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原创SQP审核清单中英文对照
1.ManagementmitmentandcontinualimprovementFUNDAMENTAL Thepanyssenior___nagementshalldemonstratetheyarefullymittedtotheimplementationoftherequirementsoftheSupplierQualificationProgram.Thisshallincludeprovisionofadequateresour___s,effectivemunication,systemsofreviewandactionstakentoidentifyandeffectopportunitiesforimprovement.该公司的高级管理层应当证明他们会全力的供应商资格认证计划的要求执行这应包括提供足够的资源,有效的沟通,审查和改进系统和采取确定的行动效果的机会
1.1Doesthepanys___nagementdefineproductsafetyandqualityobjectives贵公司管理层确定产品的安全和质量目标?Moderate
1.2Isthereviewofthe___nagementsystemscarriedoutatleastannually是管理制度的检讨进行每年至少一次?Minor
1.3Doesthereviewofthe___nagementsystemsincludeevaluationofthefollowingitems是否该管理系统的审查包括以下项目的评价?
1.
3.1Resultsofaudits(internal,secondandthird___audits);审计结果(内部,第二和第三方审计)
1.
3.2Followupactionsfromprevious___nagementreviews;按照以往管理评审的跟踪措施
1.
3.3CustomerComplaintsandfeedback;客户投诉和反馈
1.
3.4Statusofpreventiveandcorrectiveactions;预防和纠正措施的状况
1.
3.5Pro___ssperfor___n___andproductconformity;过程绩效和产品的符合性
1.
3.6ChangesthatcouldaffecttheManagementSystems;可能影响管理体系的变化
1.
3.7Productsafetyandqualityobjectives;产品安全和质量目标
1.
3.8Risk___nagement;风险管理
1.
3.9Statutoryandregulatoryrequirements;法律法规要求
1.
3.10Resour___needs;and资源需求,以及
1.
3.11Remendationsforimprovement.改善建议Moderate
1.4Arethedecisionsandactionsagreedduringthereviewmunicatedeffectivelytoappropriatestaff被审查有效适当的工作人员沟通过程中的决策和行动一致?Minor
1.5Aretheactionsimplementedwithintheagreedtimescales是在商定的时间表落实的行动?Minor
1.6Doesthepanys___nagementprovidethefollowingoverallresour___srequiredtoimplementandimprovethequality___nagementsystemandriskasses___entplan,andtoaddresslegal,productsafety,andproductquality___tters请问公司的管理提供了实现和完善的质量管理体系和风险评估计划所需的下列整体资源,以解决法律,产品的安全性和产品质量问题?
1.
6.1personnel人员
1.
6.2infrastructure(e.g.,building,equipment,transport…etc)基础设施(如建筑物,设备,交通工具...等)
1.
6.3workenviro___ent工作环境
1.
6.4financialsupport财政支持Moderate
1.7Doesthepanyhaveapro___ssinpla___toidentifyopportunitiesforimprovements公司是否制定一个过程,识别改进机会?Minor2RiskManagementFUNDAMENTAL Thepanyshallhaveaproductrisk___nagementplan,basedonariskasses___entsystemwhichshallbesyste___tic,prehensive,thorough,fullyimplementedand___intained.Companiesmustbeawareofand___kereferen___toup-to-datelegislation,productstandards,codesofpracti___anddevelopmentsinscien___ortechnologythat___yimpacttheriskcon___rningtheirproductsandpackagingwheretheseexistinthecountriesofintendedsale.该公司须有产品的风险管理计划,根据风险评估制度,应是系统的,全面的,___的,全面实施和保持企业必须了解并参考了最新的法规,产品标准,实践的科学或技术规范和发展,可能会影响到有关他们的产品和包装,其中这些存在于拟出售的国家的风险
2.1LegislativeandSafetyRequirements
2.
1.1Isthepanyawareofrelevantlegislation,___ndatorystandardsandindustry/customercodesofpracti___applicabletotheproductinthecountriesofintendedsaleModerate
2.
1.2Doesthepanyhaveameanofvalidatinginfor___tionimpactingproductsafety,qualityandlegality,wheresuchinfor___tionisprovidedbythecustomerorrelated___Minor
2.
1.3Doesthepanyhaveapro___ssinpla___forensuringitiskeptinformedofchangestorelevantlegislation,standardsetcModerate
2.2RiskAsses___ent
2.
2.1Doesthepanyestablishaproductriskasses___entforeachproductoragroupofsimilarproducts,e.g.,FMEAModerate
2.
2.2Where___nufacturingsiteshavenoresponsibilityforproductdesign,isthepanyprovidedwithavalidatedcopyoftheproductriskasses___entModerate
2.
