普通设备鉴定之管制程序 中英文对照.docx
《普通设备鉴定之管制程序 中英文对照.docx》由会员分享,可在线阅读,更多相关《普通设备鉴定之管制程序 中英文对照.docx(22页珍藏版)》请在冰豆网上搜索。
普通设备鉴定之管制程序中英文对照
evisionHistory
REV
DCN#
INITIATED
BY
EFFECTIVE
DATE(MM/DD/YY)
DESCRIPTION
A00
DRAFT
WilliamMagramo
DRAFT
MAY26
InitialRelease
ApprovedDCNonFileinDocumentControl
APPROVEDBY
MotoakiWakui
AUTHORIZEDBY
SKLam
CONFIDENTIAL
PROPERTYOFZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITED
Thisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorimpliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentof
ZhongshanSunmingOpticalTechnologiesLimited.
©2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITED
ALLRIGHTSRESERVED
1.0PURPOSE目的
1.1Todefineacorporateprocedureforequipmentqualification.
定义了设备鉴定的管制程序。
2.0SCOPE范围
2.1Thisproceduredescribestheminimumrequirementsandstepstoqualifyanewlyacquiredtypeofproductionequipmentpriortoassigningitforproductionuse.
此程序描述了在购买的新型生产设备投入生产之前,对其进行鉴定的最低要求和步骤。
3.0ASSOCIATEDDOCUMENTS有关文件
3.1InternalDocuments:
内部文件:
AP2xxxx:
DRAFT
4.0DEFINITIONS定义
4.1ECN-EngineeringChangeNotice工程变更通知
4.2P.O.-PurchaseOrder采购订单
4.3PreliminaryProcessCapability初期制程能力
5.0GENERALREQUIREMENT一般要求:
5.1Priortoplacinganorderfornewtypeofequipment,itshallbetheresponsibilityoftheDepartmentManagertogeneratetheequipmentProcurementrequirementsintheformatofanequipmentprocurementdocumentthrougharelatedECN.AfterapprovalofthisECN,thisdocumentshallbegiventoselectedsupplierswiththePOandthevendorshallcomplywithalltherequirementsstatedinthisdocument.
新类型设备下单购买前,由部门经理负责以设备采购文件的工程变更通知的形式完成设备采购需求,工程变更通知批准后,将此文件以及采购订单给已择定的供应商,供应商应提供满足文件列出的所有条件的产品。
5.2UponreceiptofsuchanequipmentattheReceivingStore,thestorepersonnelshallensuretheequipmenthasobtainedtherelated“AssetNumber”assignedbyAccountsand/orthe“CalibrationEquipmentNumber“whereapplicable,assignedbytheCalibrationEngineerbeforeequipmentistobereleasedtotheconcernedProcessEngineer/ManufacturingEngineertobuy-off(validation)activities.
接收仓库在收到此设备后,在设备交付给有关的制程工程师/生产工程师进行检查确认活动前,仓库人员应确保此设备已得到由财务部指定的相关的“资产编号”和/或校正工程师指定的“校正设备编号”(可用的话)。
5.3ItshallbetheresponsibilityofareaProcessEngineer/ManufacturingEngineertocarryouttheEquipmentqualification,tests/checksbasedontherequirementsstatedinthe“EquipmentProcurementDocuments”,whensuchequipmentarrivedatSUNMING.
当此设备到达SUNMING后,由区域制程工程师/生产工程师根据“设备采购文件”的要求执行设备鉴定。
5.3.1Consignedequipmentfromcustomershallalsoundergoqualificationandtests/checks
inaccordancetoit’sintendedfunctionandspecification.
客户委托的设备也应进行鉴定并根据其预期功能及规格进行测试/检查。
5.4Theequipmentshallbeset-upinaccordancewiththemanufacturer’sinstructionsanditshallbeassessedfortheperformancetosatisfytherequirementsstatedinrelatedSUNMINGequipmentprocurementdocument.
按照制造商的说明装设设备并对性能进行评估,是否满足SUNMING设备采购文件的要求。
5.4.1AcomprehensivemanufacturabilitytestshallbecarriedoutbytheEngineerconcerned
toconfirmallspecifiedrequirementscanbemetwith.
