制药项目质量风险管理方法工具和案例分析--姚建军

风险 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 和 方法 快递客服问题件处理详细方法山木方法pdf计算方法pdf华与华方法下载八字理论方法下载 风险分析和方法风险分析和方法风险分析和方法 Risk Analysis and Methodology David 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 www.chinapat.com 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/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 www.chinapat.com 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。 Chemical 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 气瓶 现场处置方案 .pdf气瓶 现场处置方案 .doc见习基地管理方案.doc关于群访事件的化解方案建筑工地扬尘治理专项方案下载 、操作流程、软硬件选型以及人员安全等。 � Covers engineering design, 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 www.chinapat.com 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 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 ，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 and 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 www.chinapat.com 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 Matrix L o n z a E n g in e e rin g R P M 龙 沙 工 程 的 风 险 分 布 矩 阵 现代中药制药论坛首发 www.chinapat.com slide 6 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 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 with 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 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 www.chinapat.com 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 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 www.chinapat.com 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。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 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 www.chinapat.com 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-based, 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 communication 现代中药制药论坛首发 www.chinapat.com slide 10 风险分析常用方法风险分析常用方法风险分析常用方法风险分析常用方法 Common Methods of RA � 危害与可操作性分析（HAZOP）/ Hazard and Operability Analysis (HAZOP) � 对系统进行节点划分 Technical Nodes Definition � 设置分析参数 Define analytic parameters for RA system � 设定偏离设计极限的引导语 Determine guiding words to indicate deviations � 找出导致偏差的原因、引发的影响 Find out the causes and impacts of each deviation � 制定改善措施或行动 Make improvement measures or actions � 达到人员安全的目的 Ensure safety of personnel and equipments � 特点 / Features HAZOP分析法是一个结构化、系统化检查的过程，其质量取决于参与风险分析人员的专业水 平，同时还需要相关多个专业参与讨论分析。 The essential of HAZOP analysis is a structured and systematic process. The quality of this analysis is only as good as the team and it is of high importance to assemble a multi- disciplinary group which is familiar with the process and methodology of a HAZOP study. 现代中药制药论坛首发 www.chinapat.com slide 11 风险分析常用方法风险分析常用方法风险分析常用方法风险分析常用方法 Common Methods of RA � 失效模式和影响分析方法（FMEA）/ Failure Mode, Effects Analysis (FMEA) � 以系统功能为评估基础 Assessment based on system function � 把生产操作模式化整为零 Sort out and classify the operation system into sub-systems � 分析最小零组件的潜在失效模式 Analyze each potential failure mode within a system � 根据风险出现概率和其严重程度对风险分类 Define risk classification by referring to the probability and severity of the risks � 采取预防改进措施 Adopt effectively preventive measures � 将风险降低到可接受标准 Alleviate the risks to an acceptable level � 特点 / Features 通过参考同类产品工艺开发和设计时积累的经验，一次有效的FMEA分析能识别潜在失效模式 ，花最小的功夫，使用最少资源把风险剔除出去。 A successful FMEA activity helps a team to identify potential failure modes based on past experience with similar products or processes, enabling the team to design those failures out of the system with the minimum of effort and resource expenditure, thereby reducing development time and costs. 现代中药制药论坛首发 www.chinapat.com slide 12 风险分析常用方法风险分析常用方法风险分析常用方法风险分析常用方法 Common Methods of RA � 查核表法 / Checklist Analysis � 以表核查方式列出系统内可能发生的所有危害 List out all possible hazards within a system in terms of the Checklist � 核查表中涵盖已有经验知识 Checklist should include the historical knowledge and experience � 可用于高层次详细分析、根本原因分析、设备问题、人员问题等 Can be utilized in high-level detailed analysis, root cause analysis, equipment issues, personnel issues, etc. � 通过访谈、文件审核、现场检验生产的一致性和非一致性定性分析 Generate qualitative lists of conformance and nonconformance with recommendations for corrective actions based on interviews, documentation reviews and site inspections. � 得到规避风险的意见 Get advises to avoid risks � 特点 / Features 查核表法通常由专业人员使用，同时也适用于一些没有危险分析专家的小公司使用。 Generally performed by an individual trained to understand the checklist questions, sometimes performed by a small group not necessarily risk analysis experts. 现代中药制药论坛首发 www.chinapat.com slide 13 风险分析常用方法风险分析常用方法风险分析常用方法风险分析常用方法 Common Methods of RA � 假如分析法 / What If Analysis � 一种结构化头脑风暴式讨论 A kind of structured brain-storming discussion � 分析哪些环节会出错 Filter out all links of the system exposed in risks � 分析发生问题的可能性有多大 Figure out the likelihood of the problems � 分析问题可能导致的后果 Analyze the underlying consequences of the issues � 判断系统对错误风险的承受能力 Judge the durability of the system against failure and risk � 设计出可消除风险的方法和措施 Invent reliable methods and measures to reduce risk � 特点 / Features 风险分析小组通常由一名队长带领，各成员根据自己经验参与分析，并由此逐步完成整个系统 的危险性分析。 