变更管理程序(共9页).doc

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1、精选优质文档-倾情为你奉上Procedure for Management of Change变更管理程序Rev.Published byReviewed byApproved byAmendatory RemarksDateThe latest changes were marked in light blue in the contents.Signed copy archived by document controller 目录Table of Contents1. 目的Objective 32. 范围Scope 33. 定义Definitions 34. 责任Responsibili

2、ty 45. 程序Procedure 55.1 变更申请Request for change 55.2 可行性和风险评估Operability & risk assessment 55.3 变更批准Approval of change 65.4 运行投用前审核Pre-startup review 65.5 批准运行Approval of startup 75.6 告知/沟通Notification/Communication 75.7 信息更新&文件保存Information update & documentation 75.8 特殊变更Special MOCs 75.9 培训和审核Trai

3、ning & audit 96. 附件Attachment 9附件1:基于风险的变更分级与授权矩阵Attachment 1: Risk based change classification and authorization matrix 10附件2:变更申请表Attachment 2: 11附件 3: 变更管理流程图Attachment 3: MOC Flowchart 121. 目的1. Objective建立本程序的目的是管理和控制可能影响到安全、健康和环境的有关设备、设施、程序以及组织机构的变更,并将变更带来的风险最小化。This procedure is established f

4、or 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. 2. 范围2. Scope本程序适用于赢创三征(营口)精细化工有限公司。This Procedure is applicable to the Evonik

5、Sanzheng(Yingkou) Fine Chemical Co.,Ltd3. 定义3 Definition变更:指任何在工艺或设施上发生的与已有规范或实际的偏离,包括增加,减少,修改和替换(同类替换除外)。变更的对象可以是工艺技术、控制系统、设备设施、人员组织以及程序规定。Change is considered a deviation from the specifications or practices as specified for the process or facility which may include addition, deletion, alteration,

6、 or replacement (except for replacement-in-kind). The changing objects may include process/technology, controlling system, equipment/facility, personnel/organization and procedure.同类替换:指不超出既定设计规格/控制范围的有关设备或程序的变化。包括以相同或等同的设备及零件进行替换,以及在系统试运转或测试时进行的在操作规程规定范围内的修改等。同类替换不在变更管理程序的控制范围内。Replacement-in-kind

7、(RIK) is the equipment and procedural alteration that do not vary from the documented design specifications which include identical equipment and spare parts replacement, and modification for completing trials or tests of equipment within the defined operating procedures. RIK is not subject to MOC p

8、rocedures.变更分类(基于风险的分类):按照变更所对应的风险等级的高低,可将变更分为较小变更、中等变更和重大变更。具体的划分标准参见附件1。Classification of Change (Risk basis): Based on the different levels of risk, the changes can be divided into the Minor Change, Moderate Change and Major Change. Refer the criteria of classification to Attachment1. 临时变更:指预先设定的

9、只将短期(6个月内)存在的变更。Temporary Change is a change that is intended to exist for a short, predetermined, finite period (within 6 months).紧急变更:当执行常规变更管理程序可能导致不可接受的安全风险,环境或安保事故或严重经济损失的变更。Emergency Change is a change needed in a situation where the time required for following the normal MOC procedure could r

10、esult in an unacceptable safety hazard, a significant environmental or security incident, or an extreme economic loss.变更管理协调人:负责所在区域内变更管理相关事宜执行的协调人员,他将负责确保实际变更管理执行与程序的符合性和完整性。Management of Change (MOC) Coordinator is a person to coordinate activities associated with the MOC within the responsible ar

11、ea and ensure compliance and integrity with the MOC procedure through its implementation.变更申请人:最初提出变更需求的人,他将提出书面的申请并提供相关信息和资料。Change Originator is a person who raises the idea for a change initially and submits the written request for change and provides related information & documentation.变更审核人:对申请

12、的变更进行可行性和风险评估的人员(或小组),并且在必要的情况下提供变更实施所需要的整改措施。Change Reviewer is a person (or a team) who reviews the proposed change by evaluating the operability and risk and also provides relevant amendment required for change Implementation if necessary.变更批准人:指批准变更实施以及系统运行的人,将由对应不同风险等级的变更分类(依据附件1划分)决定批准人的角色,如:

13、较小变更区域主管 中等变更工厂/部门经理 重大变更生产/部门主任变更批准人与变更审核人通常情况下由不同的人员担任。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 Moderate Cha

14、nge Plant/Dept. Manager Major Change Production/Dept. DirectorNormally Authorizer and Reviewer are taken by different people.4. 责任4. Responsibility变更管理协调人MOC Coordinator 负责组织协调变更管理流程的执行 确保落实相关变更管理程序要求 保存并维护负责区域内所有变更管理的相关文件和记录 Responsible for coordinating the MOC process related fairs within the plan

