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1、安全審查簡介Introduction of Safety Review拜耳醫(yī)藥保健有限公司北京工廠BHC Product Supply Beijing Site2012年3月March, 2012,Introduction of Safety Review ? Page 2 ?March, 2012,內(nèi)容Content,拜耳集團(tuán)工藝與工廠安全規(guī)范 Bayer Group Process and Plant Safety

2、Regulations安全概念的建立 Development of Safety Concepts 安全審查的程序 Procedures of Safety Review降低風(fēng)險(xiǎn)的基本原理 Basic Principles to Reduce Risk,拜耳集團(tuán)工藝與工廠安全規(guī)范Bayer Group Process and Plant Safety Regulations,政策方針PolicyBa

3、yer集團(tuán)工藝及工廠安全Process & Plant Safety in the Bayer Group集團(tuán)規(guī)定No. 2020 Group Regulation No. 2020 生效日期: 2010年4月1日Effective: April 1, 2010,指令Directive工藝及工廠安全Process and Plant Safety集團(tuán)規(guī)定No. 13-1 Group Regulation No

4、. 13-1 生效日期: 2004年10月1日Effective: October 01, 2004,導(dǎo)則Guideline工藝及工廠安全綱要Process and Plant Safety Compendium集團(tuán)規(guī)定No. 1928 Group Regulation No. 1928 生效日期:2007年7月1日Effective: July 01, 2007,操作規(guī)程Procedure廠房、設(shè)備及公用系統(tǒng)的安

5、全狀態(tài)回顧Safety Status Review for Facilities, Equipment and Systems標(biāo)準(zhǔn)操作規(guī)程 S 25-046SOP S 25-046生效日期:2010年3月29日Effective: March 29, 2010,,工藝及工廠安全指令和標(biāo)準(zhǔn)操作規(guī)程Directive and SOP of Process and Plant Safety,,DirectiveProcess &

6、amp; Plant Safety,安全概念 Safety concept工作流程 (含各級(jí)證書)Work flow (with certificates) 初步安全分析 (A1) Preliminary Safety Analysis (A1) 基礎(chǔ)安全審查 (A2) Basic Safety Review (A2)詳細(xì)安全審查 (A3) Detailed Safety Review (A

7、3) 開車前安全審查 (A4) Pre Start-Up Safety Review (A4)角色和職責(zé) Roles and responsibilities,對(duì)于每個(gè)工藝和工廠,安全概念必須建立、存在。For every process and plant a safety concept must be developed and in place,,For Reference,A4-R,,A3-R,生產(chǎn) /

8、運(yùn)行階段Production / Operation-Phase,,R =重新評(píng)估R = Revalidation,A1, A2, A3,A4,安全概念的建立Development of Safety Concepts,,計(jì)劃Plan,實(shí)施Do,行動(dòng)Act,檢查Check,安全審查的程序Procedures of Safety Review,A1初步安全分析A1 Preliminary Safety Analysis,

9、A2 基本安全審查A2 Basic Safety Review,A3 詳細(xì)安全審查A3 Detailed Safety Review,A4 運(yùn)行前的安全審查A4 Pre Start-Up Safety Review,重新評(píng)估Revalidation,隨著項(xiàng)目的進(jìn)展,對(duì)安全設(shè)計(jì)概念進(jìn)行逐步的,細(xì)化的安全評(píng)估。Stepwise review of safety concepts with increasing detailed i

10、nvestigation during the developing of project phases.,工作步驟:A1 初步安全分析Work Stage: A1 Preliminary Safety Analysis,,,,,工作步驟: A2 基礎(chǔ)安全審查Work Stage: A2 Basic Safety Review,,,,,工作步驟: A3 詳細(xì)安全審查Work Stage: A3 Detailed Safety R

11、eview,,,,A3審查階段Review Stage A3,系統(tǒng)地辨識(shí)危害 systematic identification of the hazards 風(fēng)險(xiǎn)評(píng)估risk assessment 確定適當(dāng)?shù)陌踩胧?definition of adequate preventive and mitigating safety measures,詳細(xì)安全審查證書Detailed Safety R

