QP040 设备控制程序Equipment Control Procedure V1.1

文件编号版本号DN QP040Version主管部门Resp.Dept.工发放编号Distribution程部Engineering No有限公司XXXXXXXXXXXX质量管理体系管理性文件QUALITY SYSTEMPROCEDURE设备控制程序Equipment ControlProcedure编制日期审核日期批准日期发放范围Distribution scope局域网生效日期Effective on在设备运行时，操作者应密切注意设备运转情况，发现故障应立即停机，不能自行处理的，应及时报告班组长，由班组长填写《设备故障报告单》报告设备管理组，由设备管理组安排维修人员检修维修正常后，QP040-RE-08由设备责任人进行试机确认，设备维修人员应及时将维修情况包括停机时间大于小时的，费用大于元的，4500需要进行验证的等有关内容详细记录在《设备维修记录》上，交设备维修主管备案；同时设备责任QP040-RE-09人应将故障处理情况记录在《设备日运行记录》中如果问题较为复杂严重，停机维修时间长到影QP040-RE-06响生产进度，或要发生大额维修费用去购买部品配件，则由设备使用部门及时上报生产部直接分管领导处理In the equipment run-time,the operator should fixhis attentionon theworking stateand whenmalfunction appears,heshould immediatelystop the equipment andreport itto thegroup leaderinstead ofdealing withit alone.The groupleader is incharge ofcompleting the Equipment MalfunctionReport QP040-RE-08to inform the equipment management teamtoarrange the maintenance.The personin charge of the equipment shouldverify thebroken-down equipmentby testingand therepairingengineers shouldrecord the maintenance situationin theEquipment RepairRecord QP040-RE-09containing thefollowingcontents that the downtime is more than4hours,the costis morethan500yuan,the mattersneed validation,etc andsubmittedto the equipment maintenancesupervisor.Meanwhile,the personin charge of the equipment shouldrecord themalfunctionin theEquipment DailyOperation Record QP040-RE-

06.Relatively complicatedtroubles,for example,thedown-timeisso longthat willinfluence the production scheduleor it will costa largeamount ofmoney topurchasecomponents,should bereported to the productiondepartment managerby the equipment user department.在停机维修过程中如涉及设备关键部件需要更换，确认新的关键部件的技术参数是否改变了原有参数及工艺，则由确定是否需要进行验证，验证按《验证规程》进行QA QR040If thedown-time maintenance contains the change of the criticalcomponents,QA will determine whether the validationisneeded or not to see if the newparameters of the newcomponents havechanged theoriginal parameters and processes.Thevalidation will be carried out according to theValidation RegulationQR

040.设备检查

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4.4Equipment Inspection为了保证设备经常处于完好的状态下，必须要对一般设备进行日常开机自检及重关设备定期巡检It isnecessary toconduct adaily POSTPower-on SelfTest for the general equipment andpatrol inspectionfor the criticalinspection.一般设备日常检查

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4.1Daily inspectionof the general equipment一般设备日常检查由操作者进行设备操作者在进入机器正常工作状态之前必须进行开机自检开机自检的内容主要有设备“完好设备”标识牌和运行状态牌是否完整；开机时是否有异常声音；各操作按钮是否灵敏可靠；与各机械部件连接是否紧固开机自检情况填写在《设备日运行记录》上QP040-RE-06Daily inspectionof the general equipment is implementedby the operators.The equipmentoperator shouldcarry out aPOST Power-on SelfTest beforethe machinegets intonormal workingstatus.The contentof aPOST mainlyincludes thefollowing items,respectively,to checkifthe“Good Equipment“card and“Operational“card arecomplete,toseeif thereis anynoisewhen poweringthe machine,to verifythe sensitivityand dependabilityof eachoperational buttonand toensure thattheconnection ofeach componentis fastened.The POSTPower-on SelfTest circumstanceshould becompleted in theEquipment DailyOperation Record QP040-RE-

