SQP审核清单中英文对照.docx
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SQP审核清单中英文对照.docx
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SQP审核清单中英文对照
SQP审核清单(中英文对照)
1.ManagementmitmentandcontinualimprovementFUNDAMENTAL:
Thepany"ssenior___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。
1.1Doesthepany"s___nagementdefineproductsafetyandqualityobjectives?
贵公司管理层确定产品的安全和质量目标?
Moderate1.2Isthereviewofthe___nagementsystemscarriedoutatleastannually?
是管理制度的检讨进行每年至少一次?
Minor1.3Doesthereviewofthe___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Moderate1.4Arethedecisionsandactionsagreedduringthereviewmunicatedeffectivelytoappropriatestaff?
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?
Minor1.5Aretheactionsimplementedwithintheagreedtimescales?
是在商定的时间表落实的行动?
Minor1.6Doesthepany"s___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Moderate1.7Doesthepanyhaveapro___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。
2.1LegislativeandSafetyRequirements2.1.1Isthepanyawareofrelevantlegislation,___ndatorystandardsandindustry/customercodesofpracti___applicabletotheproductinthecountriesofintendedsale?
Moderate2.1.2Doesthepanyhaveameanofvalidatinginfor___tionimpactingproductsafety,qualityandlegality,wheresuchinfor___tionisprovidedbythecustomerorrelated___?
Minor2.1.3Doesthepanyhaveapro___ssinpla___forensuringitiskeptinformedofchangestorelevantlegislation,standardsetc?
Moderate2.2RiskAsses___ent2.2.1Doesthepanyestablishaproductriskasses___entforeachproductoragroupofsimilarproducts,e.g.,FMEA?
Moderate
2.2.2Where___nufacturingsiteshavenoresponsibilityforproductdesign,isthepanyprovidedwithavalidatedcopyoftheproductriskasses___ent?
Moderate2.2.3Doestheproductriskasses___entaddressthefollowingaspectswhichhaveaneffectonproductsafetyandlegality?
2.2.2.1Usertypes(e.g.,newborn,youngchildren,vulnerablepeoplei.e.,elderly,disabilities)2.2.2.2Productuse(e.g.,behaviour,durability,userawareness,infor___tionandadvi___)Moderate2.2.4Doestheproductriskasses___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,Review&Improve,Aeptable)Moderate2.2.5Doesthepanyconductapro___ssriskasses___entofhazardspotentiallyintrodu___dduringtheproduction,packagingorstoragepro___sses?
Moderate2.2.6Doesthepro___ssriskasses___enttakethefollowingintoaount?
2.2.6.1___nufacturingparameterssuchaspressure,time,temperature2.2.6.3conditionsofequipment,moulds,___s,___chinery2.2.6.4chemicals/___terialsusedforequipment(e.g.lubricatingoilsandpaints)2.2.6.5calibrationofequipment2.2.6.6policiesonforeignbodycontamination(e.g.needles,metal,glassandbrittleplastics)2.2.6.7policiesonmicrobiologicalcontamination(e.g.hygieneoftoilet&canteen,pestcontrol)2.2.6.8personalprotectiveequipment(includingspecificclothingandfootwear)Moderate2.2.7Doesthepro___ssriskasses___entidentifythefollowing?
2.2.7.1Alistofpotentialriskorhazardsintheproductionpro___ss2.2.7.2Controlpointsto___nagetheidentifiedrisktoaeptablelevel2.2.7.3Aept/rejectlimitsdefinedforeachcontrolpoint2.2.7.4CorrectiveactiontobetakenwhereaCCPisoutofcontrol2.2.7.5ResponsibilityofControlPoints2.2.7.6Recordsofmonitoring&reviewsModerate2.2.8Iftheasses___entresultedinunaeptablerisk,doesthepanygobacktoproductdesignpro___ssorcustomerformodificationtoachieveaeptablerisk?
Moderate2.3VerificationofRiskAsses___ent2.3.1Istheverificationofriskasses___entcarriedoutpriortoproduction?
Moderate2.3.2Istheriskasses___entcarriedoutbypetentpersonnel(internalorexternal)?
Moderate2.3.3Istheriskasses___entregularlyreviewed,atleastannuallyorwhenchanges___detoproductdesignand___terialsand/orkey___nufacturingpro___sses?