2.3Doestheproductriskasses___entaddressthefollowingaspectswhichhaveaneffectonproductsafetyandlegality
2.
2.
2.1Usertypes(e.g.,newborn,youngchildren,vulnerablepeoplei.e.,elderly,disabilities)
2.
2.
2.2Productuse(e.g.,behaviour,durability,userawareness,infor___tionandadvi___)Moderate
2.
2.4Doestheproductriskasses___entdeterminethefollowing
2.
2.
3.1PossibleHazard/RiskIdentification(e.g.,Chemical,Physical,Regulatory);
2.
2.
3.2Risklevelforeachidentifiedhazard/risk(e.g.,Severe,High,Moderate,Slight);
2.
3.3Whethertheriskisaeptableconsideringtheprobabilityorlikelihoodandtheseverityandpotentialconsequen___softheeffectsonconsumersafety(e.g.,NotAeptable,ReviewImprove,Aeptable)Moderate
2.
2.5Doesthepanyconductapro___ssriskasses___entofhazardspotentiallyintrodu___dduringtheproduction,packagingorstoragepro___ssesModerate
2.
2.6Doesthepro___ssriskasses___enttakethefollowingintoaount
2.
2.
6.1___nufacturingparameterssuchaspressure,time,temperature
2.
2.
6.3conditionsofequipment,moulds,___s,___chinery
2.
2.
6.4chemicals/___terialsusedforequipment(e.g.lubricatingoilsandpaints)
2.
2.
6.5calibrationofequipment
2.
2.
6.6policiesonforeignbodycontamination(e.g.needles,metal,glassandbrittleplastics)
2.
2.
6.7policiesonmicrobiologicalcontamination(e.g.hygieneoftoiletcanteen,pestcontrol)
2.
2.
6.8personalprotectiveequipment(includingspecificclothingandfootwear)Moderate
2.
2.7Doesthepro___ssriskasses___entidentifythefollowing
2.
2.
7.1Alistofpotentialriskorhazardsintheproductionpro___ss
2.
2.
7.2Controlpointsto___nagetheidentifiedrisktoaeptablelevel
2.
2.
7.3Aept/rejectlimitsdefinedforeachcontrolpoint
2.
2.
7.4CorrectiveactiontobetakenwhereaCCPisoutofcontrol
2.
2.
7.5ResponsibilityofControlPoints
2.
2.
7.6RecordsofmonitoringreviewsModerate
2.
2.8Iftheasses___entresultedinunaeptablerisk,doesthepanygobacktoproductdesignpro___ssorcustomerformodificationtoachieveaeptableriskModerate
2.3VerificationofRiskAsses___ent
2.
3.1Istheverificationofriskasses___entcarriedoutpriortoproductionModerate
2.
3.2Istheriskasses___entcarriedoutbypetentpersonnel(internalorexternal)Moderate
2.
3.3Istheriskasses___entregularlyreviewed,atleastannuallyorwhenchanges___detoproductdesignand___terialsand/orkey___nufacturingpro___ssesModerate
2.
3.4Whererequiredbylegislation,doesthepanydocumentandverifytheidentity,qualificationsand/orli___n___ofthepersonprovidingthesafetyrevieworriskasses___entMajor
2.
3.5Whererequiredbylegislationorwhenitisne___ssarytoconfirmitssafetyorlegality,doestheriskasses___entincludethetestingresults(fromaqualifiedandareditedexternal/internallaboratory)ofarepresentativeproductMajor3QualityManagementSystem
3.1PolicyStatementThepanyssenior___nagementshalldevelop,documentandimplementapolicystatementwhichisauthorised,regularlyreviewed,signedanddatedbyanappropriatesenior___nager.
3.
1.1Doesthepanyestablishapolicystatementwhichhasbeenmunicatedandunderstoodbyallstaffinvolvedwithactivitiesimpactingproductsafety,legalityandqualityModerate
3.
1.2Doesthepolicystatementincludethefollowing
3.
1.
2.1Thepanysintentiontoprodu___safeandlegalproductstodefinedquality,andtomeetitsresponsibilitytoitscustomers;and
3.
1.
2.2AmitmentforreviewandcontinualimprovementMinor
3.
1.3DoesthepanyperiodicallyreviewthepolicystatementforcontinuingsuitabilityMinor
3.2GeneralDocumentationRequirements
3.
2.1ControlofDocumentThepanyssenior___nagementshallensurethatalldocuments,recordsanddataimpactingthe___nagementofproductsafety,legalityandqualityareinpla___andeffectivelycontrolled.
