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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
16、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,installationanddebugging; Qualityclaimclauses
17、; Acceptancestandardsandmanners; Warrantyandafter-salesservicerequirement; Thetechnicalcontractshouldbeeffectivewiththebusinesscontract; Thetrainingplanandrequirementaswellastechnicaldocumentsshouldbeidentified,ifnecessary.4.2.4 设备验收Theequipmentacceptance4.2.4.1 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
18、进行开箱检查和清点工作。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。Aftertheequipmentdeliveredtothecompany,thepurchasingpersonnelshouldinformtheequipmentmanagementteamofrelevantdepartmentstocheckandcounttheequipmentaccordingtotheequipmentpackinglistandcontact.4.2.4.2 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(QPo40-RE-O2),如实记录设备验收情
19、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(QPo40-RE-O2)。Aftertheequipmentacceptance,theunpackingstatusofthecriticalequipmentshouldberecordedintheEquipmentOpen-packageInspectionRecord(QP040-RE-02)andtheconformitiesoftheequipmentshouldbejudged.Theequip
20、mentfallstobeconsistentwiththerequirementshouldbereturnedorexchangedbyPurchasingDepartment,whiletheconformingequipmentwillbeinstalledanddebugged.Thegeneralequipmentandlow-valueconsumableswillonlycarryoutasimpleacceptanceandwillbehandledtotheusedepartmentwithacompletedEquipmentOpen-packageInspectionR
21、ecord(QP040-RE-02)ifapproved.4.2.5 设备安装调试Theequipmentinstallationanddebugging4.2.5.1 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。Theequipmentmanagementteam,coordinatingwithrelevantdepartments,shouldtakechargeoftheequipmentinstallation.4.2.5.2 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；Aftertheequipmentinstalled,theequi
22、pmentmanagementteamshouldaffixtheDebuggingEquipmentandorganizedebugging.4.2.5.3 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；Afterthedebugging,theimproperlyoperatingorunqualifiedequipmentshouldberelumedorexchangedtothemanufacturerbyPurchasingDepartment.Also,PurchasingDepartmentcancommunicatethemanufacture
23、rtorepairtheequipment.4.2.5.4 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。Beibethedevelopmentofseli-designedequipment,eachdemanddepartmentshouldproposedevelopingrequirements,technicalparameterrequirements,process
24、requirementsandacceptancestandardsaccordingtotheproductrequirementsothattheequipmentdevelopingdepartmentcanprovideperfectdataaftertheachievementoftheequipment.TheequipmentmanagementteamtogetherwiththetechnicalPerSonnelandprocesspersonneloftheuserdepartmentshouldinstallanddebugthenewequipmentandretur
25、nimproperlyoperatingorunqualifiedequipmenttotheequipmentdevelopingdepartmenttoimplementtheimprovement.4.2.5.5 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(QP040-RE-03)1,当移交使用部门后，使用部门通知QA部门，由设备使用部门与QA部门共同商议是否需要对该设备进行验证。如需验证，验证依照验证规程(QRo40)进行，验证合格则投入使用，否则退回采购部处理；如不需验证，则可直接投入使用。Afterdebuggednormally,theu
26、sedepartmentshallfilltheEquipmentInstallation&DebuggingReport(QP040-RE-03)forcomplicatedequipment,theusedepartmenwillsendrelatedequipmentinformationtoQA,andthentheusedepartmentandQAtogetherdeterminewhetherthevalidationwillbecarriedout.Ifyes,thevalidationshallbecarriedoutaccordingtoIheValidationRegul
