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风险分析及方法简述(中英文)

(2010-03-27 18:20:49)
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  风险分析及方法简述(中英文)

  1Basic 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)

  2Failure Mode Effects Analysis (FMEA) 失效模式与效果分析

  2.1Describe/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

  2.2Potential 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。

  3Failure Mode, Effects and Criticality Analysis (FMECA) 失效模式、效果与关键程度的分析

  3.1Describe/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。

  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。

  4Fault Tree Analysis (FTA) 失误树分析

  4.1Describe/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。

  4.2Potential 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。

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

  5.1Describe/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

  (2) determine the critical control points;

  决定关键控制点

  (3) establish critical limits;

  设立关键限度

  (4) establish a system to monitor the critical control points;

  设定监测关键控制点的系统。

  (5) establish the corrective action to be taken when monitoring indicates that the critical control points are not in a state of control;

  设立关键控制不受控时的采取的整改措施

  (6) establish system to verify that the HACCP system is working effectively;

  设立证实HACCP有效工作的系统

  (7) establish a record-keeping system.

  设定记录保持的系统

  5.2Potential Areas of Use(s) 使用的潜在的区域

  HACCP might be used to identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination). HACCP is most useful when product and process understanding is sufficiently comprehensive to support identification of critical control points. The output of a HACCP analysis is risk management information that facilitates monitoring of critical points not only in the manufacturing process but also in other life cycle phases.

  HACCP可被用来证实和控制与物理、化学和生物危害(包括微生物的污染)有关的风险。

  当有全面的产品和工艺理解支持关键控制点的识别时,HACCP是最有用的工具。HACCP分析的结果是风险管理的信息,它便于生产工艺和其他生命周期阶段的关键控制点。

  6Hazard Operability Analysis (HAZOP) 危害与可操作性/运行分析

  6.1Describe/描述

  HAZOP (see IEC 61882) is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called “guide-words”. “Guide-words” (e.g., No, More, Other Than, Part of, etc.) are applied to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions. It often uses a team of people with expertise covering the design of the process or product and its application.

  HAZOP基于这样的理论——假定来自设计和操作的偏差引来了风险事件。这是系统的鉴定危害的头脑风暴技巧,就是所谓的“指导词”。 “指导词”(非、更多的、而不是,部分)被用于相关的参数(例如:污染、温度),帮助鉴定来自正常使用或设计用途的潜在偏差。通常是利用涵盖工艺或产品的设计和其利用的专家人员。

  6.2Potential Areas of Use(s) 使用的潜在区域

  HAZOP can be applied to manufacturing processes, including outsourced production and formulation as well as the upstream suppliers, equipment and facilities for drug substances and drug (medicinal) products. It has also been used primarily in the pharmaceutical industry for evaluating process safety hazards. As is the case with HACCP, the output of a HAZOP analysis is a list of critical operations for risk management. This facilitates regular monitoring of critical points in the manufacturing process.

  HAZOP可被用于生产工艺,包括外包生产和配制和上游的供应商、药物和药品的设备和设施。它也被制药企业用来评估工艺安全性危害。在HACCP的情况下,HAZOP分析的结果是风险管理的关键操作的清单。这些设施控制生产工艺的关键点的监控。

  7Preliminary Hazard Analysis (PHA) 预先性危害分析法

  7.1Describe/描述

  PHA is a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product or system. The tool consists of: 1) the identification of the possibilities that the risk event happens, 2) the qualitative evaluation of the extent of possible injury or damage to health that could result and 3) a relative ranking of the hazard using a combination of severity and likelihood of occurrence, and 4) the identification of possible remedial measures.

  PHA是基于先前经验或危害知识或失效,识别未来危害、危害的条件和可能引起危害的事件以及估计给定的活动、设施、产品或系统发生的可能性的分析工具。这一工具包括:

  1)风险事件发生的可能性的鉴别。

  2)可能导致的健康危害的事件数量的评估

  3)结合严重程度和发生的可能性的相对序列

  4)补救措施的识别

  7.2Potential Areas of Use(s) 使用的潜在区域

  PHA might be useful when analyzing existing systems or prioritizing hazards where circumstances prevent a more extensive technique from being used. It can be used for product, process and facility design as well as to evaluate the types of hazards for the general product type, then the product class, and finally the specific product. PHA is most commonly used early in the development of a project when there is little information on design details or operating procedures; thus, it will often be a precursor to further studies. Typically, hazards identified in the PHA are further assessed with other risk management tools such as those in this section.

  PHA有助于分析已存的系统或危害分级。可用于产品、工艺、设施设计以及危害类型的评估,然后是产品的分类,最后是特殊的商品。PHA通常用于项目研发的前期,在此期间只有极少的关于设计说明或操作规程的信息。在PHA中识别的危害和其他风险管理的工具更深入的联系。

  8Risk Ranking and Filtering 风险等级和过滤法

  8.1Describe/描述

  Risk ranking and filtering is a tool for comparing and ranking risks. Risk ranking of complex systems typically requires evaluation of multiple diverse quantitative and qualitative factors for each risk. The tool involves breaking down a basic risk question into as many components as needed to capture factors involved in the risk. These factors are combined into a single relative risk score that can then be used for ranking risks. “Filters,” in the form of weighting factors or cut-offs for risk scores, can be used to scale or fit the risk ranking to management or policy objectives.

  风险等级和过滤法是比较风险和风险分级的工具。复杂系统的风险等级需要每一风险的多种不同的定量和定性的因素。这一工具涉及分解基本的风险问题。这些因素和单一的用于风险分级的相对风险中心相结合。“过滤器”,以称量因素或风险中心的短缺,可被用于衡量风险序列或方针的目标。

  8.2Potential Areas of Use(s) 使用的潜在区域

  Risk ranking and filtering can be used to prioritize manufacturing sites for inspection/audit by regulators or industry. Risk ranking methods are particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool. Risk ranking is useful when management needs to evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework.

  风险等级和过滤法可被用于优先安排检查/审计的生产企业。风险等级方法尤其有助于使用单一的工具难以比较和潜在的后果存在多样性的情形。风险等级有助于在相同的组织结构中评估相同的定量评估和定性评估的风险。

  9Supporting Statistical Tools 辅助统计学工具

  Statistical tools can support and facilitate quality risk management. They can enable effective data assessment, aid in determining the significance of the data set(s), and facilitate more reliable decision making. A listing of some of the principal statistical tools commonly used in the pharmaceutical industry is provided:

  统计学工具支持和便于质量风险管理。它们有利于有效的数据评估、辅助决定数列的重要性、利于决策的可依靠性。制药企业所用的主要的统计学工具

  9.1Control Charts /控制图

  Acceptance Control Charts (see ISO 7966)/认可的控制表

  Control Charts with Arithmetic Average and Warning Limits (see ISO 7873)/算数平均和警戒线的控制表

  Cumulative Sum Charts (see ISO 7871)/累积和图

  Shewhart Control Charts (see ISO 8258)/Shewhart控制图

  Weighted Moving Average/加权移动平均法

  9.2Design of Experiments (DOE)/进行试验设计

  9.3Histograms/柱状图

  9.4Pareto Charts/排列图

  9.5Process Capability Analysis/工艺能力分析

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