第二讲 失效模式和效果分析（ FMEA）在制药行业的应用 [ 学习要点 ] FMEA是一个经验性定量分析的工具，广泛应用于风险评估和质量持续改进过程， 这个工具是否可以良好的运用是否可以达到预期的目的，完全在于团队的知识面[ 是否足够理解工艺和产品本身] 和团队的合作情况。一、ICH Q9对于 FMEA的阐述FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.FMEA提供了工艺的潜在失败模式的评估方法，并据此评估这样的失效的后果以及起对产品性能的影响。一旦失效模式被建立起来，就可以用于估计、含盖、减少或是控制潜在的失效行为。 FMEA依靠的是对工艺和产品本身的理解。FMEA方法将复杂的工艺分割成小的可管理的步骤进行分析。本法是汇总失效项目、失效原由和可能的后果的重要模型。Potential Areas of Use(s) 潜在的应用领域FMEA can be used to prioritize risks and monitor the effectiveness of risk control activities.FMEA可以被用于风险级别的甄选以及对风险控制活动效果的监控。FMEA can be applied to equipment and facilities and might be used to analyze a manufacturing operation and its effect on product or process. It identifies elements/operations within the system that render it vulnerable. The output/ results of FMEA can be used as a basis for design or further analysis or to guide resource deployment.FMEA可以在设备和设施[ 例如水系统 ] 中应用， 也可以用于分析一个制造过程[ 例如灭菌操作 ] 及其对产品或工艺的影响。它可以确认系统中的那些脆弱环节和操作。FMEA...
