變更管理程序

1、_Procedure for Management of Change變更管理程序Rev.Published byReviewed byApproved byAmendatory RemarksDateThe latest changes were marked in light blue in the contents.Signed copy archived by document controller精品資料_目錄Table of Contents1.目的Objective32. 范圍Scope33.定義Definitions34.責(zé)任Responsibility45.程序Procedu

2、re55.1變更申請(qǐng)Request for change55.2可行性和風(fēng)險(xiǎn)評(píng)估Operability & risk assessment55.3變更批準(zhǔn)Approval of change65.4運(yùn)行投用前審核Pre-startup review65.5批準(zhǔn)運(yùn)行Approval of startup75.6告知 /溝通Notification/Communication75.7信息更新 &文件保存Information update & documentation75.8特殊變更Special MOCs75.9培訓(xùn)和審核Training & audit96.

3、附件Attachment9附件 1：基于風(fēng)險(xiǎn)的變更分級(jí)與授權(quán)矩陣Attachment 1: Risk based change classification andauthorization matrix10附件 2：變更申請(qǐng)表Attachment 2: <Request for Change Form>11附件 3 ： 變更管理流程圖Attachment 3: MOC Flowchart12精品資料_1. 目的建立本程序的目的是管理和控制可能影響到安全、健康和環(huán)境的有關(guān)設(shè)備、設(shè)施、程序以及組織機(jī)構(gòu)的變更，并將變更帶來的風(fēng)險(xiǎn)最小化。2. 范圍本程序適用于贏創(chuàng)三征（營(yíng)口）精細(xì)化工有限

4、公司。3. 定義變更： 指任何在工藝或設(shè)施上發(fā)生的與已有規(guī)范或?qū)嶋H的偏離，包括增加，減少，修改和替換（同類替換除外）。變更的對(duì)象可以是工藝技術(shù)、控制系統(tǒng)、設(shè)備設(shè)施、人員組織以及程序規(guī)定。同類替換 ：指不超出既定設(shè)計(jì)規(guī)格 /控制范圍的有關(guān)設(shè)備或程序的變化。包括以相同或等同的設(shè)備及零件進(jìn)行替換，以及在系統(tǒng)試運(yùn)轉(zhuǎn)或測(cè)試時(shí)進(jìn)行的在操作規(guī)程規(guī)定范圍內(nèi)的修改等。同類替換不在變更管理程序的控制范圍內(nèi)。變更分類（基于風(fēng)險(xiǎn)的分類）： 按照變更所對(duì)應(yīng)的風(fēng)險(xiǎn)等級(jí)的高低，可將變更分為較小變更、中等變更和重大變更。具體的劃分標(biāo)準(zhǔn)參見附件1。臨時(shí)變更： 指預(yù)先設(shè)定的只將短期（ 6 個(gè)月內(nèi)）存在的變更。緊急變更： 當(dāng)執(zhí)行常

5、規(guī)變更管理程序可能導(dǎo)致不可接受的安全風(fēng)險(xiǎn)，環(huán)境或安保事故或嚴(yán)重經(jīng)濟(jì)損失的變1. ObjectiveThis procedure is established for managing and controlling changes made to equipment, facilities, procedures and organizational structure is essential to the safety, health and environment at facilities to minimize risks associated with those changes.

6、2. ScopeThis Procedure is applicable to the EvonikSanzheng(Yingkou) Fine Chemical Co.,Ltd3 DefinitionChangeis considered a deviation from thespecifications or practices as specified for theprocess or facility which may include addition,deletion, alteration, or replacement (except forreplacement-in-k

7、ind). The changing objects mayinclude process/technology, controlling system,equipment/facility, personnel/organization andprocedure.Replacement-in-kind(RIK)istheequipmentandproceduralalterationthatdonotvaryfromthedocumenteddesignspecificationswhichincludeidentical equipment and spare parts replacem

8、ent, andmodificationforcompletingtrialsortestsofequipmentwithinthedefinedoperating procedures.RIK is not subject to MOC procedures.ClassificationofChange(Riskbasis):Basedonthedifferentlevelsofrisk,thechangescanbedividedinto the Minor Change, Moderate Change and MajorChange.Referthecriteriaofclassifi

9、cationtoAttachment1.TemporaryChange isachange thatisintendedtoexist for a short, predetermined, finite period (within 6months).Emergency Changeis a change needed in a situationwhere the time required for following the normal MOC精品資料_更。變更管理協(xié)調(diào)人 :負(fù)責(zé)所在區(qū)域內(nèi)變更管理相關(guān)事宜執(zhí)行的協(xié)調(diào)人員，他將負(fù)責(zé)確保實(shí)際變更管理執(zhí)行與程序的符合性和完整性。變更申請(qǐng)人：