12、eview Certificate:在采購之前獲得Prior to the procurement of plant components,,工作步驟:A4 運(yùn)行前安全審查Work Stage: A4 Pre Start-Up Safety Review,,A4 審查階段Review Stage A 4,運(yùn)行前安全審查證書Pre Start-Up Safety Review Certificate:在運(yùn)行前獲得Prio

13、r to start up of the plant,,,檢查在A3中提到的要求是否實(shí)現(xiàn)以及工廠是否按照之前討論的結(jié)果來建設(shè)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

14、 檢查,檢查及功能性測試 plant inspections, checks and functional equipment testing,,工作步驟:定期再評(píng)審Work Stage: Periodic Review,開車Start Up,生產(chǎn) / 操作 Production / Operation,A4,變更Modifications,,,,R =重新評(píng)估的R = Revalidation,MoC

15、= 變更管理MoC= Management of change,安全審查參與成員Participants of Safety Reviews,,技術(shù)檢查Technical Inspection,,同一人員也可能會(huì)同時(shí)擔(dān)任多個(gè)角色Several functions may be assumed by a same person,安全審查文件的重要性Safety Review Documentation,安全審查的相關(guān)文件是工藝和

16、工廠方面信息的最重要來源。它確保下列工作安全并且正確地執(zhí)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: 預(yù)防

17、性維護(hù) Preventive maintenance故障應(yīng)急維護(hù) Emergency maintenance and breakdowns過程變更 Process changes 員工培訓(xùn) Employee training按照法律要求準(zhǔn)備和更新安全報(bào)告 Preparation and updating of safety reports in

18、compliance with legal requirements.,降低風(fēng)險(xiǎn)的基本原理Basic Principles to Reduce Risk,風(fēng)險(xiǎn)= 結(jié)果的嚴(yán)重程度 x 事件發(fā)生的可能性Risk = Consequence Severity x Event Frequency,1. 消除危害或者將潛在的危害最小化 Eliminate or minimize potential hazard2. 避免失誤或者將

19、潛在的失誤降到最低 Avoid or Minimize potential failures3. 把工藝或過程設(shè)計(jì)成失誤-可接受 Design processes and plants to be fault-tolerant 4.減輕可能的事件的影響 Mitigate the effects of potential incidents,降低風(fēng)險(xiǎn)-工作流程Reduce Risk-Work Flow,,危險(xiǎn)識(shí)別

20、Hazard identification,用風(fēng)險(xiǎn)矩陣鑒定風(fēng)險(xiǎn)級(jí)別Identification of risk class with risk matrix,,,頻率 Frequency,嚴(yán)重性Severity,安全措施工具箱Measure tool box,風(fēng)險(xiǎn)評(píng)估Risk assessment后果的嚴(yán)重性Severity of consequences情景發(fā)生的頻率Frequency of scenario,風(fēng)險(xiǎn)降低

21、Risk reduction詳細(xì)的安全措施Specification of safety measures,可能的風(fēng)險(xiǎn)Scenarios,,,風(fēng)險(xiǎn)分析文件的結(jié)構(gòu)Hazard Analysis Document Structure,工藝描述 DESCRIBE THE PROCESS物質(zhì)的描述和特性 DESCRIBE AND CHARACTERIZE THE SUBSTANCES通過下面方法進(jìn)行風(fēng)險(xiǎn)評(píng)估 EVALUATE T

22、HE RISK VIAHAZOP / FMEA = 評(píng)估可能性 HAZOP / FMEA = ESTIMATE THE PROBABILITY (P)結(jié)果分析= 評(píng)估嚴(yán)重程度 CONSEQUENCE ANALYSIS = ESTIMATE HOW BIG THE PROBLEM IS (E)RISK R = P x E控制風(fēng)險(xiǎn)的措施 COUNTERMEASURES TO CONTROL THE RISK確定剩余的風(fēng)險(xiǎn)

23、DEFINE THE RESIDUAL RISK風(fēng)險(xiǎn)分析評(píng)估地點(diǎn)的分類CLASSIFY THE PLACE WHERE THE RISK IS EVALUATED爆炸環(huán)境(燃燒/爆炸) ATEX (FLAME/EXPLOSION)噪聲 NOISE生物的/致突變的/致癌的 BIOLOGICAL/MUTAGENIC/CANCEROGENIC機(jī)械的 MECHANICAL建立系統(tǒng)來控制危險(xiǎn) SET UP A SYSTEM TO C

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