06.重关设备的定期巡检

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4.2The periodicalpatrol inspectionof the critical equipment设备的定期巡检由设备管理组或设备维修人员负责；定期巡检内容根据《重关设备清单与日常巡检内容》1进行QP040-RE-15Each equipment management teamor equipmentmaintenance personnel should takecharge of the periodical inspectionof the critical equipment according to the Critical Equipment List and Daily Inspection Record QP040-RE-

15.设备管理组负责依照各个部门全年的设备管理计划和目标编写年度设备维护保养计划，再依照所编写的年度设备2维护保养计划对定期巡检的情况进行指导和督促检查；The equipment management team should be in charge of establishingthe annualmaintenance planof the equipmentaccording to the annual equipment managementplan and objectives ofeach department,and thenconducting,supervisingand inspectingthe periodicalinspection based on theannual plan.维护保养实施人员在做好定期巡检后，应填写《设备日常巡检记录表》3QP040-RE-07After theperiodicalinspection,themaintenance personnel shouldcomplete theEquipment DailyPatrol InspectionRecord QP040-RE-

07.检查时如果发现问题按条处理

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4.3443If problemsare foundduring theinspection,it will be handledaccording to

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3.设备调试将设备调整限度和允许公差的说明放在需要定期调试的设备或附近，或者从事这些调试的工

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4.5作人员都备有说明Instructions ofequipment adjustinglimitation andallowable toleranceshould beplaced onor by the equipment thatneeds regulardebugging,or stockedby thedebugging personnel.设备定置管理

4.5Equipment FixationManagement设备调拨和移装

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5.1Equipment allocation and moving设备调拨和移装时，设备部负责台帐和标牌更新；变动后设备由确定是否需耍验证，如需验证，按《验

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1.1QA证规程》进行，设备应在验证完成后正式启用QR040When equipmentallocationandmoving,the accountsand identificationsupdated by the equipment department.QAwill determine whether themoved equipmentneeds validatingor not,if necessary,it will be implemented accordingto theValidation RegulationQR040and the equipment should be usedafter the validation.设备封存和启用

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5.2Equipment sealing and enabling设备的封存和启用时，设备部负责做好标识，同时进行台帐更新；启封使用的设备由确定是否需要进

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2.1QA行验证，如需验证，按《验证规程》进行，设备应在验证完成后正式启用QR040When equipmentsealingandenabling,the identificationsprepared andlist updatedby the equipmentdepartment.QA shoulddeterminewhether thevalidationis neededornotfor theenabled equipment,of necessary,itwillbeimplemented according to theValidation RegulationQR040and the equipment should be usedafter thevalidation.设备的报废

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5.3Equipment scrapping为提高生产效率，使设备更能符合生产和发展需要，必须对一些设备进行报废更新设备的报废申请由使

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3.1用部门提出，申请提出必须符合设备报废更新原则It isnecessary toscrap andrenew someequipment with the purposeof enhancingproductivity andmaking theequipmentmore consistent with thedeveloping requirements.Equipment scrappingshould be proposed by the userdepartmentand applicableto thescrapping andupdating principle.报废更新原则

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3.2Scrapping andupdating principles）主要结构陈旧、精度低劣，生产率低不能改装利用者；1The equipment,whose mainstructure isold,precision isinferior,productivity islow andmodification isimpossible;）不能迁移的设备，因厂房改建与工艺布置改变必须拆毁者；2The equipment that cantbe movedand mustbe demolishedresulting fromworkshop rebuildingand processchange;）腐蚀过甚，无修复价值或继续使用易发生危险者；3The equipment that hasbeen corrodedtoo much,has norepairing valuesor iseasy tocause risksif usedcontinuously;）绝缘老化、性能低劣，无修复价值；4The equipmentwhose insulationis agedand performanceis badwithout any repairing values;）因事故或其它灾害使设备遭受严重损坏，无修复价值者5The equipment that hasbeen badlydamaged dueto accidentor otherdisasters withoutanyrepairingvalues报废的设备应在显著位置加以标识

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3.3The scrappedequipment should be markedin aprominent position.重要关键设备和一般设备报废按《固定资产管理制度》（）进行

