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 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 降低风险的基本原理 Basic Principles to Reduce Risk Introduction of Safety Review • Page 2 •March, 2012 拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations 政策方针 指令 Policy Directive Bayer集团工艺及工厂安全 工艺及工厂安全 Process & Plant Safety in the Bayer Group Process and Plant Safety 集团规定No. 2020 集团规定No. 13-1 Group Regulation No. 2020 Group Regulation No. 13-1 生效日期: 2010年4月1日 生效日期: 2004年10月1日 Effective: April 1, 2010 Effective: October 01, 2004 导则 Guideline 工艺及工厂安全纲要 操作规程 Procedure 厂房、设备及公用系统的安全状态回顾 Process and Plant Safety Compendium Safety Status Review for Facilities, Equipment and Systems 集团规定No. 1928 标准操作规程 S 25-046 Group Regulation No. 1928 SOP S 25-046 生效日期:2007年7月1日 生效日期:2010年3月29日 Effective: July 01, 2007 Effective: March 29, 2010 Introduction of Safety Review • page 3 • March, 2012 工艺及工厂安全指令和标准操作规程 Directive and SOP of Process and 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) Basic Safety Review (A2) • 详细安全审查 (A3) Directive Process & Plant Safety 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 Introduction of Safety Review • page 4 • March, 2012 安全概念的建立 Development of Safety Concepts 工程 / 运行前阶段 Engineering / Start-up-Phase 计划 实施 Plan Do A1, A2, A3 生产 / 运行阶段 Production / Operation-Phase 计划 行动 检查 Act Check Plan A3-R 实施 Do A4 R =重新评估 R = Revalidation Introduction of Safety Review • page 5 • March, 2012 行动 检查 Act Check A4-R 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 Revalidation Introduction of Safety Review • page 6 • March, 2012 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 A1审查阶段 Review Stage A1 ─ 安全数据的编辑和评估 compilation and evaluation of safety data ─ 检查,提出本质安全设计 的建议 examination, proposals for inherent safer design ─ 检查可选的安全概念 check of alternative safety concepts 初步安全分析证书: Preliminary Safety Analysis Certificate: 在项目投资预批准之前获得 For projects prior to Invest Pre-Approval Introduction of Safety Review • page 7 • March, 2012 工作步骤: A2 基础安全审查 Work Stage: A2 Basic Safety Review A2审查阶段 Review Stage A2 ─ 建立基本的安全概念 develop the basic safety concept ─ 使用检查表 using checklists 基础安全审查证书: Basic Safety Review Certificate: 在提交许可申请或者拨款 申请前获得 Prior to the submission of permit application or appropriation request Introduction of Safety Review • page 8 • March, 2012 工作步骤: A3 详细安全审查 Work Stage: A3 Detailed 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 Introduction of Safety Review • page 9 • March, 2012 工作步骤:A4 运行前安全审查 Work Stage: A4 Pre Start-Up Safety Review A4 审查阶段 Review Stage A 4 ─ 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 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 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 Introduction of Safety Review • page 10 • March, 2012 工作步骤:定期再评审 Work Stage: Periodic Review 生产 / 操作 Production / Operation 开车 Start Up 变更 Modifications 重大的 项目 Significant Project minor /simple A1 小的 / 简单的 变更管理 MoC A4 在最近一次A3评审的5年之内 within 5 years after last A3 A2 安全概念再评审 A3 Revalidation of Safety concept A4 当前的安全评审文件 A3-R A4-R Current Safety Review Document Introduction of Safety Review • page 11 • March, 2012 MoC= 变更管理 R =重新评估的 MoC= Management of change R = Revalidation 安全审查参与成员 Participants of Safety Reviews 团队核心 工厂/部门 工程人员 PLANT/UNIT 生产人员 维修人员 Plant Engineering Maintenance 过程控制工程 师 Production Process Control Engineering 法规事务 Regulatory Affairs Safety Review 消防 项目工程师 安全评审 Fire Prevention Process and Plant Safety 环境保护 Environmental Protection 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 Introduction of Safety Review • page 12 • March, 2012 Project Engineering 工艺安全工 程师 职业安全 Occupational Plant Safety Core-Team 技术检查 Technical Inspection 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 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. Introduction of Safety Review • page 13 • March, 2012 降低风险的基本原理 Basic Principles to Reduce Risk 1. 消除危害或者将潜在的危害最小化 Eliminate or minimize potential hazard 2. 避免失误或者将潜在的失误降到最低 Avoid or Minimize potential failures 3. 把工艺或过程设计成失误-可接受 Design processes and plants to be fault-tolerant 4.减轻可能的事件的影响 Mitigate the effects of potential incidents 风险= 结果的严重程度 x 事件发生的可能性 Risk = Consequence Severity x Event Frequency Introduction of Safety Review • page 14 • March, 2012 降低风险-工作流程 Reduce Risk-Work Flow 风险降低 风险评估 Risk reduction Risk assessment 详细的安全措施 后果的严重性 危险识别 Specification of safety measures Severity of consequences 情景发生的频率 Hazard identification Frequency of scenario 安全措施工具箱 Measure tool box 严重性表Severity Tables 可能的风险 频率表Frequency Tables Scenarios Equipment 用风险矩阵鉴定风险级别 Identification of risk class with risk matrix 压力高/低 Pressure high/low 温度高/低 Temperature high/low Introduction of Safety Review • page 15 • March, 2012 Severity 严重性 爆炸 ……. 可靠性 例子 Reliability Example Risk class A 设备 Explosion 风险 级别 D C B A F D C B F F F E D F E F B C VH (非常高) VH (very high) SIL3, PSV H (高) SIL2 H (high) 频率 Frequency D I (增强型) I (increased) BPCS E N (一般) N (normal) BPCS 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 CONSEQUENCE 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 Introduction of Safety Review • page 16 • March, 2012 谢谢! Thank you!