10、最初提出變更需求的人，他將提出書面的申請(qǐng)并提供相關(guān)信息和資料。變更審核人： 對(duì)申請(qǐng)的變更進(jìn)行可行性和風(fēng)險(xiǎn)評(píng)估的人員（或小組），并且在必要的情況下提供變更實(shí)施所需要的整改措施。變更批準(zhǔn)人：指批準(zhǔn)變更實(shí)施以及系統(tǒng)運(yùn)行的人，將由對(duì)應(yīng)不同風(fēng)險(xiǎn)等級(jí)的變更分類（依據(jù)附件1 劃分）決定批準(zhǔn)人的角色，如：較小變更區(qū)域主管中等變更工廠/部門經(jīng)理重大變更生產(chǎn)/部門主任變更批準(zhǔn)人與變更審核人通常情況下由不同的人員擔(dān)任。4. 責(zé)任變更管理協(xié)調(diào)人負(fù)責(zé)組織協(xié)調(diào)變更管理流程的執(zhí)行確保落實(shí)相關(guān)變更管理程序要求保存并維護(hù)負(fù)責(zé)區(qū)域內(nèi)所有變更管理的相關(guān)文件和記錄procedurecouldresultinanunacceptabl

11、esafetyhazard, a significant environmental or security incident, or an extreme economic loss.Management of Change (MOC) Coordinator is a person to coordinate activities associated with the MOC within the responsible area and ensure compliance and integrity with the MOC procedure through its implemen

12、tation.Change Originatoris a person who raises the idea fora change initially and submits the written request forchangeandprovidesrelatedinformation&documentation.Change Reviewer is a person (or a team) who reviews the proposed change by evaluating the operability and risk and also provides rele

13、vant amendment required for change Implementation if necessary.Change Authorizer is a person who gives the approval of implementing the change and startup, fulfilled with the role that depends on different level of changes (according to attachment 1), for example, Minor Change Area Supervisor Modera

14、te Change Plant/Dept. Manager Major Change Production/Dept. DirectorNormally Authorizer and Reviewer are taken by different people.4. Responsibility MOC Coordinator Responsible for coordinating the MOC process related fairs within the plant. Ensure the requirements of MOC procedure have been fulfill

15、ed. Keep and maintain all documentation and record associated with MOC in his/her responsible area.變更申請(qǐng)人Change Originator提出變更的書面申請(qǐng)，明確變更的初始信息，如Raise the written request for change and clearly精品資料_變更范圍、對(duì)象和類型等，并且提供變更相關(guān)的definetheinitialinformation e.g.scope,object支持文件和資料and classificationofthechangeetc.

16、and also判斷變更的分類providesupportingdocumentsanddata確保變更執(zhí)行后，及時(shí)更新關(guān)聯(lián)的信息和文檔associated with the change.確保將已更新的相關(guān)信息及時(shí)傳達(dá)給所有涉及的Classify the change.部門和人員 Ensure timely update change related informationand documents after change implementation.Ensuretheupdatedinformationistimelycommunicatedtoalldepartmentandpers

17、onnelinvolved.變更審核人Change Reviewer確保變更的可行性和風(fēng)險(xiǎn)已得到適當(dāng)評(píng)估，并且Ensurethatoperability and riskof thechange已制定了相關(guān)應(yīng)對(duì)和控制措施havebeenproperlyevaluatedand relevant跟蹤并確認(rèn)所有既定措施已落實(shí)到位control measures have been established. Follow up and verify all written control measureshave been carried out.變更批準(zhǔn)人Change Authorizer基于評(píng)估

18、的結(jié)果，最終決定是否批準(zhǔn)變更的實(shí)施 Decide to final approve the implementation of the批準(zhǔn)已變更系統(tǒng)的投入運(yùn)行change based on the outcome of assessment. Approve the changed system to be running.區(qū)域負(fù)責(zé)人Area Responsible確保在所轄范圍內(nèi)遵照變更管理程序執(zhí)行Ensurecompliance withMOC procedurewithin確保參與變更管理的人員經(jīng)過適當(dāng)?shù)呐嘤?xùn)the responsible area. Ensure proper trai