3.
2.
1.1Doesthepanyeffectivelycontrolalldocuments(internalandexternal)impactingproductsafety,legalityModerateandquality
3.
2.
1.2Areup-to-dateversionsofdocumentsavailableatpointsofuseMinor
3.
2.
1.3Aredocumentlegible,unambiguous,inappropriatelanguagesandsufficientlydetailedtoenabletheircorrectapplicationbystaffMinor
3.
2.
1.4AreobsoletedocumentsidentifiedandremovedfromuseMinor
3.
2.
1.5Doesthepanyrecordthedateandreasonforanychange/amendmenttodocumentsimpactingproductsafety,legalityorqualityMinor
3.
2.2ControlofRecordThepanyshall___intainrecordstodemonstratetheeffectivecontrolandachievementofproductsafety,legalityandquality.
3.
2.
2.1Doesthepanyestablishpro___duresforthecollation,review,___intenan___,storageandretrievalofallrecordsimpactingproductsafety,legalityandqualityMinor
3.
2.
2.2Arerecordslegible,genuineandauthorisedMinor
3.
2.
2.3Arerecordsreadilyaessible,securelystoredtopreventda___gedeteriorationMinor
3.
2.
2.4Arerecordsretainedinaordan___withperiodsspecifiedbyacustomerorlegislationModerate
3.
2.
2.5AreanyalterationstorecordsjustifiedandauthorisedModerate
3.
2.3SpecificationsThepanyshallensurethatspecificationsexistforraw___terials,ponentsandboughtinpartsincludingpackaging,intermediate/semi-pro___ssedandfinishedproductsandanyproductorservi___whichcouldaffecttheintegrityofthefinishedproduct.
3.
2.
3.1Doesthepanyestablishspecificationsforraw___terials,ponents,andbought-in-partsincludingpackaging,intermediate/semi-pro___ssedandanyproductorservi___whichcouldimpacttheintegrityofthefinishedproductModerate
3.
2.
3.2IsaspecificationofeachfinalproductdocumentedanddatedModerate
3.
2.
3.3Doesthespecificationincludethefollowinginfor___tion,whereapplicable
3.
2.
3.
3.1position,size,colour
3.
2.
3.
3.2billof___terials
3.
2.
3.
3.3assemblydiagrams
3.
2.
3.
3.4pri___rypackaging
3.
2.
3.
3.5intendedshelflife
3.
2.
3.
3.6warningsorinstructionsforuse
3.
2.
3.
3.7use,misuse,usagepatterns
3.
2.
3.
3.8productionvolumesModerate
3.
2.
3.4Arespecificationsaurateandplyingwithrelevantsafety,legislativeandcustomerrequirementsMajor
3.
2.
3.5ArecurrentspecificationsaessibletorelevantstaffMinor
3.
2.
3.6Doesthepany___intaintechnicaldossierorpackagecontainingallrelevantdata(ordetailofwheresuchdataislocated)toensurethatproductsmeettheapplicablerequirementsModerate
3.
2.
3.7Doesthetechnicaldossierorpackageincludethefollowinginfor___tion
3.
2.
3.
7.1adetailedproductspecification
3.
2.
3.
7.2safetydatasheetsonchemicalsusedwhererelevanttothesafety,legalityorqualityoftheproduct
3.
2.
3.
7.3theriskasses___ent(s)
3.
2.
3.
7.4adescriptionoftheconformityasses___entpro___dure;
3.
2.
3.
7.5testreports,inspectionreports
3.
2.
3.
7.6alistofthelegislation,productstandardswithwhichtheproductsare___nufacturedtoply
3.
2.
3.
7.7productioncontrolpro___duresandcharts
3.
2.
3.
7.8approvalsbyanygover___entbody(ifapplicable)
3.
2.
3.
7.9declarationsofconformitytolegalrequirements(ifapplicable)Moderate
3.
2.
3.8Arespecificationsfor___llyagreedwithrelevantparties(e.g.,signedoffbythecustomer)Wherespecificationsarenotfor___llyagreed,thepanymustdemonstratethatithastakenstepstoseekfor___lagreement.Minor
3.
2.
3.9ArespecificationsregularyreviewedatleastannuallytoensureitsadequacyandstatusMinor
3.3ResponsibilityandAuthorityThepanyshallhaveaclearlydefinedanddocumentedorganisationalstructurethatensurestheawarenessofjobfunction,responsibilitiesandreportingrelationshipsofkeystaff.
3.
3.1Istheorganisationalchartavailableandup-to-dateMinor
3.