27、ation(QR040),equipmentcan,tbeusedunlessthevalidationisqualified,oritshallbereturnedtoPurchaseDepartmenttohandle.Ifno,theequipmentcanbeuseddirectly.4.2.6 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“重关设备”)、“一般设备”和“低值易耗设备”三级，实行分级管理。1)重关设备：对产品性能影响重要或价值高昂的设备2)一般设备：价值大于2000元或对产品性能影响一般的设备3)低值易耗设备：价值低于2000元
28、且对产品性能影响很小的设备Basedontheequipmentsvalueand,orimportancetotheproductperformance,theequipmentmanagementteamclassifiestheequipmentintothreecategories,namely,44CriticalEqUiPment，“GeneralEquipment,andttLow-VaIucConsumablesandmanagethemaccordingtotheirgrades.1) Criticalequipmentmeanstheequipmentthatwillhav
29、eimportanteffectontheproductsorisvaluable;2) Generalequipmentmeanstheequipmentthatcostsmorethan2000yuanorwillaffecttheproductperformancegenerally;3) 1.ow-valueconsumablesmeantheequipmentthatcostlessthan20(X)yuanandwillhardlyinfluencetheproductperformance.4.2.7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。Theequipment
30、managementteamshouldestablishSOPsofthegeneralequipmentandthecriticalequipment.4.3设备档案管理EquipmentArchivesManagement4.3.1 设备台账EqUiPmenlACCoUnt4.3.1.1 设备管理组负责建立设备台帐(QPo40-RE-10),设备台帐(QPo40-RE-Io)根据实际情况随时更新；对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。Theequipmentmanagementteamshouldberesponsibleforestablishingand
31、updatingtheEquipmentAccount(QP040-RE-I0)basedontheactualsituation.Forthecriticalequipmentandthegeneralequipment,theequipmentmanagementteamshouldensureconsistencyofaccounts,cardsandobjects.1.1.2 2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)。Afterthee
32、quipmentacceptedanddeliveredtotheuserdepartment,theequipmentmanagementteamshouldtakechargeofsettingtheequipmentnumberandaffixingthe44GoodEquipmentcardintheobviouslocationoftheequipment.Theequipmentisintheemployofa“fbur-part“numberingmanner,namely,categorynumber,classificationnumber,typenumberandseri
33、alnumberofthecompany,whichisdetaileddescribedintheattachedsheetcalledEquipmentClassificationSchedule.1.1.3 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。Theequipmentmanagementteamisresponsibleforidentifyingandcheckingthecriticalequipment,theequipmenttoberepaired,thestoredequipment,etc.1.1.4 设备管理组对列入固定资产的设备建立
34、档案，对设备的技术资料等进行统一管理。Theequipmentmanagementteamshouldestablishrecordsfortheequipmentthathasbeenenrolledasfixed-assertsandmanagethetechnicaldataoftheequipment.4.4 设备的使用和维护管理TheUSeandmaintenanCemanagementOftheeqUiPment4.4.1 设备的日常使用Thedailyuseoftheequipment4.4.1.1 对设备操作者的要求Theoperationalrequirementsofthe
35、equipment1)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；Theequipmentmanagementteamshouldorganizepre-posttrainingsandequipmentoperationtrainingsrelatedtosafetyforthenewemployees.Thenewemployeesmustbetrainedbeforeusingoroperatingthenewpurchasedequipmentandtheycanonlyindepen
36、dentlyoperatetheequipmentafterexaminedqualified.2）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；Theoperatorwhochangeshisjobswithinthecompanyshouldreceivejobtrainingbeforeindependentlyoperatingtheequipment.3）设备操作者应基本掌握设备的“三好”（管好、用好、保养好）、“四会W（会使用、会保养、会检查、会调整）。Theequipmentoperatorshouldbasicallymasterthefollowingitems
37、,literally,uthree-goods,makingtheequipmentmanaged,usedandmaintainedperfectlyand“fbur-abilities“equippedwithfourabilities,namely,use,maintenance,inspectionandadjustment.4.4.1.2 设备的定人定机Certainpersonsforcertainequipment1）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；Thecertainpersonsforthecriticalequipmentsho
