关理论及文献综述 ............................ 5 2.1 医药企业项目风险管理研究综述 ................................. 5 2.1.1 项目风险管理概述 .......................................... 5 2.1.2 医药企业项目风险管理研究现状 .............................. 6 2.2 FMEA研究综述 ................................................ 6 2.2.1 FMEA概述 ................................................. 6 2.2.2 医药企业FMEA方法应用研究现状 ............................. 7 2.3 关键成功因素法研究综述 ....................................... 8 2.3.1 关键成功因素法概述 ........................................ 8 2.3.2 关键成功因素法研究现状 .................................... 8 第三章 A产品项目管理风险识别 ........................ 9 3.1 X医药企业项目风险管理现状 ................................... 9 3.2 A产品项目风险管理FMEA方法的操作流程 ........................ 10 3.3 A产品项目各阶段关键成功因素识别 ............................. 11 3.3.1 A产品项目管理目标分解 ................................... 11 3.3.2 A产品项目各阶段关键成功因素识别 ......................... 12 3.4 A产品项目各阶段风险识别与风险原因分析 ....................... 15 3.4.1 项目筹备阶段风险识别与风险原因分析 ....................... 15 3.4.2 项目启动阶段风险识别与风险原因分析 ....................... 17 3.4.3 项目实施阶段风险识别与风险原因分析 ....................... 19 3.4.4 项目收尾阶段风险识别与风险原因分析 ....................... 22 3.4.5 项目运营阶段风险识别与风险原因分析 ....................... 24 第四章 A产品项目管理风险评估 ....................... 25 4.1 风险评估指标体系构建 ........................................ 25 4.1.1 风险严重度评估指标体系构建 ............................... 26 4.1.2 风险发生频度评估指标体系构建 ............................. 27 4.1.3 风险探测度评估指标体系构建 ............................... 28 4.1.4 RPN值的计算与采取措施的原则 ............................. 28 4.2 风险评估过程 ................................................ 29 4.2.1 各阶段风险危害度评估 ..................................... 29 4.2.2 各阶段风险发生频度评估 ................................... 32 4.2.3 各阶段风险探测度评估 ..................................... 35 4.2.4 计算各阶段风险RPN值 ..................................... 41 第五章 A产品项目管理风险预防应对措施 ............... 48 5.1 项目筹备阶段风险预防应对措施 ................................ 48 5.1.1 风险F1预防应对措施 ....................................... 49 5.1.2 风险F2预防应对措施 ....................................... 49 5.1.3 风险F3、F4和F5预防应对措施 ............................... 50 5.1.4 项目筹备阶段风险预防应对措施汇总 ......................... 50 5.2 项目启动阶段风险预防应对措施 ................................ 51 5.2.1 风险F9预防应对措施 ....................................... 52 5.2.2 风险F10预防应对措施 ...................................... 52 5.2.3 风险F11和F12预防应对措施 ................................. 52 5.2.4 项目启动阶段风险预防应对措施汇总 ......................... 53 5.3 项目实施阶段风险预防应对措施 ................................ 54 5.3.1 风险F17预防应对措施 ...................................... 54 5.3.2 风险F18预防应对措施 ...................................... 54 5.3.3 风险F20预防应对措施 ...................................... 55 5.3.4 风险F21和F22预防应对措施 ................................. 55 5.3.5 风险F23预防应对措施 ...................................... 56 5.3.6 项目实施阶段风险预防应对措施汇总 .