《安全审查简介BAYER-课件》由会员分享，可在线阅读，更多相关《安全审查简介BAYER-课件（17页珍藏版）》请在金锄头文库上搜索。
1、安全审查简介 Introduction of Safety Review 拜耳医药保健有限公司北京工厂 BHC Product Supply Beijing Site 2012年3月 March, 2012,Introduction of Safety Review Page 2 March, 2012,内容Content,拜耳集团工艺与工厂安全规范Bayer Group Process and Plant Safety Regulations 安全概念的建立 Development of Safety Concepts 安全审查的程序Procedures of Safety Review 降
2、低风险的基本原理Basic Principles to Reduce Risk,拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations,政策方针 Policy Bayer集团工艺及工厂安全 Process & Plant Safety in the Bayer Group 集团规定No. 2020 Group Regulation No. 2020 生效日期: 2010年4月1日 Effective: April 1, 2010,指令 Directive 工艺及工厂安全 Process and Plant Safety 集团
3、规定No. 13-1 Group Regulation No. 13-1 生效日期: 2004年10月1日 Effective: October 01, 2004,导则 Guideline 工艺及工厂安全纲要 Process and Plant Safety Compendium 集团规定No. 1928 Group Regulation No. 1928 生效日期：2007年7月1日 Effective: July 01, 2007,操作规程 Procedure 厂房、设备及公用系统的安全状态回顾 Safety Status Review for Facilities, Equipment
4、and Systems 标准操作规程 S 25-046 SOP S 25-046 生效日期：2010年3月29日 Effective: March 29, 2010,工艺及工厂安全指令和标准操作规程 Directive and SOP of Process and Plant Safety,Directive Process & Plant Safety,安全概念 Safety concept 工作流程 (含各级证书) Work flow (with certificates) 初步安全分析 (A1) Preliminary Safety Analysis (A1) 基础安全审查 (A2)Ba
5、sic Safety Review (A2) 详细安全审查 (A3)Detailed Safety Review (A3) 开车前安全审查 (A4)Pre Start-Up Safety Review (A4) 角色和职责 Roles and responsibilities,对于每个工艺和工厂，安全概念必须建立、存在。 For every process and plant a safety concept must be developed and in place,For Reference,A4-R,A3-R,生产 / 运行阶段 Production / Operation-Phase
6、,R =重新评估 R = Revalidation,A1, A2, A3,A4,安全概念的建立 Development of Safety Concepts,计划 Plan,实施 Do,行动 Act,检查 Check,安全审查的程序 Procedures of Safety Review,A1初步安全分析 A1 Preliminary Safety Analysis,A2 基本安全审查 A2 Basic Safety Review,A3 详细安全审查 A3 Detailed Safety Review,A4 运行前的安全审查 A4 Pre Start-Up Safety Review,重新评估
7、 Revalidation,随着项目的进展，对安全设计概念进行逐步的，细化的安全评估。 Stepwise review of safety concepts with increasing detailed investigation during the developing of project phases.,工作步骤：A1 初步安全分析 Work Stage: A1 Preliminary Safety Analysis,工作步骤： A2 基础安全审查 Work Stage: A2 Basic Safety Review,工作步骤： A3 详细安全审查 Work Stage: A3 D
8、etailed Safety Review,A3审查阶段 Review Stage A3,系统地辨识危害systematic identification of the hazards风险评估 risk assessment确定适当的安全措施definition of adequate preventive and mitigating safety measures,详细安全审查证书 Detailed Safety Review Certificate:在采购之前获得 Prior to the procurement of plant components,工作步骤：A4 运行前安全审查 W
9、ork Stage: A4 Pre Start-Up Safety Review,A4 审查阶段 Review Stage A 4,运行前安全审查证书 Pre Start-Up Safety Review Certificate: 在运行前获得 Prior to start up of the plant,检查在A3中提到的要求是否实现以及工厂是否按照之前讨论的结果来建设 checked whether all required defined measures which were specified in the detailed safety review (A3) have been
10、realized and the plant is build as discussed检查，检查及功能性测试plant inspections, checks and functional equipment testing,工作步骤：定期再评审 Work Stage: Periodic Review,开车 Start Up,生产 / 操作 Production / Operation,A4,变更 Modifications,R =重新评估的 R = Revalidation,MoC= 变更管理 MoC= Management of change,安全审查参与成员 Participants
11、of Safety Reviews,技术检查 Technical Inspection,同一人员也可能会同时担任多个角色 Several functions may be assumed by a same person,安全审查文件的重要性 Safety Review Documentation,安全审查的相关文件是工艺和工厂方面信息的最重要来源。它确保下列工作安全并且正确地执行： The safety review documentation is one of the most important sources of information for a specific process
12、 or plant. It makes it possible to safely and correctly perform tasks such as: 预防性维护Preventive maintenance故障应急维护Emergency maintenance and breakdowns过程变更Process changes 员工培训Employee training按照法律要求准备和更新安全报告Preparation and updating of safety reports in compliance with legal requirements.,降低风险的基本原理 Basi
13、c Principles to Reduce Risk,风险= 结果的严重程度 x 事件发生的可能性 Risk = Consequence Severity x Event Frequency,1. 消除危害或者将潜在的危害最小化Eliminate or minimize potential hazard2. 避免失误或者将潜在的失误降到最低Avoid or Minimize potential failures3. 把工艺或过程设计成失误-可接受Design processes and plants to be fault-tolerant4.减轻可能的事件的影响Mitigate the e
14、ffects of potential incidents,降低风险-工作流程 Reduce Risk-Work Flow,危险识别 Hazard identification,用风险矩阵鉴定风险级别 Identification of risk class with risk matrix,频率 Frequency,严重性Severity,安全措施工具箱 Measure tool box,风险评估 Risk assessment 后果的严重性 Severity of consequences 情景发生的频率 Frequency of scenario,风险降低 Risk reduction
15、详细的安全措施 Specification of safety measures,可能的风险 Scenarios,风险分析文件的结构 Hazard Analysis Document Structure,工艺描述 DESCRIBE THE PROCESS 物质的描述和特性 DESCRIBE AND CHARACTERIZE THE SUBSTANCES 通过下面方法进行风险评估 EVALUATE THE RISK VIA HAZOP / FMEA = 评估可能性 HAZOP / FMEA = ESTIMATE THE PROBABILITY (P) 结果分析= 评估严重程度 CONSEQUEN
16、CE ANALYSIS = ESTIMATE HOW BIG THE PROBLEM IS (E) RISK R = P x E 控制风险的措施 COUNTERMEASURES TO CONTROL THE RISK 确定剩余的风险 DEFINE THE RESIDUAL RISK 风险分析评估地点的分类CLASSIFY THE PLACE WHERE THE RISK IS EVALUATED 爆炸环境(燃烧/爆炸） ATEX (FLAME/EXPLOSION) 噪声 NOISE 生物的/致突变的/致癌的 BIOLOGICAL/MUTAGENIC/CANCEROGENIC 机械的 MECHANICAL 建立系统来控制危险 SET UP A SYSTEM TO CONTROL THE DANGER 检查 WALKTHROUGH 提高意识/培训 AWARENESS / TRAININGS,谢谢！ Thank you!,