15、t. Ensure the requirements of MOC procedure have been fulfilled. Keep and maintain all documentation and record associated with MOC in his/her responsible area. 变更申请人Change Originator 提出变更的书面申请,明确变更的初始信息,如变更范围、对象和类型等,并且提供变更相关的支持文件和资料 判断变更的分类 确保变更执行后,及时更新关联的信息和文档 确保将已更新的相关信息及时传达给所有涉及的部门和人员 Raise the

16、written request for change and clearly define the initial information e.g. scope, object and classification of the change etc. and also provide supporting documents and data associated with the change. Classify the change. Ensure timely update change related information and documents after change im

17、plementation. Ensure the updated information is timely communicated to all department and personnel involved.变更审核人Change Reviewer 确保变更的可行性和风险已得到适当评估,并且已制定了相关应对和控制措施 跟踪并确认所有既定措施已落实到位 Ensure that operability and risk of the change have been properly evaluated and relevant control measures have been es

18、tablished. Follow up and verify all written control measures have been carried out.变更批准人Change Authorizer 基于评估的结果,最终决定是否批准变更的实施 批准已变更系统的投入运行 Decide to final approve the implementation of the change based on the outcome of assessment. Approve the changed system to be running.区域负责人Area Responsible 确保在

19、所辖范围内遵照变更管理程序执行 确保参与变更管理的人员经过适当的培训 Ensure compliance with MOC procedure within the responsible area. Ensure proper trained and qualified people fulfill the roles in MOC.EHSQ部门EHSQ Department 负责参与变更相关ESH风险评估和审核 负责维护、更新及发布变更管理程序 提供变更管理程序的相关培训 组织对变更管理程序执行情况的审计 Participate in MOC related ESH risk assess

20、ment and review. Maintain, update and release the MOC procedure. Provide MOC procedure related training. Arrange the audit for implementation of MOC. 5. 程序5. Procedure5.1 变更申请5.1 Request for Change 变更申请人首先应判断是否属于变更管理程序的控制范畴,如果属于同类替换的,则无需按照变更管理程序执行。 The change originator shall first make the judgment

21、 of whether the applied procedure belong to the scope of MOC, if it is a RIK, MOC procedure will not be followed. 变更申请人应清楚写明变更初始内容,至少包括变更理由、预期结果、相关技术设计以及工作范围,并且还应提供相关文件、资料和图表等辅助信息。 The change originator shall clearly define the initial information of the change, which shall at least include reason o

22、f change, desired results, technical design and work scope, and all supporting documents, data and diagram shall be provided as well. 变更申请人应识别变更的类型,附件1中的基于风险的变更分类指南将作为依据。当对变更分类存在疑问时,可就具体情况咨询风险评估组/审核人确定。 The change originator shall identify the classification of the change with taking the in Attachme

23、nt 1, and the risk assessment team/change reviewer could be consulted for identification if in doubt. 变更申请人将填写变更申请表(参见附件2),将填好的表格递交给相关变更管理协调人。 The change originator will submit the (see attachment 2) to the area MOC coordinator.5.2 可行性和风险评估5.2 Operability & Risk Assessment 变更协调人将基于变更的对象和规模,组建一个合适的变更

24、可行性和风险评估小组。变更小组的成员可能包括: 项目负责人 工艺工程师 设备工程师 维修工程师 化学工程师 操作人员 ESH专家 供应商和外部专家等 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 engineer Chemist E

25、SH specialist Supplier and external expert etc. 变更小组将根据变更申请表中提供的初始信息和支持文件,采取适当的工具/方法实施ESH风险评估,可以包括:检查表、HAZOP、What-if等,评估的结果将被记录下来并与变更申请表关联。 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

26、the request for change form, which may include: check list, HAZOP, What-if etc. And the results of the evaluation will be recorded and attached to the request form. 变更审核人将对评估结果作总的签字确认。 The change reviewer shall sign to confirm the assessment results.5.3 变更批准5.3 Approval of Change 变更批准人将根据审核人对变更相关可行性

27、和风险评估的结果,决定是否批准变更的实施,并在变更申请表中签字确认;如不批准变更,则需要在表格中记录原因。 The change authorizer shall decide whether approve the change into implementation or not according to the operability and risk assessment by the reviewers and sign on the form of ; if not approved, relevant reasons shall be recorded on the form.