453.4AFN003The scrappingof critical equipment andgeneral equipment should beimplementedaccordingto theFix-asserts（）Management SystemAFN

003.低值易耗设备的报废，由使用部门填写《低值易耗设备报废申请单》（）签批后进行QP040-RE-14,The scrappingof low-value consumablesshould be recorded in the Low-value ConsumablesScrapping Requestandapproved byrelevant principalswith signatures.相关文件5Relevant Documents《验证规程》（）

5.1Validation RegulationQR040记录6Records《新工艺装备申请单》

6.1Application Formfor NewProcess EquipmentQP040-RE-01《设备开箱检查记录》

6.2Equipment Open-package InspectionRecord QP040-RE-02《设备安装调试过程报告单》

6.3Equipment InstallationDebugging Report QP040-RE-03《设备定人定机表》

6.4Certain Personsfor CertainEquipment ListQP040-RE-05《设备日运行记录》

6.5Equipment DailyOperation Record QP040-RE-06《设备日常巡检记录表》

6.6Equipment DailyPatrol InspectionRecord QP040-RE-07《设备故障报告单》

6.7Equipment MalfunctionReportQP040-RE-08《设备维修记录》

6.8Equipment RepairRecord QP040-RE-09《设备台帐》

6.9Equipment AccountQP040-RE-10《设备保养记录》

6.10Equipment Maintenance Record QP040-RE-11《设备清洁记录》

6.11Equipment CleaningRecord QP040-RE-13《低值易耗设备报废申请单》

6.12Low-value ConsumablesScrapping RequestQP040-RE-14《重关设备清单与日常巡检内容》

6.13Critical EquipmentListandDailyInspectionRecordQP040-RE-15文件更改履历Document HistorySummary修改后版本或页码修改更改概述生效日期Effective号更改单编号Updated VersionSummary ofChanges DateOrPage RevisionDCR Ref目录CONTENT序号名称页码Number TitlePage目的

1.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The purposethis procedureis tostrengthen the equipment management,making the equipment operatein anappropriatestate andensuring thatthe equipment will nothave badeffect on the products.适用范围

2.Scope本公司各种产品生产所涉及的全部设备及实验设备The procedureis applicableto all the companysmanufacturing equipment and RD facilities.职责

3.Responsibilities设备管理组职责

3.1The responsibilitiesof the equipmentmanagement teams shouldinclude the following aspects:负责制订全年的设备管理计划和目标，并组织实施管理

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1.1Establish annualequipmentmanagementplans andobjectives aswell asorganize andimplement themanagement.负责设备的状态进行分析，掌握设备技术状态

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1.2Analyze andmaster the equipment technicalstate.负责设备档案的汇集和设备台帐的建立.

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1.3Take charge of collectingequipment filesand establishingequipment list.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

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1.4Take chargeof organizingthe investigationand demonstrationof the equipment introducingplan andcoordinating theequipmenttype-selection,installation,maintenance,improvement,etc.负责设备的改进，验收.

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1.5Improve andaccept the equipment.负责设备验证的、工作

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1.6IQ OQTake chargeofIQ andOQ.负责参与新设备的采购

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1.7Engage in the purchasingof new equipment.生产技术部职责

3.2The responsibilitiesof ManufacturingTechniques contain the followingitems.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

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2.1Process reviewand parameterconfirmation of the introductionplan on the equipmentrelated tonew productsandprocesses.负责设备的验证

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2.2PQEquipments PQ.采购部职责

3.3The responsibilitiesof Purchasing Department shouldcover the following aspects.负责新设备的采购管理工作

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3.1Takechargeof the purchasing management of newequipment.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

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3.2Communicating withthe supplierof thenew-purchased equipment,optimize the equipment debuggingandcoordinate withtheEquipmentManagement Teamsto carryout the equipment warrantyservice.部职责

3.4QAThe responsibilitiesof QAinclude the followingitem.负责设备验证的管理工作

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4.1Manage the equipment validation.设备使用部门职责