3.2Areresponsibilitiesandjobdescriptionsofkeystaffinvolvedwithproductsafety,legalityandqualityclearlydefinedandmmunicatedModerate
3.
3.3Doesthepanyhaveappropriatearrangementsinpla___,tocoverfortheabsen___ofkeystaffMinor
3.4InternalAuditThepanyshallauditthe___nagementsystemtoensurethatitispliedwithandappropriate.
3.
4.1DoesthepanyconductinternalauditsatplannedintervalsModerate
3.
4.2Doesthepanydefineanauditscheduledetailingauditcriteria(relevantpro___dures,requirementsandstandards),scope(includingareas,departmentsorpro___sses)andfrequencyMinor
3.
4.3Isthefrequencyofinternalauditsbasedonriskofactivities,aswellastheresultsofpreviousauditsMinor
3.
4.4Ifthereareanyex___ptionalaspectstobeauditedatafrequencyex___edingoneyear,aretheyjustifiedanddocumentedinriskasses___entMinor
3.
4.5Areinternalauditscarriedoutbypetentpersonnel,whoshallbeindependentoftheareaofoperationbeingassessedModerate
3.
4.6Arerecordsofinternalauditsandassociatedcorrectiveactions___intainedwithbothconformityandnonconformitywithrequirementsdocumentedMinor
3.5Purchasing,SupplierSub-contractorApprovalandPerfor___n___MonitoringThepanyshallcontrolallpurchasingpro___sseswhichareimpactingproductsafety,legalityandqualitytoensurethatproductsandservi___sprocuredconformtodefinedrequirements.Inthiscontextsuppliersshallincludesubcontractorsandhomeworkers.
3.
5.1DoesthepanyhaveaListofApprovedSuppliersSub-contractorsMinor
3.
5.2IstheListofApprovedSuppliersSub-contractorsup-to-datetocovertheponents,___terialsandservi___impactingsafety,legalityandqualityModerate
3.
5.3Arespecifications/requirementsmunicatedtoandagreedwiththesuppliersorsub-contractorsMinor
3.
5.4Doesthepanyestablishsuppliersub-contractorselectionandapprovalpro___ssMinor
3.
5.5Doesthepanyconductanongoingsuppliersub-contractorperfor___n___asses___entMinor
3.
5.6Doesthepanyreviewtheperfor___n___ofnewsupplierssub-contractoragainstcriteriawithinaspecifiedtrialperiodandthereafterataspecifiedfrequencytodecidethelevelofongoingperfor___n___monitoringMinor
3.
5.7Doesthepanydeterminehowex___ptionsarehandled,wheretheuseofproductsorservi___sofunapprovedsuppliersareaeptableunderemergencyorunusualcircumstan___sMinor
3.6CustomerPropertyThepanyshallexercisecarewithcustomerproperty(includingin___ectualproperty)whileitisunderthepanyscontrolorisbeingusedbythepany.
3.
6.1Isthecustomerproperty(e.g.software,in___ectualpropertyandproducts)identified,verified,protectedandsafeguardMinor
3.
6.2Doesthepanyhavemeansofreportingpropertythatislost,da___gedorotherwisefoundtobeunsuitableforusetothecustomerMinor
3.7CorrectiveandPreventiveActionFUNDAMENTAL Thepanyssenior___nagementshallensurethatpro___duresexisttorecord,investigate,___yseandcorrectthecauseofnon-conformingproductsorfailuretomeetstandards,specificationsandpro___dureswhichareimpactingproductsafety,legalityandquality
3.
7.1Doesthepanyestablishapro___duretocaptureandinvestigatethecauseofnon-conformityandpotentialnon-conformityimpactingproductsafety,legalityandqualityModerate
3.
7.2DoestheCorrectivePreventiveActionspro___dureincludethefollowing
3.
7.
2.1reviewingnon-conformities(includingcustomerplaint);
3.
7.
2.2investigatingtherootcauseofnon-conformities;
3.
7.
2.3determingandimplementingcorrective/preventiveactionsneeded;
3.
7.
2.4recordingtheresultsofactiontaken;
3.
7.
2.5evaluatingtheeffctivenessoftheactiontakenModerate
3.
7.3AreappropriatestaffmemberidentifiedandassignedtheresponsibiltyandaountabilityforeachcorrectiveandpreventiveactionMinor
3.
7.4Arecorrective/preventiveactionseffectivelytakentoeliminatethecausesofnon-conformitiesinordertopreventrecurren___/ouren___Moderate
3.
