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 Site2012 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

降低风险的基本原理 Basic Principles to Reduce Risk

Introduction of Safety Review • page 3 • 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 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

Introduction of Safety Review • page 4 • 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

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) Basic 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 R

efer

ence

Introduction of Safety Review • page 5 • March, 2012

A4-R

A3-R

生 产 / 运 行 阶 段

Production / Operation-Phase

R = 重新评估R = Revalidation

A1, A2, A3

A4

安全概念的建立Development of Safety Concepts

实施Do

行动Act

计划Plan

检查Check

工 程 / 运 行 前 阶 段

Engineering / Start-up-Phase

计划Plan 实施

Do

行动Act

检查Check

Introduction of Safety Review • page 6 • March, 2012

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

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.

Introduction of Safety Review • page 7 • March, 2012

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 8 • 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 9 • 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 10 • 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

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 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

Introduction of Safety Review • page 11 • March, 2012

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 在 最 近 一 次 A3 评 审 的 5 年 之 内

within 5 years after last A3

安全概念再评审Revalidation of Safety

concept

当 前 的 安 全 评 审 文 件Current Safety Review Document

A4-RA3-R

R = 重新评估的R = Revalidation

MoC= 变更管理MoC= Management of change

变更管理MoC

minor /simple

小的 / 简单的

项 目

Project

A3

A4

A2

重大的Significant

A1

Introduction of Safety Review • page 12 • March, 2012

安全审查参与成员Participants of Safety Reviews

技术检查Technical Inspection

Safety Review

安全评审消防

Fire Prevention

职业安全Occupational Plant Safety

生产人员Production

工艺安全工程师

Process and Plant Safety环境保护

Environmental Protection

项目工程师Project

Engineering

过程控制工程师

Process Control Engineering

维修人员Maintenance

工厂 / 部门PLANT/UNIT

团队核心Core-Team

法规事务Regulatory

Affairs

工程人员Plant

Engineering

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 13 • March, 2012

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 14 • March, 2012

降低风险的基本原理Basic 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 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

Introduction of Safety Review • page 15 • March, 2012

降低风险 - 工作流程Reduce Risk-Work Flow

风险级别

Risk

class

可靠性

Reliability

例子

Example

A

B VH (非常高 )VH (very high)

SIL3,

PSV

C H ( 高 )H (high)

SIL2

D I (增强型 )I (increased)

BPCS

E N ( 一般 )N (normal)

BPCS

危险识别Hazard identification

用风险矩阵鉴定风险级别Identification of risk class with risk matrix

严重性表 Severity Tables

频率表 Frequency Tables

频率 Frequency

严重

性S

ever

ity

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

详细的安全措施Specification of safety measures

可能的风险Scenarios

F

F D C B

F F E D

D C B A

F F E

设备Equipment

压力高 / 低Pressure high/low

温度高 / 低Temperature high/low

爆炸Explosion

…….

Introduction of Safety Review • page 16 • March, 2012

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

谢谢！ Thank you!