3.5The responsibilitiesof thedepartments thatuse the equipment areas follows.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

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5.1Implement thedaily maintenance of the equipment andcooperate withother departments to carryout theperiodicalmaintenance负责组织培训工作

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5.2Organize relevanttrainings设备的控制4The EquipmentControl设备管理计划和目标的制定和实施

4.1Establishing andimplementing the equipmentmanagementplans andobjectives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At thebeginning ofeach year,theequipmentmanagement teamin eachProduction Departmentdraws upthe AnnualEquipment Maintenance Planwhich can be resolvedinto monthlymaintenance itemsaccordingto the companysdivisions,thelast yearsbusiness stateand thecurrent yearsplan.Annual plansandobjectivesas Annual Equipment AdditionPlan,AnnualEquipmentBackup Plan”,etc.shall beestablished and implemented aftermonthly arrangementby theequipment anddeviceusing department.设备前期管理

4.2The equipmentprophase management设备购置申请

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2.1The equipmentpurchasing request设备申购由使用部门提出，并填写采购申请单The subscriptionof theequipmentisproposed by theequipmentmanagement teamof the user department.And fillinthe purchaseapplication form.设备选型

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2.2The type-selection of theequipment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

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2.1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Under theprinciple ofbeing consistentwith manufacturingrequirements,being easy to clean,sterilize andmaintainas well as preventingerrors andreducing pollution,theequipmentmanagement teams,coordinating withProductionDepartments,present theconfirmed typeand manufacturerfor Purchasing Departments reference.The newequipment,by appropriatedesign,construction,placement andinstallation,should beeasytomaintain,debug,cleanand use.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，确定

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2.2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The typeand orderof theintroducing equipmentrelated tonew productsand processesshould bedetermined after theinvestigation ofEquipment DevelopmentDepartment andother relevant departments aswell as the acquisitionoftechnical andeconomical demonstration.设备采购

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2.3The equipmentpurchasing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Purchasing Departmentimplements the purchasing accordingto theapproved requestand type-selection information.The followingtechnical factorswillbe regarded asparts ofthepurchasingcontract.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Technical contractshall includebelow factors:•Name,quantity andorigin oftheequipment;•The equipment should benew andattached withcertificate oforigin andcertification;•Major technicalindicators;•Delivery date,installation anddebugging;•Quality claimclauses;•Acceptance standardsand manners;•Warranty andafter-sales servicerequirement;•The technicalcontract should be effectivewiththebusiness contract;•The trainingplan andrequirement aswellastechnical documentsshould beidentified,if necessary.设备验收

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2.4The equipment acceptance设备到公司后采购人员通知设备管理组到场验收，设备管理组根据设备装箱单和合同进行开箱检查和清点工

424.1作设备开箱后，由使用部门根据设备的布置情况把设备放置到相应地点After theequipment deliveredto the company,thepurchasingpersonnel shouldinformtheequipment managementteamof relevantdepartmentstocheck andcount theequipmentaccordingto theequipment packinglist andcontact.验收后，对于重要关键设备，设备管理组依据开箱情况填写《设备开箱检查记录》如实记录设备验QP040-RE-02,收情况，做出符合性判断对不符合要求的由采购部负责退货或调换确认符合要求的设备可实施安装、调试其余一般设备和低值易耗设备只做简单验收，如合格即可直接移交使用部门，并填写《设备开箱检查记录》QP040-RE-02After theequipmentacceptance,the unpackingstatus ofthe criticalequipment should berecordedintheEquipmentOpen-package InspectionRecordQP040-RE-02and theconformities oftheequipment should bejudged.Theequipment fallsto beconsistentwiththe requirementshouldbereturned orexchanged byPurchasing Department,while theconforming equipment willbeinstalled anddebugged.The general equipment andlow-value consumableswillonly carryoutasimple acceptanceand willbe handledto the use departmentwith acompleted EquipmentOpen-package InspectionRecordQP040-RE-02if approved.设备安装调试