7.5ArecorrectiveandpreventiveactionsundertakeninanagreedtimeframeMinor
3.8IdentificationTra___abilityFUNDAMENTAL Thepanyshallhaveasystemtoidentifyandtra___productlotsincludingraw___terials,ponentsandpackaging___terialsandfollowthisfromthesour___oftheining___terialthroughallstagesofpro___ssingtosupplyoftheproducttothepri___rycustomerandvi___versainatimely___nner.
3.
8.1Areraw___terialsincludingpackaging,pro___ssingaids,intermediate/semi-pro___ssedproducts,part-used___terials,finishedproducts,re-workandnon-conforming___terialsclearlyidentifiedoflots/batchesduringallModeratestagesofre___ipt,production,storageanddispatch
3.
8.2Arefinishedproductslabelledaordingtothecustomerspecificationand/orlegislativerequirementsMajor
3.
8.3Dofinishedproducts(includingre-work)haveafulltra___abilityfromraw___terialssour___tothecustomer,andfromthecustomertotheraw___terialsour___Moderate
3.
8.4Istheeffectivenessofthetra___abilitysystemregularlytested,atleastannuallyMinor
3.9Incident,ProductWithdrawalandProductRecallThepanyshallhaveaplanandsysteminpla___toeffectively___nageproductwithdrawalandproductrecallpro___dures.
3.
9.1Doesthepanyhaveapro___dureoutliningmethodsandresponsibilitiesfornotifyingtheircustomersandotherrelevantpartieswherecircumstan___sarisethatrequireproducttobewithdrawanorrecalledfromdistributionModerate
3.
9.2Doesthepanyhaveawrittenagreements/consensusinpla___withrelevantpartiesinthesupplychainregardingtheproductwithdrawal/recallMinor
3.
9.3Isthereawrittenguidan___torelevantstaffregardingthetypeofissue/eventthatwouldconstituteasignificantincidentoremergencysituationtothecustomerorconsumerintermsofproductsafety,legalityandqualityModerate
3.
9.4Istheproductwithdrawalandrecallpro___dureregularlytested,atleastannuallyMinor
3.10BusinessContinuityPlanningThepanyshallhavepro___duresinpla___toidentifymethodsofensuringbusinesscontinuityinthecaseof___jorincidents/threatstoabusiness.
3.
10.1Doesthepanyhaveabusinesscontinuityplanintheeventof___jorincidents/threatssuchasdisruptiontokeyservi___s(e.g.water,power,staffavailability,keyequipmentfailuresandcustomer/fieldreturns),flood,fire,naturaldisasterand___liciouscontaminationorsabotageMinor
3.
10.2Doesthebusinesscontinuityplanincludethefollowing,asaminimum
3.
10.
2.1Asenior___nagementresponsibilityfordecision___,oversightandinitiatingactionsarisingfromacrisis___nagementincident;
3.
10.
2.2Acurrentlistofkeycontacts;
3.
10.
2.3Sour___soflegalandexpertadvi___;and
3.
10.
2.4Theresponsibilityforinternalmunicationsandmunicationswithauthorities,externalorganizationsandmedia.Minor
3.11CustomerFocusThepanyssenior___nagementshallensurethatpro___ssesareinpla___todetermineanycustomerrequirementsandexpectationswithregardtoproductsafetyandquality,andensurethesearefulfilled.
3.
11.1Doesthepanyhavepro___ssesinpla___toensurecustomerspecifications,needsandrequirementsareunderstoodandmetModerate
3.
11.2Doesthepanyhavedocumentaryeviden___ofcustomerrequirements(includingperfor___n___indicators,whereapplicable)relatingtothedevelopmentofspecification,___nufactureanddistributionofproductMinor
3.
11.3Arecustomerrequirements(e.g.,productioncapability,capacity…etc)reviewedonasuitableplannedintervalMinor
3.
11.4AreanyresultingchangestoexistingagreementsorcontractsdocumentedandmunicatedtorelevantpartiesModerate
3.
11.5Doesthepanyestablishperfor___n___indicatorsrelatingtocustomersatisfactionMinor
3.12ComplaintHandlingThepanyshalloperateaneffectivesystemforhandlingandinvestigatingthecauseandresolutionofproductplaints.
3.
12.1DoesthepanyoperateaneffectivesystemforhandlingandinvestigatingthecauseandresolutionofproductplaintsModerate
3.
12.2Doesthepanycarryoutpromptandeffectiveactionsinaordan___withtheseriousnessandfrequencyoftheproblemsidentifiedMinor
3.
12.3Doesthepany___yseanduseplaintdatatoimplementongoingimprovementsMinor
4.SiteandFacilitiesManagement
4.1LocationandPerimeterThesiteshallbeofsuitablesize,location,constructionanddesigntofacilitate___intenan___,preventcontaminationandenabletheproductionofsafeandlegalfinishedproducts.
