分層審核LAYERAUDIT介紹課件

LAYEREDAUDITS

分層審核LAYEREDAUDITSPURPOSE目的:

Toprovideasystemto保證系統(tǒng): -verifycompliancetothedocumentedprocess-確保按文件標準生產(chǎn)/裝配 -instilldiscipline-培養(yǎng)規(guī)范行為 -improvecommunication-增加交流 -improveoverallquality-提升整體質(zhì)量LAYEREDAUDITSSCOPE:范圍

AssemblyArea組裝場地ManufacturingOperations制造場所Shipping/Receiving發(fā)運/接收場地Repair/ReworkArea返修/返工場地AllOperationsandothersupportfunctions

所有生產(chǎn)和其他相關(guān)支持區(qū)域PURPOSE目的:ToprovideasystemRESPONSIBILITY職責:TheManufacturingPlantManagerisresponsibleforimplementationandexecutionofthisprocedure.生產(chǎn)工廠經(jīng)理負責執(zhí)行和完成該程序。TheManufacturingQualityManagerisresponsibleforsupportingtheimplementationofthisprocedure.生產(chǎn)質(zhì)量經(jīng)理負責支持執(zhí)行該程序。RESPONSIBILITY職責:TheManufactuREQUIREMENTS要求:

LayeredAuditsshallbeconductedformanufacturingandassemblyofhighriskitemsataminimumofoncepershift.

分層審核針對高風險項目的生產(chǎn)和裝配至少每班進行一次。FrequencyofLayeredAuditsbasedonproductionvolumeorlevelofriskassociatedwithprocess.

分層審核的頻次因依據(jù)所審核內(nèi)容的數(shù)量及風險級別進行確定。LayeredAuditssupplementongoingcontrolplanandjobinstructionchecks.

分層審核需要是當前控制計劃和操作指導書的補充和完善。AchecklistofhighriskitemstobeverifiedduringLayeredAuditsshallbeestablished.

應(yīng)建立一份需進行分層審核的高風險項目檢查列表。Elementsshouldbeconsideredindevelopingthechecklist.(Example) 應(yīng)在建立列表時考慮到以下一些相關(guān)內(nèi)容，且該列表應(yīng)是靈活的。REQUIREMENTS要求:LayeredAuditElements要素(Example)Elements要素(Example)REQUIREMENTS(continued)要求:

LayeredAuditsresultsshallberecorded.分層審核結(jié)果應(yīng)記錄。

Non-conformitiesshallbeaddressedimmediately

,andcorrectiveactiondocumented不合格情況應(yīng)立即匯報，并記錄糾正措施。Reactionplan(s)fornon-conformitiesdetectedduringLayeredAuditsshallbedocumentedandavailableforuse.對分層審核中發(fā)現(xiàn)的不一致情況應(yīng)記錄以備進一步使用。Correctiveactionsshallbedocumented.

所有已采取的改進措施應(yīng)該進行記錄。REQUIREMENTS(continued)要求:LResultsshallbesummarizedandreviewedbythemanufacturingsiteleadership.審核結(jié)果應(yīng)匯總并由上級生產(chǎn)管理者檢查。LayeredAuditdocumentationshallbecompiledinthe

LessonsLearned(keystrategy)database.

各級審核結(jié)果應(yīng)最終進行整理，并將其中的內(nèi)容記錄入Lessonslearned（keystrategy)數(shù)據(jù)庫中。分層審核LAYERAUDIT介紹課件REQUIREMENTS(continued):

Customerusedfeaturesshallbeidentified,listedandcheckedinthemanufacturingprocesswithemphasison:客戶的使用特征應(yīng)在能分解到各生產(chǎn)過程中，并且對這些使用特性進行重點的識別、列出、及檢查： -Supplierpassthroughfeatures供應(yīng)商通過率指標 -Mounting(holes,taps,etc.)裝配特性（孔，螺孔，等） -Electricalconnections/connectors電氣連接/接頭 -Mountingsurfaces安裝表面 -Clearances間隙 -Missing/wrongbrackets丟失/裝錯的支架 -Incorrectparts錯誤的零件 -Othersasidentifiedbycustomer顧客提出的其他要求REQUIREMENTS(continued):Cus

ThefollowingisanexampleofaLayeredAuditwiththreelevelsofmanagementinvolvedintheprocess:

以下是三級管理層參與生產(chǎn)過程分層審核的一個例子。 -Themanufacturingsupervisorshallverify(daily)allquality documentationiscompletedbyoperators. 現(xiàn)場制造監(jiān)督者（班組長）核查所有由操作工填寫完成的質(zhì)量記錄（每天）。

-Themanufacturingareamanagershallverify(weekly)that supervisorverificationisbeingcompleted.

現(xiàn)場區(qū)域經(jīng)理應(yīng)該核查所有現(xiàn)場制造監(jiān)督的質(zhì)量記錄（每周）。 -Siteleadershipshallconductlayeredauditsata frequencydefinedlocally.

生產(chǎn)制造負責人應(yīng)該定期進行分區(qū)域的分層審核工作。Recordsshallbemaintainedperlocalprocedures.以上所以分層審核記錄應(yīng)相應(yīng)的分別保存在各區(qū)域。ThefollowingisanexampleQUALITYELEMENT:LAYEREDAUDITREACTION(SpecialCauseCUSTOMERCONCERNSExternal-PRR’s,etcInternal8STEPCorrectiveAction-12:15p.m.Reportouts-FastResponseP.F.M.E.A.CONTROLPLANSWhat’scriticaltotheprocess?PFMEARPNREDUCTIONTEAMSCrossFunctionalShaininJOBINSTRUCTIONS-StandardizedWorkAUDITTHEPROCESSFormalLineitemdocument-ItemsCheckeddaily-Isthesystemworking?AUDIT%COMPLIANCE-DataCollection-Participation-Responsiveness-IntegrityRESULTS-QualityImproved-QualityStabilizedPrevention(CommonCause)ExampleGMPTmodelQUALITY