201001風险分析及方法简述.docVIP

风险分析及方法简述（中英文） 1 Basic Risk Management Facilitation Methods 基本的风险管理的便利方法 Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitating decision-making are: 下面是一些简单的通常使用的方法，进行风险管理和制定决策： ? Flowcharts/流程图 ? Check Sheets/检查清单 ? Process Mapping/过程图 ? Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)/因果图（或者叫鱼骨图） 2 Failure Mode Effects Analysis (FMEA) 失效模式与效果分析 2.1 Describe/描述 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提供了工艺潜在失效模式的评估和对产品性能或结果的潜在影响。一旦将建立了失效模式，风险的降低可被用来消除、囊括、降低或控制潜在的失效活动。FMEA依赖于对产品和工艺的理解。FMEA将复杂的工艺系统地分解为简单的步骤。FMEA对重要的失效模式、引起失效的因素以及失效可能带来的后果进行汇总的有力工具。 2.2 Potential Areas of Use(s) 使用的潜在区域 FMEA can be used to prioritize risks and monitor the effectiveness of risk control activities. FMEA可用来安排风险的优先顺序，监控风险控制活动的有效性。 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可用于设备和设施，也可用于分析某一生产操作及其对产品或工艺的影响。它可识别系统内的元素/操作的弱点。FMEA的结果可被作为设计或深入分析或指导资源配置的依据。 3 Failure Mode, Effects and Criticality Analysis (FMECA) 失效模式、效果与关键程度的分析 3.1 Describe/描述 FMEA might be extended to incorporate an investigation of the degree of severity of the consequences, their respec