安全審查簡介BAYER.ppt

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 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)

2、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 Policy Bayer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

3、No. 13-1 Group Regulation No. 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)的安全狀態(tài)回顧 Safety Status Review for Facilities, Equipment an

4、d Systems標(biāo)準(zhǔn)操作規(guī)程 S 25-046 SOP 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,Directive Process & Plant Safety,安全概念 Safety concept 工作流程 (含各級證書) Work flow (with certificates) 初步安全分析 (A1) Preliminary Safety Analysis (A1) 基礎(chǔ)安全審查 (A2) Basi

5、c Safety Review (A2) 詳細(xì)安全審查 (A3) Detailed Safety Review (A3) 開車前安全審查 (A4) Pre Start-Up Safety Review (A4) 角色和職責(zé) Roles and responsibilities,對于每個(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) / 運(yùn)行階段 Production / Operation-Phase

6、,R =重新評估 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,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,重新評估

7、Revalidation,隨著項(xiàng)目的進(jìn)展，對安全設(shè)計(jì)概念進(jìn)行逐步的，細(xì)化的安全評估。 Stepwise review of safety concepts with increasing detailed investigation 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 Detai

8、led Safety Review,A3審查階段 Review Stage A3,系統(tǒng)地辨識危害 systematic identification of the hazards 風(fēng)險(xiǎn)評估 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 Review 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W

9、ork 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 Prior 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

10、realized and the plant is build as discussed 檢查，檢查及功能性測試 plant inspections, checks and functional equipment testing,工作步驟：定期再評審Work Stage: Periodic Review,開車 Start Up,生產(chǎn) / 操作 Production / Operation,A4,變更 Modifications,R =重新評估的 R = Revalidation,MoC= 變更管理 MoC= Management of change,安全審查參與成員Participants

11、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

12、or plant. It makes it possible to safely and correctly perform tasks such as: 預(yù)防性維護(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 compliance with legal requirements.,降低風(fēng)險(xiǎn)的基本

13、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 hazard 2. 避免失誤或者將潛在的失誤降到最低 Avoid or Minimize potential failures 3. 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

14、Mitigate the effects of potential incidents,降低風(fēng)險(xiǎn)-工作流程Reduce Risk-Work Flow,危險(xiǎn)識別 Hazard identification,用風(fēng)險(xiǎn)矩陣鑒定風(fēng)險(xiǎn)級別 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 Ri

15、sk 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)評估 EVALUATE THE RISK VIA HAZOP / FMEA = 評估可能性 HAZOP / FMEA = ESTIMATE THE PROBABILITY (P) 結(jié)果分析= 評估嚴(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) DEFINE THE RESIDUAL RISK 風(fēng)險(xiǎn)分析評估地點(diǎn)的分類CLASSIFY THE PL