4.
1.1IsthefactorysitelocationandperimeterallowtheproductionofsafeandlegalproductsMinor
4.
1.2Wherene___ssary,aremeasurestakentopreventcontaminationfromlocalactivitiesandthesiteenviro___entwhich___yhaveanadverseimpactontheintegrityoffinishedproductsModerate
4.
1.3Isthereanyeviden___ofda___geduetoinadequatedrainageorfloodingMinor
4.2InternalSite FactoryLayout,ProductFlowandSegregationFUNDAMENTALPremisesandplantshallbedesigned,constructedand___intainedsoastocontroltheriskofproductcontaminationandtoplywithallrelevantlegislation.
4.
2.1Aresitebuildingsandfacilitiessuitablefortheintendedpurposeandproperly___intainedModerate
4.
2.2Ispro___ssflowdiagramavailableMinor
4.
2.3Isthepro___ssflowandlocationof___chineryandequipmentfromintaketodispatch,logicaltominimiseproductcontaminationrisksModerate
4.
2.4Isworkingspa___andstoragecapacitysufficientMinor
4.
2.5Arefloorswelldesignedtomeetthefollowingcriteriaa)thede___ndsofthepro___ss;b)withstandcleaning___terialsandmethods;andc)imperviousand___intainedingoodrepair.Minor
4.
2.7Arebuildingsfabricandoverheadwalkways/structures(whereforeignbo___scouldfallthrough)controlledthroughregularinspections,wherene___ssaryMinor
4.
2.8Arewalls,floors,___ilings,pipe-workandoverheadstructuresdesigned,constructed,finishedand___intainedtopreventcondensationandmouldgrowth,especiallyinthestorageareasMinor
4.
2.9Doesallwatersuppliesusedasingre___ntoftheproductsorpreparationoftheproductswhereit___yeintodirectcontactwiththeproductmeettheapplicablerequirements/standardsforpotabilityinthecountryofsaleModerate
4.3StaffFacilitiesStafffacilitiesshallbesufficienttoaommodatetherequirednumberofpersonnel,andshallbedesignedandoperatedtominimisetheriskofproductcontamination.Suchfacilitiesshallbe___intainedingoodandcleancondition.
4.
3.1Arestafffacilities(e.g.toiletrooms,cleaningfacilities,canteens,etc)well-designedandconstructedsothattheycanbeeasilycleanedand___intainedinordertopreventanypotentialcontamination(e.g.bacterialcontamination)thatcouldpromiseproductquality,safetyandlegalityModerate
4.
3.2ArethelocationofstafffacilitiesNOTjeopardisingtheintegrityofproductsModerate
4.
3.3Where___okingisallowedundernationallaw,isthereadesignatedcontrolled___okingareaswhichmustbeisolatedfromproductionareasModerate
4.
3.4Wherene___ssary,doesthepanyprovidesuitableandsufficientstoragefacilitiestoaommodateallreasonablepersonalitemsMinor
4.
3.5Wherespecificwork-wearisrequired,doesthepanyprovidedesignatedchangingfacilitiesforallpersonnel,whetherstaff,visitororcontractorMinor
4.
3.6Areoutdoorclothingandotherpersonalitemsstoredseparatelyfromwork-wearwithinthechangingfacilitiesMinor
4.
3.7Doesthepanyprovidesuitableandsufficienthand-cleaningfacilitiesataessto,andatotherappropriatepointswithin,productionareasMinor
4.4CleaningandHygienePracti___sFUNDAMENTALHousekeepingandcleaningsystemsshallbeinpla___whichensurethatadequatestandardsofcleanlinessandtidinessare___intainedatalltimesandtheriskofcontaminationisminimized.
4.
4.1Arecleaningpro___duresestablishedforthebuilding,utilities,plantandequipmentMinor
4.
4.2Arecleaningpro___duresincludethefollowingasaminimum
4.
4.
2.1responsibilityforcleaning
4.
4.
2.2item/areatobecleaned
4.
4.
2.3frequencyofcleaning
4.
4.
2.4methodofcleaning
4.
4.
2.5cleaning___terialstobeused
4.
4.
2.6cleaningresponsibilityforverification,whereappropriateMinor
4.
4.3Arecleaningschedulesestablishedand___intainedMinor
4.
4.4Arecleaningpracti___spletedeffectivelysoastominimiseriskofcontaminationModerate
4.