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2.5The equipmentinstallation anddebugging设备安装由设备管理组组织人员进行，相关的部门协助设备安装开展工作

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5.1The equipmentmanagement team,coordinating withrelevantdepartments,should takechargeofthe equipmentinstallation.设备安装到位后，由设备管理组负责做“调试中设备”标识并组织进行调试；

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5.2After theequipment installed,theequipmentmanagement teamshould affixthe DebuggingEquipment”andorganize debugging.调试认为运行不正常或不符合要求，应由采购部负责退货、调换或联系制造厂进行维修；

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5.3After thedebugging,the improperly operating orunqualified equipmentshouldbereturned orexchanged to themanufacturer byPurchasingDepartment.Also,PurchasingDepartmentcan communicatethe manufacturerto repairtheequipment.对自制设备，在设备开发前，需求部门应提出开发需求、技术参数要求、工艺要求和验收标准，以便在设

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5.4备制成后，设备开发部门应提供完善的技术资料由设备管理组会同使用部门技术人员、工艺人员进行自制新设备的安装调试，调试中认为运行不正常或不符合要求应退回设备开发部门进行改进Before thedevelopment ofself-designed equipment,each demanddepartment shouldpropose developingrequirements,technical parameterrequirements,process requirementsand acceptancestandards accordingto theproductrequirement sothattheequipment developingdepartment canprovide perfectdata afterthe achievementofthe equipment.The equipmentmanagement teamtogether withthe technicalpersonnel andprocess personnelof theuser department shouldinstall anddebug thenewequipment and returnimproperlyoperatingor unqualifiedequipmenttotheequipment developingdepartment toimplement theimprovement.调试正常后，可移交使用部门对过程特别复杂的重关设备还必须填写《设备安装调试过程报告单》

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5.5当移交使用部门后，使用部门通知部门，由设备使用部门与部门共同商议是否需要对该设QP040-RE-03o QAQA备进行验证如需验证，验证依照《验证规程》进行，验证合格则投入使用，否则退回采购部处理；如不QR040需验证，则可直接投入使用After debuggednormally,theuse department shallfill theEquipment InstallationDebugging ReportQP040-RE-03for complicatedequipment,theusedepartmen willsend relatedequipment informationto QA,andthen theusedepartmentand QAtogether determinewhetherthevalidation willbe carriedout.If yes,the validationshall be carriedout accordingtotheValidation RegulationQR040,equipment cantbe usedunless thevalidation isqualified,or itshallbereturned toPurchase Departmentto handle.If no,theequipmentcanbeused directly.设备管理组根据设备的价值和/或对产品性能影响的重要性，将设备分为“重要关键设备”简称“重关

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2.6设备”、“一般设备”和“低值易耗设备”三级，实行分级管理重关设备对产品性能影响重要或价值高昂的设备1一般设备价值大于元或对产品性能影响一般的设备22000低值易耗设备价值低于元且对产品性能影响很小的设备32000Based onthe equipmentsvalue and,or importancetotheproduct performance,theequipmentmanagement teamclassifiestheequipmentinto threecategories,namely,CriticalEquipment”,“General Equipment”and Low-valueConsumables“and managethem accordingto theirgrades.1Critical equipmentmeans theequipmentthatwill haveimportant effectontheproducts oris valuable;2General equipmentmeans theequipmentthatcosts morethan2000yuan orwill affecttheproductperformancegenerally;3Low-value consumablesmean theequipmentthatcost lessthan2000yuan andwill hardlyinfluence theproductperformance.设备管理组负责制定一般设备和重关设备的设备操作维护规程

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2.7The equipmentmanagement teamshould establishSOPs ofthe generalequipment and the criticalequipment.设备档案管理

4.3Equipment ArchivesManagement设备台账

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3.1Equipment Account设备管理组负责建立《设备台帐》《设备台帐》根据实际情况随时更新；对