38、uldbeproposedbytheuserdepartmentandimplementedbytheequipmentmanagementteam,sreview.2）属于“般设备”，由各使用部门根据实际情况实施定人定机。Thecertainpersonsforthegeneralequipmentwillbecarriedoutbyeachuserdepartmenlbasedonactualsituation.3）正常情况下，操作者不得串机使用；Normally,theoperatorisnotallowedtooperatedifferentequipmentatthesametime
39、.4）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。Theequipmentthatneedsmorethanonepersontooperateshouldbemanagedandmaintainedbycertainpersonsappointedbytheuserdepartment.4.4.1.3 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间、运行状况记录在设备日运行记录（QPo40-RE-06）上Theequipmentoperatormustusetheequipmentstrictlyaccordingtotheequi
40、pmentSOPs.ThepersoninchargeofthegeneralequipmentandthecriticalequipmentshouldrecordtheequipmentdailyoperationaltimeandstateontheEquipmentDailyOperationRecord（QP040-RE-06）.4.4.2 设备的维护与保养Theequipmentmaintenance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。Theequipmentmanagementteamshouldestablishandkeeptheequipm
41、entdebugging,cleanlinessandmaintenanceschedulestoensureregularmanufacturing.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：Theoperatortogetherwiththemaintenancepersonnelshouldbeinchargeoftheequipmentmaintenancecoveringdailymaintenanceandperiodicalmaintenance.1）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后
42、并填写设备清洁记录（QPo40-RE-13）。重点是对常用部件的性能、参数、运行条件进行确认，和对设备外表面的清洁卫生处理。Theoperatorshouldtakechargeofdailymaintenancewhichincludesthefollowingaspects,namely,relevantmattersrequiredintheSOPs,theequipmentincleanandtidyconditionandcompletingtheEquipmentCleaningRecord(QP040-RE-13)oftheequipmentthatneedsfront-endc
43、leaningafterthecleaningfinished.Thekeypointhereisthatverifyingtheperformance,parametersandoperationalconditionofthecommonpansandcleaningthesurfaceoftheequipment.2)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
44、(QP040-RE-ll),Periodicalmaintenanceisdirectedbythemaintenancepersonnelcoordinatedwiththeoperatorundertheguidanceoftheequipmentmanager.Thecriticalequipmentandthegeneralequipmentshouldbemaintainedperiodically.Suchphenomenaasperformancefluctuation,parameterchanging,componentagingetc.,afterlong-termuse,
45、shouldbeproperlydealtwithbythesiteorchangedaccordingtoplans.Movingpartsshouldbelubricatedanddecontaminatedeffectively.Whileworncomponentsshouldbechangedimmediatelyincasethathiddentroublesturnintomalfunctions.TheEquipmentMaintenanceRecord(QP040-RE-11)willbecompletedafterallthemaintenancework.3)设备保养记录
46、表(QpO40-RE-II)的No.由8位阿拉伯数字组成。从左往右，前2位是设备所在部门的部代码；第3到第6位是保养发生时所在的年月；第7和第8位是流水号，从Ol到99oThenumberoftheEquipmentMaintenanceRecord(QP040-RE-l1)ismadeupof8Arabicnumerals,fromlefttoright,theformerfouristhecodeoftheuserdepartment,thefifthandsixthnumbersstandforthemonthwhenthemaintenanceiscarriedoutandthelas
47、ttworepresenttheserialnumberfrom01to99.4)保养依据：设备操作规程中相关内容TherelevantcontentinSOPsshouldberegardedasthemaintenancebasis.5)保养周期：重关设备每6个月进行一次，一般设备每12个月进行一次。Themaintenanceperiodisregulatedasthefollowingclausethatthecriticalequipmentwillbemaintainedevery6monthsandthegeneralequipmentevery12months.6)两次保养之间
48、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(QP040-RE-11)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QA确定是否需要进行验证，验证按验证规程(QRO40)进行。Duringtheintervalbetweenthelastandthenextmaintenance,relevantmaintainingworkmustbestrictlycarriedoutaccordingtotheannualequipmentmaintenanceplan.Ifnot,thereasonandresultoftnotmaintainingonscheduleshouldberecordedintheEquipmentMaintenanceRecord(QP040-RE-11).Ifthemaintenancecontainsthechange