4.5Whenthereisbuildingor___intenan___work,changestoequipmentorintroductionofnewproducttypes,arecleaninganddisinfectionpro___duresre-validatedwherene___ssaryMinor
4.
4.6Whereexternalcleaningservi___contractorsareemployed,istheservi___contractclearlydefinedthescopeandfrequencyoftheworkMinor
4.
4.7Isthecleaningprogrammonitoredforitseffectivenessandperiodicallyverified(e.g.suchasavisualpre-operationalinspectionbyadesignatedemployeeofequipmentandfacilitiespriortothestartofoperations)Minor
4.
4.8Arecleaningchemicalsclearlylabelled(Note nochemicalsaredecantedunlessintoproperlylabelledandMinoridentifiedcontainers)
4.
4.9Ishandcleaningperformedatasuitablefrequencyto___intainhygienicconditionsandpreventproductcontaminationModerate
4.
4.9Wherethereareproductcontaminationrisks(e.g.,inthefinalpackingarea),arene___ssarymeasuresbelowtakenasappropriate
4.
4.
9.1wearsuitableglovesorfootwear;
4.
4.
9.2wearprotectiveclothing;
4.
4.
9.3controlthewearingofjewellery;
4.
4.
9.4prohibiteating,drinkingand___okinginproduction/packagingarea;
4.
4.
9.5headandfacialhairisfullycontained;and
4.
4.
9.6prohibitthefalsefingernails.Moderate
4.5Waste/WasteDisposalThereshallbeadequatesystemsforthecollection,collationanddisposalofwaste___terial.
4.
5.1Aremeasuresestablishedtopreventtheaumulationofwaste___terialsinproductionareasModerate
4.
5.2Whereapplicable,arewaste___terialscategorisedaordingtolegislativerequirementsModerate
4.
5.3Arewaste___terialscollectedinsuitablydesignedwastecontainerswithclearlabelMinor
4.
5.4Productswhicharetobedisposedofonsafetygrounds,astheresultofarecallorwithdrawal,orassubstandardtrade___rked___terials,aretheydisposedofsecurelyordelegatedtoaspecialistinsecurewastedisposalMinor
4.
5.5Arewaste___terialssuitablyquarantinedandroutedtoensurethattheyarenotre-introdu___dintonon-wasteproductionflowsModerate
4.
5.6Areexternalwastecollectioncontainersandpactors___nagedinsucha___nnerastominimiserisktotheproductMinor
4.6PestControlThepanyshallberesponsibleforminimisingtheriskofpestinfestationonthesite.
4.
6.1Ispestcontrolne___ssaryfortheauditedsiteNon-score
4.
6.2Wherenopestcontrolisconducted,doesthesitehaveasuitablejustificationforitsabsen___andreviewatleastannuallyMinor
4.
6.3AresuitablepestcontrolmeasuresestablishedforminimisingtheriskofpestinfestationonthesiteModerate
4.
6.4Doesthesiteeithercontracttheservi___sofapetentpestcontrolcontractor,orhavetrainedpersonnel,fortheregularinspectionandtreatmentofpremisesMinor
4.
6.5Whereexternalcontractorsareemployed,istheservi___contractclearlydefinedandreflecttheactivitiesofthesiteMinor
4.
6.6Arepro___duresandinspectiondocumentation(e.g.,logbookofpletedjob/activity)forpestcontrol___intainedMinor
4.
6.7Intheeventofinfestation,doesthepanytakeimmediateactiontoeliminatethehazardModerate
4.
6.8Arepestcontrolchemicalsclearlylabelled(Note nochemicalsaredecantedunlessintoproperlylabelledandidentifiedcontainers)Minor
4.
6.9Areall___terialsafetydatasheets(MSDS)forallchemicalpestcontrolchemicalsandagentsusedavailabletorelevantstaffatpointofuseMinor
4.
6.10Arebaitstationsrobustlyconstructed,tamperresistant,ingoodconditionandeffectiveinkillingthetargetpestsMinor
4.
6.11Arebaitstationspositionedtoavoidpotentialcontaminationofproduction___terialsandproductsModerate
4.
6.12Whenafumigationisne___ssary,aretheoperationscarriedoutbypetentstaffwithappropriateprofessionalqualificationsModerate
4.
6.13AredrainsfittedwithscreensandtrapstopreventpestentryMinor
4.
6.14Arefly-killingdevi___sand/orpheromonetrapscorrectlysitedandoperational(Note Ifthereisadangerofinsectsbeingexpelledfromanyexterminationdevi___andcontaminatingtheproduct,alternativepositions,systemsand/orequipmentmustbeused)Minor
4.
