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1、文件编号DN：QP040版本号Version：主管部门Resp.Dept.：工程部Engineering发放编号DistributionNo：XXXXXXXXXXXX有限公司质量管理体系管理性文件QUALITYSYSTEMPROCEDURE设备控制程序EquipmentControlProcedure编制：日期：审核：日期：批准：日期：生效日期Effective on：发放范围DiStribUtionSCope：局域网目录CONTENT序号名称页码NumberTitlePage1. 目的PURPOSE22. 适用范围SCoPE23. 职责RESPONSIBILITIES24. 设备的控制THE
2、EQUIPMENTCONTROL35. 相关文件RELEVANTDOCUMENTS116. 记录RECoRDS11文件更改履历DOCUMENTHISTORYSUMMARY121 .目的PUrPoSe加强设备管理，使其在合适的状态下工作，确保不影响产品质量。Thepurposethisprocedureistostrengthentheequipmentmanagement,makingtheequipmentoperateinanappropriatestateandensuringthattheequipmentwillnothavebadeffecton(heproducts.2 .适用范
3、围Scope本公司各种产品生产所涉及的全部设备及实验设备。TheprocedureisapplicabletoallthecompanysmanufacturingequipmentandR&Dfacilities.3 .职责Responsibilities3.1 设备管理组职责Theresponsibilitiesoftheequipmentmanagementteamsshouldincludethefollowingaspects:3.1.1 负责制订全年的设备管理计划和目标，并组织实施管理Establishannualequipmentmanagementplansandobjecti
4、vesaswellasorganizeandimplementthemanagement.3.1.2 负责设备的状态进行分析，掌握设备技术状态Analyzeandmastertheequipmenttechnicalstale.3.1.3 负责设备档案的汇集和设备台帐的建立.Takechargeofcollectingequipmentfilesandestablishingequipmentlist.3.1.4 负责组织设备引进方案的调研、论证，统筹设备的选型、安装调试、维修保养、改进更新等Takechargeoforganizingtheinvestigationanddemonstrat
5、ionoftheequipmentintroducingplanandcoordinatingtheequipmenttype-selection,installation,maintenance,improvement,etc.3.1.5 负责设备的改进，验收.Improveandaccepttheequipment.3.1.6 负责设备验证的】Q、OQ工作TakechargeofIQandOQ.3.1.7 负责参与新设备的采购Engageinthepurchasingofnewequipment.3.2 生产技术部职责TheresponsibilitiesofManufacturingTe
6、chniquescontainthefollowingitems.3.2.1 负责新产品、新工艺相关的设备引进工作的规划方案的工艺评审工作和参数确认工作Processreviewandparameterconfirmationoftheintroductionplanontheequipmentrelatedtonewproductsandprocesses.3.2.2 负责设备的PQ验证EquipmentsPQ.3.3 采购部职责TheresponsibilitiesofPurchasingDepartmentshouldcoverthefollowingaspects.3.3.1 负责新设
7、备的采购管理工作Takechargeofthepurchasingmanagementofnewequipment.3.3.2 采购负责联系新购设备供应商进行调试并协助设备管理组进行保修服务Communicatingwiththesupplierofthenew-purchasedequipment,optimizetheequipmentdebuggingandcoordinatewiththeEquipmentManagementTeamstocarryouttheequipmentwarrantyservice.3.4 QA部职责TheresponsibilitiesofQAinclud
8、ethefollowingitem.3.4.1 负责设备验证的管理工作Managetheequipmentvalidation.3.5 设备使用部门职责Theresponsibilitiesofthedepartmentsthatusetheequipmentareasfollows.3.5.1 负责本部门设备日常维护保养实施及配合进行定期保养工作Implementthedailymaintenanceoftheequipmentandcooperatewithotherdepartmentstocarryouttheperiodicalmaintenance3.5.2 负责组织培训工作Org
9、anizerelevanttrainings4 设备的控制TheEquipmentControl4.1 设备管理计划和目标的制定和实施Establishingandimplementingtheequipmentmanagementplansandobjectives每年初，设备管理组按前一年度的运营情况以及本年度规划，制订出“设备年度保养计划”，分解成每月的定期维护保养内容。由设备管理组及设备使用部门制定本年度“设备年度添置计划”、“备品备件年度添置计划”等计划和目标,每月分解后实施。Atthebeginningofeachyear,theequipmentmanagementteamine
10、achProductionDepartmentdrawsuptheAnnualEquipmentMaintenancePlanwhichcanberesolvedintomonthlymaintenanceitemsaccordingtothecompany,sdivisions,thelastyear,sbusinessstateandthecurrentyear,splan.AnnualplansandobjectivesasAnnualEquipmentAdditionPlan,AnnualEquipmentBackupPlan,etc.shallbeestablishedandimpl
11、ementedaftermonthlyarrangementbytheequipmentanddeviceusingdepartment.4.2 设备前期管理Theequipmentprophasemanagement4.2.1 设备购置申请Theequipmentpurchasingrequest设备申购由使用部门提出，并填写采购申请单。Thesubscriptionoftheequipmentisproposedbytheequipmentmanagementteamoftheuserdepartment.Andfillinthepurchaseapplicationform.4.2.2
12、设备选型Thetype-selectionoftheequipment4.2.2.1 设备管理组依据符合生产要求，易于清洗、消毒，便于生产操作和维修、保养，并能防止差错和减少污染的原则协助生产部提出确定机型、生产厂家供采购部参考；经过适当设计、建造、放置和安装的新设备，要利于保养、调试、清洁和使用；Undertheprincipleofbeingconsistentwithmanufacturingrequirements,beingeasytoclean,sterilizeandmaintainaswellaspreventingerrorsandreducingpollution,thee
13、quipmentmanagementteams,coordinatingwithProductionDepartments,presenttheconfirmedtypeandmanufacturerforPurchasingDepartmentsreference.Thenewequipment,byappropriatedesign,construction,placementandinstallation,shouldbeeasytomaintain,debug,cleananduse.4.2.2.2 新产品、新工艺相关设备的引进，由设备管理组会同相关部门进行调研，经过技术经济水平论证后
14、，确定型号订货。设备管理组负责将应征验证合格的新设备增补到定期维护保养计划内容中。ThetypeandorderoftheintroducingequipmentrelatedtonewproductsandprocessesshouldbedeterminedaftertheinvestigationofEquipmentDevelopmentDepartmentandotherrelevantdepartmentsaswellastheacquisitionoftechnicalandeconomicaldemonstration.4.2.3 设备采购Theequipmentpurchas
15、ing采购部根据审批后的申请单以及选型资料落实采购工作，签订合同时下列技术要素将做为合同条款的一部分。PurchasingDepartmentimplementsthepurchasingaccordingtotheapprovedrequestandtype-selectioninformation.Thefollowingtechnicalfactorswillberegardedaspartsofthepurchasingcontract.技术协议必须包括下列要素： 设备名称、数量、产地 设备应是全新的，并附有产地证明和合格证 主要技术性能指标 交货日期、安装和调试 质量索赔条款 明确验收标准和验收方式 明确保修期和售后服务要求 技术协议必须与商务合同同时生效 必要时，明确培训计划和要求，以及技术文件要求Technicalcontractshallincludebelowfactors: Name,quantityandoriginoftheequipment; Theequipmentshouldbenewandattachedwithcertificateoforiginandcertification; Majortechnicalindicators; Deliverydate,inst