工程师应展开一项综合的可制造型测试以确保此设备能够满足所有要求。
5.5Criticalmeasurements(mechanical)/tests/checkstotheprocessedmaterialshallsatisfythespecifiedrequirementsbeforetheequipmentcanbeacceptedascomplying.PPKstudyshallbeperformedforcriticalprocessand/orproductparameters(specifications).ChecklistforProcessCharacterization(Refer:
Attachment‘1’),ProcessCapabilityStudy(Refer:
Attachment‘2’)andPreliminaryCapabilityStudyReport(Refer:
Attachment‘3’)shallalsobecompletedwithappropriateinformation.IncaseofimplementingtheSPCmonitorforprocessand/orproductparameter,aminimum1.67ofPpkindexmustbeachieved.CpkimprovementplanisrequiredifPpkislessthan1.67.ChecklistforSPCdocumentation(Refer:
Attachment“4”)andoutofcontrolActionPlan(Refer:
Attachment‘5’)shallalsobedocumented.
在设备验收前,按照指定的需求对制程中的材料进行主要的测量(机械的)/测试/检查。
对主要制程和/或产品参数(规格书)应进行过程性能指数(PPK)研究。
制程描述清单(参考附件1),制程能力研究(参考附件2)及初步能力研究报告(参考附件3)也应建立适当的信息。
PPK最少应达到1.67以执行对制程和/或产品参数的统计制程管制(SPC)的监控.如果PPK未达到1.67,则需要工序能力指数(CPK)的提升计划。
统计制程管制文件的清单(参考附件4)及失控措施计划(参考附件5)也应文书化。
5.5.1Theprocess/manufacturingengineer,afterthecompletionofsuchasuccessful
assessment,shallpreparetherelatedevaluationreportandsubmittotheHeadof
Engineering,ManufacturingandHeadofQualityforfinalapproval.
成功的完成评估后,制程/制造工程师应准备相关的评估报告并提交给工程,生产部和品质部的领导作最终批准。
5.5.2Equipmentwhichcannotmeetthespecifiedrequirementsshallbeconsideredas
“unsatisfactory”.However,forcaseswherequalificationresultsdoesnotfullymeetthe
requirementsbutdeemedtobeclosetoit,therelatedProcess/Manufacturing
Engineerorassignedpersonnelforqualifyingthisequipmentshallreviewthe
qualificationresultswiththeHeadofQuality/EngineeringandManufacturingwho
shalljointlyassessanddetermineifaconditionalqualificationcanbeprovidedwithina
specifiedtimeframe.
当设备不能满足指定要求时应将其定义为“不符合要求”。
当设备鉴定结果只能接近要求而不能完全满足要求,出现这种情况时,相关的制程/生产工程师或鉴定此设备的指定人应同品质部领导/工程师及生产部商定评估此设备的鉴定结果,并决定是否可在指定的时间内提供一个条件鉴定。
5.5.2.1Ifmachineisplacedundertheconditionalqualification,theequipment
performanceshallbemonitored/improvedtoachievethefullperformance
capabilitiesstatedbythemanufacturerwithinaperiodof3months.The
processcapabilityoftheequipmentshallbemonitoredbytheprocess/
manufacturingengineerorbytheassignedpersonnelthroughappropriate
controlcharting/statisticsmethodsandaminimumtargetof1.67ofCpkshallbe
targetedforachievementwithinthestatedperiodof3months.Iftheequipment
failstomeetthequalityorprocesscapabilityrequirementsorduetoreliability
issues,therelatedsuppliershallbeinformedforimprovements/rectification.
若机器需进行条件鉴定,应在3个月的时期里监测/提高设备的性能以满足制造商所说明的全部性能。
制程/生产工程师或指定人应通过适当的控制图/统计方法对设备的工序能力进行监测。
工序能力指数(CPK)在规定的3个月期限内应达成的最低目标1.67。
若设备不能满足质量或工序能力要求或由于可靠性问题,应通知相关的供应商进行改善/整改。
5.5.3Whetherfullorconditionalqualificationisprovided,thequalificationreportshallinclude
afullyaccomplishedformsunderattachments1to5.Onesetofcopyshallthenbe
passedontoDCCforfilingandasecondcopyofthereportshallbesenttothe
calibrationEngineer,wheretheequipmentrequirescalibration,toproceedwiththe
necessarycalibrationactivity.
