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1、风险分析和方法风险分析和方法风险分析和方法风险分析和方法 Risk Analysis and MethodologyDavid Yao 姚建军 GM of Lonza Guangzhou Engineering & Consulting Co., Ltd 广州龙沙工程咨询有限公司 总经理现代中药制药论坛首发slide 2内容内容内容内容 Table of contents?风险分析简介 Introduction of RA?风险分析基本原理 Fundamental of RA?风险分析常用方法 RA common methods?风险分布矩阵 RA profile matrix?风险分析方法/
2、HAZOP方法，FMEA方法和RAMS软件 RA method and software: HAZOP, FMEA and RAMES?风险分析实例 Case study 现代中药制药论坛首发slide 3风险分析简介风险分析简介风险分析简介风险分析简介 Risk Analysis Introduction?什么是风险分析什么是风险分析什么是风险分析什么是风险分析（RA）？）？）？）？ What is RA?风险的背景 / Risk definition：?化工医药行业项目建设中，常面临采用高新技术、巨额投资、庞大人员队伍 组织以及持续时间长等特点，给项目带来大量不确定因素，即为风险。 Che
3、mical and pharmaceutical projects are usually involved with high technology, large investments, massive manpower organization etc., which would bring a lot of uncertain factors to project construction and that is risk.?风险的范围 / Scope of risk：?包括工程设计、技术方案、操作流程、软硬件选型以及人员安全等。?Covers engineering design,
4、technical solution, operation procedure, software/hardware selection and safety etc.?风险分析的目的：Goal of RA?有效控制、减少或消除上述风险。 Effectively control, reduce or eliminate the risks.现代中药制药论坛首发slide 4风险分布矩阵风险分布矩阵风险分布矩阵风险分布矩阵 Risk Profile Matrix?风险分布矩阵即为将风险根据 Risk profile matrix studies risks on the basis of?发生的
5、概率 Occurrence probability?后果的严重性（包括人员因素、环境影响、财产损失、经营中断等方 面） Severity of the consequences( including personnel, environment, economic loss and business interruption) 采用矩阵表格的方式表达出来，作为对风险评级的量化标准，以决定是否 需采取和如何采取进一步措施以降低风险。 Risk profile matrix provides a way that can clearly specify risks of the system an
6、d their corresponding impacts within a matrix, therefore it can be treated as a qualitative standard for risk assessment, so as to judge whether it need to take measures to defeat risk.现代中药制药论坛首发slide 5风险分布矩阵风险分布矩阵风险分布矩阵风险分布矩阵 Risk Profile MatrixLonza Engineering RPM 龙沙工程的风险分布矩阵现代中药制药论坛首发slide 6风险分布
7、矩阵风险分布矩阵风险分布矩阵风险分布矩阵 Risk Profile Matrix龙沙工程风险分布矩阵 Lonza Engineering RPM?在 A I-III、B I-II、C I和D I 区域，降低风险的措施必须是工程措施。采取这些工程 措施后的风险重新评估等级应该在粗线以下。 In areas A I-III, B I-II, C I and D I, measures to reduce these risks to acceptable risks must be of an engineering nature. A re-evaluation of these risks w
8、ith the assigned engineering measures must reduce the risk level to below the bold line.?在 A IV、B III 和 C II 区域，降低风险的措施可以是管理措施。采取这些管理措施 以后的风险重新评估等级应在粗线以下。 In areas A IV, B III and C II measures to reduce these risks to acceptable risks may be administrative in nature. A re-evaluation of these risks
9、with the assigned administrative measures must reduce the risk level to below the bold line.?等级在粗线以下的风险是可以接受的，不需要采取措施。 Hazards with risk levels below the bold line require no measures as these risks are defined as acceptable.现代中药制药论坛首发slide 7风险分析简介风险分析简介风险分析简介风险分析简介 Risk Analysis Introduction?如何进行风险
10、分析如何进行风险分析如何进行风险分析如何进行风险分析？ How to perform a RA？?风险分析的内容 / The Core Content of Risk Analysis : 有效识别项目的各种风险，找出关键控制点，针对各控制点有的放矢的逐一进行分析并提 出解决方案，最终达到控制风险的目的。 Via effective identification of potential risks, find out the key control points and then propose solutions for each one of them so as to control
11、the risks?进行风险分析的人员 / Personnel involved in RA： 有效的风险分析需要由多专业人员共同参与完成，包括： An effective RA needs the following disciplines to participate together: 业主/用户 owner/user SHE工程师 SHE engineer 项目工程师 project engineer 运行工程师 operation engineer 验证人员 validation personnel QA代表 QA representatives 组织者必须具有丰富的风险分析经验，并
12、熟悉所采用的工具 RA organizer must be experienced, familiar and well trained using the chosen method.现代中药制药论坛首发slide 8风险分析简介风险分析简介风险分析简介风险分析简介 Risk Analysis Introduction?如何进行风险分析如何进行风险分析如何进行风险分析如何进行风险分析？ How to perform a RA？?风险分析方法 / RA methodology： 进行风险分析时有多种方法，各适用于不同的行业、工艺和环节，对风险的控制程度、 项目成本、质量等产生的影响也各有不同。
13、常见的方法有： When doing risk analysis, different methods are available for different industries, process and production. These methods each has its own advantages and disadvantages, and the affection on risk controlling, project schedule, cost and quality is different as well. Common methods are: 危害与可操作性
14、分析（HAZOP）Hazard and operability study (HAZOP) ?失效模式和影响分析法（FMEA）Failure modes and effects analysis (FMEA)?查核表法Checklist Analysis ?假如分析法 What-If Analysis ?失误树分析法Fault Tree Analysis (FTA) ?对风险分析来讲，选取合适的方法和工具合适的方法和工具合适的方法和工具合适的方法和工具以及风险分析组织策划人员的专业和经验要求专业和经验要求专业和经验要求专业和经验要求 至关重要！ The selection of proper
15、methods and right tools is very important when performing RA, further more, the professional experience of planning and organizing personnel is must required! 现代中药制药论坛首发slide 9风险分析基本原理风险分析基本原理风险分析基本原理风险分析基本原理 Fundamental of RA ?风险分析是一个基于科学、按照结构化方法进行的开放透明的过程，包括风险分析、风险管理和风险交流三个部分。 RA is a science-base
16、d, structured approach in accordance with an open and transparent process. All risk analysis can be referred to the following elements风险评估风险评估风险评估风险评估 Risk Assessment风险管理风险管理风险管理风险管理 Risk Management基于科学 Science-based基于政策 Regulation-based风险交流风险交流风险交流风险交流 Risk Communication 关于风险信息和意见的互动交流 Risk information and views on interactively co