Moderate2.3.4Whererequiredbylegislation,doesthepanydocumentandverifytheidentity,qualificationsand/orli___n___ofthepersonprovidingthesafetyrevieworriskasses___ent?
Major2.3.5Whererequiredbylegislationorwhenitisne___ssarytoconfirmitssafetyorlegality,doestheriskasses___entincludethetestingresults(fromaqualifiedandareditedexternal/internallaboratory)ofarepresentativeproduct?
Major3QualityManagementSystem3.1PolicyStatementThepany"ssenior___nagementshalldevelop,documentandimplementapolicystatementwhichisauthorised,regularlyreviewed,signedanddatedbyanappropriatesenior___nager.3.1.1Doesthepanyestablishapolicystatementwhichhasbeenmunicatedandunderstoodbyallstaffinvolvedwithactivitiesimpactingproductsafety,legalityandquality?
Moderate3.1.2Doesthepolicystatementincludethefollowing?
3.1.2.1Thepany"sintentiontoprodu___safeandlegalproductstodefinedquality,andtomeetitsresponsibilitytoitscustomers;and3.1.2.2AmitmentforreviewandcontinualimprovementMinor3.1.3Doesthepanyperiodicallyreviewthepolicystatementforcontinuingsuitability?
Minor3.2GeneralDocumentationRequirements3.2.1ControlofDocumentThepany"ssenior___nagementshallensurethatalldocuments,recordsanddataimpactingthe___nagementofproductsafety,legalityandqualityareinpla___andeffectivelycontrolled.3.2.1.1Doesthepanyeffectivelycontrolalldocuments(internalandexternal)impactingproductsafety,legalityModerate
andquality?
3.2.1.2Areup-to-dateversionsofdocumentsavailableatpointsofuse?
Minor3.2.1.3Aredocumentlegible,unambiguous,inappropriatelanguagesandsufficientlydetailedtoenabletheircorrectapplicationbystaff?
Minor3.2.1.4Areobsoletedocumentsidentifiedandremovedfromuse?
Minor3.2.1.5Doesthepanyrecordthedateandreasonforanychange/amendmenttodocumentsimpactingproductsafety,legalityorquality?
Minor3.2.2ControlofRecordThepanyshall___intainrecordstodemonstratetheeffectivecontrolandachievementofproductsafety,legalityandquality.3.2.2.1Doesthepanyestablishpro___duresforthecollation,review,___intenan___,storageandretrievalofallrecordsimpactingproductsafety,legalityandquality?
Minor3.2.2.2Arerecordslegible,genuineandauthorised?
Minor3.2.2.3Arerecordsreadilyaessible,securelystoredtopreventda___gedeterioration?
Minor3.2.2.4Arerecordsretainedinaordan___withperiodsspecifiedbyacustomerorlegislation?
Moderate3.2.2.5Areanyalterationstorecordsjustifiedandauthorised?
Moderate3.2.3SpecificationsThepanyshallensurethatspecificationsexistforraw___terials,ponentsandboughtinpartsincludingpackaging,intermediate/semi-pro___ssedandfinishedproductsandanyproductorservi___whichcouldaffecttheintegrityofthefinishedproduct.3.2.3.1Doesthepanyestablishspecificationsforraw___terials,ponents,andbought-in-partsincludingpackaging,intermediate/semi-pro___ssedandanyproductorservi___whichcouldimpacttheintegrityofthefinishedproduct?
Moderate3.2.3.2Isaspecificationofeachfinalproductdocumentedanddated?
Moderate3.2.3.3Doesthespecificationincludethefollowinginfor___tion,whereapplicable?
3.2.3.3.1position,size,colour3.2.3.3.2billof___terials3.2.3.3.3assemblydiagrams3.2.3.3.4pri___rypackaging3.2.3.3.5intendedshelflife3.2.3.3.6warningsorinstructionsforuse3.2.3.3.7use,misuse,usagepatterns3.2.3.3.8productionvolumesModerate3.2.3.4Arespecificationsaurateandplyingwithrelevantsafety,legislativeandcustomerrequirements?
Major3.2.3.5Arecurrentspecificationsaessibletorelevantstaff?
Minor3.2.3.6Doesthepany___intaint
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