19、ned and qualified people fulfillthe roles in MOC.EHSQ 部門EHSQ Department負(fù)責(zé)參與變更相關(guān)ESH 風(fēng)險(xiǎn)評(píng)估和審核 Participate in MOC related ESH risk assessment負(fù)責(zé)維護(hù)、更新及發(fā)布變更管理程序and review.提供變更管理程序的相關(guān)培訓(xùn)Maintain,updateandreleasetheMOC組織對(duì)變更管理程序執(zhí)行情況的審計(jì)procedure. Provide MOC procedure related training. Arrange the audit for imp

20、lementation of MOC.5. 程序5. Procedure5.1 變更申請(qǐng)5.1 Request for Change變更申請(qǐng)人首先應(yīng)判斷是否屬于變更管理程序的The changeoriginatorshall firstmake the精品資料_控制范疇，如果屬于同類替換的，則無需按照變judgmentof whethertheapplied procedure更管理程序執(zhí)行。belong to the scope of MOC, if it is a RIK, MOCprocedure will not be followed. 變更申請(qǐng)人應(yīng)清楚寫明變更初始內(nèi)容，至少包括 T

21、hechange originatorshallclearly definethe變更理由、預(yù)期結(jié)果、相關(guān)技術(shù)設(shè)計(jì)以及工作范initialinformationof thechange,whichshall at圍，并且還應(yīng)提供相關(guān)文件、資料和圖表等輔助leastinclude reason ofchange,desiredresults,信息。technicaldesignandworkscope,andallsupportingdocuments,dataand diagramshallbe provided as well.變更申請(qǐng)人應(yīng)識(shí)別變更的類型，附件1 中的基于風(fēng)險(xiǎn)的變更分類指南將

22、作為依據(jù)。當(dāng)對(duì)變更分類存在疑問時(shí)，可就具體情況咨詢風(fēng)險(xiǎn)評(píng)估組/審核人確定。變更申請(qǐng)人將填寫變更申請(qǐng)表（參見附件2 ），將填好的表格遞交給相關(guān)變更管理協(xié)調(diào)人。5.2 可行性和風(fēng)險(xiǎn)評(píng)估變更協(xié)調(diào)人將基于變更的對(duì)象和規(guī)模，組建一個(gè)合適的變更可行性和風(fēng)險(xiǎn)評(píng)估小組。變更小組的成員可能包括：項(xiàng)目負(fù)責(zé)人工藝工程師設(shè)備工程師維修工程師化學(xué)工程師操作人員ESH 專家供應(yīng)商和外部專家等變更小組將根據(jù)變更申請(qǐng)表中提供的初始信息和支持文件，采取適當(dāng)?shù)墓ぞ?/方法實(shí)施 ESH 風(fēng)險(xiǎn)評(píng) 估 ， 可 以 包 括 ： 檢 查 表 、 HAZOP 、 What-if 等，評(píng)估的結(jié)果將被記錄下來并與變更申請(qǐng)表關(guān)聯(lián)。The chan

23、ge originator shall identify the classification of the change with taking the <RiskBasedChangeClassificationGuideline>inAttachment 1, and the risk assessment team/change reviewer could be consulted for identification if in doubt. The change originator will submit the <Request for Change For

24、m> (see attachment 2) to the area MOC coordinator.5.2 Operability & Risk Assessment The MOC coordinator shall establish a proper MOC team based on the object and size of the change. The MOC team may include:Project responsible Plant operator Process engineer Equipment engineer Maintenance eng

25、ineer ChemistESH specialistSupplier and external expert etc. The MOC team shall select an appropriate tool/method to conduct the ESH risk assessment based on the initial information and supporting documents obtained from the request for change form, which may include: check list, HAZOP, What-if etc.

26、 And the results of the evaluation willbe recorded and attached to the request form.變更審核人將對(duì)評(píng)估結(jié)果作總的簽字確認(rèn)。Thechangereviewershallsignto confirmthe精品資料_5.3 變更批準(zhǔn)變更批準(zhǔn)人將根據(jù)審核人對(duì)變更相關(guān)可行性和風(fēng)險(xiǎn)評(píng)估的結(jié)果，決定是否批準(zhǔn)變更的實(shí)施，并在變更申請(qǐng)表中簽字確認(rèn)；如不批準(zhǔn)變更，則需要在表格中記錄原因。assessment results.5.3 Approval of Change The change authorizer shall dec

27、ide whetherapprovethe changeinto implementationor notaccording to the operability and risk assessmentbythereviewersandsignontheformof<Requestforchangeform>ifnotapproved,relevant reasons shall be recorded on the form.在變更系統(tǒng)投入運(yùn)行前，變更批準(zhǔn)人將基于現(xiàn)場(chǎng)條件以及控制措施落實(shí)情況，決定是否批準(zhǔn)變更系統(tǒng)投入運(yùn)行，并在變更申請(qǐng)表中簽字確認(rèn)；如不批準(zhǔn)變更，則需要在表格中記錄