6.15Wherene___ssary,aresuitableprecautionstakentoprevententryofpestsifexternaldoorsarekeptopenMinor
5.ProductControl
5.1Referen___Samples(PreproudctionandProductionSample)Documentedpro___duresshallbeinpla___fortheselection,handling,storage,approvalanduseofreferen___samples(PreproudctionandProductionSample)aswellasforponentsamplesandsamplesofsubcontractedworkwhererelevant.
5.
1.1Doesthepanyhaveadocumentedpro___duretoidentify,select,categorize,handle,store,approveandusethereferen___samples(pre-productionandproductionsamples)Minor
5.
1.2DoesthepanyretainthesampleswhichhavebeenapprovedbythecustomerIfthecustomerapprovalisnotpossible,thesamplerepresentativeoftheagreedspecificationmustberetained.(Note Ex___ptionforthosesamplesarephysicallyverylargeorrepresentaveryhighcost,e.g.,asofa)Moderate
5.
1.3Arethesamplesretainedandsecurelystoredinsuitableenviro___entalconditionsto___intaintheiroriginalstatusModerate
5.
1.4Arerecords___intainedifreferen___samplessuppliedtootherparties,includingthedatesupplied/returnedanddetailsofthesampleMinor
5.
1.5Aresamplesretainedinaordan___withperiodsspecifiedbyacustomerorlegislation(Note Thisshouldnor___llybetheforeseeablelifetimeoftheproductunlessotherwisejustified)Minor
5.2ChemicalControlThechemicalpositionofproductsandchemicalsusedinthe___nufactureorpro___ssingofproductsshallbeidentified,monitoredandrecordedasrequiredbylegislationinthecountryofsaleand/or___nufacture.Whereapprovalsforuseneedtobeobtained,theseshallbeinpla___.
5.
2.1DoespanyhaveaListofApprovedChemicalswithCorrespondingBrands/Manufacturersincludingsu______coatings,paints,glues,adhesives,colorants,dyes,flameretardants,biocidesetc.Moderate
5.
2.2Ifyes,doestheListofApprovedChemicalswithCorrespondingBrands/ManufacturersspecifythebelowitemsNon-score
5.
2.
2.1Tradename/brandnameofthechemicalsubstan___sorponents.Minor
5.
2.
2.2Activepositions/ingre___ntsofchemicalsubstan___sorponents.Minor
5.
2.
2.3CAS#orotherrecognizedchemicalsubstan___identification.Minor
5.
2.
2.4Theintendeduseofchemicalsubstan___sorponents.Minor
5.
2.3Doesthepanyonlypurchasetheapprovedregisteredchemicalsubstan___stobeusedinproductionasdefinedbylawandregulationofthecountryinwhichtheproductsaresoldModerate
5.
2.4Doesthepanyhavedocumentedpro___durefor___naging,approvingandcontrollingtheengineeringchanges/productchangesthat___yalterthechemicalpositionofthefinalproductModerate
5.
2.5Wherethepanyuses___terialsorpreparationsforwhichthesupplierdoesnotwishtodivulgeconfidentialformulations,aremeasuresestablishedtoensurethesafetyandlegalityofsuch___terialswillbe___deavailabletotheauthoritiesifrequiredMinor
5.
2.6Istheuseofanysubstan___sclassifiedasdangerousorofveryhighcon___rn,inthecountryofsaledocumentedMinor
5.
2.7Doesthepanyhavemechani___forininginspectionofchemicalsubstan___sinordertocheckvalidatetheyareapproved(testreport,___rtificate,___tchwiththeListofApprovedChemicalsandCorrespondingSuppliers,etc)Minor
5.
2.8Aretestreportsor___rtificatesofplian___availabletodemonstrateanypresen___ofhazardoussubstan___s/Substan___sofVeryHighCon___rn(SVHC)inallining___terialsandponentsarebelowthethresholdvalueforthecountryofsaleModerate
5.
2.9DoesthepanytestfinalproductstoensuretheyarefreeofHazardousSubstan___sorSVHCarebelowthethresholdvaluerelatingtotheproductsafetyregulationsofthecountryinwhichtheproductsaresoldMajor
5.
2.10Arecontrolledstoragefacilitiesprovidedforallchemicalsusedinthefactorysite(includingcleaningandpestcontrolchemicals)___intainedaspertheremendationsonthe___nufacturerlabeltoensurethestoredsubstan___sdonotdeteriorateordegradeModerate
5.
2.11Arepro___dures,MSDS,descriptionordiagramforthehandlingofchemicalsavailableatthepointofuseMinor
5.
2.12Whereappli...模板内容仅供参考。