Lead by an energetic and focused facilitator, each member of the review team participates in assessing what can go wrong based on their past experiences and knowledge of similar situations. 现代中药制药论坛首发 www.chinapat.com slide 14 风险分析常用方法风险分析常用方法风险分析常用方法风险分析常用方法 Common Methods of RA � 失误树分析法 / Fault Tree Analysis (FTA) � 是一种模拟和分析系统失效的过程 a process used to simulate and analyze the failure mode of a system � 由表示系统状态的逻辑图构成 composed of logic diagrams that display the state of the system � 通过可视化图形技术组建 constructed using graphical design techniques � 用以识别系统潜在事故，消除昂贵的变更设计 identify potential accidents, and can eliminate costly design changes � 特点 / Features FTA常用于安全工程以及其他绝大部分工程领域 FTA is used in safety engineering and in all major fields of engineering 现代中药制药论坛首发 www.chinapat.com slide 15 HAZOP分析方法分析方法分析方法分析方法 龙沙工程通常将HAZOP方法与RAMS软件结合使用： In Lonza Engineering, HAZOP is bound together with RAMS to: � 增加风险分析的效率 � increase efficiency of RA � 提高风险分析的准确性与有效性 � boost both accuracy and validity of RA 注 / Note： RAMS (Risk Analysis Management System) RAMS软件由龙沙集团自己开发，专用于风险分析 Developed by Lonza Group, a professional software which specializes in RA. 现代中药制药论坛首发 www.chinapat.com slide 16 HAZOP分析方法分析方法分析方法分析方法 � 龙沙工程的HAZOP分析实质是工艺分析的一种系统化架构，主要步骤如下： The essential of Lonza Engineering’s HAZOP analysis is a systematic framework of process analysis, the main steps are: � 节点划分 Technical Nodes Definition 将装置划分为多个分析单元 Divide system and facilities into different analysis units � 确定关键参数 Key parameters definition � 对每个单元，确定其正常工艺状态，即控制哪些参数在什么范围内为正常状态 Define normal working specification of each unit, like parameters in the right range � 偏差确认 Deviation definition � 确定可能出现的不正常工艺状态 Define abnormal working specification � 讨论分析 Discussion and Analysis � 应用头脑风暴对偏差进行分析 Analyze deviation with brainstorm 现代中药制药论坛首发 www.chinapat.com slide 17 HAZOP分析方法分析方法分析方法分析方法 � HAZOP分析核心内容：the core content of HAZOP 工艺单元工艺单元工艺单元工艺单元 或操作步骤或操作步骤或操作步骤或操作步骤 Process unit or operation steps 引导词引导词引导词引导词Guiding Words 参数参数参数参数 Parameters 原因原因原因原因 Causes 后果后果后果后果 Result 安全措施安全措施安全措施安全措施 Safety Method 空白减量 过量部分 伴随相逆 异常 Empty Less More Partial Accompany Reverse Abnormal 液位压力 温度流量 反应混合 Level Pressure Temp Flow Reaction Mixing 阀门失效 控制失效 机械碰撞 腐蚀侵蚀 操作失误 等 Valve Failure Ctrl Failure Mech Crash Corrosion Erosion Oprt Mistake etc. 爆炸 设备损害 影响运转 毒气释放 违反许可 损失严重 火灾等 Explosion Eqpt Failure Oprt Failure Gas Release Permit-Violation Prod loss Fire etc. 行动行动行动行动 Action 报警 程序 保护系统 检修 检测 训练 试验 设计 Alarm Program Protection Maintenance Fixing Training Testing Design etc. 训练 修改设计 围堵策略 应急响应 制定程序 冗余系统 新设备 重新选址 增加互锁 等 Training Design-Change Damming Response SOP Redundancy New Eqpt Relocation Inter Lock etc. 现代中药制药论坛首发 www.chinapat.com slide 18 RAMS软件软件软件软件 � RAMS软件即为风险分析管理系统，是由龙沙集团开发， 专用于风险分析的工具软件。 RAMS (Risk Analysis Management System), developed by Lonza, is a professional software tool which can significantly simplify HAZOP analysis � RAMS拥有一系列特别定制的标准表格和格式文件 A series of standard forms and documents have also been developed to make the application easier and to improve efficiency � 用户只需要根据提示填入必要的信息，即可通过RAMS输 出得到标准的风险分析报告。 RAMS requires the user to fill in relevant information in the standard forms only (like attached Form 13, process steps) and the standard RA reports will be generated automatically. � 对应不同行业不同项目，我们都可根据客户需求提供标准 模版文件。 RAMS can provide various standard reports to our clients in consideration of the field they work at and the project they are running. 现代中药制药论坛首发 www.chinapat.com slide 19 RAMS软件软件软件软件 现代中药制药论坛首发 www.chinapat.com slide 20 FMEA方法方法方法方法 � 失效模式和影响分析法FMEA通常被用来进行GMP相关的风险分析，其核心内容和具体流程如 下图所示： FEMA is often used for GMP-related risk analysis, the specific process is shown as below GMP风险分析的准备 •定义GMP风险分析的范围 •提供必须的文件 •指定参加人员 •在文件管理系统中登记GMP风 险分析 •在验证文件中 记录 混凝土 养护记录下载土方回填监理旁站记录免费下载集备记录下载集备记录下载集备记录下载 GMP风险分 析结果 进行GMP风险分析 •步骤描述 •相关对象 •失败的概率 •风险评估 •措施、职责、最后期限 •剩余风险的确定 GMP风险分析执行完成 •执行分析措施 •完成单独的措施 •验证文件中GMP风险分析的完 成 •验证文件中GMP风险分析文件 的归档 开始 结束 Prepare GMP RA •Define the scope of GMP RA •Provide documents required •Assign Participants •Register and document the GMP RA documents •Record GMP RA in qualification report Carry Out •Process description •Objects involved •Possible failure •Risk assessment •Measures, Responsibility and Deadline •Determine residual risk Implementate & Complete •Measures implementation •Individual measure completion •Completion of GMP RAS in qualification •Filing GMP RA in qualification dossier start end 现代中药制药论坛首发 www.chinapat.com slide 21 风险分析实例风险分析实例风险分析实例风险分析实例 Case study 请参照现场实例讲解 Please refer to speaker’s case study 现代中药制药论坛首发 www.chinapat.com slide 22 Q&A 现代中药制药论坛首发 www.chinapat.com