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040.RE-10,QP040-RE-10于重关设备和一般设备，设备管理组在设备管理中应做到帐、卡、物相符The equipmentmanagement teamshouldberesponsible forestablishing andupdating theEquipment AccountQP040-RE-10basedonthe actualsituation.For the criticalequipment and thegeneralequipment,the equipmentmanagement teamshouldensure consistencyof accounts,cards andobjects.设备办理验收手续移交使用部门后，设备管理组应负责设定设备编号，并在设备的明显位置贴上“完好设

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1.2备”卡设备编号采用四节编号法大类号、分类号、型别号、公司内顺序号，具体参照附页设备分类附表After theequipment acceptedand deliveredtotheuser department,theequipmentmanagement teamshould takechargeof settingtheequipmentnumber andaffixing theGood Equipment“card inthe obviouslocation of theequipment.The equipmentisinthe employof a“four-part“numbering manner,namely,category number,classification number,type numberand serial number ofthecompany,which isdetailed describedintheattachedsheet calledEquipment ClassificationSchedule.设备管理组负责对“重关设备”、“待修设备”、“封存设备”等进行标识并检查

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3.2The equipmentmanagement teamis responsiblefor identifyingand checkingthecriticalequipment,theequipmenttobe repaired,the storedequipment,etc.设备管理组对列入固定资产的设备建立档案，对设备的技术资料等进行统一管理433The equipmentmanagement teamshould establishrecords for theequipmentthat hasbeen enrolledas fixed-assertsand managethe technicaldata oftheequipment.设备的使用和维护管理

4.4The useand maintenancemanagementoftheequipment设备的日常使用

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4.1The dailyuse oftheequipment对设备操作者的要求

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1.1The operationalrequirements oftheequipment新工人在使用设备前或操作者使用新购设备，必须经设备管理组对其进行一定时间的该设备安全1生产有关的上岗培训和设备操作培训，考核合格后方可上岗独立操作；The equipmentmanagementteamshould organizepre-post trainingsand equipmentoperation trainingsrelatedto safetyforthenew employees.The newemployees mustbe trainedbefore usingor operatingthe newpurchasedequipmentand they canonly independentlyoperate theequipment afterexamined qualified.）公司内部工种调动的操作者，须进行上岗培训后方可上岗独立操作；2The operatorwho changeshis jobswithin thecompany shouldreceive jobtraining beforeindependentlyoperating theequipment.）设备操作者应基本掌握设备的“三好”（管好、用好、保养好）、“四会”（会使用、会保养、会检查、3会调整）The equipmentoperatorshouldbasically masterthefollowingitems,literally,“three-goods“making theequipmentmanaged,used andmaintained perfectlyand four-abilities”equipped withfour abilities,namely,use,maintenance,inspection andadjustment.设备的定人定机

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1.2Certain persons for certainequipment）属于“重关设备”，由各使用部门提出定人定机的初步名单，经设备管理组审核后实施；1The certainpersons forthecriticalequipmentshouldbeproposedbytheuser departmentandimplementedby theequipmentmanagement teamsreview.）属于“一般设备”，由各使用部门根据实际情况实施定人定机2The certainpersonsforthegeneralequipmentwillbe carriedout byeach userdepartment basedon actualsituation.）正常情况下，操作者不得串机使用；3Normally,the operatoris notallowed to operate differentequipment atthe sametime.）属多人操作的设备，由使用部门指定专人负责保管与维护保养4The equipmentthat needsmorethanone persontooperateshouldbemanaged andmaintained bycertain personsappointedbytheuserdepartment.设备操作人员必须严格按照设备操作维护规程使用设备，一般设备和重关设备责任人应将每天设备运行时

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1.3间、运行状况记录在《设备日运行记录》（）上QP040-RE-06The equipmentoperator mustuse theequipment strictlyaccordingtotheequipmentSOPs.The personin chargeof thegeneralequipmentandthecriticalequipmentshouldrecord theequipment dailyoperational timeand stateonthe（）Equipment DailyOperation RecordQP040-RE-

