风险分析及方法简述

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 respective probabilities of occurrence, and their detectability, thereby becoming a Failure Mode Effect and Criticality Analysis (FMECA; see IEC 60812). In order for such an analysis to be performed, the product or process specifications should be established. FMECA can identify places where additional preventive actions might be appropriate to minimize risks.

FMEA可以延伸到结果严重程度的调查、发生的概率和可检测性，发展为FMECA。为执行这样的分析，

应建立产品或工艺的质量标准。FMECA可以鉴定何时采用预防措施可以将风险家最小化。

3.2 Potential Areas of Use(s) 使用的潜在区域

FMECA application in the pharmaceutical industry should mostly be utilized for failures and risks associated with manufacturing processes; however, it is not limited to this application. The output of an FMECA is a relative risk “score” for each failure mode, which is used to rank the modes on a relative risk basis.

制药企业的FMECA应最大的利用与生产工艺相联系的失效和风险，但是不局限于这一应用。FMECA 的结果是每一风险模式的相对的风险“中心”，用来分级相对风险根据。

4 Fault Tree Analysis (FTA) 失误树分析

4.1 Describe/描述

The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process. This tool evaluates system (or sub-system) failures one at a time but can combine multiple causes of failure by identifying causal chains. The results are represented pictorially in the form of a tree of fault modes. At each level in the tree, combinations of fault modes are described with logical operators (AND, OR, etc.). FTA relies on the experts’ process understanding to identify causal factors.

失误树分析是假定产品或工艺性能的失效的方法。这些工具评估系统失效，但是可以结合失效的多种原因。在树的每一个水平内，应描述失效模式的结合。FTA依赖于专家的工艺理解去鉴别起因。

4.2 Potential Areas of Use(s) 潜在区域的使用

FTA can be used to establish the pathway to the root cause of the failure. FTA can be used to investigate complaints or deviations in order to fully understand their root cause and to ensure that intended improvements will fully resolve the issue and not lead to other issues (i.e. solve one problem yet cause a different problem). Fault Tree Analysis is an effective tool for evaluating how multiple factors affect a given issue. The output of an FTA includes a visual representation of failure modes. It is useful both for risk assessment and in developing monitoring programs.

FTA可用于建立失效起因的途径。FTA可用于调查投诉或偏差，以便全面理解它们的起因，确保预定的改进能全面解决争议，并且不会导致其他的争议（例如：解决完一个问题但是引起了其他的问题）。失误树分析是评估多种因素怎样影响争议的有效的工具。失误树分析的结果包括失效模式的可见的代表。这对风险评估和发展监控系统是有用的。

5 Hazard Analysis and Critical Control Points (HACCP) 危害分析和关键控制点

5.1 Describe/描述

HACCP is a systematic, proactive, and preventive tool for assuring product quality, reliability, and safety (see WHO Technical Report Series No 908, 2003 Annex 7). It is a structured approach that applies technical and scientific principles to analyze, evaluate, prevent, and control the risk or adverse consequence(s) of hazard(s) due to the design, development, production, and use of products.

HACCP是确保产品质量、可靠性和安全（见WHO技术报告系列）系统的、积极的、预防性的工具。它是一综合性的方法，运用技术和科学的原则去分析、评估、预防和控制由药品的设计、研发、生产、风险和使用引起的风险或危害的后果。

HACCP consists of the following seven steps:

HACCP包括以下七个步骤：

(1) conduct a hazard analysis and identify preventive measures for each step of the process;

执行危害分析，确定过程每一步骤的预防性措施