不管提供的是全面鉴定或条件鉴定,鉴定报告应包括附件1到5所有的完成的表格。
一组报告副本应交给文控中心存档,另一组应交给校正工程师,也就是设备要求校正并进行了必要校正活动之处。
5.5.4Thebuyoffstickershallonlybeissuedwhenthefollowingrequirementsarefully
Accomplished.
当以下要求全部满足后,贴检查确认标签
5.5.4.1Approvedbuy-offreport
批准的检查确认报告
5.5.4.2Assignedassetnumber
指定的资产编号
5.5.4.3Preventivemaintenanceregistrationform
预防维护登记表
5.5.4.4CompletegageR&Rstudy,ifapplicable
完整的量具双性研究结果,可行的话
5.5.4.5Relevantcontrolplanshowingupdatedequipmentlist
显示更新设备清单的相关控制计划
5.5.4.6RelevantAP&PMspecsshowingupdatedequipmentlist
显示更新设备清单相关的AP&PM规格书
5.5.5Thebuy-offstickershallbevalidonlyifitcarriesthecalibrationstamp.
Minimuminformationinthebuy-offstickershallinclude.
检查确认标签仅在有校正印章的情况下有效,检查确认标签最少需包含以下信息
5.5.5.1Machinetype机器类型
5.5.5.2Machinenumber机器编号
5.5.5.3Serialnumber序列号
5.5.5.4Dateofissue发布日期
5.5.6Ifcalibrationisnotrequiredforanewequipmentacquired,thecalibrationengineershall
issuethebuy-offstickertotheequipmentbasedontheevaluationreportfromthe
Process/ManufacturingEngineerorassignedpersonnelearlierreceivedbythe
calibrationsection.Ifcalibrationisrequired,thenthisshallbecarriedoutincompliance
toCS20001-CorporateProcedureforCalibration.
若不需要校正一个已获得的新设备,校正工程师应根据制程/制造工程师或校正部早些时候收到设备的指定人的评估报告来发布检查校正标签。
若要求校正,则按照CS2001-校正之管制程序执行。
5.5.7Ifthecalibrationchecksaresatisfactory,thecalibrationengineershallissuethebuy-off
sticker.Ifsuchchecksdonotmeettherequirements,theProcess/Manufacturing
Engineerorassignedpersonnelappraisedthissituationanthestickershallnotbe
issueduntiltheissueisresolvedsatisfactorily.Ifcalibrationisrequiredonanew
equipment,thecalibrationmasterlistshallbeupdatedwiththerelevantequipment
detailsbuttheequipmenthistorycard,insuchcasesshallbemaintainedbysection
headofwherethemachineisused.
若校正检查结果令人满意,校正工程师应发布检查校正标签。
若不符合要求,制程/制造工程师或此状况的指定评估人在此问题没有得到满意解决前不能发布检查确认标签。
若一个新设备需校正,包含相关设备细节的校正主列表需更新,而不需要更新由设备使用部门领导维护的设备记录。
5.5.8Anewtypeofequipmentshallnotbeputintoproductionusedwithoutthemachine
“buy-offsticker”.
在没有“检查确认标签”的情况下,一个新类型的机器不允许用于生产。
5.6Outoftheexistingtypesofequipmentsthecurrentproductionuse,thoserequiringcalibrationarelistedinAttachment‘2’.
当前生产使用的已存在的设备类型,附件2列举了需校正的项目。
5.7Ifseriousdeviationfromtheabovearenoticed,certainauthorizedpersonnelshallbeempoweredtosuspendthemachinefrombeinguseduntilsatisfactoryevidenceofsuccessful‘buy-off’isproduced.
若以上发现严重偏差,某授权人员应被允许暂停此机器的使用直到有证据证明此设备“检查确认”成功。
Attachment“1”
YesNoRemarks
1.Isthereaflowcharttodescribetheprocess?
2.Isthereaparetochartofproblemsrelatingtotheprocess?
3.Isthereacauseandeffectdiagramtodetailtheproblem?
4.HasanFMEAontheprocessbeengenerated?
4.1HasaparetoofRPNsbeenconstructed?
4.2A