06.设备的维护与保养

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4.2The equipmentmaintenance设备管理组建立并保持调试，清洁和保养的设备计划表，以保证达到生产规范The equipmentmanagementteamshould establishand keeptheequipmentdebugging,cleanliness andmaintenanceschedules toensure regularmanufacturing.设备的维护保养主要由操作者和维修人员负责完成，内容包括日常保养和定期保养The operatortogether withthemaintenancepersonnelshouldbeinchargeoftheequipmentmaintenance coveringdailymaintenance andperiodical maintenance.）日常保养由操作者负责完成保养内容设备操作规程中相关内容；保持设备的整洁；前段需清洗设备清洗完1后并填写《设备清洁记录》重点是对常用部件的性能、参数、运行条件进行确认，和对设备外表QP040-RE-13面的清洁卫生处理The operatorshould takechargeofdaily maintenancewhich includesthefollowingaspects,namely,relevant mattersrequiredintheSOPs,theequipmentin cleanand tidycondition andcompleting theEquipment CleaningRecordQP040-RE-13oftheequipmentthatneeds front-end cleaningafterthecleaning finished.The keypoint hereis thatverifyingthe performance,parametersandoperational conditionofthecommon partsand cleaningthe surfaceoftheequipment.定期保养以维修人员为主、操作者配合、设备管理员指导对重关设备和一般设备进行定期保养对长期使用后2产生的性能漂移、参数改变、元器件老化等现象进行现场及时妥善处理或有计划的更换，对运动机件进行有效的润滑和去污垢，对磨损的部件进行及时更换以免隐患变成故障，完成保养后填写《设备保养记录表》QP040-RE-UPeriodical maintenanceis directedbythemaintenancepersonnelcoordinated withtheoperatorunder theguidance oftheequipment manager.The criticalequipmentandthegeneralequipmentshouldbe maintainedperiodically.Suchphenomena asperformance fluctuation,parameter changing,component agingetc.,after long-term use,should beproperlydealt withbythesite orchanged accordingto plans.Moving partsshouldbelubricated anddecontaminatedeffectively.While worncomponents shouldbe changedimmediately incase thathidden troublesturn intomalfunctions.The Equipment MaintenanceRecordQP040-RE-11willbecompleted afterallthemaintenance work.《设备保养记录表》的.由位阿拉伯数字组成从左往右，前位是设备所在部门的部门代3QP040-RE-11No82码；第到第位是保养发生时所在的年月；第和第位是流水号，从至367801U99The numberoftheEquipmentMaintenanceRecordQP040-RE-11is madeup of8Arabic numerals,from leftto right,the formerfour isthe codeoftheuserdepartment,the fifthand sixthnumbers standforthemonth whenthe maintenanceiscarriedoutandthe last tworepresent theserialnumberfrom01to

99.保养依据设备操作规程中相关内容4The relevantcontent inSOPs shouldberegardedasthemaintenance basis.保养周期重关设备每个月进行一次，一般设备每个月进行一次5612The maintenanceperiod isregulated asthefollowingclause thatthecriticalequipmentwillbe maintainedevery6monthsand thegeneralequipmentevery12months.两次保养之间的间隔须严格按照年度设备维护保养计划执行，如未能按时保养，请在《设备保养记录表》6上详细记录“未能按时保养”的原因和因此产生的后果在维护和保养过程中如涉及设备关键部件QP040-RE-11更改牵扯到技术参数改变或工艺条件改变的维护保养或技术工艺改进升级性维护，则由确定是否需要进行验QA证，验证按《验证规程》进行QR040During theinterval betweenthelastandthenext maintenance,relevant maintainingwork mustbe strictlycarried outaccordingtotheannualequipmentmaintenance plan.If not,the reasonand resultof“not maintainingon scheduleshouldbe recordedintheEquipmentMaintenanceRecordQP040-RE-

11.If themaintenancecontainsthechangeofthecriticalcomponents,involving themaintenanceoftechnical parameterchanges orprocess changes,or upgrademaintenance oftechnicalprocess improvement,then QAwilldeterminewhetherthevalidation willbe carriedout ornot seeQR040Validation Regulation.设备故障管理

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4.3Equipment MalfunctionManagement。