28、原因。5.4 運(yùn)行 /投用前審核在變更系統(tǒng)投入運(yùn)行前，變更協(xié)調(diào)人將組織相關(guān)人員對(duì)系統(tǒng)進(jìn)行 ESH 審核，以確保：變更已經(jīng)按照描述安裝沒有其他的額外變更標(biāo)準(zhǔn)操作規(guī)程已被更新 /歸檔 /溝通傳達(dá)已完成對(duì)運(yùn)行和維護(hù)人員的相關(guān)培訓(xùn)已將在風(fēng)險(xiǎn)評(píng)估中識(shí)別出的所有安全控制措施落實(shí)到位已完成開車計(jì)劃方案已建立應(yīng)急響應(yīng)預(yù)案并明確了聯(lián)系人名單已維護(hù)存在問題 /解決方法的記錄并與審查表關(guān)聯(lián)變更審核人將對(duì)關(guān)鍵項(xiàng)的完成進(jìn)行簽字確認(rèn)。對(duì)于新建項(xiàng)目或較為復(fù)雜或高風(fēng)險(xiǎn)的系統(tǒng)，在實(shí)施變更后試運(yùn)行開始之前還應(yīng)組織進(jìn)行開車前安全審查（ PSSR ），具體內(nèi)容參見開車前安全審 The change authorizer shall

29、decide whetherapprovethe changeinto implementationor notaccording to the operability and risk assessmentbythereviewersandsignontheformof<Requestforchangeform>ifnotapproved,relevant reasons shall be recorded on the form.5.4 Pre-startup review Prior to startup of the changed system, an ESHreview

30、 shall be carried out by the change coordinator to ensure:Modification is installed as described.No other changes were made.SOPs have been updated / documented / communicated.Operation and maintenance training for staff have been completed.All safety control measures identified in therisk assessment

31、 of the change have been carried out.Startup plan has been completed.Emergency response plan has been established with contact list included.Notes of issues/solutions have been maintained and attached to the review form. The Change Reviewer shall sign on the completion of key items to ensure they ha

32、ve been finished. For the new project or complex or high risksystem,implementationof changeandbeforecommissioningofthesystem,APre-Startup精品資料_查程序。Safety Review (PSSR) shallalso be conducted,refer details to <procedure for PSSR>.5.5 批準(zhǔn)運(yùn)行在變更系統(tǒng)投入運(yùn)行前，變更批準(zhǔn)人將基于現(xiàn)場(chǎng)條件以及控制措施落實(shí)情況，決定是否批準(zhǔn)變更系統(tǒng)投入運(yùn)行，并在變更申請(qǐng)表中簽

33、字確認(rèn)；如果不批準(zhǔn)變更，則需要在表格中記錄原因。5.6 告知 /溝通在變更實(shí)施前，區(qū)域變更管理協(xié)調(diào)人應(yīng)確保及時(shí)告知所有可能受到變更影響的人員。并在必要時(shí)，向相關(guān)人員提供防范措施。5.5 Approval of Start-up The change authorizer shall decide whetherapprovethe changeinto implementationornotaccording to the operability and risk assessmentby thereviewersandsignontheformof<Requestforchange-2

34、>ifnotapproved,relevant reasons shall be recorded on the form.5.6 Notification/Communication Priortotheimplementationofthechange,theareaMOCcoordinatorshallnotifyallpersonnelwhocouldbe impactedbythechange intime.Correspondingcountermeasuresandprecautionswillbegiventothosepeopleifnecessary.5.7 信息更新

35、 & 文件保存5.7 Information update & Documentation任何已變更的內(nèi)容都應(yīng)及時(shí)在相關(guān)系統(tǒng)、程序和/Any changed contents shall be timely updated in或文件中更新。all related system, procedure and/or documents.各區(qū)域?qū)⒈４嫠蠱OC 的完整文件，一份變更Each area shall keep thetotal filespackageof管理的完整文件包括：變更申請(qǐng)表、會(huì)議紀(jì)要、allMOCs whichshall include:request of

36、 change風(fēng)險(xiǎn)評(píng)估記錄、檢查清單、簽到表、培訓(xùn)記錄、forms, meetingnotes, riskassessment records,相關(guān)支持文件圖表等。區(qū)域中的變更協(xié)調(diào)員將負(fù)checklists,attendancesheets,training責(zé) MOC 文件的歸檔保存。informationandsupportingdocuments&drawingsetc. The MOC coordinatorof the areashall beresponsibleforthedocumentationofMOC files.5.8 特殊變更5.8 Special MOCs臨時(shí)