28、在变更系统投入运行前,变更批准人将基于现场条件以及控制措施落实情况,决定是否批准变更系统投入运行,并在变更申请表中签字确认;如不批准变更,则需要在表格中记录原因。 The change authorizer shall decide whether approve the change into implementation or not according to the operability and risk assessment by the reviewers and sign on the form of ; if not approved, relevant reasons sha

29、ll be recorded on the form.5.4 运行/投用前审核5.4 Pre-startup review 在变更系统投入运行前,变更协调人将组织相关人员对系统进行ESH审核,以确保: 变更已经按照描述安装 没有其他的额外变更 标准操作规程已被更新/归档/沟通传达 已完成对运行和维护人员的相关培训 已将在风险评估中识别出的所有安全控制措施落实到位 已完成开车计划方案 已建立应急响应预案并明确了联系人名单 已维护存在问题/解决方法的记录并与审查表关联 Prior to startup of the changed system, an ESH review shall be ca

30、rried 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 the risk assessment of th

31、e 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. 变更审核人将对关键项的完成进行签字确认。 The Change Reviewer shall sign on the completion of key items

32、 to ensure they have been finished. 对于新建项目或较为复杂或高风险的系统,在实施变更后试运行开始之前还应组织进行开车前安全审查(PSSR),具体内容参见开车前安全审查程序。 For the new project or complex or high risk system, implementation of change and before commissioning of the system, A Pre-Startup Safety Review (PSSR) shall also be conducted, refer details to .

33、5.5 批准运行5.5 Approval of Start-up 在变更系统投入运行前,变更批准人将基于现场条件以及控制措施落实情况,决定是否批准变更系统投入运行,并在变更申请表中签字确认;如果不批准变更,则需要在表格中记录原因。 The change authorizer shall decide whether approve the change into implementation or not according to the operability and risk assessment by the reviewers and sign on the form of ; if

34、not approved, relevant reasons shall be recorded on the form.5.6告知/沟通5.6 Notification/Communication 在变更实施前,区域变更管理协调人应确保及时告知所有可能受到变更影响的人员。并在必要时,向相关人员提供防范措施。 Prior to the implementation of the change, the area MOC coordinator shall notify all personnel who could be impacted by the change in time. Corr

35、esponding countermeasures and precautions will be given to those people if necessary.5.7 信息更新&文件保存5.7 Information update & Documentation 任何已变更的内容都应及时在相关系统、程序和/或文件中更新。 Any changed contents shall be timely updated in all related system, procedure and/or documents. 各区域将保存所有MOC的完整文件,一份变更管理的完整文件包括:变更申请表、

36、会议纪要、风险评估记录、检查清单、签到表、培训记录、相关支持文件图表等。区域中的变更协调员将负责MOC文件的归档保存。 Each area shall keep the total files package of allMOCs which shall include: request of change forms, meeting notes, risk assessment records, checklists, attendance sheets, training information and supporting documents & drawings etc. The M

37、OC coordinator of the area shall be responsible for the documentation of MOC files. 5.8特殊变更5.8 Special MOCs临时变更Temporary MOC 变更存在期限小于6个月的变更即属于临时变更。 The change with the existing period of less than 6 months is considered to be a temporary change. 变更申请人应在变更申请表中注明是否属于临时变更以及变更预计恢复的日期。 The change origina

38、tor shall mark in if it belongs to temporary change and also define the expected restore date. 临时变更与永久变更的在管理流程是一致的,但是临时变更关注变更带来的短期风险。 The temporary change will be following the same procedure as the permanent one, but more focused on the short-period risk caused by the change. 当临时变更存在时间即将超过6个月时,应执行下

39、列操作中的一种: 基于临时变更中的数据和信息提出一个新的永久变更申请并审核; 将临时变更的系统复原; 在经过进一步审核后延长临时变更的期限。 After a short-term implementation period, one of the following must occur: A new permanent MOC must be initiated for review using data from the temporary change as justification; The system must be returned to its original condit

40、ion; The temporary change can be extended, with further review.较小变更Minor MOC 当判断变更类型属于较小变更时,可执行快速变更流程,即在变更申请表执行过程中直接从附件2的部分B跳转至部分E,经过最终批准后直接实施变更。 If the change has been identified as Minor Change, the quick MOC process can be activated, which means the process in Attachment 2 can be jumped from part

41、 B to part E, and the change is able to implement after the final approval obtained. 紧急变更Emergency MOC 紧急变更只适用于延迟变更可能导致对人员安全、环境、工厂设备以及产品造成严重影响的情况。不适用于正常运行时期。 Emergency MOC are only to be used when delaying a change could result in adverse impacts on the safety of persons, the environment, plant syst

42、ems, equipment, and productivity issues. This not to be used during normal business hours. 一旦确定为紧急变更,变更申请人将执行“快速变更流程”见附件2的表E部分,并在得到所在区域负责人或其授权人员批准后执行变更。 Once the emergency change has been identified, the change originator will go through the Quick MOC process refer to the part E of attachment 2 and

43、the change shall be approved by the area responsible or delegate for implementation. 变更管理协调人应协助确保在紧急变更批准实施后的第二个工作日重新开始进行完整的变更管理流程(包括正式的风险评估)。 The MOC Coordinator will assist to insure the complete MOC process (former risk assessment included) is followed the next working day of emergency change approved to b

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