37、變更Temporary MOC變更存在期限小于6 個(gè)月的變更即屬于臨時(shí)變 The change with the existing period of less than更。6 monthsisconsideredtobe atemporarychange.變更申請(qǐng)人應(yīng)在變更申請(qǐng)表中注明是否屬于 The change originator shall mark in <Request for臨時(shí)變更以及變更預(yù)計(jì)恢復(fù)的日期。Change form> if it belongs to temporary changeand also define the expected restor

38、e date.精品資料_臨時(shí)變更與永久變更的在管理流程是一致的，但The temporary change will be following the same是臨時(shí)變更關(guān)注變更帶來的短期風(fēng)險(xiǎn)。procedureasthepermanentone,butmorefocusedon the short-periodriskcausedby thechange.當(dāng)臨時(shí)變更存在時(shí)間即將超過6 個(gè)月時(shí)，應(yīng)執(zhí)行After a short-term implementation period, one of下列操作中的一種：the following must occur:基于臨時(shí)變更中的數(shù)據(jù)和信息提出一

39、個(gè)新的A new permanent MOC must be initiated for永久變更申請(qǐng)并審核；reviewusingdatafromthetemporary將臨時(shí)變更的系統(tǒng)復(fù)原；change as justification;在經(jīng)過進(jìn)一步審核后延長(zhǎng)臨時(shí)變更的期限。The system must be returned to its originalcondition;Thetemporarychangecanbeextended,with further review.較小變更當(dāng)判斷變更類型屬于較小變更時(shí)，可執(zhí)行快速變更流程，即在變更申請(qǐng)表執(zhí)行過程中直接從附件 2 的部分 B 跳

40、轉(zhuǎn)至部分 E，經(jīng)過最終批準(zhǔn)后直接實(shí)施變更。Minor MOC If the change has been identified as Minor Change, the quick MOC process can be activated, which means the <Request for Change Form> process in Attachment 2 can be jumped from part B to part E, and the change isable to implement after the final approval obtained.

41、緊急變更緊急變更只適用于延遲變更可能導(dǎo)致對(duì)人員安全、環(huán)境、工廠設(shè)備以及產(chǎn)品造成嚴(yán)重影響的情況。不適用于正常運(yùn)行時(shí)期。一旦確定為緊急變更，變更申請(qǐng)人將執(zhí)行“快速變更流程”見附件 2 的表 E 部分，并在得到所在區(qū)域負(fù)責(zé)人或其授權(quán)人員批準(zhǔn)后執(zhí)行變更。Emergency MOC Emergency MOC are only to be used when delaying a change could result in adverse impacts on the safety of persons, the environment, plant systems, equipment, and p

42、roductivity issues. This not to be used during normal business hours. Once the emergencychangehas beenidentified,the changeoriginatorwill go throughthe QuickMOCprocess referto the partE ofattachment 2 and the change shall be approvedbythearearesponsibleordelegateforimplementation.精品資料_變更管理協(xié)調(diào)人應(yīng)協(xié)助確保在緊急變更批準(zhǔn)實(shí)施后的第二個(gè)工作日重新開始進(jìn)行完整的變更管理流程（包括正式的風(fēng)險(xiǎn)評(píng)估）。每個(gè)區(qū)域都應(yīng)定義出當(dāng)區(qū)域負(fù)責(zé)人不在現(xiàn)場(chǎng)時(shí)有權(quán)批準(zhǔn)緊急變更的人員名單。變更取消當(dāng)開始某個(gè)變更但隨后決定不繼續(xù)作業(yè)，應(yīng)在變更申請(qǐng)表中記錄取消變更原因，變更審批和執(zhí)行之間的時(shí)間通常不超過3 年。5. 9 培訓(xùn)和審核初始培訓(xùn)所有可能受到涉及到變更管理的人員，在實(shí)際介入變更管理流程前，都應(yīng)接受并通過變更管理程序的培訓(xùn)。復(fù)訓(xùn)當(dāng)出現(xiàn)下列任何一種情況時(shí)，需要對(duì)相關(guān)人員進(jìn)行復(fù)訓(xùn)：變更管理程序出現(xiàn)重大變化；在審計(jì)中發(fā)現(xiàn)培訓(xùn)需求；每隔一年；審核 ESHQ 部門將組建審核小組對(duì)各區(qū)域的變更管理程序的符合性進(jìn)